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

Monday

AAPS Plenary Session

Funded by a grant from Yamanouchi Pharma Technologies

Evolution of the Pharmaceutical Sciences: Climbing to New Heights in the 21st Century
Monday, October 22, 2001
8:30 am - 12:00 pm
ACPE Program Number: 073-999-01-073-L04

AAPS is pleased to announce the outstanding plenary session organized for this year's annual meeting. Entitled "Evolution of Pharmaceutical Sciences: Climbing to New Heights in the 21st Century," this session will focus on current and forthcoming state of the art pharmaceutical technologies and their application within the regulatory environment.

The presentations encompass the core sciences that define our great organization. Internationally recognized experts comprise the plenary speaker roster and will provide in-depth and provocative presentations on the direction of our scientific activities.

New technologies continue to challenge our ability to fully turn data produced into useful information, i.e., information that facilitates timely, intelligent decision-making. This session will provide insight into state of the art technologies, the information created by these technologies and the context in which drug development progresses in the ever more sophisticated regulatory environment.

Plenary Speakers Include

Pharmacokinetics-Scaling the Hurdles in Drug Discovery and Development
Malcolm Rowland, Ph.D.
University of Manchester

Meeting the Future Challenges in Drug Delivery-Let the Science Win!
Bob Davis, Ph.D.
University of Nottingham

Pharmaceutical Macromolecular Systems: Does Size Really Matter?
Russell Middaugh, Ph.D.
University of Kansas

Regulatory Oversight, Interactions and Boundaries
Timothy Franson, M.D.
Eli Lilly and Company

Analysis and Pharmaceutical Quality of Biotechnology Derived Products: From Development to Production

Funded by a grant from PerkinElmer

Symposium
Monday, October 22, 2001
1:30 pm - 5:00 pm
ACPE Program Number: 073-999-01-210-L04

From the food we eat to unraveling the human genome, biotechnology has become an integral part of our everyday life. The biotechnology industry has produced over 100 new medicines and there are hundreds more in development. Furthermore, through the use of comparability protocols, common technical documentation and revisions to the existing regulations, "biogeneric" drug products may be entering the market soon. It is critical that the harmonized analytical methods used to test biologics and drug products are valid and provide assurances of the drugs' safety, efficacy, purity and quality. As with traditional drug development, the physical and chemical properties of the biotechnology-derived active components and finished products need to be established. Most biotechnology-derived products utilize chromatographic and spectroscopic techniques to qualify and quantify the specifications for identity, purity, potency, stability, biological integrity, processing and production of the biological active and finished product. This symposium will discuss current analytical and bioanalytical techniques for the analysis and quality considerations of biotechnology-derived products in the laboratory and production settings.

Moderators
Robert G. Bell, Ph.D.
Barr Laboratories, Inc.

Siddharth J. Advant, Ph.D.
Covance Biotechnology Services, Inc.

Cell Bank Characterization of Biotechnology-Derived Products
Eric J. Dadey, Ph.D.
Atrix Laboratories, Inc.

Analytical Considerations in Evaluating the Comparability of a Biotechnology-Derived Protein Pharmaceutical in a Multisource Situation
Vytautas Naktinis, Ph.D.
Biotechna UAB & Institute of Biotechnology, Lithuania

Analytical Potential for Chip-Based Devices Coupled with Mass Spectrometry in Biotechnology
Jack Henion, Ph.D.
Advion BioSciences, Inc. and Cornell University

Stability Considerations for Biotechnology Products
Siddharth J. Advant, Ph.D.
Covance Biotechnology Services, Inc.

Harmonization of Pharmacopeial Biotechnology Products Testing
Roger Dabbah, Ph.D.
United States Pharmacopeia

BCS Extensions: Use of In Vitro Dissolution Methods to Support Waiver Requests for BCS Class I (Veterinary) and Class II and III (Veterinary and Human) Compounds

Symposium
Monday, October 22, 2001
1:30 pm - 5:00 pm
ACPE Program Number: 073-999-01-211-L04

The Biopharmaceutics Classification System (BCS) has proven to be an invaluable tool in product development and regulation. Through the identification of drug attributes (solubility and permeability) and the in vitro dissolution characterization, there now exists a mechanism for identifying the rate limiting steps in drug absorption and for predicting the impact of formulation and physiological variables on product bioavailability. Currently, these methods are used to support biowaivers for immediate release oral dosage forms containing Class I compounds (high solubility, high permeability). Additional proposals are being forwarded to extend BCS-based biowaivers to Class II and III compounds. The predictive strengths of these concepts are further challenged by attempts to apply these methods to non-human mammalian species, where inherent differences in diet, anatomy and gastrointestinal physiology can markedly affect product dissolution and drug absorption processes. This overarching symposium will address the appropriateness of these extensions in both veterinary and human drug regulation. Topics to be explored include the physiological and formulation variables that can impact drug absorption across mammalian species, the challenges associated with extending BCS concepts to Class II (low solubility, high permeability) and Class III (high solubility, low permeability) compounds (human and veterinary), and the establishment of prognostic in vitro methods to support these BCS extensions. As we consider evidence in support of these proposals, we also provide an opportunity to explore alternative perspectives that favor traditional conservative approaches for assuring product quality performance.

Moderator
Gordon L. Amidon, Ph.D.
University of Michigan

BCS Applications in Veterinary Medicine: A Regulatory Science Perspective
Marilyn N. Martinez, Ph.D.
Food and Drug Administration

Current Regulatory Applications of BCS and Challenges for Further Extensions of BCS-Based Biowaivers
Ajaz S. Hussain, Ph.D.
Food and Drug Administration

The Impact of Comparative Physiology on Application of the BCS
Jim E. Riviere, D.V.M., Ph.D.
North Carolina State University

Establishing In Vitro Dissolution Specifications for Class II and III Compounds
Larry L. Augsburger, Ph.D.
University of Maryland

BCS-Based Biowaivers: Are There Failures?
Val Harding, B.Pharm, Ph.D.
Pfizer Global Research and Development

Drug Delivery Devices for Biotechnology

Symposium
Monday, October 22, 2001
1:30 pm - 5:00 pm
ACPE Program Number: 073-999-01-212-L04

Interest in the field of drug delivery has spawned an entire industry focused on designing and developing newer and better methods of delivering drugs. As we move into an era of complex biological therapies, there is a need for innovative technologies that allow for targeting and tracking of delivery of drugs to a particular site in the body, offer alternatives to the injectable route, and opportunities to use agents that otherwise could not be administered.

Moderator
Deepa Deshpande, Ph.D.
Aradigm Corporation

What Can Pulmonary Delivery Devices Do for Your Macromolecule?
Igor Gonda, Ph.D.
Aradigm Corporation

Delivering Drugs and Genes by Pulsed Electric Fields — Applications in Cancer and Cardiovascular Disease
Sukhendu Dev, Ph.D.
Genetronics Biomedical Ltd.

Mapping Gastrointestinal Absorption via Remote Control Capsules and Gamma Scintigraphy as an Imaging Modality
Erik P. Sandefer, Ph.D.
Scintipharma, Inc.

Non-Invasive Opthalmic Drug Delivery
Steve Hamilton, B.S.
Iomed

Powderject Pharmaceuticals
Speaker To Be Announced

Emerging Pharmaceutics Strategies for More Efficient Drug Candidate Identification

Funded by a grant from Elan

Symposium
Monday, October 22, 2001
1:30 pm - 5:00 pm
ACPE Program Number: 073-999-01-213-L04

As drug discovery strategies have evolved in recent years, there has been a tremendous increase in the demand for early optimization of compound pharmacokinetics, physicochemical properties, and formulation. To meet these demands, there has been increased use of in vitro ADME studies, higher throughput pharmacokinetic studies, and simplified formulation approaches. This symposium will demonstrate how pharmaceutics studies have been useful in improving the efficiency of the drug discovery process and allowing the more rapid initiation of clinical trials.

Moderator
Michael B. Maurin, Ph.D.
DuPont Pharmaceuticals Company

Oral Absorption Models
Doo-Man Oh, Ph.D.
Pfizer, Inc.

Evaluation of Physical Chemical Properties
Alex Avdeef, Ph.D.
pION, Inc.

In Vitro Metabolism and Clearance Profiling
Bradley K. Wong, Ph.D.
Merck and Company Laboratories

Cassette Dosing Pharmacokinetics: Higher Throughput Screening In Vivo
David D. Christ, Ph.D.
DuPont Pharmaceuticals Company

Minimizing Time and Drug Substance Requirements for Phase I Studies
Alan F. Parr, Pharm.D., Ph.D.
GlaxoSmithKline, Inc.

Genomics: Impact on Drug Discovery and Marketing in the New Millennium

Symposium
Monday, October 22, 2001
1:30 pm - 5:00 pm
ACPE Program Number: 073-999-01-214-L04

Completion of the Human Genome Project will be a significant milestone in the understanding of cellular biology, predisposition to disease, drug discovery and marketing, and the way patients will be treated. For the pharmaceutical sciences, pharmacogenomics opens new frontiers to the understanding of drug response variations based on a population's genetic make-up. This symposium will provide an overview of the emerging field of pharmacogenomics and its impact on drug discovery and marketing.

Moderator
Prasanna R. Gore, Ph.D.
Gore & Company, a Division of PharmaCompany, Inc.

Genomics, SNPs, and Their Impact on Drug Discovery in the New Millennium
Arthur Holden, M.B.A.
The SNPs Consortium

Genomics, Genetics, Proteomics, Biochemical Markers and Their Implications to Drug Discovery
B. Michael Silber, Ph.D.
Pfizer Global Research and Development

How Will Pharmacogenomics Be Translated into Therapeutic Advances and Market Success?
William Wardell, M.D., Ph.D.
Wardell Associates International

Exploring the Post-Genome Marketplace: Focus on Pharmacogenetics
Craig Fitzgerald, Ph.D.
GlaxoSmithKline, Inc.

PK/PD Issues in the Elderly

Symposium
Monday, October 22, 2001
1:30 pm - 5:00 pm
ACPE Program Number: 073-999-01-216-L04

With the elderly becoming an increasing percentage of the population and also the group consuming, as individuals, the highest number of drugs, it seemed appropriate to look at the latest research in this field. Attendees will be introduced to the Baltimore Longitudinal Study on Aging which has been running since 1958 and will then learn about the effects of aging on PK and PD. The symposium will conclude with a regulatory perspective from the FDA on the design and conduct of clinical studies in the elderly. The speakers are at the top of their respective fields and will contribute towards making this a very interesting and stimulating symposium.

Moderators
Brian Davies, CBiol, FIBiol
Advanced Biomedical Research, Inc.

Dyal Garg, Ph.D.
Clinical Research Services, Inc.

Physiological Changes Associated with Aging
Jerome Fleg, M.D.
Baltimore Longitudinal Study on Aging, National Institutes of Health

Pharmacokinetics in the Elderly
Michael Mayersohn, Ph.D.
University of Arizona

Pharmacodynamics in the Elderly
Hartmut Derendorf, Ph.D.
University of Florida

Unresolved Areas of Current Research/Pharmacogenetics
David Greenblatt, M.D.
Tufts University School of Medicine

Age-Related Changes in Exposure-Response Relationships in the Elderly: A Regulatory Perspective on Impact on Dose and Dosing Regimens
Chandrahas G. Sahajwalla, Ph.D.
Food and Drug Administration

Recent Developments in Salt Screening, Characterization and Selection

Symposium
Monday, October 22, 2001
1:30 pm - 5:00 pm
ACPE Program Number: 073-999-01-217-L04

Salts are usually considered alternatives when the physicochemical characteristics of the parent drug molecules are unsuitable or inadequate for satisfactory formulations. Considerable variation in solubility, dissolution rate, bioavailability and other pharmaceutically important properties can result from the association of the drug with different salt forming counterions. Furthermore, because of lack of predictive relationships between the physicochemical properties of the resultant salts, the selection of an appropriate salt form with desired combination of properties, can be a difficult semi-empirical choice.

This symposium, organized by the AAPS Preformulation Focus Group, will provide recent developments in salt screening, characterization and selection. Possible strategies for addressing the impact of salt form on key decision making in various phases of drug discovery and development will also be discussed.

Moderators
Jim Zhu, Ph.D.
GlaxoSmithKline, Inc.

N. Murti Vemuri, Ph.D.
Aventis Pharmaceuticals

Application of Fundamental Physicochemical Principles in Understanding Pharmaceutical Salt Properties
Bradley D. Anderson, Ph.D.
University of Kentucky

Principles of Form Selection for Acids and Bases vs. Their Salts
Joseph B. Bogardus, Ph.D.
Bristol-Myers Squibb Pharmaceutical Research Institute

Pharmaceutical Salt Formation — Panacea or Just a Different Set of Problems?
Michael Bowker, Ph.D.
M.J. Bowker Consulting Ltd., United Kingdom

Effects of Drug-Substance Salt Form on Chemical Stability and Manufacturability of Solid Dosage Formulations
Scott W. Smith, Ph.D.
Pfizer Global Research and Development

Prediction of Optimal Salt Forms — From Blind Date to Dating Agency
Robert T. Forbes, Ph.D.
University of Bradford, United Kingdom

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