Drug Stability, Pharmaceutical Impurities, and Control Strategies Expert

Technical Consultant #2118


Expertise

  • Chemical, physical, and environmental stability and degradation.
  • Preformulation, formulation design and stability.
  • Analytical and impurity (including mutagenic impurity) control strategies, including structure elucidation, characterization, predictive technologies and risk assessment.
  • Photostability, photochemistry and photostabilization.
  • Regulatory issues and authoring, primarily chemistry, manufacturing and controls section.

Expert Witness Experience

  • Patent case in Europe, regarding differences in stability between prasugrel and clopidogrel, and testified as Expert Witness in hearing ( Munich, Germany).

Experience

Undisclosed Company, President, Present

  • Over twenty-six years of in-depth scientific / technical experience in pharmaceutical research and development; (chemistry, manufacturing, and control).
  • Consulting for pharmaceutical, biotech, animal health, agrochemicals, and consumer healthcare industries on a wide range of topics including: chemical, physical, and environmental stability and degradation, analytical and impurity (including genotoxic, mutagenic impurity) control strategies, formulation stability, photostability, photochemistry, and regulatory issues.

Eli Lilly and Company, Indianapolis, IN, Senior Research Fellow, 1989 - 2015

Research Fellow and Senior Research Fellow, 2005 - 2015

  • Scientific leader in the Small Molecule Design and Development (SMDD) organization.
  • Responsibilities include reviewing, consulting, approving, recommending, and supervising development programs and project team plans.
  • Development and implementation of new and improved technologies, business processes and strategies.
  • Special focus on degradation chemistry and stability-related issues; oversight and consulting for Degradation Chemistry Group including photostability-related investigations and protocols. A
  • Analytical technical assessments on LRL Due Diligence assessments of external assets and companies for licensing considerations.
  • Represents SMDD on numerous cross-functional teams and forums.
  • Scientific mentoring for numerous scientists in SMDD and cross-functionally in pharmaceutical product research and development.
  • Technical oversight for the analytical chemistry and control strategies required to develop products for global markets.
  • Influencing and defining the current and future scientific and technical strategy for the pharmaceutical research and development organization.

Supervisor, Degradation Chemistry Group, 1991 - 2007

  • Directing comprehensive stress testing studies of non-protein pharmaceuticals to predict stability issues and to define chemical and photochemical degradation pathways.
  • Structure elucidation of unknown degradation products and low-level impurities, response factor determination, and investigation of difficult or unusual impurity or [photo]degradation-related problems.
  • Extensive use of purification techniques such as preparative HPLC, as well as coordinating spectroscopic characterization using techniques such as NMR, MS, LC/MS, IR, and UV.
  • Significant interaction with analytical development scientists, formulation scientists, spectroscopists, synthetic organic process scientists, toxicology, regulatory, as well as general analytical aspects of the drug development process.
  • Stress testing, degradation information for all regulatory documentsand NDA submissions.
  • Served as Lilly point person for regulatory issues related to impurities and to photostability issues, especially with regard to the International Conference on Harmonization (ICH) efforts on this topic.

Supervisor, Thermal Analysis and Microcalorimetry Group, 2001 - 2006

  • Solid state characterization of compounds in ASRD. Techniques included DTA/TGA, DSC, DMA, DEA, and full microcalorimetry capabilities (high sensitivity DSC, isothermal and isoperibol microcalorimetry, etc.).

Structure Team Leader, 2000 - 2006

  • Overseeing the formal structure proof of all small molecule candidates, and the authoring of internal technical reports and regulatory documents / NDA submissions.

Photostability Tester, 1993 - 2007

  • Responsible for photostability testing of all small molecule candidates, including testing design and protocol. Oversight of all Lilly photostability investigations.

Senior Chemist, Analytical Development, 1984 - 1994

  • Pharmaceutical product development.

Additional Professional Experience

Daily Analytical Laboratories, Analysist, Environmental and Residue Chemist

  • Supervised organic section of environmental laboratory (four chemists) and developed methods for analysis of organic priority pollutants in a wide variety of sample matrices utilizing GC and GC/MS.
  • Successfully obtained certification by the Illinois EPA for the Superfund Contract Laboratory Program performing as the top organic laboratory in competitive evaluation less than six months after installation of first GC/MS.

Resource Recycling Technologies, Analytical Chemist

  • Developed methods for and performed a wide variety of chemical analyses related to both environmental and oil/solvent samples.
  • Experience with AA, GC, GC/MS, and numerous basic wet chemical methods.

Vanderbilt University, Graduate Student in Organic Chemistry

  • NIH National Research Service Award grantee in a predoctoral training program in environmental toxicology.
  • Research involved extensive hands-on use of various separation techniques, 1- and 2-D NMR, GC/MS, UV, and derivatization techniques to elucidate structures.
  • Research focused on studying the molecular basis for aflatoxin carcinogenicity, the biosynthesis and metabolism of certain prostaglandins and fatty acids.

Honors & Publications

Credentials

  • Predoctoral training program in environmental toxicology. Research involved extensive hands-on use of various separation techniques, 1- and 2-D NMR, GC/MS, UV, and derivatization techniques to elucidate structures.
  • Research focused on studying the molecular basis for aflatoxin carcinogenicity, the biosynthesis and metabolism of certain prostaglandins and fatty acids.

Academic and Professional Affiliations

  • American Chemical Society
  • American Association of Pharmaceutical Scientists
  • Steering Committee Member for APQ Stability Focus Group
  • Commission Internationale de l'Eclairage (CIE), Topic Chair for Pharmaceutical Photostability, Committee Member, Expert Working Group for "In-Use Photostability"
  • Pharmaceutical Photostability of Drugs Interest Group, Steering Committee Member Member of the American Society for Photobiology (ASP) (intermittently)
  • Member of the Customer Advisory Council (Weathering / Photostability) for Atlas Materials and Testing (Mount Prospect, IL)
  • Academy of Pharmaceutical Scientists of Great Britain
  • Fellow of the AAPS

Awards

  • NIH National Research Service Award Grantee, Vanderbilt University

Publications

  • Peer Reviewed Articles: 47 (over 1700 citations)
  • Non-Peer Reviewed Articles: 8
  • Book Chapters: 26
  • Books Edited: 2
  • Oral Presentations: 101
  • Conferences, Symposia Chaired / Organized: 28

Education

  • Ph.D. Organic Chemistry, Vanderbilt University, Nashville, TN
  • M.S. Organic Chemistry, Vanderbilt University, Nashville, TN
  • B.S. Chemistry, Lipscomb University, Nashville, TN
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