Expert Details

Expert in Pharmaceutical Science; Preformulation, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation

Expert ID: 723693 Florida, USA

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As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for analysis are defined. Expert has written several of these validation reports.

At a start up drug delivery system organization, Expert had responsibility for establishing a cGMP compliant Pilot Plant and establishing a cGMP compliance state of mind. The staff using the facility included Engineering which built the fabrication device, R&D personnel, and Quality Control and Assurance. He was responsible for training, establishing and writing SOPs, providing vendor services such as cleaning, sterilization, and components. He was also an instructor for cGMP training by an international provider of training.

As a pharmaceutical scientist who worked for big Pharma J&J, consultant to several small Pharma companies, Expert has had experience with the development of the following: Tablets, capsules, parenteral products, controlled release, immediate release, enteric/polymeric and pulsatile delivery systems; oral solutions, topical products, vaginal suppositories, tablets and creams, transdermal delivery systems; medical device containing drug; pulsatile iontophoresis; HCG, steroids, anti-cancer agents; CNS, CVS; anti microbials; sublingual tablets.

Expert has supported their development and for some such as oral and parenteral solutions, iontophoretic and vaginal non-oral effervescent delivery; He has been an actual formulator or project manager.

Expert has over 30 years experience in the development of pharmaceuticals. He has an undergraduate degree in Pharmacy, a pharmacy license in NJ (active) and an MS and PhD in Pharmaceutics, the science of drugs.

Expert has been in Pharmaceutical Development for over 30 years. He has supported development of practically every type of drug product at McNeil Pharmaceutical/The RW Johnson Pharm Research Institute (Ortho-McNeil) merger. He has sat on development teams that have moved NCEs from discovery to finished products, ACEON(R)Perindopril erbumine, LEVAQUIN(R) levofloxacin, ULTRAM(R) tramadol, TOPAMAX (R) topiramate, (Ortho) Oral contraceptive combinations, HALDOL (R) Halopperidol DECONATE inj; failed projects such as cetiedil citrate, fenobam, xilobam, fenoctimine sulfate, fenretinide, transdermal delivery systems containing an opiate.

Expert has done feasibility studies for experimental dosage/delivery systems, formulated sub-lingual dosage, NCE in oil/water IV emulsions for drug safety studies. Modeled partitioning to predict transdermal penetration in human skin.

As a consultant to a small virtual company, Expert managed development of an effervescent steroid vaginal tablet for aid in pregnancy, iontophoretic pulsatile delivery of a peptide, and an intramuscular or sc delivery of a human female hormone derived from urine. All work was performed by contract vendors.
He formulated several injectable and oral solution products at McNeil for human use as well as several for animal pre-Clinical Safety and Pharmacokinetic studies.
Expert was responsible for establishing a cGMP attitude at company. He taught cGMP compliance and several times for PT-International. Expert worked for J&J, an industry leader. As a consultant, Expert has seen other organizations' compliance.

Expert trained colleagues and new hires, including Engineering, R&D, and Control in cGMPs. He has 20 years experience at J&J, a leader in cGxP training and practices. He was a trainer for PT International, cGMP.

Expert is experienced with Controlled Release, Immediate Release, Delayed Release, Tablets and Capsules.

Expert was developing 9 OTC flash dosage forms that contained cough and cold combinations. He has consulted at a major OTC Big Pharma Company several times, including writing documents for and parts of the CMC NDA.

Expert has over 30 years in the industry, developing pharmaceuticals. He has worked with small and medium sized pharma companies as a consultant. He has worked with J&J big Pharma. He is a former chair of the Pharmaceutical technologies Section of the American Pharmaceutical Association.
At J&J, Quality Assurance meant that all written reports and documents were reviewed for compliance to notebook entries and written SOPs. Changes in the processing and scale up of NCE synthesis and recovery during development can result in the creation of polymorphic forms. Pharmaceutical processes that involve addition of energy such as milling, dissolution such as in granulation can also create new polymorphic forms. Polymorphic forms have the same chemical structure but differ in crystallinity and crystalline form. They can have differences in solubility, chemical stability, color, and bioavailability. Occasionally, pharmaceutical scientists deliberately try to create new forms to take advantage of these types of differences, particularly in a positive fashion.

Identification and characterization of polymorphics is performed by X-ray powder diffraction (XRD) and solid state NMR. DSC and hot stage microscopy are secondary tools for characterization of these forms. Expert has experience with several NCEs such as fenretinide and fenoctimine sulfate, where XRD methods for quantization and identification were developed.

Expert managed CRO development of three products, a solid dosage form for non oral delivery; a sterile biological hormone, human origin; and an iontophoretic delivery system; for virtual company over 16 month period, >$6 Mil budget each. Pre-clinical support through Phase III CTM/Registration Batches of Drug Product. Developed budgeting models. Authored issues free IND CMC. Provided critical/feasibility assessments of APIs/NCEs for pulsatile, ER and IR applications; data, projects, presentations, personnel and facilities. Wrote Pharmaceutical Development Reports and Analytical Development Reports for regulatory submissions. Reviewed Corporation’s Analytical Methods Validation Reports for compliance to ICH Guidelines and internal SOPs. Reorganized Analytical Methods.

For several clients authored reports for regulatory submissions
a) Authored 70% and critically reviewed 30% of reports from Analytical Development Dept. for inclusion in antibiotic NDA
b) Critically reviewed data/initial draft for all Analytical Dev Dept. Reports for an Rx to OTC switch NDA. validation, Chem. Development and the analytical section of the CMC in the NDA. Identified and resolved problems, errors and inconsistencies, and recommended and applied successful solutions.
c) Authored Pharm Dev History Reports for clients, effervescent steroid for non-oral delivery and OC combination for NDAs.

a) Reviewed projects with clients, where project venting was necessary to move forward.
b) Recommended contacts at FDA and other service providers to several clients.

Expert may consult nationally and internationally, and is also local to the following cities: St Augustine, FL - Jacksonville, FL - Daytona, FL

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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 Responsibilities
Years: 2002 to 2017 Employer: FA Chrzanowski, Inc. Pharmaceutical Consultants and Expert Witness Services 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 development of drug substances for unmet infectious diseases and potential terrorist agents.
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.
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).
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).
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
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.
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.
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.
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 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.
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.

Developed Pharmaceutics Laboratory Program utilizing closed circuit TV demonstrations and laboratory operations to optimize efficient use o faccilities and enhance student understanding of compounding processes.
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.

Government Experience

Years Agency Role Description
Years: 2006 to 2006 Agency: NIH/NIAD Role: Peer Review and Advisory Committee Member Description: Reviewed development contract proposals submitted by vendors for Nid/NIAD grants

International Experience

Years Country / Region Summary
Years: 2004 to Present Country / Region: Canada Summary: Expert witness for several patent infringement cases.

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.
Professional Appointments
Elected Secretary Treasurer of Pharmaceutical Technologies Section of the American Association of Pharmaceutical Sciences (AAPS) to two 3 year terms;
Elected President-PT Section of AAPS, served as Vice Chair, Chair-elect, Chair and Past-Chair)
Appointed an Adjunct Assistant Professor, Univ. of Cincinnati College of Pharmacy, Pharm and Cosmetic Sciences Depts.
Appointed in FY 2006 NIAID Peer Review and Advisory Committee Member, National Institute of Allergy and Infectious Disease (NAAID
Awards / Recognition
Rho Chi Honor Society (Pharmacy) 1967;
NSF Graduate Traineeship 1971-1972
Publications and Patents Summary
Author of 14 published manuscripts, 11 abstracts and 15 Invited symposia, seminars and courses.
Topics include preformulation, polymorphism, excipient compatibilities.

Additional Experience

Expert Witness Experience
Expert Witness for patent litigation for Canadian and US attorneys involved Hatch-Waxman Pharmaceutical Formulation related patent litigation.
Products included: omeprazole, lansoprazole, clarithromycin, clopidogrel, propafenone extended release, cefuroxime axetel, efavirenz and Liquisolid Systems, and Pregnancy Vitamin Supplement.

Due Diligence for attorneys and investors. Tramadol HCl extended release, lenalidomide
Training / Seminars
Developed training seminars for cGMP basics for new employees (at Therics) and cGMPs for Clinical Supplies as a contractor for PTI (of NYC) several times in 2002 and 2004.
Vendor Selection
Selected vendors for purchase of laboratory instruments (XRD, DSC/TGS, HPLC Systems) and contract development vendors for virtual company.
Marketing Experience
Established Consulting Company serving Pharmaceutical Development Companies. Clients ranged from Big Pharma to Virtual Companies, Academia, Rx and OTC Companies.
Other Relevant Experience
Preformulation /Physical Pharmacy
20 years experience leading a Preformulation Physical/Pharmacy Unit that included R&D Dissolution Development and Stability. Developed methods for characterizing/quantitating polymorphs of NCEs; rusting potential of drug substances, granulations and mixtures; filming and sticking potential of drug substances, granulations and mixtures; developed methods for characterizing excipient compatibilities, selection of optimal candidate forms for dosage form development.

Fields of Expertise

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