Drug Discovery and Development Expert, Including Chemistry Outsourcing Programs

Expertise

• Medicinal chemistry consulting and discovery.
• Drug research and development (pre-clinical and clinical).
• Patent interference consulting and IP management strategy.
• Managing medicinal and organic chemistry outsourcing projects.
• Licensing negotiations; due diligence.
• Chemical safety training.
• Neuroscience drug discovery.
• Cardiovascular drug discovery.
• Anti-infective drug research.
• Syntheses of complex, diverse targets through novel methodologies.
• Structure-based design using enzyme-inhibitor crystal structures.
• Global organization in leading outsourcing and multi-disciplinary discover project teams.
• Ligand-based drug design for G-protein-coupled receptors.

Expert Witness Experience

• Provided expert testimony through depositions in patent interference and trade secret cases.

Experience

Independent Consultant, Present

• Assignments include early phase research proposals of faculty or start-up entrepreneurs (e.g. QED program, University City Sciences Center).
• Advise clients on drug design, research and development.
• Guide clients on IP management strategy.

Bristol Myers Squibb, Hopewell, NJ, Senior Principal Scientist, 1987 - 2012

• Led two projects for several years as a chemistry working group co-chair. Set strategy and co-managed the discovery research efforts of an interdisciplinary team of scientists, which placed compounds into safety assessment studies and clinical trials.
• Delivered six development compounds, three Phase 1 compounds and one Phase 2b compound. Contributed to clinical development plans.
• Directed the research of chemistry collaborators from external alliances in India and America which accelerated neuroscience and cardiovascular programs through the timely delivery of intermediates and final compounds.
• Invented clinical candidates and promoted original research for schizophrenia, anxiety, depression, thrombosis and bacterial infections.
• Solved complex problems in structure-based design, lead optimization, reduction in off-target activities and optimization of pharmacokinetic properties to rapidly identify candidate compounds.
• Advised management on licensing opportunities and complex patent interference cases.
• Designed efficient syntheses of complex targets from diverse chemical series (e.g. heterocycles, carbohydrates, macrocycles, peptidomimetics).
• Wrote technical portions of external and internal regulatory documents.
• Mentored junior scientists (B.S, M.S, Ph.D.) and cooperative education students.
• Trained chemists in laboratory safety and organic chemistry.
• Analyzed crystal structure data for enzyme-inhibitor complexes to discover structurally-diverse Factor XIa or Factor VIIa inhibitors which had high potency and/or oral bioavailability.
• Designed efficient syntheses of complex macrocyclic inhibitors of Factor XIa and Factor VIIa.
• Discovered gamma-secretase inhibitors for the possible treatment of Alzheimer's disease which had high potency, good oral bioavailability in rats and dogs and good brain penetrance in rats.
• Invented Corticotropin-Releasing Factor (CRF) receptor antagonists for the possible treatment of depression or anxiety disorders.
• BMS-562086, a CRF antagonist was safe in Phase I and Phase IIa clinical trials and was entered into proof-of-concept Phase IIb clinical trials for anxiety and depression.
• Discovered sigma protein ligands for the potential treatment for schizophrenia including the clinical and backup candidates for the program.

Pfizer Inc., Groton, CT, Senior Research Scientist, 1981 - 1987

• Designed potent antibacterial and anticoccidial drugs for the treatment of drug-resistant infections.

Honors & Publications

Credentials

• Patent agent training.

Languages

• German (reading and writing)

Academic and Professional Affiliations

• American Chemical Society, Medicinal and Organic Chemistry Divisions
• Pharmaceutical Consulting Consortium International, Inc.
• ChemPharma Professional Association

Publications and Patents

• Author on 43 articles in peer-reviewed journals.
• Author on 41 presentations before national and international scientific meetings.
• Inventor on 29 published U.S. Patents and on 18 published foreign patents.

Education

• Ph.D. Chemistry, Yale University, New Haven, CT
• M.S. Chemistry, Yale University, New Haven, CT
• B.S. Chemistry, Yale University, New Haven, CT