Medical Chemist Expert Specializing in Drug Licensing and Preclinical Packaging

Expertise

• Medical Chemist specializing in synthetic, chemistry, medicinal chemistry and due diligence evaluation of preclinical packaging.
• Drug licensing for clinical development, pre-IND, (Pre-Investigational New Drug Application), with an emphasis on early clinical trials, prior to out licensing compounds.
• Identification of clinical candidates for potential licensing opportunities, including chemotype, pharmacology, pharmacokinetics,(PK) and preliminary patentability determination.
• Oncology science discovery and drug development, preclinical oncology programs and metabolic disease medical chemistry.
• Direct interaction of several clinical candidates and phase 1 clinical trial starts in the Kinase inhibitor area.
• Educator in medical chemistry, obesity and diabetes.

Experience

Independent Consultant and Expert Witness, 2008 - Present

• Serving as a scientific consultant with over ten pharmaceutical companies and providing expert witnessing for several law firms.
• Medicinal chemistry services for several companies specializing in synthetic, chemistry, medicinal chemistry and due diligence evaluation of preclinical packages.
• Providing pharmaceutical consulting for a firm based in Michigan, which is largely staffed by ex-Pfizer colleagues, as well as, a regular consultant for several of their clients.

Undisclosed Company, Chief Scientific Officer, 2011 - Present

• Providing consultancy of a start-up company being spun out of the University of Michigan.
• Medicinal Chemistry Consultant for this largely virtual company.
• Charged to identify one or more clinical candidates out of the intellectual property that the company has licensed.

Quatrx Pharmaceuticals Inc., Ann Arbor, MI, 2003 - 2008

Senior Director of Preclinical Sciences, 2007 - 2008

Director of Preclinical Sciences, 2003 - 2007

• Drug licensing for clinical development preferably pre-IND, with an emphasis on early clinical trials, prior to out licensing compounds.
• Quatrx is a virtual company doing most of CROs through computer generation.
• Responsibilities included the initial evaluation of the entire preclinical package of potential licensing opportunities, including chemotype, pharmacology, pharmacokinetics and preliminary patentability determination.
• After licensing compounds, responsible for pharmacology and PK packages were complete for IND, and were ready to be put into the IND.
• Ensuring GMP synthesis established, and that the API was in a useable form, and that the CMC section of the IND was complete.
• Designed pharmacology and PK studies, selected a salt for one API, and did the bench chemistry to design an inexpensive and patentable route to a second API, and to make novel, patentable, pro-drugs of a third.

Pfizer Global Research and Development, Ann Arbor, MI, 2000 - 2003

Oncology Discovery Executive Director

• Appointed to the Ann Arbor site in a lead position, retaining the responsibility for oncology chemistry of all oncology discovery science.
• Member of the senior discovery management team on site, and a member of the worldwide Discovery Management Committee.
• Planned for the shift of resources and staff out of oncology.
• Produced three clinical candidates, a MEK inhibitor PD 0325901, which went through Phase I, a CDK4/6-selective inhibitor PD 0332901, which is currently in Phase 2, and a second generation pan-ErbB irreversible inhibitor, PF0299804, which is currently in Phase 3 clinical trials for lung cancer.

Interim Oncology Discovery Executive Director, 2001

• Appointed as temporary Ann Arbor Oncology site head with overall responsibility for the site discovery oncology therapeutic area in a matrix system.

Director of Cancer Chemistry, 2001 - 2003

• Became member of the Pfizer Global Oncology Team, which was responsible for coordinating strategy across 3 sites where preclinical cancer research was carried out.

Parke-Davis Pharmaceutical Research Division, Ann Arbor, MI, 1992 - 2000

Director of Diabetes Chemistry

• Began start-up of the chemistry group to support our diabetes project.
• Searched for novel agents in the diabetes and obesity area with a team of sixteen chemists.
• As the Project Co-coordinator, Project Leader and a member of the joint Research Council for the Parke-avis/Ligand Pharmaceutical initiated collaboration to find novel estrogenic agents.
• As member of the Research Management Committee in the Parke-Davis/Allergan Inc. joint venture identified novel retinoids with anti-diabetic activity.

Associate Research Fellow

• Became a part of the anti-cancer project, using the latest advances in signal transduction to find original, mechanism based therapies.

Research Fellow

• Following promotion began designing and synthesizing very potent and specific tyrosine kinase inhibitors, culminating in low picomolar inhibitors of the EGFR tyrosine kinase, an improvement of 105 in potency over our original leads.
• Demonstrated that selective potent inhibitors of tyrosine kinases could be obtained, and at the highly conserved ATP-binding site.
• Developed very selective, irreversible, inhibitors of the ErbB family of RTKs from our original leads, and was heavily involved in the discovery and development of CI-1033, first clinical candidate.
• Participated with biology staff in getting new targets screened, and in coordinating strategy for both in vitro and in vivo screening.
• Identified and defined leads from kinase random screens.
• Sole identifier in the selective MEK inhibitor PD 098059 from random screening.
• As Chairman of the MAP kinase working group, developed selective, nanomolar potency, nanomolar inhibitors for the enzyme MEK, including two clinical candidates CI-1040 and PD 0325901.

Senior Scientist, 1984 - 1988

• Chemical coordination for antipsychotic evaluation in the Adenosine Receptors project.
• Lead chemist on the synthesis of the first potent, highly selective, adenosine A2a receptor agonist, in a project involving innovative use of molecular modeling.
• Began working on quinolones in the Anti-infective project, and was promoted to Research Associate.
• Developed innovative techniques for novel quinolone synthesis, including developing chemistry to exploit the ability of aryl fluorides to direct ortho-lithiation.
• Gained considerable experience interacting with both biochemists and pharmacologists, and at picking compounds for both primary and secondary screening for efficacy and liabilities.
• As a member of the Antipsychotic Project Team, and the planning teams for two clinical candidates, gained exposure to the requirements of chemical and product development, and toxicological and clinical evaluation.
• Successfully developed chemical series to optimize receptor affinity and selectivity and in vivo profiles.

Eisai Research Institute of Boston, Senior Scientist, 1988 - 1992

• One of four senior chemists, along with four senior biologists ran the Institution under guidance.
• As a part of a larger team, working on antagonists for bacterial liposaccharides as a septic shock therapy.
• Led the chemistry of our urokinase inhibitor program, for evaluation of therapy in the anti-cancer and inflammation areas. This project gave produced a successful patent filing.
• The potency of lead series was raised by more than one thousand fold, leading to a 40 nM urokinase inhibitor with good inhibitory selectivity over t-PA and plasmin.
• Utilizing this chemistry, the lithiation chemistry of aryl fluorides was further elucidated, and novel heterocyclic syntheses were developed.

Northern Illinois University, Department of Chemistry, Assistant Professor, 1978 - 1984

• Recommended for tenure and promotion to Associate Professor of Organic Chemistry.
• Taught the introductory 1 semester organic chemistry course, the non-majors introductory, the chemistry majors, organic chemistry and organic synthesis chemistry.
• Research involved the synthesis and reactions of sulfur, silicon and phosphorus substituted allenes and dienes, with an emphasis on cycloadditions.

Educator

• Adjunct Assistant Professor, Department of Chemistry, Wayne State University
• Adjunct Associate Professor, School of Pharmacy, University of Michigan
• Lecturer: Obesity and Diabetes in MedChem 533, graduate program, UM College of Pharmacy.

Honors & Publications

Credentials

Post-doctoral Experience

• NATO Fellowship at The University of Wisconsin at Madison.
• Temporary Charge de Recherche at the CNRS Gif-sur-Yvette.
• Research Associate at The University of Toronto.
• Thesis: Synthetic and Mechanistic
• External examiner on several Wayne State Ph.D. committees.

Academic and Professional Affiliations

• Royal Society of Chemistry
• American Chemical Society
• Sigma Xi
• American Association for the Advancement of Science
• American Association for Cancer Research
• SAB of Pathway Therapeutics Inc., Member

Publications

• Author and Co-Author of over 145 publications:
• College textbooks
• Peer reviewed journals in pharmaceuticals, medical chemistry and bio-organic medical chemistry.
• Conferences, symposiums and abstracts presented internationally; Amsterdam, Canada, France, Germany, Holland, London, Netherlands, and Scotland.

Patents

• Over 78 U.S. and World Intellectual Property Organization (WOIP) patents published, with 32 patents granted.

Education

• D. Phil. Chemistry, Oxford University, Wellington Square, Oxford, United Kingdom
• M B.A. Chemistry, (First Class Honors), Wellington Square, Oxford, United Kingdom