Medicinal and Process Chemistry Consultant: Drug Discovery, Drug Development and Intellectual Property Evaluations.

Expertise

• Technology transfer and business plan development.
• Marketing and contracts.
• Medicinal chemistry drug discovery.
• Catalytic methods to control stereochemistry.
• Pharmaceutical lead optimization and testing.
• Intellectual property management.
• Structure-based drug design.
• Peptide chemistry.
• Preclinical development.
• cGMP chemical process development.
• Preparation of CMC section of IND.
• Outsourcing and partnering of medicinal chemistry.
• Scientific proposal writing for government funding.

Experience

Undisclosed Company, Director of Chemistry, 2010 - Present

• Leading entrepreneurial, intellectual property and technology development for programs directed at hepatitis B, liver cancer, or multiple viruses.
• Directed the technical feasibility, contributed to business plan development, provided input into the contract negotiations, and coordinated logistics for the donation of a large pharmaceutical research laboratory - natural product collection.
• Developed marketing plan for the Natural Products Discovery Institute, resulting in initial funding from the NIH and interest from multiple Clients.
• Performing business development activities related to acquiring assets supportive of anti-viral programs.
• Filed, received, and implemented state innovation grants to support our drug discovery and diagnostic programs.
• Proposed a new anti-viral project in collaboration with Drexel University to develop PI3K p110 Delta kinase inhibitors that block host cell signally pathways important for viral replication. This project was funded by a Pennsylvania DCED Innovation Grant.

Undisclosed Company, Founder and Director of Chemistry, 2008 - Present

• Performed synthetic studies that determined the identity of the major human metabolite of JWH-018, a synthetic cannabinoid agonist, and provided reference material for LC method development.
• Prepared Drug Discovery due diligence reports and research proposals for business development opportunities (CNS, Pain, Oncology, and Metabolic Disease) within major Pharmaceutical Company to facilitate their decisions on the technologies.
• Directed the outsourcing of medicinal chemistry to Eastern Europe and Asia resulting in diverse libraries of well characterized compounds.
• Provide medicinal chemistry advice for Biotechnology Companies, Pharmaceutical Companies, and Academic Groups.
• Involved with SBIR proposal writing, lead design/optimization, literature searching, and mechanism of action investigations, biotechnology company start-up, and freedom to operate evaluations.

Johnson & Johnson, Spring House, PA, Research Fellow, 2000 - 2007

• Identified drug candidate; an alpha-v beta-3/5 integrin antagonist with oral efficacy in animal models of eye disease.
• Experimentally determined absolute stereochemistry of a medicinal compound by a combination of x-ray crystallography and synthesis.
• Implemented and researched collaborative project with J-Star Research to improve process efficiency and throughput for scale-up.
• Worked with a homogeneous catalysis contractor (Johnson-Matthey) to attain excellent stereocontrol and low catalyst loading.
• Investigated experimentally a novel organocatalytic method to control two stereocenters simultaneously.
• Identified a 2-azabicyclo[2.2.2]octane-based alpha-4 beta-1 integrin antagonist as an inhaled anti-asthmatic agent and put together compound monograph for compound development recommendation.
• Identified the minimum structural requirements for activation of the urotensin-II receptor by its peptide ligand, therefore generating a novel ligand for use in HTS.
• Developed multiple, novel series of small-molecule U-II receptor antagonists with single-digit nanomolar potency utilizing structure based drug design.
• Currently preparing a Perspective Article for J. Med. Chem. on the Urotensin-II Field.
• Wrote a postdoctoral research proposal, recruited a scientist, and participated in a project that identified self-assembling collagen-mimetic peptides with thrombogenic properties.
• Initiated collaboration with Cresset Biomolecular to quantify-stacking interactions, which led to three scientific papers in high-impact journals and potential practical applications.

Magainin Pharmaceuticals, Plymouth Meeting, PA, 1993 - 1999

• Inventor on two new molecular entities (NME's) that moved into clinical development: Squalamine and trodusquemine.
• Developed SAR on the anti-infective properties of squalamine, other natural aminosterols, and analogs.
• Redirected resources towards the development of a practical 16-step synthesis of squalamine.
• Experimentally developed a practical method of converting squalamine to trodusquemine and produced material for in vivo characterization.
• Outsourcing: Selected five external manufacturers and negotiated contracts to define intellectual property ownership, scope of project, deliverables, and specifications on intermediates and final products to meet budgetary and time line criteria.
• cGMP synthesis: Completed production of GMP squalamine drug substance on time and on budget to initiate Phase I clinical trials in oncology.
• Regulatory filings: Prepared the Chemistry Manufacturing and Controls section of the IND on squalamine lactate, as part of the IND Project Team.
• Led project team (chemistry and biology) on the centrally acting anti-obesity agent trodusquemine.
• Applied for and received a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to develop an abbreviated route to squalamine.

Wyeth-Ayerst Laboratories, Princeton, NJ, 1989 - 1993

• Designed and synthesized a structurally unusual NMDA-antagonist (Perzinfotel; EAA-090) under trial for the treatment of neuropathic pain.

Honors & Publications

Academic and Professional Affiliations

• Invited speaker at 12 scientific meetings or universities.
• Manuscript reviewer: J. Am. Chem. Soc., J. Med. Chem., Tetrahedron Lett., J. Org. Chem., Org. Lett., Synlett, Lett. Drug Design Discov., Bioconj. Chem., and Peptides.
• Co-chaired the Symposium on Polyamines at the 209th ACS National Meeting
• Participated in Ph.D. defense committees at Brown, Lehigh, and Villanova Universities.
• Developed a Lead Optimization Project Champion Training course and organized an internal Science Day Symposium
• Member, organizing committee, 13th Symposium on the Latest Trends in Organic Synthesis, Brock University, St. Catherine's, Ontario.
• Member, Study Section for Eye & Vision, to review proposals for grants from the U. S. Government.
• Invited Editor, Current Topics in Medicinal Chemistry to develop special issue dedicated to the various aspects of patent law and their impact on medicinal chemistry.

Publications and Patents

• Author on 50 scientific publications, in print.
• Inventor of 33 U.S. Patents issued.

Education

• Ph.D. Organic Chemistry, The Ohio State University, Columbus, OH
• B.S. Chemistry, The Ohio State University, Columbus, OH