Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology

ID: 724240 California, USA

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Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11.


Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition, consultant now has worked for over 14 years as a consultant assisting firms in preparing strategies and documents for submission to FDA throughout all phases of development.

Over 25 years of experience in all aspects of drug, device and biolgoic product development, including INDs, NDA, BLA, PMA and product regulation.


Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition, consultant now has worked for over 14 years as a consultant assisting firms in preparing strategies and documents for submission to FDA throughout all phases of development.

Member of DIA. former Editor in Chief of Journal.
editorial board - Global Forum

Basic research training in experience in pharmacology and toxicology and all aspects of mechanism of action of drugs.


1985 to 1990, expert worked as a reviewer in the Center for Drug Evaluation & Research at the FDA, in the Divisions of Antiviral Drug Products, Oncologic Drug Products, and the Division of Bioequivalence. As an FDA reviewer, he participated in numerous preclinical and clinical drug development review projects for generic drugs and drugs for serious and life-threatening illnesses. He also served as primary pharmacology/toxicology reviewer for hundreds of INDs and NDAs for cancer, AIDS and AIDS-related drugs. He reviewed over 200 bioequivalence studies for generic versions of major drug products and proposed and drafted guidelines for bioequivalence study requirements for a number of therapeutic classes. While at the FDA he also drafted a number of Agency documents and position papers on the issues of bioequivalence and generic drugs. Expert wrote a major policy paper on the FDA's position on bioequivalence that was published in a peer reviewed journal, for industry-wide dissemination. Expert organized the FDA Bioequivalence Hearing, including assisting in agenda planning and speaker selection and later drafted the landmark Task Force Report on Bioequivalence for the Commissioner's office.

Education

Year Degree Subject Institution
Year: 1977 Degree: Ph.D. Subject: Pharmacology Institution: USC
Year: 1973 Degree: B.S. Subject: Biochemistry Institution: UCLA
Year: 1980 Degree: Post-Doctoral Subject: Cancer Medicine Institution: Duke University

Work History

Years Employer Title Department
Years: 1994 to Present Employer: Undisclosed Title: President Department:
Responsibilities:
He provides consultation to clients in product development, regulatory affairs, compliance, strategic planning and clinical research
Years Employer Title Department
Years: 1992 to 1993 Employer: Vestar Title: Director, Regulatory Affairs Department:
Responsibilities:
He was responsible for all worldwide regulatory activities including the preparation, submission and renewal activities for pharmaceutical products
Years Employer Title Department
Years: 1990 to 1992 Employer: Division of AIDS Title: Chief, Regulatory affairs Department: NIAID/NIH
Responsibilities:
He managed all regulatory aspects of research program for clinical development of AIDS therapies
Years Employer Title Department
Years: 1985 to 1990 Employer: Food and Drug Administration Title: Pharmacologist/Reviewer Department:
Responsibilities:
He provided review and evaluation of preclinical pharmacology and toxicology studies submitted in support of INDs and NDAs. He also reviewed biopharmaceutic data for ANDAs and evaluate protocols for new bioavailability studies
Years Employer Title Department
Years: 1982 to 1984 Employer: Anaquest Title: Drug Registration Manager Department:
Responsibilities:
He was responsible for all drug registration activities in International market including the preparation, submission and renewal activities for pharmaceutical products
Years Employer Title Department
Years: 1980 to 1982 Employer: McGill University Title: Assistant Professor Department: Dept of Pharmacology/Cancer Center
Responsibilities:
He conducted research on the pharmacology of anti-tumor drugs and drugs resistance and taught pharmacology courses for medical, graduate, and undergraduate students

Government Experience

Years Agency Role Description
Years: 1985 to 1990 Agency: FDA Role: Reviewer Description: He reviewed and evaluated INDs, NDAs, ANDAs and other submissions
Years: 1990 to 1992 Agency: NIH - Division of AIDS Role: Manager Description: He managed all of the regulatory affairs functions for the AIDS development program.

Career Accomplishments

Associations / Societies
DIA, ACRP, RAPs, SQA.
Licenses / Certifications
Regulatory Affairs Certification;
Fellow, Regulatory Affairs (FRAPS);
RQAP-GCP.
CCRA
Professional Appointments
Past Editor-in-Chief – Drug Information Journal;

Editorial Board - Clinical Trials Advisor (1999- ),
Applied Clinical Trials (1990- );
Regulatory Affairs FOCUS (1990-2000);
Drug Information Journal (1995-2001);

Past Editor-in-Chief - DIA Forum;

DIA Advisory Council for North America;
DIA Chair – Portfolio Review Committee;
DIA Training Committee;
Past DIA GCP SIAC Chair;
DIA Annual Meeting Committee (2004-2007).
Awards / Recognition
DIA Founders Service Award;
DIA Outstanding Service Award;
RAPS Service Award.
Publications and Patents Summary
Over 75 articles published.

Additional Experience

Expert Witness Experience
He serves as expert witness on medical product liablity cases, development and patent issue cases.
Training / Seminars
He routinely teaches courses on drug development, licensing and approval of medical products, GMP/GLP/GCP compliance.
Vendor Selection
He has conducted vendor audits for laboratories, IRB, EDC.

Language Skills

Language Proficiency
French Basic
German Basic
Hebrew Basic

Fields of Expertise

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