- 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.
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)
- 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.
- 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