TU RAQA 50th Anniversary Book by Carl Wydra

Legacies of

RAQA

Temple University School of Pharmacy

Edition

History of the Temple University School of Pharmacy

RAQA Graduate Program 1968 to Present

History of the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance Graduate Program Published: October 2019 Author: Wendy Lebing, MALD, MS Designer: Carl Wydra

Disclaimers All rights reserved. Temple University is solely responsible for the content of this publication, which may not be copied or reproduced in part or in its entirety without the express consent of Wendy Lebing and the Regulatory Affairs and Quality Assurance (RAQA) Graduate Program of Temple University’s School of Pharmacy.

During the past fifty years, many individuals have contributed to the growth and success of the RAQA graduate program. This history, written using original source materials, attempts to summarize contributions of some of the key individuals who played a vital part in the program’s remarkable evolution. While it was not possible to name every Steering Committee member, instructor, lecturer, site administrator, HR director, technical person, or other individual who helped to push the program forward, Dean Doukas and Assistant Dean Lebing are deeply grateful to everyone who participated in the program’s development and success. It is their hope that the RAQA program continues to attract many more outstanding leaders, instructors, and students in the years to come.

Regulatory Affairs and Quality Assurance Graduate Program Temple University School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034 267.468.8560 www.temple.edu/pharmacy_QARA

Legacies of the Temple University School of Pharmacy • RAQA Edition

Table Of Contents

Foreword from Dean Peter Doukas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 RAQA Program Timeline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 History of the Temple University School of Pharmacy RAQA Graduate Program Beginnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Esprit de Corps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Academic Innovation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Program Growth and Expansion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Distance Learning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 FDA Conferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Prestigious Endowment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Pharmacovigilance and International Partnerships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Consistent Curricular Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Academic Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Affiliated Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 RAQA Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Outstanding Faculty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 RAQA Graduation Timeline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 In Gratitude from Assistant Dean Wendy Lebing, MALD, MS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Legacies of Temple University School of Pharmacy • RAQA Edition

Foreword

This document is the second of a newly launched series of testimonial pieces entitled, “Legacies of Temple University School of Pharmacy,” to celebrate and memorialize the people and initiatives that have had a lasting and transformational impact on the evolution and development of the School of Pharmacy. We herein celebrate the 50th Anniversary of the School of Pharmacy’s graduate program in Regulatory Affairs and Quality Assurance (RAQA) in the form of a historical narrative to establish the record for posterity and to illuminate the individual efforts that coalesced to construct and develop an academic program unique to Temple as well as among the many schools of pharmacy across the nation. The ascension of digital technology now affords a limitless capacity to store and dissect “data”, to distill transactions and outcomes into tabular bits and fragments, often unfortunately devoid of context and texture and of the roles that individuals play through their accumulated actions in creating opportunities that animate, sustain and enhance a successful enterprise. It is with an eye towards a narrative description of events therefore that we undertook this project, as a gesture of deep appreciation and respect for the many colleagues and friends whose efforts and work-product from many points of reference combined to create, strengthen and diversify this program which has become one of the central elements of the School of Pharmacy’s academic identity. The common thread that runs throughout the evolution and delivery of the RAQA program has been that of an extraordinary level of cooperation between three inter-related sectors of activity: academia, industry, and the regulatory process. This collaborative effort has been consistently supported by both industry and FDA leadership, and has been effected through the actions of numerous individuals animated both by a sense of loyalty to their operational domains and by a desire to impart the sinews of quality and integrity to future leaders of the drug discovery and development process: to “pay forward” as much as possible those elements that have nurtured the creation and delivery of therapeutic entities upon which all of us depend to assuage the adversities of health that we may encounter during our life’s trajectory. The School of Pharmacy has been most fortunate to engage in partnership outstanding professionals from the pharmaceutical and biotechnology corporate sectors, and the U.S. Food and Drug Administration at every level of the RAQA program, as counselors, steering committee members, and as adjunct faculty. The assets they continue to bring to the classroom dialogue are priceless for they impart a nuanced texture to the discussions that is informed by many years of work experience. The document that follows this brief introduction bears testimony to the fruits of an extraordinary collaborative enterprise over several decades, a true synthesis of what is best within the educational mission and the personal motivation of those entrusted by their industry and regulatory imperatives to achieve a quality of outcomes that meets the highest of social expectations in order to ensure the future well-being of others. At the core of this enterprise for three decades has been the fidelity to academic excellence and the prodigious work ethic of Assistant Dean Wendy Lebing. Through exceptional teamwork and collaboration she has synthesized a blend of over 100 outstanding industry-based instructors and a small group of dedicated staff into a premier professional graduate program for hundreds of working adults each semester through a customer-focused approach. In addition to her profound qualities of personal character, Assistant Dean Lebing has accomplished all of the foregoing through the exercise of integrity, initiative, originality, consistency, and a deep commitment to the founding principles of this University. Wendy Lebing has exhibited the highest level of leadership that has resulted in this celebratory milestone and for which I extend my deepest appreciation. Peter H. Doukas, PhD

Legacies of Temple University School of Pharmacy

RAQA Program Timeline 1968 to 2019

1968 - Dr. Murray Tuckerman of Temple University School of Pharmacy (TUSP) launches a graduate program in Quality Assurance specifically for pharmaceutical professionals. 1988 - The School of Pharmacy moves QA courses to a weeknight format at the Ambler Campus. 1990 - Dr. Peter Doukas, Acting Dean of the School of Pharmacy, meets with Mr. Drew at Merck to discuss the need for the QA program. He creates a Steering Committee of pharmaceutical industry executives to address whether the program should be continued. Dr. Murray Tuckerman

1991 - First QA Steering Committee meeting is held and unanimously endorses revitalizing the QA program. The first Regulatory Affairs (RA) electives are added to the program’s curriculum. The Committee suggests incorporating RA into the program’s name. 1993 - The Merck Company Foundation, Wyeth Ayerst Corporation, and Lemmon Company provide substantial development grants to help the School of Pharmacy redesign the QA program. 1994 - Starting with 30 students in 1990, QA/RA now has 250+ students and offers 15 courses a semester. Temple’s Board of Trustees formally changes the program’s title to: Master of Science in Quality Assurance and Regulatory Affairs (QA/RA). Dr. Ronald Gaultieri

1995 - Weekend courses and pharmaceutical science offerings are expanded. The first QA/RA diploma celebration is held at Temple University Ambler. The first program guide for RAQA is published. 1996 - Members of the Philadelphia District of the FDA speak at the Spring QARA Open House. Thanks to funding from the Merck Foundation’s new Challenge Grant, eight new courses are added to the RAQA curriculum. The first certificate (Drug Development) is launched.

Dr. Peter H. Doukas

1997 - Certificates in Medical Devices, Basic Pharmaceutical Development and the Post Master’s Certificate in Advanced QA and RA are launched. QA/RA courses move from the Ambler Campus to Temple University Fort Washington. 1998 - Wendy Lebing is appointed Director of QA/RA Outreach to oversee the development of distance delivery. The QA/RA website is created. The Clinical Trial Management Certificate is created. The School of Pharmacy is selected by the Pfizer Education Board to provide QA/RA courses to their sites. It is possible to complete the entire MS on weekends. Summer scheduling is expanded. 1999 - QA/RA meets with FDA Commissioner, Jane Henney, and Temple University is selected to broadcast an FDA Stakeholders’ Meeting on April 28, which is sent via satellite across the nation. The QA/RA Office moves to Fort Washington.

Wendy Lebing

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2000 - The first conference, Creating New Knowledge: FDA & Industry in Dialogue is held with keynote speakers Dr. Janet Woodcock, Director of CDER, and David Blois, Vice President of Worldwide RA, Merck Research Laboratories. Dr. Woodcock speaks at the QA/RA diploma celebration. 2000 - Video conferencing rooms are installed at Temple University Ft. Washington exclusively for QA/RA courses. The Non-Thesis MS in Pharmaceutics is launched. The demand for QA/RA courses continues to grow. QA/RA now provides live and/or video-conference courses to eleven sites on the East Coast and Mid-West. 2001 - Over 400 participants attend the second FDA & Industry in Dialogue conference. Wendy Lebing is appointed Assistant Dean for QA/RA. Mr. Edward Griffith, ASQ Biomedical Division, presents a grant to the program to purchase additional video conferencing equipment for its distance delivery. 2002 – 2004 QA/RA sponsors its third, fourth and fifth conferences, Creating New Knowledge: FDA & Industry in Dialogue. Demand for QA/RA courses continues to grow, which are delivered to nearly 30 corporate or other sites across the country, spanning four time zones. 2006 - The sixth Conference, Creating New Knowledge: FDA & Industry in Dialogue, is held. Dr. Steven Galson, Director for CDER, speaks on an Update from the FDA on Current Trends and Concerns. The FDA Alumni Association (FDAAA) selects Temple University’s School of Pharmacy for a prestigious endowment, creating the FDAAA Centennial Scholarship, exclusively for QA/RA students. (In 2018, the scholarship is renamed the James S. Benson FDAAA Centennial Scholarship). 2007 - The MS in QA/RA may be completed entirely online. QA/RA publishes Centennial Journal: A Time Capsule of Presentations given at the FDA & Industry in Dialogue Conferences (2001 -2006). Certificates in Global Pharmacovigilance: Benefit/Risk Assessment and GMPs for the 21st Century are launched. 2008 - An MOU is signed with the National University of Singapore (NUS) to deliver QA/RA courses to their graduate students. The final FDA & Industry in Dialogue conference is held. 2012 - By early 2012, 160+ students at NUS complete QA/RA courses. RAQA delivers courses to the Ministry of Health in Cairo, Egypt, and Hyderabad, India. The first QA/RA Career Night is held.

• RAQA continues to be the largest, most comprehensive and best recognized graduate program of its kind.

• Currently the program offers 13 Certificates and over 80 courses, 70 of which are available online.

• Over 2000 individuals have received the MS in RAQA since the program’s inception and continue to be leaders in regulated industry.

2014 - QA/RA announces a Certificate in Labeling, Advertising and Promotions. 2015 - QA/RA changes its name to Regulatory Affairs and Quality Assurance (RAQA). The School of Pharmacy launches the first MS degree in Global Clinical and Pharmacovigilance Regulations for students with PharmD and MD degrees. 2016 - RAQA announces three Certificates: Food Regulatory Affairs and Quality Assurance, Sterilization Process Manufacturing, Biopharmaceutical Manufacturing and Regulatory Affairs (Biotechnology). 2019 - RAQA introduces the first comprehensive graduate certificate in Validation Science, which encompasses Quality Science principles with hands-on applications. Fall 2019 - RAQA celebrates its 50th anniversary. A PhD program in Pharmaceutical Sciences with a concentration in RAQA is announced. The first QA Steering Committee

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Early Advocates

BEGINNINGS In 1990, no one would have imagined that Temple University’s School of Pharmacy would develop the nation’s foremost academic graduate program in Quality Assurance and Regulatory Affairs within a decade. In fact, Temple came perilously close to shutting down its Pharmaceutical Quality Assurance (QA) degree that year. The Graduate School conducted a comprehensive review of all University master’s programs, and the QA curriculum simply didn’t mesh with traditional academic degrees. Since the Master of Science (MS) in QA was the only one of its kind in the U.S., with no precedent or counterpart at other academic institutions, even Dr. Adelaide Van Titus, Dean of Temple’s Pharmacy School, agreed to end the program that fall. Temple’s School of Pharmacy had pioneered graduate education in QA. Created in 1968, the program was the brainchild of Dr. Murray Tuckerman, Professor of Pharmaceutical Chemistry, who worked with the Philadelphia District of the U.S. Food and Drug Administration and local drug companies to develop the outlines of the program. The pharmaceutical industry had boomed since World War II, and a need evolved for advanced education beyond the traditional disciplines of engineering, business, law, and the sciences. Creating an academic QA master’s degree to instill industry’s quality practices was a timely idea. The original QA curriculum drew from different University programs and included several electives in Pharmaceutical Sciences taught primarily by Dr. Tuckerman. Over time he created and taught a course on Good Manufacturing Practices and added Food and Drug Law to the curriculum. In the 1970s and early 1980s, the QA program attracted a handful of students annually. Courses were only available to full-time students during the day at the School of Pharmacy on North Broad Street, so students often took a leave of absence from work to pursue the degree. Even class registration was done in person at the Pharmacy School. A unique group of advocates emerged in 1990, saving the MS in QA from certain demise. On January 2, 1990, Robert (Bob) T. Drew1 at Merck Sharp & Dohme Research Laboratories in West Point, PA, wrote a letter to Dean Van Titus expressing concern over

1 Director of Quality Assurance, Regulatory Standards, and Regulatory Affairs, Merck and Company Research Laboratories.

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the rumors circulating that the QA graduate program would be discontinued. The letter was copied to Peter J. Liacouras, President of Temple University, who eventually forwarded it in July 1990 to Dr. Peter H. Doukas, the recently appointed Acting Dean of the School of Pharmacy. With a PhD in medicinal chemistry, Dr. Doukas began his career at the University in the early 1970s, mentoring several generations of pharmacy students. When his first presidential directive was to decide the fate of the QA degree, Acting Dean Doukas traveled to Merck to meet Bob Drew in person and ask, “Is there any need for this program?” Mr. Drew responded with an emphatic “Yes!,” which was echoed by a roomful of Merck employees eager to complete the QA master’s program. Acting Dean Doukas proposed the model2 of forming a QA Steering Committee of senior executives from local pharmaceutical companies. With the assistance of Dr. Thomas W. O’Connor, Associate Dean of the School of Pharmacy, and Ms. Wendy Lebing, Director of Marketing for Temple’s Ambler Campus, the following individuals were invited to participate: Robert Drew Dr. David W. Blois, Executive Director for Regulatory Affairs, Merck and Company Thomas Kirsch, Senior Director Regulatory Practice, Worldwide, McNeil Pharmaceutical, Johnson and Johnson Company Doris Conrad, Director, Quality Assurance Merion, SmithKline Beecham Dr. Elizabeth D’Angelo, Director, Medical and Clinical Affairs, ICI Pharmaceuticals Christopher Kowtna, Associate Director, Regulatory Affairs, the DuPont Merck Pharmaceutical Company Dr. William Hitchings, Vice President Scientific Affairs, Rhone-Poulenc Rorer Dr. George M. Irwin, Vice President of Quality Assurance, Wyeth-Ayerst Dr. Richard Kaplan, Director, Regulatory Compliance, Centocor Francis Butler, Director Quality Assurance U.S., Sterling Research Group Members of the Temple administration included: Dr. Peter H. Doukas Dr. Thomas O’Connor Dr. Ronald Gautieri, Director of Graduate Studies James Blackhurst, Dean of Temple University’s Ambler Campus Bonnie Frumer, Assistant Dean for the Ambler Campus Wendy Lebing

Ms. Lebing had studied international relations at the Fletcher School of Law and Diplomacy, part of Harvard and Tufts, where she earned a Master of Arts in Law and Diplomacy (MALD). While waiting to take the Foreign Service exam, she pursued a “temporary” job at Temple’s Ambler Campus, gaining experience in scheduling, curriculum, and marketing, which turned into a full-time position. Her roles at the first QA Steering Committee meeting were organizer, hostess, and scribe. She took copious notes, which included a quote from Mr. Drew: “In ten years, many companies sitting at this table won’t exist, since the cost of developing drugs will become so huge that only giant mergers will survive.” Noted in the margins of her notes were the question: “GMP? GCP? IND? Strange language.” Temple University was strategically located in the heart of the Delaware Valley’s burgeoning pharmaceutical industry. A QA master’s degree was sorely needed, but its curriculum required a complete overhaul. The Steering Committee voted unanimously to save the program and subsequently met twice a year in an advisory role to discuss industry trends, needed curricular changes, and to identify possible content area experts to serve as adjunct faculty.

As a faculty member in the 1980s, Dr. Doukas had utilized this model to create a successful medicinal chemistry training program to develop post-B.S. chemists for positions in the pharmaceutical industry.

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Curricular Expansion

ESPRIT DE CORPS Over time, the Steering Committee developed a remarkable camaraderie, welcoming new members, such as Dr. Robert Mathews,3 Dr. Charles J. Swartz,4 Ms. Susan Galle,5 Dr. Peter Hoenig,6 Mr. Jonathan Parker,7 and Dr. Alexander Giaquinto8. Rather than approaching meetings as corporate competitors, participants became colleagues, generously donating time, expertise, and ideas to develop this unique academic curriculum. Each meeting consisted of open discussions that embraced new proposals for courses and curricular ideas. Importantly, Bob Drew at Merck, George Irwin at Wyeth, and Ronald Nedich at Lemmon9 helped to provide program-development funds through foundation and corporate resources. Without this financial support, the program would have come to a standstill at Temple. Simultaneously, Dr. O’Connor and Ms. Lebing visited local pharmaceutical companies to gather valuable insights on industry trends and educational needs and to speak to prospective students. A synergy blossomed between the School of Pharmacy and the corporate sector. Rapid response to the Steering Committee’s suggestions was key to the program’s success. The program was run more like a business than a typical graduate program, expanding its curriculum with a speed uncommon in academia. Each semester new electives were created, such as Quality Audit, Good Laboratory Practices, and Computer Validation, gradually forming a true QA curriculum. As regulatory affairs courses were proposed and developed, such as IND/NDA Submissions and CMCs and the Regulatory Dossier, the Steering Committee advocated renaming the program QA/RA or Quality Assurance/Regulatory Affairs, which was officially approved by Temple’s Board of Trustees in Fall 1994.

A synergy blossomed between the School of Pharmacy and the corporate sector. 1 10

Vice President of Quality Assurance, Merck Research Labs. Senior Director of Regulatory Affairs and Acting Director of Quality Assurance at the R. W. Johnson Pharmaceutical Research Institute and Ortho Biotech, Inc., in Raritan, NJ. 5 Ms. Galle was a student in the QA program working at ESPS at the time. 6 Vice President, Risk Management, Merck Research Laboratories. 7 Senior Coordinator of Regulatory Strategy for Pfizer Central Research, Pfizer Inc. 8 Senior Vice-President, Worldwide Regulatory Affairs, Schering-Plough Research Institute. 9 Mr. Nedich joined the Committee in 1993, and Lemmon eventually became Teva. 4

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ACADEMIC INNOVATION Along with Dr. O’Connor, Ms. Lebing assumed administrative responsibility for the program in the early 1990s while working full-time at the Ambler Campus. Having authored a short history of the Ambler Campus, she was inspired by Jane Bowne Haines, founder of the first U.S. horticultural school for women in the early 1900s, which was eventually acquired by Temple University. The QA program was an opportunity to help mold another special educational program nearly a century later. Ironically, the first QA/RA office was in the Ambler Campus Haines House, one of the original buildings of the Pennsylvania School of Horticulture for Women. As the program developed in the 1990s, it became a model of academic and industry collaboration. At the University, it also became a prototype for professional master’s programs and eventually its success was copied by other pharmacy schools across the country. In the late 1980s, QA day classes were moved to evening times at Temple University’s Ambler Campus, but Ms. Lebing pushed for more change and conveniences. Having extensive scheduling experience at Ambler, she was used to fitting courses from a dozen University schools and colleges into limited room space.10 Scheduling was critical to a successful academic program. Adjustments needed to be made to the prevailing University grid to accommodate the schedules of full-time industry professionals. Ms. Lebing established a 10-week term, while satisfying contact-hour requirements. Make-up sessions were added to each course, which helped to entice industry leaders to teach, since they could reschedule lectures if they ran into unexpected travel during the semester.

Mr. Robert Drew

Other student-friendly conveniences were initiated, such as phone and fax registration, saving students unnecessary trips to Temple. Sylvia McNally, who started working with Ms. Lebing at the Ambler Campus as a “temp” in 1989, became a permanent employee in 1990 and the backbone of these services, handling countless registrations and student problems with grace and patience. In the early days, she had to walk QA/RA registrations to a different building at

Gail Pilgrim, Assistant Counsel with Rorer Group, Inc., in Collegeville, PA, had started teaching Food and Drug Law in 1985. She followed in the footsteps of Sidney H. Willig, a professor at Temple’s Law School who initially taught the course. Having served as counsel at the Sterling Drug Company for more than 45 years, he was a pioneer in the specialized area of pharmaceutical food and drug law. Ms. Pilgrim continued the tradition of teaching pharmaceutical law with passion and conviction. When Ms. Pilgrim subsequently accepted a position as Senior Regulatory Counsel for Burroughs Wellcome in NC, she proposed traveling to Ambler to teach on Saturdays, creating the first QA weekend course in 1991. She remains the longest serving instructor in the program. Within a few years, QA/RA was offering its entire master’s degree through a combination of weeknights and weekends.12 These Saturday and Sunday classes enabled students from the eastern seaboard and Midwest to travel to Philadelphia on a Friday night and pursue two courses (6 credits) scheduled on a weekend grid.

Professor Gail Pilgrim

the Ambler Campus for processing, where the registrar would invariably remind her that students were supposed to come to campus and register themselves.

Scheduling at the Ambler Campus in the early 90’s was akin to putting a size 10 foot in a size 5 shoe; there were more classes than rooms. Typically, University classes met for fifteen consecutive weeks in the fall and spring semesters and summer grids of seven weeks of classes meeting two nights a week. 12 QA/RA was the first University program to offer a master’s degree entirely on weekends as well. 11

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Marketing Marketing was central to the program’s success. Open Houses were held where local FDA representatives and Steering Committee members spoke on current industry issues. A bi-annual newsletter, QA/RA: Information and New Developments, was launched. Initially a mailing of each semester’s schedule, the newsletter eventually featured articles written by FDA personnel (Karyn Campbell, Diana Kolaitis, Debra Pagano, Thomas Gardine, and Janet Woodcock) and executive summaries of students’ research projects. With the tagline, “It’s About Quality. It’s About Time,” the program’s brochures and newsletters won national awards.13 Carl Wydra, graphic designer, created the majority of the program’s advertising. During the 1990s, he worked for Temple’s Publications Department, collaborating with Ms. Lebing in the creation of a marketing campaign for the Ambler Campus, which won a Special Finalist Award in a major international advertising competition.14 Carl Wydra continues to design much of the marketing for the School, which included launching its Facebook page in 2013. The QA/RA homepage was created in the late 1990s. Initially constructed by Robert Farley in the Publications Office and written by Ms. Lebing, it soon needed the daily attention of a webmaster, as it quickly grew into one of the University’s largest websites. Robert (Rob) E. Barsky soon served as webmaster, creating seventeen corporate-specific homepages.15 When it was time to post semester schedules, Rob needed two weeks to upload the dozens of site-specific schedules and registration forms. He even created the first password-protected “websites” for QA/RA faculty,16 years before Blackboard or Canvas existed.17 In 2015, it became necessary to rename the QA/RA program, largely because of search engine optimization protocols: Google didn’t recognize the “slash” in Quality Assurance/ Regulatory Affairs (or even QA/RA). Even worse, all of the website pages had the words “Quality Assurance/Regulatory Affairs” embedded in untitled artwork, which prevented the program name from coming up in Google searches.18 At that point, with Board approval, QA/RA became RAQA or Regulatory Affairs and Quality Assurance, since people searching online for programs of this type typically looked for “Regulatory Affairs.” 13

QA/RA won two merit awards in the Thirteenth Annual Admissions Marketing Award contest. The 1998 AME (Advertising Marketing Effectiveness) Awards, which had 12,000 entries from 52 countries. The winners in their category that year were Master Card’s “Priceless” and Volkswagen’s “Come Together” campaigns. 15 How these multiple websites developed is described in more detail below. 16 Some elements of Rob’s QA/RA website are still used today. 17 After Rob’s untimely death in 2008, Ms. Lebing volunteered to assume responsibility for the website. She received 45 minutes of training on HTML and was largely self-taught on creating and updating pages. For years, she never changed Rob’s original links until she took a course on Search Engine Optimization and realized that the hundreds of links needed to be renamed. She continues to be the webmaster. 18 Plans are underway to develop a new device-friendly RAQA website. 14

12 1

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Proponents and Partners

PROGRAM GROWTH AND EXPANSION Chris Kowtna teaching a course on Good Manufacturing Practices.

Dr. Charles Swartz

George Irwin

In many ways, the original “founders” of QA/RA education were Chris Kowtna, George Irwin and Charles Swartz. 14

In the early 1990s, several Steering Committee members served as the program’s faculty. In many ways, the original “founders” of QA/RA education were Chris Kowtna, George Irwin and Charles Swartz, who created the model of blending industry practice with academic rigor. Drawing from his years in manufacturing, Chris Kowtna studied the content of the original GMP course offered by Dr. Tuckerman, then developed a series of more technical courses, including Medical Device GMPs,19 Acceptance Sampling, and Statistical Quality Control. Chris was kind, accommodating, and very enthusiastic about rebuilding the QA/RA program. On top of a demanding work schedule that involved extensive travel, he dealt with serious health issues, yet always found time to call Ms. Lebing almost weekly to report his latest ideas for courses. George Irwin and Charles Swartz were also intrinsic players in the evolution of the QA curriculum. George Irwin suggested and taught Advanced GMPs and Non-Sterile Process Validation.20 Dr. Charles Swartz proposed the need for IND/NDA Submissions and International Drug Regulatory Affairs, then volunteered to teach them. The information these industry gurus imparted to their students was legendary. Students invariably commented that they took their course notebooks to work as references. By 1993 there were already 17 electives in QA and RA topics. As word of the revised and expanded QA/RA program spread, graduates came forward to develop electives. Jonathon Parker created courses in Labeling and Advanced Labeling. Dr. Sandra Cottrell envisioned the need for Drug Development and created such a seminal overview that it became a program requirement. Susan Galle launched a separate version of the course one semester later. Dr. Peter Smith created Good Laboratory Practices. Kevin Malobisky and Randall Brenner redesigned IND/NDA Submissions. Marcia Arentz completely restructured the early medical device courses, adding one on Global Regulations and formed an outstanding certificate in the area which she continues to teach. Dr. Thomas Schultz redesigned Pharmaceutical Manufacturing I to reflect current industry practice and eventually created Regulatory Science: Managing the Guidelines for Quality. Dan Casaburi developed numerous electives focusing on sterile products. Janis Little designed a course in Clinical Drug Safety. Wylie McVay, Michael LaBruto and Brad Diehl offered 19

Created and first taught in 1990. George Irwin’s photograph appeared on all of the original QA/RA marketing pieces as well. 20

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new electives focusing on manufacturing quality issues. Teresa Preziosi, Sarah Van Valkenburg, and Michael Kaufer, all certified SQA auditors, restructured Quality Audit. Alexa Smith launched a new course in Global Pharmaceutical Excipient Regulation. Joseph Quinn redesigned the Bioprocess Basics course, adding a true RA focus. Tamara Ely taught GMPs, and Daniel Larkins taught Global Regulatory Affairs. Denise Adelman redesigned Clinical Data Management. Daniel Walsh launched a highly popular version of Bioethics. Donna Marron team taught with Jonathan Parker. Barbara Fanelli taught courses on labeling regulation in tandem with several industry professionals. With Gerrit Jan-Nijeldt, she developed Global Labeling Regulation. Jeffrey Sheldon returned to focus on project management topics. Others received their Temple degrees from different programs, such as Dr. Cynthia Ciliberto, who earned her PhD in Chemistry or Dr. Michael McGraw, who earned his PharmD from Temple School of Pharmacy. Graduates developed a loyalty to the program that transcended being alumni; they wanted to be contributing partners in this educational venture, training the next generation of Regulatory and Quality professionals. 21 Graduates to join the faculty more recently include Mario Rubio-Morengo, Robert Arbaugh, and Stacy Wilson. Over time, prominent individuals from industry or FDA also came forward to teach outstanding courses, including Dr. Frank Diana, Dr. Kris Barnthouse, Dr. Rayanne Berman, Dr. John Clark, William Collentro, Nicole Cossrow, Dr. Frank DeLuccia, Robert Dettery, Sean Develin, Dr. Lionel Edwards, Dr. Andrew Fletcher, Dr. Jane Goeke, Craig Hammes, Doug Hisey, Kim Huynh-Ba, Dr. James Krupa, Dr. Michael Lusty, Donna Marron, Maryann McKendry, Lynn Miko, Kathleen Moran, Dr. Thomas Parry, Dr. Jurij Petrin, Preeti Pinto, Paul Savidge, Dr. Nancy Smith, Dr. Ronald Snee, Dr. Kenneth Surowitz, Alan Traettino, Dr. Donald Wallace, Andrew Walsh, Debra Weiss, Dr. Karen Weiss, Dr. Elora Weringer, Jeffrey Werrmann, and Beverly Zaber. Though not an exhaustive list of the faculty, these individuals consistently received outstanding reviews from their students for their command of the subject matter and their engaging teaching style. The Philadelphia District of the Food and Drug Administration (FDA) and the FDA’s Center for Drug Evaluation and Research (CDER) played vital roles in the program’s evolution as well. Debra Pagano and Karyn Campbell (Philadelphia District) created an outstanding course on Pre-Approval Inspections; George Pyramides (Philadelphia District) united with Dr. Frank Diana, 22 to create the first FDA/industry team-taught course.23 Rick Friedman and Kris Evans from CDER proposed and taught Microbiological Concepts in Pharmaceutical Manufacturing. FDA District Directors Diana Kolaitis and Tom Gardine encouraged their staff members to speak at QA/RA events and classes. Philadelphia District Director Kirk Sooter and Matt Noonan helped to create a certificate in Food Regulation and Quality Assurance. Most recently, the tradition of close

Karyn Campbell

collaboration with the local FDA has continued with the assistance of Anne Johnson, [Director, Philadelphia District Office (PA, DE) and Division Director, Bio-Research Monitoring Division 1 (East)], who is an integral participant in RAQA graduation exercises. From the beginning, industry and FDA worked together to form the essential elements and spirit of cooperation that dominate the program.

MaryAnn McKendry and Beverly Zaber

By late 1998, Ms. Lebing left the Ambler Campus administration to work full-time for the School of Pharmacy, implementing QA/ RA distance learning. In order to gain first-hand knowledge of the classes and curriculum, she also enrolled part time in the QA/ RA master’s program. Upon receiving the degree in 2001, she was promoted to Assistant Dean for Quality Assurance and Regulatory Affairs, implementing additional changes with the assistance of the Steering Committee and the faculty. The GMP requirement was replaced with a GxP requirement. Students were given the option of taking IND/NDA Submissions as an MS requirement rather than

Other graduates who have returned to teach include Dennis Ahern, Dom Reigle and Frank Stevenson. Director of Analytical Technology, DuPont Pharmaceuticals Company. 23 Pharmaceutical Laboratory Quality Systems and Operations. 22

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Certificates just Quality Audit. Required courses were limited to four, so students could pursue electives which were relevant to their career paths. Ms. Lebing also launched graduate certificates to provide students with more academic choices. These four- and five-course programs enabled students to explore an industry sector without committing to the entire master’s degree. They also provided credentials for a cluster of area-related courses, in case students changed companies or were relocated. Certificates were designed so students could complete them, take several years off and then return to finish their degree, counting all of the certificate credits towards the master’s program – an innovation soon copied by other schools.

The first certificate was Drug Development,24 which consisted of four courses, three of which were required: Drug Development, Food and Drug Law, and Good Manufacturing Practices. Since those courses were also required for the MS in QA/RA, students completing the certificate simultaneously finished all but one of the degree requirements. Other certificates quickly followed: Basic Pharmaceutical Development, Clinical Trial Management, and Medical Devices. Previous graduates petitioned to take the new elective courses, so a Post Master’s Certificate in QA and RA was created. Currently the program offers 13 certificates at the pre- and post-master’s levels. Recent additions are more science-based, including Biopharmaceutical Manufacturing and RA (Biotechnology), Sterile Process Manufacturing, and Validation Science.

A Certiifcate in Food RA and QA was added to the program in 2013.

The Validation Science Certificate combines scientific principles, theory, and hands-on learning.

Originally called The Basic Study Program.

Dr. Thomas Genova and Dan Casaburi were the creators of the Sterile Process Manufacturing Certificate launched in 2014.

Dr. David Lebo created the GMP laboratory at the School of Pharmacy and was the driving force behind the Certificate in GMPs for the 21st Century (which was recently renamed: Pharmaceutical Manufacturing: Process Development and Analysis.

Dr. Frank Diana was one of the designers of the Certificate in Biopharmaceutical Manufacturing (Biotechnology).

Along with Dr. John Clark, Dr. Nicole Cossrow has been an integral part of the certificate in Global Pharmacovigilance: Benefit-Risk Assessment.

After graduating with the MS in QA/RA, Marcia Arentz designed the Medical Device Certificate, which continues to be highly regarded in the device industry. 17

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Video Conferencing

DISTANCE LEARNING As recognition of the QA/RA program spread, students and companies inquired about “remote learning.” With a full-time staff of three,25 the program was not ready for the plunge - but dove in anyway. In the late 1990s, a Merck site in Georgia was the first to request a group of courses for its employees, suggesting delivery through video conferencing, since their company used that technology for intra-corporate meetings. It was a deceptively easy solution for remote class transmission, but there was a major snag: the Ambler Campus used a brand of video conferencing equipment that was almost incompatible with the one used in Georgia. Even when QA/RA hired Verizon technicians to establish video conference calls between the two sites, transmissions could easily go awry with inclement weather or site personnel touching the wrong dial. This early, “clinical trial” in distance learning unveiled some of the challenges to be navigated.

“Congratulations Wendy and team for your tremendous vision, leadership and dedication. This is a fabulous program that continues to enrich the Pharma/ biotech industry with talent, experience, and passion. Thank you!” – Kevin Malobisky, PhD, Senior Vice President, Achillion Pharmaceuticals Inc.

The next attempt was with Searle Labs in Skokie, Illinois. One of their employees, Norb Dryjanski, had commuted to Temple University on weekends to complete his MS in QA/RA degree, becoming the program’s first distance graduate. He asked Ms. Lebing if there were ways to deliver the program to his colleagues. The Searle video conferencing equipment was compatible with Temple’s, but Ms. Lebing realized that numerous protocols had to be developed for remote classes, including ways to assure the academic integrity of exams. “Student leaders” were identified in each class to help with initiating video conference calls. Exam protocols were developed, including how graded assignments must be sent, opened, administered and collected, to assure that no one had unsupervised access to test questions. Shortly afterward, Pfizer invited Dean Doukas and Ms. Lebing to submit a proposal to deliver QA/RA courses to students at their well-known Groton site in New England. Thanks to the enthusiastic support of Jonathan Parker,26 Temple was selected to launch graduate courses on site to Pfizer employees. Before the first schedule was even finalized, Pfizer New York and Pfizer Ann Arbor demanded access to the courses with Pfizer La Jolla and Pfizer Kalamazoo following soon after. The QA/RA Office was formally established in Fort Washington, and Dave Brickett was hired in 2002 to equip new videoconference rooms from scratch and to oversee all QA/RA remote class transmissions.

Wendy Lebing, Sylvia McNally, and one administrative assistant.

18 26 Senior Coordinator, CNS Regulatory Strategy & Registration at Pfizer Global Research & Development.

History of Temple University’s School of Pharmacy

Distance Delivery 1998 to 2010

MD DE

VA NC

GA CALIFORNIA Pfizer La Jolla, CA CONNECTICUT Alexion, Cheshire, CT Pfizer Groton, CT Pfizer New Haven, CT Pfizer New London, CT DELAWARE AstraZeneca, Fairfax (Wilmington), DE AstraZeneca, Newark, DE GEORGIA Merck, Flint River Plant, Albany, GA ILLLINOIS Abbott Labs, Waukegan, IL Chicago, College of Lake County, Lake Cook, IL Pharmacia, Skokie, IL Searle Labs, Skokie, IL INDIANA AstraZeneca, Mount Vernon, IN DePuy, Warsaw, IN Zimmer, Warsaw, IN Lily, Indianapolis, IN Bristol-Myers Squibb, Mount Vernon, IN MARYLAND Shire, Owings Mills (Baltimore), MD

MASSACHUSETTS Genzyme, Framingham, MA Pfizer Andover, MA Pfizer Cambridge, MA Wyeth Biopharma, Andover, MA Wyeth Cambridge, MA MICHIGAN Pfizer Ann Arbor, MI Pfizer Kalamazoo, MI MISSOURI Centocor, St. Louis, MO KV Pharma, St Louis, MO Pfizer St. Louis, MO Wyeth St. Louis, MO NEW JERSEY Bristol-Myers Squibb, Hopewell, NJ Bristol-Myers Squibb, Lawrenceville, NJ Bristol-Myers Squibb, New Brunswick, NJ Pfizer Bridgewater, NJ Pfizer Morris Plains, NJ Schering-Plough, Kenilworth, NJ Pfizer Peapack, NJ NEW YORK Bausch & Lomb, Rochester, NY Becton-Dickinson, Franklin Lakes, NY Bristol-Myers Squibb, Syracuse, NY Forest Labs, Farmingdale, NY

Pfizer New York, NY Pfizer Pearl River, NY Tarrytown, NY Wyeth Pearl River, NY NORTH CAROLINA GlaxoSmithKline, Durham, NC Merz, Greensboro, NC Pfizer Rocky Mount, NC Pfizer Sanford, NC Wyeth Sanford, NC OHIO Roxane Labs, Columbus, OH PENNSYLVANIA Bucks County Community College, Newtown, PA Frazer, PA Pfizer Collegeville, PA Sanofi Pasteur, Swiftwater, PA Pfizer Littitz, PA Wyeth Collegeville, PA Wyeth Marietta, PA RHODE ISLAND Amgen, West Greenwich, RI VIRGINIA Boeringer-Ingelheim, Petersburg, VA Pfizer Richmond, VA Wyeth Richmond, VA

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Evolution of Online Learning Dr. Andrew Clair27 at Pfizer New N York was determined to bring b the program to his site, eventually e teaching courses in Drug D Development, Good Clinical ic Practices, and IND/NDA Submissions S that were broadcast c to other Pfizer sites. He also a launched a highly popular u course in Industry Interactions a with FDA and Health Authorities. A At Pfizer Groton, n numerous individuals came Dr. Andrew Clair forward to teach, notably Jonathan Parker, who taught numerous courses and also developed an elective in Advanced Labeling. Dr. Joseph Scavone was also among the original Pfizer instructors and continues to teach his popular course in Clinical Trial Management today. He also teaches students in the School’s PharmD program. Dr. Carol Cronenberger continues to team-teach Pharmacology and Pharmacokinetics with Kevin Sweeney. 28 James Bammert also continues to teach Requirements for Product Labeling and Advertising. By the early 2000s, QA/RA was delivering courses to more than twenty-five corporate sites nationwide, which the program’s administration visited on a regular basis.29 Course scheduling was akin to a three-dimensional chess game accommodating different time zones, each site’s curricular needs, and whether videoconference systems were compatible – let alone coordinating logistics with different HR representatives and technical personnel at every location. Some courses were broadcast to six or more sites simultaneously, making the monitors displaying remote students look like the opening credits of the Brady Brunch.30 Ms. Patricia Lee became involved with the program in the late 1990s, working in the office as a student while finishing her Temple undergraduate degree. Her outstanding work ethic, attention to 27

As scheduling of video conferencing became more challenging each semester, the administration looked for alternate solutions. Though many for-profit schools had jumped into online delivery, the learning process was usually passive: schools made recordings of lectures, which were available 24/7, and students watched recordings at their convenience. There was little if any discussion of classroom materials. The School of Pharmacy knew that this model wouldn’t work for QA/RA, since a mechanical reading of FDA guidances didn’t illuminate the complexity of implementing RA and QA tenets, let alone compare ways the FDA and different corporations interpreted and applied good practices. The QA/RA curriculum demanded a system that preserved learning through discourse that dated back to the times of Socrates, where a series of questions led to deeper, critical thinking for answers. Any recorded QA/RA lecture could quickly become dated, even after just one

Senior Medical Director, Pfizer New York. Others faculty at Pfizer sites included Craig Audet, C. Evan Boswell, Jeffrey Chasnow, Don Costello, Wesley Day, Susan DeCorte, Wayne Frost, Rady Johnson, Ross Lobell, Justin McCarthy, Jeffrey Miceli, Patrick Mickevicius, Firoz Nilam, Gail Pilgrim, Armelde Pitre, Drusilla Scott, Kevin Sweeney, Elora Weringer, and Gary Wilson. 29 Site visits were a form of “quality audit.” By speaking with students at various corporations, Assistant Dean Lebing received first-hand information about curricular and technical needs as well as overall satisfaction with the program. She visited each site at least once every year or two and continues to travel extensively for the program. She is thankful for the numerous “site” coordinators who helped with registration, identifying classrooms, securing technicians, including Denise Jedinak at Roxane Labs (Columbus, OH), Penny Levin at AstraZeneca, Julie Duerr, Susan Berlam, and Gail Turner at Pfizer Groton, Barbara Munk at Pfizer Ann Arbor, Nancy West at Pfizer Kalamazoo, and MaryJo Pizollo at Pfizer New York. 30 Not only was there a schedule of classes for 25 different sites, but there were additional schedules of video conference numbers for each classroom at every site, which Ms. Lebing gladly handed to David Brickett when he arrived on the scene. 28

detail, and Zen-like calm were tremendous assets, and within a few years of being hired full-time, she was promoted to Assistant Director for QA/ RA, mastering the complex scheduling of the program. Over time she implemented the use of surveys to determine the course needed at each site. She also helped to launch the program’s first Career Night in 2012, based on a suggestion from Rob Yeaton of Clockwork Consulting in Jonathan Parker Boston. This annual event enables students and graduates to meet with companies that are actively recruiting. It includes presentations from faculty and industry experts on job-search techniques, including resume writing, interviewing skills, and the use of social media.

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semester. QA/RA continued to search for an appropriate online delivery platform. Handling multiple sites on a video conference call was also expensive and fragile. Video conferencing in the early 2000s was conducted through telephone lines, with up to six separate phone lines required per site. Though it was possible to deliver the same class to multiple students, transmission quality could be compromised. Depending on the phone line integrity, video-conferencing often had a 3-second delay between the moment something happened at the site of origin and when it was received across the country. The more sites, the longer the delay. Visual images were usually transmitted more quickly than audio, creating the visual dissonance of sound not matching the speaker’s lip movements. The QA/RA program tried multiple online platforms. At times, the formats changed in rapid succession each semester – and even within a semester. Delivery options ran the gamut of sending VHS tapes of individual classes to students worldwide,31 to web streaming,32 to Horizon – Wimba and Breeze,33 and finally to Adobe Connect.

By 2007, it was possible to complete the MS in QA/RA entirely online, providing an interactive learning experience, where students could see and hear their professors in live lectures, view class PowerPoints, and communicate through instant messaging or microphones. Within a little more than a decade, the number of courses offered online escalated from five to seventy.

Professor Barry Berger and NUS students.

Regardless of what technology David Brickett and Assistant Dean Lebing identified and suggested, Dr. Karen Zimm34 was always the first to incorporate the latest innovation in her classes. After completing the QA/RA program in 2002, she quickly developed and taught an impressive array of courses.35 Temporary, technical glitches never phased her. If a class transmission didn’t work, she would propose a quick fix – whether it was traveling to the QA/RA Office to make a recording or scheduling a makeup class. When QA/RA started video conferencing courses to the National University of Singapore in 2009, Dr. Zimm immediately agreed to offer her course between 10:15 pm and 12:30 am on Friday nights, often with her daughter Mollie playing and falling asleep under her mother’s desk. Dr. Zimm’s willingness to test new technology extended beyond teaching platforms: in 2011-12, she helped QA/RA launch Software Secure, an online proctoring system.36 She has mentored many of the faculty on numerous technologies, including Adobe Connect, Blackboard, and Canvas, demonstrating best practices in online teaching.

During several semesters, the QA/RA program recorded and sent VHS tapes to several dozen students, making the Office resemble a mailing house with piles of tapes, address labels, boxes, and twice daily visits to the post office. Students were required to return tapes to the QA/RA Office; sometimes Dave Brickett found that an episode of The Sopranos had replaced the original lecture sent to the student. 32 An early form of transmitting a class over the Internet, where remote students could see and hear the live class but couldn’t participate, so multiple teleconference lines were set up. 33 Early forms of Internet transmission that promised a “Live Classroom” environment, though often fraught with bandwidth issues. 34 Dr. Zimm originally was a pharmacist, then earned a PhD in Pharmaceutics in 1996 and immediately started working as a Scientist in the pharmaceutical industry. 35 Dr. Zimm teaches Good Manufacturing Practices, Advanced Good Manufacturing Practices – defining “c”, and Pharmaceutical Manufacturing II. She also designed and teaches Active Pharmaceutical Ingredients and Scale-Up and Post Approval Changes (or SUPAC which subsequently became PAC). 36 The first form of online proctoring required students to swipe their finger for identification and use a 360-degree “orb” camera that photographed everything in their room, including the ceiling and the floor.

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Conferences

FDA CONFERENCES In late 1998, the FDA Philadelphia District Director, Thomas Gardine, invited Dean Doukas, Associate Dean O’Connor, and Ms. Lebing37 to make a fifteen-minute presentation to FDA Commissioner Jane E. Henney about the QA/RA graduate program. The FDA was planning a live satellite transmission in April with Commissioner Henney and CDER Director, Dr. Janet Woodcock speaking on the implementation of the FDA Modernization Act (FDAMA). Temple University was being considered as one of the sites for the satellite link. A few months later, Dr. Nancy Smith, Marcia Trenter, and Elaine Frost38 of CDER’s Office of Training and Communication (OTCOM) visited and selected Temple’s Philadelphia campus as an appropriate venue. The satellite broadcast occurred in the Kiva Auditorium of Temple University’s Main Campus from 12:30 pm to 6:00 pm, where participants had the opportunity to call questions in to the Commissioner. Afterwards, the School hosted a reception for staff from OTCOM and the Philadelphia District, celebrating the flawless program delivery.

Steering Committee member Thomas Kirsch gave an address at the QA/RA Commencement Celebration, suggesting that FDA and industry lacked opportunities to hold open dialogues about needed changes. 37

Dr. Woodcock delivered the keynote address41 and so enthusiastically embraced the theme of dialogue that she joined the audience and posed questions to other CDER and industry speakers. The high-level CDER speakers included Dr. David Lepay42, Dr. Murray M. Lumpkin43, Dr. Randy Levin44, and Linda Carter45, speaking on a variety of timely topics.46 The conference featured a session given

Then Director of QA/RA Outreach and Program Development. Respectively, Director, Special Assistant, and Special Assistant for Television Production Services. 39 Vice-President, Regulatory Practices and Global Clinical Quality Assurance, R. W. Johnson Pharmaceutical Research Institute. 40 Karyn Campbell from the Philadelphia District created the title for the conferences. 41 Cooperative Efforts Between FDA & Industry: Where Might Efficiencies be Realized? 42 Director, Division of Scientific Investigations, Office of Medical Policy. 43 Deputy Center Director for Review Management. 44 Associate Director for Electronic Review, Office of Review Management, Team Leader, Division of Neuropharmacological Drug Products. 45 Associate Director for Regulatory Affairs, Office of Drug Evaluation. 46 Clinical Research Quality and Integrity, Fast Track Drug Development, Electronic Submissions for NDAs, INDs, and Safety Information to FDA, FDA interaction with Non-U.S. Agencies and Mutual Recognition Agreements, and Financial Disclosure. 38

That same year, Steering Committee member Thomas Kirsch39 gave an address at the QA/RA Commencement Celebration, suggesting that FDA and industry lacked opportunities to hold open dialogues about needed changes. Mr. Kirsch’s speech was the seed kernel of Temple’s ground-breaking FDA/Industry conference (entitled Creating New Knowledge: FDA & Industry in Dialogue40 ) first held on April 4, 2000, at Temple’s Liacouras Center with over 300 attendees.

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by the Philadelphia District Office on Agency expectations and current findings of field officers.47 Joseph X. Phillips from the FDA Central Office presented on Mutual Recognition Agreements. An equally impressive array of industry speakers participated, including Dr. David Blois48, Thomas Kirsch, Christopher Milne49, Dr. Michael Brennan50, Richard Davis51, and Dr. Robert Folger.52 QA/RA and School of Pharmacy faculty served as moderators and panelists, enhancing the depth and breadth of the frank exchanges. In many ways, the conference mirrored the QA/RA classroom on a larger stage, as students and graduates posed questions directly to CDER or industry leaders about new challenges just on the horizon (Electronic Submissions, Financial Disclosure, and Fast Track Development). The same spirit of camaraderie that marked the QA/RA Steering Committee quickly infused this initial conference. Opinions were posited and discussed in the true academic spirit, and new, controversial ideas were considered. Everyone entered the forum as equals with open minds, listening to colleagues’ opinions. This first conference enabled leaders of industry and government to hold open discussions and use critical thinking to find possible solutions. The event was so memorable that participants demanded an encore, resulting in six more conferences between 2001 and 2008. Each year’s topics arose from the iterative process between the

Dr. Janet Woodcock

Steering Committee, QA/RA faculty, and CDER leadership that was facilitated by Assistant Dean Lebing. Each year she worked closely with Dr. Nancy Smith and Ms. Marcia Trenter of CDER, while simultaneously discussing possible industry speakers with

Celebrating the successful satellite transmission of the CDER Statkeholders’ Meeting, April 28, 1999. Left to right: Susan Setterberg, Peter Liacourse, Dr. Nancy smith, Thomas Gardine, Dr. Janet Woodcock, Dean Peter Doukas.

Steering Committee members. In particular, Jonathan Parker, Dr. Peter Hoenig, and Thomas Kirsch helped to refine conference topics and identify the industry experts selected to give talks or serve as panelists. After 2003, Dr. Alexander Giaquinto53 played the major role in shaping the conferences. After joining the Steering Committee in 2001, Dr. Giaquinto invited QA/RA to teach classes on-site at Schering-Plough in fall 2002. Soon many conference topics were often his brainchild – and he helped to identify appropriate industry speakers and panelists, which meant an endless barrage of phone calls or emails from Assistant Dean Lebing. The topics raised at the seven FDA and Industry in Dialogue Conferences now read like a history of early 21st century regulation. Themes included • Risk Management in FDA Decision Making, • Safety Surveillance, • Pediatric Exclusivity, • Common Technical Document, • Counter Terrorism, • BSE in Manufacturing, • Product Security, for Drugs and Biologics, • New Labeling Guidance and Direct-to-Consumer Advertising, • GMPs for the 21st Century Initiative, • Counterfeit Drugs, • Generic Drugs and Citizens’ Petitions, • European Clinical Trials Directive, • PDUFA III.

47 Speakers included Susan Laska (Drug Investigator), Anthony Charity (Drug Investigator), Jean Blackston Hill (Inspectional Review Chemist), Debra L. Pagano (Pre-Approval Program Manager), and Karyn M. Campbell (Compliance Officer). 48 Vice President, Worldwide Regulatory Affairs, Merck Research Laboratories. 49 Senior Research Fellow, Tufts University Center for Drug Development. 50 Director of Electronic Submissions and Regulatory Communications Group, SmithKline Beecham Pharmaceuticals. 51 Senior Vice President for Quality Assurance and Compliance, The DuPont Pharmaceuticals Company. 52 Senior Associate Director, Regulatory Strategy and Registration, Head of International Liaison, Pfizer Central Research, Pfizer, Inc. 53 Senior Vice-President, Worldwide Regulatory Affairs, Schering-Plough Research Institute.

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Conferences

Thomas Kirsch

Not only did CDER’s top leadership participate as speakers and panelists, but Dr. Woodcock and Mr. Gardine encouraged their CDER and Philadelphia District staff to attend. The all-star cast from FDA and industry discussing the latest regulatory concerns attracted participants from across the U.S. After the second year, the event was moved from the University’s Liacouras Center to various hotels in center-city Philadelphia, where close access to Amtrak trains made travel to the conferences more convenient. The topics and speakers soon attracted participants from Europe and Japan; a large delegation from China’s SFDA also attended one year. Each conference ended with a reception and jazz band where participants could meet speakers and panelists to continue discussions. The QA/RA FDA and Industry in Dialogue conferences were an unparalleled success. All of them were organized and run by the small QA/RA staff, who selected the venues, created the marketing and advertising, processed ticket payments, arranged for travel, set up the AV, and attended to the hundreds of other details engendered by a large event.

Wendy Lebing

Anthony Charity, U.S. FDA

To celebrate the FDA’s 100th anniversary in 2006, QA/RA published the Centennial Journal: A Time Capsule of Presentations, a collection of some of the outstanding presentations given at the conferences, based on recordings that were subsequently transposed and edited. Initially Ms. Jean Westbrook Leavitt was hired by QA/RA to transpose the speeches from the original conference tapes, a huge job, since many were barely audible. Over time, she was hired to become the Coordinator of Student Records, a permanent part-time position that includes organizing all of the materials for the master’s applications. The selection of speeches in the Centennial Journal: A Time Capsule of Presentations provides a representative snapshot of the thinking on drug development by FDA and industry thought leaders at the turn of the 21st century. In early 2000, electronic submissions were still in their infancy and participants forming the Mutual Recognition Agreements were at odds about what type of paper to use. The Centennial Journal still reflects how history is often determined by seemingly irrelevant details which either become insurmountable obstacles or demand leaders to emerge and provide the inspiration and vision for true cooperation.

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Scholarships

PRESTIGIOUS ENDOWMENT In 2006, Robert W. Sauer from the FDA Alumni Association (FDAAA) met with Dean Doukas and Assistant Dean Lebing to discuss a possible scholarship endowment for the School of Pharmacy. To mark the Centennial Celebration of the Pure Food and Drugs Act, the FDAAA wished to establish a scholarship that would encourage academic training in regulatory and quality issues. Led by Mr. Sauer, John C. Villforth, and James S. Benson, the FDAAA appealed to its members and corporate sponsors for contributions to the fund. After a substantial endowment was raised, Mr. Sauer visited schools offering Regulatory Affairs graduate programs across the country to determine which one should receive the FDAAA scholarship. Since its earliest days, Temple’s QA/RA program had worked closely with the FDA as evidenced by the series of conferences, the Centennial Journal, and the number of FDA students and faculty involved with the program. Temple’s program also focused on QA and RA, spanning the full gamut of pharmaceutical products, medical devices, and food. Importantly, Dean Doukas and Assistant Dean Lebing proposed using all scholarship funds to support students who pay out of pocket for their education. The QA/RA program was selected to receive the prestigious endowment, naming the scholarship the FDAAA Centennial Scholarship.

The FDAAA decided to establish a scholarship that would encourage academic training in regulatory and quality issues. 26

Since the inception of the scholarship, more than 100 deserving students from industry and FDA have received funding to pursue their courses, certificates, and degree programs. When the Centennial Journal: A Time Capsule of Presentations was published, all proceeds from sales were added to the FDAAA Scholarship fund. When the 2006 and 2008 FDA and Industry in Dialogue conference revenues exceeded expenses, the monies were deposited into the scholarship fund. In 2013, Dean Doukas and Assistant Dean Lebing met with Mr. Sauer to establish a separate scholarship that would be specifically earmarked for an FDA employee. Sadly, in 2017, Mr. James S. Benson passed away. To remember his tireless work on establishing the endowment, the FDAAA membership unanimously voted to rename it the James S. Benson FDA Alumni Association Centennial Scholarship, which continues to help so many RAQA students pursue their graduate degrees.

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Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Global Outreach

PHARMACOVIGILANCE and INTERNATIONAL PARTNERSHIPS In the fall of 2005, Assistant Dean Lebing wrote to Dr. Janice Bush54 about identifying an appropriate industry expert to design and teach a course focusing on Post Marketing Safety Surveillance. Dr. Bush suggested Dr. Stephen Klincewicz55, whom she described as “a physician with a lot of safety experience.” Assistant Dean Lebing was soon to learn he was also an individual with boundless enthusiasm and generosity. Within minutes of being introduced through email, Dr. Klincewicz volunteered to teach with Dr. Adrian Thomas56, since they had already “worked together doing educational programs globally and … [with] several health authorities in Latin America and Asia over the past year.” Dr. Klincewicz added, “we would prefer to donate any remuneration that might be due for the course to the student scholarship fund.” The course content that Dr. Klincewicz and Dr. Thomas designed was surpassed only by their equally creative delivery methods. Frequently traveling abroad, they fearlessly challenged the traditional capabilities of video conferencing and laptops by devising unique ways to broadcast course lectures. They also invited experts across the globe to speak to QA/RA students about the current concerns in pharmacovigilance. Over the next few months, Dr. Klincewicz proposed developing other courses in the area of Global Pharmacovigilance, working with Assistant Dean Lebing, the Steering Committee and other QA/RA faculty in creating learning outcomes and possible topics. Under his leadership, Johnson and Johnson provided several generous grants to the QA/RA program, which resulted in late 2007 in the creation of the first Certificate in Global Pharmacovigilance: Benefit-Risk Management. Dr. Klincewicz also introduced Dean Doukas and Assistant Dean Lebing to Sui Yung Chan, Head of the Pharmacy Department at the National University of Singapore (NUS) and her colleague, Professor Wai Keung Chui, who were visiting the Philadelphia area. NUS was encouraging its Schools and Departments to develop partnerships with educational institutions around the world. NUS had already approached a few other U.S. schools offering RA programs but were disappointed 54

Dr. Bush had spoken on Risk Management at the 2004 FDA and Industry in Dialogue Conference. In fall of 2005, her title was Vice President of Quality, Education & Business Support of the Benefit Risk Management Department of the Johnson & Johnson Pharmaceutical Research and Development L.L.C. 55 Vice President of Benefit Risk Management at Johnson & Johnson Pharmaceutical Research and Development. 56 Dr. Thomas was Vice President of Benefit-Risk Management of the Johnson & Johnson Medicines & Nutritionals Group, overseeing operations, informatics and support for companies operating outside the U.S.

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when monetary concerns immediately dominated the conversations. The School of Pharmacy immediately envisioned the opportunity for QA/RA students to learn more about ASEAN (Association of Southeast Asian Nations) regulation. A year later, Dean Doukas and Assistant Dean Lebing journeyed to Singapore with Dr. Klincewicz to tour the impressive facilities and meet the delightful staff at NUS. The administration of the two Pharmacy schools proposed a partnership and worked together on the terms of the Memorandum of Understanding, which was signed within a year.

the joint Certificate in Pharmaceutical Manufacturing and Drug Development offered by the two schools.58 The administrations from QA/RA and NUS discussed further joint collaborations, including a unique degree program in Pharmaceutical and Regulatory Sciences, which would have consisted of half of the courses being taught at NUS and the other half through the QA/RA program. Though the degree was approved by Temple’s Graduate School and Board of Trustees, a change in leadership at NUS prevented the proposal from coming to fruition.

The first QA/RA courses were delivered to NUS in the Spring 2009 semester with two courses taught from the QA/RA classrooms on Friday nights from 8:00 pm – 12:15 am. Due to the 12hour time-difference, students in Singapore were watching the courses on Saturday mornings (8:00 am – 12:15 pm). The first QA/ RA instructors to participate in the international delivery were Dr. Karen Zimm and Dr. Michael McGraw, who transmitted their classes from the Fort Washington site. It wasn’t unusual for Dr. Zimm (who taught the 10:15 pm course) to arrive home well after 1:00 am. The following fall, Professor Barry Berger, Dr. David Lebo, and Dr. Thomas Schultz taught additional courses delivered solely to Singapore audiences, which included graduate students in pharmaceutical science and professionals working for the local Singapore pharmaceutical industry. Under Dr. Sui Yung Chan’s leadership, the partnership was highly successful, spanning a little over a decade, with Professor Berger, Dr. Zimm, and Dr. McGraw offering the majority of courses to NUS students.57 In 2010, Dr. Chan invited Dean Doukas and Assistant Dean Lebing to participate in the 105th anniversary celebrations for NUS, featuring an international conference on Pharmacy in Asia that highlighted educational programs throughout the ASEAN region. In lieu of attending in person, Assistant Dean Lebing delivered a presentation via video conferencing that focused on the educational scheduling grid used for creating and delivering the QA/RA graduate program across the U.S. and world. In 2012, a delegation from Singapore visited Temple University, including the Honorable Lawrence Wong, Minster of State for Education and Defense, and Eng Chye Tan, Provost of the National University of Singapore. The delegation had been arranged by Provost Hai-Lung Dai to inaugurate a broad educational partnership between NUS and Temple University. Dean Doukas and Assistant Dean Lebing were invited to give a presentation on the NUS/Temple partnership, demonstrating how over 160 students from Singapore had completed QA/RA courses, with nearly a dozen receiving

The signing of the MOU between NUS and the Temple University School of Pharmacy.

Nonetheless, individual students from Singapore continue to pursue the School of Pharmacy’s MS in RAQA. Also in 2012, QA/RA delivered a series of courses to an educational site in India. Courses started at 8:00 am in the U.S. so students in Hyderabad could participate in classes after work at 5:30 pm their time. The students sat together around a crowded table, eager to learn all they could about U.S. regulations. Eventually the students traveled to the U.S. to complete their MS degrees at the RAQA site in Fort Washington, PA. Later that fall, thanks to the efforts of Dr. Magid Abou-Gharbia,59 a group of courses was delivered to the Ministry of Health in Cairo, Egypt, also through video conferencing. Lectures were taught in the morning at Fort Washington, so professionals at the Ministry of Health could view them late afternoon their time. Though the courses carried no academic credit, the Ministry of Health students displayed an amazing tenacity and dedication to their studies, distinguishing themselves with a 100% pass rate and earning the equivalent of A’s in exams. Even during the protests in Cairo in late 2012 and early 2013, the students never missed a

In 2011, Professor Berger also visited Singapore during a vacation. Dr. Chan and Assistant Dean Lebing arranged for him to give a presentation to an audience of over 150 students and government officials. 58 When she began her presentation, Assistant Dean Lebing placed a small statue of the Singapore Merlion on the conference table. 59 Former Vice President of Wyeth, Dr. Abou-Gharbia was appointed Professor of Medicinal Chemistry and Associate Dean for Research at the School of Pharmacy and Director of the Moulder Center for Drug Discovery Research. He established a partnership with the Future University of Egypt as well as the Ministry of Health in 2012.

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Global Outreach lecture, since they felt the training was so valuable to their professional development. Between 2013 and 2014, Dean Doukas and Assistant Dean Lebing met with Chief Executive Officer of the U.S. Pharmacopeia, Dr. Roger L. Williams, and other staff (including Nelufar S. Moharjeri) in Rockville, MD, to discuss global delivery of academic curricula and training sessions. Within a year the U.S. Pharmacopeia launched a Consortium Series of lectures by various U.S. RA schools that was open to participants across the globe. The session sponsored by QA/RA included Dr. David Lebo speaking on GMPs for the 21st Century – Case Studies of Quality by Design, and Professor Berger discussing FDA Enforcement Remedies and Trends. Assistant Dean Lebing also presented a short overview of the QA/ RA graduate program.

In 2019, another new venture was launched in partnership with KENX, which offers high-level training conferences in Quality and Regulatory Science areas. The founder of KENX, 60 Mr. John Kirchner, reached out to Assistant Dean Lebing in 2017, offering to donate scholarship funds to RAQA as his way of encouraging education and giving back to industry. In late 2017, Dean Doukas

and Assistant Dean Lebing attended a KENX Computer Validation Conference in Washington, D.C., and were impressed by current, hands-on content presented as well as the participation of RAQA faculty, graduates, and students. After numerous discussions, RAQA and KENX formed a partnership, which allows students to earn a maximum of 3 credits for attending KENX conferences and completing graded assignments. The first conference providing that option was one on Laboratory Integrity held in Philadelphia in June 2019 with another following on GMP issues in San Diego in August 2019. In many ways, the KENX conferences return to the model of RAQA education originally conceived by Temple University School of Pharmacy: professionals from different companies attend class together to discuss and debate industry issues, network, and learn as much from one another as they do from instructors. KENX conferences provide an immersive learning experience, where students ponder a particular industry discipline over three days, even iinvolving lunch ffocus groups. The KENX/RAQA partnership p provides yet ano other convenient sscheduling opttion for working professionals purp ssuing their graduaate education. Sui Yung Chan, Wendy Lebing, Robert Palaima.

Knowledge Exchange Network.

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Academic Excellence

CONSISTENT CURRICULAR REVIEW The challenge of maintaining the top-ranking RAQA program is that regulations and industry practice change frequently, making a static curriculum an elusive, if not impossible goal. Just as industry must audit itself, a viable RAQA curriculum must perform regular and consistent curricular reviews to assure that the faculty’s courses, learning objectives, and exams, reflect the most current practices. Dr. Richard Kaplan was hired to be the program’s first Academic Coordinator from industry, serving from the 1990s through the early 2000s. He helped to define the program’s original Mission Statement and advised students on the then required “Research Project.” He contributed a column, Kaplan’s Corner, to the Information and New Developments newsletter, and also taught Quality Assurance in Research and the first Quality Audit (which became a required course in the program). For a eight years, John Zenno61 assisted with curriculum issues, analyzing course and certificate proposals, as well as resumes of prospective instructors. He also created a lengthy assessment of the core learning objectives of all required RAQA MS courses.

Many individuals have helped with the development of the curriculum. 61

Since spring 2016, Dr. Thomas Genova62 has helped Assistant Dean Lebing with detailed reviews of the RAQA curriculum. Dr. Genova created the High Purity Water Systems course in 1999, along with other courses in sterile products. At his suggestion, the program launched a certificate in Sterile Process Manufacturing, which involved discussions with Dan Casaburi. Dr. Genova also worked with key faculty63 in developing Validation Science, the first academic certificate which identifies validation practices as a science and which also combines philosophical discussions along with hands-on application. In addition, Dr. Genova helped with structuring the Certificate in Biopharmaceutical Manufacturing and RA (Biotechnology). He approaches every curricular project with his meticulous, engineering mindset: charts are constructed of learning objectives, syllabi, and the amount of time devoted to each topic. Other reviews have included the Global Pharmacovigilance curriculum to ensure it continues to reflect current industry practices.

John was also a graduate of the RAQA program and was the Director of RA and QA, at Takeda America Research and Development Center, Inc., Princeton, NJ, before establishing his own consulting firm. 62 Dr. Thomas Genova was the Worldwide Team Lead for the implementation of ICH Q9 within Johnson & Johnson Pharmaceuticals. 63 The idea of creating a certificate on validation was first discussed by Assistant Dean Lebing and Erik Muegge, Manager, Operations Quality – Dallas, Abbott Diagnostics Division. The group involved with creating the certificate included Kris Barnthouse, Teresa Preziosi, Matt Noonan, and Greg Kleinert. Assistant Dean Lebing coined the term Validation Science for the program.

RAQA Edition

Associate Professor Linda Bowen has had an equally powerful impact on the review and analysis of Regulatory Affairs courses. Her involvement with the RAQA program dates back to the late 1990s, when she served as a guest lecturer in a Global Regulatory Affairs course and received such outstanding reviews that it became evident that she should be the sole instructor for that course, which was offered on weekends Students invariably commented that the 8 hours of class time flew by, since Ms. Bowen kept them actively engaged in discussions, projects, and workshops. In 2008, Ms. Bowen identified a new area developing in RA known as Regulatory Intelligence. After several years of developing the content, she officially launched the course in 2011. In June 2019, the RAQA program sponsored Ms. Bowen’s webinar on Regulatory Intelligence to RAPS (the Regulatory Affairs Professional Society), which generated the largest online attendance and participation of any similar RAPS event. Ms. Bowen has also been the driving force in forming partnerships between RAQA and the local New Jersey, New York, and Philadelphia Chapters of RAPS, sponsoring joint Career and Mentoring nights that provide excellent opportunities for our students and graduates to meet with prospective employers and gain valuable job hunting tips. Professor Barry Berger was appointed the first full-time Professor for the RAQA program. Subsequently, Associate Professor Christine Wittrock was hired full-time, also teaching numerous courses. She also participated in an extensive review of the Pharmacovigilance certificate and the creation of a manual of commonly used pharmacovigilance terms. Both have mentored RAQA students about course selection, career paths, and academic concerns.

ington, meeting many RAQA students in person, and he advises RAQA faculty when academic questions arise. Dr. Daniel Canney workes closely with Assistant Dean Lebing, in reviewing all curricular proposals, assuring they comply with Graduate School standards. He has mentored countless students in the RAQA and Pharmaceutical Science programs, ranging from scientific insights on their research projects to providing empathic, supportive advice for those struggling to balance academic assignments with a fulltime professional career. The RAQA program is also indebted to Dr. Zebulon Kendrick, Vice Provost of the University’s Graduate School, for his continued support of the RAQA program and its constant need for new courses, certificates, and student services. There have been countless times when Dr. Kendrick has polished academic proposals, gently suggesting needed components or facilitating requests for new programming as quickly as possible. His staff, including Dr. Shawn Schurr, Dr. Michael Toner, and Marge Pippet (recently retired) have also kindly helped with approving graduate applications well past the stated deadlines. Finally, several financial officers at the University provided invaluable assistance and advice to RAQA regarding the administration of international agreements and program endowments, including Carol Buck, Assistant Dean for Finance and Administration at the School of Pharmacy, David Glezerman (former Bursar of Temple, now retired), and Conrad Muth, Acting Bursar.

Several full-time staff at the School of Pharmacy have helped with the development of the curriculum, including the Graduate Studies Chairs between the late 1980s and the present day. After Dr. Tuckerman retired, Dr. Ronald Gautieri was selected to serve as Director of Graduate Studies in the late 1980s through 1995, serving on the original QA/RA Steering Committee, reviewing MS applicants for the program, and evaluating proposals for new QA/RA courses. Students from that era may remember his assistant, Ms. Kathy Sementelli, who claims that she disagreed with Dr. Gautieri so much that they were jokingly called “the Bickermans.” After Dr. Gautieri suffered a sudden and fatal heart attack in 1995, Drs. Reza Fassihi and Cherng-Ju Kim, both Professors of Pharmaceutical Science, served as Graduate Studies Chairs. Ms. Sheila Forman served as their assistant. Dr. Daniel Canney, Associate Professor of Medicinal Chemistry, was appointed Director of Graduate Studies in June 2002, and has had the most lasting impact on this position, particularly in his service to RAQA. In addition to overseeing MS applications and academic matters, he participates in RAQA faculty dinners, conferences, graduation celebrations, and other special events. He team-teaches Pharmaceutical Analysis every fall at Fort Wash-

Dr. Thomas Genova Dr. Daniel Canney

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program Standards

ACADEMIC STANDARDS The RAQA program c continues to focus on maintaining high o aacademic standards, sso that past, current aand future students would always be w proud of the degree p tthey received from Temple. T As soon as video A conferencing was initiated, Assistant Dean Lebing created SOPs (Standard Operating Procedures) for how exams should be administered at remote sites. It was imperative that all students in a course – regardless of location - take exams on the same date, for the same amount of time, and under the same conditions (open book, closed book, etc.) Representatives of company HR departments occasionally helped RAQA with distributing exams to their students; however, since most exams were administered after business hours, specific instructions were developed on how exams must be mailed, opened, and returned. This ensured that no student had unsupervised access to the questions either before or after the test. By the time RAQA launched online class delivery, all courses were required to include at least one proctored exam, regardless of location or learning modality. In many ways, proctoring was an extension of the forms of “validation” observed by regulated industry to verify that manufacturing equipment, computerized systems, and design of utilities and facilities met specific standards. Instructors were free to choose the exam format (open book, essays, objective Q&A, etc.), but every student had to be proctored by a credible source (the instructor, the School’s administration, an official testing site or library). Proctoring validated that the student registered for the course was the same individual taking the exam under the same conditions as all of the other students. The RAQA program continues to spend 3 - 5 weeks each semester overseeing the administration of proctored exams. Though the process consumes a tremendous amount of staff time, the program remains steadfast in its commitment to proctoring. Proc-

tored exams assure that tuition from a student’s company is being spent on a strong academic program. Many early online schools failed to put safeguards in place to verify who was completing take home or online exams. This was particularly true of “for profit” ventures which were often not accredited by external agencies. Over time the credentials earned at those schools became suspect. Assistant Dean Lebing wanted to ensure that every student earning the RAQA degree was proud of their academic credentials from Temple. In 2010, Assistant Dean Lebing started to investigate external sources offering “online proctoring.” She watched numerous demonstrations from multiple vendors, working closely with Dave Brickett, Dr. Karen Zimm, and Sheri Stahler from Temple’s Computer Services. In late 2011, the first online proctoring system was tested in one of Dr. Zimm’s courses. It required students to use an expensive “orb” camera that resembled a launch pad for an alien hatchling. The device filmed a 360-degree picture of the test environment and required a fingerprint swipe to operate. Though the School purchased the cameras for student use, the general consensus was that the computer surveillance was oppressive and Dr. Karen Zimm unnerving. The next generation of online proctoring allowed students to use webcams and microphones, but they needed to be highly computer-literate to install the software. Assistant Dean Lebing patiently wrote step-by-step instructions for students. After two semesters, students started to demand more use of online proctoring, since they enjoyed the convenience of taking exams at home or when traveling around the world. The sysytem was eventually used for courses delivered to Singapore. Though the online proctoring company reviews all exam recordings, the RAQA staff also scrutinizes them, adding another level of quality audit to the process. Though many schools in RA have populated since the early 1990s, imitating the model forged by Temple University School of Pharmacy, only a handful have also copied the adherence to academic standards and proctored exams. Most recently many accrediting agencies have focused on the importance of proctoring processes for online courses. Once again, RAQA was well ahead of the curve.

RAQA Edition

AFFILIATED PROGRAMS The success of the RAQA graduate program led the School to establish two new related degree programs, each with a different focus. In early 2001, Dean Doukas, Associate Dean Michael Borenstein, and Dr. Daniel Canney created the Non-thesis MS in Pharmaceutics, which balances courses in the pharmaceutical sciences with electives in RAQA, preparing students with science backgrounds for career paths in the pharmaceutical, medical device, and biotechnology industries. This degree introduces students to the science of dosage form design and development, while also imbuing the importance of abiding by regulations and quality practices. Graduates pursue research and regulatory careers in the pharmaceutical and related industries. The program continues to be based at Fort Washington and many courses are now available online. In 2008, the School incorporated RAQA courses into its Doctor of Pharmacy (PharmD) curriculum. Third-year PharmD students were given the option of pursuing three elective courses focusing on clinical trials.63 Faculty for the Clinical Trial Track are selected from the industry, including Dr. Michael McGraw64 and Dr. Joseph Scavone.65 Several years later, Assistant Dean Lebing urged the School to create a new degree program in Global Clinical and Pharmacovigilance Regulations (GCPR) that combined the clinical training students obtained in the PharmD degree with RAQA courses in clinical trials and global pharmacovigilance. The planning committee included Dean Doukas, Associate Dean Michael Borenstein, Dr. Dan Canney, Associate Dean Ina Calligaro, and Assistant Dean Lebing. By carefully selecting coursework in the PharmD program, students are able to complete several required courses by the end of their third year, earning the MS in GCPR either along with or soon after receiving the PharmD degree. Now available entirely online, the MS in GCPR is open to PharmD and Medical degree graduates from schools across the country. Most recently in 2019, a track in Regulatory Affairs and Quality Assurance has been added as a new concentration to the PhD in Pharmaceutical Sciences at the School of Pharmacy. This research-based thesis program will be reserved for a highly limited number of industry or FDA professionals in senior positions, who have worked a minimum of 15 years in positions of ascending authority and have developed a thesis which will involve original, independent research done in conjunction with a committee of industry and academic experts.

64 65

The group included Dr. Frank Diana, Dr. Thomas Parry, Joseph Quinn, Dan Casaburi, and others. Senior Director and Therapeutic Area Head for CNS, Ophthalmology and Oncology at Pfizer Central Research.

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program RAQA Personnel

STAFF 2019 marks Sylvia McNally’s 30th year workM iing for the RAQA program. Her greatest asset continues H tto be her one-on-one intteractions with prospective aand current students, since sshe is always willing to help. Aside from assisting stuA dents with registration, billd iing, scholarship, and procttoring issues, she organizes tthe RAQA diploma ceremony each year, an event that is n aakin to planning a 300-attendee wedding. She distributes invitations, selects the menu, determines the seating plan, and suggests the small touches that make everyone feel welcome. She is always willing to sacrifice personal time to help proctor students or prepare for special events. David Brickett, Assistant Director of Technology, has distinguished himself as one of the most technologically savvy employees at the University. When he first started in RAQA, he challenged the limits of video conferencing by delivering courses to multiple sites that had different equipment. He personally installed video conferencing equipment in RAQA classrooms, just as he investigated numerous forms of online class delivery. He has devised unique ways to use technology, whether it is setting up personalized video conferencing for students in South America or looping recordings of lectures through a class capture system to create instant links for the Internet. A former member of the U.S. Marine Corps reserves, he ensures that students, faculty, and staff are safe in any emergency (blizzards, hurricanes or local flooding) before he leaves his RAQA post.

Assistant Director Patricia Lee has an unparalleled work ethic, spending months to create each semester’s schedule for the MS degrees in RAQA, Pharmaceutics, and Global Clinical and Pharmacovigilance Regulations (GCPR). She has developed surveys for students to voice their choices for course electives, and then she patiently juggles faculty availability to satisfy on-campus and online curricular needs. Over the years she has processed literally thousands of registrations, meticulously reviewing each student’s academic record for prerequisites. She is responsible for the highly successful Career Night events each year, which enable current RAQA students and graduates to meet with corporate recruiters and listen to presentations on job search skills. After nearly a decade of o working for the RAQA program as a consultant, p Ms. M Jean Westbrook Leavitt was w hired to be the Coordinator of Student Records, d assisting U.S. and internaa tional students with their t applications to the various a MS M programs in RAQA, Pharmaceutics, and GCPR. P She S provides an outstanding “concierge” service to appli“ cants, advising them on the c best b time to apply, keeping track of their materials, and gently nudging them to meet stated deadlines. She also coordinates the applications for the Post Master’s Certificates, keeping in touch with those students each semester to make sure they finish their required courses in a timely fashion. She has an intuitive knack for knowing the best way to advise students in their course choices and degree paths.

RAQA Edition

“What a meaningful and proud opportunity to be a part of such a well respected program that has provided such a tremendous contribution to the healthcare industry. It is such an honor to have been given the gift to participate and be associated with a program that is such a gift to our industry….It isn’t every day that you have the chance to be involved with such a noble cause. Than you, Wendy, for the opportunities you have given me through the years. Your confidence in my ability is a treasure, and I look forward to such a monumental celebration.“ – Sarah Van Valkenburg, Senior QA Auditor, Church & Dwight Co. I 2015, Ms. Brenda HasleIn ggo joined the staff as the Coordinator of Student C Outreach, serving as the O first point of contact in the RAQA Office for informaR ttion and registration. She ccontinues to greet new and prospective students with p a joyful heart and ebulllient spirit, making sure iinformation packets and Open House invitations are O mailed in a timely fashion. m SShe spends hours on the phone making sure students obtain the information they need to start their graduate education, apply for financial aid, or obtain career advice. She assists with every aspect of the RAQA Office from overseeing exam proctoring to helping students navigate Temple’s Banner system. In 2017, Michael Doukas joined RAQA as Technical Support Staff, helping David Brickett answer questions posed by students about online learning technology. One of his first projects was launching an RAQA FlickR page, which finally gave a home to the decades of photographs that resided in Assistant Dean Lebing’s filing cabinets. The page continues to attract tens of thousands of viewers and was such a success that he also created a similar page for the School of Pharmacy. He also helps Assistant Director Brickett with updating classroom computers and answering student questions about using Adobe Connect or Software Secure proctoring.

Carl Wydra and Assistant Dean Lebing have created award-winning marketing pieces for over three decades. He has created all of the program’s marketing pieces since the late 1990s in addition to launching its Facebook and YouTube pages. Students immediately recognize when a Facebook post or a course flyer has been designed by Carl Wydra: the images jump off the page with fresh ideas and subtle twists of meaning. Sometimes Assistant Dean Lebing presents him with an inchoate concept that he needs to capture artistically (“Create a logo for the Validation Science certificate that involves measurement, water, calibrations, cleaning, and manufacturing – just make sure it has a scale…”). Other times she is less specific (“Please post something on Facebook that the Fall Semester Schedule is available.”). He is also the photographer of the RAQA Diploma Ceremony and the designer of its website where students may download the images free of charge.

Legacies of Temple University School of Pharmacy

History of the Temple University School of Pharmacy

RAQA Graduate Program 1968 to Present

OUTSTANDING FACULTY Since the late 1980s, nearly 250 industry and regulatory professionals have taught courses in the RAQA program, bringing their unique insights and valuable experience to the classroom. The program’s strength and power can be attributed to the fact that instructors come from numerous corporations and the FDA, representing nearly every aspect of the pharmaceutical, medical device and biotechnology industries. Students receive insights from the regulators and the regulated, tapping into decades of experience offered by both faculty and students in each class. It is beyond the scope of this short history to describe in detail each instructor’s contributions to the program. Close to 200 industry and FDA professionals have taught five years or more for the program, and more than 50 have taught ten years or more, most while still working full-time, providing a consistency in the academic standards and curriculum that continues to be unmatched by other schools. Several from that group teach two courses every semester, while also maintaining high-level professional positions.

Some teach five or more topics, allowing the program to schedule whichever course(s) best meets the program’s needs each semester. Students often comment how difficult it is to juggle classes and assignments with a full-time career and family obligations. This dedication is matched by the RAQA faculty who often create entire courses from scratch and develop appropriate PowerPoint slides and teaching aids to bring their subject to life. Many also interact with students through email, threaded discussions and phone calls. Instructors continue to be available to their students well after the semester has ended, helping them to find positions or answer questions about work-related issues. The RAQA program has been blessed in the number of faculty who remain dedicated to its mission and ideals. The RAQA faculty have always been motivated by a personal commitment to give back to industry by educating the next generation. The blend of expertise and experience from so many top corporations has established a true fortress of industry knowledge singularly available at Temple University School of Pharmacy.

RAQA Edition

RAQA Graduate Program

Faculty

RAQA Graduation Timeline 1996 to 2019

DEDICATED STUDENTS In 1968, the entering QA class consisted of three students, two of whom worked for the Philadelphia District of the FDA. Though class sizes remained small throughout the 1970s and early 1980s, literally thousands of students have taken RAQA courses since 1990. Just as the pharmaceutical and related industries hire individuals with diverse backgrounds and degrees, the program welcomes students from around the world with a variety of undergraduate or graduate degrees. The majority are employed in regulated industry, including pharmaceutical and biopharmaceutical companies, medical device firms, CROs, generic and biosimilar organizations, as well as regulatory agencies, such as the FDA. The program has also attracted participants from the food industry and the health care sectors, including physicians and nurses involved with clinical trials. Some students are just starting their careers, while others have twenty years or more of related experience. Their titles range the gamut from scientists and RA, QA or clinical research assistants, to managers, supervisors and vice presidents. Because students’ experience and knowledge vary considerably, everyone benefits from the tremendous networking opportunities available in RAQA classes. Friends made in classes become valuable professional associates for life. Career paths in regulated industries often make it difficult for students to complete a degree program. Sometimes industry and FDA students are relocated. (One current student is adjusting to a new assignment by FDA in China). Industry auditors travel extensively, making it difficult to pursue classes every week or take exams on the scheduled date. During the past two decades there have been countless buy-outs and corporate mergers, resulting in unexpected lay-offs or sudden changes in students’ tuition remission benefits. One student changed companies and locations at least five times during the 12 years it took to finish her MS. Helping students through these difficult transitions continues to be a priority for Assistant Dean Lebing, who works with Dr. Canney and the Graduate School to make sure that every student who wishes to finish a certificate or degree program is able to do so. The staff of the RAQA program are known for the personal concern they have for their students.

Legacies of Temple University School of Pharmacy

In Gratitude Currently the RAQA program awards the MS degree to more than seventy-five hard-working industry and regulatory professionals each year, who complete the program on a part-time basis with all of the personal sacrifice that entails. Since 1990, the School has awarded the MS in RAQA degree to over 2000 graduates, many of whom continue to be leaders in the regulated industries of pharmaceuticals, medical devices, and biotechnology or the FDA. Importantly, the administration of the School of Pharmacy remains steadfast in its commitment to quality education, fostering the most successful form of learning: the dynamic relationship between teacher and students. True graduate education encourages critical thinking and the ability to determine the validity and cogency of arguments. The growth of the program has occurred only with a fidelity to the policies and expectations of Temple’s Graduate School. We thank all of our faculty, students, corporate partners, and members of the Temple administration who have helped build the RAQA program. We thank them for the many times they have presented brilliant, new ideas or have asked bureaucracies, whether they be academic, governmental, or corporate, to make essential changes for the greater good. When people come together and give of their hearts and minds, a unique transcendence occurs. This is the history of the RAQA graduate program and its very special relationship with the pharmaceutical, medical device, biotechnology and affiliated industries and the world’s foremost regulatory agency. We are grateful to the many special individuals who selflessly give more than is required and thus form an extraordinary program with an unparalleled camaraderie, spirit, and purpose. Finally, my deepest thanks go to Dr. Peter Doukas, for his inspirational leadership of the School for nearly three decades and for his continuous support in developing the RAQA into the best of its type in the nation.

Wendy Lebing, MALD, MS Assistant Dean for the Regulatory Affairs and Quality Assurance Graduate Program Temple University School of Pharmacy September 2019