Pharmaceutical executive with over 25 years of progressively responsible experience and accomplishments in all areas of drug development, from product concept to marketing and sales. Designed, established and implemented a unique and highly successful program to develop, register and market pharmaceutical products worldwide including extending brand penetration and market share of multiple products in a wide range of therapeutic areas. Direct relevant experience in drug substance and drug product issues as they relate to manufacturing and control, pre-clinical and clinical studies and regulatory parameters related to drug approval, manufacturing, labeling, marketing and distribution.

• Demonstrated success in completing multifunctional tasks on time and on budget.
• Leadership ability documented by direction of several multifaceted development programs simultaneously.
• Thorough understanding of the nature of the business, budgeting, financial controls, strategic planning and the regulatory forces which control many of these functions.
• A track record of developing commercially successful pharmaceutical products with development time and budget significantly under industry average.
• Strategic and working knowledge of the FDA drug approval process as demonstrated by rapid review time using CANDA for a wide range of therapeutic formulations.
• Extensive experience working with Japanese and other European and Asian pharmaceutical companies.

J and C MANAGEMENT COMPANY, INC., Green Oaks, Illinois and Delray Beach, Florida
1993 - Present
Principal, Chief Consultant
Founded the consulting firm for the purpose of providing advice as well as strategic and operational support and experience for a wide range of applications in the pharmaceutical, medical device, healthcare and biotechnology industries. Some areas which services are provided include enhancing the efficiency of drug development (for new chemical entities and existing products), scientific affairs, new and existing facility compliance auditing, manufacturing, microbiology, quality assurance, licensing, pre-clinical and clinical program design and implementation, clinical auditing, training, drug regulatory affairs, monitoring, publications and a wide range of other functions. All services are designed with the sponsor to assure compliance with regulations while building quality and efficiency into developing and marketed healthcare products and to increase market share and maintain that competitive advantage. Provide expert testimony in legal cases, including appearance in State and Federal Court.

G.D. SEARLE AND CO., Skokie, Illinois
1987-1993
Vice President, Drug Development
Directly responsible for all phases of development of licensed compounds, line extensions and new dosage forms of existing products. Development activities included compound evaluation, alliance building and licensing negotiations, pre-clinical and all phases of clinical development including phase IV, and coordination with marketing and regulatory affairs, U.S. and international. Supervised preparation, directed and approved strategic design of worldwide development plans. Supervised a staff of 30+ including M.D.s, Ph.D.s, Pharm.D.s, R.N.s and clinical scientists.

• Developed the concept of multifunctional Drug Development using a "Product Champion"; identified strategic and medical needs required to bring drugs to market and satisfied these needs by selection and training of professional staff teams whose efforts resulted in development and/or marketing of Maxaquin (lomefloxacin oral and I.V), Cytotec (misoprostol) and spironolactone topical for treatment of acne.
• Chaired Development Steering Committee resulting in centralized control of worldwide development of Maxaquin, licensed from Hokuriku Seikaku (Japan), and an earlier than expected launch in the U.S. with the needed market support of symposia, abstracts, and publications in major refereed journals. Chief scientific and business contact with the licensor since the signing of the licensing agreement. This product was developed and registered with FDA in less than half the time such products usually take, with the full compliment of claims submitted in the original CANDA.
• Conducted an international development program for Maxaquin through contacts in Europe and around the world aided by a matrix management system controlled by the Steering Committee. This resulted in earlier than expected product introductions in Europe and a timely acceptance of the product in key countries.
• Accomplished marketed product support by utilizing a team of product dedicated clinical research associates led by a product leader to ensure rapid deployment of clinical resources. This resulted in on time and on budget performance of all scientific studies, rapid publication of promotional and regulatory sensitive results and timely presentation of data at scientific meetings. This approach had been responsible for Calan SR annual sales of over $650 MM.
• Designed, developed, obtained approval and implemented an entirely new set of Clinical Research Policies. Established a formalized CRA training program which had been used to train all clinical staff. Strategically designed, hired and managed a complete drug development research staff who successfully developed and supported multiple new drug products and existing product lines.
• Coordinated and expedited the scientific and medical evaluation of potential development drug candidates from worldwide sources. Instituted marketing evaluation earlier in the process to attain more effective business perspective in the scientific evaluation.

WARNER LAMBERT COMPANY/PARKE-DAVIS
1983-1987

Parke-Davis, Ann Arbor, Michigan
1986-1987
Director, Clinical Therapeutics-Antiinfectives
Responsible for consolidating all phases of drug development for antiinfectives for U.S. and International into a single entity. Responsibilities expanded to include review of licensing candidates and appointed chairman of Planning Team.

• Analyzed results of manufacturing and clinical studies in support of filing NDA for enoxacin (licensed from Dainippon Pharmaceutical Co., Japan) resulting in approval in the U.S. and multiple international markets.
• Participated in design and implementation of marketing plans in early launch countries.
• Operated consistently with on time and on budget performance while expanding the function of teams.

Warner Lambert Company, Morris Plains, New Jersey
1983-1986
Director, Drug Development, Chemotherapy-International Operations
Responsible for microbiological and clinical development of new quinolone antiinfective in the international marketplace for the Company. Represented International on Planning Team which required frequent interaction with the licensor (Dainippon) in Japan. Represented Warner Lambert Company in the international antiinfective community.

• Formulated a development plan resulting in successful registration of enoxacin in several international markets.
• Improved relationship with Dainippon Pharmaceutical Company resulting in further opportunities for Warner Lambert Company.

PFIZER INTERNATIONAL INC., New York, New York
1979-1983
Pharmaceutical Medical/Marketing Division
Assistant/Associate Director, Scientific Affairs
Analyzed scientific data and prepared registration documents for a series of antiinfective products including cephalosporins, antifungals and antianaerobic products.

• Participated in efforts to attain registration of Cefobid (cefoperazone, Toyama) in most international markets.

PFIZER INC., Brooklyn, New York
1976-1979
Development Scientist-Quality Control Division

EDUCATION
Ph.D., Microbiology, University of Dayton, Dayton, Ohio, 1976
M.S., Microbiology, University of Dayton, Dayton, Ohio 1973
B.S., Biology, S.U.N.Y. at New Paltz, New Paltz, New York 1971

PROFESSIONAL AFFILIATIONS AND ACTIVITIES
Member, American Society for Microbiology (A.S.M.)
Member, Continuing Education Committee of A.S.M.
Fellow, American Academy of Microbiology
Lecturer, A.S.M. National Foundation
Member, Drug Information Association
M.I.T. Forum, Chicago Branch
Licensing Executives Society

PUBLICATIONS
Siporin, Clifford. How You Can Capitalize on Phase 3b. Medical Marketing and Media, October, 1994, CPS Communications.

Siporin, Clifford. Want Speedy FDA Approval? Hire a "Product Champion". Medical Marketing and Media, October, 1993, CPS Communications.

Siporin, C. Quinolones. In: Encyclopedia of Microbiology. 1992, Academic Press.

Siporin, C., et al. Editor, "The New Generation of Quinolones", July, 1990, Marcel Dekker, Inc.

Siporin, C., et al., Clinical Experience with Lomefloxacin. Quinolones, 1989.

Siporin, C., The Evolution of Fluorinated Quinolones: Pharmacology, Microbiological Activity, Clinical Uses and Toxicities. Ann. Rev. Microbiology. 43:601-627, 1989.

Cox, C., Siporin, C. et al., A Multicenter, Double Blind Trimethoprim/Sulfamethoxazole Controlled Study of Enoxacin in the Treatment of Patients with Complicated Urinary Tract Infection. J. of Urology. 141:575-578, 1989.

Siporin, C., and Towse, G., Worldwide in vitro Activity of Enoxacin. J. Antimicrob. Chemother. 14(C):45-56, 1984.

Cooney, J.J., Siporin, C. et al., Physiological and Cytological Responses to Hydrocarbons by the Hydrocarbon-Using fungus Cladosporium resinae. Botanica Marina 23: 227. 1980.

Cooney, J.J., Siporin, C. et al., Inhibition of Glucose Metabolism by n-Hexadecane in Cladosporium resinae. J. Bacteriol. 128: 235, 1976.

Siporin, C. et al., Extracellular Lipids of Cladosporium resinae Grown on Glucose or on Hydrocarbons. Appl. Microbiol. 29:604, 1975.