Synthetic and Medicinal Chemistry Consultant Specializing in the Integration of All Aspects of Drug Discovery; Chemistry, Biology, Patent Protection, Pre-Clinical Development and IND

Expertise

• Synthetic and medicinal chemistry.
• The integration of all aspects of drug discovery, from early-stage research in chemistry and biology, through patent protection, pre-clinical development, CMC, IND-filing and support of Phase I and II clinical trials.
• Indication areas of experience: Inflammation, cancer, neurological and neurodegenerative diseases, age-related macular degeneration, and diabetic retinopathy.
• 18 years of fast-paced research and management experience involving pivotal invention and/or development roles in 5 compounds through Phase I and/or II clinical trials.
• Establishment and management of successful research programs from leads generated by:
• High throughput screening of synthetic compounds and natural products, peptide mimetics of protein-protein interactions, native ligands, and molecular modeling (de novo and rational drug design).
• Management of in vitro and in vivo pharmacology research and development teams.
• Development of intellectual property strategies.
• Establishment of commercially viable process chemistry routes to APIs.
• Management of CMC activities for API and drug product manufacture; stability testing from candidate selection through IND filing to preparation for Phase 3 clinical trials.
• Management of ADME programs in support of Phase 2 trials including identification, structural determination, and bioanalytical method development for all human-relevant metabolites.
• Management of toxicology programs in support of Phase1 and 2 clinical trials including 3, 6 and 9 month toxicology studies in several species; reproductive and developmental toxicity studies and translational toxicity studies.

Drug Targets:

Experience

Undisclosed Company, Senior Director of Chemistry and Biology, 2005 - 2010

• Principle inventor of Phase II trials for AMD.
• Delivery of clinical candidate in less than 9 months.
• Discovery of 6 novel, related chemical classes.
• Authorship of 6 patent applications.
• Leadership of the working groups with Otsuka in areas of research, CMC, toxicology, and non-clinical pharmacology.
• Creation of overall research plan including initial SAR, back-up program, IP, MOA studies, and the generation of new animal models for ocular disease.
• Chemistry team leader (5 internal, 6 external chemists).
• Biology team leader (9 biologists including the vivarium).
• Initiated, managed and completed studies including: 3, 6, and 9-month toxicology, pilot development and pilot fertility.
• Managed the metabolite identification program - Identified major human metabolites.
• Managed the CRO responsible for development and validation of bioanalytical methods for parent and metabolites.
• Designed and implemented translational toxicology studies.
• Managed CMC including API and drug product manufacture, and submission of CMC Section 7.
• Established and implemented patent protection strategies.
• Managed chemistry outsourcing to India.

AMRI, Bothell, WA; Chicago, IL; Albany, NY, Executive Director, Lead Discovery, 1999 - 2005

• Head of Operations, Bothell Research Center, Bothell, WA, 2003 - 2005
• Head of Operations, The Biosciences Group, Chicago, IL, 2003 - 2005
• Creator, The Oncology Group, Cross-Divisional, 2002 - 2005
• Mandate as Head of Operations required the evaluation of ongoing research programs, teams, and scientific approaches, and to implement changes to maximize potential.
• Responsibilities spanned all departments including science, finance, facilities, and business development.
• Accomplished in less than two years: organizational restructuring to improve efficiency and product marketability, creation of structural analysis and microbiology teams, creation of a new high throughput screening group, institution of new protocols for the establishment of quality natural product libraries, design and management of a new building facility, creation of a new billing paradigm (the flexi-FTE), the co-invention of a novel approach for the discovery of new antibiotics from natural products.

Texas Biotechnology Corporation, Houston, TX, Assistant Director, 1992 - 1999

• Project Team Leader: VLA-4/VCAM Integrin.
• Project Team Leader: FGF and VEGF Growth Factor programs.
• Responsible for design of entry compound into a new series (peptide mimetic); lead optimization.
• Used De Novo design to discover a new class of inhibitors.
• Principle Inventor on 4 issued U.S. patents.

Honors & Publications

Academic and Professional Affiliations

• Member, American Chemical Society
• Member, Royal Society of Chemistry: MRSC, CCHEM

Publications and Patents

• 19 issued U.S. patents and 12 patent families in prosecution.
• 34 publications (scientific, peer reviewed journals) and presentations.
• 6 invited speaking engagements.

Education

• Ph.D. Synthetic Chemistry, University of Sheffield, England
• M.Phil. Synthetic Chemistry, University of Sheffield, England
• B.Sc. Chemistry, (with Honors), University of Sheffield, England