Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Barbara J. Potts, Ph.D. joined the Biologics Consulting Group, Inc. as a Senior Consultant in November, 2009.

Barbara has 28 years experience in the science , compliance and business aspects of the control of adventitious agents (TSE, viruses, mycoplasma) in the bio pharmaceutical,  HIV vaccine and immuno therapy, xenotransplantation and cell therapies industries  This experience was gained at the University of California, School of Medicine, San Francisco, the NICDS/NIH, NIAID/NIH, University of MN School of Veterinary Medicine, two contract testing companies and three biotechnology companies. She is an experimental pathologist with a specialty in virology and has experience from product R&D to IND and BLA acceptance. She has interacted with regulatory agencies, biotechnology companies, Veterinary, Medical, animal owner communities (raw material sources) and recently with the manufacturing diagnostic industry on the development of a commercial PCR kit for the detection of mycoplasma in GMP lot release testing. She was a leader in the acceptance of a touchdown PCR assay for the detection of mycoplasma by regulatory agencies in the USA and Europe. Her specialties include the development and successful implementation of policy’s for the control of CHO cell banking, adventitious agents and parvovirus cross contamination, TSE , raw material review, and safety practices in a BSL2 environment. Her specialty also includes her ability to effectively communicate this information to multiple audiences including senior management (CEO, COO,CFO), Engineers and Manufacturing , Process Development , Regulatory  and Quality staff so that  appropriate risk evaluation can be done  at each level of a business.
As the Director of Quality Control Biology and Raw Materials at Genentech, Inc  Barbara directed scientific and compliance activities for microbiology, raw materials, virology, mycoplasma, potency ,environmental monitoring, cell bank testing for adventitious agents, nucleic acid methods and method development in molecular biology.

Her  responsibilities as Director and Principal Scientist of Virology at Genentech, Inc. included serving as the Project Team Leader for the BSE Task Force providing updates and strategic planning to Senior Management for presentation to Genentech’s Executive Committee and Board of Directors. Additional responsibilities included developing Quality/Regulatory strategies in the field of virology and new technologies for the detection of mycoplasma. She was also responsible for providing technical review for IND and BLA/CTD submissions, discrepancy reports and responses to regulatory questions on virology, TSE and mycoplasma issues and a member of the risk assessment steering committee.
As the Director of Excellence in Xenodiagnostics at the University of MN school of Veterinary Medicine , Barbara’s responsibilities were to administer and coordinate xenodiagnostic-related research and service functions of the center and at ViroMed a contract testing company.  She interacted with regulatory agencies, the biotechnology industry, and veterinary, medical and animal owner communities and developed a basic research program in swine infectious disease and risk assessment of xenozoonotic agents.

She developed peptide-based ELISA and Taqman PCR assays for the detection of circovirus, porcine CMV, and swine HEV.

As Director of Retrovirology at Charles River/Tektagen Barbara established and directed the  Human Retrovirology contract services program, including research, development, assay development, and validation studies under cGMP/GLP guidelines. She developed study plans, directed research, and prepared  GMP/GLP reports for inclusion in IND applications. She worked with multiple biopharmaceutical firms as a consultant in Human Retroviral Studies , Cell Therapies and Xenotransplantation and participated with a Xenotransplantation firm with pre IND meetings with the FDA.

As a Director of Virology at United Biomedical Inc.. Barbara established and directed the  Human Retrovirology program for development of an HIV-1 vaccine and immune-based therapy. She participated in the filing of the IND, pre IND meeting with the FDA and phase I clinical trial in China.

As a Research scientist and Principal Scientist at Repligen Corp. Barbara directed a human and simian retrovirology program for basic research leading to the development of an HIV-1 vaccine and of humanized mouse monoclonals for therapeutic use. Multiple HIV antibody detection methods were developed using ELISA, Vaccinia expressing HIV-1 proteins and HIV-1 replication assays.

During Barbara’s years at the NIH she served as a Staff Fellow in the NICDS/NIH and then as a Senior Staff Fellow in the NIAID/NIH working on basic research on the pathogenesis of pestiviruses in the central nervous system of sheep and humans. She also conducted independent research on the mechanism of stem cell destruction by HIV-1 and HIV-2 in human bone marrow and  in monocytes. She worked with the HIV-1 positive community in the evaluation of a rapid test kit for HIV-1.

Barbara received her Ph.D. in Experimental Pathology School of Medicine  from the University of CA , San Francisco in 1981. Her research laboratory and dissertation sponsor were in the Department of Neurology (Neurovirology lab) and her research animal was sheep thus she also worked in the Department of Pathology at the School of Veterinary Medicine in Davis CA.

Barbara has served on many NIAID/NIH grant reviews including on the AIDS and related research study section member and HIV/AIDS clinical trials network. She chairs the PDA Mycoplasma Task Force that works on the science, compliance and business aspects of the control of mycoplasma in the bio pharmaceutical industry. She is a member of the Biotechnology Advisory Board for the PDA   that governs the Task Force activities in the bio technology field. This board also reviews FDA, EMEA and WHO draft documents. Barbara is also a member of the PDA Cell Substrate Task Force. She has published 41 papers, and has three HIV-1 related patents.

View Dr. Potts' Curriculum Vitae...

Page Updated April 13, 2010