Summary of 2005 ACPA Regional Conference on Biopharmaceutical Comparability

The 2005 ACPA Regional Conference on Biopharmaceutical Comparability was held on October 1, 2005 at the University of Maryland Shady Grove Center in Rockville, Maryland. The event was sponsored by four organizations, including ACPA; Centocor R&D, Inc.; CAAJJ; and GloboAsia. The conference started with opening remarks from the 2005 ACPA President, Dr. Keith Chan, and the conference program chair, Dr. Haishan Jang. Four speakers presented at the event. They represented major pharmaceutical associations, various international pharmaceutical companies, or consulting firms and were respected entrepreneurs in the biopharmaceutical industry. The topics, presentation titles, and presenters were as follows:

• Regulatory

Duu Gong Wu, Ph.D.

"Regulatory and Scientific Perspectives on Biopharmaceutical Comparability and Follow-on Biologics"

• Pharmacokinetics/Pharmacodynamics

Charles Pendley, Ph.D.

"Challenges of Demonstrating Biocomparability of Therapeutic Antibodies in Nonhuman Primates"

• Pharmaceutical Development

Fredric G. Bader, Ph.D.

"Demonstrating Comparability for Biotechnology Products, Issues and Challenges in a Global Environment"

• Toxicology

David J. Pepperl, Ph.D.

" Nonclinical Toxicity and Immunogenicity Testing:  Key issues facing Developers of Biogeneric Products"

An excellent lunch was served at the conference, and participants were able to enjoy authentic Chinese cuisine while interacting with their peers. Positive feedback was obtained from the participants after the event. Colleagues enjoyed the open forum of communication that the conference had provided and found the sessions very enjoyable and informative. Dr. Haishan Jang stated, "I was very excited about our program this year, as it provided everyone an opportunity to discuss significant scientific issues impacting the biotechnology community, and I am pleased that everyone had found this memorable experience."

Please click here to access pictures or here to access slide presentations from the meeting.

ACPA-CACS Joint Conference

ACPA held a joint regional conference with the Chinese American Chemical Society (CACS) on a highly practical and demanding topic: "Mass Spectrometry in Biomedical Research and Drug Discovery." The conference was held on September 30, 2005 at the Clarion Hotel & Towers in Edison, New Jersey. There were approximately 120 attendees from pharmaceutical industry. The presentations were well received, and the ensuing discussions were very enthusiastic. The presentation titles (speakers) were as follows:

(1) Bioanalytical Challenges in the Use of Deuterium and Oxygen-18 Labeled Compounds in Drug Metabolism Studies ( Bogdan Matuszewski , Merck) ;

(2) Successful Strategies for Discovery ADME-PK Studies (Wa lter Korfmacher, Schering-Plough);

(3) New Developments on the QSTAR XL LC/MS/MS System for Metabolomics and MALDI Imaging (Julie Wingate, Applied Biosystems);

(4) Maximizing the Power of LC-Tandem Mass spectrometry: UPLC-Quattro Premier Applications in DMPK (Kate Yu, Waters);

(5) LC-MS/MS in the Drug Discovery and Development Process (Timothy Olah, Bristol-Myers Squibb);

(6) ADME Concerns Addressed with LC-MS (Cornelius E.C.A. Hop, Pfizer);

(7) Simultaneous Quantitation of Parent Compounds and Screening of Metabolites in Biological Samples Using Qtrap (Wilson Shou, Covance);

(8) New TSQ Quantum; Products and Developments (Rohan Thakur, Thermo Electron);

(9) Quantitation Aspects for LC-MS/MS on State-of-the-Art API Instruments (Yong-Xi Li, XenoBiotic Laboratories, Inc.).

The symposium revealed one key puzzle: With the recent advances in modern instrumentation, why is the pharmaceutical industry not able to find and develop more effective and better new drugs?