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FDA Regulatory Affairs Expert Witness

Keywords

FDA Regulatory Affairs, Food Drug, Government Regulations, Drug Regulatory Practices, Regulatory Affairs, Initial Product Development, Transfer Of Technology, QA Compliance, Commercial Drug Delivery, Iontophoretic Medical Device Drug Delivery, IND, NDA, ANDA,

New Jersey

Expert Witness No. 1076

New Jersey

PROFESSIONAL EXPERIENCE

Over 25 years regulatory affairs and drug development experience, both hands-on and management (drugs, biologics, devices), with success interacting and negotiating with FDA and international health authorities.

Experienced monoclonal antibody expert.

Rx (drugs and biologics, innovator and generic), Rx to OTC switch, OTC and medical device experience.

Extensive experience in marketing support (advertising and promotion) and DDMAC.

Strategic thinker in global regulatory policy, member of several corporate steering committees, hold 5 US and several international drug delivery patents.

Created and filed 19 NDA and 2 BLA successful marketing applications, more than 24 INDs, 10 CTAs and several 510(k) device applications. Several Rx to OTC switches, OTC support. Therapeutic areas include allergy; inflammation; asthma and COPD; pain; metabolism; diabetes; MS; RA; oncology; dermatologicals; fertility, contraceptive and other women’s health; gastrointestinal; hormonal; cardiovascular and neurology for both small molecules and biologics and extensive dealing with DDMAC.

Ph.D. in tumor immunochemistry and virology, Acting Section Chief of NCI BRMP monoclonal antibody laboratory; experience with protein drugs, biologicals and small molecule drugs.

CONSULTING

1997 - Present
Private Associates, Inc.
President and Founder
Expert 1076 established this pharmaceutical and medical device consulting company first to pursue a patent for a unique poison ivy treatment and then to assist other companies in strategic planning, FDA liaison and negotiation, FDA meetings, writing submissions and execution of plans and to help meet unanticipated needs and challenges. Expert 1076 acted as expert reviewer for EU submissions for two major international pharmaceutical companies, numerous FDA submissions, strategic advice, etc. Recently completed 2 successful INDs for humanized anti-tumor monoclonal antibodies.

FULL TIME EMPLOYMENT

2007 - December 2008
At a Therapeutics, Inc.
Vice President, Global Regulatory Affairs
Expert 1076 recruited to establish this family run Indian generic company’s new drug regulatory affairs department. Expert 1076 was responsible for building the group, advising the R&D, clinical and preclinical groups on requirements for new drug applications (US and EU) and strategies to meet these requirements; member of Strategic Steering Committee and performed due diligence audits. Expert 1076 built the group from nothing to seven people in the US and India. Expert 1076 successfully created and filed US IND (monoclonal antibody) and six Clinical Trial Applications (in England, Netherlands, Italy and India). Expert 1076 initiated implementation of electronic eCTD software to automate submission compilation. Reported to CEO.

Major therapeutic areas included: pain, inflammation (arthritis, muscular dystrophy, clotting), diabetes, metabolism (obesity, fatty liver) and oncology.

2005 - 2007
At a Pharmaceuticals, Inc.
Senior Director and Head, Regulatory Affairs
Expert 1076 was recruited to MedPointe to lead growing regulatory affairs department in this privately held pharmaceutical company as it entered a period of rapid growth preparatory to anticipated public offering. Expert 1076 built the department from three to six people. Prepared and submitted company’s first new NDA (approved), six major NDA supplements (approved), including four new line extensions with full clinical, CMC and pharm/tox data. Two successful Type A FDA dispute resolution meetings which challenged FDA positions regarding required clinical and toxicology programs and successfully pared FDA requested programs, saving over one year and ~$10MM on each program. Filed 4 new INDs and numerous IND amendments, including world wide clinical trials, one Rx-to-OTC switch ready for filing. Numerous FDA meetings. Member of the Commercial Development Team. Expert 1076 reorganized department, initiated electronic internal files and CTD format submissions, automated NDA publishing and reduced NDA publishing time from eight weeks to two weeks. Responsible for all advertising and promotional review activities, including the company’s first direct to consumer advertising campaigns. Reported to the Senior Vice President, Research and Development.

Major FDA Interactions: Divisions of Pulmonary and Allergy Products; Anesthesia, Analgesia and Rheumatology Products, Anti-Infective and Ophthalmologic Products and DDMAC.

1999 - 2005
At a Pharmaceuticals, Inc.
Senior Director and Head, Regulatory Affairs (and QA)
Expert 1076 was responsible for all US regulatory and QA (including glycoprotein-based product development) for this privately owned, international company. With a regulatory staff of one assistant, set the strategy for, prepared, filed and received 10-month approvals of four NDAs. Expert 1076 filed 5 new INDs and numerous NDA and IND amendments, supported OTC product. Set FDA strategy, wrote CMC sections, member of clinical strategy team, assisted in creating clinical protocols, submitted and received approval (as CBE-30s) for several manufacturing site changes for sterile biologically-derived products, held numerous successful type B meetings with FDA and maintained productive contact with FDA reviewers and division directors. Audited manufacturing and clinical sites, handled five pre-approval inspections, three "for cause" FDA inspections, many routine FDA inspections (including manufacturing plants in Argentina and Sweden) and two field alerts with no major 483s, no product withdrawals, recalls, etc. Expert 1076 performed QA release of all manufacturing batch records and supervised OOS investigations. Expert 1076 was responsible for setting and implementing the regulatory strategy for all four of the NDAs and all supplements filed during this time. Set the regulatory strategy for several additional NDAs, now approved, as well as two drug-device combination products and filed and received 510(k) clearance for two drug delivery devices. Reported to the Executive VP of Medical and Regulatory and to the President and CEO of US operations. Presented to the Board of Directors, member of the US Operating Committee and responsible for managing inter-company operations (CMC) with two major pharmaceutical companies that licensed Ferring products.

Major FDA Interactions: Reproductive and Urologic Drug Products, Metabolic and Endocrine Drug Products and DDMAC.

1998 - 1999
CSO and Vice President, Pharmaceutical Company
Expert 1076 was recruited to lead the scientific and regulatory operations of this innovative, entrepreneurial, drug delivery (device) company as it made the transition from R&D to commercialization. Expert 1076 was responsible for research and development, regulatory affairs, QA, clinical product development, manufacturing/operations, R&D and liaison with corporate partners. Expert 1076 the key contributor to product licensing, contract negotiation and business development. Expert 1076 designed an innovative clinical program that saved ~33% of clinical costs and initiated the development of two unique new drug delivery programs. Reported to the COO and CEO.

1995 - 1998
A Medical Supplies and Devices Supplier Company
Director, Research & Development
Expert 1076 recruited to lead the scientific and regulatory operations of this entrepreneurial division to develop miniaturized, wearable iontophoretic drug delivery devices (drug-device combination) to electronically deliver drugs through the skin. Expert 1076 supervised a staff of approximately 40 regulatory specialists, scientists (QC lab, pharmaceutical formulation development, computer programming and ASIC development, physical patch design, adhesives and materials). Expert 1076 was also responsible for support of clinical studies, R&D, QC, analytical services, pharmaceutical formulations, iontophoretic reservoirs (polymers including hydrogels), electrochemistry and electrodes, electronics (microprocessors, integrated circuits, power sources), manufacturing scale-up, clinical supply manufacturing and participated in business development activities. Made presentations to potential business partners. As a member of the three person division Operating Committee I was also involved in setting business strategy. In addition to managing the scientific staff, budgeting and setting goals and objectives, Expert 1076’s 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. Expert 1076 successfully supported and completed clinical studies with three NCEs (first time in man) demonstrating equivalence to I.V. infusion. Expert 1076 received five US and several European patents for critical processes and product designs. Reported to the division president.

1990 - 1995
At a Pharmaceutical Company

1992 - 1995
Vice President, Worldwide Pharmaceutical Product Development
After successfully leading the regulatory affairs department, promoted to lead worldwide pharmaceutical product development. Responsibilities included short, medium and long term planning for a division, including developing 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. Expert 1076 was an active member of the preclinical/clinical protocol review committee, licensing and acquisitions committee, and the due diligence and contract negotiation committee. Reported to the Executive Vice President, Block Drug.

Expert 1076’s major accomplishments include developing the 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) to lower costs. Expert 1076 was responsible for developing the first new ANDAs in 10 years and new Rx and OTC products for U.S. and international markets. Expert 1076 was also responsible for 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, established the preparation of development reports and extensive cGMP/cGCP training programs and assisted in the sale of the company.

1990 - 1992
Director, Drug Regulatory Affairs
Expert 1076 was recruited to Block Drug to help build a new regulatory affairs department. Expert 1076 was responsible for new drug and generic products, including OTC, CMC, pre-clinical and clinical (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.) Expert 1076 initiated a company-wide compliance effort which resulted in six FDA inspections and five pre-approval inspections with only minimal observations. Major CMC supplements for reformulations, line extensions and manufacturing site changes were approved after many years of FDA inaction. Expert 1076 prepared, iled and received approval for the company’s first new NDA in 10 years. Expert 1076 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
Expert 1076 was responsible for products with over $1 billion in annual sales, including allergy, asthma, cold, dermatological, oncology, new dosage forms, 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 (gyne-lotrimin).

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, CMC, 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.

Set strategy for approval of Claritin and managed FDA relations and submissions to support this NDA.

Major FDA interactions:

Pulmonary-Allergy (Immunology), Anti-Infectives, Metabolic Products, Dematologics, Oncology, Pilot Review Division, Biopharmaceutics, DDMAC, and CBER.

1983 - 1987
At a Pharmaceutical Company
Associate Director, Research and Development and Regulatory Affairs
Expert 1076 was responsible for all regulatory affairs and research and development aspects of parenteral biopolymers, including initial bench work, pilot plant, scale-up, full-scale manufacturing, CMC, preclinical, clinical, and regulatory aspects of projects (including FDA liaison) and product licensing.

Specifically:

Prepared and filed BLA.

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, analytical procedures, 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
At a Immunology
Assistant General Manager
Expert 1076 developed tumor-associated and other antigen specific monoclonal antibodies for imaging and treating human tumors; perfected EPICS technology (fluorescent activated live cell sorting) and supervised production and pilot plant.

1980 - 1982
NCI
Expert and Acting Section Chief
Expert 1076 was one of first scientists in this new National Cancer Institute program. Expert 1076 established and ran the first NCI lab to develop monoclonal antibodies for the diagnosis and treatment of human cancers.

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

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

New York University (fellowship) - M.S.
Transplantation and Tumor Immunology
Established first human tissue transplantation (kidney) laboratory in New York City to support kidney and other human organ transplantation.

Tufts University - B.S.
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, and Controlled Release Society.

HONORS AND AWARDS

2005, 06, 07
MedPointe Special achievement stock awards

2002
Strathmore’s Who’s Who

1998 - 99
New Jersey Center for Biomaterials Advisory Board

1998
Becton Dickinson Exceptional Performance Stock Award

1996
Marquis Who’s Who in Medicine and Health Care

1994
Food and Drug Law Institute annual advertising and promotion seminar, invited speaker

1994
Marquis Who’s Who in the World

1992
Marquis Who’s Who in America, Science and Engineering

1990 - 1992
Marquis Who’s Who in the Southeast

1989
DIA Annual Meeting: Chairman of "NDA Days" session

1986
Invited participant, Gordon Cancer Conference

1985 - 86
Miami-Dade Chamber of Commerce, Biotechnology Council

1983 - 86
Key Pharmaceuticals Corporate "Exceptional Accomplishment" stock awards

1982
Invited speaker: American College of Nuclear Medicine

1981 - 84
National Cancer Institute Grant, Principal Investigator

1979
Pratt Foundation Award, Outstanding Research, University of Virginia Medical Center

1977
Invited speaker: Third International Symposium, on Oncogenesis and Herpesviruses

1977 - 78
Richard Molin Memorial Foundation for Cancer Research: Richard Molin Scientist of the Year Award

1977 - 78
Young Investigator Award, New York State Health Research Council

1976 - 79
National Cancer Institute Project Grant

1976 - 78
Post-Doctoral Fellowship, Sloan-Kettering Institute for Cancer Research

1976 - 77
Richard Molin Memorial Foundation for Cancer Research: Richard Molin Scientist of the Year Award

1976 - 77
Young Investigator Award, New York State Health Research Council

1975
Sloan-Kettering Institute "Outstanding Research" presentation to board of directors

1969 - 76
Pre-Doctoral Fellowship, Sloan-Kettering Institute for Cancer Research

PUBLICATIONS

Available Upon Request

ABSTRACTS

Available Upon Request


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