4th Symposium on the Analysis of Well Characterized Biotechnology
Pharmaceuticals
Co-sponsored by the California Separation Science Society and the US Food
and Drug Administration
January 9 - 12, 2000
The Palace Hotel, San Francisco, CA, USA
The WCBP series is recognized as the preeminent conference addressing the
analytical development/regulatory control interface for biotechnology
derived health intervention products. The Program Committee has created
another outstanding scientific program. The program consists of invited
lectures, submitted abstracts and posters, interactive workshop
discussions, and panel discussions, all preceded by the Sunday afternoon
training session. Please browse the preliminary program at
http://www.casss.org/wcbp. Abstracts for each of the lectures, the panel
discussion and the training session are included on the Web site, as well
as most of the workshop discussion session descriptions. Participants are
encourage to email the workshop co-leaders prior to the meeting to express
ideas, raise questions and begin the interaction. Sponsors, exhibitors and
vendor seminars will be updated as information becomes available.
December 3, 1999 is the deadline for submission of "late-breaking"
abstracts for consideration for oral presentation, poster abstracts for
inclusion in the final program and to receive the early registration discount.
Sunday, January 9, 2000
12:00-18:00 Registration
13:00-17:00
Complimentary Training Session
Chair: Thomas Layloff, CDER, FDA
FDA Inspections of Biologic Products - Responsibilities, Adverse Findings
and 483 Observations
John D. Finkbohner, Ph.D., Chemist, FDA/CBER/Division of Manufacturing and
Product Quality
Philip Lindeman, Compliance Officer, Team Biologics, FDA/ORA/Division of
Compliance Management and Operations
FDA Team Biologics Field Inspections-Case Studies
Bruce Mackler, Heller Ehrman
Frank Matarrese, Chiron Corporation
Glen Wright, Eli Lilly & Company
15:00 Break
17:00 Welcome Reception
Monday, January 10
7:00-18:00 Registration
8:00 Continental Breakfast & Exhibits
9:00 Regulatory Issues Plenary Session
Session Chairs: Michael Kunitani and Thomas Layloff
Welcome & Introductory Comments, Michael Kunitani
Biotechnology Pharmaceuticals 2000, Kathryn Zoon, CBER, FDA
FDA Pacific Region Initiatives on the Biotechnology Industry, Richard
Baldwin, Pacific Region FDA
An Update of ICH Activities on Quality, Yuan-Yuan Chiu, CDER, FDA, Rockville
10:20 Coffee Break & Exhibits
10:45-12:00 Panel discussion
Moderator: Kenneth Seamon, Immunex Corporation
When Are "Equivalent " Biotechnology Pharmaceuticals Possible?
Yuan-Yuan Chiu, CDER, FDA
Greg Davis, Eli Lilly & Company
Bruce Mackler, Heller Ehrman
Anthony Ridgway, Bureau of Biologics & Radiopharmaceuticals
Robert Zeid, TLI Development
12:00-13:10 Lunch Break
13:10 Poster Session #1
14:25 Workshop Session 1
* Pharmaceutical and Bio-Equivalence for Approved Products: How Much
Clinical Testing is Needed? Duu-Gong Wu, CDER, FDA and James Green, Biogen
Inc.
* The Art of Setting Specifications, William Egan, CBER, FDA and John
Hennessey, Jr., Merck & Co. Inc
* Validation of In-Vitro Potency Assays, Gerald Feldman, CBER, FDA and
Venkat Mukku, Amgen
* Characterization of Glycoproteins, Niels Kristian Klausen, Novo Nordisk
A/S and Willie Vann, CBER, FDA
15:40 Coffee Break & Exhibits
16:05 Gene Delivery Plenary Session
Session Chairs: John O'Connor, Michael Washabaugh
Physical Analysis of Nonviral Gene Delivery Vehicles, Russ Middaugh,
University of Kansas
Purification and Characterization of Therapeutic Plasmids, Joachim Schorr,
Qiagen, Germany
Structural Characterization of Gene Delivery Viruses by Cryo-EM, Phoebe
Stewart, UCLA
17:40-19:00 Reception
Tuesday, January 11
8:00-18:00 Registration, Continental Breakfast & Exhibits
9:00 Bioanalytical Separations Plenary Session
Session Chairs: Daan Crommelin, Robert Cunico
Recent Developments in HPLC Supports for Biopolymer Separations, Ronald
Majors, Agilent Technologies, Inc.
Biopolymer Separations in Microfluidic Devices, Aran Paulus, Norvartis
Institute for Functional Genomics
Characterization of Complex Biological Systems Using Field-Flow
Fractionation, Marcia Hansen, FFFractionation
10:20 Coffee Break & Exhibits
10:45 Workshop Session 2
* Streamlining the Development of Second Generation Molecules, William
Berlin, CDER, FDA and Inger Mollerup, Novo Nordisk A/S
* Characterization of Protein Conformation, Daron Freedberg, CBER, FDA and
Wayne Gombothz, Immunex Corporation
* Recombinant Vaccines as WCBP's? Hira Nakhasi, CBER and Robert Sitrin,
Merck & Co., Inc.
* Analytical Challenges in Manufacturing Therapeutic Agents in Transgenic
Animals and Plants, Scott Fulton, Genzyme Transgenics Corporation and
Li-Shan Hsieh, CDER, FDA
12:00-13:10 Lunch Break
13:10 Poster Session #2
14:25 Standards in Biotechnology Plenary Session
Session Chairs: Nga Nguyen, Elizabeth Fowler
USP Initiatives in Biotechnology and Biologic Standard Setting, Gene
Murano, United States Pharmacopeia
NIST Traceable Standards for Biotechnology, Dennis Reeder, NIST
15:15 Coffee Break & Exhibits
15:40 Workshop Session 3
* Are Public Standards for Biotechnology Products Useful?, Neil Goldman,
CBER, FDA and Gene Murano, United States Pharmacopeia
* Process Changes, Process Validation and Comparability Protocols, Stephen
Moore, CDER, FDA and Marge Winkler, Genentech, Inc.
* Validation of MALDI-TOF Methods for Macromolecular Identification,
Timothy Hayes, Bayer Corporation and Robin Mhatre, Biogen, Inc.
* Can a Single Viral Validation Study be Applied for Multiple Products
Derived from the Same Cell Line?, Rebecca Sheets, CBER, FDA and Yuan Xu,
Genentech, Inc.
17:00 Vendor Seminars
Microcalorimetric Methods for Characterizing Biotechnology Pharmaceuticals,
MicroCal Inc.
New Tools for the Assessment of Nucleic Acid Sample Quality, Agilent
Technologies
Promega Corporation
18:00-19:00 Reception
19:00-22:00 Symposium Banquet
Wednesday, January 12
8:00-17:00 Registration, Continental Breakfast
9:00 Emerging Technologies Plenary Session
Session Chairs: Bill Hancock, Edward Yeung
Accelerator Mass Spectrometry-An Ultra Sensitive Analytical Tool to Improve
Biologics Discovery and Development Programmes, Colin Garner, CBAMS, UK
High Throughput Identification and Characterization of Proteins by
MALDI-TOF MS and MS-MS, Marvin Vestal, PE Biosystems
New Applications for Real Time Quantitative PCR, Russell Higuchi, Roche
Molecular Biosystems
10:25 Coffee Break
10:50 Formulation Plenary Session
Session Chairs: Vince Anicetti, Davendra Kalonia
Stabilization of Proteins by Freeze Drying, Michael Pikal, University of
Connecticut
Aerosol Delivery of Protein, Peptide and Gene Therapeutics, Igor Gonda,
Aradigm Corporation
11:50-13:00 Lunch Break
13:00Poster Session #3
14:15 Workshop Session 4
* Characterization in Alternate Delivery Systems: Microencapsulation and
Inhalation Products, Mike Eldon, Inhale Therapeutics, Inc. and Dale Koble,
CDER, FDA
* Immunogenicity of Recombinant Proteins, Jim Fernandez, Berlex Biosciences
and Kathryn Stein, CBER, FDA
* System Suitability Parameters for Protein HPLC, Robert Hageman, Chiron
Corporation and Blair Fraser, CBER, FDA
* Identification and Control of Deamidation and Isoaspartic Acid Formation,
Reed Harris, Genentech, Inc. and Anita Hong, Anaspec, Inc.
15:30 Coffee Break
15:55 Late Breaking Plenary Session
Chairs: Maureen Costello, Linda Geier
Characterization of Immunomodulating Protein-Oligonucleotide Conjugates,
Roberto Rodriguez, Dynavax Technologies Corporation
ABSTRACTS RECEIVED BY DECEMBER 3 WILL BE CONSIDERED FOR THIS SESSION
16:55-17:00 Closing and Invitation to next WCBP, Michael Kunitani
Please note our address and telephone numbers as of April, 1999:
--------------------------------------------
Joan Oefner, Executive Director
California Separation Science Society
156 South Spruce Ave., Suite 207A
South San Francisco, CA 94080-4556
Tel: 1-650-876-0792
FAX: 1-650-876-0793
Website: http://www.casss.org
E-mail: info@casss.org