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 Expert  724240

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


Available for your Consulting and Expert Witness Needs

California (CA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
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.

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21 CFR Part 11

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clinical pharmacology

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Current Good Manufacturing Practice

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Food and Drug Administration compliance

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Food and Drug Administration regulation

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pharmaceutical manufacturing facility auditing

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pre-approval inspection

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.

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drug development

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drug product approval

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drug regulation

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Food and Drug Administration

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investigational drug

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generic drug

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investigational drug procedures

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new drug

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new drug application

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pharmaceutical research

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over-the-counter drug regulation

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prescription drug

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abbreviated new drug application

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

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.

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drug resistance

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drug screening

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drug toxicology

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molecular pharmacology

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pharmacokinetics

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pharmacology

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toxicology


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California;  San Diego, California;  Long Beach, California;  Santa Ana, California;  Anaheim, California;  Riverside, California;  Glendale, California;  Huntington Beach, California;  San Bernardino, California;  and Chula Vista, California.

Often requested
with this expert:

Food Additives and Ingredients, Food Processing
FDA Compliance, Pharmaceutical New Products, Management...
FDA Regulatory Consultant for Medical Devices, Cosmetics,...
Pharmaceutical Development & Validation

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

Work History:
Years   Employer   Department   Title   Responsibilities

1994 to

 

(Undisclosed Consulting Company)

 


 

President

 

He provides consultation to clients in product development, regulatory affairs, compliance, strategic planning and clinical research

1992 to 1993

 

Vestar

 


 

Director, Regulatory Affairs

 

He was responsible for all worldwide regulatory activities including the preparation, submission and renewal activities for pharmaceutical products

1990 to 1992

 

Division of AIDS

 

NIAID/NIH

 

Chief, Regulatory affairs

 

He managed all regulatory aspects of research program for clinical development of AIDS therapies

1985 to 1990

 

Food and Drug Administration

 


 

Pharmacologist/Reviewer

 

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

1982 to 1984

 

Anaquest

 


 

Drug Registration Manager

 

He was responsible for all drug registration activities in International market including the preparation, submission and renewal activities for pharmaceutical products

1980 to 1982

 

McGill University

 

Dept of Pharmacology/Cancer Center

 

Assistant Professor

 

He conducted research on the pharmacology of anti-tumor drugs and drugs resistance and taught pharmacology courses for medical, graduate, and undergraduate students


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:
Publications and Patents Summary

Over 75 articles published.


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

Consulting Services:
Recent Client Requests:
  • Expert in Needed to meet FDA Compliance.
  • Expert in Pharmaceutical Manufacturing, Research and Development, Education & Training expert,Generic pharmaceutical products.
  • FDA expert for consulting on a Label review project for new herbal product
  • Expert in FDA GMP training and SOPs for staff to manufacture/assemble medical devices.
  • FDA expert for consulting on USA labeling requirements.
  • Toxicology expert for consulting on advice on preparation of an NDA for the FDA.
  • Expert for consulting on Warehouse storage and handling.
  • IND expert for consulting with biologics or cell therapy preclinical and clinical experience.
  • Expert in FDA labeling for consulting on labeling problem, review approval, and FDA non approval.
  • Adhesives formulating expert for consulting on formulation of towel & tissue pick-up adhesive.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
He serves as expert witness on medical product liablity cases, development and patent issue cases.
Recent Litigation Client Requests:
  • Expert in FDA applications for consulting on IND requirements.
  • FDA new drug application expert for consulting on acute renal failure legal case.
  • Expert on cell banking for consulting on Cell Banking (Related to testing and development of drug).
  • Fda labeling expert for consulting on FDA labeling.
  • Expert in drug development process for litigation case.
  • Expert for consulting on breach of contract case.
  • Expert witness pharmaceutical industry for consulting on Pharmaceutical industry reporting obligations to insurance carrier.
  • Pharmaceutical regulatory forensic expert for consulting on GCPs, potential fraudulent clinical data.
  • FDA expert needed for consulting regarding FDA regulation needed for ongoing litigation.
  • Expert fda labelling for consulting on Correcting Ingredient Label.
  • Expert for consulting on Inquiry.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language   Description
French   Basic
German   Basic
Hebrew   Basic

Additional Skills and Services:
Training/Seminars

He routinely teaches courses on drug development, licensing and approval of medical products, GMP/GLP/GCP compliance.

Supplier and Vendor Location and Selection

He has conducted vendor audits for laboratories, IRB, EDC.


 

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