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

Technical Consultant #1778


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.

Medical Experience:

  • Inflammation
  • Congestive Heart Failure
  • Psoriasis
  • Parkinson's Disease
  • Schizophrenia
  • Dry-Eye

  • Cancer
  • Diabetes
  • Hypertension
  • Cocaine Abuse
  • Neuropathic Pain
  • Glaucoma

  • Alzheimer Disease
  • Rheumatoid Arthritis
  • Age-Related Macular
  • Degeneration
  • Diabetic Retinopathy

Drug Targets:

  • Kinases (P38, MAPKAP2, MK-2)
  • Growth Factors (FGF, VEGF)
  • Integrin VLA-4/%u0105 4%u03B2 1
  • Endothelin A
  • E-Selectin

  • HDAC
  • PTP-1B
  • GABA
  • %u03B2-Secretase
  • Dopamine D2

  • Retinoid Isomerization
  • RPE65
  • Serotonin
  • NMDA

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
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