management

Our professional staff has a high level of expertise in product development, clinical trial development and management, medical writing, regulatory affairs, and government contract procurement and capital investments and partnering. Our experience from product inception through licensure allows us to develop streamlined approaches for program management. We work closely with our clients to provide a flexible approach to fulfill their program support needs. We are ever cognizant of timelines and cost control to keep our projects on time and on budget.

Curricula Vitae for some of our staff are provided below:

  Janet Ransom, PhD, President

President and Co-founder of Fast-Track Drugs and Biologics, Dr. Ransom has over 25 years experience in biomedical research including product inception, research, development, clinical trials, and product licensure. She has managed diverse projects including the development of therapeutic cancer vaccines, therapeutic biological products and drugs to treat carcinomas, genetically engineered T cells for the treatment of AIDS/HIV, antitoxins for the treatment of neurotoxins, biological defense vaccines, medications for the treatment of substance abuse, and cardiovascular disease in vitro diagnostic tests. Depending upon the development phase of these projects, she was involved with the regulatory development strategy, clinical trial design, pre-clinical development plans, and data analysis and reporting to support product licensure. Dr. Ransom has designed and written Phase 1, 2, 3, and 4 clinical protocols to assess the safety and therapeutic effect of numerous biological and chemical agents for the treatment of malignancies. Furthermore, she has analyzed data from multi-institutional clinical trials and written the Clinical Summary Reports of numerous phase 2 and 3 studies according to the ICH Guidelines for inclusion in Biologics License Applications and New Drug Applications. Her clinical trials coordination activities have included the development of a clinical data management system using an Oracle database, electronic data capturing technology, and web-based applications to collect, store, analyze and report pre-clinical and clinical data in support of therapeutic product development for government and pharmaceutical clients. She established systems specifications and implemented system installation, validation, release for production, and system oversight for multiple large multicenter clinical trials enrolling thousands of study participants.

  William Rickman, PhD, Chief Executive Officer

Chief Executive Officer and Co-founder of Fast-Track Drugs and Biologics, Dr. Rickman has over 25 years of clinical research experience involving numerous biological products under various phases of clinical development. Dr. Rickman has prepared a broad range of regulatory documents to support IND applications and NDAs. He is responsible for development, maintenance, and oversight of Fast-Track Quality Systems for clinical investigations, clinical data management, and regulatory document preparation and submission. Dr. Rickman has over 10 years of GMP experience with cell and gene therapy products, vector production, and recombinant protein products (cytokines, growth factors, and monoclonal antibodies) to support drug development efforts in both industry and government funded environments. Dr. Rickman conducts GMP, GLP, and GCP compliance audits, and provides regulatory compliance guidance to clients throughout the drug development process. Over his 25 year career, Dr. Rickman has provided professional leadership in research programs with the U. S. Army, pharmaceutical, biotech, and contract research communities. He has received extensive clinical training in laboratory medicine, immunology, transplant immunology, immunohematology, virology, oncology, and infectious diseases. Dr. Rickman is an active member of RAPS and received his PhD in Microbiology from Michigan State University in 1981.

  Jonathan Berman, MD, PhD, Senior Vice President for Clinical Affairs

Senior Vice President for Clinical Affairs at Fast-Track Drugs and Biologics, Dr. Berman received a PhD in Biophysics from Harvard University, and then engaged in medical training with an MD from Einstein College of Medicine, pediatric residency at Mt Sinai Hospital (NY), infectious disease fellowship at Cornell Medical Center (NY), and further infectious disease training at the Laboratories of Clinical Investigation and Parasitology at NIH. Dr. Berman then joined the Army where his research centered on drug development: biochemical pharmacology of antiparasitic and anti-biothreat agents, pre-clinical development of antiparasitic agents, and clinical trials of antileishmanial and antimalarial drugs. While in the Army, he held the role as Research Coordinator of the Malaria Drug Development Program and Chief of the Biology Department at the Walter Reed Army Institute of Research in Washington, D.C. He retired at the rank of Colonel after 30 years of service. Before joining Fast-Track, Dr. Berman held the position of Director of Clinical and Regulatory Affairs through the National Center for Complementary and Alternative Medicine (NCCAM) at NIH. At NCCAM, Dr. Berman’s research activities centered on clinical evaluation of alternative agents, with a particular focus on botanical drugs. Presently, Dr. Berman is Chair of the World Health Organization/Tropical Disease Research Product Development Teams for antileishmanial agents, participates on the Editorial Board of Antimicrobial Agents and Chemotherapy, and is Secretary-Treasurer of the American Society of Tropical Medicine and Hygiene. He has published over 150 peer-reviewed articles and received the 1997 Louis Weinstein Award for the best clinical article in Clinical Infectious Diseases. Major publications include: Berman JD, Young DM. Purification and properties of acetylcholinesterase. Proceedings National Academy Science USA 1971; 68: 395-398. Berman J. Human leishmaniasis: Clinical, diagnostic, and chemotherapeutic developments in the last 10 years. Clinical Infectious Diseases 1997; 24: 686-703. Soto J, Toledo J, Rodriquez M, Sanchez R , Herrera R, Padilla J , Berman J. Double-blind, randomized, placebo-controlled assessment of primaquine prophylaxis against malaria in non-immune Colombian soldiers. Annals Internal Medicine 1998; 129: 241-244. Sundar S, Jha TK, Thakur CP, Engel J, Sindermann H, Fischer C, Junge K, Bryceson A, Berman JD. Oral miltefosfine for Indian visceral leishmaniasis. New England J Medicine 2002; 347:1739-1746. Berman J, Straus S. Research Agenda for Complementary and Alternative Medicines. Ann Rev Med. 2004; 55:239-254.

  Stephen C. Ransom, PhD, Director of Biostatistics and Data Management

Director of Biostatistics and Data Management at Fast-Track Drugs and Biologics, Dr. Ransom has over 20 years of experience involving chemistry, molecular biology, cell biology, biochemistry, quantitative analysis, statistical analysis, database management and computer programming. Prior to joining Fast-Track, Dr. Ransom gained GMP experience as manufacturing supervisor of gene therapy products. Shortly thereafter in the capacity of scientist, he performed bio-physical assays on viral vector products. Dr. Ransom has also worked on process development, formulation development, and assay development for cell and viral vector products. He has experience in automating the data collection and analysis, tech-transfer of manufacturing and analytical methods, and validation of analytical equipment and methods and data systems. Dr. Ransom has instituted and maintained Laboratory Information Management Systems and has prepared reviews of Laboratory Information Management Systems. Dr. Ransom received his PhD in Chemistry from Pennsylvania State University in 1984.