Return on Investment and Minimizing Risk in Partnering with Preclinical CROs
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Copyright 0 1997 Drug Information Association hc.
MAXIMIZING RETURN ON INVESTMENT AND MINIMIZING RISK IN PARTNERING WITH PRECLINICAL CROS BRUCEL. MALOFF,PHD KARENL. VALENTINO,PHD Director of Pharmacology, IDUN Pharmaceuticals, San Diego, California
RICHARDJ. NELSON,DVM Research Scientist, Neurocrine Biosciences Inc., San Diego, California
BRIANR. BROXUP,DVSc Vice Resident, R & D, ClinTrials BioResearch Ltd., Senneville, Quebec
The pharmacoeconomic realities of drug discovery are that biopharmaceuticalfirms need to discover and develop innovative leads in less time, while shifting costs from a f i e d to a flexible basis. The result of this new paradigm is that the need to outsource various aspects of drug development--from preclinical toxicology to posmtarketing Phase N trials-is so strong at the present time that it has created growth in the contract industry as a whole at about 15-20% annually. With new players entering thefield, and established contract research organizations (CROs) facing increased demands, it is important to select a CRO with scient$c skills of the highest standards and business per$ormance with a compelling sense of urgency. There is substantial risk in choosing a preclinical partnel; that is, optimizing a lead compound, achieving jnancial benchmarks, and success of incipient clinical trials. This review addresses expectations and opportunities in toxicology research, the interactions between companies, and integration of studies to accelerate drug and device development. Key Words: CROs; Contract research; Toxicology; Preclinical research; Outsourcing
INTRODUCTION OVER THE PAST DECADE many novel drug therapies have been discovered and developed as a result of clinical or academic research. Small biotechnology or biopharmaceutical companies are born from these concepts or discoveries. The goal is to get the This paper is based on a presentation made at the DIA 32nd Annual Meeting ‘The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June 9-13, 1996, Sari Diego, California. Reprint ad&ess: Bruce L. ~ a l ~ fpfm, , 710 sudbury Rd., Wilmington, DE 19803.
concept to the clinic as quickly as possible. Start-up companies normally concentrate on efficacy studies, especially for proof-of-principle, to provide the means to raise the capital necessary for drug development. The strategy to maximize efficiency of preclinical testing becomes critical as novel scientific technologies are faced with changing regulatory requirements and demand increases to move products to market sooner for a competitive advantage. Concomitantly, partneringwith contract research organizationsis an important Of saving time and accessing expertise for the biopharmaceutical and medical device industries.
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B. L. MalofJ; K. L. Valentino, R. J. Nelson, and B. R. Broxup
Making the decision to bet the future of a drug lead on research an
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