Steve Litwin, M.D., joined the Biologics Consulting Group, LLC
(BCG) as a senior clinical consultant in October 2003.

Dr. Litwin joined BCG in 2003 after a long and active career in academia, and government.

After full training in Internal Medicine, he developed an independent research program as a faculty member and teacher in several Medical Institutions including Cornell Medical School where he served as a Full Professor. He held research and administrative positions from 1982 to 1991 when he joined the FDA in 1991 as a Senior Medical Reviewer in the Center for Biologic Evaluation and Research, Office of Therapeutics, ( Oncology & Gene, Cell and Tissue therapies Divisions).

In 2003, he retired from FDA after serving for 12 years He has had intensive FDA regulatory, hands-on review experience for numerous INDs, IDEs and BLAs licensure of IL-2 ( for Melanoma), GM-CSF , Bexxar ( NH Lymphoma), CD34+ selection devices, erythropoeitic agents, IL-3 & related lymphokines, monoclonal antibodies and others. His major current consultant activities are in Clinical Oncology, and Cell and Gene therapies relating to:

• clinical regulatory issues in Oncology & Cell therapy
  
• critical review of FDA packages, INDs/ BLAs/NDAs
  
• assistance in formulating drug development plans
  
• assistance in responding to FDA questions and comments
  
• preparing various regulatory application documents, Position Papers, due diligence reviews, etcetera
  
  

View Dr. Litwin's Curriculum Vitae...

Page Updated June 8, 2007