2013 CRS Annual Meeting & Exposition Registration Brochure

40th Annual Meeting & Exposition of the Controlled Release Society July 21–24, 2013 Hawaii Convention Center Honolulu, Hawaii, U.S.A.

Emerging Challenges for Global Delivery

Program Team 2013 Annual Meeting Program Planning Committee Chair: Mark Saltzman, Yale University, U.S.A. Deputy Chair: Ick Chan Kwon, KIST, Korea Marcel Bally, British Columbia Cancer Research Centre, Canada Marcus Brewster, Johnson & Johnson, Belgium Sarah Eccleston, Aptuit Ltd., United Kingdom Chuck Frey, Coating Place Inc., U.S.A. Justin Hanes, Johns Hopkins University, U.S.A. Hideyoshi Harashima, Hokkaido University, Japan Nicole Papen-Botterhuis, TNO, The Netherlands Joshua Reineke, Wayne State University, U.S.A. Christian Seiler, Merck Sharp & Dohme, United Kingdom

Photo Credits Cover: Aerial view of Honolulu Convention Center, ©David Cornwell Page 2: ©shutterstock.com Pages 3, 8, 10: ©istockphoto.com Pages 3, 27, Mail panel: ©Honolulu Tourism Authority, Tor Johnson

Say Aloha to the CRS Annual Meeting The Controlled Release Society is excited to meet in Honolulu, Hawaii, U.S.A., a Pacific gateway to Asia and the Pacific Rim. Register now to join your delivery science colleagues at the 40th Annual Meeting & Exposition. Discover the latest on all the hottest topics in delivery science and technology, including ocular and oral delivery, drug combinations, nanotechnology, interspecies variability, nutraceuticals, peptide and protein delivery, and more.

See you on the island!

Why Hawaii?

Hawaii is a unique location and its Aloha spirit are perfect for research, international networking, and business development.

Hawaii offers: R5 An Excellent Location. Hawaii is positioned as a center of commerce with global appeal.

The emerging markets of China, India, and other Asian and Pacific Rim countries offer huge potential in delivery science.

R5 The Chance to Reach All CRS Members. CRS is truly an international society, with members representing more than 50 countries.

R5 A Price That is Right. Honolulu is considered less expensive than most major U.S. convention cities.

R5 Worldwide Appeal. The exceptional year-round climate and hospitality make Hawaii the perfect meeting place. The islands are tropically exotic, yet professional in how business is done.

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Invitation from the President “The beautiful island of Hawaii will offer the perfect location to learn about the latest in delivery science while making vital business connections. I look forward to seeing all of you in Honolulu.�

Kazunori Kataoka President Controlled Release Society

Table of Contents Schedule-at-a-Glance .................................................. 4 Program Highlights ..................................................... 6 CRS Innovation Sunday ............................................. 11 Workshops ................................................................. 16 CRS Foundation ......................................................... 20 Networking Opportunities ....................................... 20 Exposition .................................................................... 22 Sponsorship ............................................................... 23 Registration Information ........................................... 23 Convention Center & Hotel Information .................. 26 The Islands Are Calling: Exotic, Tropical Hawaii ....... 27

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. www.controlledreleasesociety.org/meeting 3

Schedule-at-a-Glance Saturday, July 20

Monday, July 22

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

07:00 – 08:00 07:00 – 17:30 07:00 – 18:00 08:00 – 09:30 09:30 – 10:30 09:30 – 10:30 09:30 – 17:30 09:30 – 17:30 10:30 – 12:00 11:30 – 13:30 12:00 – 13:30 13:30 – 14:45 15:00 – 16:30 16:30 – 17:30 17:30 – 18:30 21:00 – 22:30

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

Sunday, July 21 07:00 – 17:30 07:30 – 18:00 08:00 – 12:00 08:00 – 12:00 08:00 – 14:00 09:00 – 12:30 11:30 – 12:30 12:30 – 14:00 13:00 – 15:10 15:30 – 17:30 17:30 – 19:30

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

Get Up! Get Educated!

Speaker Preparation Room Open CRS Registration Open CRS Opening Session Poster Session 1 (authors present) Exposition Open – Meet with Exhibitors Exposition Hall Open Poster Viewing Scientific Sessions Mentor/Protégé Meet and Greet Exposition Open – Meet with Exhibitors Plenary Session Scientific Sessions Poster and Exposition Happy Hour – Meet with Exhibitors Preclinical Sciences & Animal Health Get-Together Young Scientist Networking Event

Tuesday, July 23

Wednesday, July 24

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

07:30 – 12:00 08:00 – 09:30 09:45 – 11:00

Get Up! Get Educated!

Poster Viewing Speaker Preparation Room Open CRS Registration Open Plenary Session Poster Session 2 (authors present) Exposition Open – Meet with Exhibitors Exposition Hall Open Scientific Sessions C&DP Luncheon Exposition Open – Meet with Exhibitors Scientific Sessions Poster Session 3 (authors present) Poster Take-down Roundtables and Focus Groups Exhibit Take-down CRS President’s Banquet

CRS Registration Open Scientific Sessions Plenary Session

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Program Highlights Access the latest in delivery science and technology through a wide variety of learning opportunities, including CRS Innovation Sunday, featured plenary sessions, educational workshops, interactive roundtables, mini-symposia, and more. You will have the chance to discover the latest findings in your area of delivery science, plus expand your knowledge of and apply technologies from other areas.

Exposition Grand Opening & Welcome Reception The official welcome to the CRS Annual Meeting and Exposition! Join your colleagues and exhibiting companies for an evening of appetizers and beverages, along with the chance to connect one-on-one with your fellow scientists and company representatives.

CRS Opening Session The opening session will feature a welcome by President Kazunori Kataoka and the presentation of the 2013 Fellows awards, along with the CRS T. Nagai Postdoctoral Research Award and the Young Investigator Award. The session will conclude with a lively panel discussion organized by our College of Fellows.

“It is the best meeting for overall drug delivery science and technology.�

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Plenary Sessions Headlining this year’s program are plenary lectures on the successful launching of new technology in immunology, the application of nanotechnology, and insights from within the venture capital world. These lectures offer a high-level look at technology and paths to bringing it to practical use.

Monday, July 22 13:30 – 14:45 Kenzo Takada

Tuesday, July 23 08:00 – 09:30 Josh Wolfe

Wednesday, July 24 09:45 – 11:00 Paula T. Hammond

Chairman and Founder, Evec, Inc., Professor Emeritus, Hokkaido University, Japan

Founding Partner and Managing Director, Lux Capital, U.S.A.

David H. Koch Professor of Engineering, Department of Chemical Engineering and Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, U.S.A.

Human B-Lymphocytes as a Source of High-Affinity, Really Fully Human Antibodies Producing antibody medicines through the hybridoma method in which transgenic mice are grafted with human antibody genes results in lowaffinity antibodies that are not fully human. In contrast, human blood B-lymphocytes are activated through natural immune reactions. They are stimulated repeatedly with a small amount of antigen, so only those producing high-affinity antibodies are activated. Thus, human lymphocytes are an excellent source of high-affinity, really fully human antibodies. This session covers Evec’s antibody production technology using Epstein-Barr virus and its experience in license negotiations.

Hype and Hope: A View from a Venture Capitalist Josh Wolfe provides a venture capital investor perspective on commercializing scientific breakthroughs, raising capital, recruiting talent, and building a high-growth high-tech venture. He dispels myths and shares insider views on the highstakes, risky, and competitive world of venture investing. How can you secure non-dilutive funding?

What are the key terms to seek or be wary of when negotiating a deal? What are the new and emerging trends VCs are pursuing, and where are they shunning opportunities?

Electrostatic Nanolayer Delivery Platforms: From Macro- to Nanopharmacies The electrostatic layer-by-layer process is a simple and elegant method of constructing highly tailored ultrathin polymer and organic–inorganic composite thin films to deliver proteins and biologic drugs in a highly tunable way. This approach can be adapted to achieve various goals, including releasing drugs in specific regions, increasing the half-life of the particle in the bloodstream, and preventing recognition of the particle as a foreign body. It is also possible to synthesize extremely long strands of RNA for cellular delivery, yielding active siRNA strands at significant doses.

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Invited Speakers The 40th 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 Scientific Sessions form the core of the annual meeting and are focused on various aspects within the extensive scope of controlled release and delivery. The 20 sessions highlight the latest information on bioactives, consumer & diversified products, and preclinical sciences & animal health. Each session features an invited speaker and includes four additional speakers to round out the session. These sessions offer an exciting lineup of top scientists representing the continuum of delivery science and technology. Full session descriptions and speakers can be found online.

Session Information Y Challenges Around Brain Delivery:

Sampling Site Issues and Interspecies Extrapolations Margareta Hammarlund-Udenaes, Uppsala University, Sweden

Y Food, Nutraceuticals, and Personalized Diet

Martin Kussmann, Nestlé Institute of Health Sciences SA, Switzerland Y Imaging and Characterization Techniques

Y Drug Delivery for Developing Countries/

Global Challenges Kim Woodrow, University of Washington, U.S.A.

for Drug Delivery: Systems and Targeted Drug Delivery Karsten Mäder, Martin-Luther University Halle-Wittenberg, Germany Y Micro- and Nanoparticle Design

Y Drug Targeting, Pharmacokinetics and

Biodistribution: Differences Between Species Jim Klostergaard, University of Texas, M.D. Anderson Cancer Center, U.S.A.

David Weitz, Harvard University, U.S.A. Y Modern Agriculture and Aquaculture

Speaker to be named Y Emerging Technologies

Dan Luo, Cornell University, U.S.A.

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Y Oral CR—Pharmaceutical Formulations,

Technologies and Development Strategies Peter Timmins, Bristol-Myers Squibb, United Kingdom

Y Personal and Home Care

Jiten Dihora, Procter & Gamble, U.S.A.

Y Smart Building and Construction

Materials and Coatings Henk Jonkers, Delft University of Technology, The Netherlands

Y Processing Technology/Manufacturability

Speaker to be named Y Oral CR—Predictive Tools

(In Vitro/In Vivo/In Silico) Sandra Klein, UNI Greifswald, Germany Y Parenteral Sustained Release

Drug Delivery Steven Schwendeman, University of Michigan, U.S.A.

Y Solubilization Technology—A Key Y Regional Delivery: Challenges in Ocular

Delivery and Pulmonary Delivery Samir Patel, Clearside Biomedical, U.S.A.

Enabler for the Delivery of Poorly Soluble Drugs Ravi Shanker, Pfizer, U.S.A. Y Topical/Transdermal Drug Delivery

Y Rising Suns in Asia

Rainer Müller, Freie University Berlin, Germany

Yukio Nagasaki, University of Tsukuba, Japan Y Peptide and Protein Delivery

Tarek Fahmy, Yale University, U.S.A.

Y RNAi and DNA Delivery

Chae-Ok Yun, Hanyang University, Korea

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

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

Breakthrough Technologies in Drug Delivery Systems from Asia R5Kwangmeyung Kim, KIST, Korea R5Hirofumi Takeuchi, Gifu Pharmaceutical University, Japan R5Zhiyuan Zhong, Soochow University, China Drug Combination Products R5Charlie Boone, University of Toronto, Canada R5Lawrence Mayer, Celator Pharmaceuticals Corporation, Canada R5Liangfang Zhang, University of California, U.S.A. Energy: Problems within the Industry that Controlled Delivery Can Solve R5Anne Dalager Dyrli, RESMAN AS, Norway R5Jo Darkwa, University of Nottingham Ningbo, China R5James Oxley, Southwest Research Institute, U.S.A.

“A ‘must attend’ meeting for anyone in the drug delivery field.”

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Hybrid Groups: Bridging the Gap Between Industry and Academia R5Karimah Es Sabar, Center for Drug Research and Development, Canada R5Bert Klebl, The Lead Discovery Center at Max Planck, Germany R5Speaker to be named Nanoparticles and Cancer R5Michelle Bradbury, Memorial Sloan-Kettering Cancer Center and Sloan-Kettering Institute, U.S.A. R5Peter Senter, Seattle Genetics Inc., U.S.A. R5Sonke Svenson, Cerulean Pharma Inc., U.S.A.

CRS Innovation Sunday Delivery Science Meets Business Opportunities Sunday, July 21

Soapbox Sessions

CRS Innovation Sunday is all about the business of delivery science, taking innovative ideas and technologies into the commercial sector. All of these sessions give you new, important information on companies and technologies as well as great opportunities for networking face-to-face. This is the start of the CRS Annual Meeting program—don’t miss it!

Co-sponsored by Catalent

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

Interested in a new technology from the company that developed it? Open to all registered attendees, Technology Forums give you the opportunity to gain indepth information presented by the hosting company. Presentation titles, details, and speakers are posted on the CRS Innovation Sunday webpage for these participating companies: Capsugel Catalent CIMA Labs Colorcon Inc. Medimetrics

Mott Corporation OctoPlus Particle Sciences, Inc. SOTAX Corporation

What’s new in delivery science? Come to the program where presenters “get up on their soapbox” to give you a quick glimpse of some of the most innovative technologies and products in development today. Linger to network with the presenters as you enjoy refreshments, with thanks to our sponsor. Soapbox applications will be received and reviewed until the session is full. Watch the CRS Innovation Sunday webpage for topics and presenters.

Industry Roundtable: Global Perspectives on Emerging and Established Delivery Markets A global panel of business development and R&D executives from Asia, Europe, and North America will provide insight on the latest trends, challenges, and needs they see in delivery science. CRS welcomes your audience participation in this session that is all about the international business of delivery science, offering a mix of presentations, panels, and case studies.

Exposition Grand Opening & 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 from CRS exhibitors, including new companies in the Asia Pacific Pavilion. Take this opportunity to enjoy light hors d’oeuvres, view scientific posters, and connect one-on-one with your fellow scientists and company representatives. www.controlledreleasesociety.org/meeting 11

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 Nanomedicine, Ocular and Oral Drug Delivery roundtable discussions.

Nanomedicine Roundtable—Challenges Associated with Commercialization of Nanomedicines

Ocular Drug Delivery Roundtable—Novel Biomaterials for Ocular Drug Delivery

Tuesday, July 23

Tuesday, July 23

Chaired by Christine Allen, University of Toronto, Canada, and Marcel Bally, British Columbia Cancer Research Centre, Canada

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

Nanomedicines have the potential to transform healthcare, improving patient outcomes worldwide. However, their translation from bench to bedside has been challenging. Significant hurdles need to be overcome to move nanomedicines developed in the preclinical setting to the market. Successful commercialization of nanomedicines requires a multidisciplinary approach that brings together scientists, clinicians, and business professionals. World experts in the nanomedicine field will share their experiences related to the highs and lows of nanomedicine development and commercialization.

Eye diseases such as glaucoma, age-related macular degeneration, and diabetic retinopathy are rising at an alarming rate and are leading causes of blindness.

Local delivery of therapeutic agents is considered key for effectively treating these diseases while minimizing systemic toxicity. Advances in materials science and engineering have created unprecedented opportunities for the development of intraocular drug delivery systems. This roundtable will discuss the current status of biomaterials used in ocular drug delivery systems and novel materials that are emerging.

“The best opportunity to get in touch with skills of the art of pharmaceutical sciences and to share knowledge with others.”

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Oral Drug Delivery Roundtable—Multiparticulate Oral Drug Delivery Systems for Fixed Dose Combinations Tuesday, July 23 Chaired by Sarah Eccleston, Aptuit Ltd., United Kingdom, and Ali Rajabi-Siahboomi, Colorcon Inc., U.S.A. Many drug products utilize multiparticulate technologies. This is a key platform technology for delivering multidrug therapies for general use, special patient groups (geriatric and pediatric population), and emerging markets. Regardless of the purpose of the multiparticulate systems, the development process may require careful consideration. Multiparticulate opportunities for fixed dose combinations, including case studies to illustrate challenges and best practices, will be discussed. Hear from industry leaders on this hot topic, and share your experiences during the discussion.

Young Scientist Roundtable—Commercializing Ideas from Academia: Past Lessons and Current Challenges Sunday, July 21 Chaired by Adam Bohr, Veloxis Pharmaceuticals A/S, Denmark, and Hardik Shah, Alkermes Pharma Ireland Ltd., Ireland Novel idea, proof of concept, in-depth analysis… At what point are an academic researcher’s results sufficient to start a company or bring a new product to the market? This roundtable will discuss the challenges to develop a business/marketing model while competing with the pharmaceutical industry. It will provide insight into intellectual property, evaluation of business opportunities, licensing, industrial collaborations, and regulatory aspects. Successful entrepreneurs will share their experiences and discuss challenges in commercializing ideas from academia. www.controlledreleasesociety.org/meeting 13

Get Up! Get Educated!

Nanomedicines for Drug Delivery Across Epithelial Barriers: Intestines, Skin, and Lungs

Quality by Design: Systematic Development of Pharmaceutical Products

Monday, July 22

Tuesday, July 23

Chaired by Prajakta Dandekar Jain, Institute of Chemical Technology, Mumbai, India

Chaired by Joshua Reineke, Wayne State University, U.S.A., and Pirthi Pal Singh, Panacea Biotec Ltd., India

Speaker: Claus-Michael Lehr, Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Germany

Beyond development of delivery systems, formulation scientists must integrate scientific development along with regulatory requirements. Regulatory agencies monitor the path selected for initial screening, prototype development, process and composition optimization, and stability of drug product in addition to the final developed product. Quality by Design (QbD) ensures the systematic approach to development that begins with predefined objectives and emphasizes process understanding and process control, based on sound science and quality risk management.

This session is a must-attend for young scientists and will educate them on how nanoscale drug formulations have an edge over conventional formulations for improved drug delivery across epithelial barriers. Discussion involving experimental evidence will prove the advantage of drug/antigen loaded nanoparticles for targeted therapy of inflammatory bowel diseases, as needle-free vaccines via the dermal route to avoid the need for painful injections, and for delivery across the air-blood barrier while controlling mucociliary and macrophage clearance.

Please indicate your attendance when registering. Complimentary event.

CRS serves industry, academia, student, and government affiliations—industry being the largest with 44%

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Please indicate your attendance when registering. Complimentary event.

Young Scientist Mentor/Protégé Meet and Greet Monday, July 22 Organized by the CRS Young Scientist Mentor/Protégé Subcommittee Are you interested in being a mentor or protégé? Provide your knowledge and encouragement to a young scientist or be the recipient of expertise and experience from academics or industry scientists for your professional and career development. Preregistration for the 2013–2014 CRS Young Scientist Mentorship Program is strongly encouraged. Do not miss this exciting session for the opportunity to meet face-to-face your mentor or protégé.

“Tell me and I forget, teach me and I may remember, involve me and I learn.”

– Benjamin Franklin Please indicate your attendance when registering. Complimentary event.

Posters CRS Posters and Poster Author Sessions All scientific posters will be set up and available for viewing Sunday evening during the Exposition Grand Opening & 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. CRS will again be offering Poster Snapshots – three-minute audio recordings that provide a summary preview of poster content. The snapshots can be listened to at the attendee’s convenience via the CRS Mobile App. Poster take-down will take place on Tuesday, July 23, 16:00 – 17:00.

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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.

Oral Delivery of Bioactives Using Lipid-Based Drug Delivery Systems

Controlled Release Dosage Forms and Product Development Strategy for Expected New Regulatory Trends

Saturday, July 20 – Sunday, July 21 (1 ½ days)

Saturday, July 20 (Full day)

Chaired by Sarah Hook, University of Otago, New Zealand, and Anette Müllertz, University of Copenhagen, Denmark

Chaired by Yanning Lin and Ubrani Venkataram, Food and Drug Administration, U.S.A.

The three major challenges in the development of oral delivery systems are poor aqueous solubility of low-molecular “classical” drugs, the development of oral delivery systems for modern biologics, and the development of oral vaccines. In all three areas lipid delivery systems have a lot to offer. This workshop will explore new developments in the formulation and delivery of small-molecularweight drugs, proteins, and vaccines. Analytical techniques for the development of lipid-based delivery systems will also be included.

The FDA expects the application of QbD principles. Speakers will discuss new trends and technology approaches for robust formulations, a development strategy via in vitro–in vivo relationships, the use of spectroscopic methods, and scale-up for the Wurster process. FDA staff will discuss current expectations for regulatory submissions in the Office of Generic Drugs with a focus on application of QbD principles to the product development of controlled release solid oral dosage forms.

Workshop Price Regular Student/Postdoc

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Early (by May 2, 2013) $525 $250

Regular/Onsite (after May 2, 2013) $625 $300

Workshop Price Regular Student/Postdoc

Early (by May 2, 2013) $350 $160

Regular/Onsite (after May 2, 2013) $400 $200

Leadership Workshop for Women in Science Saturday, July 20 (Full day) Chaired by Diane Burgess, University of Connecticut, U.S.A. Organized by the CRS Women in Science Task Force This highly-interactive professional development workshop includes bestpractice theory, personal reflection and small group work. Each participant will leave with a clear understanding of their management strengths and challenge.

Attendees will also learn how to enhance their ability to lead a team, build a coalition with peers and a better understanding of how to influence “up�. Prior to the course, each participant will be asked to take two online personal assessments. Results from this pre course work will be used to create personalized binders for each participant to use during the workshop.

Taste-Masking Technologies and Formulations: Meeting the Challenges for Bitter Drug Actives Saturday, July 20 (Full day) Chaired by Tom Farrell, Colorcon Inc., U.S.A., and Nigel Langley, BASF Corporation, U.S.A. The workshop will discuss the growing importance and relevance of taste masking in pharmaceutical drug development. Areas such as life-cycle management, pediatric, geriatric, and veterinary medicines will be highlighted.

The FDA will provide insight into the current requirements for pediatric medicines. Existing and new technologies for taste masking solid oral dosages and liquid formulations will be described. An open panel discussion will provide attendees an opportunity to debate this important issue.

Registration deadline for this course is July 4, 2013 due to the pre course work.

Workshop Price Regular Student/Postdoc

Early (by May 2, 2013) $525 $250

Regular (after May 2, 2013) $625 $300

Workshop Price Regular Student/Postdoc

Early (by May 2, 2013) $350 $160

Regular/Onsite (after May 2, 2013) $400 $200

continued

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Educational Workshops (continued) Using In Vitro–In Vivo Correlation (IVIVC) to Meet Challenges in Global Delivery

Locally Acting Dermal Drug Products: Global Challenges for Development and Registration

Saturday, July 20 (Afternoon)

Sunday, July 21 (Morning)

Chaired by Tapash Ghosh, ONDQA/CDER/FDA, U.S.A., and Vivian Gray, V. A. Gray Consulting, Inc., U.S.A.

Chaired by Tapash Ghosh, ONDQA/CDER/FDA, U.S.A., and Howard Maibach, University of California, U.S.A.

This workshop will provide a stimulus to develop in vitro–in vivo correlations (IVIVC), highlighting the utility of the correlation. A discussion of global expectations for IVIVC will review regulatory guidance and FDA experiences.

The key factors in developing the in vitro test and supporting the formulation will be explored, along with case studies of biowaivers using IVIVC. The traditional approach to IVIVC and in vitro–in vivo relationships (IVIVR) using deconvolution will be presented.

The workshop will bring a sound understanding of topical dermal products across multiple disciplines and multiple sectors. It will also discuss challenges associated with demonstration of bioequivalence for topical products from both new and generic drug perspectives in light of considerations for future regulatory submissions. Alternative and novel technologies for determining bioequivalence of topical drug products as well as the value of in vitro drug release in semisolid dosage forms will also be discussed.

Workshop Price Regular Student/Postdoc

Early (by May 2, 2013) $200 $125

Regular/Onsite (after May 2, 2013) $225 $145

80% of attendees indicated that the most important reason to attend the annual meeting is to learn about new technology 18

Workshop Price Regular Student/Postdoc

Early (by May 2, 2013) $200 $125

Regular/Onsite (after May 2, 2013) $225 $145

Young Scientist Workshops The Young Scientist 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 five years’ experience in the field of delivery science.

Young Scientist Workshop II—Professional and Self Development for Young Scientists and Protégés: Effective Communication

Young Scientist Workshop I—Fundamentals of Controlled Release Drug Delivery: Physiochemical and Biological Aspects

Chaired by Michael Rathbone, International Medical University, Malaysia, and Teresa Virgallito, Microtek Labs Inc., U.S.A.

Saturday, July 20 (Full day)

The workshop will provide young scientists with a training program for developing interpersonal relationships, improving listening skills, teaching negotiation skills, resolving conflict, and strengthening assertiveness.

Young scientists will be able to improve their communication skills by increasing their awareness, attentiveness, and empathizing capacity, and so facilitate better communication throughout their organization. The workshop will also focus on intercultural communication. Global communication is essential in today’s international business and academic communities.

Chaired by Raid Alany, Kingston University London, United Kingdom, Giorgia Pastorin, National University of Singapore, Singapore, and Zimei Wu, University of Auckland, New Zealand Whether you are a Ph.D. student, a postdoctoral fellow, or an established researcher, it is vital that you brush up on the fundamentals of the design and performance of innovative controlled release drug delivery systems (DDS). The key physicochemical and biopharmaceutical concepts essential for successful DDS design will be reviewed, and various routes of drug delivery will be compared and contrasted. Furthermore, this workshop will shed light on cuttingedge innovations underpinned by the fundamental principles.

Sunday, July 21 (Morning)

Please indicate your attendance when registering. Complimentary event.

Please indicate your attendance when registering. Complimentary event.

“Very good possibility to get an insight into actual topics and talks with key opinion leaders from all over the world.”

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CRS Foundation

Networking Opportunities

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, more than $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. The next fellowship honors Alexander “Sandy” Florence in 2014.

CRS Connect

Donate when you register for the annual meeting.

As a CRS Annual Meeting attendee, CRS Connect is your premier opportunity to network with colleagues while in Honolulu. As part of the CRS Mobile App, CRS Connect is easily accessible from your mobile phone, tablet, or computer.

This networking tool allows you to plan the scientist-to-scientist or business development collaborations you seek at the annual meeting while maintaining your full privacy, as personal contact information is never shared. For instructional information, please visit www.controlledreleasesociety.org/meeting.

CRS Foundation Reflections

First Timers’ Meeting

Tram Dang

Sung Wan Kim Postdoctoral Fellowship, 2012–2013: A Year in Review You will see, firsthand, the outcomes of the CRS Foundation’s support. CRS Foundation awardee Tram Dang will present outcomes of her fellowship year engineering high-throughput in vitro systems for the investigation of immunological interaction in the Ali Khademhosseini Laboratory at Brigham and Women’s Hospital, Harvard Medical School.

“Very good meeting for academics to meet pharma.”

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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.

Please indicate your attendance when registering. Complimentary event.

Preclinical Sciences & Animal Health Get-Together

C&DP Division Luncheon

Monday, July 22

Tuesday, July 23

Co-Sponsored by Merial

Co-Sponsored by The Coating Place, Fleet Laboratories, and Ronald T. Dodge Co.

This year’s Get-Together promises to be better than ever! Dr. Marilyn Martinez addresses the question “Why is the beagle the dog of choice for preclinical studies?” Simcyp will describe recent advances in the development of a canine physiologically based pharmacokinetic model to support within- and betweenspecies extrapolations. An enticing discussion will follow. Included in the ticket price are one drink ticket and hors d’oeuvres.

Join your fellow Consumer & Diversified Products Division members for this networking buffet luncheon at the Hawaii Convention Center. All attendees interested in C&DP are welcome to attend.

Advance registration and payment required. Ticket price $15.

CRS President’s Banquet

Advance registration and payment required. Ticket price $10.

Young Scientist Networking Event Monday, July 22 Organized by the Young Scientist Committee Co-Sponsored by Upsher-Smith Labs and Diurnal Ltd. Spend an enjoyable evening networking with colleagues when you attend the Young Scientist Networking Event at the world-famous Jimmy Buffett’s at the Beachcomber Restaurant and Honolulu Surfing Museum. Reunite with familiar faces and make new connections as you tour the surfing museum, which includes a premier collection of surfing artifacts, videos, and surf-inspired items. Then enjoy hors d’oeuvres and cocktails in a venue that truly celebrates the people, culture, and incredible natural wonders of Hawaii.

Get into the Aloha Spirit by attending this year’s President’s Banquet to be held at the beautiful, tropical Hilton Hawaiian Village. The evening will feature scientific highlights from CRS chapters showcasing their recent achievements.

You will enjoy a sumptuous dinner reflecting the Hawaiian Islands’ cuisine and culture. Experience the flavors, sights, and sounds of Hawaii while meeting with old friends, creating new friendships, and celebrating a successful CRS Annual Meeting!

Advance registration and payment required. Ticket price $95.

“High-quality contacts and networking.”

Advance registration and payment required. Ticket price $30. www.controlledreleasesociety.org/meeting 21

Exposition Exposition Hall Activities Come to the Exposition Hall for discovery, solutions, opportunities, and refreshments! Kicking off with the Sunday evening Exposition Grand Opening & 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 CafĂŠ Sponsors (*) for providing complimentary beverages. NEW! Stop by the Asia Pacific Pavilion to meet first-time exhibiting companies from the Asia Pacific region.

3M Drug Delivery Systems

NanoSight

PolySciTech Div Akina, Inc.

Advanced Polymer Materials Inc.

DURECT Corp./Lactel Absorbable Polymers

Nisso America Inc.

Purac Biomaterials

Agilent Technologies

Elsevier

NOF Corp

Saint-Gobain Performance Plastics

Asahi Kasei America

EMD Millipore

Northern Lipids Inc.

Scintipharma Inc.

*Avanti Polar Lipids

Evonik Degussa Corporation Pharma Polymers

Novozymes Biopharma

Sekisui Medical Co., Ltd.

*Octoplus NV

Simulations Plus

ONdrugDelivery Magazine

Sirius Analytical

Particle Sciences, Inc.

SkyePharma

*Hovione

Partnership Opportunities in Drug Delivery – PODD

SOTAX Corporation

*Lipoid

Patheon

Lubrizol

Springer

Pharmaceutical Technology

Medimetrics

Surface Measurement Systems

PharmaCircle

The Methodist Hospital Research Institute

*Technology Catalysts

Polymun Scientific Immunbiologische Forschung GmbH

Texture Technologies Corp.

Michelson Prize & Grants

PolyPeptide Group

BASF Bend Research Inc. Catalent CIMA Labs Colorcon Inc. Corden Pharma CoSci Med-Tech Co., Ltd. *Covaris Dissolution Technologies Drug Delivery Partnerships Drug Development & Delivery

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Freund-Vector Corp.

Glatt Air Techniques, Inc. Halozyme Therapeutics

Southwest Research Institute

Wyatt Technology

Sponsorship

Registration Information

Sponsors Make It Happen

Annual Meeting Registration

Many of the annual meeting events are possible only through the generosity of sponsors. Please join CRS in thanking the following 2013 sponsors, current as of February 12, 2013:

Registration Options

3M Drug Delivery Systems Advanced Polymer Materials Inc. Aptalis Pharmaceutical Technologies Avanti Polar Lipids Catalent The Coating Place Colorcon, Inc. CoSci Med-Tech Co., Ltd. Covaris Diurnal Ltd Elsevier Fleet Laboratories Hovione

Lipoid LLC Merial Mylan Technologies Inc. The Nagai Foundation Tokyo OctoPlus Patheon PharmaCircle PolySciTech div of Akina, Inc Ronald T. Dodge Co. Springer Technology Catalysts International Upsher-Smith Labs

Interested in Exhibiting or Sponsorship?

Connect with the CRS international delivery science community.

Contact Debby Woodard, Business Development ‰g8lkg8ooj8ingm5R5 1)) , H- #-) 8),!

➤ Register online at www.controlledreleasesociety.org/meeting ➤ Print and complete the registration form at www.controlledreleasesociety.org/meeting 2013 CRS Registration Fees All CRS Annual Meeting & Exposition registration fees are in U.S. dollars (USD).

Early Registration Classification (by May 2, 2013) Member $845 Student Member $300 Postdoc Member $345 Meeting + Membership Registration + Regular Membership $998 Registration + Student Membership $352 Registration + Postdoc Membership $407 Nonmember $999 Student/Postdoc Nonmember $395 Single Day $675 (Sunday, Monday, Tuesday, Wednesday)

Regular/Onsite (after May 2, 2013) $1,045 $390 $435 $1,198 $442 $497 $1199 $485 $725

continued www.controlledreleasesociety.org/meeting 23

Registration Information (continued) Annual meeting registration* includes access to the following: Abstracts (available June 21, 2013) CRS Connect CRS Innovation Sunday Sessions Exposition Focus Groups Exposition Grand Opening & Welcome Reception

Get Up! Get Educated! Sessions Podium and Poster Scientific Sessions Technology Forums Roundtable Discussions Soapbox Sessions Young Scientist Events (except as noted)

Exhibitor Registration Each exhibiting company is entitled to a specified number of complimentary annual meeting registrations based on exhibit 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.

Complimentary allotment: Space 10 x 10 Foot Booth 10 x 20 Foot Booth 6 x 2 Foot Tabletop

Rates for exhibitors beyond the complimentary allotment are:

*Does not include single-day registrations Tickets must be purchased for all educational workshops, Young Scientist Networking Evening, CRS President’s Banquet, Preclinical Sciences & Animal Health Get-Together, and C&DP Luncheon.

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 early annual meeting registration is May 2, 2013.

“Excellent, and improving all the time.”

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Complimentary Registrations 2 Full Program + 2 Exhibit Personnel 4 Full Program + 3 Exhibit Personnel 1 Full Program + 1 Exhibit Personnel

Exhibitor Full Program Exhibitor Personnel Add CRS Membership

Early (by May 2, 2013) $765 $345 $169

Regular/Onsite (after May 2, 2013) $995 $345 $169

Member Rates Discounted member rates apply only to current paid members of the Controlled Release Society. If you are not a current member of CRS, renew or join when you register to take advantage of everything that CRS membership has to offer.

Full-time Student/Postdoc Rates Full-time students and postdocs qualify for discounted registration rates. Proof of graduate student or postdoctoral research status will be required when registering for the annual meeting.

Cancellation Policy Cancellations must be made in writing and be received by CRS no later than May 16, 2013. 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 16, 2013, 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.

Payment options are: Credit card: Pay when registering online. Alternatively, 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.

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, ‰g8lgh8ngi8filj65),5 7' #&5& ,( H- #-) 8),!85ĝ#-5#( ),' .#)(5-")/& 5 5, ceived no later than June 1, 2013, 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 ModiďŹ cations

Check: Mail the completed form and check payment to:

All information is subject to change without notice.

CRS Meeting Registration 3340 Pilot Knob Road St. Paul, MN 55121 U.S.A.

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

Attire and Weather

Photo Release

Business casual is the recommended dress for the CRS Annual Meeting & Exposition. Comfortable walking shoes and casual, light-weight clothing are recommended for after-meeting activities. Weather in Hawaii is consistent, with only minor changes in temperature throughout the year. The average mid-July high temperature in Honolulu is 88°F (31.1°C). The average evening low temperature is 73°F (22.8°C).

Many 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.

www.controlledreleasesociety.org/meeting 25

Convention Center & CRS Hotel Information Hawaii Convention Center All scientific sessions, poster sessions, the exposition, and the welcome reception will take place at the Hawaii Convention Center.

Hilton Hawaiian Village— CRS Headquarters Hotel 2005 Kalia Road Honolulu, HI 96815 U.S.A. Telephone: +1.808.949.4321 Toll-free U.S.A./Canada: +1.800.445.8667

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

Hawaii Convention Center 1801 Kalakaua Avenue Honolulu, HI 96815 U.S.A.

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

Reservation Deadline: June 19, 2013 All hotel rates are in U.S. dollars (USD). Tax on guest rooms is presently 13.962% (subject to change). CRS discounted room rates are available three days before and after annual meeting dates, based on availability. The Hilton Hawaiian Village is very busy after the CRS Annual Meeting. If possible, the Hilton recommends booking holiday time before the annual meeting. Regardless, book early to ensure availability, as summer is one of Honolulu’s busiest times of the year!

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Room Types and Rates* Resort View Partial Ocean View Ocean View Rainbow Tower Ocean View Rainbow Tower Ocean Front

$229 Single or Double occupancy $249 Single or Double occupancy $269 Single or Double occupancy $299 Single or Double occupancy $329 Single or Double occupancy

*Rates do not include tax. All rooms come with 2 double beds or 1 king bed. Please call the Hilton Hawaiian Village for other available room types/suites for which CRS discounted rates may be applied.

The Islands Are Calling: Exotic, Tropical Hawaii The beautiful city of Honolulu lies on the island of Oahu, part of the chain of islands that make up Hawaii. Honolulu offers the pristine beaches and waters of Waikiki, historic landmarks, world-class shopping, a flourishing cultural scene, and a variety of dining options. Climb Diamond Head, visit Pearl Harbor, snorkel at Hanauma Bay, or simply swim in the warm waters of the Pacific while enjoying your time in paradise.

Getting to Hawaii Honolulu International Airport (HNL) on Oahu is Hawaii’s major airport, serving as the entry point for most of Hawaii’s visitors. All 23 major U.S.A. carriers and 16 international carriers serve Oahu, so you can get there from just about anywhere. Honolulu International Airport is conveniently located 9 miles (14.4 km) west of Waikiki Beach, 4 miles (6.4 km) west of Central Honolulu, and 7.5 miles (12 km) west of the Hawaii Convention Center.

International Travel The U.S. Department of State encourages you to apply for your visa as soon as possible.

The U.S. government is working to expedite visa processing; however, visas can take up to three months to obtain, so we encourage you to plan ahead to avoid any delays. The process of applying for your visa may have changed from the last time you applied or may take longer. If you have any difficulty obtaining a visa for the meeting, visit www.controlledreleasesociety.org/meetings/annual/travel/ for more details. Letters of invitation are provided to attendees from outside the U.S.A. after they have registered for the meeting.

Although the CRS Annual Meeting is conducted in English, CRS has provided introductory websites in additional languages for your convenience: http://crs2013.hawaiiconvention.com www.controlledreleasesociety.org/meeting 27

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

The Forefront of Delivery Science and Technology

40th Annual Meeting & Exposition of the Controlled Release Society Emerging Challenges for Global Delivery

➤ Register Now! July 21 – 24, 2013 Hawaii Convention Center Honolulu, Hawaii, U.S.A.