Chemical Consultant and Expert Witness: Drug Development & Registration and Drug Analytical Method Development

Technical Consultant #1682


Expertise

  • Drug development focused on chemistry manufacturing and control for drug substances and drug products.
  • Analytical method development, validation, technology transfer, trouble-shooting.
  • HPLC, GC, chiral analysis, other separations techniques, trace analysis.
  • Physical property and solid state characterization, polymorphism, crystal form, particle size.
  • IND, NDA, CTD regulatory document preparation, briefing documents for end-of-phase 2 meetings, pre-NDA meetings, responding to regulatory questions.
  • Pharmacopeial monograph development, anti-counterfeiting analysis.
  • Impurity control, genotoxic impurities, residual solvents, specification setting, stability studies, forced or stress degradation studies.
  • Patent litigation support and experience as an expert witness.
  • Due diligence assessments.

Experience

Independent Consultant, 2009 - Present

  • Analytical method development, API process development problem-solving, and global product registration related to synthetic and semi-synthetic drug substances as well as intermediates and raw materials.
  • Contributed to the development and support of over 25 commercial drugs and numerous developmental drugs.

Aptuit and Aptuit Consulting, Managing Director, 2009

  • Manage consulting efforts and develop new opportunities for a 5-person patent litigation support group.
  • Direct contract research organization efforts with management team of SSCI-an Aptuit Company.

Eli Lilly and Company, Indianapolis, IN, 1979 - 2008

  • Multiple scientific promotions culminating in position as Senior Research Fellow.
  • Analytical method development, API process development problem-solving, and global product registration related to synthetic and semi-synthetic drug substances as well as intermediates and raw materials.
  • Contributed to the development and support of over 25 commercial drugs and numerous developmental drugs, including cephalosporin and macrolide antibiotics and several central nervous system drugs.
  • Commercial drugs include: Ceclor® , Dynabac® ,Prozac® ,Gemzar® , Zyprexa® , Evista® ,Cialis® , Alimta® ,Strattera® , Cymbalta® , and Effient®.
  • Mentoring and training of many Lilly scientists at all levels and in several functions (analytical, chemical process, formulation process, regulatory, quality, technical services, discovery).
  • Developed successful project partnerships with staff at multiple Lilly sites and outsourcing to third-party companies.
  • Contributed to stewardship of Lilly products including pharmacopeial monograph development and defense, patent infringement investigations.
  • Published and lectured (many invited) widely on a wide array of drug development and analytical topics including high performance liquid chromatography, impurity determination and control, genotoxic impurities, physical property characterization, drug counterfeiting, regulatory aspects of drug development, and quality control.

Honors & Publications

Credentials

  • Wisconsin Alumni Research Foundation fellowship.
  • Recognition award from President of Lilly Research Laboratories, Co-organizing the first Lilly Lab Expo, an internal scientific conference that has been continued for 20 years.
  • Lilly Research Laboratories President's Award.
  • Eli Lilly Research Technologies, Product Development and Project Management - Change the World Award.
  • Journal of Pharmaceutical and Biomedical Analysis - Top Referee recognition.
  • Academic and Professional Affiliations
  • American Chemical Society (Analytical Division)
  • American Association of Pharmaceutical Scientists
  • Reviewer: Journal of Chromatography, Journal of Pharmaceutical and Biomedical Analysis, Journal of Pharmacy and Pharmacology, Chromatographia
  • Editorial Advisory Board: Journal of Pharmaceutical and Biomedical Analysis
  • United States Pharmacopeia, Committee of Experts, Vice chair of Committee for Monograph Development - Ophthalmology, Oncology, and Dermatology
  • Product Quality Research Institute, working group on Drug Substance Specifications
  • Purdue University, Adjunct Professor, Department of Industrial and Physical Pharmacy
  • Co-moderator, APQ open forum on QbD for Analytical Methods, AAPS National Meeting

Publications and Patents

  • 39 Publications, 9 invited papers and 3 book chapters.
  • 60 external presentations, many invited presentations at international venues.

Education

  • Ph.D. Analytical Chemistry, University of Wisconsin, Madison, WI
  • B.S. Chemistry, Nebraska Wesleyan University, Lincoln, NE
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