AAPS San Diego Pharmaceutical Forum

Officers:

Introduction to SDPF:

The AAPS-San Diego Pharmaceutical Forum (AAPS-SDPF) is a local discussion group and an affiliate of the American Association of Pharmaceutical Scientists. The group was founded in April 1996 with the sole purpose of promoting scientific exchange between members within San Diego's pharmaceutical and biotech community. The forum has typically drawn 100-150 scientists per seminar. Seminars are held on average, every other month.

Anyone can become a member of the SDPF at no charge, however, members are strongly encouraged to join the AAPS. Participation in the SDPF seminars, meetings, and discussions are open to all parties interested in the Pharmaceutical Sciences and Biotechnology.

Specific topics and locations will be published in advanced at this website and on the flyers mailed (or e-mailed) to those persons whose names appear on the mailing list maintained by the SDPF.

Upcoming Events:

Thursday, April 27, 2000
from 6:00pm - 8:00pm at Dura Pharmaceuticals (directions below).
(Refreshments will be served at 6:00pm)

Topic: "Expediting the Transition from Research/Discover to Development by Maximizing Developability"

Abstract - When research/discovery efforts are promising, rapid progress requires a substantial investment in time, personnel and capital resources, regardless if the business objective is to out-license the technology or molecule to "Big Pharma" or to map out the process all the way to a BLA/NDA. In either case, management typically emphasizes the completion of Proof-of-Principle or evidence of therapeutic effectiveness studies but with the absolute minimum tox and CMC program. However, this investment can be wasted when promising compounds are delayed in development or killed altogether. Most often, the elevation of a lead compound to a clinical candidate is based predominantly on in-vitro or animal potency. Most often, failure of compounds to realize commercial or out-license success are predominantly due to poor "developability" and can be most often traced to poor biopharmaceutical properties.

The featured speaker will be: David F. Bernstein, Ph.D. of Cato Research

David Bernstein earned MS and Ph.D. degrees in Pharmaceutical Chemistry from the University of Michigan and a BS in Pharmacy from Columbia University. He has 24 years of industrial experience developing solid, topical and parenteral dosage forms for prescription and OTC firms and for a generic drug manufacturer. He has coupled his product development knowledge with the CMC regulatory requirements for NDA, OTC and ANDA products. Dr. Bernstein was the principle scientist for developing Oil of Olay, Clearasil and Oxy-5 consumer products and has authored the CMC sections for over 60 IND's, NDA's and ANDA's. At Cato Research, Dr. Bernstein is a regulatory and technical consultant to several biotechnology and pharmaceutical companies and provides guidance in conceptual and implementation strategy and tactics for expediting the drug development process through integrating pre-clinical formulation efforts, preparation of investigational drug supplies and scale up to commercialization activities with the clinical development plan. He conducts GLP/GMP audits and has prepared over 12 companies for PAI audits.

Please RSVP by return email (by Monday, April 24th) to David Evitts at: dpe@fda.net

Sponsored by: MFIC, Corporation (https://www.microfluidics.com) and Perry Scientific (https://www.perryscientific.com)

Directions to Dura Pharmaceuticals:
Interstate 805 to Vista Sorrento Parkway/Mira Mesa Exit. Vista Sorrento Parkway to Lusk Boulevard (right turn). First left on Lusk into Dura Pharmaceuticals (across from Wateridge & Stellcom). AAPS/SDPF meeting will take place in the cafeteria, the second building on left. For other directions, call: (858) 457-2553

NOTE: SPECIFIC SEMINAR TOPICS, LOCATIONS AND DATES WILL BE PUBLISHED IN ADVANCE AT THE AAPS/SDPF WEB SITE: https://www.aaps.org/disc/sandiego.html

Past Meetings