2012 CRS Registration Brochure

The Forefront of Delivery Science and Technology 39th Annual Meeting & Exposition of the Controlled Release Society July 15–18, 2012 Centre des congrès de Québec Québec City, Canada

Smart Materials—From Innovation to Translation

Acknowledgements

Bienvenue a Québec avec CRS!

Bioactive Materials Program Chairs Hamid Ghandehari, University of Utah, U.S.A. Dusica Maysinger, McGill University, Canada

The Controlled Release Society is very excited to meet for the first time in beautiful and historic Québec City, Canada. Register now to join CRS at the 39th Annual Meeting & Exposition, which promises, as you will discover in the following pages, a superb lineup of world-class scientists covering all of the hottest topics in delivery science and technology.

Join your colleagues and discover the latest in nanotechnology; hydrogels; nanofibers; tumor targeting; transdermal, oral, mucosal, and DNA and RNAi delivery; and much more.

Voyez-vous au Québec!

Consumer & Diversified Products Program Chairs Chris McDaniel, Fleet Laboratories, Inc., U.S.A. Teresa Virgallito, Microtek Laboratories, U.S.A. Veterinary Program Chairs Arlene McDowell, University of Otago, New Zealand Thierry Vandamme, University of Strasbourg, France

Photo Credits Cover: Fountaine de Tourney in front of the Parliament. La Maison Simons Page 2 ©Shutterstock Pages 3, 6, 10, 19, and mail panel ©istockphoto.com Pages 8 and 14 ©Comstock Page 23: Panoramic View of Old Québec. Luc-Antoine Couturier Page 27: Gates to the Old Québec. Brigitte Ostiguy

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➤ Abstracts will be available online for all registered attendees so that they may plan their meeting experience beginning June 15, 2012.

About the Society The Controlled Release Society is the premier international, multidisciplinary society dedicated to delivery science and technology. In the constantly and quickly expanding field of delivery science, keeping up with the latest scientific research and technological breakthroughs is crucial. CRS serves members from industry, academia, and government in more than 50 countries worldwide by providing innovative research, targeted networking, and career advancement. Access a diverse, stimulating international society that is dedicated to this multidisciplinary field.

Invitation from the President

Martyn C. Davies President Controlled Release Society

The CRS Annual Meeting & Exposition will bring together delivery scientists from around the world and across disciplines— nothing else can match that. There is no better way to get up-tothe-minute reports in regard to delivery science and technology.

This is the chance not only to hear presentations but actually to have discussions with the authors and others interested in the research. In addition to hearing the latest cutting-edge science, you will also find out what the industry is looking for and make connections with colleagues, helping guide your work for the next year. If you are working in delivery science and technology, this is by far the one “must attend” meeting for you.

Table of Contents Schedule-at-a-Glance .................................................... 4 Program Highlights ....................................................... 6 CRS Foundation .......................................................... 13 CRS Innovation Sunday ............................................... 14 Workshops .................................................................. 15 Networking Opportunities ......................................... 19 Exposition and Sponsorship ....................................... 21 Registration Information ............................................. 22 Convention Center & Hotel Information .................... 25 Québec City, Canada—Always Enchanting! ............... 27

www.controlledreleasesociety.org/meetings/annual 3

Schedule-at-a-Glance Saturday, July 14

Monday, July 16

07:00 – 17:00 07:00 – 15:00 08:00 – 17:00 08:00 – 17:00 08:00 – 17:00

07:00 – 17:30 07:00 – 18:00 07:00 – 18:00 07:00 – 08:00 08:00 – 09:30 09:30 – 10:30 09:30 – 10:30 10:30 – 12:00 11:30 – 13:30 12:00 – 13:30 13:30 – 15:00 15:00 – 16:00 16:30 – 17:30 17:30 – 18:30 21:00 – 22:30

Speaker Ready Room Open CRS Registration Open Educational Workshops Young Scientist Workshop Exhibit Set-up

Sunday, July 15 07:00 – 17:30 07:30 – 18:00 08:00 – 12:00 08:00 – 17:30 08:00 – 14:00 08:30 – 13:30 11:30 – 12:30 12:30 – 14:00 13:00 – 15:00 15:30 – 17:30 17:30 – 19:30

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Speaker Ready Room Open CRS Registration Open Young Scientist Workshop Educational Workshops Exhibit and Poster Set-up Releasing Technology Workshops First Timers’ Meeting Young Scientist Roundtable Soapbox Session Industry Roundtable Exposition Grand Opening and Welcome Reception

Speaker Ready Room Open CRS Registration Open Poster Viewing Hours Get Up! Get Educated!

CRS Opening Session Poster Session 1 (authors present) Exposition Open Scientific Sessions Mentor/Protégé Meet and Greet Exposition Open Plenary Session Scientific Sessions NEW! Poster Viewing and Exposition Happy Hour Preclinical Sciences and Animal Health Get-Together Young Scientist Networking Evening

Tuesday, July 17

Wednesday, July 18

07:00 – 17:30 07:00 – 17:30 07:00 – 17:30 07:00 – 08:00 08:00 – 09:30 09:30 – 10:30 09:30 – 10:30 10:30 – 12:00 12:00 – 13:30 12:00 – 13:30 12:00 – 16:00 13:30 – 15:00 15:00 – 16:00 16:00 – 17:00 16:00 – 18:00 16:00 – 17:30 18:30 – 22:00

07:00 – 11:00 07:30 – 12:00 08:00 – 09:30 09:30 – 11:00 12:00 – 16:00

Speaker Ready Room Open CRS Registration Open Poster Viewing Hours Get Up! Get Educated!

Plenary Session Poster Session 2 (authors present) Exposition Open Scientific Sessions Women in Science Luncheon C&DP Luncheon Exposition Open Scientific Sessions Poster Session 3 (authors present) Poster Take-down Exhibit Take-down Roundtables and Focus Groups CRS President’s Banquet

Speaker Ready Room Open CRS Registration Open Scientific Sessions Plenary Session Educational Workshop

www.controlledreleasesociety.org/meetings/annual 5

Program Highlights The CRS Annual Meeting offers access to the latest research through a variety of sessions, including the popular CRS Innovation Sunday, featured plenary sessions, educational workshops, interactive roundtables, mini-symposia, and more. This creates many opportunities for you to learn about the latest findings in delivery science and technology, expand your knowledge, and apply technologies from other areas.

Exposition Grand Opening and Welcome Reception Join your colleagues and exhibiting companies for the official welcome to the CRS Annual Meeting & Exposition. The Exposition Hall will be brimming with new products, services, and innovations, presented by more than 100 exhibitors. Take this opportunity to enjoy some light hors d’oeuvres and connect one-on-one with your fellow scientists and company representatives.

Event included in registration fee. Extra tickets $75.

CRS Opening Session The Opening Session will feature a welcome by President Martyn Davies and the presentation of the 2012 Fellows awards, along with the CRS T. Nagai Postdoctoral Research Award, Founders Award, and Young Investigator Award.

The session will conclude with a lively panel discussion organized by our College of Fellows.

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Plenary Sessions Molly Shoichet Professor of Chemical Engineering and Applied Chemistry, Chemistry of Biomaterials, and Biomedical Engineering, University of Toronto, Canada

Drug and Cell Delivery Strategies to the Central Nervous System Three regenerative medicine strategies will be described in the central nervous system for treatment of spinal cord injury, stroke, and blindness. In each strategy, delivery to the tissue is key to success, necessitating a local delivery strategy. Both stem cell transplantation and endogenous stem cell stimulation strategies are being pursued using a minimally invasive, injectable, controlled release strategy. These strategies of cell stimulation and transplantation provide promise for the future of regenerative medicine.

Donald Tomalia CEO/Founder, NanoSynthons LLC, National Dendrimer and Nanotechnology Center, U.S.A.

Dendrimer-Based Nanomedicine—The Present and Future “Future management of human health, disease and longevity will involve the new emerging field of nanomedicine.� Current use of dendrimers in nanodiagnostics, drug delivery, imaging, and nanopharma will be overviewed. Important dendrimer properties such as polyvalency, nanoscaffolding, and nanocontainer properties have underpinned intense activity toward many new nanomedical applications. Recent reports of intrinsic anti-inflammatory properties, new siRNA/DNA transfection properties, and oncology targeting strategies portend the emergence of many new dendrimer-based nanomedical applications.

Vladimir Torchilin Distinguished Professor and Director, Center for Pharmaceutical Biotechnology and Nanomedicine, Northeastern University, U.S.A.

Targeting Cell Organelles The combination of targeted delivery of drug-loaded nanocarriers to target cells and their subsequent delivery inside cells might significantly improve the efficiency of therapy. Intracellular delivery with subsequent organelle targeting opens new opportunities in treating multiple pathologies, including lysosomal storage diseases and multidrug resistance tumors. Examples of specific targeting of lysosomes and mitochondria in cells, as well as analytical methods developed to follow the intracellular fate of nanomedicines, illustrate the benefits of this new approach.

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Mini-Symposia Mini-symposia offer in-depth knowledge into a specific area of delivery science and technology, featuring multiple invited speakers sharing their research on the topic.

Topic descriptions can be found on the CRS website. Speakers subject to change.

New Chemistries: Click It, Fit It, Test It Daniel Anderson, MIT, U.S.A. Dennis Discher, University of Pennsylvania, U.S.A. David Lynn, University of Wisconsin, U.S.A. Kathy Uhrich, Rutgers University, U.S.A.

Active Targeting vs. Passive Targeting Terry Allen, University of British Columbia, Canada Jindrich Kopecek, University of Utah, U.S.A. Ranata Pasqualini and Wadih Arap, University of Texas, MD Anderson Cancer Center, U.S.A. Gert Storm, University of Utrecht, The Netherlands Morphologies and Cell Responses Warren Chan, Toronto University, Canada Hamid Ghandehari, University of Utah, U.S.A. Samir Mitragotri, University of California–Santa Barbara, U.S.A. Hannadi Sleiman, McGill University, Canada

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Recombinant Polymers Joseph Cappello, Protein Polymer Technologies, U.S.A. Ashutosh Chilkoti, Duke University, U.S.A. David Kaplan, Tufts University, U.S.A. Arash Hatefi, Rutgers University, U.S.A. Smart Textiles John Ellis, Devan, U.K. Bernd Liesenfeld, Quick-Med Technologies, U.S.A. Guowen Song, University of Alberta, Canada Teresa Virgallito, Microtek Laboratories, U.S.A.

Invited Speakers The 39th Annual Meeting & Exposition of the Controlled Release Society is pleased to announce the following invited speakers. Topics and speakers are subject to change.

Scientific Sessions—Bioactive Materials This track offers an exciting lineup of top scientists, representing the continuum of materials science and engineering and the cellular and biological responses to materials and related translational considerations, with a common focus on the controlled delivery of bioactive agents.

Session Information Biomaterials Kazunari Akiyoshi, Kyoto University, Japan DNA and RNAi Delivery Suzie Pun, University of Washington, U.S.A. Drug Delivery to the Brain Laurent Lecanu, McGill University, Canada Inorganic Nanosystems Vincent Rotello, University of Massachusetts, U.S.A. Intracellular Processes Silvia Muro, University of Maryland, U.S.A. Nanomedicine Dusica Maysinger, McGill University, Canada Oncology and Tumor Targeting Alberto Gabizon, Hebrew University, Israel Oral Controlled Release Randy Mrsny, University of Bath, U.K. Stem Cell and Regenerative Medicines David Schafer, University of California–Berkeley, U.S.A.

Theranostics and Cancer Nanotechnologies Shawn Chen, National Institute of Health, U.S.A. Transdermal Drug Delivery Richard Guy, University of Bath, U.K. Translational Nanomedicine Michel Bouvier, University of Montréal, Canada Scientific Sessions—Consumer & Diversified Products Discover the latest in consumer and diversified products from leading researchers in the area, including new applications of encapsulation and hydrogels, and how nanotechnology is changing the field.

Session Information Consumer and Industrial Applications of Nanoparticle Technology Fanwen Zeng, The Dow Chemical Company, U.S.A. Fragrances and Flavors Patrick Ott, Symrise AG, Germany Hydrogel Delivery Systems in Consumer Products Heather Sheardown, McMaster University, Canada Imaging Diagnostics for Material Characterization Martyn Davies, University of Nottingham, U.K. Nanofibers/Nano Particles Speaker to be named.

Nutraceuticals and Functional Foods Speaker to be named. www.controlledreleasesociety.org/meetings/annual 9

Roundtable Discussions Join your colleagues for these in-depth interactive sessions where a panel of experts will share their findings and opinions, creating an extended discussion on focused topics. This is a great opportunity to connect with colleagues with similar interests.

Note that the focus group meetings follow the roundtable discussions.

Nanomedicine Roundtable—Enhanced Permeability and Retention Effect: Opportunities and Challenges Scientific Sessions—Veterinary Join your animal health colleagues for sessions focused on delivery science’s impact on veterinary treatments, including delivering proteins and peptides and other therapeutics for animal patients.

Session Information Protein and Peptide Therapeutics for Animal Patients Frank Aldwell, University of Otago, New Zealand Protein and Vaccine Delivery Cory Berkland, University of Kansas, U.S.A.

Chaired by Hamid Ghandehari, University of Utah, U.S.A., and Dusica Maysinger, McGill University, U.S.A. More than 25 years has passed since the discovery of the enhanced permeability and retention (EPR) effect. This discovery has paved the way for the utility of nanosystems in clinical settings. Despite this success, challenges ahead are to address the following questions, among others: Is the EPR effect universal to all tumors or inflamed tissues? Does tumor staging or type influence localization?

Can results from animal models be directly correlated with humans? What methods can be designed to enhance the EPR effect? In this roundtable, the opportunities and challenges that the EPR effect presents are discussed, followed by an open panel discussion.

Roundtable Invited Speakers: You Han Bae, University of Utah, U.S.A. Hiroshi Maeda, Sojo University, Japan

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Ocular Drug Delivery Roundtable—Protein Therapeutics for the Treatment of Retinal Diseases

Oral Drug Delivery Roundtable—Solubility Enhancement in Oral Drug Delivery: A Breakthrough or a New Hurdle?

Chaired by Ruiwen Shi, Allergan Inc., U.S.A., and Clive Wilson, University of Strathclyde, U.K.

Chaired by Sarah Eccleston, Encap Drug Delivery, U.K., and Ali Rajabi-Siahboomi, Colorcon Inc., U.S.A.

A number of retinal diseases, including age-related macular degeneration (AMD) and diabetic retinopathy (DP), are marked by abnormal blood-vessel growth and increased vascular permeability. Vascular endothelial growth factor (VEGF) is an important modulator of the diseases. Protein or macromolecule VEGF inhibitors provide the most effective and promising treatment for these diseases. However, to effectively deliver these agents to the disease sites over extended durations remains very challenging. This roundtable discussion will focus on the challenges, opportunities, and strategies in targeted protein delivery to the posterior segment of the eye. The session will feature two invited presentations and a panel discussion following the presentations.

This session will review the significance of drug solubility on absorption and design it into an oral delivery system. Reports show that as high as 40–50% of new active chemical entities suffer from poor water solubility. It has been the focus of many research and development institutions to enhance solubility of the drugs and, in turn, improve their oral bioavailability. Oral formulation of lowsolubility drugs is challenging, and robustness may be compromised. In addition, depending on the approach taken to improve the solubility, this “solubilityenhanced form” also poses significant formulation and handling issues, which have been hot topics in recent scientific literature. The need to establish a clear bioavailability advantage over the existing formulation techniques is at the root of research and development. Case studies will be provided to illustrate some of these challenges and potential approaches to overcome them. Please join us to hear from industry leaders on this hot topic and share your experiences during the roundtable discussion.

Roundtable Invited Speakers: Ann Daugherty, Genentech Inc., U.S.A. Clive Wilson, University of Strathclyde, U.K.

Roundtable Invited Speakers: Kevin Edgar, Virginia Tech, U.S.A. Sherry Ku, CSOTWi Pharma and TWi Biotech, U.S.A. Navnit Shah, Roche, U.S.A. continued www.controlledreleasesociety.org/meetings/annual 11

Roundtable Discussions (continued) Young Scientist Roundtable—Entrepreneurship: A Journey from Conception to Commercialization Chaired by Sara Yazdi, Pfizer, U.S.A., David Chen, Pfizer, U.S.A., and Hardik Shah, Alkermes Pharma Ireland Ltd., Ireland Discover a new way to use your lab skills and make a change for your organization or yourself! Every great company started with a novel idea that was recognized and developed at the right time. You might have an innovative and exciting idea, but then what? This roundtable discussion will bring together thought leaders from academia, industry, legal, and finance to discuss the whirlwind journey from conception to commercialization and how scientists can recognize and seize opportunities for starting a business.

Get Up! Get Educated!

Interface of Biomaterials Elucidated Monday, July 16 Chaired by Joshua Reineke, Wayne State University, U.S.A. Are protein adsorption, cellular adhesions, immune responses, or inflammatory reactions fogging the surface of your biomaterials? Wake up to this session illuminating the interactions of biomaterial surfaces with the complex biological milieu. This session will cover interactions and forces at the interface of materials with proteins, cellular membranes, organelles, and DNA. Learn how these interactions can determine the fate of biomaterials and novel approaches to circumvent or advantageously utilize these interactions.

Please indicate your attendance when registering. Complimentary event.

How to Get Published in JCR—Editor’s and Publisher’s Views Tuesday, July 17 Chaired by Jaap van Harten, Elsevier, The Netherlands Speakers: Kinam Park, Purdue University, U.S.A., and Jaap van Harten, Elsevier, The Netherlands Getting your work published in any highly ranked journal is a matter of presenting good research. Each manuscript needs to be tailor-made for a specific journal.

In this workshop, the editor-in-chief and the publisher of JCR will explain and give opportunity for discussion on the editorial decision-making process of JCR, including main reasons for acceptance and author–editor–reviewer communication.

Get up! Get educated! Get more successfully published!

Please indicate your attendance when registering. Complimentary event.

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Young Scientist Mentor/Protégé Meet and Greet

CRS Foundation

Monday, July 16

At the annual meeting you will see, firsthand, the outcomes of the CRS Foundation’s support. Founded as an educational endowment in 2007, the CRS Foundation honors leaders who have made notable contributions to delivery science and supports the scientific training of its future leadership. Thanks to generous donors, nearly $120,000 has been raised for postdoctoral fellowships that expand research and travel opportunities for outstanding young scientists.

Please help the Foundation expand its fellowships by giving annually.

Chaired by Padma V. Devarajan, Institute of Chemical Technology, India, and Mike Rathbone, International Medical University, Malaysia This is a must-attend session for anyone enrolling in the 2012–2013 CRS Young Scientist Mentorship Program. You will be introduced to your mentor and be given the opportunity to meet face-to-face to discuss how you are going to interact with your mentor over the next 12 months, what your career ambitions are, and what you want out of the program. Attend this meeting for your first CRS mentorship experience.

Please indicate your attendance when registering. Complimentary event.

Posters New Format for 2012!

CRS Posters and Poster Author Sessions All scientific posters will be set up and available for viewing Sunday evening during the Exposition Opening and Welcome Reception and all day Monday and Tuesday. Three poster author sessions are scheduled on Monday and Tuesday. One-third of poster authors will be present at each session. Poster take-down will take place on Tuesday, July 17, 16:00 – 17:00.

Donate when you register for the annual meeting.

CRS Foundation Award Presentation and Reflections Monday, July 16 Sung Wan Kim Postdoctoral Fellowship, 2012 Attend the award presentation of this $30,000 postdoctoral fellowship to the outstanding scientist selected in May 2012. This year’s fellowship honors CRS leader and University of Utah professor Sung Wan Kim, whose pioneering career in drug delivery research has led to discoveries in hydrogels, biodegradable drug conjugates, self-regulating drug delivery, and stimuli-sensitive polymers.

Professor Kim will award the fellowship to a deserving postdoctoral scientist whose research will be displayed in CRS Central.

Tsuneji Nagai Postdoctoral Fellowship, 2011–2012: A Year in Review CRS Foundation awardee Soo Hyeon Lee will present outcomes of her fellowship year designing and demonstrating a gastrointestinal disease therapy with a nucleic acid drug in the laboratory of Professor Jean-Christophe Leroux at ETH Zurich. www.controlledreleasesociety.org/meetings/annual 13

CRS Innovation Sunday Sunday, July 15

Industry Roundtable: Game-Changing Innovation

Co-sponsored by Pfizer

Invited Speakers: Julia Rashba-Step, Pfizer, U.S.A., and Ronald L. Smith, Merck & Co., Inc., U.S.A.

Build your networks for success! Designed to connect you with people, companies, novel technologies, and research that address challenges in delivery, come to Sunday’s interactive program open to asking questions and finding answers.

Releasing Technology Workshops Are you interested in learning more about a company’s research and products?

The Releasing Technology Workshops (RTWs) allow you to gain in-depth information presented by the hosting company. As of press time, workshops will be offered by: Agilent Technologies Ashland Chemical Catalent Pharma Solutions Colorcon Inc. Gattefossé

Grunenthal GmbH OctoPlus SOTAX Corporation Team Consulting Ltd.

Soapbox Sessions What’s new in delivery science? Come to the program where presenters “get up on their soapbox” to share some of the most innovative technologies in development today. Linger to network with the presenters as you enjoy refreshments sponsored by Catalent Pharma Solutions.

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From Incremental to Exponential Game Changer Innovation: Game Changing!

Definition: A visionary. A If most innovation is incremental and game person or idea that transforms changers spark exponential innovation, how the accepted rules, processes, do you find a game changer? How do you strategies, and management identify one, or a dozen, game changers for of business functions. your organization? Who has the skills to put the new rules into play? How do you recognize, integrate, and fully benefit from a game changer arriving from an entirely different discipline? Through panels, presentations, and audience participation, gain insight for game-changing Strategies • Communication • Nontraditional partners • Relationships.

Exposition Grand Opening & Welcome Reception The day dedicated to innovation culminates in the Exposition Hall where thousands of products, services and still-to-be-developed innovations can be discussed one-on-one.

Workshops Educational Workshops These workshops offer focused presentations on specific topics by noted speakers, and are open to a limited number of participants for an additional fee.

Mitigating Risks for Patients When Developing Oral Controlled Release Dosage Forms

Critical Appraisal of EPR Effect and Intratumoral Distribution of Nanomedicine

Saturday, July 14 – Sunday, July 15 (1–1/2 days)

Saturday, July 14 (Full day)

Chaired by Ali Rajabi-Siahboomi, Colorcon Inc., U.S.A.

Chaired by Khaled Greish, University of Otago, New Zealand, and You Han Bae, University of Utah, U.S.A.

The focus will be to understand the possible risks to patients and approaches to manage them when developing oral extended-release (ER) dosage forms. The discussion will relate to the design, development, and manufacture of commonly used ER systems. Industry leaders and subject-matter experts will provide scientific basis to the material science, formulation, and process attributes that will help to mitigate risks, under the umbrella of quality by design (QbD).

The overall goals of such approaches are to improve quality and reduce costs but maintain patient safety and treatment.

Enhanced permeability and retention (EPR) effect is the most popular strategy for the delivery of nano-size anticancer drugs to solid tumor tissues. Workshop attendants will gain in-depth understanding of the phenomenon and how it can be influenced by variables such as tumor diversity, animal models, biodistribution, intracellular interaction, and release rate of active agents from their nanocarriers. The workshop will identify and explicate the critical factors that are essential for the success of EPR-based nanomedicine.

Advance registration and payment required.

Advance registration and payment required.

Early Regular/Onsite Workshop Price (by May 7, 2012) (after May 7, 2012) Regular $525 $625 $300 Student/Post-doc $250

Early Regular/Onsite Workshop Price (by May 7, 2012) (after May 7, 2012) Regular $350 $400 $200 Student/Post-doc $160 continued www.controlledreleasesociety.org/meetings/annual 15

Educational Workshops (continued) Formulation and Process Considerations in the Development and Scale-up of Osmotic Dosage Forms Saturday, July 14 (Morning) Chaired by Don Barbieri, Patheon, U.S.A., and Karen Coppens, Dow Wolff Cellulosics, U.S.A. Participants will be provided a practical overview of formulation and process considerations involved in the successful development and scale-up of osmotic dosage forms. Participants will gain a greater understanding of the theory behind osmotic dosage forms and how they could offer an advantage over other types of controlled released formulations. The speakers will involve the participants in practical discussions on formulation development, membrane coating considerations, and the use of specialized laser drilling and vision system inspection equipment.

Advance registration and payment required.

Early Regular/Onsite Workshop Price (by May 7, 2012) (after May 7, 2012) Regular $200 $225 $145 Student/Post-doc $125

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Setting Release Specifications for In Vitro Testing of Controlled Release Dosage Forms Saturday, July 14 (Afternoon) Chaired by Bob Stagner, Patheon, U.S.A. This workshop will educate formulators, analytical scientists, QA/QC professionals, regulatory professionals, and nonclinical statisticians about approaches and relevant issues in the evolution of setting in vitro specifications from early development, scale-up, and registration scale manufacture and corresponding phase-appropriate limits for controlled release products. The attendees will gain insight into how phase and manufacturing-scale appropriate limits are applied and specifications are set and verified for controlled/modified release products.

Advance registration and payment required.

Early Regular/Onsite Workshop Price (by May 7, 2012) (after May 7, 2012) Regular $200 $225 $145 Student/Post-doc $125

Preserving and Enhancing Vision via Ophthalmic Drug Delivery Sunday, July 15 (Afternoon) Chaired by Charles Doillon, University of Laval, Canada, and Todd Hoare, McMaster University, Canada Whether you are actively involved in developing ophthalmic drug delivery vehicles or are interested to learn more about the unique complexities presented by the eye in controlled release applications, this workshop will bring together industrial researchers, clinicians, and research scientists to discuss the current state-of-the-art technology in ophthalmic drug delivery (at both the front and the back of the eye) and the opportunities and challenges for future developments.

Advance registration and payment required.

Early Regular/Onsite Workshop Price (by May 7, 2012) (after May 7, 2012) Regular $200 $225 $145 Student/Post-doc $125

continued www.controlledreleasesociety.org/meetings/annual 17

Educational Workshops (continued)

Young Scientist Workshops

Considerations for Future Regulatory Submissions of Transdermal Products

These workshops are specifically designed with the interests of young scientists in mind. Young scientists are typically students and early career scientists under the age of 40 years, or those with less than 5 years experience in the field of delivery science.

Wednesday, July 18 (Afternoon) Chaired by Tapash Ghosh, ONDQA/CDER/FDA, U.S.A. This workshop will bring a sound understanding of transdermal drug delivery system (TDDS) across multiple disciplines and multiple sectors with the goal of meeting the challenges of 21st-century TDDS and discuss considerations for future regulatory submissions from an FDA perspective as a whole with emphasis on new drug quality assessment.

Advance registration and payment required.

Early Regular/Onsite Workshop Price (by May 7, 2012) (after May 7, 2012) Regular $200 $225 $145 Student/Post-doc $125

Young Scientist Workshop I—Mucosal Drug and Gene Delivery: Barriers and Opportunities Saturday, July 14 (Full day) Chaired by Olivia Merkel, Wayne State University, U.S.A., Emmanuel Ho, University of Manitoba, Canada, and Joshua Reineke, Wayne State University, U.S.A. This is a workshop not to be missed by young scientists. Local drug and gene delivery offers various advantages; however, many local administration routes involve delivery to the dynamic and complex mucosa. The mucosal layer and underlying membrane are involved in the absorption and secretion of molecules and are important targets for vaccine development and treatment of diseases.

This workshop will discuss all relevant barriers and present successful approaches for various administration routes.

Please indicate your attendance when registering. Complimentary event.

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Networking Opportunities Young Scientist Workshop II—Professional and Self-Development for Young Scientists and Protégés: Time Management Sunday, July 15 (Morning) Chaired by Teresa Virgallito, Microtek Laboratories, Inc., U.S.A., and Padma V. Devarajan, Institute of Chemical Technology, India Effectively managing time is extremely important for young scientists. This workshop will cover time-management skills essential for coping with busy schedules, planning and executing projects, and meeting deadlines. Special emphasis will be on time-management techniques and on utilization of those techniques to function effectively under intense pressure. Applying the skills learned in this workshop will ensure optimal effectiveness when undertaking tasks. Above all, young scientists will gain a clearer understanding of the value of time.

Please indicate your attendance when registering. Complimentary event.

CRS Connect

New for 2012

Connecting with fellow meeting attendees is easier than ever with CRS Connect.

While in Québec City, use CRS Connect on the CRS Annual Meeting Mobile App, or via the internet, to directly contact colleagues by searching by name or company. Plan one-on-one meetings wherever and whenever you choose to gain the insight you need for your next project, product, or innovative idea. This tool maintains your full privacy, as personal contact information is never shared through CRS Connect. You come to the annual meeting to network; allow CRS Connect to facilitate the collaboration you are seeking.

First Timers’ Meeting Plan to attend this special meeting where CRS leaders and seasoned meeting attendees will provide suggestions to help you make the most of your first meeting experience.

Preclinical Sciences and Animal Health Get-Together CRS is excited to announce that the Veterinary Division has evolved into the Preclinical Sciences and Animal Health Division. The new division will aim to foster opportunities for collaboration between CRS members interested in animal and human health (for more information, please visit the CRS website). If you are interested in exploring novel delivery systems for this area, come to the Preclinical Sciences and Animal Health Get-Together and discover new opportunities for multifaceted collaborations with other CRS members.

Please indicate your attendance when registering. Complimentary event. continued www.controlledreleasesociety.org/meetings/annual 19

Networking Opportunities (continued) Women in Science Forum Luncheon

C&DP Division Luncheon

Tuesday, July 17

Tuesday, July 17

Speaker to be named.

Join your fellow Consumer & Diversified Products Division members for this networking luncheon at the Hilton Québec which is located just next to the convention center. Meal includes salad and sandwich buffet as well as one drink ticket. All attendees interested in C&DP are welcome to attend. Sponsored by The Coating Place, Fleet Laboratories, and Ronald T Dodge Co.

Don’t miss this popular annual event, which provides an insightful and informative presentation relevant to women in science and allows for ample networking time.

Advance registration and payment required. Ticket price $30.

Advance registration and payment required. Ticket price $15.

Young Scientist Networking Evening Monday, July 16

CRS President’s Banquet

Organized by the Young Scientist Committee Chaired by Sarah Eccleston, Encap Drug Delivery, Scotland, Joshua Reineke, Wayne State University, U.S.A., Amrita Mehta, Pfizer, U.S.A., and David Chen, Pfizer, U.S.A.

Tuesday, July 17

Enjoy an evening of interacting with colleagues when you attend the Young Scientist Networking Evening and dessert reception at the only revolving rooftop restaurant in Québec City, L’Astral Restaurant at Loews Hôtel Le Concorde. Enjoy French Canadian desserts, crepes, coffee, and tea. Loews Hôtel Le Concorde will be offering a dinner special for those who wish to dine at L’Astral Restaurant before the networking event.

Advance registration and payment required. Ticket price $50.

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Speaker: Kinam Park, Purdue University, U.S.A. The President’s Banquet is a premier opportunity to meet and dine with your colleagues from around the world. Join us for an elegant evening showcasing French Canadian cuisine and culture at the Hilton Québec. One drink ticket is included with your dinner, and a cash bar will be available.

Advance registration and payment required. Ticket price $95.

Exposition and Sponsorship Exposition Come to the Exposition Hall for discovery, solutions, opportunities, and refreshments! Kicking off with the Sunday evening Exposition Opening and Welcome Reception, the Exposition/Poster Hall will also be open Monday and Tuesday as the central hub for poster viewing, program breaks, and refreshments. Be sure to thank the CRS Café Sponsors (noted by *) for providing complimentary beverages during the breaks.

3M Drug Delivery Systems Adhesives Research Advanced Polymer Materials Agere Pharmaceuticals Agilent Akina Inc. Alkermes Pharma Ireland Ltd. Apricus Bio/NexMed U.S.A.* Aptalis Pharmaceutical Technologies Aptuit Inc. Asahi Kasei America, Inc. Avanti Polar Lipids Aveva Drug Delivery Systems* Banner* BASF BETATEK, Inc. Bio-Images Research & Drug Delivery International Buchi Catalent Pharma Solutions Celanese EVA Performance Polymers Colorcon, Inc. Corden Pharma

Croda Inc. Delta Industrial Services Dissolution Technologies Distek, Inc. Dow Water & Process Solutions DURECT Corp./Lactel Absorbable Polymers* Elsevier EMD Millipore Corp.

Evonik Degussa/Pharma Polymers Fluid Imaging Technologies Gateway Analytical, LLC Gattefossé* Gaylord Chemical Company Giltech Ltd. Glatt Pharmaceutical Services Grunenthal GmbH Hanson Research Corp.

Henkel Corporation Hovione LLC InGell Labs BV InnoCore Pharmaceuticals KORSCH America Inc.

Lipoid LLC* LTS Lohmann Therapy Systems Lubrizol Advanced Materials Inc. Medimetrics Michelson Prize & Grants Microfluidics Mylan Technologies Inc. NAL Pharma Ltd. NanoImaging Services Nanosight National Experimental Biology Centre – INRS National Institute of Biomedical Imaging and Bioengineering NOF America Corporation Northern Lipids Inc. Novozymes Biopharma OctoPlus NV O’Hara Technologies Inc. Pace Analytical Life Sciences Inc. Patheon Inc. PharmaCircle Pierre Fabre Medicament Super Critical

Fluids Division Purac Biomaterials QPharma AB SAIC-Frederick Inc. Scintipharma, Inc. Sensient Pharmaceutical Coating Systems* Shin-Etsu Chemical Co. Ltd./Biddle Sawyer Corp.

Simulations Plus, Inc. Sirius Analytical SOTAX Corporation Southwest Research Institute Springer Sympatec, Inc. Technology Catalysts International* Texture Technologies Thermo Scientific Vector Corporation Wyatt Technology Corporation

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Registration Information

Sponsorship Sponsors Make It Happen Many of the annual meeting events are possible only through the generosity of sponsors. Please join CRS in thanking the following 2012 sponsors, current as of February 24, 2012: 3M Drug Delivery Systems Apricus Bio/NexMed U.S.A. Aptalis Pharmaceutical Technologies Aveva Drug Delivery Systems Banner Catalent The Coating Place Colorcon DURECT Corp./Lactel Absorbable Polymers Elsevier EMD Millipore/Merck Millipore Fleet Laboratories Gattefossé Lipoid LLC

LTS Lohmann Therapy Systems Medimetrics Merial Mylan Technologies Inc. The Nagai Foundation Tokyo Northern Lipids Inc. Pfizer Pfizer Animal Health Ronald T. Dodge Co. Sensient Pharmaceutical Coating Systems Springer Technology Catalysts International Texture Technologies Corp.

Upsher-Smith Labs

Interested in Exhibiting or Sponsorship?

Connect with the CRS international delivery science community.

Contact Debby Woodard, Business Development +1.651.994.3817 • dwoodard@scisoc.org

Annual Meeting Registration Registration Options ➤ Register online at www.controlledreleasesociety.org/meeting. ➤ Print and complete the registration form at www.controlledreleasesociety.org/meeting.

2012 CRS Registration Fees All CRS Annual Meeting & Exposition registration fees are in U.S. dollars (USD).

Early Regular/Onsite Registration Classification (by May 7, 2012) (after May 7, 2012) Member $830 $1025 Student Member $295 $385 Post-doc Member $345 $435 Meeting + Membership* Registration + Regular Membership $985 $1,185 Registration + Student Membership $344 $434 Registration + Post-doc Membership $404 $494 Nonmember $999 $1,195 Student/Post-doc Nonmember* $395 $485 Single Day $675 $725 (Sunday, Monday, Tuesday, Wednesday)

*See page 23 for information regarding Member Rates, and Full-time Student/Post-doc rates.

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Exhibitor Registration Each exhibiting company is entitled to a specified number of complimentary annual meeting registrations based on booth size. Please see the Exhibitor Checklist on the CRS Annual Meeting & Exposition website for more information and to register each exhibitor individually with the customized form.

Rates for exhibitors beyond the complimentary allotment are: Annual meeting registration (member, nonmember, exhibitor, post-doc and student categories) includes access to the following: Abstracts (available June 15, 2012) CRS Connect CRS Innovation Sunday Sessions Exposition Focus Groups Grand Opening and Welcome Reception Get Up! Get Educated! Sessions

Podium and Poster Scientific Sessions Releasing Technology Workshops Roundtable Discussions Soapbox Sessions Young Scientist Events (except as noted)

Tickets must be purchased for all Educational Workshops, the Women in Science Forum Luncheon, the Young Scientist Networking Evening, CRS President’s Banquet, and C&DP Luncheon.

Early (by May 7, 2012) Exhibitor Registration $765 Registration + Membership $915

Regular/Onsite (after May 7, 2012) $995 $1,155

Member Rates Member rates apply only to current paid members of the Controlled Release Society. Become a member before you register for the CRS Annual Meeting & Exposition to qualify for exclusive savings.

Full-time Student/Post-doc Rates Full-time students and post-docs qualify for discounted registration rates. Student and post-doc nonmembers must register via fax or mail and have a faculty member sign the registration form to qualify for the student or post-doc rates.

Proof of graduate student or post-doctoral research status must accompany student nonmember registration.

Please indicate your attendance for the free workshops and events scheduled throughout the week so that we may plan accordingly. Tickets are limited for some events, and early registration is recommended. The deadline for advance annual meeting registration is May 7, 2012. continued www.controlledreleasesociety.org/meetings/annual 23

Registration Information (continued) Cancellation Policy Cancellations must be made in writing and be received by CRS no later than May 21, 2012. Cancellations received by this date are subject to a $100 processing fee.

Ticketed events will be fully refunded before this date. CRS Annual Meeting & Exposition registration and ticketed event cancellations received after May 21, 2012, are not subject to refund.

Payment Payment must accompany your registration. Registrations will be charged in U.S. dollars. Payment vouchers or purchase orders are not considered payment.

Registration options are: Credit card: Pay when registering online, or fax (+1.651.454.0766) or mail (see address below) the completed form with credit card information. For security reasons, we do not recommend sending your credit card information via e-mail.

Check: Mail the completed form and check payment to: CRS Meeting Registration 3340 Pilot Knob Road St. Paul, MN 55121 U.S.A.

Attire and Weather Business casual is the recommended dress for the CRS Annual Meeting & Exposition. The average mid-July high temperature in Québec City is 25°C (76°F). The average evening low temperature is 17°C (63°F). A light jacket or sweater is suggested. Québec City is a walking city, so comfortable walking shoes are also recommended.

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Emergency Information If you have a medical condition that CRS should be aware of during the meeting, please fax your information to CRS Annual Meeting & Exposition, +1.651.454.0766, or e-mail lbarna@scisoc.org. This information should be received no later than June 1, 2012, and is optional. Your information will not be shared with anyone, except in case of emergency, and then only with emergency personnel.

ADA/Special Requests For full and equal enjoyment of the CRS Annual Meeting & Exposition, please tell us of any special requirements you may have in the “Special Accommodation” area of the registration form, and a CRS staff person will contact you to further discuss your needs.

Program Modifications All information is subject to change without notice.

Official Language English is the official language of the CRS Annual Meeting & Exposition.

Photo Release Photographs will be taken throughout the CRS Annual Meeting & Exposition and are used in CRS electronic and printed promotional materials during the meeting and after it has concluded. By virtue of your attendance, you agree to the Controlled Release Society’s use of your likeness in said promotional media.

Convention Center & Hotel Information Centre des congrès de Québec All scientific sessions, poster sessions, the exposition, and the welcome reception will take place at the Centre des congrès de Québec.

Please consult the annual meeting program for venue locations for all social events.

Centre des congrès de Québec 1000, Boulevard René-Lévesque Est. Québec City, G1R 5T8 Canada

CRS Hotels CRS has reserved a block of rooms at each of the following hotels, at discounted rates. Detailed hotel information and booking instructions for reserving rooms online, by telephone, or by fax can be found on the CRS Annual Meeting & Exposition website www.controlledreleasesociety.org/ meeting.

Reservation Deadline: June 15, 2012 All hotel rates are in Canadian dollars (CAD). Tax on guest rooms is 18.42%. CRS discounted room rates are available three days before and after meeting dates, based on availability. Book early to ensure availability.

Summer is Québec City’s busiest time of year!

Hilton Québec—CRS Headquarters Hotel 1100 René-Lévesque Est. Blvd.

Québec City, G1R 4P3 Canada Hotel Tel: +1.418.647.2411 Hotel Fax: +1.418.647.6488

Early Bird Rates! Book by April 29: $236 CAD Single or Double occupancy $246 CAD Triple occupancy $256 CAD Quad occupancy $296 CAD Single occupancy—Executive floors $321 CAD Double occupancy—Executive floors After April 30 rates: $241 CAD Single or Double occupancy $251 CAD Triple occupancy $261 CAD Quad occupancy $301 CAD Single occupancy—Executive floors $326 CAD Double occupancy—Executive floors

continued

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Hotel Information (continued) Loews Hôtel Le Concorde 1225 cours du Général-De Montcalm Québec City, G1R 4W6 Canada Hotel Tel: +1.418.647.2222 Hotel Fax: +1.418.647.4710

Hôtel Palace Royal 775 Avenue Honoré-Mercier Québec City, G1R 6A5 Canada Hotel Tel: +1.418.694.2000 Hotel Fax: +1.418.380.2553

Rates $215 CAD Single or Double occupancy $235 CAD Triple occupancy $255 CAD Quad occupancy

Rates $179 CAD Single or Double occupancy (one or two queen beds) $20 CAD each additional guest in room (maximum of 2 persons per single-bedded room and 4 persons per double-bedded room)

Hôtel Delta Québec 690 René-Lévesque Est. Blvd.

Québec City, G1R 5A8 Canada Hotel Tel: +1.418.647.6553 Hotel Fax: +1.418.647.9573 Rates $199 CAD Single or Double occupancy MODE rooms (one or two queen beds) $20 CAD each additional guest in room (maximum of 2 persons per single-bedded room and 4 persons per double-bedded room)

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Québec City, Canada—Always Enchanting!

Québec City is the capital of the Canadian province of Québec and an open-air treasure chest that will delight history and culture buffs alike. Its European background and modern, North American character are set off by a heady blend of 400 years of history, traditional and contemporary art, and culture.

Old Québec is a UNESCO World Heritage site and is alive with history. Visitors to Old Québec (Vieux-Québec) will marvel at this fortified part of the city, which exudes old-world charm with winding cobblestoned streets, museums, attractions, shops, and restaurants.

Québec City…always enchanting, filled with history and brimming with joie-de-vivre!

International Travel Passport Requirement—A passport is required of all non-Canadian attendees for entry into Canada.

TRV (Temporary Resident Visa)—All visitors to Canada require a TRV, except citizens of countries where an exemption has been granted. Consult the complete list of countries whose citizens require a TRV to visit Canada: www.cic.gc.ca/english/visit/visas.asp#cn-tphp. Exemptions are also listed for those countries whose citizens do not require a visa to travel to Canada. All visas must be obtained at a Canadian visa office closest to where you live or work. Visas are not available at the border or at the airport.

For complete international travel requirements to Canada, please visit the CRS Annual Meeting website.

Arrive Early and Enjoy Canada’s Largest Outdoor Music Festival!

Music lovers, arrive a few days early and enjoy music superstars in the exciting Festival d’été de Québec held in Québec City, July 5–15, 2012. In the past, performers have ranged from Plácido Domingo to KISS to Madonna to The Black Eyed Peas. The festival includes jugglers, acrobats, stilt walkers, and troupes of performers captivating crowds in the winding streets of Old Québec. Learn more and view the lineup at www.infofestival.com/The-Festival. Book your hotel room early to ensure availability.

www.controlledreleasesociety.org/meetings/annual 27

Controlled Release Society 3340 Pilot Knob Road St. Paul, MN 55121 United States of America

The Forefront of Delivery Science and Technology

39th Annual Meeting & Exposition of the Controlled Release Society Smart Materials—From Innovation to Translation

➤ Register Now!

July 15 – 18, 2012 Centre des congrès de Québec Québec City, Canada