FDA Regulatory Affairs Expert Witness

Expert Witness No.1076

New Jersey

Recruited to Ferring Pharmaceuticals Inc. to assume responsibility for regulatory affairs, initial product development, transfer of technology, QA/compliance, project leadership and contractor liaison in this fast growing women’s health oriented company.  Member of operations and due diligence committees, reported directly to CEO of US division.  Submitted 3 NDAs in 4 years, all now approved.

Recruited to FEI Technologies, Inc. to lead this innovative, entrepreneurial drug delivery company in its transition from an R&D to a commercial drug delivery company.  Initiated development of two unique new products and designed innovative clinical program that saved 33% of clinical development costs.  Company was sold on the basis of two projects I initiated.

Recruited to Becton Dickinson Transdermal Systems to bring pharmaceutical experience to this innovative, entrepreneurial, iontophoretic medical device drug delivery division of Fortune 20 company.  Promoted after one year to director of all R&D, including formulations, adhesives, electronics, computers, clinical development programs (in house and with drug company partners), to set regulatory strategy and to assure appropriate assistance from corporate regulatory affairs.

Recruited to Block Drug Company (Reed and Carnrick) as director, drug regulatory affairs, to help rebuild department, obtain FDA approvals and assure regulatory and cGMP compliance.  Success led to promotion to Vice President Worldwide Pharmaceutical Product Development.

Transferred from Key Pharmaceuticals to Schering-Plough Research as director, regulatory affairs, to improve quality of submissions and relationship with FDA, set strategies for dealing with FDA, and manage FDA relations for products generating more than $1 billion in annual sales (allergy/respiratory, including Claritin and some indications for interferon; immunology, monoclonal antibody, dermatological, OTC, Rx-to-OTC and line extensions). Filed 15 INDs, 8 NDAs, 2 PLAs, 8 OTC submissions and 6 Rx-to-OTC switch applications during 2 1/2 years; maintained more than 60 INDs, 60 NDAs and 100 OTC products.  Obtained 5 NDA approvals and two OTC switches, including the first dual-status Rx/OTC product

Recruited to Key Pharmaceuticals to bring critical focus and lead research, product development and manufacturing, preclinical/clinical studies and regulatory affairs for therapeutic and diagnostic biologic products (allergy, immunology and monoclonal antibodies).

Designed, equipped, staffed and managed two major biological research and development laboratories, one at the National Cancer Institute (monoclonal antibodies for in vivo tumor imaging and treatment) and one at a major pharmaceutical company (high molecular weight biopolymers for the treatment of allergic disorders).  Established pilot plant for scale-up and directed full scale manufacturing plant.

Developed first successful in vivo imaging and treatment of solid tumors in a heterogenic animal model  - used radionuclides and toxins conjugated to tumor-specific monoclonal antibodies.

Professional Experience

1999-Present: Major Private Pharmaceutical Company - Senior Director, Regulatory Affairs

Brought in to lead the US regulatory affairs group (IND, NDA, ANDA) including, in addition to US drug regulatory affairs: compliance, QA, assistance in US product development, advise on clinical activities, liaise with contract manufacturers (US and foreign), corporate partners and corporate headquarters in Copenhagen and participate in developing international regulatory strategies.  Was entire Regulatory department for four years, developed two parenteral formulations for glycoprotein products, initiated preclinical development of a new drug delivery method, set regulatory strategy for, wrote/compiled and filed three INDs and three NDAs, received approval for all three NDAs and achieved approval of a NDA filed just as I joined Ferring. Conducted four FDA type B meetings, submitted and received approval, as 30-day CBEs, of several manufacturing site changes for sterile products, etc. Three pre-approval inspections, three “for cause” FDA inspections, three routine FDA inspections (including manufacturing plants in Argentina and Sweden), two field alerts with no product withdrawals or recalls, etc.  Set regulatory strategy for several additional NDAs now under development as well as two drug-device combination products.  Reported to the Executive VP of Medical and Regulatory and directly to the President of US operations; many presentations to the Board of Directors; member of the US Operating Committee; member of due diligence committee.                         

1998- 1999:     FEI Technologies, INC. - Vice President, Pharmaceutical Development

Recruited to lead this innovative, entrepreneurial, silicone based drug delivery company to make the transition from R&D to commercial success.  Responsible for research and development, regulatory affairs, QC, clinical product development, manufacturing/operations, R&D and clinical liaison with corporate partners.  Key contributor to product licensing, contract negotiation and business development.  Designed innovative clinical program that saved ~33% of clinical costs and initiated the development of two unique new programs.  Reported directly to CEO.  Company was since sold with valuation based upon two new projects that I initiated.

1995 – 1998:   Becton Dickinson Transdermal Systems - Director, Research & Development

Recruited to lead this entrepreneurial division to develop miniaturized, wearable iontophoretic drug delivery devices (drug-device combination) to electronically deliver drugs through the skin. Supervised staff of approximately 40 scientists, responsible for clinical studies, R&D, QC, analytical services, pharmaceutical formulations, iontophoretic reservoirs (polymers including hydrogels), electrochemistry and electrodes, adhesives, electronics (microprocessors, integrated circuits, power sources), manufacturing scale-up, clinical supply manufacturing, assisted in business development activities and regulatory strategy.  Member of division operating committee.  In addition to managing the scientific staff, budgeting and setting goals and objectives, daily functions
included liaison with drug company partners and upper management in BD, negotiation of contractual agreements, product and technology licensing, product design, support of clinical studies, cGMP, cGCP and medical device cGMP compliance, regulatory strategy, etc.  successfully completed clinical studies with two NCEs (first time in man) demonstrating equivalence to I.V. infusion.  Received five critical patents with several more patent applications still pending.  Reported to division president.

1990 - 1995:    Block Drug Company, Reed and Carnrick Pharmaceuticals
1992 - 1995:    Vice President, Worldwide Pharmaceutical Product Development

After success in regulatory affairs, promoted to lead worldwide pharmaceutical product development.  Responsibilities included short, medium and long term planning for Reed and Carnrick Division, including development of new pharmaceutical products, line extensions, and acquired products; maintenance of existing products within the U.S. and affiliates worldwide;
production and maintenance of clinical supplies; preparation of regulatory submissions and responses to deficiency letters worldwide.  Preclinical/clinical protocol review committee, licensing and acquisitions, due diligence and contract negotiation.  Reported to Executive Vice President, Block Drug.

Major accomplishments include company's first five year research and development plan, development of a new OTC product from original bench research to full scale production in 8 months (a company record), many line extensions and major manufacturing site changes (NDA products).   First new ANDAs in 10 years; new Rx and OTC products for U.S. and international markets.  The company's first NCEs, new product licensing, manufacturing scale-up and optimization of licensed products (OTC and Rx).  Seven preapproval inspections without a major 483 citation.  Instituted preparation of development reports and extensive cGMP/cGCP training programs.  Assisted in sale of company.

1990-1992:      Director, Drug Regulatory Affairs

Recruited to Block Drug to help build regulatory affairs department.  Responsibilities included setting regulatory strategies, review of clinical development programs including clinical protocols, FDA liaison, new NDAs and ANDAs, supplements, FDA inspections, cGMP, cGCP, NDA and ANDA compliance, labeling and advertising for NDA and ANDA products, line extensions, FDA
audits and inspections, etc.  Initiated a company-wide compliance effort which resulted in six FDA
inspections and five pre-approval inspections with only minimal observations.  All existing NDAs and ANDAs were updated and procedures were brought into regulatory and cGMP compliance.  New procedures were implemented to assure continued compliance.  Major supplements for reformulations, line extensions and manufacturing site changes were approved after many years of inaction. First new NDA was approved, including prime responsibility for cGMP compliance of foreign bulk drug manufacturer.  Participated in product licensing and due diligence.

Major FDA interactions: GI, Cardio-Renal, Anti-Infective (dermatology) and DDMAC,

1983 – 1990:   Schering-Plough Research
1987 – 1990:   Director, Drug Regulatory Affairs

Responsible for products with over $1 billion in annual sales, including allergy, asthma, cold, dermatological, new dosage forms and line extensions (including sustained release), OTC products and Rx-to-OTC switches.  Specifically:
Obtained 5 NDA approvals and approval for first dual status Rx and OTC product;

Planned and participated in four major FDA advisory committee meetings.

Filed 15 INDs, 8 NDAs, 2 PLAs, 8 OTC submissions and 6 Rx-to-OTC switch applications;

Maintained over 60 INDs, 60 NDAs and 100 OTC products;

Responsible for regulatory strategies, quality of clinical and technical studies, review of clinical
protocols, advertising and labeling, cGMP and cGCP audits;

Extensive interface with clinical, technical, legal, manufacturing and marketing groups;

Managed FDA relationships (both drugs and biologics) with division directors, reviewers and
supervisors;

Set regulatory strategy, conducted FDA meetings and negotiations;

Developed strategies for establishing bioequivalency of dosage forms;

Protected established products from generic competition (asthma metered dose inhalers);

Reviewed potential in-licensing opportunities;

Managed staff of 13.

Major FDA interactions:   Pulmonary-Allergy, Anti-Infectives, Metabolic Products, Pilot Review Division, Biopharmaceutics, DDMAC, CBER

1983 – 1987:  Key Pharmaceuticals:  Associate Director, Research and Development 

Responsible for all research and development aspects of parenteral biopolymers for allergy
therapy, including initial bench work, pilot plant scale-up, full-scale manufacturing, preclinical, clinical, and regulatory aspects of projects and product licensing.  Specifically:       

Responsible for presentations to CBER FDA advisory committees;

Direct responsibility for submissions and negotiations with CBER;

Designed, staffed and directed laboratory and pilot plant;

Wrote master manufacturing batch records, SOPs, etc.;

Planned and instituted production changes resulting in saving 30% of production costs;

Identified products for in-licensing;

Wrote clinical protocols, conducted clinical site selection audits and monitoring.

1982 - 1983:    Coulter Immunology - Associate Director, Research & Development

1980 – 1982:   National Cancer Institute, Biological Response Modifiers Program - Expert and Acting Section Chief, Monoclonal Antibody Section

1978 – 1980:   University of Virginia Medical School
Assistant Professor and Director, Surgical Oncology Laboratory

1976 – 1978:   Sloan-Kettering Institute For Cancer Research         
Post Doctoral Fellow, Division of Human Cancer Serology

Education

Continuing Education: Harvard University Executive Development Program
Master’s Program in Management, Frostburg State College

Ph.D.  Cornell University School of Medical Sciences Sloan-Kettering Division, NYC
(full scholarship)Immunology/Virology/Biochemistry

M.S.     New York University, Transplantation and Tumor Immunology

B.S.     Tufts University,  Biomedical Sciences                      

Advanced studies in management science and numerous advanced management, communications, writing, time management and professional courses and workshops as well as drug and device specific workshops and courses; chaired DIA workshop session.

Patents

Available Upon Request

Professional Affiliations

American Association of Pharmaceutical Scientists, Food and Drug Law institute, Drug Information Association, Regulatory Affairs Professionals Society, Association of Food and Drug Officials, New Jersey Pharmaceutical Quality Control Association, Controlled Release Society

Honors and Awards

Available Upon Request

Publications

Available Upon Request

Abstracts

Available Upon Request