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“The
Biogeneric Dilemma – A Global Perspective”
Rob Garnick, Sr. Vice President, Regulatory, Quality and Compliance, Genentech Inc. (bio)
ABSTRACT
Robert L. Garnick, Ph.D. - Robert L. Garnick joined Genentech in 1984 as manager of Quality Control. After a series of promotions in the Quality group, he became vice president of Quality in 1994. In 1997, he was named vice president of Regulatory Affairs. Dr. Garnick was named to his current position as senior vice president of Regulatory, Quality and Compliance in March 2001. In this role, Dr. Garnick is responsible for all the regulated aspects of Genentech's business including drug development, commercial production, and promotional and labeling compliance. For the last 15 years, Dr. Garnick also has been extensively involved with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This project brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration from a global perspective. Prior to Dr. Garnick's employment with Genentech, he was manager of Quality Control at Armour Pharmaceutical Company and section head of analytical development at Merrell National Laboratories. Dr. Garnick holds a Bachelor of Science degree in chemistry from Rutgers University and a doctorate in organic chemistry/natural products from Northeastern University.
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The
Biotechnology Industry after a quarter century of incredible successes
is poised to face the challenge of low cost biogeneric competition.
The need for low cost biogenerics coupled with the patent expiration
of many of the block buster biotechnology products paves the way for
the emergence of a 20-40 billion dollar biogeneric industry.
Nevertheless, there are significant scientific issues that the
legislators, public and regulatory authorities will need to resolve.
Unlike generic copies of small molecule drugs, the regulatory approval
of biogenerics will need to be based on a combination of analytical
characterization, in vitro biological activity measurements and
potentially human clinical trials, in order to answer important public
health questions about efficacy, safety and immunogenicity. This
presentation will describe the regulatory and legal issues facing the
development of biogenerics as well as present some scientific evidence
of the hurdles which must be surmounted. Finally, the role of academic
institutions in helping to solve this dilemma will be explored.
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