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 Expert  722568

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms


Available for your Consulting and Expert Witness Needs

New Jersey (NJ)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of the formulations demonstrated faster and more complete absorption to marketed tablet forms of the pharmaceuticals.
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buccal drug delivery

As head of clinical research for four different companies, Expert designed numerous clinical trials (wrote protocols, selected investigators, supervised monitoring and auditing of trials, and wrote clinical summaries). This included 15 IND formulations in arthritis, anti-fungals, dermatology, cardiology, immunology, pediatric apnea of prematurity, oncology, anesthesiology, generic drugs, and buccal delivery. As a consultant, Expert monitored and/or audited clinical trials for 6 different IND formulations in the areas of organ rejection, oncology, X-ray imaging and anti-infectives.
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drug clinical trial

As head of clinical research for four different organizations, Expert oversaw development efforts which led to the approval of six new chemical entities (NCEs) by the FDA. These included anti-fungal, allergy, immunomodulating, anesthesia, and pediatric apnea control products. He also oversaw the development of three generic drugs. As head of quality assurace for Janssen Pharmaceutica, he identified an invalidating flaw that would have led to rejection of the NDA. Correction of the flaw, although delaying submission of the NDA by four months, led to approval of the product by FDA.
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drug development

As head of clinical research for four different companies, Expert participated in the development efforts of 23 different investigational drug programs, all of which were granted IND status by the FDA. These included 13 new chemical entities (NCEs), five generic drugs and five drugs that had been re-formulated for rapid absorption by buccal delivery. All clinical trials were conducted according to FDA's Good Clinical Practices regulations. As a consultant, Expert has assisted four different clients in administering the development programs of their investigational drugs through monitoring, auditing, data review, and summarization of clinical and adverse event data. He has also identified unacceptable clinical trial practices for two principal investigators which has led to permanent disqualification by FDA.
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investigational drug

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Good Clinical Practice

As a consultant for Cyberonics, Expert audited completed clinical trials, device accountability, document control, investigations, and the company quality system, which helped the company receive approval for the PMA for their implanted device for epilepsy. As a consultant to the government of Pakistan, he assisted approximately 20 stainless steel surgical device manufacturers receive re-approval for sale of their products in the U.S. This involved audits of their facilities and procedures, designing training programs for employees, and implementing process changes. The U.S. F.D.A., due to prior continued cGMP violations, had previously sanctioned the companies. As a consultant to Dervidaos de Gasa, Expert recommended the company withdraw their registration with the U.S. government as a manufacturer of medical devices. An audit of this Mexican company revealed a total lack of procedures and cGMP controls. The company's refusal to withdraw registration led to their permanent disbarment by the FDA.
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medical device auditing

Expert has taken the information gathered in animal pharmacology and human Phase I pharmacokinetic studies to design later stage clinical trials. This data has been used to select dosage timing and dose levels to achieve maximum benefit and minimum adverse events. This has involved early stage data from single and chronic dosing studies. In addition, drug delivery comparison trials between liquid formulations, administered sublingually, and tablet formulations have been analyzed. This data has been used to design dosing regimens for buccally delivered formulations to maximize the time to effect for symptomatic relief and to minimize the effect of a rapidly absorbed dose on the development of adverse events.
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oral drug delivery

Expert was responsible for all Quality Assurance Unit activities at Oread Laboratories, a contract laboratory that specialized in toxicology and ADME studies. In addition to supervision of all daily QA activities, he conducted numerous training sessions for laboratory staff, consultants and administration. He was also the Course Director for the Good Laboratory Practices program at The Center for Professional Advancement from 2001 through 2004. The twelve three-day classes he conducted trained more than 300 people in Good Laboratory Practices. Expert has consulted with more than 15 domestic and foreign companies in Good Laboratory Practices, having conducted inspections, training, and planning for compliance with GLP regulations.
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Good Laboratory Practice

Expert was responsible for cGMP compliance for 5 different division of the Seton Company. This encompassed manufacturing activities for bulk drug manufacturing, production of bulk adhesive-coated roll stock (contract manufacturing), cosmetic ingredient manufacturing, importation and distribution of sterilized medical devices, and pet foods preparation. He has consulted with four different domestic companies about Federal Court Consent Decree-related issues, and the government of Pakistan about an FDA-imposed Import Embargo for stainless steel surgical equipment. This has resulted in reversal of two Consent Decrees and the Import Embargo. Expert has written three quality system manuals to meet the federal Quality System Requirements for medical devices. FDA inspectors have reviewed two of these with no resulting FDA-483 observations. He has conducted training programs at more than 10 companies on cGMP and QSR. These sessions have encompassed both general training and specific training in defined areas of the regulations. In addition, Expert has conducted more than 100 first-, second-, and third-party audits for both manufacturers and contractors.
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Good Manufacturing Practice


Show Only Primary Areas of Expert Consulting

Secondary Expertise
510(k) document, biocompatibility testing, biomedical application, biomedical diagnostic instrumentation, bulk drug, bulk mixing, bulk pharmaceutical chemical manufacturing, capsule packaging process, chemical processing, clinical measurement, contract manufacturing, Current Good Manufacturing Practice, dosage form, drug, drug allergy, drug degradation, drug delivery, drug dosage form development, drug formulation, drug processing, drug product approval, drug regulation, drug screening, drug stability, excipient, FDA medical device regulation, Food and Drug Administration new drug code, Food and Drug Administration validation, generic drug, governmental registration process, implantable device, informed consent, investigational medical device exemption regulation, medical device, medical device clinical research, medical device design, medical device endurance testing, medical device hazard analysis, medical device inspection, medical device manufacturing, medical device manufacturing quality control, medical device manufacturing troubleshooting, medical device premarket approval, medical device product development, medical device product improvement, medical device reporting, Medical Device Reporting regulation, medical device testing, medical product, medical protocol, medical regulation, medical software quality assurance, medical technology, nasal drug delivery, ocular drug delivery, over-the-counter drug product development, parenteral drug delivery, pharmaceutical drug, pharmaceutical industry, pharmaceutical manufacturer, pharmaceutical manufacturing, pharmaceutical product formulation, pharmaceutical research, pharmaceutical technology, pharmacodynamics, pharmacoeconomics, pharmacology, plastic medical device, polymer implantable device, precision liquid dispensing device, premarket approval assessment, stent, tablet manufacturing, transdermal drug delivery

Basic Expertise
alpha 2 pharmacology, bioadhesion, bioethics, bioinformatics, bioinstrumentation, biomedical chemical sensor, biomedical device, biomedical instrument, biomedical instrumentation, biomedical sensor, biometrics, bulk packaging material, calcium alginate, cannula, cast (rigid dressing), chiral synthesis, colonic drug delivery, color additive, combinatorial chemistry, computer-aided drug design, cream, disposable medical device, drug release polymer, drug validation, durable medical equipment, electronic medical device, endoscope, foreign medical device regulation, gelatin, gelatin capsule, generic drug manufacturing, gynecologic drug development, hemostat, high-pressure sterilization, hospital equipment, hospital equipment safety, inhaler, irradiation sterilization, life support system, medical adhesive tape, medical coating material, medical composite, medical device coating material, medical device corrosion, medical device endotoxin detection, medical device irradiation sterilization, medical device manufacturing automation, medical device mechanical stress analysis, medical device package testing, medical device packaging material, medical device packaging process, medical device process validation, medical device reliability testing, medical device safety, medical device soldering, medical device sterility, medical device sterilization, medical elastomer, medical filter, medical injection process, medical instrument, medical instrument cleaning, medical instrument sterilization, medical lexicon, medical lexicon development, medical polymer, medical pressure-sensitive adhesive, medical pump, medical seal, medical tubing extrusion, medical waste management regulation, medical X-ray equipment, muco-adhesive, nerve stimulator, outcomes research, pharmaceutical capsule, pharmaceutical coating material, pharmaceutical design, pharmaceutical engineering, pharmaceutical reactor, polymer drug-delivery method, polymer drug-delivery microsphere, positive-displacement pipette, precision liquid dispensing, programmable drug delivery, surgical instrument, therapeutic device, wheelchair
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;  Yonkers, New York;  Newark, New Jersey;  Jersey City, New Jersey;  Paterson, New Jersey;  Elizabeth, New Jersey;  Bridgeport, Connecticut;  Stamford, Connecticut;  Philadelphia, Pennsylvania;  and Allentown, Pennsylvania.

Often requested
with this expert:

GMPs for Drugs, Devices, Biologics
Pharmaceutical Manufacturing
Pharmaceutical Technology, Manufacturing, Quality Systems...
Pharmacoepidemiology, Pharmacoeconomics, Epidemiology, FDA,...

Education:
Year   Degree   Subject   Institution  
1984   Ph.D.   Pharmaceutics   Temple University  
1975   M.A.   Organic Chemistry   Temple University  
1968   B.S.   Chemistry   Albright College  

Work History:
Years   Employer   Department   Title   Responsibilities

2001 to

 

(Undisclosed)

 


 

Consultant

 

Expert provides consulting expertise for the interpretation of GLP, GCP, and cGMPs to the pharmaceutical, medical device, and biotechnology industry.

1998 to 2001

 

Flemington Pharmaceutical Corporation

 

Product Development

 

Vice President

 

He was responsible for the formulation and quality assurance of products which were designed for rapid delivery of drugs for therapeutic benefit.

1992 to 1998

 

Medical Development Quality Associates

 


 

President

 

Expert provided consulting expertise and development assistance to pharmaceutical and medical device companies.

1991 to 1992

 

Oread Laboratories

 

Regulatory Affairs

 

Manager

 

He supervised all laboratory activities in GLP and cGMP. He developed staff and facilities to secure new business for their contract laboratory.

1990 to 1991

 

Pharmaceutical Consultants, Inc.

 

Business Development

 

Director

 

Expert supervised all staff activities of this CRO. He recruited new clients and increased business by 150%.

1988 to 1989

 

Martec Pharmaceuticals

 

Clinical Research

 

Director

 

He directed all clinical research operations for ethical and generic drugs.

1984 to 1987

 

Seton Company

 

Regulatory Affairs

 

Director

 

Expert directed all regulatory activities for five different company divisions.

1976 to 1984

 

Janssen Pharmaceutica

 

Clinical Research/QA

 

Director

 

He directed all clinical research activities that led to the approval of seven new chemical entities.


Career Accomplishments:
Associations/Societies

Expert is a member of the American Society for Quality and the Regulatory Affairs Professionaal Society.


Publications:
Publications and Patents Summary

He has authored four publications, one patent, two book chapters, and ten technical presentations.

Selected Publications and Publishers  
 - Temple University Press  

Consulting Services:
Selected Consulting Examples:
  • Expert has assisted four different clients reverse Federal Court Consent Decrees.
  • He helped a client obtain U.S. product approval for a PMA medical device, as well as ISO 9000 certification.
  • Expert provides assessments of GLP, cGMP, GCP, and ISO 9000 quality systems at client sites.
Recent Client Requests:
  • Expert for consulting on Biotech in need of advice.
  • GLP expert for consulting on a facility evaluation for GLP conduction and IND and beyond.
  • Expert in GMP certification for consulting on the manufacturing of small scale ca. 2-5 kg of product.
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:
Recent Litigation Client Requests:
  • Generic drug manufacturing expert for consulting on generic drug issues.
  • Expert in testimony where pharmaceutical company alleges a chemical supplier did not follow GMP.
  • Expert witness is clinical trials for consulting on in house co clinical trial.
  • Expert for consulting on Inquiry.
  • Expert in buccal drug delivery and formulation for patent litigation.
  • Expert in drug manufacturing safety for consulting on drug manufacturing safety.
  • Expert in pharmaceutical manufacturing.
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.

International Experience:
Years   Country / Region   Summary
1995 to 1995   Pakistan   Expert assisted stainless steel device manufacturers obtain approval to re-introduce their devices into the U.S. marketplace.
1999 to 1999   South Africa   He audited a device manufacturer and helped them prepare a QA system, which eventually enabled them to gain U.S. product approval.
1993 to 1994   Mexico   Expert audited a company and recommended that they withdraw their application for U.S. product approval. The company ignored his advice and was placed on FDA's permanent embargo list.
2004 to 2004   Canada   He reviewed manufacturing and laboratory variances for an API manufacturer in preparation for their Pre-Approval Inspection. Numerous suggestions for re-writes and corrections were provided to the manufacturer.
2002 to 2004   Netherlands   Expert taught courses in Good Laboratory Practices to 95 all-European professionals to assist them in submission of pre-clinical and toxicology data to the U.S. FDA.

Language Skills:
Foreign Language   Description
German   Expert studied German for four years and can converse in and read German moderately.
Russian   He studied Russian for one year and can read Russian articles with a dictionary.

Additional Skills and Services:
Training/Seminars

Expert has presented numerous training classes in both GLP and cGMP. He is currently the Course Director for a professional training organization and presents four three-day seminars annually on Good Laboratory Practices.

Supplier and Vendor Location and Selection

He has conducted numerous third-party audits for clients in order to help them select qualified vendors.


 

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