2013 CRS Program Book by Scientific Societies

CRS 2013 Program 40th Annual Meeting & Exposition of the Controlled Release Society

©David Cornwell

July 21–24, 2013 Hawaii Convention Center Honolulu, Hawaii, U.S.A.

©istockphoto.com

Emerging Challenges for Global Delivery

Download the CRS Annual Meeting Mobile App

President’s Welcome to the Annual Meeting Welcome. Aloha. 歓迎. Dear Colleagues and Friends, In the Hawaiian language, aloha stands for more than just “hello” or “goodbye.” Its deeper meaning is “the joyful (oha) sharing (alo) of life energy (ha) in the present (alo).” It is fitting that we find ourselves in Hawaii, a global crossroads with a history of graciously welcoming explorers and travelers alike. As researchers, scientists, and innovators, we too are travelers of a sort: intrepid explorers looking toward new frontiers and imagining worlds of possibility. We are here because we share a passion for investigation and discovery—and it is passion that makes everything you are about to experience over the next several days possible. You will see it in the nearly 700 posters on display. It will be evident in the quality, diversity, and interdisciplinary nature of the scientific programs and mini-symposia you will attend, and you will feel it as you interact with your colleagues at the roundtable sessions, the networking events and exposition. We live in a digital world, and technology has enabled us to share information and knowledge on a scale that the original inhabitants of these islands could never have imagined. But passion is something not easily shared by e-mail or on social networks. It is only when we bring passion and knowledge together that innovation and discovery can begin.

Kazunori Kataoka

“It is only when we bring passion and knowledge together that innovation and discovery can begin.”

The explorers who originally came to these islands could not have imagined how their interactions with the people they found here would profoundly change both them and the world. We can only imagine how our interactions here will impact the future of delivery science. Thank you for being part of CRS and for your continued commitment to our society and our science. Thank you as well for honoring me by allowing me to serve as your president. Sincerely, Kazunori Kataoka President, Controlled Release Society

Table of Contents

2013 Program Team

Chair W. Mark Saltzman Yale University, U.S.A.

Deputy Chair Ick Chan Kwon KIST, Korea

Marcel B. Bally British Columbia Cancer Research Centre, Canada

Marcus E. Brewster Johnson & Johnson, Belgium

Charles R. Frey Coating Place Inc., U.S.A.

Nicole Papen-Botterhuis TNO, Netherlands

Justin S. Hanes Johns Hopkins University, U.S.A.

Joshua J. Reineke Wayne State University, U.S.A.

Sarah J. Eccleston Aptuit Ltd., United Kingdom

Hideyoshi Harashima Hokkaido University, Japan

Christian Seiler Merck Sharp & Dohme, United Kingdom

General Meeting Information .................................... 4 Hawaii Convention Center Level 3 Floor Plan ......... 7 Schedule-at-a-Glance Saturday – Sunday ................................................. 8 Monday – Tuesday .............................................. 10 Tuesday – Wednesday ......................................... 11 Daily Schedule Saturday .............................................................. 12 Sunday ................................................................ 14 Sunday Technology Forums ............................... 17 Sunday Soapbox Sessions ................................... 19 Monday .............................................................. 21 Tuesday ............................................................... 28 Wednesday .......................................................... 37 Posters ...................................................................... 40 Exposition ................................................................ 51 Sponsors ................................................................... 57 Awards & Recognition ............................................. 62 Acknowledgements .................................................. 68 2013 CRS Presenting Author Index ......................... 70

Advertisers’ Index Biopharm Solutions .................................................. 13 www.biopharmsolutions.com Catalent Pharma Solutions.......................................... 3 www.catalent.com EMD Millipore........................................................... 9 www.emdmillipore.com OctoPlus ......................................... Inside Front Cover www.octoplus.nl Patheon....................................................... Back Cover www.patheon.com Texture Technologies Corp............... Inside Back Cover www.texturetechnologies.com Controlled Release Society 41st Annual Meeting & Exposition of the ............... 31 Controlled Release Society Accessing 2013 Annual Meeting Abstracts .............. 15 CRS Foundation ...................................................... 67 CRS Headquarters Staff ........................................... 72 Educational Opportunities from CRS ..................... 23 Job Center ........................................................... 29, 30 LATTE .................................................................... 37 Membership ............................................................. 20 Mobile App ................................................................ 6 Publications .............................................................. 36

Front cover photo ©David Cornwell; front cover Illustration ©istockphoto.com

two new sites opening in china

rp scherer softgel & clinical trial supply

optimized therapeutic profiles. better treatments. As a global leader in drug development and delivery, we have the expertise in innovative and proven drug delivery technologies to optimize the therapeutic profiles of your treatments.

CONTROL API BLOOD LEVELS

We can help deliver the right amount of API when it is needed to control plasma profiles and onset of action with our controlled release technologies, including enteric-coated softgel and OSDrC‰ OptiDose™.

IMPROVE TARGETED DELIVERY

From pulsatile to extended to delayed, we can tailor a delivery profile to release the right amount of drug where it is needed in the body, reducing potential side and food effects.

OPTIMIZE PATIENT DOSAGE

Reduce pill burden and dose frequency with our softgel, modified release or fixed dose combination tablets (multi-API), coatings and expert formulation.

IMPROVE ABSORPTION

˝ 2013 Catalent Pharma Solutions. All rights reserved. Zydis is a registered trademark, and Optiform and OptiMelt are trademarks of Catalent Pharma Solutions. OSDrC is a registered trademark of Sanwa Kagaku Kenkyusho Co., Ltd

Overcome solubility and permeability challenges to deliver your product with increased bioavailability with our softgel, Optiform™, OSDrC‰ OptiDose™ and OptiMelt™ hot melt extrusion technologies.

Every molecule has challenge. We have a solution. Call: + 1 888 SOLUTION (765 8846) Email: solutions@catalent.com Visit: www.catalent.com

DEVELOPMENT

DELIVERY

SUPPLY

General Meeting Information Registration Desk

The Registration Desk is located on Level 1 in the entrance of Exhibit Hall III Saturday through Tuesday and on Level 3 Ala Halawai Concourse on Wednesday. The desk will be open: Saturday, July 20 Sunday, July 21 Monday, July 22 Tuesday, July 23 Wednesday, July 24

07:00 – 15:00 07:30 – 18:00 07:00 – 17:30 07:00 – 17:00 07:30 – 12:00

Access the Abstracts

CRS Annual Meeting abstracts can easily be accessed using the CRS Annual Meeting mobile app, the CRS website, and the abstract printing station. The mobile app provides access via your mobile device or laptop; simply click on the Posters icon to begin viewing or view podium abstracts directly from the schedule. Sign into the CRS website to view and search the abstracts, available to all registered attendees. The abstract printing station is located in CRS Central and provides the convenience of printing abstracts as needed.

Visit CRS Central

CRS tools and resources help you stay on top of the growing global and multidisciplinary field of delivery science. Check out CRS books, journals, and other resources at CRS Central, located across from the Registration Desk.

CRS Connect

As a CRS Annual Meeting attendee, CRS Connect is your foremost opportunity to network with colleagues while in Honolulu. After accessing the CRS Annual Meeting mobile app, select the CRS Connect icon and search through the database of meeting attendees. Once you identify an individual you wish to contact, click on their name to either send them a private message or request an appointment. All of this takes place through CRS Connect while maintaining full privacy, as personal contact information is never shared. CRS has designated an area in the Exposition Hall in which CRS Connect meetings can take place.

CRS 2013 Mobile App

Sponsored by Aptalis Pharmaceutical Technologies Check the schedule, read the abstracts, create your personal schedule and to-do lists, receive announcements, connect with fellow attendees using CRS Connect, and see what companies are in the Exhibit Hall—all with your CRS meeting mobile app. Download the CRS 2013 mobile app by searching for “CRS Meeting” in the iTunes Store or Google Play. Reach the mobile app from your BlackBerry or laptop via the mobile app website mobileapp.controlledrelease.org.

Electronic Devices

As a courtesy to other meeting attendees, please turn off or silence all electronic devices during all workshops, sessions, and presentations.

WiFi Access

Cosponsored by BASF, Bend Research, and Lactel Absorbable Polymers CRS has contracted with the Hawaii Convention Center to provide WiFi access during the annual meeting. This access will be available to all attendees for the duration of the meeting. WiFi coverage is available throughout the convention center. Power up your laptop to connect to meeting abstracts on the CRS website, or use your mobile device to utilize CRS Connect and the mobile app. Network: CRS2013 Access Code: CRS

Photography

Photography is not permitted in the session rooms, exhibit hall, or poster sessions. Contact CRS staff at the Registration Desk for further clarification.

Awards

CRS will be honoring several awardees throughout the meeting. Awards will be given out at the Monday Opening Session/ Award Ceremony and during the three plenary sessions. See daily highlights and the Awards & Recognition information in this program book.

Exposition Hours and Location

The Exposition is located in Exposition Hall III and has dedicated hours when all exhibitors are present at their booths. The scheduled Exposition activities are as follows: Set-Up Saturday, July 20 08:00 – 17:00

Sunday, July 21 08:00 – 14:00

Exposition Open Sunday, July 21 17:30 – 19:30 Exposition Grand Opening and Welcome Reception Monday, July 22 09:30 – 10:30 Exposition Open Meet with Exhibitors, Prize Drawing, Refreshment Break 09:30 – 17:30 Exposition Hall Open 16:30 – 17:30 Poster Viewing and Exposition Happy Hour Meet with Exhibitors, Prize Drawing, Refreshment Break Tuesday, July 23 09:30 – 10:30 Exposition Open Meet with Exhibitors, Prize Drawing, Refreshment Break 09:30 – 16:00 Exposition Hall Open 15:00 – 16:00 Exposition Open Meet with Exhibitors, Prize Drawing, Refreshment Break Take-Down Tuesday, July 23 16:00 – 18:00 Exhibit Take-Down

Poster Sessions

The posters are located in Exhibit Hall III. All posters will be on display Sunday through Tuesday during the designated hours. Poster authors will be present during one of three prespecified time slots. All posters must be removed during Poster Take-Down or they will be removed and discarded. The poster viewing area will be secured overnight. Photographing posters is not permitted. 2013 Poster Schedule Sunday, July 21 08:00 – 14:00 Exhibit and Poster Set-Up 17:30 – 19:30 Poster Viewing Hours, Exposition Grand Opening and Welcome Reception Monday, July 22 09:30 – 10:30 Poster Session 1 – Authors Present 09:30 – 17:30 Poster Viewing Hours 16:30 – 17:30 Poster Viewing and Exposition Happy Hour Tuesday, July 23 09:30 – 10:30 Poster Session 2 – Authors Present 09:30 – 16:00 Poster Viewing Hours 15:00 – 16:00 Poster Session 3 – Authors Present 16:00 – 17:00 Poster Take-Down

Poster Snapshots

Poster Snapshots are three-minute audio recordings that provide a summary preview of poster content. Attendees can listen to a recording at any time, including prior to attending the poster sessions and even while standing in front of a poster. Poster snapshots are submitted by poster presenters and are available through the CRS Annual Meeting mobile app.

Speaker Preparation Room

Room 301 A/B The Speaker Preparation Room is available for PowerPoint previewing and downloading presentation materials. Speakers are to upload presentations one day prior to their presentation date, i.e., if you speak on Monday, July 22, you will upload your presentation on Sunday, July 21. Presenters are not allowed to use their own laptops to give their presentations. The Speaker Preparation Room will not be open on Wednesday, July 24. The Speaker Preparation Room will be staffed and open as follows: Saturday, July 20 07:00 – 17:00 Sunday speakers upload presentations Sunday, July 21 07:00 – 17:30 Monday speakers upload presentations Monday, July 22 07:00 – 17:30 Tuesday speakers upload presentations Tuesday, July 23 07:00 – 17:30 Wednesday speakers upload presentations

Committee Meetings

CRS committees (and other attendees) are invited to schedule meetings by reserving a meeting room at the Registration Desk. A limited number of meeting rooms are available for use Sunday through Wednesday. Meeting Schedule (as of May 31, 2013) Sunday, July 21 2014 CRS Annual Meeting Program Committee

09:00 – 10:00

317B

Monday, July 22 Young Scientist Committee/ Mentor-Protégé Subcommittee 09:30 – 10:30 Finance Committee 15:00 – 16:00

317A 317B

Tuesday, July 23 DDTR Editorial Board Chapter Committee Consumer & Diversified Products Division Board of Scientific Advisors Wednesday, July 24 Books Committee Preclinical Sciences & Animal Health Division

07:00 – 08:00 09:30 – 10:30

317A 317B

16:00 – 17:00 16:00 – 17:30

317B 317A

07:00 – 08:00

317A

08:30 – 09:30

317B

Photo Release

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.

Children and the CRS Annual Meeting & Exposition

The CRS Annual Meeting & Exposition is a professional, scientific meeting. CRS does not permit children under the age of 18 to attend the scientific sessions, poster sessions, exposition, and social events. For safety reasons, only registered exhibitors and poster presenters are permitted in the exposition/ poster hall during set-up and take-down hours. Children 18+ must register and buy applicable individual tickets if not attending/registering as a student.

Message Board

For your convenience, a message board is located in CRS Central. The board may be used to post job openings/resumes, messages to colleagues, or other relevant information.

Meeting and Future Event Literature

Space for the display of promotional materials for future educational meetings is available in CRS Central. Organizers of educational meetings and events may display their materials in this reserved location. Any literature that is left in areas other than the designated location or that does not promote educational meetings will be discarded.

Access the meeting anytime, anywhere The 2013 CRS Annual Meeting & Exposition Mobile App

• • • • • •

Check the schedule Read the abstracts Create your personal schedule and to-do lists Receive announcements Connect with fellow attendees See what companies are in the exhibit hall

Download Now. It’s Fast and Easy. Search for “CRS Meeting” in the iTunes store, or the Android App Store/ Google Play. Access the mobile app from your Blackberry or laptop at the mobile app website: mobileapp.controlledrelease.org Sponsored by

WiFi for your mobile device or laptop is available in the Hawaii Convention Center for all CRS annual meeting attendees, free of charge. Sponsored by

PĀ KALOKA COURTYARD

76 9

808

GRAND STAIRCASE

8 54

PORTE COCHERE

MAIN LOBBY (Level 1)

SERVICE CORRIDOR

PĀ KAMALI`I COURTYARD

310

Exhibit Hall III Located on Level 1

808

Hawaii Convention Center • Level 3

Schedule-at-a-Glance Saturday, July 20 07:00 – 15:00 07:00 – 15:00 07:00 – 17:00 08:00 – 17:00 08:00 – 17:00 08:00 – 17:00 09:00 – 17:00 12:00 – 14:00 13:00 – 17:30

CRS Registration Open Exhibit Hall III CRS Central Open Exhibit Hall III Speaker Preparation Room Open 301A/B Educational Workshop: Controlled Release Dosage Forms and 323A Product Development Strategy for Expected New Regulatory Trends* Exhibit Set-Up Exhibit Hall III Young Scientist Workshop: Fundamentals of Controlled 323B Release Drug Delivery: Physiochemical and Biological Aspects Educational Workshop: Oral Delivery of Bioactives Using 324 Lipid-Based Drug Delivery Systems* (continued on Sunday) Leadership Forum (by invitation) 306A/B Educational Workshop: Using In Vitro–In Vivo Correlation 323C (IVIVC) to Meet Challenges in Global Delivery*

Sunday, July 21 07:00 – 17:30 Speaker Preparation Room Open 07:30 – 18:00 CRS Registration Open 07:30 – 18:00 CRS Central Open 08:00 – 12:00 Young Scientist Workshop: Professional and Self Development for Young Scientists and Protégés: Effective Communication 08:00 – 14:00 Exhibit and Poster Set-Up 08:30 – 12:00 Educational Workshop: Oral Delivery of Bioactives Using Lipid-Based Drug Delivery Systems* (continued from Saturday) 09:00 – 10:00 2014 CRS Annual Meeting Program Committee Meeting 09:00 – 10:00 Technology Forum: CIMA Labs 09:00 – 10:00 Technology Forum: Colorcon and Dow Food and Pharma Alliance 09:00 – 10:00 Technology Forum: Mott Corporation 09:00 – 11:00 Technology Forum: Purac Biomaterials and OctoPlus 10:15 – 11:15 Technology Forum: Catalent Pharma Solutions, LLC 10:15 – 11:15 Technology Forum: Medimetrics Personalized Drug Delivery, Inc. 10:15 – 11:15 Technology Forum: SOTAX Corporation 11:15 – 12:00 Technology Forum: Hovione 11:30 – 12:30 Technology Forum: Capsugel 11:30 – 12:30 Technology Forum: MedinCell 11:30 – 12:30 Technology Forum: Halozyme Therapeutics 11:30 – 12:30 First Timers’ Meeting 12:30 – 14:00 Young Scientist Roundtable: Commercializing Ideas from Academia: Past Lessons and Current Challenges 13:00 – 15:10 Soapbox Sessions 15:30 – 17:30 Industry Roundtable: Global Perspectives on Emerging and Established Delivery Markets 17:30 – 19:30 Exposition Grand Opening and Welcome Reception 17:30 – 19:30 Poster Viewing Hours

*Additional registration, payment, and ticket required.

301A/B Exhibit Hall III Exhibit Hall III 323B Exhibit Hall III 324 317B 323A 319B 319A 322A/B 319A 319B 323A 322A/B 319A 323A 319B 306A/B 323B 312 312 Exhibit Hall III Exhibit Hall III

Improve your strike rate With enhanced Bioavailability for your successful final drug Developing drugs often seems like scoring a goal that is all boarded up. While your API is innovative and safe, it still may fail. Bioavailability is one key to success. With drug targeting, increased solubility, PK/PD modifiers, and optimized formulation, we help you to bring APIs out of the pipeline and improve your life cycle management. Suddenly, that goal is wide open. Find out how to improve your strike rate at www.emdmillipore.com/bioavailability

EMD Millipore is a division of Merck KGaA, Darmstadt, Germany

7 Booth 31

Schedule-at-a-Glance Monday, July 22 07:00 – 08:00 07:00 – 17:30 07:00 – 17:30 07:00 – 17:30 08:00 – 09:30 09:30 – 10:30 09:30 – 10:30 09:30 – 10:30 09:30 – 17:30 09:30 – 17:30 10:30 – 12:00

Get Up! Get Educated! Nanomedicines for Drug Delivery Across Epithelial Barriers: Intestines, Skin, and Lungs CRS Registration Open CRS Central Open Speaker Preparation Room Open CRS Opening Session Exposition Open – Meet with Exhibitors, Prize Drawing, Refreshment Break Poster Session 1 – Authors Present Young Scientist Committee/Mentor-Protégé Subcommittee Meeting Exposition Hall Open Poster Viewing Hours Scientific Sessions • Food, Nutraceuticals, and Personalized Diet • Mini-Symposium: Hybrid Groups: Bridging the Gap Between Industry and Academia • Parenteral Sustained Release Drug Delivery • Rising Suns in Asia • RNAi and DNA Delivery 10:45 – 12:00 2014 Exhibit Selection, Group A 11:30 – 13:30 Mentor/Protégé Meet and Greet 13:30 – 14:45 Plenary Session: Kenzo Takada 15:00 – 16:00 Finance Committee Meeting 15:00 – 16:30 Scientific Sessions • Challenges Around Brain Delivery: Sampling Site Issues and Interspecies Extrapolations • Micro- and Nanoparticle Design • Mini-Symposium: Breakthrough Technologies in Drug Delivery Systems from Asia • Smart Building and Construction Materials and Coatings • Topical/Transdermal Drug Delivery 16:30 – 17:30 Poster Viewing and Exposition Happy Hour – Meet with Exhibitors, Prize Drawing, Refreshment Break 17:30 – 18:30 Preclinical Sciences & Animal Health Get-Together* 21:00 – 22:30 Young Scientist Networking Event*

316B Exhibit Hall III Exhibit Hall III 301A/B 315 Exhibit Hall III Exhibit Hall III 317A Exhibit Hall III Exhibit Hall III 314 316B 316A 316C 315 Exhibit Hall III 306A/B 315 317B 316A 315 316B 314 316C Exhibit Hall III 306A/B Jimmy Buffett’s at the Beachcomber Restaurant and Honolulu Surfing Museum

Tuesday, July 23 07:00 – 08:00 07:00 – 08:00 07:00 – 17:00 07:00 – 17:00 07:00 – 17:30 08:00 – 09:30 09:30 – 10:30 09:30 – 10:30 09:30 – 16:00 09:30 – 10:30 09:30 – 16:00

317A 316B Exhibit Hall III Exhibit Hall III 301A/B 315 Exhibit Hall III Exhibit Hall III Exhibit Hall III 317B Exhibit Hall III

Schedule-at-a-Glance Tuesday, July 23 (continued) 10:30 – 12:00

Scientific Sessions

• Drug Delivery for Developing Countries/Global Challenges • Imaging and Characterization Techniques for Drug

Delivery: Systems and Targeted Drug Delivery • Mini-Symposium: Energy: Problems Within the Industry That Controlled Delivery Can Solve • Peptide and Protein Delivery • Solubilization Technology: A Key Enabler for the Delivery of Poorly Soluble Drugs 10:45 – 12:00 2014 Exhibit Selection, Group B 12:00 – 13:30 C&DP Division Luncheon* 13:30 – 15:00 Scientific Sessions: • Drug Targeting, Pharmacokinetics, and Biodistribution: Differences Between Species • Mini-Symposium: Drug Combination Products • Modern Agriculture and Aquaculture • Oral CR – Pharmaceutical Formulations, Technologies, and Development Strategies • Processing Technology/Manufacturability 15:00 – 16:00 Exposition Open – Meet with Exhibitors, Prize Drawing, Refreshment Break 15:00 – 16:00 Poster Session 3 – Authors Present 16:00 – 17:00 Consumer & Diversified Products Division Business Meeting 16:00 – 17:00 Poster Take-Down 16:00 – 17:30 Board of Scientific Advisors Meeting 16:00 – 17:30 Roundtables and Focus Groups • Ocular Drug Delivery • Oral Drug Delivery 16:00 – 18:00 Exhibit Take-Down 18:30 – 22:00 CRS President’s Banquet*

316A 316C 316B 315 314 Exhibit Hall III 306A/B 316A 316B 314 316C 315 Exhibit Hall III Exhibit Hall III 317B Exhibit Hall III 317A 316B 316C Exhibit Hall III Hilton Hawaiian Village / Rainbow Tower – Rainbow Suite

Wednesday, July 24 07:00 – 08:00 07:30 – 12:00 07:30 – 12:00 08:00 – 09:30

Books Committee Meeting CRS Registration Open CRS Central Open Scientific Sessions • Emerging Technologies • Mini-Symposium: Nanoparticles and Cancer • Oral CR – Predictive Tools (In Vitro/In Vivo/In Silico) • Personal and Home Care • Regional Delivery: Challenges in Ocular Delivery and Pulmonary Delivery 08:30 – 09:30 Preclinical Sciences & Animal Health Committee Meeting 09:45 – 11:00 Plenary Session: Paula Hammond *Additional registration, payment, and ticket required.

317A Ala Halawai Concourse Ala Halawai Concourse 316A 316B 316C 314 315 317B 315

Daily Schedule Saturday, July 20

Saturday

07:00 – 15:00 CRS Registration Open Exhibit Hall III 07:00 – 15:00 CRS Central Open Exhibit Hall III 07:00 – 17:00 Speaker Preparation Room Open 301A/B 08:00 – 17:00 Educational Workshop: Controlled Release Dosage Forms and 323A Product Development Strategy for Expected New Regulatory Trends* 08:00 – 17:00 Exhibit Set-Up Exhibit Hall III 08:00 – 17:00 Young Scientist Workshop: Fundamentals of Controlled 323B Release Drug Delivery: Physiochemical and Biological Aspects 09:00 – 17:00 Educational Workshop: Oral Delivery of Bioactives Using 324 Lipid-Based Drug Delivery Systems* (continued on Sunday) 12:00 – 14:00 Leadership Forum (by invitation) 306A/B 13:00 – 17:30 Educational Workshop: Using In Vitro–In Vivo Correlation 323C (IVIVC) to Meet Challenges in Global Delivery *

Saturday Program Highlights Educational Workshops*

Young Scientist Workshop

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

Fundamentals of Controlled Release Drug Delivery: Physiochemical and Biological Aspects

Cosponsored by Ashland Specialty Ingredients 08:00 – 17:00 • 323A

Chairs: Raid Alany, Kingston University London, United Kingdom; Kaushalkumar Dave, South Dakota State University, U.S.A.; Giorgia Pastorin, National University of Singapore, Singapore; and Zimei Wu, The University of Auckland, New Zealand

Chairs: Ubrani Venkataram and Yanning Lin, Food & Drug Administration, U.S.A. Workshop Co-Hosts: Sherry Ku, TWi Biotech and TWi Pharmaceutical Inc., Taiwan; and Ali Rajabi-Siahboomi, Colorcon Inc., U.S.A.

Oral Delivery of Bioactives Using Lipid-Based Drug Delivery System Cosponsored by Avanti Polar Lipids Inc., and Gattefossé USA 09:00 – 17:00 • 324

Chairs: Anette Müllertz, University of Copenhagen, Denmark; and Sarah Hook, University of Otago, New Zealand

Using In Vitro–In Vivo Correlation (IVIVC) to Meet Challenges in Global Delivery Cosponsored by Simulations Plus, Inc. and SOTAX Corporation 13:00 – 17:30 • 323C Chair: Vivian Gray, V. A. Gray Consulting, Inc., U.S.A.

*Additional registration, payment, and ticket required.

8:00 – 17:00 • 323B

Speakers: Ben Boyd, Monash University, Australia; Diane Burgess, University of Connecticut, U.S.A.; Per Gisle Djupesland, OptiNose, Norway; Pankaj Karande, Rensselaer Polytechnic Institute, U.S.A.; Anette Müllertz, University of Copenhagen, Demark; Yvonne Perrie, Aston University, United Kingdom; Michael J. Rathbone, International Medical University, Malaysia; Ian G. Tucker, University of Otago, New Zealand; Alex van Herk, Institute of Chemical and Engineering Sciences, Singapore; and Zimei Wu, The University of Auckland, New Zealand Whether you are a Ph.D. student, a postdoctoral fellow, or an established researcher, it is absolutely vital to brush up every now and then on the fundamentals of the design and performance of innovative controlled release drug delivery systems. This is exactly the focus of this workshop. The essential physicochemical and biopharmaceutical concepts that are needed for the successful design of controlled release drug delivery systems will be reviewed. Furthermore, the various routes of drug delivery will be compared and contrasted. The workshop will also shed light on some of the cutting-edge innovations in the area underpinned by the fundamental principles.

Daily Schedule Sunday, July 21

Sunday

07:00 – 17:30 Speaker Preparation Room Open 07:30 – 18:00 CRS Registration Open 07:30 – 18:00 CRS Central Open 08:00 – 12:00 Young Scientist Workshop: Professional and Self Development for Young Scientists and Protégés: Effective Communication 08:00 – 14:00 Exhibit and Poster Set-Up 08:30 – 12:00 Educational Workshop: Oral Delivery of Bioactives Using Lipid-Based Drug Delivery Systems* (continued from Saturday) 09:00 – 10:00 2014 CRS Annual Meeting Program Committee Meeting 09:00 – 10:00 Technology Forum: CIMA Labs 09:00 – 10:00 Technology Forum: Colorcon and Dow Food and Pharma Alliance 09:00 – 10:00 Technology Forum: Mott Corporation 09:00 – 11:00 Technology Forum: Purac Biomaterials and OctoPlus 10:15 – 11:15 Technology Forum: Catalent Pharma Solutions, LLC 10:15 – 11:15 Technology Forum: Medimetrics Personalized Drug Delivery, Inc. 10:15 – 11:15 Technology Forum: SOTAX Corporation 11:15 – 12:00 Technology Forum: Hovione 11:30 – 12:30 Technology Forum: Capsugel 11:30 – 12:30 Technology Forum: MedinCell 11:30 – 12:30 Technology Forum: Halozyme Therapeutics 11:30 – 12:30 First Timers’ Meeting 12:30 – 14:00 Young Scientist Roundtable: Commercializing Ideas from Academia: Past Lessons and Current Challenges 13:00 – 15:10 Soapbox Sessions 15:30 – 17:30 Industry Roundtable: Global Perspectives on Emerging and Established Drug Delivery Markets 17:30 – 19:30 Exposition Grand Opening and Welcome Reception 17:30 – 19:30 Poster Viewing Hours *Additional registration, payment, and ticket required.

301A/B Exhibit Hall III Exhibit Hall III 323B Exhibit Hall III 324 317B 323A 319B 319A 322A/B 319A 319B 323A 322A/B 319A 323A 319B 306A/B 323B 312 312 Exhibit Hall III Exhibit Hall III

Sunday Program Highlights Soapbox Sessions

Delivery Science Meets Business Opportunities! CRS Innovation Sunday is all about the business of delivery science, taking innovative ideas and technologies into the commercial sector. Designed to connect you with people, research, companies, and novel technologies that address challenges in delivery, come to Sunday’s interactive program open to asking questions and finding answers.

Technology Forums

These complimentary workshops are open to all registered attendees, offering in-depth coverage of controlled release technologies and services, hosted by the following companies: 09:00 – 10:00 09:00 – 10:00 09:00 – 10:00 09:00 – 11:00 10:15 – 11:15 10:15 – 11:15 10:15 – 11:15 11:15 – 12:00 11:30 – 12:30 11:30 – 12:30 11:30 – 12:30

CIMA Labs Colorcon and Dow Food and Pharma Alliance Mott Corporation Purac Biomaterials and OctoPlus Catalent Pharma Solutions, LLC Medimetrics Personalized Drug Delivery, Inc. SOTAX Hovione Capsugel Halozyme Therapeutics MedinCell

323A 319B 319A 322A/B 319A 319B 323A 322A/B 319A 319B 323A

Cosponsored by Catalent Pharma Solutions Cochairs: Eyal S. Ron, MADASH LLC, U.S.A.; and Michael J. Valazza, Catalent Pharma Solutions Moderated by Michael J. Valazza, Catalent Pharma Solutions 13:00-15:10 • 312 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. Session breaks allow time to network with presenters at their designated tables during beverage breaks, hosted by our sponsor. Acuitas Therapeutics Bend Research BioModics Bioneer: Farma Faculty of Health Sciences Ceridia Pty. Limited GrayBug Losan Pharma Paraytec Ltd. Particle Dynamics, International PNST LLC dba Tranzerm Solutions Polymer Therapeutics, LLC RESMAN AS Serina Therapeutics Simulations Plus, Inc. Surface Measurement Systems Theraly Pharmaceuticals TNO

Industry Roundtable

Looking for the Abstracts?

Three easy ways to access the abstracts. 1. USE THE ABSTRACT PRINTING STATION Search and print abstracts for both podium and poster presentations at the Abstract Printing Station located at CRS Central across from the registration desk.

2. USE YOUR MOBILE DEVICE

15:30 – 17:30 • 312

Global Perspectives on Emerging and Established Delivery Markets A global panel of business development and R&D executives from major companies in 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.

Access the abstracts from your mobile device using the 2013 CRS Annual Meeting mobile app. Search for “CRS Meeting” in the iTunes store, or Google Play. Access the mobile app from your Blackberry or laptop at the mobile app website: mobileapp.controlledrelease.org.

3. VISIT THE CRS WEBSITE The abstracts are also available on the CRS

website and can be accessed using your CRS username and password.

Sunday

CRS Innovation Sunday

Sunday Program Highlights Educational Workshop* (continued from Saturday)

Young Scientist Roundtable

Cosponsored by Avanti Polar Lipids Inc., and Gattefossé USA 08:30 – 12:00 • 324 Chairs: Anette Müllertz, University of Copenhagen, Denmark; and Sarah Hook, University of Otago, New Zealand

12:30 – 14:00 • 323B

Oral Delivery of Bioactives Using Lipid-Based Drug Delivery System

Sunday

Young Scientist Workshop

Professional and Self Development for Young Scientists and Protégés: Effective Communication Cosponsored by Microtek Labs Inc. and Vision Processing Technologies, Inc. 08:00 – 12:00 • 323B

Chairs: Michael J. Rathbone, International Medical University, Malaysia; and Teresa Virgallito, Microtek Labs Inc., U.S.A. Speakers: Michael J. Rathbone, International Medical University, Malaysia; and Teresa Virgallito, Microtek Labs Inc., U.S.A. The workshop will provide the young scientists with a training program for improving interpersonal relationships, improving listening skills, teaching negotiation skills, resolving conflict, and strengthening assertiveness. The young scientists will be able to improve their communications skills by increasing their awareness, attentiveness, and empathizing capacity, and facilitate better communication throughout their organization. The workshop will also focus on intercultural communication. Global communication is essential in today’s international business community and academic community.

Commercializing Ideas from Academia: Past Lessons and Current Challenges Chairs: Adam Bohr, Veloxis Pharmaceuticals A/S, Denmark; Hardik Shah, Alkermes Pharma Ireland Ltd., Ireland; and Jorrit Water, University of Copenhagen, Denmark Speakers: Daniel Bar-Shalom, University of Copenhagen, Denmark; Debra Bingham, Valeo Partners, U.S.A.; Tamás Letoha, Pharmacoidea, Hungary; and Peter Thomsen, Biomodics, Denmark 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.

First Timers’ Meeting 11:30 – 12:30 • 306A/B

If this is your first CRS Annual Meeting & Exposition, or even if you have attended for many years, learn how to get the most from the annual meeting program by attending this welcome and question-and-answer session presented by the CRS Board of Directors.

Exposition Grand Opening and Welcome Reception 17:30 – 19:30 • Exhibit Hall III Innovation Sunday concludes in the Exposition Hall, where you’ll find more new and emerging products and services, along with the opportunity to connect with some of delivery science’s leading suppliers. Enjoy an array of foods and beverages as you visit with exhibitors and colleagues.

*Additional registration, payment, and ticket required. 16

Technology Forums These complimentary forums are open to all registered attendees, offering in-depth coverage of controlled release technologies and services, hosted by the following companies:

09:00 – 10:00 Forums

CIMA Labs: Oral Drug Delivery Technology Development and Partnership

Room 323A Presenter: Vickie O’Neil, Director Formulation Development Presentation Areas: Formulation, Quality & Analytical CIMA Labs specializes in the development and manufacturing of new and improved drug products utilizing our oral drug delivery technologies. Our formulation technology offerings include ODT, oral transmucosal, solubilization, and tamperresistant extended and immediate release technologies. This presentation will showcase CIMA’s OraGuard™ technology and its advantages as an extended release delivery platform. Company website: www.cimalabs.com

Influence and Control of Performance-Related Characteristics for Hydrophilic Polymers Utilized in Controlled Release Dosage Forms Room 319B Presenters: Kurt Fegely, General Manager – Alliance Products, Colorcon; and True Rogers, Senior Research Specialist, Dow Pharma and Food Solutions Presentation Area: Formulation This forum will examine the fundamentals of particle nature and polymer chemistry on the performance of hypromellose and polyethylene oxide in oral, controlled release dosage forms. Strategies to mitigate variability in the performance of a dosage form and methods to prevent regulatory obstacles will be discussed. Company websites: www.colorcon.com, www.dow.com

Novel Uses for Porous Metal Technology in Medical, Pharmaceutical, and Biotechnology Applications

Room 319A Presenter: Dr. Kenneth L. Rubow, Vice President for Filtration and Advanced Media Science

Presentation Area: Processing Recent advances in porous metal technology are highlighted for sterilizing filtration, drug delivery and flow control via gradual diffusion or metering, and time released coatings. Porous metal is supplied in various shapes, sizes, and biocompatible metallurgies, including proprietary nanotechnology, and provides designers unique solutions for medical and life sciences applications. Company website: mottcorp.com

09:00 – 11:00 Forum

PLGA in Ocular Controlled Release—From Biomaterials to Drug Product

Room 322A/B Presenters: Dr. Michiel van Alst, Purac Biomaterials; Dr. Ruud Verrijk, OctoPlus; Presentation Areas: Biomaterials, Controlled Release Formulation, Quality & Analytical, Process Development Ocular Controlled Release using PLGA microspheres : Michiel van Alst (Purac Biomaterials) covers quality aspects in synthesis of PLGAs suitable for ocular controlled release. Ruud Verrijk (OctoPlus) explains the process of making GMP grade controlled release microspheres for ocular application specifically. Company Websites: www.purac.com/ purac-biomaterials + www.octoplus.nl

10:15 – 11:15 Forums

Techniques for Enabling the Delivery of Poorly Soluble Drugs

Room 319A Presenter: Michael J. Valazza, R.Ph., Vice President, Modified Release Technologies Presentation Areas: Formulation, Processing The global pharmaceutical industry has recently been challenged by the decrease of new active compounds—caused partially by low solubility. What cannot be dissolved cannot be absorbed. This presentation will focus on Zydis® nano technology, formulation and compression of hot melt extrudates, and other current techniques for enabling drug delivery. Company website: www.catalent.com 17

11:30 – 12:30 Forums

Overcoming the Impact of Physiology Factors with IntelliCap, a New Oral Electronic Drug Delivery Device

Room 319B Presenters: Prof. Werner Weitschies, Center of Drug Absorption and Transport, University Greifswald, Germany; Jeff Shimizu, CTO, Medimetrics; Dr. Dieter Becker, CEO, Vivo Drug Delivery GmbH, Switzerland Presentation Area: Formulation Physiology factors have an often underestimated impact on in vivo drug absorption. The IntelliCap system employs a swallowable electronic capsule that identifies location by gut pH profile and releases drug formulations in a flexible programmable manner. Case studies are presented using the IntelliCap system to ensure success in modified release development. Company website: www.medimetrics.com

In Vitro Drug Release—A Regulatory Perspective

Room 323A Presenter: Samir Haddouchi, Managing Director, SPS Pharma Services Presentation Areas: Formulation, Quality & Analytical New types of formulations and drug delivery technologies call for a new approach to in vitro drug release testing. Traditional dissolution methods are not tailored to these novel dosage forms. Products such as medical devices, combination products, nanoparticles, and parenterals can be challenging when it comes to drug release testing. Company website: www.sotax.com

A Novel Two-Piece Enteric Capsule

Room 319A Presenter: Maryline Clauzel, Polymer Science and Technology Specialist Presentation Areas: Formulation, Processing Capsugel has developed a capsule that is intrinsically enteric, eliminating the need for coating either a capsule shell or tablet. Formulation and processing steps can be removed from clinical development, resulting in speed-to-clinic evaluation of new compounds. Company website: www.capsugel.com

Building A Better SubQ Product: Improved Subcutaneous Delivery With ENHANZE™ Technology

Room 319B Presentation Area: Formulation Halozyme Therapeutics’ ENHANZE™ technology is a novel drug delivery platform that improves the bioavailability of co-injected drugs by increasing SC absorption. With ENHANZE™, it is feasible to administer large volumes via a single SC injection. The platform is in late stage development with partners that include Roche, Pfizer and Baxter. Company Website: www.halozyme.com

11:15 – 12:00 Forum

Overcoming Poor Solubility Using Solid Dispersion—From Research to Commercial Reality

Room 322A/B Presenter: Dr. Filipe Gaspar, Director of Drug Product Technologies Presentation Areas: Formulation, Processing This presentation will start by showing typical platforms used to overcome poor solubility of oral drugs. A case study for development and scale-up of solid dispersions using spray drying will be shown. The development of such processes using a Quality by Design approach will be illustrated and the benefits quantified. Company website: www.hovione.com

MedinGel™—Custom Tailored Delivery Durations from 3 Days to 1 Year

Room 323A Presenter: Mark S. Wilson, Vice President, Business Development Presentation Area: Formulation MedinCell’s injectable technology forms an in situ depot after subcutaneous (systemic) or intra-articular (local) administration. Burst and bioresorption rates can be tailored for osteoarthritis, mental health, diabetes, fertility, pain control, and many other applications. By protecting drug molecules within the hydrogel matrix, drug cargo can be substantially reduced for cost therapies. Company website: www.medincell.com

Soapbox Sessions Cosponsored by Catalent Pharma Solutions 13:00 – 15:10 • 312

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. Session breaks allow time to network with presenters at their designated tables during beverage breaks, hosted by our sponsor. 13:00 – 13:10 Introduction and Welcome Moderator, Michael J. Valazza, Catalent Pharma Solutions

14:05 – 14:10

Controlled Release of Tracer Compounds into Well Fluids in Oil Wells for Production Profiling Anne Dalager Dyrli, RESMAN AS, Norway

14:10 – 14:15

Polyoxazoline, Not Just Another Biopolymer Tacey Viegas, Ph.D., Serina Therapeutics, Inc., U.S.A.

Session I 13:10 – 13:15

Dosage Form Evaluation in the Dynamic Gastric Model Daniel Bar-Shalom, Bioneer: Farma Faculty of Health Sciences, Denmark

13:15 – 13:20

A Dispersible Bioadhesive Film for Oral Delivery of Peptides Paul Foreman, Losan Pharma (in collaboration with Henkel Corporation), Germany

13:20 – 13:25

Therapeutic Protein Expression In Vivo Using mRNA LNP Thomas Madden, Ph.D., Acuitas Therapeutics, Canada

13:25 – 13:30

Lipoceramics: A New Solution to LipidBased Formulation and Delivery Clive Prestidge, Ceridia Pty. Limited, Australia

13:30 – 13:35

Compelling Therapies One PEG at a Time Seulki Lee, Theraly Pharmaceuticals, U.S.A.

13:35 – 13:40

A New Oral Dosage Form: A Chewable Liquid Dr. Irwin C. Jacobs, Particle Dynamics International, U.S.A.

13:40 – 13:50

Networking Break

Session II 13:50 – 13:55 13:55 – 14:00

14:00 – 14:05

Enabling Pharmacokinetic Control of Solubilized Forms W. Brett Caldwell, Ph.D., Bend Research Inc., U.S.A. Physiologically-based Absorption Modeling and the Future of IVIVCs Grazyna Fraczkiewicz, Simulations Plus, Inc., U.S.A.

14:15 – 14:20

Oxygen Protection of Food and Pharma Ingredients in Humid Conditions Using New Barrier Coatings Nicole Papen-Botterhuis, TNO, The Netherlands

14:20 – 14:30

Networking Break

Session III 14:30 – 14:35 14:35 – 14:40

GrayBug: Innovation in Ocular Drug Delivery Justin Hanes, GrayBug, U.S.A. Novel Protein Nanocarriers for Skin Delivery Applications Omathanu Perumal, PNST LLC dba Tranzerm Solutions, U.S.A.

14:40 – 14:45

Biodegradable Drug-Eluting Polymers for Antimicrobial, Antibiofilm Medical Device Applications Kathryn Uhrich, Ph.D., Polymer Therapeutics, LLC, U.S.A.

14:45 – 14:50

A Hybrid Polymer Material for Controlled Long-Time Drug Release Peter Thomsen, BioModics Aps, Denmark

14:50 – 14:55

Surface Energy Analysis: A Novel Approach to Heterogeneity Mapping of the Surface Chemistry of Materials Joe Domingue, Surface Measurement Systems, U.S.A.

14:55 – 15:10

Networking Break

A Miniaturized Instrument for Rapid In Vitro Permeation Testing Alexander Chapman, Paraytec Ltd., U.K. 19

Your Membership:

Your Access to the Future of Delivery Science and Technology Your membership is your all-access pass to leading research and the delivery science community.

Innovative Research From the research presented in the journals Drug Delivery and Translational Research and the Journal of Controlled Release, to the science presented at the CRS Annual Meeting & Exposition, to books and online webcasts, CRS is your source for the best delivery science and technology research.

Targeted Networking The CRS Annual Meeting & Exposition is just the beginning of the great opportunities to connect with delivery scientists. Utilize the online community through the website, find experts through the LATTE database, join a committee, connect on LinkedIn, or join your local chapter, and access one of the most valuable resources â&#x20AC;&#x201C; each other.

Test tubes and shampoo images courtesy of istock.com. Eye drops courtesy of Comstock.

Career Advancement Advance your professional skills through volunteering, participating in the mentoring program, and more. CRS offers fellowship programs and recognition through awards. The online career center is one more chance to develop your career in delivery science.

Take advantage of everything your membership has to offer now. Access it all online. controlledreleasesociety.org 20

Daily Schedule Monday, July 22

Get Up! Get Educated! Nanomedicines for Drug Delivery Across Epithelial Barriers: Intestines, Skin, and Lungs CRS Registration Open CRS Central Open Speaker Preparation Room Open CRS Opening Session Exposition Open – Meet with Exhibitors, Prize Drawing Refreshment Break Poster Session 1 – Authors Present Young Scientist Committee/Mentor-Protégé Subcommittee Meeting Exposition Hall Open Poster Viewing Hours Scientific Sessions • Food, Nutraceuticals, and Personalized Diet • Mini-Symposium: Hybrid Groups: Bridging the Gap Between Industry and Academia • Parenteral Sustained Release Drug Delivery • Rising Suns in Asia • RNAi and DNA Delivery 10:45 – 12:00 2014 Exhibit Selection, Group A 11:30 – 13:30 Mentor/Protégé Meet and Greet 13:30 – 14:45 Plenary Session: Kenzo Takada 15:00 – 16:00 Finance Committee Meeting 15:00 – 16:30 Scientific Sessions • Challenges Around Brain Delivery: Sampling Site Issues and Interspecies Extrapolations • Micro- and Nanoparticle Design • Mini-Symposium: Breakthrough Technologies in Drug Delivery Systems from Asia • Smart Building and Construction Materials and Coatings • Topical/Transdermal Drug Delivery 16:30 – 17:30 Poster Viewing and Exposition Happy Hour – Meet with Exhibitors, Prize Drawing, Refreshment Break 17:30 – 18:30 Preclinical Sciences & Animal Health Get-Together* 21:00 – 22:30 Young Scientist Networking Event*

316B Exhibit Hall III Exhibit Hall III 301A/B 315 Exhibit Hall III Exhibit Hall III 317A Exhibit Hall III Exhibit Hall III

Monday

07:00 – 08:00 07:00 – 17:30 07:00 – 17:30 07:00 – 17:30 08:00 – 09:30 09:30 – 10:30 09:30 – 10:30 09:30 – 10:30 09:30 – 17:30 09:30 – 17:30 10:30 – 12:00

314 316B 316A 316C 315 Exhibit Hall III 306A/B 315 317B 316A 315 316B 314 316C Exhibit Hall III 306A/B Jimmy Buffett’s at the Beachcomber Restaurant and Honolulu Surfing Museum

*Additional registration, payment, and ticket required.

Monday Program Highlights Get Up! Get Educated!

Mentor-Protégé Meet and Greet

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

11:30 – 13:30 • 306A/B

07:00 – 08:00 • 316B

Chair: Prajakta Dandekar Jain, Institute of Chemical Technology, Mumbai, India

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

Monday

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.

Opening Session 08:00 – 09:30 • 315

The Opening Session will feature a welcome by President Kazunori Kataoka, who will provide a brief update on what your association is doing to further delivery science and technology during the annual business meeting portion of the meeting. This session will also be a time to honor the 2013 CRS Distinguished Service awardee and Fellows awardees, along with the CRS T. Nagai Postdoctoral Research Achievement Award and talks from our Founders Award winner, Richard Guy, and Young Investigator Award winner, Ali Khademhosseini. Five new members of the College of Fellows will also be inducted. The session will conclude with our third annual College of Fellows event, a special panel discussion on “Global Collaboration in Delivery Science” moderated by College of Fellows member Clive Wilson, featuring a distinguished panel of leaders in delivery science and technology. This College of Fellows panel is considering global collaboration in delivery science and the ways in which technology or culture facilitates or interferes with progress. Learning to function together in ever bigger teams in an efficient way will be important in the future. Panelists: Diane Burgess, University of Connecticut, U.S.A.; David Friend, CONRAD, U.S.A.; and Kazunori Kataoka, University of Tokyo, Japan

Poster Session Cosponsored by AstraZeneca All scientific posters will be on display throughout the meeting. Poster authors have been designated into one of three sessions. On Monday, authors will be present at posters during the time specified below. To determine which poster authors will be present during Monday’s session, please use the poster information found in the CRS program book, the mobile app, CRS website, and abstract printing station. Poster Session 1: 09:30 – 10:30 • Exhibit Hall III 22

Organized by the Young Scientist Mentor/Protégé Subcommittee This is a must-attend session for those who preregistered for the 2013-2014 CRS Young Scientist Mentor-Protégé Program. Mentors and protégés will be introduced during this event and be given the opportunity to discuss the protégé’s goals, exchange expectations for what is hoped to be gained from the mentoring relationship, and develop a plan of interaction for the year-long program. Do not miss this exciting occasion to meet face-to-face with your mentor or protégé. Please note, only those who received notification of acceptance into the program may attend this event. Lunch will not be provided; however, attendees are invited to bring their own lunch.

Plenary Human B-Lymphocytes as a Source of High-Affinity, Really Fully Human Antibodies 13:30 – 14:45 • 315 Moderator: Kinam Park

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

Producing antibody medicines through the hybridoma method in which transgenic mice are grafted with human antibody genes results in low-affinity 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 highaffinity 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. Prior to the plenary, the CRS Foundation’s 2012 Sung Wan Kim Postdoctoral Fellowship recipient, Tram Dang, will present research from her fellowship year at the Ali Khademhosseini Laboratory, Brigham and Women’s Hospital and Harvard Medical School.

Poster Viewing and Exposition Happy Hour 16:30 – 17:30 • Exhibit Hall III With nearly 700 posters to see, this is time well spent, and it’s made even better with the beverage of your choice. A variety of selections will be available for purchase during the event.

Preclinical Sciences & Animal Health Get-Together* 17:30 – 18:30 • 306A/B Organizers: Marilyn Martinez, FDA Center for Vet Medicine, U.S.A.; and Michael J. Rathbone, International Medical University, Malaysia The Preclinical Sciences & Animal Health (PSAH) Division is very active in sharing with its members the most recent information on the study of therapeutics in animals, from drug development for that species to the perspective of their use to support human drug product development. The PSAH GetTogether will begin with a presentation entitled “The Beagle Dog as a Preclinical Species: History, Potential Pitfalls, and Future Directions.” After the presentation, the event will conclude with valuable face-to-face networking time for those in attendance. To attend the event, it is not necessary to be a member of the PSAH Division but only to have an interest in this area of delivery science. Each attendee will receive one drink ticket, as well as light hors d’oeuvres.

Young Scientist Networking Event* Cosponsored by Upsher-Smith Labs and Diurnal Ltd 21:00 – 22:30 • Jimmy Buffett’s at the Beachcomber Restaurant and Honolulu Surfing Museum Spend an enjoyable evening networking with colleagues when you attend the Young Scientist Networking Event, hosted at 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, their famous Who’s to Blame Margarita and other beverages in a venue that truly celebrates the people, culture, and incredible natural wonders of Hawaii. *Additional registration, payment, and ticket required.

Upcoming Educational Opportunities from CRS These CRS workshops will take place at the 2013 AAPS Annual Meeting & Exposition November 10–14, 2013 San Antonio, Texas, U.S.A.

Introduction to Microencapsulation Technologies Workshop Knowledge of multiple encapsulation technologies and how they are applied is valuable information for developing new products or solving existing problems. It is important, at a minimum, to have a basic understanding of all commonly available processes and their applications. This workshop provides an introduction to common micro- and nanoencapsulation processes and their various applications. The workshop is structured to 1) introduce common encapsulation techniques, 2) review common materials, and 3) provide an overview of the wide range of applications for controlled release products. Workshop Organizers James Oxley, Southwest Research Institute, U.S.A. Irwin Jacobs, Particle Dynamics International, LLC, U.S.A.

Mitigating Risks for Patients When Developing Oral Controlled Release Dosage Forms Workshop 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, reduce costs, but maintain patient safety and treatment. Workshop Organizers Ali Rajabi-Siahboomi, Colorcon, U.S.A. Mansoor Khan, CDER, USFDA, U.S.A.

•••••••••

Register online at www.aaps.org. Information about these workshops is also available on the CRS website at controlledreleasesociety.org.

Monday

Cosponsored by Merial

Podium â&#x20AC;˘ Monday Morning Monday Morning

314

316B

316A

Food, Nutraceuticals and Personalized Diet

Mini Symposia: Hybrid Groups Bridging the Gap Between Industry and Academia

Parenteral Sustained Release Drug Delivery

I Jacobs, R Perez

J Hanes, L Mayer

K Park, J Remenar

Invited Speaker: Systems Approaches to Personalized Nutrition and Ingredient Bioavailability M Kussmann Nestle Institute of Health Sciences, Switzerland

Invited Speaker: Transforming Discovery into Opportunity - The Centre for Drug Research and Development (CDRD) and New Models for Commercialization K Es Sabar The Centre for Drug Research and Development, Canada

11:00

Novel protein based microparticles for intestinal delivery of bioactive compounds Z Tian, R Wang, L Chen University of Alberta, Canada

Invited Speaker: Connecting Academia and Pharmaceutical Industry â&#x20AC;&#x201C; A Max Planck Initiative Toward Closing the Innovation Gap in Drug Discovery B Klebl Lead Discover Center GmbH, Germany

10 Enhanced Exposure of a Chemotherapeutic Drug to the Lymphatic System with the use of PEG-Modified and Nano-Sized Drug Carriers G M Ryan Monash University, Australia