Pharmaceutical Development Consultant and Expert Witness

Technical Consultant #1394

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.

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.

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.