Mindell Seidlin MD
580 West End Ave.
New York, N.Y. 10024
Telephone: (201) 779-3283
Physician with Board Certification in Internal Medicine and Infectious Diseases with eight years of experience in academic medicine followed by fifteen years of increasing scientific and managerial responsibility in global clinical development in the pharmaceutical industry, culminating as President of the global clinical development subsidiary of a major Japanese Pharma company. Strengths include design and review of clinical development strategies across a broad range of therapeutic areas for both early and late stage projects, organizational development and management of a scientific organization in a multicultural environment. Experience also includes defense of products at FDA Advisory Committees, and expansion of franchise value for diverse products. Management experience includes building and integrating global organizations and recruiting top talent for such organizations, and aligning global functions with empowered global project teams.
Education: A.B. 1973 Magna Cum Laude in Biology and Biochemistry,
Barnard College, Columbia University
M.D. 1977 Harvard Medical School
Postdoctoral Training:
1977-81: Intern, resident and chief resident in Internal Medicine, Mt. Sinai Medical Center, NY
1981-84: Medical Staff Fellow, Infectious Diseases, National Institutes of Allergy and Infectious Diseases, NIH, Bethesda, MD
1984-85: Research Associate, Virology, Dept. of Microbiology, Advisor: Dr. H. S. Ginsburg, Columbia University College of Physicians and Surgeons, NY
Licensure: New York State, November 3, 1987
Board Certification: Internal Medicine, 1981
Infectious Disease, 1984
Pharmaceutical Industry Appointments:
11/92-3/95:Senior Associate Director, Anti-Infectives, Medical Research
Division, Lederle Laboratories, American Cyanamid Company, Pearl River, NY
5/95-3/97: Director, Clinical Development, Anti-Infectives and Safety,
Daiichi Pharmaceutical Corp., Ft. Lee, NJ
4/97-10/99: Senior Director, Clinical Development, Anti-Infectives,
Daiichi Pharmaceutical Corp., Ft. Lee, NJ
3/98-10/99:Senior Director, Medical Services and Drug Safety,
Daiichi Pharmaceutical Corp., Ft. Lee, NJ (concomitant with the above)
10/99-5/00:Executive Director, Clinical Development, Safety and Medical Services,
Daiichi Pharmaceutical Corp., Ft. Lee, NJ
5/00-9/01:Vice President, Global Therapeutic Area Head Anti-Infectives,
Aventis Pharmaceutical CO, Bridgewater, NJ
11/01-5/02 Vice President, Research and Development, Eisai Inc. Teaneck, NJ
6/02 -12/06 President, Eisai Medical Research Inc., Ridgefield Park, NJ
6/04-12/06 President, Eisai Global Clinical Development, Ridgefield Park, NJ
1/07-6/07 Senior Advisor to the Chairman, Eisai Global Clinical Development
1/07- present President, Seidlin Consulting LLC
Pharmaceutical Industry Experience
President, Seidlin Consulting LLC
Provide consultative support to pharmaceutical and biotech companies seeking to develop a broad range of compounds for therapeutic use in humans. Have also provided support to venture capital and to public-private consortia interested in supporting development projects.
President, Eisai Global Clinical Development
Responsible for all Eisai clinical development activities globally with clinical development organizations based in the US, Europe, Japan and Singapore. Integrated development activities of formerly separate US, EU and Japanese organizations and founded the organization in Singapore. Responsibilities include all aspects of clinical development Phase I-IIIB and regulatory submissions for approximately 25 different drugs under development. Therapeutic areas include CNS, oncology, sepsis/anti-inflammatory and internal medicine. Also involved in review of partnership and licensing opportunities. Annual budget approximately $600 million, with over 500 employees globally. Member of Global Research and Development Committee. Report to US Board of Directors and dotted line report to Global Head of R& D.
President, Eisai Medical Research Inc.
Responsible for formation of an independent clinical development subsidiary in the US to ensure efficient approval of NCE’s in the US in collaboration with Eisai global partners. Restructured the organization and grew from approximately 100 to 170 employees in two years. Total annual budget grew to approximately $80 million. Functional areas included therapeutic areas, clinical pharmacology, clinical operations, quality assurance, regulatory affairs, biometrics and information technology.
Vice President, Research and Development (Eisai Inc.)
Oversee US clinical development strategy and operations for this Japanese pharmaceutical company reporting to the President of the US Commercial Organization. Direct reports included: Heads of four therapeutic areas (CNS, GI, Oncology, Sepsis/Anti-infectives), Clinical Pharmacology, Biometrics and Clinical Operations as well as Medical Affairs. Responsible for approximately 90 employees and annual budget of approximately $40 million.
Vice President, Global Therapeutic Area Head (Aventis)
Anchor preparations for FDA Advisory Committee presentation for Ketek and present and moderate the Sponsor presentation. Oversee US and EU labeling negotiations.
Develop strategy for global development and regulatory submissions of anti-infective products. Oversee global clinical development of all anti-infective products.
Work with Discovery, Lead Optimization and Marketing/Medical Affairs to optimize choice and development of anti-infective products.
Executive Director, Clinical Development Safety and Medical Services (Daiichi)
Clinical Development Phase 1-4, all therapeutic areas other than Oncology. Oversight of sNDA for Floxin Otic. Label Negotiations and launch activities for Evoxac. Global Clinical Development plan for sitafloxacin (oral and iv). Oversight of all Medical Services and Safety activities. Review of licensing opportunities.
Director/Senior Director, Clinical Development (Daiichi)
Clinical Development of Anti-infectives Phase 1-4. NDA Submitted 12/96, Approved 12/97 (Ofloxacin Otic Solution). First NDA for the company. Overall Responsibility for Clinical and Statistical Sections, major input into CANDA, Pre-Clinical and Human Pharmacology Sections. Some input into CMC Section. Presented Data at FDA Advisory Committee Meeting, prepared briefing book, negotiated final labeling with FDA.
Initiated Phase 3B, Phase IV and Pharmacoeconomic Program. Review and revision of sales training and promotional materials. Participation in launch activities.
Senior Director for Medical Information and Safety (Daiichi)
Responsible for supervision of evaluation of company wide safety events. Oversaw implementation of safety tracking system. Supervised development of medical information department consisting of two professional and one support staff and medical information materials. Presentations to managed care organizations, co-promotion partners, etc.
Sr. Associate Director Anti-Infectives Medical Research Division (Lederle Laboratories)
Clinical Team Leader for PAF Antagonist :Clinical Team Leader for soluble TNF receptor – European sepsis trial. Medical Monitor for global antibiotic trials (pipercillin/tazobactam, biapenam). Preparation of Protocols, Clinical Summaries, Integrated Safety Reports. Prinicipal reviewer of Virology Discovery Program. Review of product licensing opportunities.
Academic Appointments:
August 1985-June 1987:
Clinical Instructor in Medicine, NYU School of Medicine
June 1987 date:
Assistant Professor of Clinical Medicine, NYU School of Medicine
Hospital Appointments:
August 1985 September 1992:
Medical Director of the AIDS Program, Bellevue Hospital Center, NY
New York Lung Association Task Force on AIDS
Principal Clinical Administrative and Hospital Service Responsibilities:
Director of AIDS Program, Bellevue Hospital Center, 8/85 9/92. The components of this program included in-patient AIDS units, a multidisciplinary AIDS consultative team, AIDS education program, Virology clinic and HIV testing and counseling program. Staff included 12 physicians, and approximately 40-50 other personnel. Attending in Infectious Diseases, NYU School of Medicine 8/85 date.
Publications available on request