experience

Fast-Track Drugs and Biologics, LLC was founded in 2003 in response to the rapid developmental needs for countermeasures to bioterrorism agents. Initially projects involved the development of therapeutics for anthrax (anthrax vaccine), botulism (botulinum antitoxin), and toxic shock (broad spectrum therapeutic). However, our company has expanded our support to include subject matter expertise in medical regulatory and clinical trials management for the National Institute on Drug Abuse, the National Institute of Allergy and Infectious Disease, the National Institute on Alcohol Abuse and Alcoholism, the Defense Threat Reduction Agency, the U.S. Army Medical Materiel Development Activity, and the Centers for Disease Control and Prevention. In addition, Fast-Track has provided product development, strategic regulatory and clinical trial support to a myriad of U.S. based and international biotech and pharmaceutical companies.

• Gene Therapy – adenoviral and retroviral vectors, plasmids, vaccinia
• Recombinant biologically active peptides/proteins
• Cytokines
• Monoclonal antibodies
• Cell Therapy – T cells, LAK cells, gene-modified T cells
• Chemotherapeutic drugs
• Psychoactive drugs
• Anti-depressants
• Vaccines – cell based, protein based, virus based, bacteria components, and adjuvants

• Cancer – bladder, colorectal, lung, pancreatic, breast, lymphoma, melanoma, renal cell carcinoma
• AIDS
• Anthrax
• Plague
• Small Pox
• Staphylococcal Enterotoxic Shock
• Botulism
• Hypercholesterolemia
• Ischemic Cardiovascular Disease
• Alcohol Abuse and Alcoholism
• Cocaine addiction
• Methamphetamine addiction