| Aron Stein, PhD has over twenty years of pharmaceutical experience with demonstrated
ability to lead, build, mentor, develop, and manage in both small and
large organizations. Dr. Stein has experience in broad areas
of management responsibilities including Toxicology, Regulatory, and
Medical Affairs, and Quality Assurance. Strategic FDA initiatives
involved partnering with the Agency to develop CDER Guidance and
reintroduction of marketed products (ABBOKINASE). Project specific
regulatory strategies have led to rapid registration for multiple drug
products including DOXIL for ovarian cancer, VIAGRA, TIKOSYN, and
supplements for DIFLUCAN and ZITHROMAX.
Dr.
Stein has served as Study Director conducting toxicology GLP studies in
support of new therapeutics entering clinical trials. Utilized
scientific training and expertise on early staged compounds to assume a
broader role in drug development. Directed and/or supervised as a Vice
President, the management of FDA interactions for preclinical, CMC, and
clinical activities in Phase 1 through 3 development programs. These
responsibilities applied to as many as 40 INDs at a given time and
across a variety of review divisions including Oncology,
Neuropharmacology, Cardio-Renal, Dermatology, Anti-Infective,
Anti-Viral, Gastrointestinal, Metabolic and Endocrine, Anesthesia and
Rheumatology, and Cellular, Tissue, and Gene Therapy. Chemical classes
of compounds include small molecules, natural products,
oligonucleotides, and recombinant proteins. As
a means to expand services to our clients, Aron formed an integrated
collaboration with other highly experienced and knowledgeable
consultants. The Principals bring over 100 years of collective drug
development experience to our clients’ programs. The Principals are:
Kate Hanham, Ph.D. CMC and Clinical Development
mentara.comBruce Merchant,
M.D., Ph.D.
Clinical Development and Regulatory Affairs
James Taylor, Ph.D.
CMC and Regulatory Affairs
merchant-taylor.com |
