The Pharmacologist June 2017

the

A Publication by The American Society for Pharmacology and Experimental Therapeutics

Pharmacologist Vol. 59 • Number 2 • June 2017

The Promise and Perils of Pharmacy Compounding

Inside: 2017 Annual Meeting in Review Call for 2018 Award Nominations Strategic Plan

The Pharmacologist is published and distributed by the American Society for Pharmacology and Experimental Therapeutics.

Contents 79 Message from the President 81 2017 Annual Meeting in Review 94 Call for 2018 Award Nominations 97 Feature Story: The Promise and Perils of Pharmacy Compounding

110 Strategic Plan 114 SURF 25th Anniversary 116 Meeting News 117 Science Policy News 122 Education News 126 Journals News 127 Membership News 129 Members in the News 131 Division News 139 Chapter News

THE PHARMACOLOGIST PRODUCTION TEAM Rich Dodenhoff Catherine L. Fry, PhD Dana Kauffman Judith A. Siuciak, PhD Suzie Thompson COUNCIL President David R. Sibley, PhD President-Elect John D. Schuetz, PhD Past President Kenneth E. Thummel, PhD Secretary/Treasurer Charles P. France, PhD Secretary/Treasurer-Elect John J. Tesmer, PhD Past Secretary/Treasurer Dennis C. Marshall, PhD Councilors Wayne L. Backes, PhD Carol L. Beck, PharmD, PhD Margaret E. Gnegy, PhD Chair, Board of Publications Trustees Mary E. Vore, PhD Chair, Program Committee Scott A. Waldman, MD, PhD FASEB Board Representative Brian M. Cox, PhD Executive Officer Judith A. Siuciak, PhD The Pharmacologist (ISSN 0031-7004) is published quarterly in March, June, September, and December by the American Society for Pharmacology and Experimental Therapeutics, 9650 Rockville Pike, Bethesda, MD 20814-3995. Annual subscription rates: $25.00 for ASPET members; $50.00 for U.S. nonmembers and institutions; $75.00 for nonmembers and institutions outside the U.S. Single copy: $25.00. Copyright Š 2017 by the American Society for Pharmacology and Experimental Therapeutics Inc. All rights reserved.

Periodicals postage paid at Bethesda, MD. GST number for Canadian subscribers: BN:13489 2330 RT. ASPET assumes no responsibility for the statements and opinions advanced by contributors to The Pharmacologist.

Postmaster: Send address changes to: The Pharmacologist, ASPET, 9650 Rockville Pike, Bethesda, MD 20814-3995.

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Message from

The President Dear ASPET Members,

It’s been a very busy and productive year for ASPET. Our most important event, the ASPET Annual Meeting, was just held in Chicago as part of Experimental Biology 2017. This was the first time that the ASPET meeting was held in Chicago, and everyone seemed to enjoy this venue tremendously. Highlights of the meeting included the Presidential Symposium, Leveraging New Paradigms for GPCR Drug Discovery (see page 88), the Journals Symposium, Hear it from the Editors, chaired by Dr. Mary Vore, and the Japanese Pharmacological Society guest lecture by Dr. Masamitsu Iino, Imaging Ca2+ Signals in the Brain in Health and Disease. The meeting also hosted 7 ASPET lectures, 44 themed symposia, and almost 900 posters (the highest number of ASPET meeting posters to date). Our latest BIG IDEAS initiative led by Drs. Kan He, Tom Woolf, and Paul Hollenberg, Surmounting the Insurmountable: Obstacles in Drug Discovery and Development – Real World Case Studies, debuted at the meeting this year. Events for young scientists took place during the meeting, including the Graduate Student – Postdoctoral Colloquium, the networking luncheon for undergraduates (led by Drs. Carol Beck and Catherine Davis) and the ASPET Mentoring Network (led by Drs. Susan Ingram and Lynn Wecker). Please see page 81 for more complete coverage of one of our most exciting and best meetings ever. Also, look for an upcoming online survey to provide us with your detailed feedback of the meeting. Next year’s ASPET Annual Meeting will be held in San Diego from April 21-25.

A major effort this year has been the development of a new strategic plan for the Society, led by the ASPET Council and several committees. Last October, ASPET Council convened a retreat during which an outline for the new plan was formulated. New vision and mission statements were developed and six major goals were identified along with associated objectives. An online survey was conducted to obtain feedback from the membership, and the results were summarized in the March issue of the The Pharmacologist. Each goal was assigned to a standing committee or a designated task force to identify strategies and tactics to accomplish the objectives. Council has now approved the new strategic plan, which you can read more about on page 110. ASPET staff and Council will prioritize the proposed strategies and begin implementation planning under the guidance of my successors, Drs. John Schuetz, President-elect, and Eddie Morgan, President-elect-elect.

In addition to the strategic plan, another prominent accomplishment over this last year has been an expanded legislative/science policy outreach led by Dr. Annette Fleckenstein, Chair of the Science Policy Committee, and Susanna Aguirre, ASPET Manager of Government Affairs and Science Policy. ASPET has published several position statements and recommendations addressing the NIH budget and travel restrictions affecting foreign scientists, among other topics.

Also of note, the Washington Fellows program is now in its 5th year with over 50 alumni, and our Summer Undergraduate Research Fellowship (SURF) program celebrated its 25th anniversary this year. Our Young Scientists Committee, chaired by Dr. Karen Tonsfeldt, continues to be very active, in part working with the Mentoring and Career Development Committee, chaired by Dr. Susan Ingram. These committees collaborated to organize an undergraduate outreach event at the University of Illinois, Chicago, directly before the Experimental Biology meeting. Related to

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80 the theme of engaging young scientists, ASPET members have just voted this month to amend the Society’s Bylaws, allowing post-baccalaureate trainees to become members in the Society. This membership option should become effective later this summer.

ASPET continues to expand its international outreach to other pharmacology societies. This past December, we were well represented at the annual meeting of the British Pharmacological Society (BPS), where we sponsored a symposium and over 50 posters by ASPET members. Next year, the BPS will join us as a guest society during our annual meeting in San Diego. This coming November, ASPET will send a delegation to the annual Chinese Pharmacological Society meeting to be held in Hangzhou, China, where we will co-sponsor two symposia: one on molecular pharmacology and drug discovery and another on natural products as therapeutics. ASPET is also planning a significant presence at the World Congress on Basic and Clinical Pharmacology in 2018 (WCP2018). The WCP2018 meeting, sponsored by the Japanese Pharmacological Society, will be held in Kyoto, Japan from July 1 to 6. ASPET will be sponsoring travel awards for young scientists to attend this meeting – watch for an upcoming announcement this fall.

In closing, I am honored to have served as ASPET’s president this past year. It has been an especially engaging year, and I think a lot has been accomplished. I thank all of my colleagues on Council and the president’s team for their support as well as Dr. Judy Siuciak, ASPET Executive Officer, and the entire ASPET staff for their invaluable help and hard work for the Society. I am grateful to the ASPET membership for giving me the opportunity to serve the Society as its president and I look forward to watching ASPET thrive in the future.

Warm regards,

David R. Sibley, PhD President, ASPET

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2017 ANNUAL MEETING

IN REVIEW

The ASPET Annual Meeting at Experimental Biology 2017 took place on April 22–26, 2017 in Chicago, IL. With over 14,000 attendees, the meeting boasted an excellent scientific program with great networking and social events.

This year’s business meeting took place on Saturday, April 22 led by President David Sibley. Dr. Sibley updated members on the Society’s current activities, programs, and initiatives. Highlights from his presentation included: •T he 25th anniversary of the ASPET Summer Undergraduate Research Fellowship (SURF) program •A summary of ASPET’s undergraduate activities at EB 2017 •T he announcement of two new commemorative travel awards •A summary of the recent strategic planning efforts, including ASPET’s vision, mission, and strategic planning goals (see page 110 for more information about the strategic plan) •A proposed change to the membership categories section of the bylaws ASPET’s Executive Officer Judy Siuciak provided a quick update on ASPET’s increased advocacy activities, improved member communications, and highlights of the EB 2017 meeting. Following Dr. Siuciak, Secretary/Treasurer Dr. Charles France reported on ASPET’s financial status, and Board of Publications Trustees Chair Dr. Mary Vore provided an update on ASPET’s journals. We also had the pleasure of welcoming Dr. Masamitsu Iino, who gave a

presentation on the upcoming 18th World Congress of Basic and Clinical Pharmacology, taking place in Kyoto, Japan in July 2018. Directly following the business agenda, Dr. Sibley recognized and presented awards to this year’s scientific achievement award winners and travel award winners.

President-Elect John Schuetz thanks President David Sibley for his service to ASPET.

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(1) 2017 ASPET Graduate Student Travel Award Winners (2) 2017 Undergraduate Student Travel Award Winners (3) 2017 Norman Weiner Lecturer Jack Bergman (left) with Charles France (4) 2017 ASPET Young Scientist Travel Award Winners (5) 2017 Robert R. Ruffolo Career Achievement Award in Pharmacology Winner Donald P. McDonnell (left) with President David Sibley (6) 2017 ASPET Scientific Achievement Award Winners (from left to right) Samie R. Jaffrey, Paul Insel, Margaret R. MacLean, President David Sibley; Joan Heller Brown, Craig W. Lindsley, and Michel Bouvier (7) 2017 Mentoring Network Participants (8) 2017 Commemorative Travel Award Winners

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83 This year’s opening reception was held jointly across all six EB host societies. In the spirit of collaboration, members from all societies gathered in the Skyline Ballroom of the McCormick Place Convention Center to celebrate the start of the annual meeting. New this year, ASPET’s very own “JJ” the donkey made his first appearance at the reception.

“JJ” the ASPET Donkey Greets Attendees at the Opening Reception

The ASPET booth in the exhibit hall recruited 112 new members, including 10 regular members, 3 postdoc members, 1 affiliate member, 63 graduate student members, and 35 undergraduate student members.

We also offered several items for sale in our store, including a new t-shirt design.

If you didn’t get a chance to purchase an ASPET product at the meeting, you can make purchases online at www.aspet.org/store.

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84 The ASPET member lounge was a huge hit this year. The lounge offered a place for members to get their morning coffee, hold one-to-one meetings with colleagues, and relax between sessions. Several members took a break from sessions to complete the group puzzle, play games, and meet new friends in the lounge. Events hosted in the lounge included “Ask the Presidents” and “Ask the Editors” sessions as well as the ASPET Young Scientists Committee’s photo booth.

Members take a break from sessions in the member lounge.

The 2017 Student and Postdoctoral Poster Competition gave undergraduate students, graduate students, and postdocs an opportunity to present their work and compete for cash prizes.

Student and Postdoctoral Poster Competition

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85 The 2017 Dolores C. Shockley Best Presentation Award was given out at this event.

Dr. Shockley was the first African American woman to earn a PhD in pharmacology and the first to be appointed to chair a pharmacology department in the US. The graduate student Shockley poster competition winners were Elizabeth Vargas (3rd place) from New York Institute of Technology College of Osteopathic Medicine, Aurellia Whitmore (3rd place) from Florida A&M University, Colleen Carpenter (2nd place) from the University of Michigan, and Alexa Hendricks (1st place) from Wake Forest University School of Medicine. In the postdoctoral category, the Shockley poster competition winners were Patrick Garcia (3rd place) from the University of Alabama at Birmingham, Natalie Scholpa (2nd place) from the University of Arizona, and Adeleke Badejo (1st place) from the Pacific University School of Pharmacy.

Dolores C. Shockley Graduate Student Poster Award Winners

Dolores C. Shockley Postdoctoral Poster Award Winners

The ASPET divisions held their competitions simultaneously, providing a forum for students to talk about their work and network with senior members, colleagues, and friends. To find out the award winners, please turn to the division news section on page 131.

Following the poster competition, ASPET students and postdocs socialized at the Student/Postdoc Mixer.

To view the full album of EB 2017 pictures, visit us online at: https://www.flickr.com/photos/ aspet_photo_gallery/albums/ 72157680070061394

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Fun Stats at EB 2017 ASPET provides outstanding education and science 57 educational and scientific sessions were presented over 5 days 267 pharmacology speakers Highly Attended Sessions:

252 240

227

The CRISPR-Cas9 Revolution in Pharmacology

Graduate Student - Postdoctoral Colloquium: Effective Science Communication

Top 3

ASPET Presidential Symposium: Leveraging New Paradigms for GPCR Drug Discovery

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173

Otto Krayer Award in Pharmacology Lecture

Julius Axelrod Symposium: Evolving Insights Regarding GPCRs: Compartmentation, Signaling and Clinical Utility

"Experiment. Fail.

Learn. Repeat.” t-shirt

ASPET items purchased Einstein Quote t-shirt

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"Keep Calm and Study Pharmacology” t-shirt

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EB attendees embrace technology

57% of the ASPET sessions were rated on the mobile app The session that received the most ratings on the mobile app was Mushrooming Potential of Psychedelics as Therapeutics

12,472

• unique devices logged in to the EB WiFi at the convention center (71% Apple devices / 29% Android devices)

6,400 concurrent

• WiFi usage peaked at users on Monday, April 24

• The mobile app was downloaded on devices

10,859

ASPET sessions were rated an average of 4.7 out of 5 stars on the mobile app (one star higher than other EB sessions)

EB draws cutting-edge science presentations and pharmacology enthusiasts from around the world!

ASPET Abstracts •

888 abstracts (regular: 87% / late-breaking: 13%) A 27% increase over 2016

• 71% of first authors are from the United States / 29% are international • Pharmacology abstracts submitted show extent of research by young scientists: 17% are postdocs 42% are graduate students 8% are undergraduates 2 students are from high school

Overall EB Meeting • EB registration increased 11% over last year

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Annual Meeting Highlights ASPET Presidential Symposium: Leveraging New Paradigms for GPCR Drug Discovery The ASPET Presidential Symposium was held on Sunday, April 23 and chaired by Dr. David Sibley, ASPET President.

The audience was treated to outstanding presentations by Dr. Arthur Christopoulos from Monash University on Molecular, Cellular and Translational Studies of GPCR Allostery; Dr. Laura Bohn from The Scripps Research Institute on Using Signaling Bias to Refine and Improve GPCR-based Therapeutics; Dr. Ron Dror from Stanford University on Revealing the Structural Basis for GPCR Drug Action through Atomiclevel Simulations; and Dr. Bryan Roth ASPET President David Sibley (on right) is shown with the Presidential Symposium speakers (from left) Bryan Roth, Laura Bohn, Arthur Christopoulos, and Ron Dror. from the University of North Carolina on Drugging the Hidden GPCR-ome. biology, and computational biophysics are being used The symposium illustrated how the field of GPCR to advance the development of novel therapeutics biology is moving very rapidly with new structures of possessing greater efficacy and fewer side effects.

GPCRs being published at an ever-increasing rate.

Next year’s Presidential Symposium titled Deadly At the same time, novel paradigms of GPCR-based Liaisons: Squeezing the Life Out of Cancer will be signaling, such as allosteric modulation and biased chaired by President-Elect Dr. John Schuetz. The agonism, are recognized as wide-spread phenomena symposium will be held at the ASPET Annual Meeting and applicable to nearly all GPCR families. The at EB 2018 in San Diego. presentations described how novel information at the intersection of GPCR structure, signaling, chemical Submitted by Dr. David Sibley

Journals Symposium a Success For the second year, ASPET’s Annual Meeting included a journals symposium. Restructured into a workshop format, this year’s session included presentations followed by discussion among the attendees facilitated by editors and associate editors from ASPET’s journals. Dr. Ken Tew, Dr. Eddie Morgan, and Dr. Eric Barker, respectively, spoke about the manuscript decision process, how to review a

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manuscript and become a reviewer, and how to write a review article. ASPET journals director Rich Dodenhoff addressed publications ethics and copyright issues.

Each presentation was accompanied by questions or scenarios for attendees to work through in groups at tables, and each table had at least one editor or associate editor to help.

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The presentations are available online at http://bit.ly/2raAefh.

Those who attended the session are encouraged to submit feedback via the meeting app or by email to journals@aspet.org. Comments will be used to plan the workshop for next year’s meeting. The session is intended to serve primarily younger researchers by providing them with practical information that they can use when submitting manuscripts. Several more experienced attendees said they picked up useful information as well.

Submitted by Rich Dodenhoff

Attendees discuss publications issues from peer review to writing a review.

Surmounting the Insurmountable: Obstacles in Drug Discovery and Development – Real World Case Studies We were pleased to launch the inaugural ASPET session titled “Surmounting the Insurmountable” at the ASPET Annual Meeting at EB 2017. The session focused on real-world case studies, and was organized as part of ASPET’s BIG IDEAS initiative

by Kan He, President of Biotranex, LLC, and Paul F. Hollenberg, Professor Emeritus of the University of Michigan. Four speakers focused on the obstacles that invariably emerge in drug discovery and development, and they shared case studies from the real world to highlight experienced scientists’ challenges when things go wrong at any stage of the process. The session’s real-world examples provided a unique forum for student, academic,

Speakers of the ASPET session Surmounting the Insurmountable, which took place on Tuesday, April 25 during ASPET’s Annual Meeting at EB 2017.

government, and industrial scientists to learn directly from researchers who are or have been involved in just such situations. The goal of this session was to provide true-life examples and thus share with biomedical scientists the need to think critically and creatively when unexpected and challenging roadblocks occur in their careers.

Gerald Miwa of the University of North Carolina Eschelman School of Pharmacy presented a case study entitled Sustiva: A Rescue from Death Due to Nonclinical Toxicity, describing how a series of detailed mechanistic metabolism investigations were used to solve a critical toxicological issue and ultimately allowed the successful development of this important anti-HIV medicine.

Madhu Chintala of Johnson & Johnson titled his presentation Challenges in the Discovery and Development of Vorapaxar, A Novel Antiplatelet Drug, in which the challenge centered on overcoming a species difference in the PAR-1/PAR-4 receptor distribution in blood platelets in order to demonstrate efficacy and safety.

Mitchell Taub of Boehringer Ingelheim Pharmaceuticals presented Empagliflozin: Sex, Species, and Tissue-Specific Metabolism, which illustrated in a carcinogenicity study how the major unexpected issue of tumor formation in male mice was overcome by a detailed investigation into gender and species differences in metabolism.

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Kan He detailed the key problem of volume of distribution in the discovery and development of the important anti-coagulant Apixaban in his fascinating presentation titled Apixaban: How Volume of Distribution Became Critical in Optimizing Efficacy and Minimizing Toxicity.

Planning for next year’s session has begun.

The session committee strongly encourages you to send suggestions for topics and/or presenters

with an interesting case study that illustrates our theme: how complicated it can be to bring successful drugs to the market when you are “surmounting the insurmountable” in drug discovery and development.

Contact Kan He at khe@biotranex.com or Paul Hollenberg at phollen@umich.edu.

Submitted by Drs. Kan He, Paul Hollenberg, and Thomas Woolf

Trainee Mentoring and Career Development: Diversity, Difficulties, and Different Directions in TCP Careers The ASPET Division for Translational and Clinical Pharmacology organized its third special “Trainee Mentoring and Career Development” session aimed at providing trainees with an interactive and personal opportunity to gain advice from scientists at all levels of their careers. This year the theme was “diversity, difficulties and different directions.” To that end, the event featured pharmacologists from across the world representing a wide variety of careers in government/ regulatory, pharmacology education, science policy, medical writing, as well as academic, biotech or industry research, as follows: • Kathryn Sandberg - professor and vice chair of research, Department of Medicine; director, Center for the Study of Sex Differences in Health, Aging and Disease, Georgetown University, Washington, DC • Yvette Seger - director of science policy, FASEB, Bethesda, MD • Mike Holinstat - associate professor of pharmacology and cardiovascular medicine, University of Michigan Medical School; chairelect of the TCP Division, Ann Arbor • Felix Kim - founder and CSO at Context Therapeutics; assistant professor of pharmacology; director of the Graduate Program in Pharmacology, Drexel University College of Medicine, Philadelphia, PA • Ahmed El-Yazbi - assistant professor, Department of Pharmacology and Toxicology, American University of Beirut, Lebanon

• Darrell Abernethy - associate director of drug safety, US Department of Health and Human Services, Washington, DC • Arti Sawanti - senior principal scientist PDM, Pfizer Inc., Cambridge, MA • Allyson Marshall - medical communications writer, TKL Research Inc., Fairlawn, NJ • Sandeep Bansal - research associate professor, course director, pharmacology, University of Illinois College of Medicine at Urbana-Champaign • Pamela Hornby - senior scientific director and fellow, CVM Discovery Research, Janssen R&D LLC, Spring House, PA

The TCP Division’s Trainee Mentoring and Career Development was held Tuesday, April 25 during the ASPET Annual Meeting at EB 2017.

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The event was well received among the trainees as demonstrated by the fact that around 35 TCP members attended the event, and there were many trainees on the waiting list who were eager to attend. During lunch, each facilitator provided a brief summary of their current responsibilities, situations that had a major impact on their career, and a challenge. Then they finished up with their perspective on how clinical and translational research has shaped their approach to their work.

After this, trainees had an opportunity to personally interact and network with each of the mentors.

Most stayed for the entire session and some well beyond the allotted time! The session provided the trainees with valuable insights in terms of the diverse career opportunities available after graduate studies and the inherent challenges in achieving desired positions.

“One thing that I found very interesting about it is to hear the obstacles that the speakers had throughout their professional careers, and how they changed that obstacle into an opportunity to grow as a professional and as a person”

The trainees’ enthusiasm for the session was reflected in the great feedback from the participants during and after the session. A common theme among the comments was the benefit of insight into careers and the ability to have conversations that they did not feel they could have with their own academic advisors.

The email follow-up from those who attended the event suggests that this event helped trainees to gain firsthand information from experts in diverse career fields. From Yadira Pérez-Páramo we heard “One thing that I found very interesting about it is to hear the obstacles that the speakers had throughout their professional careers, and how they changed that obstacle into an opportunity to grow as a professional and as a person” Jugajyoti Baruah commented that “I especially liked the format of telling their story with the questions listed out. As a final year

PhD trainee, it was indeed an eye opener to some of the struggles that speakers mentioned.”

The TCP division anticipates organizing this event again at next year’s annual meeting in San Diego.

Trainee participation is highly encouraged, and interested trainees are also encouraged to consider involvement in the TCP division’s Executive Committee activities. Stay tuned for further exciting opportunities offered by the TCP division!

Submitted by Drs. Naeem Patil and Pam Hornby

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“Partnering for Success” Peer Mentoring Program at EB 2017!

The Partnering for Success (PfS) program is an initiative conceived and designed by the Young Scientists Committee (YSC) of ASPET. Program design and initiation was primarily spearheaded

by YSC committee members Ore Adedoyin and Eman Gohar with the YSC Chair Karen Tonsfeldt and with tremendous support from Catherine Fry (ASPET's Director of Education). Established findings in the literature suggest that mentoring is as vital in scientific training as in other areas of life. It is against this backdrop that the PfS program was initiated: to be a mentoring program designed for ASPET graduate students to be mentored by postdocs while at the ASPET Annual Meeting. Since postdocs are one simple step ahead in the career ladder, they can help by providing tips on navigating graduate school and handling the transition into postdoctoral training upon graduation. We thought this program would provide a great mentorship experience for participating postdocs as well.

After a series of discussions and planning sessions, the inaugural “Partnering for Success” peer mentoring program was launched at the 2017 ASPET Annual Meeting!

Members of the Young Scientists Committee having a great time at EB 2017.

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The primary goals of this program were to: 1. Support, encourage, and motivate younger ASPET members and first-time attendees 2. Provide a mentoring experience for ASPET postdocs and increase networking opportunities 3. Increase trainee interactions across ASPET divisions Consequently, an initial recruitment call for postdoctoral scholars (mentors) and graduate students (mentees) was launched in April 2017. At the end of the recruitment phase, we had over 100 participants (41 mentors and 64 mentees). Moreover, we administered a pre-program survey to ascertain the mentoring needs of graduate students in ASPET. Based on the results of our data, we were able to match interested graduate students with postdoc mentors having similar research interests. Furthermore, qualitative responses obtained from pre-program surveys indicated common threads among the students’ goals for participating in this program. These findings also guided our program design, interventional content, and the provided resources, which we anticipated that postdocs would need to effectively mentor the graduate mentee during the EB 2017 conference.

Mentors were matched with mentees primarily according to their areas of research interest, and care was taken to ensure that matches did not include individuals from the same institution. Most postdocs were assigned one mentee while a few mentors had two. We gave a $10 Starbucks gift card to each of the first 30 postdocs who responded as an incentive to encourage participation, as well as to facilitate the mentor-mentee meeting during EB. From our post-program survey of participants, about 95% of the respondents (70 out of 74) rated the PfS program favorably. About 85% indicated their willingness to recommend this program to other postdocs and graduate students. Furthermore, over 96% of the respondents were able to meet with their mentor/mentee(s) during the EB conference, and it was encouraging to note that about 85% of respondents intend to stay in touch after EB 2017.

Comments from participants indicated that one of the strengths of this program was the opportunity to network, make new connections, and have one-onone interactions with a mentor. Moreover, mentors

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were also able to acquire new perspectives and obtain new information from their mentees; this mentoring initiative was not completely one-sided but a two-way exchange.

Going forward, one of the areas of improvement suggested by participants was a need to have an initial meet-and-greet event/dinner aimed at bringing all the participants together prior to individual oneon-one mentor-mentee meetings in order to facilitate interactions and subsequent meetings. We intend to explore options for doing this during the next PfS program at EB 2018.

In conclusion, based on the aforementioned preliminary qualitative and quantitative findings, it can

be safely concluded that this inaugural Partnering for Success mentoring program was a great success.

Without doubt, the PfS program is uniquely poised to prepare the next generation of pharmacology researchers, and the overall benefit of this program to the society is inestimable!

Submitted by Drs. Oreoluwa Adedoyin, Eman Gohar, and Karen Tonsfeldt

What Do Participants Have to Say About the Program?

Giving postdocs an opportunity to mentor, giving mentees an opportunity to be mentored but also to network, helps mentees to feel connected to the society and acclimates mentees to the meeting.

My mentor was amazing! I am so glad I met her! I was at EB by myself and she helped me feel comfortable and meet new people. I am very appreciative for her time and expertise!

My mentor was a perfect match for me. She was very polite and helpful. I learned quite a lot from her which would help me in my career exploration.

My mentor is very knowledgeable about the career options for international students after graduation, which helps me a lot to realize my real situation here.

My mentor was (is) awesome; I thought we were perfectly matched; my mentor was very easy to talk to, very open to questions, and very willing to stay in touch even after the meeting; my mentor offered some great advice.

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Call for 2018 Award Nominations ASPET is dedicated to recognizing the best research in, contributions to, and accomplishments in all areas of pharmacology. We encourage members to nominate deserving scientists to raise awareness of the outstanding work being done in our field.

Who can submit a nomination?

You must be an ASPET member to submit nominations.

Who is eligible to receive awards?

Scientists from all over the world and at all career stages are eligible for ASPET’s various awards. Learn more about the specific eligibility details for each award at www.aspet.org/awards.

How do I submit a nomination?

To nominate someone, visit: www.aspet.org/ awards. Review the award criteria and nomination

requirements. Then log in as a member and select “Go to Awards Portal” to be routed to the nomination forms.

When are nominations due?

The deadline for nominations is Friday, September 15, 2017 at 5:00 PM EDT. What happens after a nomination is submitted?

Each nomination is reviewed by all members of the award’s designated award committee. Scores and rankings are given, and compiled results are discussed by the committee, leading to the final selection of the 2018 awardee.

ASPET Scientific Achievement Awards Have you mentored a young investigator whose original research is outstanding?

John J. Abel Award in Pharmacology This award is presented for original, outstanding research in the field of pharmacology and/or experimental therapeutics by a candidate who is younger than 45. This award, named after the founder of ASPET, was established in 1946 to stimulate fundamental research in pharmacology and experimental therapeutics by young investigators.

Did your mentor have a profound impact on you and the pharmacology community?

Julius Axelrod Award in Pharmacology This award is presented for significant contributions to understanding the biochemical mechanisms underlying the pharmacological actions of drugs and for contributions to mentoring other pharmacologists. This award was established in 1991 to honor the memory of the eminent American pharmacologist who shaped the fields of neuroscience, drug metabolism, and biochemistry and who served as a mentor for numerous notable pharmacologists around the world.

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Do you know someone who is performing outstanding research in the pharmacology of biological receptors?

Louis S. Goodman and Alfred Gilman Award in Receptor Pharmacology This award was established in 1980 to recognize and stimulate outstanding research in the pharmacology of biological receptors. Such research might provide a better understanding of the mechanisms of biological processes and potentially provide the basis for the discovery of drugs useful in the treatment of diseases

Do you know someone who epitomizes high standards of ethical behavior, scientific scholarship, publication, and teaching?

Otto Krayer Award in Pharmacology This award is presented to commemorate the enduring legacy of Otto Krayer's personal qualities: his ethical behavior, his commitment to teaching, his high standards of scientific scholarship, publication, and editorship, his promotion of interdisciplinary research to reveal the actions of drugs or other chemicals, and his guidance and support of younger scientists. The purpose of the award is to recognize an individual whose character and career contributions to pharmacology are in accord with those exemplified by Otto Krayer.

Is the head of your department or lab at the height of their career, having made significant contributions to an area of pharmacology?

Robert R. Ruffolo Career Achievement Award in Pharmacology This award honors the scientific achievements of scientists who are at the height of their careers (typically mid-to late-career) and who have made significant contributions to any area of pharmacology. This award recognizes the contributions made to drug discovery and development by Dr. Ruffolo.

Do you have a colleague who has made a major impact on the pharmacological treatment of disease?

Pharmacia-ASPET Award in Experimental Therapeutics This award recognizes and stimulates outstanding research in pharmacology and experimental therapeutics, basic laboratory, or clinical research that has had, or potentially will have, a major impact on the pharmacological treatment of disease.

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ASPET Division-Sponsored Awards Sponsored by the ASPET Division for Drug Metabolism The B. B. Brodie Award in Drug Metabolism recognizes outstanding original research contributions in drug metabolism and disposition, particularly those having a major impact on future research in the field.

This award was established to honor the fundamental contributions of Bernard B. Brodie in the field of drug metabolism and disposition.

Sponsored by the ASPET Division for Behavioral Pharmacology The P. B. Dews Award for Research in Behavioral Pharmacology recognizes outstanding lifetime achievements in research, teaching, and professional service in the field of behavioral pharmacology. The award honors Peter Dews for his seminal contributions to the development of behavioral pharmacology as a discipline.

Sponsored by the ASPET Division for Cardiovascular Pharmacology The Paul M. Vanhoutte Distinguished Lectureship in Vascular Pharmacology was established to honor Dr. Vanhoutte’s lifelong scientific contributions to our

better understanding and appreciation of the importance of endothelial cells and vascular smooth muscle function in health and disease and for his mentoring of countless prominent endothelial and vascular biologists and pharmacologists. This award includes a state-of-theart lecture on recent advances in vascular biology and pharmacology at the ASPET Annual Meeting at EB 2018.

Sponsored by the ASPET Division for Neuropharmacology The ASPET Division for Neuropharmacology Early Career Independent Investigator Award recognizes and honors a young investigator who is working in any area of neuropharmacology. The award is open to early career stage investigators from all types of organizations, including academia, industry, private, or government institutes.

Sponsored by the ASPET Division for Toxicology The ASPET Division for Toxicology will present three awards to recognize outstanding research contributions to toxicology by members at various career stages. The awards include the Career Award and the Junior Investigator Award.

Exercise your membership benefits! Nominate someone who has made an impression on you. What better way to give long-deserved kudos to our everyday unsung heroes!

Only ASPET members may nominate candidates for awards, so please make sure your membership is up to date.

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The Promise and Perils of Pharmacy Compounding Rebecca J. Anderson, PhD

On September 18, 2012, April Pettit, an internist at Vanderbilt University Medical Center, sent an email to the Tennessee Department of Health, describing a patient with a rare form of meningitis (1). The patient had contracted a fungal infection after receiving a contaminated epidural injection for back pain. The contaminated product was a steroid solution made by a compounding pharmacy in Massachusetts. Soon, other meningitis cases emerged, leading to what one lawyer called “the deadliest catastrophe in the history of modern medicine” (2).

Compounding through the Ages Compounding is a pharmacy term that describes the process of combining ingredients to produce a medication tailored to meet the needs of an individual patient. It is a practice that dates back thousands of years. The earliest descriptions of compounded medicines are contained in the cuneiform tablets of Mesopotamia (3). The ingredients in these ancient prescriptions, which were written in 2600 BC, included about 1,000 plant-derived compounds (4).

Traditional Chinese medicine began even earlier, but the first text was the Huang Ti Nei Ching (The Yellow Emperor’s Classic of Medicine), which was written around 300 BC. The Nei Ching documented medicinal preparations that had been in use since 2600 BC and encompassed diet and acupuncture as well as drugs (3, 4).

June 2017 • The Pharmacologist

Source: Centers for Disease Control and Prevention

Egyptian medicine began around 2900 BC, but the first known medical text, the Kahun Papyrus, was written around 1900 BC (3, 4). The Ebers Papyrus and Smith Papyrus date from 1550 BC (4, 5). Collectively, these papyrus fragments, written in hieroglyphs, contain roughly 800 prescriptions, many prepared through compounding (3-5).

Among the plant ingredients that the Egyptians incorporated in their medicines were the resins of pine, fir, and cedar trees. The most important of those resins were frankincense and myrrh, which came from a small region bordering the Gulf of Aden: the eastern Horn of Africa and the South Arabian coast (3).

In India, the Ayurveda, a holistic system of medicine, emerged in 1000 BC (4). The medicinal component of the Ayurveda relied on plant-derived substances. Prominent among the plant ingredients were spices, especially cinnamon and pepper (3).

Knowledge of medicinal ingredients in the Western world was based mainly on the Greek and Roman cultures. Greek prescriptions date from the time of Socrates (469-399 BC) and Hippocrates (460-380 BC). Hippocrates favored myrrh, which has bacteriostatic properties, but his prescription books also include thyme, cinnamon, and other spices as ingredients (3).

The most significant Greek contribution to compounding came from Galen (130-201 AD), a Greek physician who practiced in Rome (4). He wrote a 22-volume compendium that dominated medicine for 15 centuries. Among the Galenic remedies were

Reprinted from https://commons.wikimedia.org/wiki/File:PEbers_c41-bc.jpg under the Creative Commons-Share Alike 3.0 License.

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The Ebers Papyrus (c. 1550 BC) from Ancient Egypt

a variety of colored salves that were loaded with the salts of arsenic, mercury, and lead (3).

The Roman physician Pliny the Elder (23-70 AD) is most noted for Historia naturalis (Natural History).

Rather than an original work, Pliny’s book compiled thousands of medical facts written by 100 authors and was revered as a pillar of human knowledge for 1600 years. Some of those folk remedies proved to be very effective drugs (e.g., fern for intestinal worms and ephedra for asthmatic cough) (3).

The Roman Cornelius Celsus (15 BC-50 AD) also wrote an encyclopedia, De medicina (On Medicine). Like the medicines of the Greeks, Celsus’s ingredients included myrrh and heavy metal salts (alum, copper acetate, lead oxide, and sulfides of mercury and antimony), which were mixed with resins, pitch, bitumen, and wax to produce salves and ointments (3).

By the 16th century, medicine in Western Europe had evolved into a hierarchy of practitioners: physicians, surgeons, apothecaries, and midwives (6). The recently invented printing press greatly facilitated their ability to acquire knowledge about medicinal Persons with fungal infections linked to NECC-manufactured steroid compounding. Among Johannes Gutenberg’s injections, by state.

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Reprinted from https://commons.wikimedia.org/wiki/File:Th%C3%A9riaque1.jpg under the Wikimedia Commons-Public Domain.

most influential and widely distributed books in Europe were those that described Greco-Roman herbal medicines (4).

Lady Grace Mildmay, a well-to-do 16th century English woman, collected compounding recipes from various reliable sources and tweaked them based on the outcome of the patients she treated.

Like her contemporaries, she used a wide range of ingredients: plants, metal salts, minerals, animal parts (hooves, horns, and claws), ale, and wine. Her compounding methods often involved rituals, as well as procedures. For example, Mildmay’s “precious balm” consisted of more than 160 ingredients, required 10 distillations in a complicated ritual of 14 steps, and took at least 5 weeks to prepare (6).

The most enduring of all medicinal compounds was theriac, which dates from the time of Nero (37-68 AD). Fearful of poisoning, Nero directed his physician, Andromachus, to develop new and better antidotes (3). Andromachus took a traditional and already effective antidote and increased the number of ingredients to 64, including chunks of viper flesh.

He also increased the opium content by 500% (3).

Theriac became wildly popular—no doubt due to opium addiction. Galen wrote a whole book about it, Theriaké. Those who could afford the expensive preparation took it for everything, from the Black Death to routine prophylactic use for almost anything (3).

By the 13th century, theriac had been adopted in China, and versions of it were also available in India. In Europe, it survived the Renaissance, with even more elaborate ceremonies required for its preparation. Theriac was included in the official German pharmacopoeia until 1872 and in the French pharmacopoeia until 1884 (3).

Compounding in the US In the US, compounding pharmacies began emerging in the early 1800s (5, 7). Several of today’s well known drug companies originated as 19th century shops owned by pharmacists: George Merck (Merck & Co.), William Warner and Jordan Lambert (Warner-Lambert—now Pfizer), John K. Smith (GlaxoSmithKline), and Eli Lilly (7).

The medicines these pharmacists compounded were crude mixtures from natural sources, such as opium and belladonna. To increase the potency of their remedies, they often performed an extraction using water or alcohol and concentrated the solution through evaporation (e.g., laudanum, a tincture of opium).

An estimated 80% of all prescriptions were made by compounding up to the 1920s (5). By the 1940s, compounding accounted for about half of all medications (7, 8). As modern pharmaceutical manufacturing became established, compounding declined and pharmacists simply dispensed formulations that had been manufactured by drug companies (5, 8).

Although compounding now represents only about 1% of all US prescriptions, it remains an integral part of the pharmacy profession and is practiced in the pharmacies of hospitals, chain drug stores, and local communities (9). Customized drugs are needed by patients who may be allergic to a manufactured drug’s ingredients (e.g., preservatives and dyes), need a liquid to alleviate difficulties in swallowing pills, or need a nonstandard dosage strength (9, 10).

Vessel for storing Theriac

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Sterile Compounding Intravenous (IV) drug administration dates back to the London cholera epidemic of 1832. William O’Shaughnessy replenished cholera patients’ fluid depletion by IV infusion of normal saline (11). In the 1880s, Sydney Ringer, a British physician and physiologist, improved the electrolyte formula by including the chlorides of calcium and potassium, in addition to sodium. He used the solution to perfuse isolated organs in the laboratory. The subsequent addition of sodium lactate resulted in lactated Ringer’s solution, which is still widely used (11).

To ensure sterility, IV solutions were originally sealed in steam-cleaned glass vacuum bottles.

In 1933, Baxter Travenol introduced the first commercial product, but throughout the 1930s, only the sickest and most critical patients received fluids intravenously (11). During World War II, demand for intravenous fluids grew substantially to treat injured soldiers, and in the late 1950s, sterile plastic bag containers were developed (11).

In the 1960s, hospital-based pharmacies were established to provide a centralized center for compounding sterile solutions for hospitalized patients (12). Typically, these hospital pharmacists took commercially available sterile solutions and added ingredients (such as electrolytes and vitamins) to meet the needs of individual patients.

As the number of marketed injectable medications increased, so did sterile compounding at hospitals.

By the 1980s, nearly 70% of hospital pharmacies prepared customized IV solutions for their hospitalized patients (12).

In the 1990s, preparation of the sterile compounded products used in hospitals shifted from local hospital pharmacies to large pharmacies that offered outsourcing services Demand for compounded sterile solutions grew further with the introduction of total parenteral nutrition (TPN) and cardioplegia solutions. TPN by its very nature is a complex solution, requiring multiple additives. Cardioplegia solutions, which are used to perfuse tissues when the heart is stopped during

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open-heart surgery, typically include just electrolytes, but premixed cardioplegia solutions were not commercially available until 2000 (12).

Compounded sterile drugs for infusion pose more risks than orally administered drugs, because pharmacies must implement special safeguards to prevent injury or death from microbial contamination (9). The risk of contamination increases with the complexity of the compounding process (12).

Opportunity Knocks In the 1990s, preparation of the sterile compounded products used in hospitals shifted from local hospital pharmacies to large pharmacies that offered outsourcing services (9, 12). Several factors contributed to this shift. Schools of pharmacy were placing less emphasis on the compounding skills of their students. In addition, the required standards for sterile compounding facilities and procedures and training personnel had become more stringent.

Periodic shortages of commercial injectable medications pushed hospitals to find alternative sources (9, 12).

To meet these needs, a new industry emerged: large compounding pharmacies that specialized in outsourcing (12). Like community- and hospital-based pharmacies, these large outsourcing operators were regulated by state pharmacy boards. They were required to comply with laws for recordkeeping, certifications, and licensing of the state where they are located (1, 9, 12). There was little federal oversight.

As the large compounding outsourcers began producing drugs beyond what had historically been done within traditional compounding, officials at the Food and Drug Administration (FDA) became increasingly concerned (10). The outsourcers were engaging in interstate commerce—large scale manufacturing that was normally the purview of the FDA (9, 12).

In 1997, Congress passed the FDA Modernization Act (FDAMA) to clarify the scope of federal oversight.

Over the strong objections of FDA Commissioner David Kessler, FDAMA (Section 503A) exempted compounded drugs with a valid prescription from FDA’s requirements for Good Manufacturing Practices (1, 13).

The FDA could not proactively gather information about pharmacy practices and procedures. Without

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Compounding Pharmacy Safety Incidents Investigated by the FDA (10) Year

No. deaths

No. Injuries

Drug

Comments

Riboflavin

Contaminated sterile injection

1997

0

2

2001

3

35

Steroid

Contaminated sterile injection

2002

1

5

Methylprednisolone acetate

Contaminated sterile injection

2005

3

5

Cardioplegia solution

Contaminated sterile solution

2007

3

Colchicine

Super-potent compounding (640% of labeled strength)

2010

0

Avastin

Contamination from repackaging sterile injection product

> 12

2011

9

19

Total Parenteral Nutrition

Contamination of sterile product

2012

0

43

Ophthalmic drugs

Contaminated sterile products (29 suffered vision loss)

2012

64

753

Methylprednisolone acetate

Contaminated sterile injection

knowledge of the actual conditions at compounding pharmacies, FDA regulators could not address violations before a crisis erupted (1). The agency’s authority was limited to reacting once a problem became “obvious” (i.e., “for-cause” inspections) (1, 9).

Ambiguities in the law gave both NECC and the FDA a legal rationale.

Kessler was concerned that poor and inconsistent manufacturing standards—especially for sterile drugs—would cause unnecessary patient injuries and deaths. Unfortunately, his concerns proved correct, and a steady stream of incidents, mostly related to contaminated sterile products, began appearing (see table). All of these incidents resulted from poor manufacturing procedures at compounding pharmacies that specialized in outsourcing (10).

A Compound Problem One pharmacy that took advantage of the new FDAMA provisions was the New England Compounding Center (NECC), which was founded in 1998 in Framingham, Massachusetts, by the Conigliaro family (headed by Carla and Douglas Conigliaro). NECC was run by Barry Cadden, his wife (Lisa Conigliaro Cadden), and her brother (Gregory Conigliaro). The Conigliaro family’s broader business operations included a recycling plant next door to NECC (1, 14).

Barry and Lisa Cadden, who were both pharmacists, specialized in producing sterile injection solutions. From the beginning, they ran afoul of regulatory standards. In 2002, FDA

inspectors cited NECC for failing to resolve consumer complaints, address adverse drug reactions, and correct product defects (1, 15).

Over the next few years, state pharmacy inspectors also visited NECC (sometimes accompanied by FDA officials) and also found safety problems at the facility. NECC negotiated a settlement with the Massachusetts pharmacy board and avoided disciplinary action (1).

Because outsourcing pharmacies could legally refuse to turn over their records to the FDA, even when FDA officials received support from state inspectors, NECC resisted FDA’s requests (9, 10).

Ambiguities in the law gave both NECC and the FDA a legal rationale.

The 5th and 9th Circuit Courts and the US Supreme Court had responded to challenges of the FDAMA legislation by issuing separate decisions, but from state to state, the courts’ interpretations of the law were conflicting and contradictory (1, 9).

FDA’s influence over large compounding pharmacies depended on where the pharmacy was located.

Despite this confusion, the FDA was always able to obtain warrants and proceed with “for-cause” inspections of pharmacy records, facilities, and practices, but it was a drawn-out and tedious process (10).

In addition, unlike the state pharmacy boards, the FDA lacked the authority to enforce corrective actions. In the case of NECC, publicly available correspondence suggests that NECC was less than cooperative in correcting the deficiencies cited

by FDA inspectors (16). Cadden cited statues to support his position, and FDA officials rebutted those arguments by citing other regulations.

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Despite significant overlap and an expanded gray area, one distinction between drug manufacturers and the large compounding pharmacies remained legally clear. Drug companies (with FDA oversight) manufactured drugs in batches and could distribute them to wholesalers, retailers, and other customers. On the other hand, compounding pharmacies—large and small—were required to prepare medications for individual patients, and in each case, the compounded drug needed a doctor’s prescription (1, 9).

This prescription requirement posed a bureaucratic challenge for compounding pharmacies when hospitals and clinics placed orders for large quantities of commonly used injectable solutions. A typical example was methylprednisolone, a steroid that is routinely injected to relieve joint and back pain. Orthopedic practitioners and pain clinics stock ample supplies of methylprednisolone and inject many patients with it every day.

Methylprednisolone is manufactured by Pfizer and several generic pharmaceutical companies (1).

The St. Thomas Outpatient Neurosurgery Center in Nashville, Tennessee, had been purchasing its methylprednisolone from Clint Pharmaceuticals, a generic drug company. But when Clint raised its price to $8.95 per 1 ml vial in June 2011, Debra Schamberg, the clinic’s director, contacted NECC’s persistent regional salesman. She said if he was still offering a price of $6.50 per vial, they had a deal (17).

The large shipments from Clint Pharmaceuticals did not require individual prescriptions, but NECC was a pharmacy and licensed only to sell drugs to patients who presented a prescription.

Healthcare providers wanted the convenience of having drugs like methylprednisolone in stock. The pharmacy-prescription process created an additional layer of paperwork and interfered with how they practiced pain management for their patients. To accommodate these customers, NECC began selling large shipments of drugs without prescriptions as early as 2009 (17).

Realizing that NECC’s shipments needed prescriptions, Barry Cadden, NECC’s president and head pharmacist, suggested a compromise.

He told his national sales manager that perhaps

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names could be attached to the orders after the drugs were injected. This linked each dose to a patient, but it clearly stretched the intent of the law. NECC assumed that the names they received corresponded to legitimate patients, but clinics that treated many patients each day found shortcuts.

They sent NECC names like Calvin Klein, Jimmy Carter, Octavius, Burt Reynolds, Filet O’Fish, and Coco Puff (17).

At the St. Thomas Outpatient Neurosurgery Center, they printed out the daily patient schedules and submitted those names with each NECC order (17).

But some employees got creative, and one patient name they submitted was Mickey Mouse. Cadden was not amused and issued a stern internal memo saying that the names “must resemble ‘real’ names… no obviously false name! (Mickey Mouse)” (17).

The Index Patient On July 30, 2012, Thomas Rybinski checked in to the Outpatient Neurosurgery Center at St. Thomas Hospital (17). The 56-year-old autoworker from Smyrna, Tennessee, suffered from chronic back pain caused by degenerative spinal disks.

His doctor gave him a 1 ml epidural injection of methylprednisolone (17, 18).

The St. Thomas Outpatient Center administered thousands of injections each year, and on its website, epidural steroid injections were listed as its “top procedure” (19). Experts say that doctors overprescribe invasive back-pain therapy. Although some patients clearly get much-needed relief, most academic researchers say there is no conclusive

Minnesota Department of Health

No More Mickey Mouse

Vials of methylprednisolone acetate manufactured by NECC

Harrison McClary / Reuters Pictures

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and opiates and NSAIDs to control his pain.

Routine cultures of Rybinski’s blood and spinal fluid showed no bacteria, but the drug treatment eased his symptoms and he was discharged (18).

Despite continuing his antibiotic treatment at home, Rybinski’s headache and back pain worsened (18). A week after his discharge, he returned to Vanderbilt and was obviously ill, uncomfortable, and A sample of Aspergillus fumigatus in the Vanderbilt Clinical Microbiology Lab for patient care agitated. His speech was incomprehensible. evidence that steroid injections are useful in easing The analysis of a new spinal tap was still consistent straightforward chronic low back pain (1, 19). with meningitis, but now an MRI revealed brain Despite the weak evidence, the use of steroid inflammation. Intravenous antibiotics improved his injections to treat back pain has skyrocketed in the mental state over the next two days (18). last 15 years, much more rapidly than the number Unfortunately, by his sixth day in the hospital, of patients with back pain or the aging of the Rybinski was increasingly drowsy, he stared population (1, 19). Some patients receive more than intermittently, and the right side of his face drooped.

10 shots per year (19).

A brain scan showed mild hydrocephalus (18).

NECC had been shipping its drugs to the St. Pettit’s team began to suspect that Rybinski’s Thomas Center for about a year when Rybinski meningitis symptoms might stem from a far rarer arrived for his steroid treatment. His injection fungal infection, and they began treatment with the came from a 12.5 l batch of methylprednisolone antifungal agent, amphotericin B (17, 18, 20). acetate that NECC had manufactured two months The following day, Vanderbilt’s microbiology lab earlier (17). It was labeled as a sterile solution, confirmed the diagnosis. A culture of the spinal but unlike the vials produced by Pfizer and other fluid that had been drawn on the day Rybinski was drug manufacturers, NECC’s solutions were re-admitted to the hospital showed Aspergillus preservative-free (9). Even more troublesome, fumigatus (18). The doctors began intravenous NECC’s compounding pharmacists had sidestepped voriconazole and continued treatment with liposomal batch testing that would have ensured the amphotericin B. An MRI revealed newly damaged methylprednisolone solution was sterile (17), blood vessels in his brain (18).

A month later, Rybinski went to the Vanderbilt University Medical Center in Nashville, complaining Sleuthing the Cause of headache, neck pain, nausea, fatigue, and Unlike bacterial meningitis, fungal meningitis is decreased appetite (18). Based on blood tests, a not contagious (21). Petitt’s team investigated the spinal tap, and a CAT scan, April Pettit and her team possible source of Rybinski’s infection. Aspergillus diagnosed meningitis (17, 18). The most common species are ubiquitous in the air, soil, and organic cause of meningitis is a bacterial infection, and matter. The fungus typically enters the body through Pettit’s team prescribed antibiotics for the infection the sinuses, lungs, or a break in the skin, but it rarely

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causes illness in people with a healthy immune system (18). Rybinski showed no signs of infection on his skin, in his respiratory tract, or in his blood. That left direct contact with his spinal meninges.

Pettit tracked Rybinski’s activities in the weeks before his symptoms appeared, and his family mentioned the steroid injection at St. Thomas (17).

Rybinski had likely been exposed to the fungus from the epidural injection of methylprednisolone.

Presumably, the solution was contaminated and spread the fungus into the intradural space, causing his meningitis (18).

Pettit emailed a copy of Rybinski’s lab results describing the fungal infection to the Tennessee Department of Health (1, 17). At that point, Rybinski had suffered brain damage from hemorrhages and increased intracranial pressure (17, 18). He was unresponsive and began shaking his head rhythmically. The doctors put him on a respirator and inserted a catheter to drain spinal fluid and relieve the pressure on his brain. They also began anticonvulsant drug treatment, which controlled his seizures, but his brain function continued to decline (18).

After obtaining more information from Vanderbilt, Tennessee state officials contacted St. Thomas Hospital, where they discovered two patients were also being treated for meningitis. Both had received steroid injections (17). Prior to those patients and Rybinski, 78-year-old Eddie Lovelace had been treated at Vanderbilt for what seemed to be a mild stroke. Unfortunately, he quickly deteriorated and died on September 17, 2012—the day before Pettit contacted state health authorities. Lovelace had also received a recent steroid injection at the St. Thomas clinic, and, in retrospect, he was the first fatality of what would become the largest outbreak of healthcare-related infections ever reported in the US (20).

On September 24, 2012, the Tennessee Department of Health contacted the Massachusetts Department of Public Health. Working with the Centers for Disease Control and Prevention (CDC), the Tennessee health officials had identified eight cases of meningitis, all of which had been traced to methylprednisolone acetate manufactured by NECC (1, 17, 20, 21). The Tennessee officials also contacted NECC directly to request the lot numbers of the methylprednisolone acetate vials associated with

The Pharmacologist • June 2017

the meningitis patients who received shots at St. Thomas (17).

On September 26, 2012, Massachusetts investigators arrived at NECC to begin an inspection of the facilities, and NECC voluntarily recalled three lots of methylprednisolone acetate (1, 20, 21). The meningitis patients had received injections from lots manufactured by NECC in May, June, and August 2012 (1, 20). Federal authorities promptly contacted all clinical centers that had received those three lots, which could have exposed an estimated 13,500 patients to fungal contamination (2, 20, 22).

Clinics, along with state and local health officials, then began the tedious process of contacting each of those patients by telephone, home visits, or letters (20). Unfortunately, their efforts were hampered because the drug lot number was often not recorded in the patients’ medical records (20). Nevertheless, they managed to contact more than 99% of the patients at risk (20).

On September 27, 2012, the CDC received a report from North Carolina that Elwina Shaw, a patient at High Point Regional Hospital, was suffering from meningitis, strikingly similar to the symptoms seen in the Tennessee patients. Shaw had received a steroid injection a few weeks earlier at the High Point Surgery Center, another NECC customer (17, 20).

At Vanderbilt, Thomas Rybinski continued to suffer brain hemorrhages. The damage was irreparable, and his family elected to discontinue life support. He died on September 29, 2012 (17, 18).

The Investigation This cluster of reports now gave the FDA sufficient “cause,” and on October 1, 2012, the agency sent a team to begin its own inspection of the NECC facilities (1, 16, 23). In a bin of 321 vials of methylprednisolone manufactured in August 2012, the inspectors saw visible signs of contamination in 90 vials. The records of NECC’s lab analysis indicated that the lot was sterile, but FDA analysts found microbial growth in all 50 of the vials they tested (23). Further FDA analysis identified the microbe as Exserohilum rostratum, a black fungus (16, 20).

It seemed that everywhere the state and federal inspectors looked—clean rooms, prep rooms, weigh stations, laminar flow hoods—they found evidence

105

Source: Centers for Disease Control and Prevention

of contamination: greenish yellow discoloration, white filamentous substances, yellow residue, cloudy brown discoloration, and dark hair-like discoloration (23). NECC’s own environmental monitoring of the labs, lab equipment, and workers’ hands had documented unacceptable levels of microbial contamination. But the inspectors found no records indicating that NECC had investigated these “out-of-spec” results or taken corrective actions to prevent contamination of the pharmacy’s sterile products (23).

In addition, NECC’s air intake units were within 100 feet of the Conigliaro family’s recycling facility.

Excavators and freight trucks at the facility kicked up dust, presenting another possible source of contamination to the pharmacy (14, 23).

On October 3, 2012, while the state and federal officials were in the midst of their inspection, NECC voluntarily ceased all operations (16). The following day, NECC expanded its voluntary recall to include all of its compounded products (1, 21, 22). On October 9, 2012, NECC surrendered its license to the Massachusetts pharmacy board (1).

On October 5, 2012, the FDA issued the first in a series of public alerts to doctors, patients, and the general public. The CDC had received reports of 35 cases of meningitis, including 5 deaths (1, 16).

Further testing by FDA and CDC labs of NECC’s unopened vials revealed a potpourri of microorganisms: Bacillus bacteria and various species of fungus, including Aspergillus, Exserohilum, Cladosporium, and Penicillium (20, 21). On October 11, 2012, the FDA issued another MedWatch Alert, expanding its warning to include other NECC products: preservative-free injectable betamethasone, triamcinolone, and cardioplegia solution. A few days later, the MedWatch Alert was further expanded to include NECC’s sterile ophthalmic drugs (21).

No Easy Treatment Although Thomas Rybinski, the index patient, had been infected with Aspergillus, the major culprit in the subsequent meningitis cases was determined to be Exserohilum rostratum, a black mold that is widely found on plant debris, in soil, and in water (20, 21, 22). It rarely causes invasive infection in people, but direct exposure to nervous system tissues can cause meningitis (22). The incubation period for patients who developed meningitis was 1-14 weeks after their steroid injection (20, 22).

The rapid alerts and frequent updates posted by the FDA and the CDC undoubtedly saved many lives (20). Because laboratory results often could not provide a conclusive diagnosis, doctors and clinics were advised to begin aggressive treatment for patients who showed even subtle signs of fungal infection (16, 20, 22).

As the outbreak evolved, diligent monitoring and rapid treatment of the fungal infections circumvented meningitis. In these later cases, manifestation of the fungal infection was often confined to the injection site (20). Epidural abscesses and bone inflammation at the injection site caused back pain, which differed in quality from the patients’ chronic

Exserohilum rostratum

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back pain (22). Fewer patients who received steroid injections in their joints became infected, but those who did experienced increasing pain for several months after injection (22).

Initially, the CDC and the FDA recommended aggressive treatment with the antifungal agents voriconazole and liposomal amphotericin B for 3-6 months, based on the Aspergillus fumigatus infection diagnosed in Thomas Rybinski. Unfortunately, the high doses of amphotericin B required to clear the spinal infection caused a host of adverse reactions and drug-drug interactions (22).

In view of this, and the discovery that Exserohilum rostratum was the primary culprit, the treatment regimen was modified in favor of monotherapy with voriconazole (22). Although voriconazole is usually well tolerated, it caused adverse reactions at the doses needed to treat fungal meningitis. So, the sickest patients and those who had substantial side effects from voriconazole were given liposomal amphotericin B alone or in combination with lower voriconazole doses (22).

Poor Prognosis Eventually, the CDC compiled 753 cases of infection and reports of 64 deaths spread across 20 states, all traced back to NECC’s contaminated methylprednisolone acetate (21). Although the first reports came from Tennessee, Michigan was hit hardest, with 264 cases and 19 deaths (2, 17, 21). About half of the victims developed fungal meningitis, and more than 30 suffered a stroke. The other half acquired joint or spinal infections (13, 20).

Interestingly, no infections or deaths were reported in Massachusetts, where NECC was located.

The CDC compiled 753 cases of infection and reports of 64 deaths spread across 20 states, all traced back to NECC’s contaminated methylprednisolone acetate For many of those who survived meningitis, recovery was long and painful due to residual effects of the initial fungal infection, adverse drug reactions, or both (22). Some suffered blinding headaches and burning pain (19, 24). Two years after receiving the

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contaminated steroid for back pain, one woman told reporters, “My head is always in a vice. Even if I get the pain under control with medication, I still feel the grip” (24). In Howell, Michigan, 64-year-old John Nedroscik struggled to recover and experienced nightmares (24).

In Nashville, 71-year-old Joan Peay recovered after contracting fungal meningitis in the fall of 2012 (2). But a year later, she was again in the hospital with meningitis. “The whole month of October my family thought I was going to die. And I was so sick I wish I would’ve” (2). As a result of the recurring infection, Peay suffered hearing loss and still deals with the back pain that brought her to the clinic in the first place. She looks and feels 10 years older than her age, but she says she has learned to cope with the lingering consequences of her infection and treatment (2).

Cracking Down The widespread injuries and deaths from NECC’s contaminated drugs focused public attention on compounding pharmacy practices. State pharmacy boards and national pharmacy organizations strengthened their oversight of drug compounding and increased their pharmacy inspections. The National Association of Boards of Pharmacy and state pharmacy boards began coordinating efforts to ensure regulatory compliance of compounded drugs shipped across state lines (9).

Public pressure also prompted Congressional hearings. In testimony before the US House of Representatives, FDA Commissioner Margaret Hamburg and FDA Center for Drug Evaluation and Research Director Janet Woodcock both cited the confusing and conflicting statutory constraints that complicated FDA’s ability to regulate large compounding pharmacies such as NECC (10).

“We believe there are hundreds of other firms operating as compounding pharmacies, producing what should be sterile products and shipping across State lines in advance of or without a prescription,” Woodcock said (10). The FDA’s lack of tools for oversight and/or enforcement had resulted in a string of unnecessary patient injuries and deaths of which the NECC incident was only the most recent example.

On November 27, 2013, the Compounding Quality Act (which was part of the Drug Quality and Security

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Act) was signed into law (25). Five days later, the FDA held a press briefing and released several documents that provided guidance on implementing the Act. Under the Act, pharmacies that compound sterile drugs on a large scale were defined as “outsourcing facilities.” These large pharmacies may elect to register with the FDA (25). Registration as an outsourcing facility requires the pharmacy to comply with FDA inspections and recordkeeping requirements. And all of the outsourcing facility’s compounded products must also be registered, tested, and labeled according to FDA requirements (25). The FDA maintains a publicly available list of registered outsourcing facilities along with the results of FDA inspections.

Legislators hoped that, given a choice, hospitals and other healthcare providers would prefer to purchase their compounded sterile drugs from an FDA-compliant source, thus encouraging compounding pharmacies to seek registration (25). Currently, 68 compounding pharmacies have registered with the FDA, most of them have been inspected, and they are cooperating with FDA officials to correct any deficiencies in their outsourcing operations (16).

Seeking Justice Hundreds of lawsuits were filed against NECC, its executives, and their related companies, as well as the outpatient centers and hospitals that administered the tainted drug (17). Many of those suits were settled on May 19, 2015.

NECC had declared bankruptcy, and its assets had been frozen by a court order since December 2012 (17, 22). In the settlement, a federal bankruptcy judge approved liquidation of NECC’s assets to create a $200 million compensation fund (13).

About 3,300 victims and creditors qualified for compensation, with the largest payments going to those most seriously impacted (13).

On September 4, 2014, Glenn Chin, a supervisory pharmacist at NECC, was arrested at Boston’s Logan Airport as he and his family prepared to board a flight to Hong Kong (17). Chin oversaw the rooms where NECC’s sterile drugs were compounded (2).

On December 17, 2014, federal agents launched a series of predawn raids and arrested 13 other NECC

executives, owners, and staffers including company president Barry Cadden (14, 17). The 131-count indictment encompassed a wide assortment of crimes, including racketeering, fraud, conspiracy, violating federal drug laws, and financial crimes.

In addition, Cadden and Chin were charged with second-degree murder (14, 17).

Owners Carla and Douglas Conigliaro were accused of transferring $33 million in assets to 8 different bank accounts after the pharmacy declared bankruptcy and the court-ordered freeze on the company’s assets (14).

Regarding the racketeering charges, the prosecutors said that NECC’s executives and staff had devised a scheme for producing methylprednisolone acetate in unsanitary conditions and sold it, knowing that it posed a risk to patients (14). The indictment also said that employees and managers mislabeled batches and shipped vials that they knew had expired or had never been tested (14). These federal racketeering charges represented the largest US criminal case ever brought over contaminated medicine (13).

The indictment also referenced the FDA inspectors’ reports, which showed that NECC had consistently failed cleanliness tests. Prosecutors said Chin instructed his technicians to “prioritize production over cleaning and inspecting” and that he told them to “fraudulently complete cleaning logs” (14, 17).

In bringing murder charges, the prosecutors’ aim was to portray Cadden and Chin’s actions as a broad pattern of criminal fraud that went beyond routine regulatory violations (14). Cadden’s trial began on January 9, 2017, in Boston. He was charged with 25 counts of second-degree murder connected to deaths in 7 states, along with the racketeering crimes (2, 14).

On March 22, 2017, the jury found Cadden guilty of racketeering, conspiracy, mail fraud, and introduction of misbranded drugs into interstate commerce with intent to defraud and mislead. He faces up to 20 years in prison on each of the mail fraud and racketeering counts. The jury found Cadden not guilty of second-degree murder (2, 14, 17).

At press time, Cadden’s sentencing was slated for June 21, 2017, and Glenn Chin’s trial was scheduled to begin on August 9, 2017.

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Biosketch:

References 1. Outterson K (2012) Regulating compounding pharmacies after NECC. New Engl J Med 367(21): 1969-1972.

2. Barchenger S (January 8, 2017) First criminal trial in deadly meningitis outbreak to begin. The Tennessean. available from: http://www.floridatoday.com/story/news/ nation-now/2017/01/09/first-criminal-trial-deadly-fungal-meningitis-outbreak-beginsmonday/96331252/ 3. Majno G (1978) The Healing Hand: Man and wound in the ancient world. Harvard University Press, Cambridge.

4. Atanasov AG, Waltenberger B, Pferschy-Wenzig E-M, Linder T, Wawrosch C, Uhrin P, Temml V, Wang L, Schwaiger S, Heis EH, et al. (2015) Discovery and resupply of pharmacologically active plant-derived natural products: A review. Biotechnol Adv 33(8): 1582-1614.

Rebecca J. Anderson holds a bachelor’s in chemistry from Coe College and earned her doctorate in pharmacology from Georgetown University. She has 25 years of experience in pharmaceutical research and development and now works as a technical writer.

Her most recent book is Nevirapine and the Quest to End Pediatric AIDS. Email rebeccanderson@msn.com.

In the next issue of The Pharmacologist…

Dr. Anderson will share the story of Rosalyn Yalow and the discovery of the radioimmunoassay.

Don’t miss the September 2017 issue.

5. Pryor TCS (January 29, 2014) The history of the legal and regulatory issues surrounding pharmacy compounding. FDLI presentation. available from: http:// docplayer.net/21295868-The-history-of-the-legal-and-regulatory-issues-surroundingpharmacy-compounding.html 6. Anderson RJ (2011) Lady Mildmay’s modern medical cures. Mol Interv 11(2): 72-78.

7. University Compounding Pharmacy. History of compounding. available from: http:// ucprx.com/compoundinghistory 8. Adams Drugs. The history of compounding. available from: http://www.adamsdrugs. net/pharmacy-services/history-of-compounding.php 9. Crosse M (July 31, 2013) GAO Report to Congressional Requesters. Drug Compounding: Clear authority and more reliable data needed to strengthen FDA oversight (GAO-13-702). available from: http://www.gao.gov/products/GAO-13-702 10. Woodcock J (May 23, 2013) Examining drug compounding: Testimony before Subcommittee on Health, Committee on Energy and Commerce, US House of Representatives. available from: http://www.fda.gov/NewsEvents/Testimony/ ucm353654.htm 11. Kunac T (July 2013) Intravenous Therapy: Then and now. available from: http://www. ivnnz.co.nz/files/file/7748/Intravenous%20Therapy%20%20Then%20and%20Now%20 %20July%202013.pdf 12. Cantrell S A (2016) Improving the quality of compounded sterile drug products: A historical perspective. Ther Innov Regul Sci 50(3): 266-269.

13. CBS/AP (May 20, 2015) Judge approves $200 million settlement over meningitis outbreak. available from: http://www.cbsnews.com/news/judge-approves-200-millionsettlement-over-meningitis-outbreak/ 14. Bidgood J and Tavernise S (December 17, 2014) Pharmacy executives face murder charges in meningitis deaths. New York Times; available from: https://www.nytimes. com/2014/12/18/us/new-england-compounding-center-steroid-meningitis-arrests.html?_ r=0 15. FDA (February 10, 2003) Form 483 Inspectional Observations. FEI Number 3003623877. available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/ OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ UCM325834.pdf 16. FDA (December 2, 2013) Historical pharmacy compounding information. available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ PharmacyCompounding/ucm376286.htm 17. Eichenwald K (April 16, 2015) Killer pharmacy: Inside a medical mass murder case.

Newsweek. available from: http://www.newsweek.com/2015/04/24/inside-one-mostmurderous-corporate-crimes-us-history-322665.html 18. Pettit AC, Kropski JA, Castilho JL, Schmitz JE, Rouch CA, Mobley BC, Wang XJ, Spires SS, and Pugh ME (2012) The index case for the fungal meningitis outbreak in the United States. New Engl J Med 367(22): 2119-2125.

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19. Rosenthal E (November 17, 2012) How back pain turned deadly. New York Times. available from: http://www.nytimes. com/2012/11/18/sunday-review/steroids-and-back-pain-anuneasy-match.html 20. Smith RM, Schaefer MK, Kainer MA, Kainer MA, Wise M, Finks J, Duwve J, Fontaine E, Chu A, Carothers B, et al.

(2013) Fungal infections associated with contaminated methylprednisolone injections. New Engl J Med 369(17): 1598-1609.

21. CDC (October 30, 2015) Multistate outbreak of fungal meningitis and other infections. available from: https://www. cdc.gov/hai/outbreaks/meningitis.html 22. Kauffman CA, Pappas P, and Patterson TF (2013) Fungal infections associated with contaminated methylprednisolone injections. New Engl J Med 368(26): 2495-2500.

23. FDA (October 26, 2012) Form 483 Inspectional Observations. FEI Number 3003623877. available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/ OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ ORAElectronicReadingRoom/UCM325980.pdf 24. Germano B (December 17, 2014) Mixed emotions for meningitis victims following NECC arrests. CBS Boston. available from: http://boston.cbslocal.com/2014/12/17/mixedemotions-for-meningitis-victims-following-necc-arrests/ 25. Kennan SA (December 4, 2013) Drug Quality and Security Act: What you need to know. McGuireWoods Legal Alert. available from: https://www.mcguirewoods.com/ClientResources/Alerts/2013/12/Drug-Quality-and-Security-Act.aspx

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Strategic Plan

At the April 2017 ASPET Business Meeting, President David Sibley presented the results of a year-long strategic planning effort put forth by the ASPET Council.

Last summer, ASPET conducted a thorough interview process of key stakeholders in the organization about the current needs of ASPET members and the future of the society. Following the group interviews, a membership survey was sent to all members in an effort to guide ASPET’s strategic planning priorities.

The results of the survey were reported in the March 2017 issue of The Pharmacologist. In Fall 2016, the ASPET Council participated in a retreat where they

developed the vision and mission statements and identified six strategic planning goals for ASPET. These goals were assigned to standing committees or task forces to further develop the goals and to define specific strategies.

ASPET’s strategic plan highlights the approaches that the Council sees as necessary to keep pharmacology at the cutting edge of biomedical research. The new strategy was planned to enhance the core functions of the Society in a way that is consistent with ASPET’s vision and mission.

ASPET’s Vision

ASPET’s Mission

Pharmacology is an essential integrative discipline that creates new knowledge about drug action and translates those discoveries into novel therapeutics. In order to improve health and cure disease, ASPET will be an advocate for everyone practicing this discipline.

To be the professional home for educators, students, researchers, healthcare practitioners, and other professionals working to advance pharmacology research, exchange knowledge, and increase the impact and influence of this scientific discipline.

April 2016

April 2016 through August 2016

ASPET announces strategic planning initiative

Research phase, individual and group interviews

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August 2016

October 2016

Member survey

Strategic planning retreat

October 2016 through EB 2017 meeting Task force and committee work to refine goals and objectives

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ASPET’s Goals A. P romoting Pharmacology and ASPET

B. A ttracting and Developing the Next Generation of Pharmacologists

ASPET will promote society membership and educate the broader health science community and the general public about the contributions of pharmacology to public health.

Objectives: 1. For the general public and broader health community: Increase public awareness of pharmacology as a discipline and the contributions of pharmacologists 2. To pharmacologists and scientists in pharmacologyrelated disciplines: Advocate for the discipline of pharmacology, stress the importance of pharmacological principles, and promote membership in ASPET

ASPET will recruit and foster the next generation of pharmacologists while supporting career development for all of its members.

Objectives: 1. Introduce and attract pre-college and undergraduates to pharmacology and its spectrum of careers 2. Help graduate students and postdoctoral fellows explore the diversity of career options and become competitive in pursuing careers that match their interests and capabilities 3. Help early career and mid-level scientists thrive in their careers and support them through career transitions 4. Enhance gender and ethnic diversity within the profession and in ASPET’s leadership

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C. R eimagining the Annual Meeting Experience The ASPET Annual Meeting will be the place to discover and to present the highest quality, innovative science in pharmacology and experimental therapeutics.

Objectives: 1. Present science of popular interest across pharmacology-related disciplines 2. Make the meeting a forum for attendees to achieve their professional objectives (at all career levels and various organizational types) 3. Create a meeting experience appealing to more ASPET members 4. Improve the poster experience for both the abstract submitter and the viewer by employing best practices and innovative presentation methods

D. E nhancing the ASPET Journals ASPET will increase subscriptions, citations, and submissions to our journals, and identify other ways our knowledge products can generate income.

Objectives: 1. Increase the quality and visibility of ASPET’s pharmacology publications 2. Increase citations and the Impact Factors of ASPET journals 3. Investigate the feasibility of establishing one globally recognized high impact journal, with cascade to discipline journals

E. Advocating for Critical Science Policies ASPET will identify, develop and advocate for actionable science policies that are critical to our membership.

Objectives: 1. Continue to engage with FASEB and other coalitions on global science issues while developing new coalitions to further ASPETspecific initiatives

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2. Identify policy issues and interests that are uniquely and especially relevant to our members 3. Identify and convene when necessary expert advocates from within the ASPET membership 4. Create policy positions reflecting views widely held

by ASPET members 5. Disseminate policy information and targeted calls to action to the ASPET membership 6. Leverage the Washington Fellows program to build a cadre of committed advocates of pharmacology

F. Strengthening ASPET ASPET will assess its financial and governance policies, identify priorities for change, and leverage global partnerships that strengthen the society.

Objectives: 1. Conduct a financial evaluation to develop sustainable business models for association activities and programs including meetings, journals, and divisions, and establish an operating philosophy for reserves and dues 2. Develop a global partnership strategy with defined metrics of success that proactively identifies key partners and opportunities that strengthen ASPET 3. Initiate a governance review of ASPET’s organizational structure, policies, and procedures to encourage meaningful member engagement and increase leadership diversity Stay tuned for additional information about the proposed strategies under consideration, which will be available on the ASPET website this summer.

Thank you to all members who took part in the strategic planning process, especially the task force and committee members who participated in creating the objectives and strategies. The ASPET Council welcomes your feedback. Please send your comments and suggestions to membership@aspet.org.

Promote Your Graduate Program in Explore Pharmacology ASPET’s Explore Pharmacology booklet provides students with a broad overview of the discipline of pharmacology. It describes the many employment opportunities that await students who pursue pharmacology and outlines the academic path that they are advised to follow. The 2017 edition, due out in fall 2017, will be redesigned with a fresh new look.

Take advantage of this unique opportunity to reach students interested in your graduate program.

Directly Reach Students Interested in Pharmacology Through mailings and distribution at national meetings

Benefits of Advertising Your ad will also be highlighted on ASPET’s Departments and Training Programs in Pharmacology webpage as a featured graduate program.

Deadlines Space and materials deadline is Monday, July 31, 2017.

Reserve Your Ad Now Contact Suzie Thompson at sthompson@ aspet.org or call (301) 634-7069 to reserve your ad.

Visit www.aspet.org/advertise_with_explore_pharmacology for print specifications and pricing information or contact Suzie Thompson, ASPET Marketing Director at sthompson@aspet.org.

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ASPET Celebrates the 25th Anniversary of the SURF Program ASPET’s SURF program has a rich network of over 2200 alumni, with some former participants serving as mentors to the next generation of researchers. In celebration of SURF’s 25th anniversary, we continue to share stories from SURF programs to highlight their potential as transformative experiences. Look for additional stories in upcoming issues and in the booklet celebrating this SURF milestone available at http://bit.ly/2ntx2vs.

David Brown Participation year: 2005 Fellowship type and location: Institutional, University of North Carolina at Chapel Hill Current title: Postdoctoral Fellow, University of North Carolina at Chapel Hill My experience doing summer research at UNCChapel Hill was exceptional. I spent the summer of 2005 as a SURF fellow in the lab of Lee Graves. I was given an independent project to fluorescently tag two proteins and assess their colocalization and potentially their interaction with FRET microscopy. While this project may seem challenging for an undergraduate research project, the support that I received from the Graves lab and others at UNC made it manageable and exciting! For example, early on I had some struggles with subcloning one of the proteins (which is particularly large) into a fluorescent vector. A PI from another lab, Rob Nicholas, personally walked me through the molecular biology. When I do cloning now, I still do it the same way! With the data that I generated during the summer fellowship, I was able to attend the Experimental Biology 2006

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conference in San Francisco to present my work in a poster competition. Beyond the laboratory portion of the SURF program, we were exposed to possible career options in academia and industry. We even had field trips to visit small and large pharmaceutical companies in Research Triangle Park. Overall, I consider my time in the SURF program to be a defining period of my development as a scientist. It taught me the value of collaboration and passing on one’s knowledge to future scientists. The positive experience that I had here played no small role in my decision to return to UNC as a postdoctoral fellow.

Tyler Hinshaw Participation year: 2015 Fellowship type and location: Individual, Wake Forest University Current title: student, Wake Forest University The summer I spent as a SURF researcher allowed me to experience the full research process. I developed protocols, learned to troubleshoot, and immersed myself in scientific literature. I was able to dedicate myself to the lab full time without interruptions from classes or work.

After the summer, I was granted an undergraduate travel award to attend the Experimental Biology 2016 conference in San Diego, CA. Attending the conference was an incredible experience; I was able to travel to a new part of the country, attend lectures and learn about other aspects of research, and compete in the undergraduate poster competition. After my experience with SURF, I decided to delay applying to medical school and complete a master’s degree. While I want to practice medicine, a master’s degree would give me in-depth knowledge of pharmacology and physiology and research experience that I can apply to practice. I am currently working on my thesis in the same lab I worked in during my SURF summer, and I hope the experience will allow me to become a well-rounded and investigative doctor of medicine in the future.

Tanecia Mitchell Participation year: 2004 Fellowship type and location: Institutional, University of Arkansas for Medical Sciences Current title: Assistant Professor, University of Alabama at Birmingham I was selected to participate in the SURF program in 2004 at the University of Arkansas for Medical Sciences in Little Rock, AR. I decided to participate in this program because I wanted to determine whether I should attend graduate or medical school and to learn more about biomedical research. Prior to the program, I had limited research experience that consisted of performing protein assays and prepping samples for HPLC. I was initially overwhelmed at the beginning; however, I enjoyed the problem solving, the challenges, and the concept that what I was doing could be beneficial to kidney transplantation and human life. Little did I know that the SURF program would set the course of my scientific career. I was introduced to cell culture (by far still one of my favorite components of research), designing experiments, dose response curves, and the list goes on. I often think of the summer of 2004 as the year I fell in love with research. I was so nervous when I started, but it became something that gave me great joy. It was from this summer program that I decided I wanted to become a biomedical researcher. Thus, I applied to graduate school and became a PhD scientist.

Thereafter, I completed my postdoctoral training, and I am now in the early stages of being a faculty member.

I would not have made it to this point in my career if I hadn’t participated in the SURF program. I met so many great mentors during this time that I still keep in contact with. The SURF program was definitely the foundation of my career. Even to this day, I tell every undergraduate student to participate in a summer research program because of the great benefits I received from the SURF program.

We thank these SURF alumni for sharing what the fellowship experience meant to them. Stay tuned for more stories throughout the year.

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Meeting News Fueling Innovation: Public Programs Driving Drug Discovery

Save the date for the 2nd ASPET/ADDC Colloquium on Academic Drug Discovery entitled Fueling Innovation: Public Programs Driving Drug Discovery, which will take place at the Natcher Conference Center on the NIH campus in Bethesda, MD, on October 12 – 13, 2017. The focus of the second collaboration between ASPET and the Academic Drug Discovery Consortium (ADDC) will explore a domain critical to innovation – how to fund it. The first collaborative meeting between ASPET and the ADDC directly following the ASPET Annual Meeting at EB 2016 brought together a diverse range of scientists from industry, biotech and academia to ponder a collection of academic drug discovery success stories. In addition, a series of more than 200 one-on-one meetings between academic centers and industry representatives were held, providing a unique opportunity for networking and collaborative interactions. This first ASPET/ADDC initiative triggered some very positive feedback and provided the impetus for planning the 2nd ASPET/ADDC Colloquium on Academic Drug Discovery.

Pharmaceutical companies have steadily decreased their research ranks for years. Recognizing a potential crisis in the making, governments have responded to the evolving R&D landscape by creating new mechanisms to fund research focused on identifying novel therapies for untreated patients.

This phenomenon has occurred on a national scale; individual states and even some metropolitan regions

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now have funding instruments. A single investment can trigger the invention of a new treatment, support the education of the next generation of scientists, and build economies in meaningful and lasting ways. If you are interested in academic drug discovery and would like to build your network of collaborators, learn firsthand how other scientists have successfully developed their programs, and explore the funding options available to launch and sustain a treatment discovery program, you will want to attend the 2nd ASPET/ADDC Colloquium on Academic Drug Discovery.

The meeting will begin on October 12, 2017 with a series of speakers highlighting exemplary government drug discovery initiatives including the National Cancer Institute Chemical Biology Consortium, Cancer Research UK, the NIH Blueprint for Neurotherapeutics, Wellcome Trust’s Innovations Division, and the National Institute on Drug Abuse Molecular Targets and Medications Discovery Branch. The afternoon will feature a series of speakers highlighting individual programs enabled by government support. Confirmed keynote speakers include Carlos A. Zarate, MD of the National Cancer Institute and Bryan Roth, MD of the University of North Carolina and Director, NIMH Psychoactive Drug Screening Program. A series of partnering sessions will be held on October 13, 2017 with the primary purpose of enabling access to representatives of government programs focused on fostering academic drug discovery.

Submitted by Drs. Michelle Arkin, Janet Clark, and Mike Wood To register for the meeting and submit an abstract, please go to www.aspet.org/2017colloquium

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Science Policy News

Congress Reaches 2017 Funding Deal to Avoid Shutdown; NIH to Get $2 Billion Boost Republican and Democratic legislators reached an agreement in early May on spending for fiscal year (FY) 2017. Known as an omnibus spending package, the legislation totals more than $1 trillion and will fund the government through the rest of FY2017, which ends September 30. Under this agreement, the National Institutes of Health (NIH) will get a $2 billion funding boost over the next five months, as outlined during the appropriations process.

As reported in The Hill, the bill's $15 billion increase in defense funding is matched by a $15 billion increase in non-defense discretionary (NDD) funding over the FY2017 caps. This "extra" $15 billion for defense and $15 billion for NDD over the sequester caps is what was agreed to in the Bipartisan Budget Act of 2015 (BBA), and was the level the House and Senate Appropriations Committee had always assumed.

Conservative opposition to the BBA is

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why the House never brought their FY2017 budget to the floor for a vote last year.

Despite the call to slash the NIH’s budget by about a fifth, or $5.8 billion in President Trump’s recent budget proposal for 2018, many see the omnibus spending bill outcome in Congress as a clear message from lawmakers that both sides of the aisle prioritize funding for medical research.

The next spending showdown is not far off, however, as Congress will need to pass a new package by October 1 for 2018 or the cycle of continuing resolutions (CRs) will begin again.

ASPET has been actively engaged throughout the appropriations process, submitting letters to Congress imploring a finalized spending package and releasing a public statement applauding the final measure.

Additionally, ASPET released a public statement responding to President Trump’s FY2018 budget blueprint, which proposed devastating cuts to the NIH and other agencies. Specifically, cutting $54 billion in NDD spending across the government, including reducing the NIH budget by $5.8 billion (nearly 20 percent) and the DOE Office of Science budget by $900 million (approximately 17 percent).

The release of the administration’s budget proposal was the first step in the lengthy federal budget and appropriations process, which is ultimately overseen

by Congress. ASPET is submitting testimony with a funding recommendation ($35 billion) as usual and will continue to advocate throughout the cycle.

David R. Sibley

For Immediate Release Contact: Susanna Aguirre 301-634-7062 saguirre@aspet.org

John D. Schuetz

ASPET Statement in Response to the President Trump’s Fiscal Year (FY) 2018 Budget Blueprint

Council President Bethesda, Maryland President-Elect St. Jude Children's Researc h Hospital

Kenneth E. Thummel

Past President University of Washington

Charles P. France

Secretary/Treasurer The University of Texas Health Science Center at San Antonio

John J. Tesmer

Secretary/Treasurer-Elect University of Michigan

Dennis C. Marshall

Past Secretary/Treasurer Ferring Pharmaceuticals, Inc.

Margaret E. Gnegy

Councilor University of Michigan Medical School

Wayne L. Backes

Councilor Louisiana State University Health Sciences Center

Carol L. Beck

Councilor Thomas Jefferson Univers ity

Mary E. Vore

Chair, Board of Publications Trustees University of Kentuck y

Brian M. Cox

FASEB Board Representative Bethesda, Maryland

Scott A. Waldman

Chair, Program Committee Thomas Jefferson Univers ity

Judith A. Siuciak

Executive Officer

BETHESDA –The American Societ y for Pharmacology and Exper imental Therapeutics (ASPET) expresses deep concern regard ing the proposed cuts to the National Institutes of Health (NIH) in President Trump’s recen tly released fiscal year (FY) 2018 budget blue print.

A robust, sustainable investment in the medical research enter prise is critical to improving patient health and strengthenin g the economy while maintaining the global preeminence of the United States in scientific innovation. More than 80 perce nt of the NIH budget supports research in all 50 states at medic al schools, teaching hospitals, universities, and research institutes, which often are the largest employers in their respe ctive communities.

The proposed dramatic cut to NIH funding would profoundly disrupt the forward progress our biomedical research discov of eries and consequently have a major negative impact on the well-being and health of our citizens; by disrupting progress in the continuity of our Natio complex and interdisciplinary n’s biomedical research, we will reduce the rate of therapeutic discoveries and thereby increa se healthcare costs. NIH funde d biomedical research is the foundation for therapeutic discov eries, which are linked to FDA-a pproved therapeutics and represent a critical path to impro ved healthcare for our Nation.

Additionally, we appeal to Congr ess to recognize the profoundly disruptive consequences of a proposed 20% reduction in NIH funding to employment and communities related to medical research centers across our Country.

Congress has consistently shown bipartisan support for biome dical research in the appropriations process and these proposed cuts undermine the positive momentum gained from the recent passage of the st 21 Century Cures legislation and the increased funding approved by the Senate Appro priations Committee for FY 2017.

To ensure America’s continued leadership in the face of increa sing competition in biomedical research, we must prioritize a budget trajectory for NIH that advances sustainable, predictable growth.

ASPET calls on Congress to stand with us and reject these drasti c proposed cuts and maintain a course of sustained funding for America’s premier health agency, which benefits the entire nation and is critical to ensur ing the United States’ position as the world leader in biome research. dical

ASPET is a scientific society whose members conduct basic and clinical pharmacological researc for academia, government, large h and work pharmaceutical companies, small biotech companies, and even organizations. ASPET membe non-profit rs work in a variety of differe nt fields and include neuroscientis chemical biologists, pharmacists, ts, toxicologists, cardiovascular scientists, and many more. These research efforts develop new medicines and therap help eutic agents to fight existing and emerging diseases.

9650 Rockville Pike | Bethe sda | MD | 20814-3995 P: (301) 634-7060 | F: (301) 634-7061 | E: info@aspet .org | www.aspet.org

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ASPET Submits Testimony to Congress on the Importance of NIH Funding in the FY2018 Appropriations Cycle The House and Senate appropriations committees solicited testimony on funding priorities from stakeholder organizations as they began their work on the FY2018 budget for federal science agencies, and ASPET responded with statements to the appropriations subcommittee on Labor, Health and Human Services, and Related Agencies (LHHS).

ASPET’s testimony outlined the importance of sustained funding and appreciates the final outcome

Dr. David Sibley on behalf of & Experimental Therapeutics (ASPET) The American Society for Pharmacology and Human Services, Education, and riations Subcommittee on Labor, Health Approp Senate the to record the Submitted for Related Agencies s of Health Institute l Nationa the for Budget Regarding the Fiscal Year (FY) 2018 June 1, 2017 global competitiveness and ng human health, maintaining the nation’s improvi to critical is in NIH  Steady and sustained investment ies. econom local and state ing stimulat funded, the lowest 1 out of 6 grant applications can be ed funding for NIH will be that only human health.  The short-term implications of decreas that have important implications for unfunded many highly innovative ideas rate in the agency’s history, leaving dire: the U.S. share of global research are research ical biomed in ent n sustaining federal investm  The long-term implications of not spending by China, Russia, and the Europea ence of increasing research-related in and development will decline, as a consequ in the U.S. will leave to pursue careers of scientists who trained in and/or working economy. global the of sector Union. In addition, an increasing number health the in competiveness and leadership our mising compro further s, other countrie ical research can n so that vital investments in biomed an, balanced approach to deficit reductio  Lawmakers must secure a bipartis the nation. be sustained in the best interests of of $35 billion to by awarding an FY2018 minimum budget that NIH remains a national priority, s who pursue a career in  We call upon Congress to ensure the pool of talented young scientist increase to and decade last the over restore purchasing power lost the health of the American people. biomedical research that will advance ny respectfully submits the following testimo and Experimental Therapeutics (ASPET) cology onal society, whose Pharma for Society n The America . ASPET is a 5,100-member professi appropriations for biomedical research ic, industrial and government sectors academ regarding Fiscal Year (FY) 2018 federal the within research l and clinical pharmacologica r and develop new members conduct basic, translational, professionals. Our members discove , dental, pharmacy and other health health. and are educators of research, medical nate that knowledge to improve human and emerging diseases, and dissemi ies. To this end, modalit nt treatme and ion therapeutic agents that fight existing prevent development of new disease the to critical is research for Sustainable, funding billion for NIH in FY 2018.

ASPET recommends a minimum of $35 for NIH included Overview

by Congress with increased funding tes the investment in research made l to mitigate losses that still ASPET recognizes and very much apprecia ment from Congress in FY 2018 is essentia commit d sustaine r, Howeve costs leading to bills. in the FY2017 appropriations to keep pace with inflation in research From 2003-2013, the NIH budget failed grant mechanism that supports exist from the budget sequestration. power and a 34% reduction in the primary ing purchas s could fund and agency’ the in power n ing a nearly 25% reductio restore the agency’s lost purchas capacity 2018 budget of $35 billion will help investigator-initiated research. A FY in reversing the 22% loss of research ator-initiated research, a critical step investig and for costs grants rising R01 with new pace 2,000 approximately ration, and the failure to keep to 2015 due to budget cuts, sequest that NIH experienced from FY 2003 cture. infrastru in ents investm of funding for recognizing the critical importance an, bicameral support and vision in NIH budget to $35 billion is st We commend legislators for their bipartis Cures legislation this year. Raising the Century 21 passing by priority l Committee’s nationa medical research as a as well as the Senate Appropriations that were included in the Cures Act, support consistent with the authorization levels bill. NIH will need additional funds to 2017 Labor, Health and Human Services FY the in n advantage of endatio take and recomm s, bipartisan funding trials to test new therapie ion of researchers, accelerate clinical ongoing efforts to train the next generat ues. new research methods and techniq ely Impact Human Health cannot replace the Diminished Support for NIH Will Negativ elements of health research but they philanthropy can supplement some ken by industry Industry, venture capital, and private d by NIH. Much of the research underta clinical biomedical research provide biomedical research is basic in ent investm investment in basic, translational and NIH’s of ded projects. The majority NIH-fun from ed cial entities to generat ies commer by discover builds upon the of discoveries that are utilized thereby providing an ongoing source ment programs broad with a long-term commitment, have shrunk their research and develop pact drugs and devices. Many such entities tics, high-im but diagnos k market High-ris and mature. cture manufa years to fully may be of higher risk and require several and are investing less in research that

by NIH and its funded investigators. represent the essential role played efforts, especially in basic research,

of the 2017 omnibus, which yielded a $2 billion increase for NIH in FY2017; and urged Congress to continue their support for biomedical research with a recommendation of $35 billion for NIH in FY2018.

For the full version of the testimony ASPET submitted, please go to http://bit.ly/2sjm6Bi.

Past investment in NIH-funded basic research has led to many innovative medicines. In addition, NIH-funde d research has provided major gains in our knowledge of the human genome, resulting in enhanced drug efficacy and a reduction in adverse drug reactions that currently limit the effectiveness of potential life-saving medications. NIH is the world leader in efforts to prevent and treat HIVAIDS; recent genetic studies have pinpointed disease-ca using variants that have led to improved cure rates, but further advances and improvements in technology will be delayed with diminished NIH funding. The evolution of patient care into what has been termed “personalized” or “precision medicine” and its application to a wide range of clinical disorders, including cancer, necessitates research to identify and test optimal diagnostic and therapeutic approaches for individuals. NIH-suppo rted research has revealed new frontiers of immunopharmacology and regenerati ve medicine, which are saving millions of dollars by reducing in-patient hospital care for debilitative autoimmune diseases, such as rheumatoid arthritis, and restoring movemen t and function through regenerative interventions. Moreover, NIH is the only organization capable of mounting an effective response to understand the mechanisms and develop treatments for rapidly emerging infectious diseases. Enhanced and sustained funding of NIH is essential for continued improvements in the prevention and treatment of these and many other diseases.

Investing in NIH Helps America Compete Economica lly NIH research funding catalyzes private sector growth.

More than 83% of NIH funding is awarded to over 3,000 universities, medical schools, teaching hospitals and other research institution s in every state in our nation. One national study found that combined federal and state funded research at the nation’s medical schools and hospitals supports almost 300,000 jobs and adds nearly $45 billion to the U.S. economy. NIH funding also provides the foundation for major scientific innovations in the pharmaceutical and biotechnology industries, with new drug targets being discovered through NIH-supported basic research that can then be translated into novel drug treatments. Thus, an investmen t in NIH will help create jobs and promote economic growth. Relinquishing NIH world leadership in biomedical research with budget reductions will forfeit future discoveries and force relocation of research and jobs to other countries eager to assume this leadership role.

If funding for the next ten years is similar to that of the past decade, we will lose a generation of young scientists. Increasingly, these individuals, seeing no prospects for careers in biomedica l research, will leave the research enterprise or look for employment in foreign countries. The “brain drain” of young scientific talent seriously jeopardizes the nation’s leadership in biomedical research and compromises future advances in the prevention and treatment of disease. A 2013 survey of ASPET’s membership revealed that 45% of post-doctoral trainees and 25% of graduate students say they are no longer considering a career in biomedical research due to the restrictive funding environment; 50% of graduate students and 29% of post-doctoral trainees say they are willing to consider leaving the U.S. in order to pursue a career in biomedica l research.

It is a sobering fact that the U.S. share of global research and development investment has declined substantially over that last two decades. In contrast, other nations are investing aggressively in science. For example, China has grown its science portfolio with annual increases to their research and developme nt budget averaging over 20% annually since 2000.

Russia plans to increase support for research substantially over the next decade. The European Union, despite economic distress among some of its member nations, plans to increase spending on research and innovation by 45% between 2014 and 2020.

All of these nations recognize the long-term economic value of scientific research and they are prioritizing their budgets accordingl y.

Conclusion ASPET acknowledges the many competing and important spending decisions that are made by the Subcommittee. However, NIH’s contribution to the nation’s economic well-being and to the health of its citizens should make it one of the nation’s top funding priorities. Ensuring a long-term commitment to discovering cures for disease is one major way in which we can work together as a nation to reduce Medicare-Medicaid expenditu res without cutting benefits. Moreover, investmen t in research today has the potential, through new discoveries, to improve the quality and lower the cost of health care, especially through efforts on the major causes of death of Americans. Lawmakers must replace sequestration in 2018 and beyond with a bipartisan, balanced approach to deficit reduction so that vital investments can be made that are in the best long-term interest of the nation.

With enhanced and sustained funding, NIH can begin to reverse the decline in its operational footprint and help achieve its potential to address the most promising scientific opportunities and critical healthcare needs of our country.

To sustain our nation’s leadership in conductin g biomedical research, to expand on opportuni ties for young investigators, to discover new therapeutic discoveries, and to build on the momentum from the funding increases provided in the last two years, and through the 21st Century Cures Act, ASPET recommends at least $35.0 billion for NIH in FY 2018.

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ASPET Washington Fellows Visit Congress For the fifth consecutive year, ASPET’s Washington Fellows traveled to Washington, DC for meetings with their Congressional delegations to discuss the importance of funding for biomedical research and to make the case for steady and sustained support for the NIH. The 2017 Fellows visited fiftyKaren Tonsfeldt of University of three Congressional California San Diego, outside offices from all over the of the Capitol building before visiting with California and Oregon country.

Congressional delegations.

Many Fellows were encouraged by a sense of genuine awareness that the unstable funding situation over the past decade has impacted aspiring early-career scientists, which has major implications for the future of America’s scientific workforce. Even the most fiscally conservative Congressional offices acknowledged that sustained funding for the NIH is important and their state does not want to see young people leave for other opportunities.

The consecutive funding increases for NIH and the passage of the 21st Century Cures legislation indicate that much progress has been made in making the case for funding on both sides of the aisle.

Fellows provided their delegations with state and district funding data, discussed their research, and offered to be available as a future resource or host at their respective institutions. Additionally, Fellows will be working throughout the summer on op-eds on their experiences in DC and the importance of advocacy efforts from early-career scientists.

Washington Fellow Raghav Tripathi said of his experience, “I had minimal experience with advocacy but was always interested in getting involved. After all of our meetings on the Hill, I felt truly inspired to get involved in advocacy as a component of my career and make this a significant part of my future.

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At first, I was a little nervous for our meetings but the encouragement and preparation provided took all of that away and I'm very excited to continue this on both the local and national level. I am grateful to ASPET for this wonderful opportunity!”

Following in the footsteps of the 2016 Fellows, the 2017 group has submitted a proposal for a policy symposium at EB 2018 in San Diego.

ASPET would like to acknowledge the commitment and great effort by the 2017 Washington Fellows to serve as knowledgeable representatives of ASPET, advocates for biomedical research, and future leaders!

Senator Debbie Stabenow (D-MI) with Sophia Kaska of Michigan State University.

Raghav Tripathi of Case Western Reserve University, meeting with Senator Rob Portman (R-OH).

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2018 Washington Fellows Program Submit your application by October 20, 2017 S Program Mission

Who Should Apply?

The mission of the ASPET Washington Fellows Program is to enable developing and early career scientists interested in science policy to learn about and become more engaged in public policy issues. Fellows will develop an understanding of how public policy decisions made in Washington help shape science policy, such as funding for the National Institutes of Health and other science agencies. Fellows will also learn how to advocate effectively on Capitol Hill and in their home districts. This program will help Fellows develop the skills and insights to become future leaders in science.

The ASPET Washington Fellows Program is open to any graduate student, postdoctoral trainee, or researcher no more than four years past the completion of his/her postdoctoral training. Applicants must be members of ASPET in good standing and have a strong interest in science and its intersection with public policy. Fellows will be selected by the ASPET Science Policy Committee.

Application Information ASPET anticipates up to 10 Washington Fellows Program participants in 2018. Fellows serve one-year terms.

What Will ASPET Fellows Do?  Advocate on Capitol Hill: ASPET Fellows will come to Washington, DC, to meet with their congressional delegation to advocate for biomedical research and increased funding for the NIH. Fellows will be well trained by ASPET and prepared with the appropriate message to deliver to Congress. ASPET will cover transportation costs, hotel, and other reasonable expenses that follow ASPET’s reimbursement policy.

All applications must contain the following information and be submitted by October 20, 2017, as a single combined PDF:

 Become Advocates in their Home Districts: ASPET Fellows will meet with members of Congress in their home district, act as a conduit to inform colleagues within their departments/institutions about federal legislative matters, write op-ed pieces to local papers, etc. All these activities will be undertaken with the support and advice of ASPET.

 A letter (no more than two pages) from the applicant stating their interest in public policy and why they are interested in the ASPET Washington Fellows Program  A Curriculum Vitae  A letter of support from the candidate’s mentor and/or department chair

 Attend the ASPET Annual Meeting at Experimental Biology 2018: ASPET Fellows will receive complimentary registration to attend the 2018 ASPET Annual Meeting in San Diego.

Incomplete applications and/ or applications received after October 20, 2017, will not be considered.

For more info: www.aspet.org/ASPET_Washington_Fellows_Program (301) 634-7060 publicaffairs@aspet.org

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Education News ASPET Names 2017 Individual Summer Undergraduate Research Fellows

The ASPET Summer Undergraduate Research Fellowship (SURF) program is designed to introduce undergraduate students to pharmacology research through a 10-week summer laboratory research experience. The goal of the program is to use authentic, mentored research experiences in pharmacology to heighten student interest in careers in research and related health care disciplines. ASPET offers both institutional and individual SURF awards. Institutions with funded fellowship programs are listed at: http:// www.aspet.org/awards/SURF/institutional-Funded/. The individual fellowships are designed to support students whose home campus lacks an institutional program, or who seek more specialized training opportunities at a different university. ASPET congratulates the 5 students selected for 2017 individual fellowships: Rachel Harenchar, a student at Saint Vincent College, will conduct research with Dr. Shawn Anderson. Rachel’s research will investigate the effects of larval nicotine exposure on anxiety-like behavior and place preference to ethanol in adolescent zebrafish (Danio rerio). The goal of her research is to develop a robust and reliable preclinical model that can ultimately be used to study the developmental and molecular effects of early nicotine exposure.

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Gillian Hecht, a student at Emory University, will conduct research with Dr. Brandi Wynne.

Gillian will study IL-6, a proinflammatory cytokine that is independently correlated with clinical hypertension. Prior data suggest that IL-6 can activate the mineralocorticoid receptor (MR), which is involved in mediating distal nephron sodium reabsorption. The purpose of Gillian’s research is to determine if IL-6 increases sodium retention via MR activation, leading to hypertension in vivo.

Jason Nguyen, a student at Pacific University, will conduct research with Dr. Brendan Stamper. The goal of Jason’s study is to differentiate toxicologic mechanisms between diquat and paraquat. Specifically, RNAi will be used as a tool to investigate the role of p53 and MAPK during hepatocellular injury. Immunoblotting will also be used to characterize the expression of downstream p53 and MAPK targets.

Dhvani Patel, a student at D’Youville College, will conduct research with Dr. Yasser Heakal. Dhvani will study the pharmacological activity of novel chloroquine analogs in a panel of breast cancer cell lines to establish their efficacy and potency as autophagy inhibitors in various breast cancer subtypes.

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Aneesh Singal, a student at the University of Vermont, will conduct research with Dr. Yuval Silberman at the Pennsylvania State University College of Medicine. Aneesh will study interactions between insulin resistance, chronic

neuroinflammation, and increased central amygdala (CeA) activity, which are all associated with obesity.

Aneesh’s project will test the hypothesis that insulin and astrocyte/glia signaling mechanisms regulate CeA function and will be altered by high fat diet to promote increased CeA excitability.

We wish the 2017 individual fellows as well as the fellows participating in the SURF institutional programs a productive and fun summer of research!

AAMC-CFAS Meeting in Review The Association of American Medical Colleges Council of Faculty and Academic Societies (AAMCCFAS) annual meeting was held March 7-9, 2017 in Orlando, FL. As an AAMC-CFAS member society, ASPET was represented by John Szarek (Geisinger Commonwealth School of Medicine) and Joe Blumer (Medical University of South Carolina) as senior and junior faculty society representatives, respectively.

CFAS meetings allow faculty representatives to identify, communicate, and advise the AAMC on critical issues facing medical schools and academic societies and to learn about ways to affect change at their institutions. A total of 195 AAMC-CFAS representatives attended the 2017 annual meeting.

Discussion topics were diverse, but major themes most important to ASPET included discussions of describing the faculty of the future, the opioid epidemic, the value, challenges, and strategies to promote and enhance discovery science to the public, and the value of PhDs in the medical schools of tomorrow.

Several topics important to ASPET were raised in the breakout session “Collaboration to Support the Faculty of Tomorrow’s Academic Health Centers,” including promotion and tenure, mentoring, the educational mission and educators, and leadership.

As the requirements for promotion and/or tenure vary among institutions and even between clinical faculty and basic scientists within an institution, it was proposed that CFAS help develop a framework

for the promotion and tenure process as well as best practices gathered from master educators.

The breakout session “Discovery Science in the Biomedical Research Center” focused on the role of basic and clinical translational science in the biomedical research center, how science is pursued in basic and clinical departments, challenges facing this discovery mission, and how the discovery science mission may change in the future. Speakers at this session stressed the importance of basic scientists at academic medical centers: faculty who are committed experts on mechanisms related to disease and drug action, use state of the art technology to make groundbreaking discoveries to improve patient outcomes, and train the students and postdocs as the next generation of discovery scientists.

The breakout session “First Things First: Educational Reform Starts with Educating the Faculty” addressed faculty development needs to help prepare faculty to practice, model, and teach the next generation of learners for 21st century healthcare.

Key discussion points were the concept of dedicated teaching faculty who can ultimately be promoted and/ or tenured as educators, and improving resources, incentives, and logistics of faculty development sessions. AAMC-CFAS could help develop a repository of best practices and how-to topics that could be hosted on the AAMC website.

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In the leadership plenary, AAMC President and CEO Darrell Kirch, MD discussed the current priorities of the AAMC in the face of a changing political climate in Washington. Dr. Kirch discussed six great challenges for academic medicine: the era of uncertainty in healthcare, brought about by the new political reality; the role of science in the “post-truth” era, defined as relating to circumstances in which objective facts are less influential in shaping public opinion than appeals to emotion and personal beliefs; new realities of learning and assessment, reflecting the changes occurring in education including innovative models of learning; discussion of inequity, division and injustice and the role of academic health centers as “beacon” institutions in the community that attend to social repair; increasing burnout among health professionals; and a leadership deficit and the need to better develop leaders and the different leadership development programs offered by the AAMC. Karen Fisher, JD, AAMC Chief Public Policy Officer, introduced two freely available AAMC publications updated for 2017 which would be of particular interest to ASPET members, “Compact Between Biomedical Graduate Students and Their Research Advisors” and “Compact Between Postdoctoral Appointees and Their Mentors.” AAMC believes that research needs sustainable, predictable growth in NIH funding, with a focus on keeping the $2 billion NIH boost in 2017 and getting ready for the same fight in FY 2018. Dr. Fisher emphasized that we have a responsibility to influence Congress, and the AAMC rolled out an advocacy program called “Ask Me About My Research.” Buttons were distributed at the meeting and are available from AAMC.

A breakout and a plenary session at the meeting were devoted to “The Opioid Dilemma.” These were timely presentations with respect to ASPET members.

V.J. Periyakoil, MD (Stanford) described the current situation with opioids as being one of a “feast,” with high drug availability and risk factors, and “famine,” with too little available for patients in pain who are not being appropriately treated. Additional discussion topics included the rise in neonatal abstinence syndrome and training in addiction medicine.

A breakout session on “Communicating the Value of Discovery Science Research: How and Why to Do It” was chaired by Susan Nagel, PhD (University of Missouri), who led exercises directed at communicating the value of discovery science.

As most Americans have limited science knowledge with widespread distribution of misinformation, we scientists should be considered the trusted source.

When communicating, it is important for us to know our audience and make a personal connection with them.

Dr. Nagel showed a figure that emphasizes the need to flip the order of a presentation when communicating science to other scientists or to the lay person.

Figure from https://www.aaas.org/page/communicating-engage; From AAAS Center for Public Engagement with Science & Technology Communication Toolkit. Reprinted with permission.

The final session was a special session on “The Place for PhDs in the Medical Schools of Tomorrow.”

Richard L. Eckert, PhD (University of Maryland) described an investigator as a manager of a small business whose survival depends on research grant income in the face of declining NIH funding. He emphasized that the value of basic science research to the institution includes the opportunity to make progress in improving health, making institutions competitive for funding, attracting intellectual talent, enhancing prestige and distinguishing research centers from community health centers.

Future strategies included mentoring new faculty, reducing the burden of tenured/unfunded faculty,

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advocating for improved NIH funding, managing the regulatory burden, setting aside bridge funding, encouraging participation in philanthropy, establishing collaborations with clinical departments, and providing PhDs with clinically relevant training. Lee Fleisher, MD (University of Pennsylvania) presented a clinician’s perspective and agreed that collaboration grows infrastructure, that learning basic science helps make better clinicians, that, by keeping up with basic science, PhDs provide content expertise and that PhDs need to be more engaged in the curriculum. He concluded by emphasizing that PhDs are invaluable in medical schools and that collaboration between clinicians and basic scientists can only enhance care and cures.

AAMC-CFAS continues to evolve, and evaluations from CFAS members will be used to help prioritize programming at upcoming CFAS meetings as well as to provide additional focus for CFAS activities and initiatives. The CFAS working group on communications is drafting letters that will be sent to medical school deans and academic society executive directors explaining CFAS meeting activities. We have represented ASPET at the AAMC-CFAS meetings for the last three years. Each year we come away with the conviction that basic science, particularly

pharmacology, needs to be represented at these meetings, but our voice and those of other basic scientists could be stronger. Although the agenda for the meeting is weighted more toward physicians and their experience, there is no doubt that basic science is valued by the participants and AAMC. Our engagement in, and support of, AAMC-CFAS activities demonstrate our commitment to enhancing the profile of basic science within AAMC and, more importantly, the general public. As your AAMC-CFAS representatives, we welcome any comments and suggestions you may have.

Joe Blumer Department of Cell and Molecular Pharmacology and Experimental Therapeutics Medical University of South Carolina Charleston, SC blumerjb@musc.edu John Szarek Department of Basic Sciences Geisinger Commonwealth School of Medicine Scranton, PA jszarek@tcmc.edu

S p o t t h e D i ffe re n c e .

Answer key for puzzle on the back cover.

1. Fire alarm is missing.

2. J.J.’s nose is bigger and a different color.

3. Glasses are now sunglasses.

4. Computer icon is now pink.

5. Man’s arm in background is moved.

6. SURF on sign now says ASPET. 7. Pen is missing from the table.

8. Chair is now green.

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Journals News New Editorial Board Members The Board of Publications Trustees is pleased to welcome two new editorial board members: Dr. Annarita Di Lorenzo (Weill Cornell Medical College) has joined the JPET Editorial Advisory Board.

Dr. Gunnar Schulte (Karolinska Institutet) is a new associate editor for Pharmacological Reviews.

Dr. Schulte represents the Swedish pharmacology society Sektionen för Läkemedeslära. Since its

inception, editorial supervision of Pharmacological Reviews has been shared with the British Pharmacological Society and the pharmacological societies of Scandinavia.

The BPT is grateful to both new editorial board members for their willingness to serve the journals in these important roles.

New Journals Features Over the last few months, we have been working to add new features to ASPET’s journals to better serve our authors and readers.

TrendMD

Kudos

This service recommends additional articles that might be of interest based on a reader’s viewing history. It’s similar to the feature on Amazon that makes product recommendations depending on items a user has viewed or purchased. Suggested articles will be unobtrusively listed in the column to the right of the journal articles. An equal number of articles from within the journal and from journals of other publishers will be included in the suggested reading list.

TrendMD will highlight articles from ASPET’s journals to readers of other publications that use the service, providing more exposure for ASPET’s authors. Science, Nature, and journals published by Elsevier, The Royal Society, Rockefeller University Press, and Wolters Kluwer, are among those using TrendMD. Given the overlap of pharmacology with other disciplines, the service could bring ASPET’s content to the attention of audiences that don’t normally think to look at pharmacology journals.

Researchers can use this service to explain their work in plain language and share it with potential readers through email, social media, and academic networks. Summaries provided by authors to Kudos summarize research in a way that can make it more accessible and more likely to be read. An article entry in Kudos provides answers to the questions “What’s it about?” and “Why is it important?”

Over 130,000 researchers have signed up to use Kudos, and more than 230 ASPET articles have been written about by their authors. By working with Kudos, ASPET will make the process easier. The corresponding author will automatically receive an emailed invitation from Kudos when the formatted version of an article goes online. The author can click through to a form that will be prepopulated with the metadata for the article. With the addition of a brief summary, the article will be ready for sharing on social media networks.

Both of these features will go live in June.

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Membership News New Members AFFILIATE MEMBERS Janine R. Appleton, Massachusetts General Hospital George Einstein, Einstein Med Inst, FL Beth Fleck, Neurocrine Biosci, CA Md. Tanvir Kabir, BRAC Univ, Bangladesh Paul A. Moench, Novartis Inst for Biomedical Res, NJ John H. Sausen, Agilent Technologies, WI

REGULAR MEMBERS Wonder K. Abotsi, Kwame Nkrumah Univ of Sci & Tech, Ghana Suresh V. Ambudkar, National Cancer Inst, NIH, MD Karen S. Anderson, Yale Univ Sch of Med, CT Vasily Belov, Massachusetts General Hospital Joe E. Bentz, Drexel Univ, PA Koji Chiba, Yokohama Univ of Pharmacy, Japan John D. Clarke, Washington State Univ Laurie B. Cook, The College at Brockport, SUNY Susan Corey, Univ Puerto Rico Sch Med Marina D'Angelo, PCOM, PA Annarita Di Lorenzo, Weill Cornell Med Coll, NY Onur Duygu, Kent Hospital, AK Ulrich L. Eisel, Univ of Groningen, Netherlands Sally A. El-Awdan, National Res Ctr, Egypt Lori Hazlehurst, West Virginia Univ L. Keith Henry, Univ of North Dakota W. Griffith Humphreys, Bristol-Myers Squibb Pharmaceutical Res Inst, NJ

Marlene Jacobson, Temple Univ Sch of Pharmacy, PA Lixia Jin, Arcus Biosci, CA Partha Kasturi, Univ of Kansas Med Ctr Philip D. Kiser, Case Western Reserve Univ, OH Charlotte Kloft, Freie Univ Berlin, Inst of Pharmacy, Germany Yan Li, Alkermes Inc, MA Willmann Liang, Chinese Univ of Hong Kong Gwen A. Lomberk, Mayo Clinic, MN Kevyn Merten, Univ of Louisville, KY Paras K. Mishra, Univ of Nebraska Med Ctr Fatima Mraiche, Qatar Univ Senthil Natesan, Washington State Univ Bukola O. Oyebanji, Obafemi Awolowo Univ, Nigeria Mark T. Poch, Benedictine Univ, IL Mamoon M. Rashid, Appalachian Coll of Pharmacy, VA Muhammad F. Rasool, Bahauddin Zakariya Univ, Pakistan Darren E. Richard, Univ Laval, Canada Saktimayee M. Roy, Northwestern Univ, IL John M. Seubert, Univ of Alberta, Canada Chien-Chang Shen, Pharmacology Discovery Services Taiwan Ltd. Vinayak Shenoy, California Health Sci Univ Jin-Peng Sun, Shandong Univ, China David L. Vollmer, 4Life Res, UT Kaori Yamada, Univ of Illinois at Chicago

POSTDOCTORAL MEMBERS Adrian P. Campbell, Univ of Michigan Aldo Moreno Ulloa, Ctr for Scientific Res & Higher Educ (CICESE), Mexico Ann Tenneil O'Connor, Nova Southeastern Univ, FL Paramita Pati, Univ of Alabama

GRADUATE STUDENT MEMBERS Dolapo T. Adejumobi, Univ of Arkansas for Med Sci Aisha Alfituri, Univ of Liverpool, United Kingdom Evan Asher, New York Inst of Tech Coll of Osteopathic Med Ashley Blanchard, A.T. Still Univ of Hlth Sci, MO Juliette A. Brown, Michigan State Univ Adrienne M. Bushau-Sprinkle, Univ of Louisville, KY Lizzette D. Cambron, North Dakota State Univ Leslie Cuellar Vite, Case Western Reserve Univ, OH Jia Cui, Univ of Alabama at Birmingham Chelsea DeLeon, Saint Louis Univ, MO Bijay Dhungel, Univ of Queensland, Australia Michelle R. Doyle, Univ of Texas HSC San Antonio Christopher S. Hofmann, Vanderbilt Univ, TN Md. Amin Hossain, Tufts Univ, MA Argel Islas Robles, Univ of Arizona Chanaka N. Kahathuduwa, Texas Tech Univ Waqar Khalid, New York Instof Technology June 2017 • The Pharmacologist

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Nguyen Phuong Khanh, Univ of Saskatchewan, Canada Keyona N. King-Medina, Wayne State Univ, MI Alexandros Kokkosis, Stony Brook Univ, NY Naveen Chandra Kondru, Iowa State Univ Zhen Li, Louisiana State Univ HSC New Orleans Charles S. Lott, Louisiana State Univ HSC New Orleans Jordan A. Marckel, Univ of Cincinnati, OH Fereshteh Movahedi, Roseman Univ of Hlth Sci, NV Pacifique Ndayishimiye, Muhimbili Univ of Health & Allied Sci, Tanzania Austin O'Dea, St. Louis Univ, MO Manisha J. Oza, Shobhaben Pratapbhai Patel Sch of Pharmacy & Tech Mgmt, India Thomas A. Parks, Univ of South Florida Maria Paz Prada, Univ of California, Davis Jhansy T. Rani, Sri Padmavati Mahila Visvavidyalayam, India

Devarajan Rathish, Rajarata Univ of Sri Lanka Md. Rahatullah Razan, Univ of the Pacific, CA Atefehalsadt Seyedan, Univ of Malaya, Malaysia Kristin N. Skubic, Saint Louis Univ, MO Kaitlyn C. Stickel, IUPUI, IN Sachin V. Suryavanshi, Shobhaben Pratapbhai Patel Sch of Pharmacy & Tech Mgmt, India Majid Mufaqam Syed Abdul, Univ of Missouri-Columbia Tesfaye W. Tefera, Univ of Queensland, Australia Rishi K. Trivedi, Louisiana State Univ HSC New Orleans Agu S. Tsekohol, Univ of Agriculture, Nigeria Md. Sahab Uddin, Southeast Univ, Bangladesh Shaoxun Wang, Univ of Mississippi Med Ctr Xiao Zhang, Univ of Mississippi Med Ctr Mariya Y. Zhudeva, Roseman Univ, NV

Congratulations to Drs. Melanie Felmlee and Emily Scott on being the winners of the ASPET 2016-2017 Member-Get-A-Member program raffle. Thanks to the recruiting efforts of our members, we welcomed 43 new members this year through the MGM program. We appreciate your contribution to the growth of ASPET!

UNDERGRADUATE STUDENT MEMBERS Esther H. Bae, Univ of Arizona Matt J. Dick, Univ of Findlay, OH Amanda M. Eichel, Univ of Findlay, OH Michael T. Gee, Univ of Arizona John P. Gotham, Univ of Alabama at Birmingham Megan E. Hawley, Univ of Michigan Caleb Y. Kim, Univ of Arizona Tamee E. Livermont, Univ of South Dakota Amr Maani, Med Univ of Lublin, Poland Patricia Mendonca, Florida A&M Univ Cassandra B. Orahood, Univ of Findlay, OH Alexander Pabon, Univ of Puerto Rico Bayamon Dhvani Patel, D'Youville Coll, NY Aneesh M. Singal, Univ of Vermont Carolyn A. Stine, Univ of Arizona

In Sympathy Alan A. Rubin E.L. Way

As this issue went to press, ASPET learned of the passing of Dr. E.L. Way on June 12, 2017. Dr. Way was a member of ASPET since 1947 and served as ASPET President in 1976.

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Members in the News Achievements, Awards, Promotions, and Scientific Breakthroughs Eric L. Barker, PhD Purdue University College of Pharmacy Eric L. Barker, PhD, professor of medicinal chemistry and molecular pharmacology, and associate dean for research in Purdue’s College of Pharmacy, will become dean of the College of Pharmacy effective July 1, 2017.

Dr. Barker is a distinguished neuropharmacologist and noted pharmacist. His research interests include molecular actions of drugs of abuse and other drugs that affect the brain. Dr. Barker has received grant support from the National Institute on Drug Abuse, National Institute of Mental Health, National Alliance for Research on Schizophrenia and Depression, Lilly Research Laboratories, and the Defense Advanced Research Projects Agency. Dr. Barker has also garnered recognition for teaching medicinal chemistry and pharmacology, having received the Purdue College of Pharmacy Dr. Aziz Outstanding Teacher of the Year Award as well as additional awards and achievements. He is a member of several professional associations, including the American Pharmacists Association and the Society for Neuroscience.

Dr. Barker has been a member of ASPET since 1998, where he has served in leadership positions for the Division for Neuropharmacology. In January 2016, Dr. Barker became editor-in-chief of ASPET’s Pharmacological Reviews.

Helmut Gottlieb, PhD University of the Incarnate Word, Feik School of Pharmacy Helmut Gottlieb, PhD was recently awarded the University of the Incarnate Word Presidential teaching award, the university’s highest teaching award.

Dr. Gottlieb is mainly involved in teaching pharmacology. His current research combines whole animal integrative pharmacology/physiology with functional neuroanatomy and molecular biology to understand the role opioid systems play in the regulation of fluid and electrolyte balance and cardiovascular function. This research is crucial for the prevention and treatment of a number of diseases, as well as to the development of new therapeutics.

Dr. Gottlieb’s work has been published in journals such as the Journal of Pharmacology and Experimental Therapeutics, American Journal of Physiology, Journal of Neuroendocrinology, and Experimental Neurology. He has acquired research funding from NIH and many intramural grants.

Dr. Gottlieb currently serves on the ASPET Division for Pharmacology Education Executive Committee. He has been a member of ASPET since 2008 and is a member of the Divisions for Pharmacology Education, Cardiovascular Pharmacology, Molecular Pharmacology, and Neuropharmacology.

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Michael T. Piascik, PhD University of Kentucky, College of Medicine Michael T. Piascik, PhD was recently promoted to Assistant Dean for Foundational Sciences at the University of Kentucky College of Medicine.

His major role will be to ensure the integration of the foundational sciences throughout the four years of medical school.

Dr. Piascik’s work has been published in several journals, including the Journal of Pharmacology and Experimental Therapeutics, Molecular Pharmacology, Journal of Biological Chemistry, and the European Journal of Pharmacology.

Dr. Piascik has been a member of ASPET since 1985 and is a member of the Divisions for Pharmacology Education, Cardiovascular Pharmacology, and Molecular Pharmacology.

Marxa L. Figueiredo, PhD Purdue University Marxa L. Figueiredo, PhD was recently promoted to associate professor at Purdue University in the Basic Medical Sciences Department.

Dr. Figueiredo’s laboratory in the Basic Medical Sciences Department aims to understand the interactions between the skeletal

and immune systems, with the goal to develop novel therapeutic applications. Her laboratory focuses on integrating biological mechanisms with the development of strategies that can leverage the immune system to simultaneously promote restoration of bone and alter immune responses to control inflammation or cell viability.

Dr. Figueiredo has been a member of ASPET since 2016 and is a member of the Divisions for Cancer Pharmacology, Drug Discovery and Development, Molecular Pharmacology, and Toxicology.

Margarita L. Dubocovich, PhD University at Buffalo Margarita L. Dubocovich, PhD, SUNY distinguished Professor and senior associate dean for diversity and inclusion at the University at Buffalo (UB), has been awarded the UB President’s Medal, given in recognition of extraordinary service to the university. The UB President’s Medal recognizes outstanding scholarly or artistic achievements, humanitarian acts, contributions of time or treasure, exemplary leadership or any other major contribution to the development of the University at Buffalo and the quality of life in the UB community.

Dr. Dubocovich has been an ASPET member since 1983 and is a member of the Divisions for Neuropharmacology, Behavioral Pharmacology, Drug Discovery and Development, Pharmacology Education, and Molecular Pharmacology.

Share your achievements, awards, promotions and scientific breakthroughs with fellow ASPET members.

Send your news to your division’s communications officer: Behavioral Pharmacology: Kevin S. Murnane, PhD at murnane_ks@mercer.edu Cancer Pharmacology: R. Kiplin Guy, PhD at kip.guy@uky.edu Cardiovascular Pharmacology: Rayna J. Gonzales, PhD at rjgonzal@arizona.edu Drug Discovery and Development: Przemyslaw Radwanski, PharmD at Przemyslaw.Radwanski@osumc.edu Drug Metabolism: Lindsay Henderson at lmhender@uw.edu, Yurong Lai, PhD at yurong.lai@bms.com Molecular Pharmacology: Kathryn E. Livingston, PhD at kelsaliv@umich.edu, Amy E. Moritz, PhD at amy.moritz@nih.gov Neuropharmacology: Anil Kumar, PhD at kumaran@umkc.edu Pharmacology Education: Catherine M. Davis, PhD at cdavis91@jhmi.edu Toxicology: Monica Valentovic, PhD at valentov@marshall.edu Translational & Clinical Pharmacology: Naeem K. Patil, PhD at naeem.patil@vanderbilt.edu

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Division News Division for Behavioral Pharmacology Best Presentation Competition Winners (Poster Sessions) In the postdoctoral scientist category, prizes were awarded to Brenda Gannon (1st) from the University of Texas Health Science Center San Antonio and Sarah Withey (2nd) from Harvard University.

In the graduate student category, prizes were awarded to Julie Finnell (1st) from the University of South Carolina and Rachel Altshuler (2nd) from the University of Michigan.

In the undergraduate student category, prizes were awarded to Taylor Spoon (1st) from Temple University School of Pharmacy and Akhila Padi (2nd) from the University of South Carolina.

Division for Cancer Pharmacology Best Presentation Competition Winners (Poster Sessions) In the postdoctoral scientist category, prizes were awarded to Fokhrul Hossain (1st) from Louisiana State University Health Sciences Center and Milu Cherian (2nd) from St. Jude Children's Research Hospital.

In the graduate student category, prizes were awarded to Nathaniel Mabe (1st) from Duke University and Charles Umbaugh (2nd) from Purdue University.

In the undergraduate student category, the top prize was awarded to Alice Allcock (1st) from the University of Bath.

Young Investigators Symposium Winners (Oral Sessions) In the young investigator category, the finalists were Abigail Boyd from the University of South Alabama, Milu Cherian from St. Jude Children’s Research Hospital, Vincent DiGiacomo from Boston University School of Medicine, Fokhrul Hossain from Louisiana State University Health Sciences Center, Amanda Salzwedel

from the University of Minnesota, and Weicang Wang from the University of Massachusetts-Amherst.

Division for Cardiovascular Pharmacology Best Presentation Competition Winners (Poster Sessions) In the postdoctoral scientist category, prizes were awarded to Alessandro Cannavo (1st) from Temple University and Hicham Labazi (1st) from Nationwide Children’s Hospital.

In the graduate student category, prizes were awarded to Puneet Raman (1st) from the University of Arizona College of Medicine-Phoenix, Nicole Hensch (2nd) from Western University of Health Sciences, and Amreen Mughal (3rd) from North Dakota State University.

In the undergraduate student category, prizes were awarded to Raghav Tripathi (1st) from Case Western Reserve University, Trinny Tat (2nd) from the University of Arizona, and Dillion Hutson (3rd) from Tulane University.

Trainee Showcase Winners (Oral Sessions) In the postdoctoral scientist category, prizes for trainee talks were awarded to Sarah Schumacher (1st) from Temple University, Arsalan Syed (2nd) from University of California Davis, and Margaret Zimmerman (3rd) from Tulane University.

In the graduate student category, prizes for trainee talks were awarded to Corina Marziano (1st) from the University of Virginia, Shrinidh Joshi (2nd) from North Dakota State University, and Reem Atawia (3rd) from Medical College of Georgia, Augusta University.

Division Award - Benedict R. Lucchesi Young Scientist Travel Award in Cardiac Pharmacology The winner of this award was Laurel A. Grisanti, PhD, from Temple University.

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5 (1) Division for Drug Metabolism Best Presentation Competition Postdoctoral Scientist Category Winners (2) Division for Molecular Pharmacology Best Presentation Competition Graduate Student Category Winners (3) Division for Neuropharmacology Best Presentation Competition Postdoctoral Scientist Category Winners (4) TCP Young Investigator Awards Platform Session Winners (5) Division for Toxicology Best Presentation Competition Graduate Student Category Winners

Additional pictures of the division best presentation competition winners can be found on the division websites at https://www.aspet.org/divisions/.

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Division for Drug Discovery and Development Best Presentation Competition Winners (Poster Sessions) In the young investigator category, prizes were awarded to Madeline Pantoni (1st) from the University of California San Diego, Dinesh Thapa (2nd) from Dalhousie University, and Rohun Palekar (3rd) from Northwestern University, Feinberg School of Medicine.

Division for Molecular Pharmacology Best Presentation Competition Winners (Poster Sessions)

Best Presentation Competition Winners (Oral Sessions) In the postdoctoral scientist category, prizes were awarded to Erin Calipari (1st) from the Icahn School of Medicine at Mount Sinai, Erin Bobeck (2nd) from the Icahn School of Medicine at Mount Sinai, Matthew Robson (3rd) from Florida Atlantic University, Natalie Scholpa (3rd) from the University of Arizona, and Karen Tonsfeldt (3rd) from the University of California San Diego.

Early Career Independent Investigator Award The winner of this award was Carrie R. Ferrario, PhD, from the University of Michigan Medical School.

In the graduate student category, prizes were awarded to Souvarish Sarkar (1st) from Iowa State University, Amy Chinn (2nd) from the University of California San Diego, Whitney Gibbs (2nd) from the Medical University of South Carolina, Nicholas Griggs (2nd) from the University of Michigan, and Makaia Papasergi-Scott (2nd) from the University of Rochester.

In the undergraduate student category, prizes were awarded to Simran Polce (1st) from the New York Institute of Technology and Krista Lotesto (2nd) from Northeastern Illinois University.

Best Presentation Competition Winners (Oral Sessions) In the postdoctoral scientist category, prizes were awarded to Hannah Stoveken (1st) from the University of Michigan, Matthew Gorr (2nd) from the University of California San Diego, and Jaclyn Wisinski (3rd) from the University of Wisconsin-Madison.

Division for Neuropharmacology Best Presentation Competition Winners (Poster Sessions) In the graduate student category, prizes were awarded to Melodi Bowman (1st) from the University of Texas Health Science Center San Antonio, Colleen Carpenter (2nd) from the University of Michigan, Juliany Marrero Vega (3rd) from the University at Buffalo, Molly McGinnis (3rd) from Wake Forest University Health Sciences, and Eric Wold (3rd) from the University of Texas Medical Branch.

Dr. Ferrario (left) was presented with the Early Career Independent Investigator Award during the ASPET Annual Meeting at EB 2017

by Dr. Beverly Greenwood-Van Meerveld.

Division for Translational and Clinical Pharmacology Best Presentation Competition Winners (Poster Sessions) In the postdoctoral scientist category, prizes were awarded to Benjamin Tourdot (1st) from the University of Michigan, Mohamed Ghonim (2nd) from the Louisiana State University School of Medicine, Jaclyn Wisinski (2nd) from the University of WisconsinMadison, and Jason Conley (3rd) from Purdue University.

In the graduate student category, prizes were awarded to Rachel Fenske (1st) from the University

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Division for Translational and Clinical Pharmacology Continued of Wisconsin-Madison, Cameron Kieffer (2nd) from Creighton University, and Jeffery Wang (3rd) from Louisiana State University Health Sciences Center New Orleans.

Junior Investigator Award The winner of this award was Elaine M. Leslie, PhD, from the University of Alberta.

Young Investigator Awards Platform Session Winners (Oral Sessions) In the young investigator category, prizes were awarded to Jennifer Yeung (1st) from Thomas Jefferson University, Jeremy Miyauchi (2nd) from SUNY Stony Brook, and Robert Helsley (3rd) from the Cleveland Clinic Lerner Research Institute.

Division for Toxicology Best Presentation Competition Winners (Poster Sessions) In the postdoctoral scientist category, the top prize was awarded to Hridganth Donde (1st) from the University of Louisville.

In the graduate student category, prizes were awarded to Dahea You (1st) from Rutgers University, Ryan Mui (2nd) from Michigan State University, and Anthony Jones (3rd) from the University at Buffalo.

Career Award The winner of this award was Curtis D. Klaassen, PhD, from the University of Kansas Medical Center.

Dr. Leslie (left) is presented with the Junior Investigator Award during the TOX mixer at EB 2017.

Division for Drug Metabolism Best Presentation Competition Winners (Poster Sessions) In the postdoctoral scientist category, prizes were awarded to Deepak Bhatt (1st) from the University of Washington, Tao Hu (2nd) from the University of Washington, and Malika Godamudunage (3rd) from the University of Michigan.

In the graduate student category, prizes were awarded to Aaron Bart (1st) from the University of Michigan, John Connick (2nd) from Louisiana State University Health Sciences Center, and Samantha Carlisle (3rd) from the University of Louisville.

Division for Drug Metabolism Has Changed Its Name Earlier this year, the Division for Drug Metabolism voted to change the name of the division to Division for Drug Metabolism and Disposition. The rationale for the change was that the new name was more inclusive. The name change was ratified at the last division business meeting in April and will officially go into effect on July 1, 2017.

Dr. Klaassen accepts the Career Award at EB 2017.

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Division for Drug Metabolism Continued

Early Career Achievement Award The winner of this award was Hyunyoung (Young) Jeong, PharmD, PhD, from the University of Illinois.

Dr. Jeong accepting the Early Career Achievement Award at EB 2017.

James R. Gillette Best Paper Award Each year, the Division for Drug Metabolism presents the James R. Gillette Best Paper Award for two outstanding papers: one for the best paper in drug metabolism and one for the best paper in pharmacokinetics and Dr. Kazui was transporters. The 2016 award awarded the 2016 winners presented their work at Gillette Best Paper Award for Drug the 2017 ASPET Annual Meeting, Metabolism. and each received a cash award and certificate. The Gillette Award honors the late NIH pharmacologist James R. Gillette, PhD (http:// dmd.aspetjournals.org/cgi/reprint/31/12/1474.pdf), who was a scholar, scientist, philosopher, and mentor of pharmacologists worldwide. During his career, Dr. Gillette published more than 300 papers and book chapters and coedited seven books. He was considered a visionary and significant contributor to the field of drug metabolism and pharmacokinetics.

The 2016 Gillette award in the drug metabolism category was awarded for the paper “Human Intestinal Raf Kinase Inhibitor Protein (RKIP) Catalyzes Prasugrel as a Bioactivation Hydrolase,” authored

by Miho Kazui, Yuji Ogura, Katsunobu Hagihara, Kazuishi Kubota, and Atsushi Kurihara. The authors investigated the involvement of hydrolases other than human carboxylesterase-2 (hCE2) in the bioactivation of prasugrel in the human intestine. Prasugrel hydrolase activity was found to be localized in the cytosolic fraction of monkey small intestine as well as the microsomal fraction, which contains CE2. The previously unknown hydrolase in the cytosolic fraction was purified and identified as the Raf-1 kinase inhibitor protein (RKIP) by liquid chromatography-tandem mass spectrometry. Enzyme kinetics suggest that hRKIP is responsible for 40% of prasugrel hydrolysis, with hCE2 contributing the other 60%. RKIP has previously been shown to be involved in protein kinase signaling cascades, but this paper was the first to report that RKIP participates in drug metabolism as a hydrolase.

The 2016 Gillette award winner in the pharmacokinetics and transporters category was “Functional Integrity of the Chimeric (Humanized) Mouse Liver: Enzyme Zonation, Physiological Spaces, and Hepatic Enzymes and Transporters,” Dr. Chow was authored by Edwin C. Y. Chow, awarded the 2016 Gillette Best Jason Z. Y. Wang, Holly P. Quach, Paper Award for Hui Tang, David C. Evans, Albert pharmacokinetics and transporters.

P. Li, Jose Silva, and K. Sandy Pang. The authors examined liver integrity and microcirculation in a chimeric, humanized mouse liver model with the triple knockout of Fah, Rag2, and Il2rg genes on the nonobese diabetic strain background (FRGN), using single-pass perfusion techniques. The study showed that, in the hFRGN liver, sinusoids were more tightly packed with hepatocytes than in normal mouse liver, metabolic zonation was lost, and mouse gene expression persisted, contributing to drug metabolism and transport. Thus, this paper demonstrated unique structural and functional properties of the chimeric mouse liver, which are important factors to consider when using this model as an in vivo tool for studying human drug metabolism.

Submitted by Lindsay Henderson and Yurong Lai

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Division for Pharmacology Education Travel Award for Pharmacology Educators The winners of the Travel Award for Pharmacology Educators were Ashim Malhotra, PhD, Pacific University School of Pharmacy, and Helen O. Kwanashie, PhD, Ahmadu Bello University.

Drs. Helen O. Kwanashie (left) and Ashim Malhotra accept their travel awards during EB 2017.

Division for Pharmacology Education Inducts Three New Fellows into the Academy of Pharmacology Educators The Academy of Pharmacology Educators was established in 2010 to recognize individuals who have made exemplary contributions to pharmacology education in one or more of the following areas: student-teacher interaction, innovative contributions, scholarly endeavors, professional development, and service. Three new fellows were inducted into the Academy during the Division for Pharmacology Education’s meeting at EB 2017. More information about the Academy, including application instructions and a roster of inductees, can be found here: http://www.aspet.org/Education/Academy/.

Dr. Peter G. Bradford received his PhD in biochemistry from the University of Rochester and was an NIH Fellow in Pharmacological Sciences.

Prior to joining the University at Buffalo, he was a research Dr. Peter G. Bradford assistant professor at the Medical College of Virginia and assistant professor at Hahnemann Medical School. His lab-based research focuses on hormonal regulation of signal transduction and gene expression in endocrine systems. He is the author and editor of books entitled Nutrition and Cancer Prevention and Adipose Tissue and Inflammation.

Currently, he is associate professor at the University at Buffalo and serves as course director for principles of pharmacology in the School of Dental Medicine and module co-director for endocrine-reproductive biology in the School of Medicine. He received the Outstanding Dental Educator Award in 2014 and the State University of New York Chancellor’s Award for Excellence in Teaching in 2015. He served as visiting scholar at Beijing Medical University, as a member of the American Dental Association National Board Pharmacology Test Construction Committee, and for eight years as director of graduate studies in pharmacology and toxicology at the University at Buffalo. He is active in continuing dental education, delivering system-wide courses on bisphosphonates, pain management, and drugs commonly used in dentistry. He is actively engaged with ASPET, being co-founder and director for five years of the New York Pharmacology Society chapter of ASPET. He served for ten years as an editorial board member of the Journal of Pharmacology and Experimental Biology.

Dr. Katharina Brandl

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Dr. Katharina Brandl is currently an assistant professor at the University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. She graduated as a pharmacist from the School of Pharmacy at the University of Regensburg in Germany.

Dr. Brandl received her

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Division for Pharmacology Education Continued doctoral degree (summa cum laude) in Regensburg from the School of Medicine in immunology and infectious diseases. After finishing her PhD, she did postdoctoral studies in the laboratory of Dr. Eric Pamer at Memorial Sloan Kettering Cancer Center in New York City and in the laboratory of the recent Nobel-laureate Dr. Bruce Beutler at Scripps Research Institute in La Jolla. During her postdoctoral studies she continued to teach several courses at the University of Regensburg in Germany to achieve the title of a German academic lecturer. Due to her excellent teaching skills and her passion for teaching, she decided to dedicate her career to teaching and the facilitation of teaching to pharmacy students at the Skaggs School of Pharmacy and Pharmaceutical Sciences. She joined the faculty in 2012 and is responsible for the pharmacology education in the Doctor of Pharmacy curriculum. Dr. Brandl serves as a course director in the year-long pharmacology course for second-year pharmacy students. She has been honored with multiple teaching awards including the “Excellence in Teaching Award” from pharmacy students at the School of Pharmacy (2013 and 2016), the “Pharmacology Educator Travel Award” from ASPET, and the “Distinguished Teaching Award” from the University of California, San Diego (both in 2016).

Dr. Brandl’s research mainly focuses on educational innovations in the classroom.

Dr. Craig. W. Clarkson

Dr. Craig. W. Clarkson obtained his undergraduate training at the University of Puget Sound where he graduated with a BS in biology and chemistry in 1977. During his undergraduate years, he worked with a team at the University of Hawaii to refine

HPLC techniques to purify the ciguatera marine toxin that is responsible for causing major health problems in the South Pacific and Caribbean. This project sparked an interest in pharmacology and was the catalyst for causing him to enter graduate school in pharmacology at Northwestern University.

After receiving his PhD in 1982, he completed three years of postdoctoral training at the University of California, San Francisco. In 1985, Dr. Clarkson joined the faculty at Tulane as an assistant professor in pharmacology. Over the years he took on an increasing responsibility for medical and graduate teaching. Following hurricane Katrina, he took over directorship of his department’s MS and PhD programs, and left bench research to devote his time to curricular development. Over the past 30 years, Dr. Clarkson has helped to implement a variety of learner-centered methods of teaching at Tulane, including problem-based learning, team-based learning, just-in-time-teaching, peer instruction, and high-fidelity patient simulation. More recently, he has developed an open access wiki learning resource (Pharmwiki) that contains drug monographs, case-based learning modules, and interactive selfassessment quizzes designed to foster self-directed learning in medical pharmacology. He has been the recipient of 18 academic awards at Tulane, including the School of Medicine and University’s top awards for excellence in teaching.

The Division for Pharmacology Education considers it a privilege to add these three educator scholars to the roster of the Academy of Pharmacology Educators and is greatly appreciative of their many contributions to the discipline.

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2017 Division Mixers ASPET members attended division-sponsored mixers at EB 2017 to network and socialize with friends and colleagues. Several divisions held their award presentations and recognized their out-going leadership at the mixers.

View our photo collection from the 2017 annual meeting on Flickr: http://bit.ly/2pOiCov

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Chapter News Great Lakes Chapter 30th Annual Meeting, June 23rd, 2017 The Great Lakes Chapter (GLC) of ASPET will hold its 30th Annual Scientific Meeting on Friday, June 23, 2017 at the University of Illinois, Chicago, Moss Auditorium, College of Medicine Research Building.

Dr. Stephen Miller The goal of the 2017 meeting is to highlight major advances in the pharmacological understanding and treatment of immune diseases and provide an opportunity for students, postdoctoral fellows, and scientists working in related areas to learn about the field. The annual meeting of the GLC also provides a forum for learning and exchanging ideas in all fields of pharmacological sciences and is a major networking event for biomedical scientists in the area. The meeting schedule includes: • Poster Session (8:30AM – 10:30AM) • Vendor Exhibit (8:30AM – 12:00PM) • Young Investigator Symposium (10:45AM – 11:45AM) • Lunch & Learn Career Workshop (12:00PM – 1:30PM) • Symposium: Advances in Pharmacoimmunology (1:30PM – 5:00PM) Keynote: Dr. Stephen Miller, Northwestern University From bench to bedside: Translation of a novel nanoparticle approach for tolerogenic therapy of autoimmune and allergic diseases Speakers: Dr. Jochen Salfeld, AbbVie Dr. Anne Sperling, University of Chicago Dr. Dolly Mehta, University of Illinois, Chicago Dr. Gustavo Martinez, Rosalind Franklin University • Poster Awards & Business Meeting (5:00PM – 5:30PM) Check the GLC website www.aspet.org/GLC for more information about the 30th annual GLC meeting.

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Spot the Difference

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