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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. One of these formulations has been approved for marketing by the U.S. F.D.A.

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.

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.

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 five 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.

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.

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.

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.

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.



Expert has assisted five different clients reverse Federal Court Consent Decrees and has assisted at least five clients respond to FDA Warning Letters..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 and ISO-13485 quality systems at client sites.