This document provides a summary and curriculum vitae for Steven R. Vallespir, including his professional experience, education, awards, areas of therapeutic expertise, licensing evaluations conducted, and publications. Key points include over 30 years of experience in pharmaceutical marketing, business development, licensing, and new product development. He has held roles such as CEO, VP Marketing, Director of Business Development, and Associate Director. Results include developing a $1 billion product and presenting before the Venture Association of New Jersey where he received third place.
1. Curriculum Vitae
STEVEN R. VALLESPIR, BS MBA
270 W Jericho Tpk. Huntington Station, NY 11746
631-421-3900 242 (516-983-0665)
vallespir@aol.com
SUMMARY
An entrepreneurial executive with business experience for developing new pharmaceutical/medical products
(Rx/OTC/Device), forecasting, marketing research, product management and marketing, evaluating/negotiating
licensing opportunities, portfolio, pricing and strategic planning along with competitive intelligence plus a medical
background. Results include developing a $1B product per annum and working from the ground up in start-up
ventures. Now writing a book, “The Making of Medicine” [on hold]. (Comment: In the last years slowly became
disabled and need a cane to walk, otherwise healthy. But many doctors took time to discover have a rare issue, my
feet. Been unemployed and Social Service is putting me in hotels etc. Looking for a real job as now adjusted to a new
status.) Well things happen and this is why we always need new medicine.
PROFESSIONAL EXPERIENCE
“Consultant “ & Entrepreneur, Park Ridge NJ, Long Island, NY. 2005-Present
CEO Staval Pharma LTD (& consultant Vice President, NeuroSci 2005-2008)
Private consulting concerning licensing, marketing and new product development of healthcare OTC/Rx/Device
products.
• Activities include developing initial business plans and PPM, developing P&Ls; including pricing, SG&A, COGs
estimates, primary and secondary marketing target customers, finance raising activity, in general, all fundamentals for
an emerging Pharma company plus patent concepts and development.
• Presented before VANJ (Venture Association of New Jersey) and received 3rd
place award. Two patents “pending”.
• Still have all the plans and work available to develop a $500 million consumer medical product and make it happen.
Gfk Market Measures, Princeton, NJ 2003-2005
Associate Vice President - Research, Therapeutic Class Expert & Market Assessment Practice
Responsible to support Market Researchers, Product Managers and Account Executives for custom and multi-client
primary market research studies in the fields of oncology, neurology, HIV, hepatitis and anti-fungals.
• Conducted a comprehensive evaluation of oncology leading to recommendation to provide major focus on oncology for
the company future direction and add 5 additional fields for research.
• Lead a team to revise and enhance Therapeutic Class Syndicated studies.
• Developed and provided a seminar for developing and marketing new drugs.
• Developed and launched a promotional campaign to licensing/business development Pharma individuals.
• Managed a $15-20 million portfolio of market research products.
SANKYO PHARMA INC., Parsippany, NJ. 2001-2002
Associate Director, Business Development-Licensing
Managed all licensing and business development activities for primary care, diabetes and cardiovascular products with one
direct report.
• Negotiated co-promotion deal for WelChol in 4 weeks and coordinated preparation of 650 reps concurrently within 5
weeks.
• Identified and evaluated 12 potential late stage licensing candidates and conducted one complete due diligence and
negotiating terms for a PCP product to launch 2Q 2004.
• Developed the first global capability presentation for Sankyo and set up business development website for lead
generation.
INNOVEX, INC., Parsippany, NJ (A division of Quintiles Transnational Corp.) 1998 – 2001
Strategic Opportunity & Alliance Assessment 1999 – 2001
2. Director, Business Development 1998 – 1999
Responsible for business development and to build and manage a market research department with 5 direct reports to
identify and evaluate business opportunities.
• Collaborated with the President attaining a $150M sales force contract, the largest in Innovex history.
• Evaluated the top 40 pharmaceutical company’s marketed products and development portfolios and provided
opportunity leads to the Business Development Department.
• Joined Japanese Mission Team to visit Japanese companies and offer services to establish an American affiliate
leading to continuous relationship building for future business opportunities.
MEHL/BIOPHILE INTERNATIONAL CORPORATION, Gainesville, FL 1995 – 1998
A start-up novel & patented hair removal laser medical device technology public company.
VP Marketing& overall management
Reporting to the CEO with overall responsibility for business and marketing issues related to the hair removal laser
with 6 direct reports.
• Oversaw successful 510(k) FDA submission, approved within 9 months.
• Identified and presented before major Wall Street investment banking and investor relations firms.
• Wrote the original 10k SEC filing.
• Developed regulatory strategy and presented to state government authorities and attained favorable regulations.
• Implemented consumer and professional marketing and promotional strategies for laser system introduction and
launch.
• Over 75 lasers placed within six months.
SANDOZ PHARMACEUTICAL CORP., East Hanover, NJ 1981 – 1995
Associate Director of Commercial Development-Licensing 1994 – 1995
Responsible to identify and evaluate opportunities such as licensing, alliances and acquisitions as a founding member
in the new department.
• Licensed a novel diabetic wound-healing product.
Associate Director of Marketing Management 1991 – 1994
Responsible for product management of a novel dermatology product with a budget of $60 million with one direct
report.
• Launched the product (1400 sales reps). Market share ($) after 90 days: 40% Podiatry, 16% Dermatology, 11%
Family Practice. Created a Direct to Consumer campaign.
• Developed/implemented new marketing strategy for an asthma product resulting in 30% increase in revenues with
200% ROI.
Associate Director of New Product Management 1987 – 1991
Responsible for business development and strategy for new products under development plus identification and
negotiation of licensing candidates for CNS, dermatology, gastroenterology, diabetes/metabolic, endocrinology,
asthma/pulmonology and oncology with one direct report.
• Set worldwide development strategy resulting in a product, now $1B worldwide – Lamisil.
• Found and negotiated licensing opportunity for diabetes worth several hundred million dollars.
• Major responsibility for removing 6-year-old FDA clinical hold on a new product.
• Developed and implemented GO/NO GO strategy resulting in successful breakthrough NDA registration approved
within 18 months.
• Evaluated/implemented $2.1M new manufacturing equipment capital investment.
• Designed and conducted first long-term outcomes (cost/benefit) and Quality of Life studies.
• First member in a new department. Developed new policies and procedures for managing a portfolio of R&D
projects by establishing goals, as well as setting worldwide strategy plus managing teams involving various
research, development and manufacturing groups. Included development of comprehensive computer netplan.
Marketing Planner of Marketing Research 1984 – 1987
(Plus Sales Representative)
SANDOZ RESEARCH INSTITUTE 1981 – 1984
Scientist A (preclinical drug discovery)
3. VA MEDICAL CENTER 1980 – 1981
Medical Technologist of Electron Microscopy
EDUCATION
MBA, Marketing, Graduate School of Business Administration, 1986
Stern School of Business, New York University, New York, NY
Doctoral Studies, Physiology, Department of Physiology, 1979
Rutgers University Medical School CMDNJ, Piscataway, NJ
BS, Animal Science, 1977
Cook College, Rutgers University, New Brunswick, NJ
- Magna cum Laude
TEACHING:
Guest lecturer for developing new drugs and products, University of Mississippi School of Pharmacy, Pharmaceutical
Program.
AWARDS:
Eagle Scout, currently Commissioner
American Academy of Dermatology Silver Award for Medical Exhibit (1988)
Sandoz Ideas at Work Award ($35,000 Maximum possible), 1988 (Volume Discount Pricing Policy)
Sandoz Ideas at Work Award, 1987 (Utilization of Ampoule Production Facility)
Center for Creative Leadership
Presented before VANJ (Venture Association of New Jersey) and received 3rd
place award (2009). Two patents pending.
THERAPEUTIC AREA EXPERIENCE:
Headache Migraine Pain
TMJ Epilepsy Parkinson’s Disease
Cocaine/Alcohol/Nicotine Abuse Narcolepsy Stroke
Senile Dementia Chemotherapy Emesis Estrogen Dependant Neoplasia
Testosterone Infertility Menopause & Vaginal Atrophy
Osteoporosis Hyperprolactinemia Osteo & Rheumatoid Arthritis
Obesity Atherosclerosis Diabetes
Ulcerative colitis Chrons Disease GERD
Irritable Bowel Syndrome AIDS Asthma & Allergy
Wounds Psoriasis Fungal Disease (dermatophytes)
Vaginal Candidosis Anxiety/depression Laser Hair Removal
LICENSING EVALUATIONS:
Etomoxir, Type 2 diabetes GFAE, psoriasis
Metformin/Glucophage, Type 2 diabetes CV 205-502, hyperprolactinemia (outlicense)
Graftskin/Apligraf, diabetic would healing Alprox-TD/alprostidil, erectile dysfunction
AGI-1067, atherosclerosis IBAT inhibitor, bile acid transport
GLP/glucagon like peptide, diabetes antibiotic
Tostrex, hormone replacement therapy Trospium, urinary incontinance
ATL-962/Alizyme, Type 2 diabetes lipase inhibitor Ragweed vaccine
CS 758, antifungal CS 526, GERD acid pump antagonist
SLV 306, CHF cardiovascular stents
WelChol, hypercholesterolemia co-promotion partner
4. PUBLICATIONS:
Roberts RB and Vallespir SR (1978). Specialization of Hairs Bearing Pollen and Oils on the Legs of Bees (Apoides:
Hymenoptera). Ann. Entomol. Soc. Amer. 71(4):619.
Ghosh A, Vallespir SR, and Ghosh BK (1984), Specificity of Sub-cellular Distribution of Alkaline Phosphatase in
Bacillus licheniformis 749/c. Can. J. Microbiol. 30:113.
Federman Q and Vallespir S (1984). A New Device and Method for Rapid Processing of Cytologic Smears, Histologic
Sections and Cell Cultures for Electron Microscopy. Acta Cytologica 28(4):509.
Winslow CM, Vallespir SR, et al (1985). A Novel Platelet Activating Factor Receptor Antagonist. Symposium: Is
There a Case for PAF-acether Antagonists, Paris. Prostaglandins 30:697.
Winslow CM, Vallespir SR, et al (1989). Platelet Activating Factor Induced Bronchoconstriction and Extravasation in
the Guinea Pig: Effects on Ketotifen and the PAF Antagonist, CV-3988. Academic Press: Perspectives in Asthma, p.
103-15.
ABSTRACTS / PRESENTATIONS:
Ghosh A, Menengus M, Vallespir S, and Ghosh BK (1979). Purification and Characterization of Two Different Forms
of Exo-Alkaline Phosphatase from Bacillus licheniformis 749/c. Meeting of American Society of Microbiology – San
Francisco, CA.
Vallespir SR, Handley DA, and Ghosh BK (1979). Possible Native Morphology of the Mesosome in Freeze-
substituted Bacillus licheniformis 749/c. (G.W. Bailey, ed.), Proc. Elec. Microsc. Soc. Amer. 1:262.
Ghosh A, Smolensky M, Vallespir S, and Ghosh BK (1980). A Possible Alkaline Phosphatase Receptor in Bacillus
licheniformis 749/c Membrane. Meeting of American Society of Microbiology – Miami, FL.
Handley DA and Vallespir SR (1980). Comparative Advantages of Different Fixatives Suitable for Freeze-substitution
Fixation. (G.W. Bailey, ed.), Proc. Elec. Microsc. Soc. Amer. 1:640.
Saunders RN, Van Valen RG, Vallespir SR, Labriola-Tompkins E, and Handley DA (1982). Platelet Activating Factor
Induced Alterations in Aortic Endothelial Morphology. Electron Microscopy Society of America – Poster Session.
Saunders RN, Vallespir SR, and Handley DA (1983). Biological Parameters of Vascular Extravasation Induced by
Acetyl Glyceryl Ether Phosphorylcholine. Federation of American Societies for Experimental Biology – Chicago, IL.
Handley DA, Vallespir SR, Saunders RN, and Arbeeny CM (1983). Enhanced Endothelial Permeability to
Lipoproteins Induced by Acetyl Glyceryl Ether Phosphorylcholine. Federation of American Societies for Experimental
Biology – Chicago, IL.
Winslow CM, Vallespir SR, Lee ML, and Saunders RN (1984). Effect of Known Pharmacologic Agents od PAF-
Induced Guinea Pig Responses. 3rd
International Congress of Inflammation - Paris.
Winslow CM, Vallespir SR, et al (1989). Platelet Activating Factor Induced Bronchoconstriction and Extravasation in
the Guinea Pig: Effects on Ketotifen and the PAF Antagonist, CV-3988. Platelet Activating Factor, Pulmonary
Hyperreactivity and Asthma - Montreal.
OTHER:
Acknowledgement Initiation & Contribution: D.P.Lubeck et al (1993), Quality of Life of Persons with
Onychomycosis. Quality of Life Research 2: 341.