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WILLIAM M. WARDELL MD PhD
Wardell Associates International LLC
2622 Lighthouse Bend Dr, Ponte Vedra, FL 32082
(904) 285-0160 (904) 309-2300 cell
Email: WardellAssocs@cs.com
Website: www.WardellAssocs.com
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SUMMARY OF EXPERIENCE
CONSULTING:
Wardell Associates International LLC (President & Manager): 1995 to date:
Consulting to the Pharmaceutical, Biotechnology and Medical Device Industries.
MAJOR CRO:
Covance, Inc., Princeton, NJ: 1996-2000:
Senior VP; Senior Scientific Officer & Executive Director, Covance Institute for Drug Development Sciences
(Fulltime 1996-2000). Led most of Covance USA's high-level medical & regulatory drug, biotech and device consulting projects:
~ 100 (internal+ external) projects;Wrote & evaluated over 100 Strategic Product Development Plans;
Performed Global Clinical Research, Phases 1-4, including liaison with Laboratories and Pharmacoeconomics;
Founded the Covance Institute for Drug Development Sciences (external and 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 and scientists;
Represented Covance Drug Development Sciences externally (presentations,
papers);
Led Technical Services (Medical, Regulatory, Safety, Biometrics, Training) to the
Business Centers.
BIOTECH COMPANY:
President, Protein Engineering Corp. (now a Division of Dyax in Cambridge, MA), 1993-95 Development Programs & Pharmaceutical Corporate Partnering Strategy for Discovery, Development, Regulatory, and Marketing proteins as therapeutics, imaging, and diagnostic agents.
TWO MULTINATIONAL PHARMA COMPANIES:
Boehringer Ingelheim & Parke Davis, 1983-1992.
Parke Davis: Snr VP, Drug Development (Headed Project Management).
Boehringer Ingelheim (VP- Medical & Regulatory). Head of Medical (all functions, including Clinical Research Phases 1-3, Medical-Marketing Services & Phase 4, Regulatory, Biostatistics, and Safety).
PHARMA INDUSTRY SERVICES:
PhRMA/PMA Medical Committee & International Regulatory Harmonization (ICH
Representative).
ACADEMIC MEDICINE:
Clinical Pharmacology, Drug Development, & Pharmaceutical
Policy, 1971-1983
Academic Medicine, Pharmacology, and Clinical Pharmacology/Therapeutics (University of Rochester);Founding Director, Center for the Study of Drug Development (CSDD, now at Tufts University); Pharmaceutical, Regulatory and Drug Development Sciences; Pharmaceutical Public Policy.
PRESENTATIONS & PUBLICATIONS:
4 Books & 110 papers.
Gave 30 invited outside presentations in 1999-01.
Click here for list of Presentations & Publications.
CORPORATE BOARDS:
Orphan Medical, Inc, Minneapolis, since 1995: Chairman, Regulatory Oversight Committee.
PharMetrics, Inc, Boston, since its inception in 1998.
PhytoCeutica, Inc., New Haven, since its inception in 1999.
Scientific Advisory Boards: Protea, QED Rx, EvoRx.
PHARMACEUTICAL DRUG
DEVELOPMENT, NDA APPROVAL, & MARKET-SUPPORT
ACHIEVEMENTS:
NDA APPROVALS While in Large-Pharma Operational Pharmaceutical Role:
1995 Combivent MDI (Fixed combination of ipratropium+albuterol) - for COPD.
1995 Atrovent Nasal Solution (ipratropium bromide) for Perennial & Non-perennial Rhinitis.
1995 Atrovent Nasal Solution (ipratropium bromide) for Common Cold.
1993 Neurontin (gabapentin) Refractory epilepsy.
1990 Thalitone (chlorthalidone) Low-dose formulation for hypertension.
1989 Persantine I.V. (dipyridamole). Diagnosis of myocardial ischemia using thallium imaging.
1988 Alupent Solution (metaproterenol) Asthma - pediatric indications.
1988 Atrovent MDI (ipratropium bromide) - the first anticholinergic bronchodilator, for COPD.
1986 Persantine (dipyridamole) for prevention of heart-valve thromboembolism).
1985 Mexitil (mexiletine) for cardiac antiarrhythmias).
1984 Catapres TTS (clonidine). The first once-a-week antihypertensive transdermal patch.
CORPORATE EXPERIENCE IN
DRUG DEVELOPMENT & MARKET SUPPORT:
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
Protein therapeutics and diagnostic imaging
Inhibitors of elastase, plasmin, & kallikrein
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 & function
Worldwide Corporate Drug Safety System
Management of responses to 2 worldwide drug safety problems.
HONORS AND AWARDS:
1994 Henry Elliott Award for Distinguished Service, American Society for Clinical
Pharmacology and Therapeutics
Merck International Fellowship in Clinical Pharmacology
University of Oxford: Commonwealth Medical Scholarship
University of Oxford: Christopher Welch Scholarship in Biology
University of Oxford: Radcliffe Prize for Research in Medical Science
Otago University Medical School: John Malcolm Memorial Prize in
Physiology
EDUCATION AND LICENSURE:
MD Medicine, PhD Pharmacology, MA Physiology & Biochemistry:
Oxford University, England
Medical Licensure (current): Connecticut and New York, formerly
New Zealand & UK
Board Certification: American Board of Clinical Pharmacology
PROFESSIONAL AFFILIATIONS AND SERVICE
(current and former):
American Society for Clinical Pharmacology and Therapeutics (ASCPT):
Vice President, Board of Directors. Committees: Government Affairs,
Long Range Planning, Certification in Clinical Pharmacology, Clinical
Trials Methodology (Chairman), Publications (Vice Chairman),
Membership
PhRMA / PMA: Commissioner, Commission on Orphan Drugs; Member,
Medical Section Steering Cmttee; International Committee on
Harmonization (ICH): Member of US Delegation and speaker, ICH-1;
Chairman, Subcommittee on ICH-2 (Efficacy Expert Working Group;
Dose-Response Panel)
American Medical Association - ASCPT Section Council on Clinical
Pharmacology and Therapeutics (Chairman)
American Society of Pharmacology and Experimental Therapeutics (ASPET)
American College of Clinical Pharmacology: Public Affairs Committee,
Publication Committee
American Academy of Clinical Toxicology
Australasian Society of Clinical and Experimental Pharmacology (ASCEP)
ACADEMIC AND PROFESSIONAL
APPOINTMENTS (current and former):
Adjunct Professor of Pharmacology and Therapeutics, Tufts University
Medical School
Founder and Lecturer, Tufts University Annual Postgraduate Course in
Clinical Pharmacology, Drug Development, and Regulation
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
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Curriculum
Vitae
