AAPS 2001 Annual Meeting and Exposition Pharmaceutical Sciences: Climbing New Heights October 21-25 Colorado Convention Center Denver, CO Headquarters Hotel - Adams Mark

Sunday

Biotechnology as a Business

AAPS Workshop for Graduate and Postdoctoral Fellows
8:00 am - 3:30 pm

All attendees must be registered for the Annual Meeting and must register separately in order to attend this workshop. This workshop is designed to introduce graduate students and postdoctoral fellows of AAPS to career opportunities in biotechnology. Registration is free, but students must complete the registation form online. Please note: students must include the signature of their professor for their registration to be considered.

Chairpersons
Carol Stotz
Graduate student, The University of Kansas Ajit D'Sousa
Graduate student, The University of Kansas

Welcome
Ronald T. Borchardt
President of AAPS

Growing Up in Biotech
Rodney Pearlman
President and CEO, David Pharmaceuticals

Starting a Biotechnology Company
Dana Ault-Riche
President and CEO, Pointilliste, Inc.

The Academic Career as a Platform for Launching a Company. Positive and Negative Features. Opportunities Created by Biotechnology for Conventional Pharmaceutical Research.
Pete Kissinger
Chairman and CEO, Bioanalytical Systems, Inc.

Comparison of Scientific Roles Within Large and Small Pharmaceutical Companies
Cynthia Stevenson
Technical Leader, Inhale Therapeutic Systems

An Academic View of Starting a Biotechnology Company
Valentino Stella
University Distinguished Professor, The University of Kansas

A VC's View of Biotechnology: What Does the Future Hold?
Mike Powell,
Vice President, Sofinnova, Inc.

Panel Discussion

Annual Product Review — How to Comply With Regulatory and Industry Requirements

Short Course
Sunday, October 21, 2001
8:30 am - 4:00 pm
ACPE Program Number: 073-999-01-201-L04

The CGMP Regulations require that the quality of drug products be reviewed at least annually to assess needs for product changes (see 21 CFR 211. 180e). Further, similar requirements for “regular reviews” are specified in the Draft ICH GMP guideline for APIs and in the ISO 9000 standards. These requirements are usually referred to as “Annual Product Reviews” (APRs) and are fully in keeping with the long recognized business principle that regular product reviews protect or increase profits by playing a key role in “continuous product improvement” and in minimizing product and process failures. This course explores how these requirements can be met. In particular, it covers the following aspects: details of the regulatory and industry requirements; what documents should be reviewed; how the release, in-process, packaging, stability, recall, complaint and returned goods data can be reviewed with a special emphasis on the use of statistical techniques; the special problems involved in handling complaint data; the importance of carefully scrutinizing investigation reports; how the APR confirms validation and change control; who should be involved in the APR process and how it can be organized with a special emphasis on the role of management; and what forms should be used and what the SOP should contain.

The course includes a question and answer session designed to provide the attendees with a forum for discussing current problems concerning APRs.

This course should benefit all who are involved in: complying with the regulatory requirements for APRs for drug products and APIs; understanding the status of product quality; learning needs for designing programs for corrective action.

Typically personnel from the following departments will benefit: QA, QC, Regulatory Affairs, Production and personnel responsible for product development including those involved in analytical development and technology transfer.

By attending this course you will gain a knowledge of the regulatory, industry and management requirements for Annual Product Reviews and of techniques which can be used to meet these requirements with an emphasis on what records should be reviewed, how the data can be analyzed and reported, how the review can be organized and what the SOP should contain.

Moderator
Alan Smith, Ph.D.
Pharmaceutical Quality and Technology Consultant

Speakers
Alan Smith, Ph.D.
Pharmaceutical Quality and Technology Consultant

Pamela Wertalik
Consultant

Joseph F. Mastronardy, Ph.D.
Quality Regulatory Consultants

Chirality: Implications in Drug Product Development

Short Course
Sunday, October 21, 2001
8:30 am - 4:00 pm
ACPE Program Number: 073-999-01-202-L04

The choice of developing either a racemic drug or individual enantiomer must be based on a sound and critical evaluation of the chiral characteristics of drug molecules with respect to their biopharmaceutic, pharmacodynamic, pharmacokinetic, and toxicological considerations. This short course addresses various issues pertaining to chirality in drug product development, including enantioselectivity in drug transport and permeation, pharmacokinetic/pharmacodynamic issues, and bioequivalence considerations. A detailed discussion on the regulatory perspectives of chiral drugs will also be presented. This course is designed for scientists in the industry and academia who are involved in the product development of chiral drugs.

Moderators
Indra Reddy, Ph.D.
Texas Tech School of Pharmacy

Chandrahas G. Sahajwalla, Ph.D.
Food and Drug Administration

Introduction/Overview
Indra Reddy, Ph.D.
Texas Tech School of Pharmacy

Chandrahas G. Sahajwalla, Ph.D.
Food and Drug Administration

Biopharmaceutic Considerations: Enantioselective Transport and Permeation of Chiral Drugs
Indra Reddy, Ph.D.
Texas Tech School of Pharmacy

Enantioselective Pharmacokinetics/Pharmacodynamics
Dion Brocks, Ph.D.
Western University of Health Sciences

Stereoselective Metabolic Drug Interactions: Cisapride
Zeruesenay Desta, Ph.D.
Georgetown University Medical Center

Bioequivalence of Chiral Drugs
Aziz Karim, Ph.D.
G.D. Searle and Company

Regulatory Issues in Chiral Drug Development
Chandrahas G. Sahajwalla, Ph.D.
Food and Drug Administration

Clinical Trial Simulations

Short Course
Sunday, October 21, 2001
8:30 am - 4:00 pm
ACPE Program Number: 073-999-01-203-L04

Simulation of clinical trials has recently gained attention as an emerging technique for knowledge synthesis and exploration of possible clinical trial results based upon a mathematical/stochastic model of the trial, including sub-models of the drug action and disease process. The application of simulation in the domain of pharmaceutical medicine, clinical pharmacology and drug development has been largely restricted in the past to evaluation of statistical methodology and forecasting of individual or population pharmacokinetics. The simulation has a much broader potential to aid in the clinical development, regulatory review, commercialization, and medical application process. The key objective of this short course will be to outline the theory, methodology and application of clinical trial simulations. Participants will receive theoretical and practical instructions on techniques in use today, from leading researchers with an academic and industrial background. Special emphasis will be given to theory, methodology and application of trial simulations by stressing the importance of a simulation plan, which will provide the course participants the real life experience, thus maximizing the benefit of acquiring new knowledge and scientific experience in a short course format.

Moderator
Andrej Skerjanec, Ph.D.
Novartis Pharmaceutical Corporation

Review of Clinical Trial Simulations: History and Current State of the Art
Carl Peck, M.D.
Georgetown University, Center for Drug Development Science

Objectives of Clinical Trial Simulations and Role of Clinical Trial Simulations vs. Other Methods of Trial Design
Hui C. Kimko, Ph.D.
Georgetown University, Center for Drug Development Science

Simulation Models: Covariate Distribution, Input-Output, Execution
Lewis B. Sheiner, M.D.
University of California, San Francisco

Building a Simulation Model, Defining a Simulation Experiment
Hui C. Kimko, Ph.D.
Georgetown University, Center for Drug Development Science

Applications of Clinical Trial Simulations: Examples and Illustrations
Jaap W. Mandem, Ph.D.
Pharsight Corporation

Evaluation and Comparison of Clinical Trial Simulations Strategies
Diane R. Mould, Ph.D.
Georgetown University, Center for Drug Development Science

Simulation Software (Excel, ModelMaker, NONMEM, Trial Simulator)
Nick Holford, M.B., Ch.B.
University of Auckland, New Zealand

Plenary Session and Roundtable Discussion
Diane R. Mould, Ph.D.
Georgetown University, Center for Drug Development Science

Evaluation and Investigation of Out-of-Specification Results — A Methodical and Rationale-Based Approach

Short Course
Sunday, October 21, 2001
8:30 am - 4:00 pm
ACPE Program Number: 073-999-01-204-L04

A comprehensive evaluation and investigation of out-of-specification (OOS) results is a major regulatory requirement and presents quite a challenge to managers and scientists involved with analytical, quality assurance, regulatory affairs and manufacturing areas in the pharmaceutical industry. OOS results must be evaluated carefully using scientific rationale and investigated methodically and in a timely manner.

This course will provide a critical understanding of the expectations from the FDA’s “Draft Guidance Document on Investigation of OOS Results,” strategies for implementation in the laboratory for development stage and marketed products and approaches to interpretation of investigation results. Attendees will participate in solution of selected OOS investigation problems and discuss the approaches used. Effective approaches to conduct investigations in a contract laboratory environment to benefit both sponsor and contractor will be discussed. Instructions on how to develop and implement preventative steps to minimize occurrence of OOS results will also be provided.

A hands-on and how-to approach will be used in the course so that every participant can take away a thorough understanding of the regulatory requirements for OOS investigation and implement effective procedures in their own work place. The course will conclude with a panel discussion including questions from participants.

Moderator
Dilip R. Choudhury, Ph.D.
Pharmaceutical Development Center

Program Overview
Dilip R. Choudhury, Ph.D.
Pharmaceutical Development Center

Critical Elements of FDA Draft Guidance Document and Strategies for Their Effective Implementation Including Implementation During Early Development Stages
Dilip R. Choudhury, Ph.D.
Pharmaceutical Development Center

Effective Methodologies for OOS Investigation of Marketed Products Including OOS Occurrences During Stability Samples Analyses
Frank Diana, Ph.D.
DuPont Pharmaceuticals

Successful Approaches for OOS Investigation in a Contract Laboratory Environment — Roles of Sponsor and Contractor
R. Harris Cummings, Ph.D.
Magellan Laboratories, Inc.

Methodical Investigation of OOS Results — A Problem Solving Session
Abbie E. Gentry, Ph.D.
Johnson and Johnson/Merck Consumer Pharmaceuticals Co.

Developing and Implementing Effective Steps to Prevent Occurences of OOS Results
Gaby I. Aced, Ph.D.
Quintiles, Inc.

Panel Discussion

Fundamentals of the use of the USP-NF, and the Standards Development Process

Short Course
Sunday, October 21, 2001
8:30 am - 4:00 pm.

• Changes have been made through the online registration to include this additional Short Course.
• Changes have also been made to the .pdf version of the Registration.
• Forward any Questions/Concerns/Problems regarding this registration to me.

Process Development and Equipment Considerations of Solid Dispersions — Case Study and Demonstration

Short Course
Sunday, October 21, 2001
8:30 am - 4:00 pm
ACPE Program Number: 073-999-01-205-L04

Process development could play a critical role in a successful development of a solid dispersion formulation. This short course will comprise of two parts:

Part I: Review the principles of solid dispersion techniques, equipment such as fluid-bed processor, perforated pan coating, high-shear processor and extrusion process, effects of process parameters, equipment consideration and scale-up issues. The presentation will focus on actual case studies, process development, scale-up, stability evaluations, problem solving and trouble shooting.

Part II: Demonstrate different types of solid dispersion manufactured by fluid-bed processor, perforated pan coating, high-shear processor and extrusion process. Attendees will be divided into 3-4 groups and each group will be rotated to attend different sessions. Each session will cover a 15 minute presentation from each speaker, 30 minute manufacturing process and 15 minute discussion.

Moderators
George Wong, Ph.D.
The R.W. Johnson Pharmaceutical Research Institute

Jatin J. Shah, Ph.D.
Faulding Pharmaceutical

Wendy Dulin, Ph.D.
Wyeth-Ayerst Research

Lirong Liu, Ph.D.
Penwest Pharmaceutical

Influence of Drug Physicochemical Properties and Processing Challenges in Developing Solid Dispersion Systems — Part I
Devalina Law, Ph.D.
Abbott Laboratories

Influence of Drug Physicochemical Properties and Processing Challenges in Developing Solid Dispersion Systems — Part II
Yihong Qiu, Ph.D.
Abbott Laboratories

Multi-Unit Controlled Release Systems of Nifedipine and Nifedipine — Pluronic F-68 Solid Dispersions: Characterization of Release Mechanisms
Ketan Mehta, Ph.D.
Röhm America

Comparison of Hot Melt Fluid Bed and High Shear Granulation Processes — A Case Study
Orapin Rubino, Ph.D.
Glatt Air Techniques, Inc.

Practical Aspects of “Hot-Melt Processing” or “Hot-Melt Coating” in a Top-Spray Fluid Bed
Gary Sackett, M.B.A., B.S.
Vector Corporation

Process and Equipment Considerations of Hot-Melt Granulation
Mark Wojcik, R.Ph., B.S.
Vector Pharmaceutical Service

Hot Melt in a Fluid Bed Processor
John Woods, B.S.
Glatt Air Techniques, Inc.

Extrusion Process
Robert Fortier, B.S., M.S.
AC Compacting

Regulatory Issues for Analytical Sciences

Short Course
Sunday, October 21, 2001
8:30 am - 4:00 pm
ACPE Program Number: 073-999-01-206-L04

This course will provide analytical scientists with a framework and approaches for considerations during analytical development in order to address and manage regulatory requirements. This short course will highlight the scope of analytical work and process for CMC development. The course will focus on requirements and issues related to the general topics of:

• Analytical Methods Development and Validation
• Technology Transfer
• Pre-Approval Inspection (PAI)

Current issues and specific examples related to these topics will be discussed from both analytical laboratory and regulatory perspectives.

The course is directed towards analytical scientists, project coordinators, compliance and regulatory specialists who are charged with the responsibility of analytical methods development and CMC documentation for product registration. This course will also be beneficial to those coordinating and/or reviewing various aspects of CMC analytical development.

Moderator
Rajni B. Patel, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.

Analytical Laboratory Perspective
Rajni B. Patel, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.

Methods Development — Validation and Transfer, Analytical Laboratory Perspective
Terrence Tougas, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.

Current Requirements and Trends, A Drug Regulatory Affairs Perspective
Patricia Watson, M.S.
Boehringer Ingelheim Pharmaceuticals, Inc.

Methods Development — Validation, FDA Perspective
Speaker To Be Announced

Pre-Approval Inspections Requirements and Preparation
Frank Chow, Ph.D.
Lachman Consultant Services, Inc.

Opening Session

Pharmaceutical Sciences: Climbing New Heights
Sunday, October 21, 2001
4:30 pm - 6:30 pm

The Opening Session marks the formal opening to the Annual Meeting and will feature the following:

Opening Remarks
Ronald T. Borchardt, Ph.D.
AAPS President

Keynote Address
Funded by a grant from Magellan Laboratories
Donald P. Francis, M.D., D.Sc.
President and CEO
VaxGen, Inc.

One of the pioneers of AIDS research, Dr. Francis' early efforts to call attention to the AIDS threat were chronicled in the book and movie And The Band Played On.

Incoming President’s Remarks
Diane J. Burgess, Ph.D.
AAPS President-Elect

Executive Director’s Report
John B. Cox
AAPS Executive Director

Presentation/Recognition of Awards

AAPS Distinguished Pharmaceutical Scientist Award
Sponsored by Zeneca Pharmaceuticals Group

AAPS Research Achievement Award in Pharmaceutics and Drug Delivery
Sponsored by G.D. Searle and Company

AAPS Research Achievement Award in Pharmaceutical Technologies
Sponsored by GlaxoSmithKline, Inc.

AAPS Research Achievement Award in Biotechnology
Sponsored by Hoffmann-LaRoche, Inc.

AAPS Research Achievement Award in Clinical Sciences
Sponsored by Axelson Biopharma Research, Inc.

AAPS Meritorious Manuscript Award
Sponsored by Pfizer Central Research

AAPS Outstanding Manuscript Award in Analysis and Pharmaceutical Quality
Sponsored by the Analysis and Pharmaceutical Quality (APQ) Section

AAPS Fellows

AAPS New Investigator Grant in Oral Lipids-Based Drug Delivery Systems
Sponsored by Gattefossé, s.a.

AAPS New Investigator Grant in Pharmaceutics and Pharmaceutical Technologies
Sponsored by Pfizer Central Research

AAPS Postdoctoral Fellow Award
Sponsored by FMC Corporation

AAPS Graduate Symposium in Analysis and Pharmaceutical Quality
Sponsored by Celltech Pharmaceuticals, Inc.

AAPS Graduate Symposium in Biotechnology
Sponsored by Pharmacia Corporation

AAPS Graduate Symposium in Drug Delivery and Pharmaceutical Technology
Sponsored by Procter & Gamble Pharmaceuticals, Inc.

AAPS Graduate Symposium in Pharmacokinetics, Pharmacodynamics and Clinical Sciences
Sponsored by Eli Lilly and Company

AAPS Outstanding Graduate Research Award in Pharmaceutical Technologies
Sponsored by EM Industries

AAPS/AFPE Pre-Doctoral Fellowships

AAPS/AFPE Gateway Undergraduate Research Scholarship

AAPS Welcome Reception

Sponsored by Pfizer Global Research & Development

Special Event
Sunday, October 21, 2001
7:00 pm - 8:00 pm

Meet your peers and see old friends during the Welcome Reception, the social opening to the Annual Meeting and Exposition. The reception will be held at the Adam’s Mark Denver Hotel immediately following the AAPS Opening Session. Bus service will be provided.

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