Associates
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. Curriculum Vitae
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. 
Aron Stein, Ph.D., Senior Associate Aron Stein, Ph.D., with advanced degrees in Toxicology from Texas A&M University,
was formerly Vice President of Regulatory Affairs and Quality Assurance at Isis Pharmaceuticals,
Vice President of Regulatory and Medical Affairs for Abbott Laboratories, Vice President of
Regulatory and Quality Affairs at Sequus Pharmaceuticals, Director of Drug Regulatory Affairs for Pfizer, Inc.
Dr. Stein started his career at DuPont Pharmaceuticals (now BMS) as a Study Director conducting GLP
toxicology studies in support of IND development programs. He has over 18 years of experience providing
regulatory leadership for multiple NDAs in both large and small organizations.
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. 
Gary Christiansen, Ph.D., Senior Associate
With advanced degrees in organic chemistry from the University of
California, Los Angeles, Dr. Christiansen has over 30 years of experience with 11
years of directorship positions with Hybritech Incorporated as Director of Process
Development, Director of Therapeutic Process Development, Director of Therapeutics
Quality Control/Quality Assurance, and Director of Corporate Validations. In his
consulting career, Dr. Christiansen's expertise is in validation and compliance
programs for biotechnology, drug and device manufacturing, and gene therapy research.
His clients have included international and domestic companies ranging from small
start-up companies to major pharmaceutical and device companies. He has prepared
and presented numerous professional training programs on topics such as validation,
compliance, QA/QC, GLPs and GMPs. He has published several articles and is a
contributing author for several books.
Janice D. Callahan, Ph.D., Senior Associate A Ph.D. statistician from Johns Hopkins University, Dr. Callahan has been a statistical consultant since 1969. In 1982 she formed Callahan Associates, Inc. (CAI) to provide a wide range of statistical services. Her experience covers clinical trials, quality control, environmental impact studies, econometric modeling and artificial intelligence. She is expert in ANOVAs, linear and non-linear regression, categorical data analyses, discriminate analysis and CART, and time series analyses. Dr. Callahan offers consulting to over 25 biotech companies and regulatory support with the FDA for product approval. She has participated in the design, analysis and submittal of numerous successful 510Ks, IDEs, PMAs, and NDAs. She also works with assay development teams in developing statistical methods for qualifying and validating assays. CAI licenses SAS and owns BMDP.
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.
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.