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Pharmaceutical Development Consultant and Expert Witness

Technical Consultant #1394


Expertise

  • Expert Witness for pharmaceutical patent litigation.
  • Pharmaceutical reformulation and the physical-chemical characterization of new chemical entities (NCE) and APIs.
  • X-Ray diffraction, polymorphism, solubilization, stabilization and kinetics of pharmaceutical materials.
  • Author of regulatory (IND/NDA/CTD) CMC sections and support documents.
  • Project planning and management for pharmaceutical development projects, including virtual contract research (CRO) companies.
  • Pharmaceutical method development preformulation and pilot plant laboratories.
  • Pharmaceutical pilot plant operation and validation.

Experience

Pharmaceutical Consultant, 2002 - Present

  • Practice focused on pharmaceutical materials, regulatory issues and expert witness related to patent litigation.
  • Managed CRO development of 3 products: Solid dosage form for non oral delivery; sterile biological hormone with human origin; and an iontophoretic delivery system.
  • Authored or critically reviewed all of Analytical Development Department Reports to support NDA filing for novel amoxicillin dosage form.
  • Reviewed Corporation's Analytical Methods Validation Reports for compliance to ICH Guidelines and internal SOPs.
  • Provided feasibility assessments of APIs/NCEs for pulsatile, ER and IR applications.
  • Authored Project Summaries, SOPs and IQOQ Protocols for R&D projects and facilities.
  • Provided cGMP training for clinical supplies manufacturing course.

Therics, Inc.,1997 - 2001

  • Pilot Plant Laboratory Operations Manager for novel 3D-printing drug delivery and medical device company.
  • Furnished and maintained pilot plant with equipment, SOPs, APIs, excipients and related materials and services.
  • Responsible for sourcing and purchasing vendor services, packaging and gamma irradiation.
  • Managed documentation, technical writing, and pilot plant operation procedures.
  • Authored over 60 SOPs and led GMP training for R&D and Engineering Departments.
  • Created and maintained electronic inventory systems for raw materials and finished products.
  • Responsible for sourcing raw materials, disposables, equipment, contract services, preventive maintenance (PM), calibration, packaging and gamma sterilization.

Johnson & Johnson Family of Companies, 1976 - 1996

  • Physical pharmacy supported all phases and departments, pre-clinical safety, metabolism and pharmacokinetics.
  • Worked on issues related to: medicinal chemistry and pharmacology; pharmaceutical formulation; dissolution development and stability; and, chemical process development.
  • Member of anti-secretory, anti-histamine, oral contraceptive, CNS and CVS development teams.
  • Performed and managed preformulation and physical pharmacy studies to ensure understanding of NCE properties and correct submission of IND/NDA reports.

The R. W. Johnson Pharmaceutical Research Institute, 1989 - 1996

  • Served as Research Manager and Group Leader, Physical Pharmacy. Supervised preformulation, materials characterization and dissolution technical groups.
  • Developed, validated and published model methods for evaluation/selection of final salt and polymorphic forms for NCE development. Co-developed with method for assuring/demonstrating polymorphic control of final commercial recrystallization method for APIs.
  • Maintained cGMP laboratories.
  • Wrote and reviewed Numbered Reports and Pharm. Dev. CMC Sections for IND and NDA submissions for 5 new APIs imcluding a sulfonamide, chlorzoxazone, ofloxacin, tramadol HCl, topiramate).

McNeil Pharmaceutical Corporation, 1976 - 1988

  • Worked as Senior Scientist, Principal Scientist, and Group Leader of Physical Pharmacy.
  • Provided support for discovery including pharmacology, drug metabolism, drug safety and toxicology and chemical development.
  • Determined and published reliable experimental pKa and log P values for structure SAR for use by CNS, NSAID, CVS and Diabetes Medicinal-Chemistry, Pharmacology, Discovery. Involved with all McNeil NCEs including tolmetin, zomepirac, butaclamol, cetiedil, topiramate, and perindopril.
  • Pioneer/leader in the use of X-ray Powder Diffraction for qualitative/quantitative analysis of APIs. Established specification methods and criteria for polymorphic mixtures and advantages of preferred forms.
  • Developed and published methods for studying corrosivity and filming of APIs, API-excipient compatibilities, and vapor pressures of solids.

Honors & Publications


Professional Affiliations

American Association of Pharmaceutical Scientists (AAPS)- Charter Member and leadership positions.

American Pharmaceutical/Pharmacists Association (APhA)

Academy of Pharmaceutical Sciences (APS)

Publications: 14 Journal Manuscripts; 11 Meeting Abstracts; 15 Seminars and Training Courses.


Education

  • Ph.D. Pharmaceutics, Philadelphia College of Pharmacy and Science
  • M.Sc. Pharmaceutics, Philadelphia College of Pharmacy and Science
  • B.Sc. Pharmacy, Philadelphia College of Pharmacy and Science
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