Creating a Comprehensive Drug Development Strategy | Page 2

Mapping a Path to Market: Creating a Comprehensive Drug Development Strategy Concept of Drug Development PRESCRIBING INFORMATION ways to cut costs, shorten timelines, and increase the probability that their compound will be one of the few to succeed. Clearly, the key determinate of success is the efficacy and safety of the drug itself. If your compound for Type II diabetes doesn’t cause significant decreases in blood sugar levels—or if 25% of study participants develop migraines while on drug— then it’s time to stop development. But many compounds fail for less clear-cut reasons, such as slow study enrollment, trial designs that do not meet regulatory expectations, or prohibitively expensive raw materials. Many of these issues can be more easily managed or, in some cases, avoided altogether if development starts OTH ER pharmaceutical and biotechnology companies large and small are looking for ORY LAT EGU R it to market.1 With approximately 5,200 drugs in preclinical testing in 2012,2 ITY QUAL RING/ FACTU MANU every 5,000 to 10,000 compounds entering the pipeline, only one will make CLINI CAL D EVELO PMEN T The Pharmaceutical Research and Manufacturers of America estimate that for Figure 1. PRECLINICAL/NONCLINICAL DEVELOPMENT There’s no getting around it—drug development is expensive, time consuming, and risky. » DRUG DEVELOPMENT FOUNDATIONAL QUESTIONS with a comprehensive strategy. Unfortunately, this critical step is often overlooked or undervalued because of the time and significant energy required to think through the various scenarios. DRUG OR BIOLOGIC This paper provides an overview of a comprehensive drug development strategy, starting with three foundational questions and moving through the key areas of regulatory, manufacturing/quality, preclinical/nonclinical development, clinical development, and other (e.g., intellectual property, marketplace, and reimbursement). The Pharmaceutical Research and Manufacturers of America estimate that for every 5,000 to 10,000 compounds entering the pipeline, only one will make it to market. clinipace.com 1