8:00am–10:00am
Roundtable

Clinical Trial Simulations:
Many Questions, Few Answers
ACPE #073-999-07-538-L04
Room 2 – Convention Center

MODERATOR
Prasad Tata, Ph.D., FCP
Mallinckrodt, Inc.

Road Map to Clinical Trial Simulations 
Conceptualization, Design, and Execution

Sandra Allerheiligen, Ph.D.
Eli Lilly and Company

Overcoming Obstacles in Delivering M&S Results for Drug Development and Regulatory Decision-making
Ted Grasela, Pharm.D., Ph.D.
Cognigen Corporation

Clinical Trial Simulations in the Critical Path Initiative and Regulatory Decision-making
Lawrence Lesko, Ph.D., FCP
U.S. Food and Drug Administration

8:00am–10:00am
Roundtable
Functionality Testing of Excipients
ACPE #073-999-07-511-L04
Room 7 – Convention Center

MODERATORS
Moji C. Adeyeye, Ph.D.
Duquesne University

Chris Moreton, Ph.D.
FinnBrit Consulting

Drug-excipient Interaction and Characterization
Moji C. Adeyeye, Ph.D.
Duquesne University

Excipient Functionality in the Pharmacopeias
Chris Moreton, Ph.D.
FinnBrit Consulting

Excipient Functionality; an IPEC-Americas Perspective
Dave Schoneker, M.S.
Colorcon, Inc.

8:00am–10:00am
Mini–Symposium
Selection of Efficient Cleaning Validation Strategies
ACPE #073-999-07-512-L04
Room 8 – Convention Center

MODERATORS
Saji Thomas, Ph.D.
Par Pharmaceuticals

Chris Ames, Ph.D.
Hoffman-LaRoche, Inc.

Speech Title to be Announced
Muralidhara Gavini
U.S. Food and Drug Administration

Selection and Efficient Cleaning Validation Strategies
Richard Forsyth, Ph.D.
Merck and Company, Inc.

Development and Validation of Analytical Test Methods for Equipment Cleaning Verification
Yanxi Tan Cain, Ph.D.
Wyeth Pharmaceuticals

AAPS Plenary Session
The Economics of Pharmaceutical Development
ACPE #073-999-07-509-L04
Ballroom 20 – Convention Center

MODERATOR
William Weiser, Ph.D.
Liquidia Technologies, Inc.

When R&D is Not Enough: Delivering Essential Medicines
Victoria Hale, Ph.D.
Institute for One World Health

Pharmaceutical Innovation at a Crossroads: Economic Perspectives
    on the Drug Development Process
Kenneth I. Kaitin, Ph.D.
Tufts University

Adaptive Clinical Development: Strategic and Tactical Aspects
Michael J. Rosenberg, M.D., M.P.H.
Health Decisions, Inc.

12:00pm–1:15pm
Hot Topic

An Innovative Graduate Program Balancing Science and Engineering: Meeting the Needs of Industry for Ph.D. Entry-level Scientists in Pharmaceutical Technology
Room 7 – Convention Center
Lee Kirsch, Ph.D.
University of Iowa

2:00pm–4:00pm
Roundtable
Making a Decision on Drug Metabolism Data — Go or No Go
ACPE #073-999-07-539-L04
Room 5 – Convention Center

MODERATORS
Raimund M. Peter, Ph.D.
AstraZeneca

Dhiren Thakker, Ph.D.
University of North Carolina

Human-specific Metabolites — Industry Perspective
Kevin Bateman Merck Frosst

Human-specific Metabolites — Industry Perspective
Volker Fischer, Ph.D.
Abbott Laboratories

Human-specific Metabolites — Regulators’ Perspective
Shiew-Mei Huang, Ph.D.
U.S. Food and Drug Administration

2:00pm–4:00pm
Roundtable
Pediatric Drug Development
— Identifying the Needs, Meeting the Challenges
ACPE #073-999-07-557-L04
Room 1 – Convention Center

MODERATORS
Lorraine E. Pena, Ph.D.
Pharma Formulation Development, LLC

Joseph P. Reo, R.Ph., Ph.D.
Schering-Plough

The Pediatric Pharmaceutical and
Clinical Trial Environment:
Understanding and Removing the Barriers

Jon B. Bruss, M.D.
Pediatric Formulation Strategies

Lorraine E. Pena, Ph.D.
Pharma Formulation Development, LLC

2:00pm–4:00pm
Roundtable
Preparedness for Question Based Review
in Drug Approval — Role of Analytical Chemist
ACPE #073-999-07-513-L04
Room 2 – Convention Center

MODERATOR
Prasad N. Tata, Ph.D.
Mallinckrodt, Inc.

Experiences of Pharmaceutical Analyst on QBR
Ganapathy Mohan, Ph.D.
Sanofi-Aventis

Biopharmaceutics and Toxicity Input Into QBR Responses
Prakash T. Diwan, Ph.D.
Indian Institute of Pharmaceutical Education
and Research

Why We Ask Specific Questions — FDA Perspective
Lawrence Yu, Ph.D.
U.S. Food and Drug Administration

2:00pm–4:00pm
Student/PostDoc Outreach and Development (SPOD) Committee Roundtable
Scientific Research Integrity
Room 4 – Convention Center

MODERATOR
Sudip K. Das, Ph.D.
Butler University

Editor’s Perspective on Scientific Integrity
Vincent H.L. Lee, Ph.D.
The Chinese University of Hong Kong

Publication Ethics: The Good, the Bad and the Ugly
Diane Scott-Lichter
The Endocrine Society

Responsible Conduct of Research: What Goes Wrong?
Christine C. Boesz, Ph.D.
National Science Foundation

2:00pm–4:30pm
Symposium
In Vitro Release Testing of Dosage Forms Based
on Novel Technologies: Developments and Challenges
ACPE #073-999-07-514-L04
Room 7 – Convention Center

MODERATORS
Susan S. D’Souza, Ph.D.
Schering Plough Research Institute

Sunil S. Iyer, Ph.D.
Virginia Commonwealth University

2:00pm
A New ‘Biorelevant’ Approach
to Accelerated Release Testing
and IVIVC of a Long-acting
Biodegradable Implant
Sunil S. Iyer, Ph.D.
Virginia Commonwealth University

2:30pm
Accelerated Methods to Characterize
In Vitro Drug Release from Biodegradable Microspheres
Susan S. D’Souza, Ph.D.
Schering Plough Research Institute

3:00pm
Poster Podium

Combinatorial Design of Biomaterials and
Drug Delivery: Challenges and Opportunities
Balaji Narasimhan, Ph.D.
Iowa State University

3:30pm
Poster Podium

Drug Eluting Stents: Characterization of Release Kinetics
Micheline Markey, Ph.D.
Conor Medsystems

4:00pm
Dissolution of Low Solubility Products: Case Studies
Pradeep Sathe, Ph.D.
U.S. Food and Drug Administration

2:00pm–4:30pm
Symposium

Monocarboxylate Transporters in Drug Disposition:
Characterization, Regulation and Significance
ACPE #073-999-07-551-L04
Room 6A – Convention Center

MODERATORS
Marilyn E. Morris, Ph.D.
University at Buffalo, State University
of New York

Reina Bendayan, Pharm.D.
University of Toronto

2:00pm
Overview of the Proton-coupled MCT (SLC16)
Family of Transporters: Characterization, Function and Role in Drug Transport
Marilyn E. Morris, Ph.D.
University at Buffalo, State University
of New York

2:30pm
Sodium-coupled MCTs: Role in Health and Disease and
in Drug Transport
Vadivel Ganapathy, Ph.D.
Medical College of Georgia

3:00pm
Monocarboxylate Transporters in the Central Nervous System: Distribution, Regulation and Function
Lester R. Drewes, Ph.D.
University of Minnesota Medical School, Duluth

3:30pm
Targeting the MCT Transporter in Drug Delivery to Increase Bioavailability
Mark S. Warren, Ph.D.
Xenoport, Inc.


2:00pm–4:30pm
Symposium
Risk-based CMC Review and Quality Assessment: How Well is it Working?
ACPE #073-999-07-558-L04
Room 6D – Convention Center

MODERATORS
Sanjay Sehgal, Ph.D.
Wyeth Pharmaceuticals
Robert Bell, Ph.D.
Drug & Biotechnology Development, LLC

2:00pm
Risk-based Pharmaceutical Quality Assessment: An FDA Perspective
Moheb M. Nasr, Ph.D.
U.S. Food and Drug Administration

2:30pm
Risk-based Pharmaceutical Quality Assessment: Translating Experience to Date into Direction for the Future
Jeffrey J. Blumenstein, Ph.D.
Johnson and Johnson

3:00pm
FDA Proposal for Risk Based Regulatory Quality Assessment: Approaches to Managing Regulatory Uncertainties
Ajaz Hussain, Ph.D.
Sandoz

2:00pm–4:30pm
Symposium
Technology Challenges and Risk Analysis of Immunogenicity Assessment on Biologics
ACPE #073-999-07-531-L04
Room 6B – Convention Center

MODERATORS
Steve Swanson, Ph.D. Amgen, Inc.
Patrick M. Liu, Ph.D.
Genentech, Inc.

2:00pm
Emerging Technologies for Immunogenicity Assessment
Steve Swanson, Ph.D.
Amgen, Inc.

2:30pm
Risk Analysis of Immunogenicity
Assessment on Biologics,
A Case Study
Patricia Siguenza, Ph.D.
Genentech, Inc.

3:00pm
Drug Interference in Immunogenicity Assays: Issues, Approaches to Resolve
Deborah Finco-Kent, Ph.D.
Pfizer, Inc.

3:30pm
Challenge of Choosing Appropriate Bioanalytical Approaches for Immunogenicity Assessment of Biotherapeutics
Dong Geng, Ph.D.
Bristol-Myers Squibb Company

4:00pm
Comparison of Neutralizing Antibody Assays for Receptor Binding and Activity of the Enzyme Replacement Therapeutic Naglazyme
Erik Foehr, Ph.D.
BioMarin Pharmaceuticals

2:00pm–4:30pm
AAPS/ACCP Joint Symposium
Innovative Opportunities for Early Phase Drug Development
Room 6C – Convention Center

MODERATORS
Peter Bonate, Ph.D.
Genzyme

Daniel Salazar, Ph.D.
Sankyo Pharma Development

2:00pm
Theranostics: Real-time PD/PK Monitoring
Elizabeth Holmes, Ph.D. Theranos, Inc.

2:30pm
Adaptive Dose-ranging Studies for Efficient and Accurate Dose Selection
Jose Pinheiro and Jeff Maca Novartis Pharmaceutical

3:00pm
Transcriptonal Biomarkers in Early Clinical Development: The Importance of Baseline Variation
Karen Brown, Ph.D.
Daiichi Sankyo Pharma Development

3:30pm
Regulatory Perspective on Pharmacogenetics of Warfarin and Relabeling
Myong-Jin Kim, Ph.D.
U.S. Food and Drug Administration

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