CURRICULUM VITAE



Expert Witness & Consultant Services



EXPERIENCE


CONSULTANT / EXPERT WITNESS

  • Provided Expert / Expert Witness Services for Law Firms and Companies in US Paragraph IV Hatch-Waxman and Canadian Notice of Allegation innovator vs. generic pharmaceutical dosage form patent litigation, in-licensing due diligence, and contract dispute involving commissions and patented technologies.
  • Supported Claims Construction; • Provided Expert Opinions regarding patent claims, contemporary scientific understanding of claims.
  • Wrote Expert Reports for US and Canadian patent litigation.
  • Testified twice at both Deposition and at Trial.
  • Served as a Consultant to Big, Medium and Virtual Pharma Companies, Universities and NIH for Pharmaceutical Development Issues in the Preformulation and Chemistry, Manufacturing and Control (CMC) Areas.
  • ExpertPharma, LLC, Consultant and Expert Witness Services 2018 – present
    • Principal / President 2018 – Present.
  • FA Chrzanowski, Inc., Pharmaceutical Consultant and Expert Witness Services 2002 - 2017
    • Principal / President 2002 - 2017.
  • fac Consulting, Inc., Pharmaceutical Consultant, 1996 – 1997
    • Vice President 1996 – 1997.

PHARMACEUTICAL DEVELOPMENT


THERICS, Inc. 1997 – 2001

  • Assistant Director for Pilot Plant Laboratory Operations 1999 – 2001
  • Manager, Pilot Plant Operations 1997 – 1999
    • Founding Pilot Plant Laboratory (PPL) Operations Manager, for novel 3D-ink-Jet Printing Drug Delivery and Tissue Engineering (Bone) Development Company.
    • Provided and maintained 4200 sq. ft. PPL with equipment, SOPs, APIs, excipients, intra- and extra- mural services, cGMP compliance and training, for GLP and cGMP batches.
    • Managed Documentation, Technical Writing, and PPL Operations
    • DEA and NJ Controlled Drug Substance Registrant for Researcher Schedules I to V.


  • JOHNSON & JOHNSON FAMILY OF COMPANIES 1976 - 1996
    • THE R. W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
      • Research Manager, Physical Pharmacy, 1991 - 1996
      • Group Leader, Physical Pharmacy, 1989 – 1990 McNeil PHARMACEUTICAL CORPORATION / McNeil LABORATORIES
      • Group Leader, Physical Pharmacy 1986 - 1988
      • Principal Scientist, Basic Pharmaceutics Section 1980 – 1986
      • Senior Scientist/Research Scientist, Basic Pharmaceutics Section 1976 – 1979
      • Member of multiple Lead Compound Project Development Teams and Task Forces
      • Managed Section, consisting of 3 Ph.D. level supervisors, 6 B.S. Chemists/, and Chem Technicians divided among Preformulation/Physical-Pharmacy and Dissolution Laboratory Groups. that provided data and services to all of Research, Development, and Commercial Manufacturing Departments
      • Managed the integration of the Physical/Pharmacy/Dissolution Development & Stability Section from the Pharmaceutical Dev Dept into the Analytical Dev Dept.
  • Physical-Pharmacy / Preformulation
    • Providing relevant experimental studies to create data characterizing NCEs and APIs in support of Research and Development with primary responsibility to support formulation development and remediation of problematic properties of NCEs,
    • Evaluation and feasibility of novel drug delivery systems and analytical methods, • Providing Numbered Departmental Reports and documents for IND/NDA regulatory submissions
    • Method Development o Validated and published model methods for evaluation/selection of final salt and polymorphic forms of lead NCEs for formulation, clinical and commercial development.
    • Published methods for studying corrosivity and filming of APIs, API-excipient compatibilities.
    • Created an apparatus and published method for determination of the vapor pressures of API solids.
    • Published Method for API-Drug Excipient Compatibilities simulating wet granulation.
  • Discovery: Medicinal Chemistry and Pharmacology Support
    • Determined and published reliable experimental pKa and log P values for intramural structure SAR by CVS, CNS, Endocrine and NSAID Medicinal-Chemistry and Pharmacology Discovery Teams that led to the discovery and selection of lead NCEs.
  • Clinical and Pre-Clinical (Drug Safety and Pharmacokinetics/Drug Metabolism) Support
    • Determined NCE solubilities to support/create novel preclinical and clinical delivery systems for animal safety, animal and human Bioavailability (BA), Metabolism and Pharmacokinetic studies. Delivery systems included drug laden oil/water iv emulsion, in situ solubilization, and softgel delivery systems for practically insoluble NCEs.
  • Chemical Development Support
    • Initiated an in house practice utilizing X-ray Powder Diffraction (XRD) for qualitative/quantitative polymorphic analyses of every new batch of each NCE in development from project initiation to commercialization, to identify, study, and control polymorphic form (pedigree) and quantity.
  • Line Extensions
    • Developing less soluble salt forms of haloperidol for i.m. administration and linogliride oral extended release; highly (5000 x more) soluble salts of zomepirac for i.m. administration; and log P – SAR models for selection of an optimal form of an API for transdermal delivery.
  • Dissolution Laboratory
    • Developed dissolution methods for immediate (IR), controlled (CR), sustained (SR), extended (ER) dosage forms and topical drug delivery systems (TDDS).
    • Provided Dissolution data for all formulations of NCEs, competitor’s products and reference compounds and reformulated/encapsulated reference products for Formulation Development and Clinical Development.
    • Provided data for Dissolution Stability Program for dosage forms and packaging stability studies. • Maintained cGMP compliant laboratories by developing and training staff, establishing SOPs for preformulation activities; developing expertise within staff, rational development and validation of dissolution methods; evaluation and incorporation of new methodologies, and delegating to responsible staff members.
  • Authored / Reviewed Numbered Reports and Pharm. Dev. CMC Sections for IND and NDA submissions for 5 NCEs and 6 API supplier or commercial synthesis procedure changes. Set/reviewed/authorized changes to specifications for particle size and dissolution, polymorphic form and responded to regulatory questions.