Mark Lostrom, M.S., Senior Associate, with degrees in biochemistry, immunology and microbiology from UCLA and Washington State University, was formerly Director of Therapeutics Research for Bristol Myers Squibb, VP of Product Development, VP Business Development and Interim President for Viagene, Inc., Acting President for CancerVax, Inc. and President, CEO and Chairman for Confirma, Inc. In addition he founded and operates Lostrom & Co. Biotechnology Consulting for over 10 years. He has 25 years experience forming and growing products and companies. His specialty areas include Product Development, Product Commercialization Strategy, Business Development, and Licensing. He has worked in large and small companies with diagnostic, therapeutic and medical device products defining and implementing the best available strategic positions for R&D, regulatory, business and marketing issues.
William R. Tolbert, Ph.D., Senior Associate, with advanced degrees in Biophysics from the University of Wisconsin, has over 25 years of experience with 10 years as Vice President at Invitron, Centocor and Advanced Tissue Sciences, providing leadership over Technology, Quality Assurance, Quality Control, Validation and Clinical Production Departments. Dr. Tolbert's expertise is in product/process development and cGMP manufacturing of biopharmaceutical cell-based products: including rDNA proteins, monoclonal antibodies and cell/gene therapy modalities. He is an inventor on 26 patents and author of over 80 publications. He has been a Senior Associate with Merchant-Taylor International since 1996. In his consulting career, Dr. Tolbert has developed significant expertise in facility design and optimization to support incorporation of regulatory requirements. In that regard, he has presented novel facility plans to the FDA Division of Manufacturing and Product Quality in the Center of Biological Evaluation and Research on numerous occasions.Curriculum Vitae
Frederick E. Reno, Ph.D., Senior Associate Dr. Reno is an internationally renowned toxicologist providing expertise in the areas of preclinical aspects of drug development, strategies for product safety evaluation, and liaison with regulatory agencies. With over 35 years experience, including 20 years with Hazelton Laboratories, Dr. Reno's experience includes organizing and directing safety evaluation programs and interfacing with contract laboratories, providing scientific opinions on toxicology aspects of potential candidate compounds for licensing, and preparation of preclinical summaries for U.S. (IND and NDA) and foreign pharmaceutical submissions to regulatory agencies. His clients include both domestic and foreign companies, and he has authored numerous publications and papers.Curriculum Vitae
Jim McCormack, Ph.D., Associate With advanced degrees from Boston University and the Massachusetts Institute of Technology, has over 20 years of research experience. Prior to joining Merchant-Taylor International, Inc. as an Associate in 2000, Dr. McCormack was Scientific Director and Consultant to The Paik-Inje Memorial Institute, focusing on immune responses in transplantation, and a research scientist for Chiron Technologies Center for Gene Therapy characterizing immune responses associated with retroviral vector gene therapy. In his consulting career, Dr. McCormack applied his expertise in immunology, molecular biology, gene therapy, and animal modeling and his experience with immunotherapy, autoimmunity, and inflammatory diseases to assist biotechnology companies with a variety of services ranging from basic research to regulatory filings. He currently has three patents pending and has authored 25 publications. Curriculum Vitae
Marianne Mowrer Nealan, Associate With over 10 years experience in technical writing and document preparation for the biotechnology industry, Ms. Nealan joined Merchant-Taylor International, Inc. as an Associate in 2001, following a seven-year career with Sierra Biomedical in San Diego, CA. She developed policies and procedures for electronic reporting, data reduction and analysis, and the management and coordination of preclinical protocol and report generation in compliance with regulatory guidelines. In her consulting career, Ms. Nealan has provided technical and regulatory assistance in protocol development, data input, verification, quality control, and analysis. She has also assisted domestic and international clients in the generation and filing of INDs with the FDA. Curriculum Vitae