Rob Lindberg, Ph.D., R.A.C., is the Center's BATON Director. He holds a Ph.D. in Physiology and Biophysics. His specialty is microvascular physiology, with emphasis in endothelial function in inflammation, thrombosis and cancer.
Full Biography.
Drug Development and Regulatory Approval: A Primer
Editor's Note: The following is one of a series of columns by Rob Lindberg, Ph.D. Rob directs the Center's Business Acceleration and Technology Out-licensing Network (BATON) program, designed to link university technologies with necessary commercialization resources in the community.
In this and his previous position as the Technology Development Director, Rob has gained an understanding of what it takes to move a biotechnology product from the mind to the marketplace. He shares his insights here.
Thanks to Dr. Ted Murphy of BioMarck Pharmaceuticals for his editorial help with this primer.
The commercial development of most biotechnology products is subject to extensive regulation by U.S. and international authorities. In the U.S., these agencies include (but are not limited) the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). A primary interest of these agencies is to assure the safety and efficacy of new products for the public. Development, manufacturing and use of biotechnology products in a manner compliant with federal regulations often represent the greatest financing challenges to biotechnology companies.
The FDA regulates pharmaceutical and biological therapeutics, diagnostic and reagent products, medical devices, radiologic imaging devices, foods, cosmetics, etc. The primary concern of the FDA is public safety, although it also protects the public from inaccurate or overstated claims of benefit or effect.
In our world, the primary divisions of the FDA, and their acronyms, are:
- Center for Drug Evaluation and Research (CDER) - regulates pharmaceutical drugs and now-common biological products (e.g., therapeutic monoclonal antibodies).
- Center for Biologics Evaluation and Research (CBER) - regulates biological therapeutics (e.g., vaccines, blood products, and gene therapies).
- Center for Devices and Radiologic Health (CDRH) - regulates medical devices, in vitro and imaging diagnostics, medical imaging technologies, radiation-emitting tracers, etc.
The types of drugs that these divisions regulate fall into six areas. They are:
- Pharmaceutical Drugs - synthetic small molecule compounds, easily identified and characterized
- Generic Drugs - identical, or bioequivalent, to a brand name drug
- Biological Drugs - complex mixtures that are not easily fully identified or fully characterized
- Orphan Drugs - Pharmaceutical and biological products that target diseases that affect less than 200,000 patients
- Medical Devices and Diagnostics
- Combination Products - products with two or more drug, biologic or device components
(Select one of the areas above or start with Pharmaceutical Drugs.)