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.