Expert Details
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
ID: 723693
Florida, USA
In the late 1990s, Expert moved into pilot plant leadership, serving as founding Pilot Plant Operations Manager and later Assistant Director at a novel drug delivery and tissue engineering company, where he built and managed a cGMP/cGLP-compliant facility supporting pre-clinical, clinical, and regulatory stability production. Since 2002, he has led his own independent consulting practices, providing pharmaceutical development advisory services to multinational, mid-size, and virtual pharma companies, as well as academic institutions and the NIH, on preformulation, CMC development, and process validation matters.
Since 2003, Expert has built an extensive expert witness practice, serving in more than a dozen Paragraph IV Hatch-Waxman and Canadian Notice of Allegation patent litigation matters involving well-known branded pharmaceutical products. His engagements have covered claims construction, patent prosecution history, formulation and preformulation issues, polymorphism, and particle size, on behalf of both innovator and generic pharmaceutical companies. He has authored numerous expert reports and declarations and has testified at both deposition and trial.
Alongside his industry and litigation work, Expert has maintained an active academic and scholarly presence, holding adjunct and visiting faculty appointments at several universities and delivering dozens of invited seminars, symposia, and training courses over his career. He is the author of 17 peer-reviewed journal manuscripts, 12 meeting abstracts, and 5 technical magazine articles, and has been recognized for his contributions as a peer reviewer for national scientific journals and NIH grant panels. He holds a Ph.D. in Pharmaceutics from the Philadelphia College of Pharmacy and Science and is a long-standing member of the American Association of Pharmaceutical Scientists, where he has held multiple leadership roles within its Pharmaceutical Technologies Section.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1975 | Degree: Ph.D. | Subject: Pharmaceutics | Institution: Philadelphia College of Pharmacy and Science |
| Year: 1972 | Degree: M.S. | Subject: Pharmaceutics | Institution: Philadelphia College of Pharmacy and Science |
| Year: 1968 | Degree: B.S. | Subject: Pharmacy | Institution: Philadelphia College of Pharmacy and Science |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2018 to Present | Employer: Undisclosed | Title: President / Principal | Department: |
Responsibilities:Consultant to Multinational Big, Medium and Virtual Pharma Companies, Academia and NIH. Projects and Services included Preformulation / Physical Pharmacy, Product Development, Project Management, Author and Reviewer of Chemical Development, Pharmaceutical Development, and Process Validation Reports, CMC Sections of INDs and NDAsExpert Witness for Law Firms and Companies in US Paragraph IV Hatch-Waxman Paragraph IV and Canadian Notice of Allegation innovator vs. generic companies, pharmaceutical dosage form patent litigation, in-licensing due diligence, and contract disputes. Supported Claim Construction, Consulted as an Expert, Wrote Expert Reports, and testified at Deposition and Trial. |
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| Years | Employer | Title | Department |
| Years: 2002 to 2017 | Employer: Self Employed | Title: Principal/President | Department: |
Responsibilities:Consultant to Multinational Big, Medium and Virtual Pharma Companies, Academia and NIH. Projects and Services included Preformulation / Physical Pharmacy, Product Development, Project Management, Author and Reviewer of Chemical Development, Pharmaceutical Development, and Process Validation Reports, CMC Sections of INDs, and NDAs.Expert Witness for Law Firms and Companies in US Paragraph IV Hatch-Waxman Paragraph IV and Canadian Notice of Allegation innovator vs. generic companies, pharmaceutical dosage form patent litigation, in-licensing due diligence, and contract disputes. Supported Claim Construction, Consulted as an Expert, Wrote Expert Reports, and testified at Deposition and Trial. Served on three NIH, National Institute of Allergy and Infectious Disease (NIAID) Grant Peer Reviewer: 1. Advisory Committee, FY; 2. Special Emphasis Panel (Biodefense, AIDS and Emerging Infectious Disease.), 3. Centers of Excellence for Translational Research (Emerging Infectious Diseases Pathogens). Served on three NIH Contract Review Panels, grading and reviewing proposals for NIH grants for the development of drug substances for unmet infectious diseases and potential terrorist agents. |
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| Years | Employer | Title | Department |
| Years: 1997 to 2001 | Employer: Therics Inc. | Title: Manager then Assistant Director Pilot Plant Laboratory (PPL) Operations | Department: Pilot Plant Operations |
Responsibilities:Founding Pilot Plant Laboratory (PPL) Operations Manager, for novel 3D-Printing Drug Delivery and Medical Device Development Company. Furnished/maintained 4200 sq. ft. PPL with equipment, SOPs, APIs, excipients, intra- and extra- mural services. Established cGMP mind set and compliance; provided training and facilities for production of pre-clinical, clinical, stability, regulatory and R&D batches. Was responsible for sourcing and purchasing vendor services, packaging and gamma irradiation. Managed Documentation, Technical Writing, and PPL Operations. |
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| Years | Employer | Title | Department |
| Years: 1991 to 1996 | Employer: THE R. W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE | Title: Research Manager | Department: Physical Pharmacy |
Responsibilities:Managed Section of 12 scientists, with 3 Ph.D. level supervisors for Preformulation, Materials Characterization, and Dissolution Laboratory Groups. Managed Section’s integration from the Pharmaceutical. Dev. Dept. into the Analytical Dev. Dept.• Wrote and reviewed Numbered Reports and Pharm. Dev. CMC Sections for IND and NDA submissions for 5 new APIs and 6 supplier or commercial synthesis procedure changes (e.g., a sulfonamide, chlorzoxazone, ofloxacin, tramadol HCl, topiramate). Set/reviewed/authorized changes to specifications for particle size and dissolution, polymorphic form and responded to regulatory questions (fenretinide, topiramate, norgestimate, tramadol and perindopril). • Maintained cGMP laboratories by developing and training staff, establishing SOPs for preformulation activities; developing expertise within staff (polymorphism, moisture sorption of dosage forms and packaging of OC patient inserts), rational development and validation of dissolution methods; evaluation and incorporation of new methodologies, and delegating to responsible staff members. • Developed three user-friendly computerized databases that provided instant and complete information and references facilitating reports and regulatory submissions. • Developed dissolution methods for immediate (IR), controlled (CR), sustained (SR), extended (ER) and topical drug delivery systems (TDDS). |
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| Years | Employer | Title | Department |
| Years: 1989 to 1990 | Employer: THE R. W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE | Title: Group Leader | Department: Physical Pharmacy |
Responsibilities:Method Development - Developed, validated and published model methods for evaluation/selection of final salt and polymorphic forms for NCE development. Co-developed with Chem. Devel. Dept., a systematic method for assuring/demonstrating polymorphic control of final commercial recrystallization method for APIs. (Utilized in 3 NDA CMC submissions, tramadol HCl, perindopril erbumine, and topiramate.Maintained cGMP laboratories by developing and training staff, establishing SOPs for preformulation activities; developing expertise within staff (polymorphism, moisture sorption of dosage forms and packaging of OC patient inserts), rational development and validation of dissolution methods; evaluation and incorporation of new methodologies, and delegating to responsible staff members. • Developed 3 user-friendly computerized databases that provided instant and complete information and references facilitating reports and regulatory submissions. • Developed dissolution methods for immediate (IR), controlled (CR), sustained (SR), extended (ER) and topical drug delivery systems (TDDS). • Wrote and reviewed Numbered Reports and Pharm. Dev. CMC Sections for IND and NDA submissions for 5 new APIs and 6 supplier or commercial synthesis procedure changes (e.g., a sulfonamide, chlorzoxazone, ofloxacin, tramadol HCl, topiramate). Set/reviewed/authorized changes to specifications for particle size and dissolution, polymorphic form and responded to regulatory questions (fenretinide, topiramate, norgestimate, tramadol and perindopril). |
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| Years | Employer | Title | Department |
| Years: 1986 to 1988 | Employer: McNeil Pharmaceutical | Title: Group Leader | Department: Physical Pharmacy |
Responsibilities:Provided support for Discovery Research (Medicinal-Chemistry, Biochemistry and Pharmacology) and Development (Drug Metabolism, Drug Safety/Toxicology, Chemical-Development, and Pharmaceutical Development, and Tech-Services) in Physical-Chemical characterization, selection of candidate final salt and polymorphic forms |
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| Years | Employer | Title | Department |
| Years: 1980 to 1986 | Employer: McNeil Pharmaceutical | Title: Principal Scientist | Department: Basic Pharmaceutics Section |
Responsibilities: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. All McNeil NCEs (1976-96) including tolmetin, zomepirac, butaclamol, cetiedil, topiramate, and perindopril.Determined API solubilities to support/create novel preclinical delivery systems, improvement in bioavailability (BA) and drug delivery systems (DDS) development. Formulated novel Preclinical i.v. emulsions, in situ solubilization, and softgel delivery systems for practically insoluble APIs. Supported line extensions by developing less soluble forms of i.m. haloperidol and oral linogliride for extended/controlled release, more soluble forms of zomepirac for parenteral delivery, and log P – SAR models for selection of an optimal form of an NCE for transdermal delivery. |
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| Years | Employer | Title | Department |
| Years: 1976 to 1980 | Employer: McNeil Pharmaceutical | Title: Senior Scientist | Department: Basic Pharmaceutics Section |
Responsibilities: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. Published methods/results. Developed and published methods for studying corrosivity and filming of APIs, API-excipient compatibilities, and vapor pressures of solids. |
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| Years | Employer | Title | Department |
| Years: 1983 to 1993 | Employer: University of Cincinatti | Title: Adjunct Assistant Professor | Department: Pharmacy / Cosmetics Sciences Department |
Responsibilities:Supervised thesis research of 2 MS candidates leading to enhanced understanding of model systems for solubilization and insoluble salt forms for controlled release dosage forms. Work led to publication of an abstract and a manuscript. |
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| Years | Employer | Title | Department |
| Years: 1975 to 1976 | Employer: Northeastern University, College of Pharmacy and Allied Health and Professions | Title: Assistant Professor of Pharmacy | Department: Pharmacy |
Responsibilities:Taught Undergraduate Pharmaceutics and Sterile Products courses, Lecture and Laboratory. |
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| Years | Employer | Title | Department |
| Years: 1974 to 1975 | Employer: Massachusetts College of Pharmacy | Title: Assistant Professor of Pharmacy | Department: Pharmaceutics |
Responsibilities:Taught Undergraduate Pharmaceutics, Lecture and Laboratory, and Pharmaceutical Calculations courses. |
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Additional Experience
| Expert Witness Experience |
|---|
| Served as an expert witness and expert consultant since 2003 in more than 20 pharmaceutical patent litigation matters, spanning both U.S. Hatch-Waxman Paragraph IV litigation and Canadian Notice of Allegation proceedings brought by innovator companies against generic manufacturers. His engagements have covered a broad range of branded products — including BIAXIN®, PREVACID®, PRILOSEC®, PLAVIX®, RYTHMOL®, CEFTIN®, SUSTIVA®, DUEXIS®, UNIVASC®, ABILIFY®, CHAMPIX®, VIMOVO®, TRUVADA®, SENSIPAR®, KAZANO®, RIOMET®, and POMALYST® — representing both innovator and generic litigants across firms such as McCarthy Tétrault, Cohen Pontani Lieberman & Pavane, Husch Blackwell, Knobbe Martens, McAndrews Held & Malloy, and Pillsbury Winthrop, among others. His technical opinions have centered on formulation science issues at the heart of patent validity and infringement disputes: excipient selection and reduction, pH and residual base content, polymorphic form and DSC characterization, particle size, dissolution behavior, and disintegrant concentration relative to prior art ranges — consistently applying his preformulation and physical-pharmacy expertise to determine whether claimed features were novel or dictated by ordinary formulation practice. Beyond patent litigation, the Expert has also served as the sole expert and consultant in a contract dispute over royalty commissions tied to patented liquisolid drug delivery technology, where he authored the expert reports and testified at both deposition and trial in a case that resulted in a multi-million dollar award for his client. He has also supported product liability and manufacturing-quality matters, including a pretrial engagement reviewing batch records and laboratory data to establish the cause of contamination in an injectable riboflavin product. Across these engagements, his work has included authoring expert reports, declarations, and rebuttal reports; reviewing and countering opposing experts' opinions; advising counsel through memos and teleconferences; and testifying at deposition and trial, with case outcomes including favorable court decisions, negotiated settlements, summary judgment, and case withdrawal by plaintiffs. |
Career Accomplishments
| Associations / Societies |
|---|
| American Associan of Pharmaceutical Scientists (AAPS) Pharmaceutical Technologies (PT) Section; American Pharmaceutical/Pharmacists Association (APhA) |
| Licenses / Certifications |
|---|
| NJ: Registered Pharmacist (R.Ph.) 1970 - 2017, now retired. NJ: Immunizing Pharmacist, 2010 - 2013, now retired. FL: Registered Pharmacist (R.Ph.) 2010 - 2015, now retired. |
| Awards / Recognition |
|---|
| Rho Chi Honor Society (Pharmacy) NSF Graduate Traineeship |
| Publications and Patents Summary |
|---|
| He is the author of 17 peer-reviewed journal manuscripts, 12 meeting abstracts, and 5 technical magazine articles, and has been recognized for his contributions as a peer reviewer for national scientific journals and NIH grant panels. |
Fields of Expertise
analytical method optimization, Current Good Manufacturing Practice, dosage form, drug, drug development, drug dosage form development, Good Manufacturing Practice, Good Manufacturing Practice training, oral drug delivery, over-the-counter drug product development, pharmaceutical industry, pharmaceutical drug, pharmaceutical quality assurance, pharmaceutical research, polymorphic, polymorphism, Chemistry, Manufacturing and Controls