Name and Educational Degree(s)
Moyer, Elizabeth, PhD
M/P Biomedical Consultants LLC
Postdoctoral fellowship: Department of Pharmacology and Experimental Therapeutics, Johns Hopkins University School of Medicine, Baltimore, MD.
Postdoctoral fellowship: Departments of Biochemistry and Surgery, State University of New York at Buffalo, Buffalo, NY.
Ph.D. Biochemistry (Clinical chemistry predoctoral program, AACC accredited), State University of New York at Buffalo, Buffalo, NY.
B.A. Chemistry and Biology, Randolph College, Lynchburg, VA. Awarded a Given Distinguished Scholarship.
402 Live Oak Dr.
Mill Valley, CA 94941
Working collaboratively with company personnel, we are a catalyst for and amplifier of product development activities to most effectively and efficiently achieve client company objectives.
With an extremely broad range of experience in the individual technical areas that support pharmaceutical development- pharmacology, toxicology, CMC, program management, regulatory affairs, clinical - M/P Biomedical Consultants provides an integrated expertise in product development. Our clients range from virtual companies consisting of three or four individuals to multinational pharmaceutical companies. Our projects have ranged from transitioning academic research into the clinic to generating marketing applications for US, Canada and Europe, from small molecule oncology and ophthalmologic drugs to botulinum toxin and monoclonal antibodies and from the fine detail of a QA audit of Phase IV clinical study reports to the macroscopic view of the development of a new chemical entity.
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CEO at M/P Biomedical Consultants (1989-present)
M/P Biomedical Consultants LLC have worked with a wide range of types of companies, from startups and virtual companies to multinations, from pre-Phase I to postmarketing projects, providing advice and services: program review and contract management of preclinical, manufacturing, clinical and regulatory activities required for gaining market approval for drugs and biologics.
Product Experience: •Alzheimer’s drugs •Analgesics •Anticonvulsants •Anti-sense drugs •Antispasmodics •Botulinum toxin •Cancer drugs •Diabetes drugs •Iron chelator •Multiple Sclerosis drugs •Nutraceuticals •Novel anti-infectives •Parenteral nutrition solutions •Plasma volume expanders •Therapeutic monoclonal antibodies
SVP Product Development & Operations at Kinetek Pharmaceuticals (1999 - 2000)
Responsible for all phases of Product Development including clinical development and regulatory affairs, as well as for managing common service units within Kinetek (animal facility, in vitro facility, chemistry, computers, building and facilities)
VP Product Development at Kinetek Pharmaceuticals (1997 - 1999)
Responsible for coordinating preclinical and clinical development of the company’s proprietary technology, for clinical and regulatory affairs, as well as for manufacturing.
• Preclinical development - Oversaw pharmacology program, initiated, contracted for, and monitored toxicology studies.
• Manufacturing - Initiated, contracted for, and oversaw manufacturing of drug substance(s) and drug product(s), including batch record review, setting specifications, lot release approval, and labeling for drug substance and drug product, and oversaw clinical trial material distribution.
• Clinical and Regulatory - Directed the preparation and filing of regulatory documents to initiate clinical trials and to gain marketing approval in North America and Europe. Initiated and oversaw clinical trials in North America and Europe. Led meetings with the FDA and HPB. Wrote, used and maintained clinical study SOPs. Wrote clinical study protocols, Investigator’s Brochure, Clinical Study report. Wrote IND (clinical, CMC and nonclinical sections).
• Officer of the Company.
Products approved or in clinical trials:
• KP-102 - an organo-vanadium compound in-licensed from an academic institution for treatment of Type II diabetes in a Phase I clinical trial, accomplished in approximately one year.
Director, Preclinical Development at Elan Pharmaceuticals (1989 - 1997)
Responsible for coordinating and providing pharmacology and toxicology data for regulatory submissions and for managing manufacture of drugs and biologics.