Pharmaceutical CMC and New Drug Development Expert: Small Molecules, Proteins and Biologics

Expertise

• Accomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.
• CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).
• CMC programs for oral, inhaled, topical and parenteral dosage forms.
• Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufacturing processes for small molecule, protein, and plasmid therapeutics.
• Strategic, technical, and regulatory direction for pharmaceutical development.
• INDs/NDAs for the U.S. FDA, developing regulatory strategy, and liaison with FDA.
• Regulatory and development.

Experience

Undisclosed Company, Founder and CEO, 2009 - Present

• Consulting, pharmaceutical development for small molecules and biologics.
• Advancing IND, (Investigational New Drug), projects from preclinical to POC, (Proof of Concept).
• Development of formulations, dosage form, analytical methods, stability programs.
• Outsource management of CMC, (Chemistry Manufacturing and Controls) and bioanalytical from audit to clinical studies.
• Frequent interaction with CBER, (Center for Drug Evaluation and Research,) and CDER, (Center for Drug Evaluation and Research) of U.S., FDA.
• Writing and review of regulatory documents to support INDs and NDAs.
• Initiated operations: CMC consulting.
• Planning and executing CMC regulatory submissions.
• Managed intellectual property portfolio and patent prosecution.
• Consulted and authored STTR (Small Business Technology Transfer), SBIR, (Small Business Innovation Research) and ATP, (Advanced Technology Programs) proposals.

Summit Drug Development Services, LLC, Rockville, MD, 2007 - 2009

Vice President, Pharmaceutical Development Services, 2008 - 2009
Consultant, CMC and Analytical Chemistry, 2007 - 2008

• Managed development projects for multiple clients.

Scynexis, Inc., Research Triangle Park, NC, 2002 - 2007

Director of Scientific Affairs and Drug Development

• Advanced HCV program from preclinical and pre - IND to Ph. 2 in 18 months.
• Responsible for HIV and HCV discovery and development.
• Responsible for preclinical research and regulatory operations.
• Team leader for proprietary discovery program: antiviral and ophthalmology.
• Inventor of several new therapeutics: antiviral and dry eye compounds.

Director of Analytical Sciences

• Responsibility for QC analytical chemistry and bioanalytical functions.
• Team of 14 scientists: GLP and cGMP compliant operations.
• Project Team leader for drug-discovery project: antiviral agent.

Phytera, Inc., Worcester, MS, Director, Chemistry, 2000 - 2001

• Medicinal chemistry and analytical chemistry in drug development programs.
• CMC Regulatory writing.

Paradigm Genetics, Inc. , Research Triangle Park, NC, 1998 - 2000

Group Leader, Biochemistry

• Small-molecule biomarker development.
• Established initial metabolite screening, analytical methods/systems, and automation platform.
• Biochemical-assay development team.

OSI Pharmaceuticals, Inc., Durham, NC, Uniondale, NY, Director of Chemistry, 1994 - 1998

• Research-operations director for drug discovery center (screening and chemistry).
• Responsible for research activities in biology and chemistry.
• Member of Technology Development Committees.
• Team leader in drug discovery projects (cancer, virology, hematopoiesis): Discovered antiviral agents, EPO inducers, and anti-sickle-cell agents.
• Directed SAR programs.

Sterling Winthrop Pharmaceuticals, Research Division, Collegeville, PA, 1989 - 1994

Principal Research Investigator, 1993 - 1997
Senior Research Investigator, 1991 - 1993
Research Investigator, 1989 - 1991

• For the Department of Biochemistry and Biomolecular Screening, managed biochemistry and biocatalysis research team.
• Developed high-throughput assays for inflammation programs.
• Developed functional and binding assays for new targets.
• Developed novel HTS assay for metalloproteases.
• Managed enzymology and biochemistry group.

Los Alamos National Laboratory, Los Alamos, NM, 1987 - 1989

Fellow, Isotope and Structural Chemistry Group

• Enzyme kinetics and mechanisms of alcohol dehydrogenases.
• Biocatalysis using PPQ-based dehydrogenase.
• Synthesis and biosynthesis of isotopically labeled coenzymes and enzymes.

Merck and Company, Inc., Rahway, NJ, 1981 - 1987

Senior Biochemist, 1986 - 1987
Research Biochemist, 1984 - 1986
Biochemist, 1981 - 1984

• Development research on biocatalytic processes, and production of anti-bacterials,statins, CCK receptor antagonists.
• Developed analytical methods for over 100 compounds.

Honors & Publications

Academic and Professional Affiliations

• Editorial Board, Journal of Antibiotics
• North Carolina Regulatory Affairs Forum
• Center for Entrepreneurial Development, NC
• American Association of Pharmaceutical Scientists (AAPS)
• Drug Information Association (DIA)

Awards

• Recipient of Merck Ph.D. Fellowship and Research-Achievement Award

Publications and Patents

• Author and Co-Author of Numerous: Meeting abstracts, scholarly journals, book chapters and symposia with the following topics:
• National and international patents.

Education

• Ph.D. Chemistry, Ohio State University, Columbus, OH
• M.S. Biochemistry, Purdue University, West Lafayette, IN
• B.S. Biology, Summa Cum Laude, Alma College, Alma, MI