Fast-Track 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 H. Ransom, Ph.D., President

President and Co-founder of Fast-Track Drugs and Biologics. Dr. Ransom has over 20 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. She 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. Dr. Ransom’s 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 J. Rickman, Ph.D., Chief Executive Officer

Chief Executive Officer and Co-founder of Fast-Track Drugs and Biologics. Dr. Rickman has over 15 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. He received extensive clinical training during his academic and postdoctoral studies in the general area of laboratory medicine, and gained specific expertise in the subdisciplines of immunology, transplant immunology, immuno-hematology, histopathology, virology, oncology, and infectious diseases. 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. Prior to joining Fast-Track, Dr. Rickman was employed as a clinical research scientist on the NCI’s CTEP support contract at Technical Resources, Intl., Inc. (TRI). In this position, Dr. Rickman was responsible for preparing annual reports, Investigator’s Brochures, and clinical data summaries to support 14 separate INDs for biological products under evaluation at the NCI. Products included cytokines, monoclonal antibodies, vaccines, and cell therapy products for the treatment of cancer and HIV associated lymphomas. A key part of this program was working with CTEP’s database development contractor on automated systems for generation of clinical data for regulatory and summary data reports. In this role, Dr. Rickman worked with developers to establish business requirements and perform beta testing of applications.

Katalin K. Lindmayer, M.D.

Direct of Medical Affairs for Fast-Track Drugs and Biologics. Dr. Lindmayer has over 12 years professional experience in the biotech and pharmaceutical industry overseeing the clinical development of products for smoking cessation, cardiovascular, renal, and infectious diseases. Currently, she is responsible for a wide array of clinical research activities including adverse event monitoring and reporting, staffing and overview of Data Safety Monitoring Boards. Coordinates activities with Institutional Review Boards, sponsors, and medical directors of corporate partners. Dr. Lindmayer also contributes to the design of clinical studies and serve on the team of medical writers contributing to clinical protocols, IND applications, sponsor SOPs, and other regulatory documents.

Ernest M. Jones, M.S., Director, Clinical Trial Operations

Mr. Jones has over 10 years of clinical trial management expertise including research agreement and budget negotiation, preparation of clinical trials materials for clinical studies including clinical protocols, procedures manuals, case report forms, and data management systems, and conducting clinical site identification, investigator recruitment, site initiation, study monitoring, regulatory file maintenance, site closure, and investigational article disposition. Mr. Jones has prior experience supporting CTEP as a clinical research specialist working at TRI under a CTEP support contract. For this program, he was mainly responsible for writing INDs, Investigator Brochures, and Annual reports. Additionally, he attended drug company meetings, prepared meeting summaries, prepared data used for NCI meetings and presentations, and drafted letters to investigators including safety warning letters and responses to Letters of Intent (LOI) proposals. His drug portfolio was focused on cytotoxic agents, however, he was also cross-trained in the discipline of biologic agents. Mr. Jones has also gained experience with adverse event coding using the MedDRA dictionary while working for the MedWatch program supported by the FDA.