Kelehan, Kevin J

Jur Strobos brings a diverse background in pharmaceutical company management, food and drug law, medical product development, and health care to OFW Law.  After law school, a federal court clerkship, and an associate position at a large national law firm, Jur received an appointment to the Food and Drug Administration where he worked closely with Commissioner Kessler on regulatory policies.  His prior medical background and four years of residency training in general surgery allowed him to engage in policy development across the broad array of FDA activities from foods to devices to drugs and biological products.  He has subsequently served as research and FDA regulatory counsel to five start-up pharmaceutical companies and as an executive with Medicis Pharmaceuticals to establish a clinical research and regulatory department to permit downstream acquisitions.

AREAS OF EXPERTISE

Food and Drug Law
Clinical Study Design
Good Manufacturing Practices
HACCP
REMS

KEY CLIENTS

Pharmaceutical, device, and food manufacturing companies

SIGNIFICANT REPRESENTATIONS

Successfully limited FDA device reclassification proposals.
Obtained reduced clinical data requirements.
Obtained six month expedited approval of new drug product.

AWARDS AND RECOGNITION

PHS Special Recognition Award
FDA Award of Merit
Two Commissioner Special Citations
FDA Group Recognition Award

MAJOR PEER-REVIEWED PUBLICATIONS

Senior Author, Adverse Outcome Analyses of Observational Data: Assessing Cardiovascular Risk in HIV. 
Clinical Infectious Diseases 2011; doi: 10.1093/cid/cir829

Senior Author, Global Pharmacovigilance for Antiretroviral Drugs: Overcoming Contrasting Priorities. PLoS. 2010

Co-Author, Immunogenicity Studies of Cosmetically-Administered Non-Animal Stabilized Hyaluronic Acid (NASHA) Particles. Dermatolog Surg 2007.

Senior Author, Sodium Ferric Gluconate Complex In Sucrose is Safe and Effective In Hemodialysis Patients: North American Clinical Trial. Am J Kidney Dis 1999.

EDUCATION

J.D., University of Pennsylvania, 1987

M.D., University of Chicago, 1978

B.A., cum laude, Johns Hopkins University, 1974

Board Certification, Emergency Medicine, 1996

ADMITTED TO PRACTICE

Washington, D.C.
California