Pharmaceutical & Biotechnology Expert Witness

Expert 2158 owns a consulting firm in New Jersey. A large part of his consulting includes solving problems in Drug Development, Regulatory Approval, and Safety, for both large Pharma companies and small startups.

His Pharmaceutical and Biotechnology industry experience includes: President, Protein Engineering Corporation (now DYAX); Senior-VP, Drug Development, Parke-Davis; VP-Medical Director, Boehringer Ingelheim Pharmaceuticals; Senior Scientific Officer at Covance and Executive Director of the Covance Institute for Drug Development Sciences. He serves on two Corporate Boards (OrthoLogic, Inc., and PhytoCeutica, Inc.), several Scientific Advisory Boards, and the Board of the American Board of Clinical Pharmacology.

Prior to Industry, his academic and clinical career was mainly at the University of Rochester Medical Center, as Associate Professor of Pharmacology, Toxicology and Medicine, attending on the Clinical Pharmacology consultation service of Strong Memorial Hospital. He co-founded and directed the University's Center for the Study of Drug Development (now at Tufts).

He testified as an expert in Drug Development in several Congressional hearings.

In addition to drug discovery and development and its contribution to medicine, his interests include clinical pharmacology, clinical trial methodology, drug safety, regulation, biotechnology, pharmacogenomics, and botanicals -- topics on which he has published over one hundred scientific papers and four books.

Expert 2158 earned his MA, PhD (in pharmacology), and MD at the University of Oxford (UK), and was a Merck International Fellow in Clinical Pharmacology and Medicine at the University of Rochester / Strong Memorial Hospital.

SUMMARY OF EXPERIENCE

CONSULTING FIRM
(1995-1996 and 2000 to Present) A Consulting Firm In New Jersey, President - Consulting on Drug Development, Regulatory Approval, and Safety to the Pharmaceutical, Biotechnology, and Medical Device Industries.

Contract Research Organization
Covance, Inc. (1996-2000): Snr VP; Senior Scientific Officer, Covance, Inc., & Executive Director, Covance Institute for Drug Development Sciences:
Led most of Covance's high-level medical & regulatory drug, biotech, and device consulting projects, over 100 Internal and external projects;
Wrote & evaluated Strategic Product Development Plans (over 100 across all therapeutic areas);
Responsible for Global Clinical Research, Phases 1-4; liaison with Clinical Laboratories, Preclinical, & Pharmacoeconomics;
Founded the Covance Institute for Drug Development Sciences (external & internal responsibilities);
Led Technical Evaluations of outside firms and technologies for Corporate Business Development;
Created and managed the Internal Career Enrichment program for Covance's physicians & scientists;
Represented Covance Drug Development Sciences externally (Approximately 50 presentations and papers);
Led and managed Technical Services (Medical, Regulatory, Safety, Biometrics, Training) to the Business Centers.

BIOTECH COMPANY
President: Protein Engineering Corporation, now Dyax in Cambridge, MA (1993-95):
Development Programs & Pharmaceutical Corporate Partnering; Strategy for Discovery, Development, Regulatory, & Marketing; Proteins as therapeutics, imaging, and diagnostic agents.

TWO MULTINATIONAL PHARMA COMPANIES
Boehringer Ingelheim & Parke-Davis (1983-1992):
Senior VP, Drug Development, Parke-Davis: Including Project Management and Future Pharmaceutical Markets.
VP- Medical & Regulatory, Boehringer Ingelheim: Head of Medical (all functions, including Clinical Research Phases 1 - 3, Medical-Marketing Services & Phase 4, Regulatory, Biostatistics, and Drug Safety).

PHARMA INDUSTRY POLICY
PhRMA Medical Committee & International Regulatory Harmonization (ICH Representative and Speaker).

ACADEMIC MEDICINE, CLIN. PHARMACOLOGY, DRUG DEVELOP'T & PHARMACEUTICAL POLICY (1971-1992)
Clinical Professor of Medicine, University of Connecticut Health Sciences Center.
Medicine, Pharmacology, and Clinical Pharmacology/Therapeutics (Univ. of Rochester & Strong Memorial Hospital).
Founding Director, Center for the Study of Drug Development (now at Tufts University).
Pharmaceutical, Regulatory, and Drug Development Sciences; Pharmaceutical Public Policy.

BOOKS, PUBLICATIONS, INVITED PRESENTATIONS IN CLINICAL PHARMACOLOGY, DRUG DEVELOPMENT & USE:

4 Books & 110 papers

CORPORATE BOARDS

OrthoLogic, Inc. 2006 -- (Chairman, Clinical and Regulatory Review Board). Center for Orphan Drug Development of the University of Minnesota 2006 -- (Advisory Board). Orphan Medical, Inc., Minneapolis, 1995-2005 (Chairman, Regulatory Oversight Cmtee). PhytoCeutica, Inc., New Haven (Board Member since its inception in 1999). American Board of Clinical Pharmacology (Board Member). PharMetrics, Inc., Boston, 1998 - 2003 (Chairman, SAB). Eleos, Inc, Omaha, SAB. Protea, Inc., Morgantown, WV, SAB. MDS Pharma Services, Phila, SAB.

DETAILS OF PHARMACEUTICAL AND BIOTECHNOLOGY COMPANY EXPERIENCE

Available upon request.

SELECTION OF DRUGS NOW MARKETED THAT I HAD A ROLE IN DEVELOPING

Available upon request.

DRUG DEVELOPMENT & MARKET SUPPORT EXPERIENCE

Protein therapeutics and diagnostic imaging: inhibitors of elastase, plasmin, and kallikrein
Antibiotics and cancer chemotherapy
Atherosclerosis: 3 lipid-regulating drugs
Endocrine/Metabolism: Contraceptives, Estrogen Replacement, Diabetes
HIV Infection, AIDS
Immune System, Allergy, Cell Adhesion: Organ Transplantation, Asthma, Rhinitis, Sjogren's
PAF (Platelet Activating Factor) Antagonists: Asthma, Rhinitis
Coronary Mortality, Heart Failure, Hypertension, Arrhythmias, Angina
Asthma, COPD, Respiratory Mucus, Rhinorrhea Inhibition
Alzheimer's, Epilepsy, CNS Dopamine Systems (Parkinson's, Schizophrenia)
Analgesics (Non-steroidals, Opiate Agonists) Hypnotics
Peptic Ulcer
Statistical Methodology, Pharmacoepidemiology, and Adverse Drug Reactions
Health Economics studies and methodology
Worldwide reorganization of Corporate Drug Development structure and function
Worldwide Corporate Drug Safety System; Responses to 2 worldwide drug-safety problems

ACADEMIC MEDICINE, CLINICAL PHARMACOLOGY, AND PHARMACEUTICAL PUBLIC POLICY

1983 - 1992 University of Connecticut Health Sciences Center
Clinical Professor of Medicine

1971 - 1983 University of Rochester Medical Center, Rochester, NY
Strong Memorial Hospital
Associate Professor of Pharmacology and Toxicology (tenured)
Assistant Professor of Medicine
Associate Physician, Strong Memorial Hospital (Clinical Pharmacology Service)
Director (Co-founder), Center for the Study of Drug Development (now at Tufts)
Merck International Fellow in Clinical Pharmacology and Medicine
1968 - 1970, Otago University Medical School, Dunedin, New Zealand
Dunedin Hospital
Lecturer - Pharmacology and Clinical Pharmacology (Pharmacology Dept, Medical School)
Clinical Assistant, Dunedin Hospital
Medical Research Officer, NZ-MRC Clinical Pharmacology & Toxicology Research Unit
Staff Physician, National Adverse Drug Reaction Center & National Poisons Center
Intern in Medicine and Surgery

HONORS AND AWARDS

Available upon request.

STATEMENTS BEFORE U.S. CONGRESSIONAL COMMITTEE; STATEMENTS OR PARTICIPATION IN OTHER GOVERNMENT PANELS, AND OTHER NATIONAL ACTIVITIES

Available upon request.

PROFESSIONAL AFFILIATIONS AND SERVICE (CURRENT AND FORMER)

Available upon request.

EDUCATION, LICENSURE

MD Medicine
PhD Pharmacology
MA Physiology & Biochemistry: all from Oxford University, England
Medical Licensure: Connecticut and New York [formerly New Zealand and UK]
Board Certification: American Board of Clinical Pharmacology, 1990

ACADEMIC AND PROFESSIONAL APPOINTMENTS

Adjunct Professor of Pharmacology and Therapeutics, Tufts University Medical School
Lecturer, Tufts Univ. Annual Postgrad. Course in Clinical Pharmacol, Drug Development, and Regulation
Faculty, Pharmaceutical Development, Drexel University MBA Program in Pharmaceutical Management
Founder/Director, Boehringer Ingelheim Fellowship Program in Clinical Pharmacology
National Sjogren's Syndrome Foundation, Board of Directors
National Organization of Rare Diseases (NORD), Member, Research Advisory Board
Connecticut Academy of Science and Engineering, Member

RECENT INVITED PRESENTATIONS (GROUPED BY TOPIC)

DRUG DEVELOPMENT (GENERAL), INCLUDING OUTSOURCING AND REGULATORY REFORM

Available upon request.

BIOTECHNOLOGY AND EMERGING/SMALL COMPANIES

Available upon request.

MEDICAL DEVICE DEVELOPMENT AND REGULATION

Available upon request.

PHARMACOGENOMICS

Available upon request.

DEVELOPING BOTANTICAL MEDICINES TO US IND/NDA STANDARDS

Available upon request.

RECENT PAPERS, BOOK CHAPTERS

Available upon request.

BOOKS

Available upon request.

FULL BIBLIOGRAPHY OF 110 PUBLISHED PAPERS AND FOUR BOOKS

Available upon request.

KEYWORDS

Pharmaceuticals Expert Witness; Biotechnology Expert Witness; Medical Devices Expert Witness; Product Development and Approval Expert Witness; Drug Safety Expert Witness; Adverse Reactions Expert Witness; Regulation for Pharmaceuticals Expert Witness; Regulation for Biotechnology Product Expert Witness; Regulations for Medical Devices Expert Witness; Clinical Pharmacology Expert Witness; Medical and Regulatory Due Diligence for Company and Product Acquisition Expert Witness; Medical Product Evaluation Expert Witness; Strategy Expert Witness Development Plans Expert Witness; Operations Medical-Marketing Expert Witness; Adverse Reaction Problems regarding Strategy, Management and Operations Expert Witness; Interim Corporate Management regarding Medical, Safety and Regulatory Expert Witness; Expert Opinion Regarding Legal Cases Expert Witness; Drug Development Expert Witness; Diagnostics Company Expert Witness

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