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Pharmaceutical Development Scientist Expert Witness

Provides Opinion & Testimony In:

Pharmaceutical Scientist, Pharmaceutical Consultant, Hatch Waxman, Pharmaceutical patent litigation, CMC Development issues, Preformulation, Pharmaceutics, GMP Operations, Polymorph, Formulation Development, Drug Delivery, Due Diligence, IND NDA, SOPs

Expert Witness No. 3798

SUMMARY

·    Pharmaceutical Development Scientist, Expert Witness and Consultant having more than 30 years
     experience.
·    Consultant to 16 clients including Big, Medium and Virtual Pharma Companies, Academia and US
     Government.  Projects included Project/Product Development Management; Preformulation Support;
     Author and Reviewer of Chemical Development, Pharmaceutical Development, and Process
     Validation Reports, CMC Sections of INDs, NDAs and CTD.
·    Expert Witness for US and Canadian Pharma Companies and Law Firms in pharmaceutical
     formulation patent litigation, in-licensing due diligence, and civil suit involving commissions and
     technology.
·    Pharmaceutical Development Scientist/Manager for 20 years for Johnson & Johnson Family of
     Companies in Preformulation support, anticipating needs; solving problems; advancing projects,
     regulatory filings and departmental capabilities; supporting and interacting with internal
     departments and extramural vendors; keeping projects and filings on schedule.
·    Pilot Plant Operations Manager for 4 years for a new, novel Drug Delivery and Medical Device
     Company, responsible for all services and establishing cGMP mindset.
·    Core specialties include CMC Development issues, Preformulation, Physical-Pharmacy, Analytics,
     cGMP Operations, Project Planning and Management.
·    Overall Experience has resulted in highly developed management and writing skills; extremely wide
     range of direct and indirect product development experiences in multi-national large, medium, small
     and virtual Pharma companies. 
·    Author of 15 published Manuscripts, 12 Meeting Abstracts, 18 Invited Symposia, Seminars and
     Courses, and 5 Articles in Pharmaceutical Magazines.
 

EXPERIENCE

CONSULTANT / EXPERT WITNESS
    2002 – Present
·   Principal / President 2002 – present .

FAC Consulting, Inc., Pharmaceutical Consultants,  1996 - 1997
·    Vice President 1996 - 1997.
·    Established FA Chrzanowski, Inc. in 2002 and FAC Consulting Inc. in 1996.
·    Served as an Expert Witness for Canadian and USA Pharmaceutical Companies and Law Firms for
     dosage form patent litigation, and technology review.
·    Served as a Consultant to Big, Medium and Virtual Pharma Companies, Universities and US g
     government (NIH) for Pharmaceutical Development Issues in the Preformulation and  
     Chemistry, Manufacturing and Control (CMC) Areas.

Consultant
·    Managed CRO development of 3 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.
·    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 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.
·    Authored Project Summaries, SOPs and IQOQ Protocols for R&D projects and facilities.
·    Provided cGMP training for clinical supplies manufacturing course. 
·    PEPCID ACâ famotidine Gelcap: Authored NDA CMC Analytical Section (95 pp).  Critically and
     reviewed preliminary Analytical Methods Validation Report.  Identified and resolved problems, errors
     and inconsistencies, and recommended and applied successful solutions.  Also authored every CMC
     supportive report document such as Methods Development History, Methods Validation (90 pp), and
     Dissolution Method Rationale.  Assignment completed on time in 5 months free of regulatory issues.
·    Published three articles related to Preformulation: Vendor-client mismatched SOPs, utility of SOPs
     in the Preformulation Laboratory, and the current state of Preformulation.


PHARMACEUTICAL DEVELOPMENT

THERICS, Inc.    1997 - 2001
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.  Responsible for sourcing and purchasing vendor services, packaging and gamma irradiation.  Managed Documentation, Technical Writing, and PPL Operations.
·    Assistant Director for Pilot Plant Laboratory Operations 1999 - 2001
·    Manager, Pilot Plant Operations 1997 - 1999
·    Managed $250,000 annual PPL budget.
·    Authored over 60 SOPs, developed Documentation Management Systems, provided SOP and GMP
     training to R&D and Engineering Departments. 
·    Created/maintained electronic inventory systems for raw materials and finished products, and
     electronic intranet homepage for SOPs, forms, abstracts and proposals. 
·    Responsible for sourcing raw materials, disposables, equipment, contract services, preventive
     maintenance (PM), calibration, packaging and gamma sterilization.  
·    DEA and NJ Controlled Drug Substance Registrant for Researcher Schedules I to V.
·    Wrote protocols, project development plans, feasibility reports, and proposal critiques.
·    Consultant member to all project teams.  Provided regulatory guidance on GMP issues.
 
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, 3 Ph.D level supervisors, 6 B.S, Chemists/Analysts and 2 Technicians divided
     among Preformulation, Batch Materials Characterization, and Dissolution Laboratory Groups that
     provided to all of R&D from Discovery through Commercialization and post-Approval Stages. 
·    Providing Dissolution data for formulation development support, scale up and tech transfer, clinical
     supplies, packaging and stability studies in timely fashion. 
·    Providing relevant data and experimental studies to ensure an accurate, timely  and complete
     understanding of the physical-chemical properties NCEs,
·    Remediation of problematic properties of NCEs,
·    Evaluation and feasibility of novel processes and products,
·    Timely reports and documents for IND/NDA regulatory submissions,
·    To facilitate rapid product commercialization of small molecule NCEs. 
·    Managed Section’s integration from the Pharmaceutical Dev Dept into the Analytical Dev Dept.   
·    Method Development – Developed, validated and published model methods for evaluation/selection
     of final salt and polymorphic forms of lead NCEs for formulation, clinical and commercial
     development.  Co-developed with Chem. Dev. Dept., a systematic method for
     assuring/demonstrating polymorphic control of final commercial recrystallization method for NCEs
     that was utilized in NDA CMC submissions for tramadol HCl, perindopril erbumine, and topiramate.
·    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.
·    Developed 3 user-friendly computerized physical-chemical property databases that provided instant
     and complete information and references to R&D colleagues and facilitated completion of reports
     and regulatory submissions.
·    Developed dissolution methods for immediate (IR), controlled (CR), sustained (SR), extended (ER)
     dosage forms and topical drug delivery systems (TDDS).
·    Wrote / 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.
·    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.
·    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 i.v. emulsion, in situ solubilization, and softgel
     delivery systems for practically insoluble NCEs. 
·    Supported line extensions by 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.
·    Initiated the in house use 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, or control polymorphic form (pedigree) and quantitation of
     identified forms where when necessary.  Work led to several published manuscripts. 
·    Developed and published methods for studying corrosivity and filming of APIs, API-excipient
     compatibilities.
·    Developed an apparatus and method for determination of the vapor pressures of NCE solids. 
     Apparatus was constructed from available laboratory equipment (Nitrogen gas, flow meter, tubing,
     water bath and sample holder).

EDUCATION

PHILADELPHIA COLLEGE OF PHARMACY and SCIENCE
Ph.D.  Pharmaceutics, 1975    M.Sc.  Pharmaceutics, 1972    B.Sc. Pharmacy, 1968

LICENSURE

Pharmacist (R.Ph.) New Jersey, 1970 - present
Pharmacist (R.Ph.) Florida, 2010 - present
Immunizing Pharmacist New Jersey 2010 – present


ACADEMIC EXPERIENCE

·    UNIVERSITY OF CINCINNATI COLLEGE OF PHARMACY  1983 – 1993
·    Adjunct Assistant Professor, Pharmacy Department       
     Supervised on site MS thesis research of two University Graduate Students at the RW Johnson 
     Pharmaceutical Institute.  Their work led to an enhanced understanding of (1) model systems used
     for solubilization of an NCE and (2) the formation of insoluble salt forms for creating controlled
     release dosage forms.  Work led to publication of a manuscript and an abstract.

·    NORTHEASTERN UNIVERSITY COLLEGE OF PHARMACY and ALLIED HEALTH PROFESSIONS 1975 – 
     1976
·    Assistant Professor, Pharmacy Department
·    Taught undergraduate Pharmaceutics and Sterile Products courses, both with Laboratory.
·    Developed Pharmaceutics Laboratory program that utilized close circuit TV demonstrations and
     laboratory operations to optimize efficient use of facilities and enhance student understanding of
     compounding processes.

·    MASSACHUSETTS COLLEGE OF PHARMACY    1974 – 1975
·    Assistant Professor, Department of Pharmaceutics
·    Taught undergraduate Pharmaceutics, Pharmaceutics Laboratory and Pharmaceutical Calculations
     courses.


PROFESSIONAL AFFILIATIONS

·    American Association of Pharmaceutical Scientists (AAPS)
·    Charter Member, 1986 – Present. 
·    Pharmaceutical Technologies (PT) Section:  Past-Chair, Chair, Chair-Elect, and Vice Chair,

1997-2000; and Secretary-Treasurer, 1991 – 1996.

·    AAPS Membership Committee, 1986 1989, Chairman 1988 – 1989.
·    Philadelphia Pharmaceutical Forum (PPF), 1986 – 2010.
·    American Pharmacists Association (APhA)
·    Industrial Pharmaceutical Technology (IPT) Section, 1974 – 1986.
·    Academy of Pharmaceutical Research and Science (APRS), 1993 - 2010.
·    Philadelphia Discussion Group (PDG)/Philadelphia Pharmaceutical Forum (PPF), College Seminar

Program Speaker, 1983 – 1989.

·    Johnson & Johnson Corporate Drug Delivery Subcommittee
·    Annual Symposium Co-chair, 1988 – 1994.
·    Contract Pharma Advisory Committee
·    Moderator at Annual Contracting and Outsourcing Conferences, 2007 – present.

SCIENTIFIC PROFESSIONAL

·    National Institutes of Health (NIH)
·    FY 2006 NIAID Peer Review and Advisory Committee Member, National Institute of Allergy and
     Infectious Disease (NAAID)
·    Journal Manuscript Reviewer
·    PharmSci Tech, 2002 – 2003 and 2007 – present.
·    Drug Dev Ind Tech, 2007 - present.
·    J Pharm Sci, 1984 -1992, and 2002 – 2003.

INVITED SYMPOSIA, SEMINARS AND TRAINING COURSES:

1.      Facilitating Small Molecule Dosage Form Development Using Solubility Adjustment, Seminar       
        University of Florida Pharmaceutics Dept, 2012-Jan, Gainesville, (FL).
2.      Pharmaceutics 101: Determining the Physical-Chemical properties of an NCE and Resolving 
        Problems in Supporting Dosage Form Development, Seminar, University of Northern Florida,   
        Chemistry Dept, 2011 Sept, Jacksonville, (FL).
3.      Preformulation Considerations for Dosage Form Development, Visiting Scientist Seminar University
        of Florida Pharmaceutics Dept, 2009 Oct, Gainesville (FL).
4.      Preformulation Considerations for Controlled Release Drugs Including Selecting Candidates,
        Training
        Conference, 41st Annual Pharmaceutical Technologies Arden Conference - Oral Controlled
        Release
        Development and Technology, American Association of Pharmaceutical Scientists Pharmaceutical
        Technology Section: 2006 Jan, West Point (NY).
5.      How to Contract Effectively with Clients, Round Table, American Association of Pharmaceutical  
        Scientists Annual Meeting; 2005 Nov, Nashville (TN).
6.     Preformulation Characterization of Drug Substances for Dosage Form Development, A module in
        Formulation & Process Development for Oral Solid Dosage Forms Training Course,
        PTI-International;  2004 April, Princeton (NJ).
7.     Complying with GMPs for Clinical Manufacturing, Training Course, Pharmaceutical Training
        Institute;
        Presentations: 2002 Washington (DC), Raleigh (NC); 2004 Raleigh (NC), Boston (MA), Washington
        (DC) and San Juan (PR).
8.     Preformulation Characterization of a Poorly Soluble Retinide, Symposium, American Association of
        Pharmaceutical Scientists Annual Eastern Regional Meeting; 1996 Jun, New Brunswick (NJ), and 
        University of Florida Pharmaceutics Dept, 2009 Oct, Gainesville (FL).
9.     Application of Crystallographic Data to the Manufacture of Drug Substance and Drug Product,
        Symposium, American Crystallographic Association Annual Meeting; 1995 Jul, Montreal (Canada).
10.    Non-Classical Approach to Preformulation, Workshop, 29th Annual Arden House Conference,
        American Association of Pharmaceutical Scientists Pharmaceutical Technologies Section; 1994
        Jan, Harriman (NY).
11.    Practical Aspects of Physical Characterization Techniques, Symposium, University of Wisconsin,
        35th Annual International Industrial Pharmaceutical Research Conference (Land-O-Lakes), 1993
        Jun, Merrimac (WI).
12.    Preformulation Characterization of Drug Substance Forms for Parenteral Product Development,
        Symposium, Parenteral Drug Association, Annual Meeting and Exhibition; 1992 Mar, Philadelphia
        (PA).
13.    Preformulation Studies in Pharmaceutical Development, Lecture, Temple University College of
        Pharmacy, Industrial Pharmacy Elective Course; given annually 1989 through 1994, Philadelphia
        (PA).
14.    Preformulation Characterization of Solid-State Drug Substance Forms for Drug Product
        Development, Symposium, Pharmaceutical Technology, Annual Spring Conference, 1989 Apr, New
        York (NY).
15.    Preformulation Excipient Compatibility Testing, Seminar, Philadelphia College of Pharmacy and
        Science; 1985 Sep, Philadelphia (PA); and University of Cincinnati; 1986 Apr, Cincinnati (OH).
16.    The Automated Pharmaceutical Development Laboratory, Symposium, 25th Annual Eastern
        Regional Industrial Pharmaceutical Technology Meeting; 1985 Nov, King of Prussia (PA).
17.    X-ray Diffraction as a Product Development Tool, Seminar, North Jersey Pharmaceutical Research
        Discussion Group; 1984 Feb; and Rutgers College of Pharmacy; 1984 Mar, New Brunswick (NJ).
18.    Qualitative and Quantitative X-ray Diffraction, Seminar, Philadelphia College of Pharmacy and
        Science; 1983 Mar, Philadelphia (PA).

PUBLICATIONS

Available Upon Request

TECHNICAL MAGAZINES

Available Upon Request

MEETING ABSTRACTS

Available Upon Request

Groups