Preliminary Program
`
`2011 AAPS Annual Meeting and Exposition
`October 23–27, 2011
`Walter E. Washington Convention Center, Washington, DC, USA
`
`FOR UP-TO-DATE INFORMATION, LOG ON TO: www.aapspharmaceutica.com/annualmeeting
`
`REGISTER
`AS A GROUP
`AND SAVE
`HUNDREDS
`OF DOLLARS!
`
`(SEE PAGE 106)
`
`These Company Employees Receive
`$125 Discount on Full Registration:
`(cid:115)(cid:0)AMGEN
`(cid:115)(cid:0)DPT
`(cid:115)(cid:0)ASTRAZENECA
`(cid:115)(cid:0)ELI LILLY & CO.
`(cid:115)(cid:0)CATALENT PHARMA
`(cid:115)(cid:0)PFIZER
`SOLUTIONS
`(cid:115)(cid:0)SANOFI-AVENTIS
`(SEE PAGE 106)
`
`CLICK HERE
`TO REGISTER
`
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`

`

`®
`
`American Association of
`Pharmaceutical Scientists
`
`From the President
`
`(cid:87)
`
`Dear Colleagues and Friends:
`
`I would like you to join the world’s largest gathering of pharmaceutical scientists at the 2011 AAPS Annual
`Meeting & Exposition in Washington, DC; the city where AAPS conducted its first Annual Meeting!
`
`Scientists from all over the globe will be gathering at this foremost event of the year. This can be your
`premier opportunity to meet colleagues, learn about and promote breakthrough research and technologies,
`and improve your professional edge.
`
`I’m also excited to present a completely electronic and searchable Preliminary Program. This online tool will
`help you navigate through the more than 90 programming sessions, consisting of:
`(cid:385)(cid:3)6 Short Courses
`(cid:385)(cid:3)35 Roundtables
`(cid:385)(cid:3)4 Hot Topics
`(cid:385)(cid:3)31 Symposia
`(cid:385)(cid:3)15 Sunrise Sessions
`(cid:385)(cid:3)10 Open Forums
`
`Additionally, the American Association of Pharmaceutical Scientists is celebrating its 25th anniversary
`in 2011! AAPS has spent the past 25 years offering timely educational proginramming and professional
`development opportunities to pharmaceutical scientists. During this anniversary year, AAPS has been
`recognizing how we have developed science and impacted health. This full year of activities will be
`culminating at the AAPS 25th anniversary celebration at the 2011 AAPS Annual Meeting and Exposition in
`Washington, DC. This is one more reason to register early!
`
`Start exploring this online Preliminary Program now for current program and schedule information.
`And, the all-important housing information is also available, so be sure to book your hotel reservations soon.
`
`October 23–27, 2011 are dates to block out now so you don’t miss a single day of the 2011 AAPS Annual
`Meeting & Exposition, the biggest pharmaceutical sciences event of the year and it will be AAPS’ biggest
`celebration ever!
`
`See you in Washington, DC and Happy Anniversary!
`
`Sincerely,
`
`Philip R. Mayer, Ph.D.
`AAPS PRESIDENT
`
`EXECUTIVE COUNCIL
`
`Officers
`Philip R. Mayer, Ph.D.
`President
`
`David Y. Mitchell, Ph.D.
`President-Elect
`
`Danny D. Shen, Ph.D.
`Immediate Past President
`
`WAYNE GOMBOTZ, Ph.D.
`Treasurer
`
`Members-At-Large
`
`Jeffrey S. Barrett, Ph.D. (2011)
`Gary A. Thompson, Ph.D. (2011)
`Marilyn E. Morris, Ph.D. (2012)
`James E. Polli, Ph.D. (2013)
`Raman Venkataramanan, Ph.D. (2013)
`
`2011 Section Chairs
`H. Thomas Karnes, Ph.D.
`Analysis & Pharmaceutical Quality
`
`Mary Cromwell, Ph.D.
`Biotechnology
`
`Dale Yu, Ph.D.
`Clinical Pharmacology & Translational
`Research
`
`Thomas Prisinzano, Ph.D.
`Drug Design & Discovery
`
`Dave Wallick, Ph.D.
`Formulation Design & Development
`
`Mike Yelvigi, Ph.D.
`Manufacturing Science & Engineering
`
`Duxin Sun, Ph.D.
`Physical Pharmacy & Biopharmaceutics
`
`Lane Brunner, Ph.D.
`Pharmacokinetics, Pharmacodynamics &
`Drug Metabolism
`
`Abbie Gentry, Ph.D.
`Regulatory Sciences
`
`Executive Director
`John Lisack, Jr., CAE
`
`2107 Wilson Blvd. Suite 700 Arlington, VA 22201-3042 USA | +1.703.243.2800 | +1.703.243.9650 fax | aaps@aaps.org | www.aaps.org
`
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`

`Opening Session & Plenary Speakers
`
`Plenary Session — Monday, October 24
`SUPPORTED BY A GRANT FROM
`
`AAPS is celebrating its 25th Anniversary and has themed the Keynote and Plenary Sessions for the 2011 AAPS Annual Meeting
`and Exposition: The Next 25 Years. A panel of visionary opinion leaders will provide their insights into the shape of today’s
`pharmaceutical sciences; the state of the industry; the regulatory climate and societal pressures on the cost-benefit of therapies;
`and, what will happen in our industry in the next 25 years?
`Opening Session — Sunday, October 23
`Keynote Speaker: Janet Woodcock, M.D.
`As the Keynote Speaker on Sunday October 23,
`Janet Woodcock, M.D., will provide her views on
`regulation into the future.
`Janet Woodcock is the Director of the Center for Drug
`Evaluation and Research at the U.S. Food and Drug
`Administration. She previously served as FDA Deputy
`Commissioner and Chief Medical Officer.
`Dr. Woodcock has close interactions with diverse
`constituencies, including the clinical and scientific
`communities, members of Congress and the
`Administration, national media, patient and consumer advocacy groups,
`the international drug regulatory community, the regulated industry, and
`representatives of the Federal and State agencies. She frequently appears in or
`is quoted by the national media and has testified repeatedly before Congress.
`Dr. Woodcock has led many cross-agency initiatives while at FDA. She
`introduced the concept of pharmaaceutical risk management in 2000 as
`a new approach to drug safety. She has led the “Pharmaceutical Quality for the
`21st Century Initiative” since 2002. This effort, to modernize pharmaceutical
`manufacturing and its regulation through the application of modern science
`and quality management techniques, has been highly successful in meeting
`its objectives. She has spearheaded an initiative on pharmacogenomics that
`has led to unprecedented agency-industry interactions on pharmacogenomics
`use in drug development. In 2004, she introduced FDA’s “Critical Path”
`initiative, which is designed to improve the scientific basis for medical product
`development. Most recently, she launched the “Safety First” and “Safe Use”
`initiatives that are designed to improve drug safety management within and
`outside the FDA, respectively.
`Dr. Woodcock was director of the Center for Drug Evaluation and Research
`(CDER) from 1994–2005. During this period, review processes for new
`and generic drugs were streamlined, while the standards for quality, safety
`and effectiveness were improved. Dr. Woodcock also oversaw initiatives to
`automate submission and review of applications and adverse event reports.
`Under Dr. Woodcock’s leadership, CDER’s regulatory decision-making was
`made more open and transparent to the public. Changes included publishing
`CDER’s regulatory procedures and policies, developing over 100 technical
`“guidances” that describe regulatory standards, providing an unprecedented
`degree of participation of consumer and patient representatives in FDA
`processes, and creating an extensive Center web site which includes drug
`reviews and consumer information.
`Prior to joining CDER, Dr. Woodcock was director of the Office of Therapeutics
`Research and Review, Center for Biologics Evaluation and Research (CBER).
`There she oversaw approval of the first biotechnology-based treatments for
`multiple sclerosis and cystic fibrosis. She also served as Acting Deputy
`Director of CBER for several years.
`
`John Lechleiter, Ph.D., Francis S. Collins, M.D., Ph.D.,
`Sir Michael Rawlins, M.D.
`On Monday October 24 at the Plenary Session, John Lechleiter, Ph.D., will
`speak to the future shape of the global pharmaceutical industry; Francis S.
`Collins, M.D., Ph.D., will speak on current research that may lead to new
`therapies in the future; and, Professor Sir Michael Rawlins will speak on the
`cost benefits of therapies and the societal ability to pay for the therapies.
`John C. Lechleiter, Ph.D., has served as president and chief
`executive officer of Eli Lilly and Company since April 2008.
`He was named chairman of the board of directors in December
`2008. In 2001, Lechleiter was appointed executive vice president
`for pharmaceutical products and corporate development.
`In 2004, he became Lilly’s executive vice president for
`pharmaceutical operations. And, in 2005, he was named president and chief
`operating officer and joined the board of directors.
`Dr. Lechleiter received a bachelor of science degree in chemistry from Xavier
`University in 1975. He subsequently studied organic chemistry as a National
`Science Foundation Fellow at Harvard University, where he received his
`master’s and doctorate degrees. In 2006, Dr. Lechleiter received an honorary
`doctorate of business administration from Marian University.
`Francis S. Collins, M.D., Ph.D. is the Director of the National
`Institutes of Health (NIH). In that role he oversees the work
`of the largest supporter of biomedical research in the world,
`spanning the spectrum from basic to clinical research. Dr.
`Collins, a physician-geneticist noted for his landmark discoveries
`of disease genes and his leadership of the international Human
`Genome Project, served as director of the National Human Genome Research
`Institute (NHGRI) at the NIH from 1993-2008. The Human Genome Project
`culminated in April 2003 with the completion of a finished sequence of the
`human DNA instruction book.
`Dr. Collins received a B.S. in chemistry from the University of Virginia, a Ph.D.
`in physical chemistry from Yale University, and an M.D. with honors from the
`University of North Carolina at Chapel Hill. Prior to coming to the NIH in 1993,
`he spent nine years on the faculty of the University of Michigan, where he was
`a Howard Hughes Medical Institute investigator. He is an elected member of
`the Institute of Medicine and the National Academy of Sciences. Dr. Collins
`was awarded the Presidential Medal of Freedom in November 2007 and the
`National Medal of Science in 2009.
`Sir Michael Rawlins, M.D. has been chairman of the National In-
`stitute of Health & Clinical Excellence (NICE) since its formation
`in 1999. He is also an Honorary Professor at the London School
`of Hygiene and Tropical Medicine, University of London, and
`Emeritus Professor at the University of Newcastle upon Tyne.
`Sir Michael Rawlins was the Ruth and Lionel Jacobson Professor
`of Clinical Pharmacology at the University of Newcastle upon Tyne from 1973
`to 2006. At the same time he held the position of consultant physician and
`consultant clinical pharmacologist to the Newcastle Hospitals NHS Trust. He
`was vice-chairman (1987–1992) and chairman (1993–1998) of the Committee
`on Safety of Medicines; and chairman of the Advisory Council on the Misuse of
`Drugs (1998–2008).
`
`2011 AAPS Annual Meeting and Exposition
`
`3
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`TABLE OF CONTENTS
`
`REGISTRATION INFORMATION. . . . . . . . . . . . . . . . . . . . . . . . . . 6
`
`2011 AAPS ANNUAL MEETING AND EXPOSITION
`SPONSORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
`
`ABOUT WASHINGTON, DC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
`
`AAPS EXPOSITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
`
`DESCRIPTION OF AAPS SECTIONS . . . . . . . . . . . . . . . . . . . . . . 11
`
`PROGRAM
`Meeting-at-a-Glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
`
`SECTION PROGRAMMING TRACKS
`General Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
`Professional Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
`Analysis & Pharmaceutical Quality (APQ) . . . . . . . . . . . . . . . 24
`Biotechnology (BIOTEC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
`Clinical Pharmacology & Translational
`Research (CPTR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
`Drug Design & Discovery (DDD) . . . . . . . . . . . . . . . . . . . . . . . 50
`Formulation Design & Development (FDD) . . . . . . . . . . . . . . 56
`Manufacturing Science & Engineering (MSE) . . . . . . . . . . . . 65
`Physical Pharmacy & Biopharmaceutics (PPB) . . . . . . . . . . . .73
`Pharmacokinetics, Pharmacodynamics &
`Drug Metabolism (PPDM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
`Regulatory Sciences (RS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
`Pre-conference Workshops . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
`
`WORKSHOPS (PRE-CONFERENCE EVENTS)
`AAPS Workshop on Facilitating Oral Product
`Development and Reducing Regulatory Burden
`through Novel Approaches to Assess
`Bioavailability/Bioequivalence . . . . . . . . . . . . . . . . . . . . . . . . 102
`AAPS Workshop on the Role of Pharmacogenetics
`(PGx) in Reducing Adverse Drug Reactions (ADRs) . . . . . . .103
`AAPS Workshop on Pharmaceutical Stability:
`Scientific and Regulatory Considerations for Global
`Drug Development and Commercialization . . . . . . . . . . . . . .103
`ASMS Workshop on High Resolution Mass
`Spectrometry in Drug Discovery and Drug Development:
`Current Applications and Future Perspectives . . . . . . . . . . . .103
`CRS Workshop on Developing Pharmaceutical
`Products for Controlled Pulmonary Delivery . . . . . . . . . . . . 104
`NIAAA Symposium on Development and Applications
`of Biomarkers of Alcohol Abuse and Tissue Damage,
`Cancer and Neurodegeneration . . . . . . . . . . . . . . . . . . . . . . . 104
`
`SHORT COURSES (PRE-CONFERENCE EVENTS)
`Short Course #1: Learning the Drug Discovery
`and Delivery Interface Process . . . . . . . . . . . . . . . . . . . . . . . . . .51
`Short Course #2: Understanding the Role
`of Mathematical Models in the Drug
`Development Paradigm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
`Short Course #3: Establishing Efficient Regulatory
`and Science-based Strategies for Seamless
`Technology Transfer from Development to Commercial
`Manufacturing: Roles of ICH Q8, Q9 and Q10 . . . . . . . . . . . . 94
`Short Course #4: PK/PD Systems Analysis:
`Hands-on Modeling with Adapt 5 . . . . . . . . . . . . . . . . . . . . . . .41
`Short Course #5: Recent Advances in Non-invasive
`Drug Delivery of Biopharmaceuticals . . . . . . . . . . . . . . . . . . . .57
`Short Course #6: PK and PK/PD Modeling
`of Biologics: Theory and Applications in
`Drug Discovery and Development . . . . . . . . . . . . . . . . . . . . . . .41
`
`4
`
`Preliminary Program
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`

`

`2011 AAPS Annual Meeting and Exposition
`(cid:115)(cid:0) Online Registration
`(cid:115)(cid:0) Registration Form
`
`AAPS OPEN FORUMS (POST-CONFERENCE EVENTS)
`Biomarker-companion Diagnostic Challenges in the
`Development of Personalized Medicines (CPTR). . . . . . . . . . .45
`Biosimilars: Regulatory Update and Practical Considerations
`for Successful Development and Approval (RS) . . . . . . . . . . . 96
`Drug Product Development Considerations and
`Challenges In Emerging Markets (MSE) . . . . . . . . . . . . . . . . . .71
`Successful Clinical Case Studies (DDD) . . . . . . . . . . . . . . . . . .53
`Novel Approaches to Address Challenges in Oral
`Dosage Form Development (FDD) . . . . . . . . . . . . . . . . . . . . . 64
`PPDM Lost in Translation: Utility of Preclinical Models
`of Human ADMET (PPDM) . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
`Successful Interactions and Approvals with the FDA
`and Regulatory Agencies (PPB) . . . . . . . . . . . . . . . . . . . . . . . . 79
`Therapeutic Equivalence of Complex Dosage Forms
`and Drug Products: Emerging Issues and Evolving
`Regulatory Standards (RS) . . . . . . . . . . . . . . . . . . . . . . . . . . . .101
`DBS and Microsampling: Moving Past the Hype
`to Knowledge and Implementation . . . . . . . . . . . . . . . . . . . . . 30
`Antibody Drug Conjugates: Bioanalytical Strategies and
`Validation to Fulfill both Good Scientific and Regulatory
`Requirements (BT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
`REGISTRATION INFORMATION
`3 Easy Ways to Register . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
`Special Discounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
`Spouse/Guest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
`Continuing Education (CE) Credits . . . . . . . . . . . . . . . . . . . . .107
`International Registrants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
`Lost Badges and Expocards . . . . . . . . . . . . . . . . . . . . . . . . . . .107
`Exposition Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
`Cancellations/Refunds/Substitutions . . . . . . . . . . . . . . . . . . .107
`
`SITE/HOTEL INFORMATION
`What’s Held Where? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
`Hotel Accommodations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
`Hotel Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
`
`TRAVEL & TRANSPORTATION
`Air Travel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
`Airport Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
`Ground Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
`Public Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
`Parking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
`Driving Directions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
`Convention Center Shuttle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
`
`GENERAL INFORMATION
`Contributed Papers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
`Professional Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
`Graduate Students . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
`About Children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
`Childcare Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
`Family Friendly Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
`Speaker Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
`Expocard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
`Photography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
`Electronic Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
`Recycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
`Message Center/Internet Cafe . . . . . . . . . . . . . . . . . . . . . . . . .116
`Business Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
`Smoking Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
`What to Wear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
`AAPS Central . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
`Get ROCK’d! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
`Wi-Fi Lounge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
`Student Lounge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
`Press Room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
`AAPS Fun Booth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
`AAPS on Social Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
`
`MEMBERSHIP INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . 118
`
`UPCOMING AAPS ANNUAL EVENTS . . . . . . . . . . . . . . . . . . . . 118
`
`TOURS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
`Tour Registration Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
`
`STUDENT SHORT COURSE APPLICATION FORM . . . . . . . . . 121
`
`REGISTRATION APPLICATION FORM AND FEES . . . . . . . . . .122
`
`2011 AAPS Annual Meeting and Exposition
`
`5
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`NEW FOR 2011
`Registration badge and event tickets will NOT
`be mailed out prior to the meeting.
`Please pick up your items on-site at registration.
`
`RESERVE YOUR
`HOTEL ROOM EARLY!
`
`Rooms are assigned on a first-come, first-served basis.
`RESERVATIONS SHOULD BE MADE BY SEPTEMBER 29, 2011.
`After September 29, 2011, all reservations will be accepted
`on a space-and rate-available basis.
`See page 108 for more housing information or click on the link below.
`Housing Site
`
`Registration
`3 EASY WAYS
`TO REGISTER
`REGISTER BY SEPTEMBER 9, 2011
`AND SAVE!
`
`ONLINE
`
`Secure online registration (credit card
`payments only)
`ONLINE REGISTRATION
`
`FAXFax or mail your completed registration form
`
`(check, wire transfer or money order
`payments only)
`REGISTRATION FORM
`FX: +1 301.694.5124
`
`MAIL
`
`2011 AAPS Annual Meeting and Exposition
`P.O. Box 590
`Frederick, MD 21705 USA
`
`Meeting Registration Questions/Confirmation:
`+1 301.694.5243, or +1 866.229.2386
`(toll free for U.S., Canada, and Mexico)
`Register promptly to take advantage of
`the early discounts! For registration to be
`processed, the appropriate registration fee
`must be received with your registration form.
`Registration forms received without payment
`will be considered received on the date the
`check or wire transfer arrives. All credit card
`payments must be made online.
`To verify receipt of your registration or to make
`changes, contact:
`Experient
`PH: +1 301.694.5243
`EM: registration@aaps.org
`
`6
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`

`

`October 23–27, 2011 ● Walter E. Washington Convention Center ● Washington D.C.
`SUSTAINING SPONSORS
`
` as of June 15, 2011
`
`SUPPORTER LEVEL
`
`DIAMOND LEVEL
`
`PLATINUM LEVEL
`
`SM
`
`BRONZE LEVEL
`
`SILVER LEVEL
`
`OFFICIAL MEDIA PARTNERS
`
`TM
`
`®
`
`Interested in supporting the 2011 AAPS Annual Meeting and Exposition? Contact Grace Jones at sponsors@aaps.org.
`
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`

`

`Scientific Award Sponsors
`
` as of April 26, 2011
`
`8
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`

`

`About Washington, DC
`
`With its ideal mid-Atlantic location and comprehensive air and rail service,
`it’s easy to get to Washington, DC. And, thanks to a quick and efficient
`Metrorail subway system, friendly tour guides and broad, welcoming streets,
`it’s also easy to navigate the nation’s capital once you’re here. Visitors can
`fly into one of Washington, DC’s three airports, ride a train into magnificent
`Union Station or navigate the region’s network of major highways for a
`speedy arrival and easy conveyance downtown. Once in town, hop aboard a
`site-seeing trolley, travel across town on Metro or on the DC Circulator or to
`the scenic Potomac River to experience the cityscape from a different angle.
`Either way, you will be delighted…and inspired.
`Never before has Washington, DC provided so much to do in so many
`places. Culture, heritage, nationally-acclaimed theatre, FREE musical
`concerts, festivals, world-renowned shopping and all the inspiring
`monuments and museums you expect, offer ideal touring choices. Start at
`the National Mall and take in one of the 11 free museums or take a moonlight
`tour of the Monuments. But Washington, DC is much more than a city of
`monuments and museums. It is a thriving cultural capital where opera, jazz
`and classical music lovers can find a tempting lineup of performances.
`To find out more about Washington, DC, go to
`www.washington.org.
`
`WALTER E. WASHINGTON CONVENTION CENTER
`801 Mount Vernon Place, NW, Washington, DC 20001, USA
`The 2011 AAPS Annual Meeting and Exposition will
`be held at the Walter E. Washington Convention
`Center (WCC) conveniently located to major points
`throughout the city. The Walter E. Washington
`Convention Center, just two blocks from the city’s
`original 1974 site, opened in 2003 to tremendous
`fanfare. Located in the heart of downtown, the
`facility is ushering in unparalleled residential and
`commercial development. The Center is among the
`top ten largest convention centers in the nation and
`is the primary catalyst for the renaissance of nearby historic communities and a
`new, vibrant, living downtown district.
`The Exposition will be located in Hall A-B and Attendee Registration will be
`located in West Salon of the Grand Lobby. The Career Center and Poster
`Sessions will be located in Hall C.
`For more information on the Walter E. Washington Convention
`Center, visit: www.dcconvention.com.
`
`2011 AAPS Annual Meeting and Exposition
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`The Exposition
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`Preliminary Program
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`AAPS Sections
`
`AAPS is comprised of nine (9) sections. Some of the sessions are listed under these sections. AAPS Central will be staffed
`by representatives from these sections. To assist you in finding the section that best represents your interests, brief descriptions
`for each section are below.
`
`The APQ Section is composed of members
`whose interests are in the areas of analytical
`methods development for bulk drug substances
`as well as drugs in pharmaceutical dosage
`forms and biological matrices, and methods and
`procedures for assuring that quality is designed into
`pharmaceutical products. APQ provides a forum for
`the exchange of information pertaining to analytical
`techniques, bioanalytical techniques, regulatory and
`compendial issues, and assurance of quality. The
`APQ Section interacts with all disciplines involved
`in the discovery, development and production of
`pharmaceutical products, and many of its programs
`and activities are undertaken with other sections of
`the association.
`
`
`
`The BIOTEC Section is comprised of members
`from many diverse backgrounds in industry and
`academia who share a common interest in the
`evolving field of biotechnology. The primary goal
`of this section is to unite multiple scientific
`disciplines in a forum where they can share
`experimental results as well as concerns regarding
`the research, development, and commercialization
`of new biotechnology based pharmaceuticals.
`Members in this section can meet at national
`and regional meetings to exchange ideas and
`present scientific data. Applied and basic scientists,
`at all phases of research and development, for
`both therapeutic and diagnostic agents, are actively
`involved in the AAPS BIOTEC section. In particular,
`the successful discovery, production, delivery,
`and commercialization of biotechnology derived
`drugs requires input from many diverse fields
`including molecular biology, cell culture, recovery
`process, pharmacokinetics, metabolism,
`analytical biochemistry, regulatory affairs, and
`formulation sciences.
`
`The CPTR Section provides the clinical research
`dimension within the comprehensive range of
`pharmaceutical sciences represented in AAPS
`and is concerned with developing knowledge
`and understanding related to the clinical use of
`pharmaceuticals (chemical agents and biological
`agents). The CPTR Section serves as a forum
`for those scientists engaged in research on
`the therapeutics and clinical assessment of
`drugs and biologics. This section addresses
`the rational application of pharmaceutical and
`related sciences in the clinical setting, including
`experimental design, conduct and analysis
`of clinical trials; regulatory aspects of clinical
`trials and drug registration; risk assessment,
`therapeutic extrapolation from animals to humans;
`pharmacoepidemiology; drug interactions; and
`in appropriate populations, therapeutic efficacy/
`safety and the response to alternative dosage
`forms. The CPTR Section provides an opportunity
`for interaction between scientists in academia,
`government, and industry who are engaged
`in clinical research. The section facilitates the
`interaction of AAPS members with scientists
`from other clinical organizations using joint formats
`such as symposia, workshops, and regional/
`national meetings.
`
`The FDD Section is comprised of members from
`many diverse backgrounds in industry, regulatory
`and academia who share a common interest
`in the area of formulation design, research and
`development — a multidisciplinary field drawing
`upon the physical, chemical, biological and
`engineering sciences. The primary goal of this
`section is to unite multiple scientific disciplines
`in a forum where they can share experimental
`results, consider new formulation and dosage
`form technologies, and discuss issues and
`concerns regarding the design and development
`of formulations/drug products for all dosage
`forms. This section collaboratively interfaces with
`other sections which focus on pre-formulation,
`biopharmaceutics, formulation strategies, and
`manufacturing process optimization. Aspects
`of formulation design and development include
`the study of dosage forms for drug delivery via all
`routes of administration wherein the dosage form
`encompasses the formulation, process by which
`it is made, and primary packaging. The section’s
`focus on development includes product design,
`delivery systems and technology, stability, quality,
`and performance both in vitro and in vivo that is
`appropriate to its development stage.
`
`The DDD Section engages in all aspects of the
`design and discovery of molecular pharmaceutical
`entities, and fosters interactions at the interface
`between drug discovery and development. DDD
`provides leadership and a forum for interactions
`among scientists from academia, industry, and
`research institutions. The section invites and
`supports collaborative relationships with scientists
`in other disciplines within AAPS and other
`scientific and professional organizations whose
`efforts are directed toward the interface of drug
`design and discovery and drug development.
`The DDD Section is truly unique among scientific
`organizations serving the needs of medicinal and
`natural products chemists and scientists engaged
`in other emerging technologies and disciplines
`involved in drug development, including drugability,
`by providing a single organization for all members
`associated with pharmaceutical drug discovery
`and development.
`
`
`
`The MSE Section of AAPS brings together all
`members who are interested in and contribute to
`the application and advancement of science and
`technology as it relates to process development
`and manufacture of pharmaceutical and
`pharmaceutically related products including
`medical devices and active pharmaceutical
`ingredients. It will provide a forum for exchange of
`information and networking between members and
`with members of allied sections and organizations.
`Areas of specific interest include pharmaceutical
`product manufacturing (both investigational and
`commercial), quality assurance and engineering
`principles as applied to manufacturing, process
`optimization, scale-up and technology transfer, and
`quality systems including manufacturing technical
`support and quality by design.
`
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`AAPS Sections
`
`The RS Section of AAPS is composed of members
`whose interests focus on multidisciplinary scientific
`aspects of pharmaceutical development and
`regulatory approval as they relate to quality, safety
`and efficacy of the product (e.g., manufacturing,
`quality, pharmacology, toxicology, clinical trials, law,
`and intellectual property).
`
`The PPB Section is composed of AAPS members
`whose scientific interests are in the physicochemical
`and biological factors that impact the design
`and delivery of small molecules and biologics.
`PPB is a multidisciplinary section that focuses on
`preformulation, biopharmaceutics, drug absorption,
`nanotechnology, and drug delivery systems
`design and performance including targeted drug
`delivery. PPB provides an interactive forum for the
`exchange of information pertaining to the selection
`of developable drug candidates at the drug
`discovery-development interface, characterization
`of drug substance and excipients, studies of
`relationships between drugs’ physicochemical and
`biopharmaceutical properties and physiological
`considerations at the cellular, organ,