Drug Development: Time and Money

Translating R&D investment into new drugs The pharmaceutical industry’s expectations for increasing revenue rely to a large extent on ensuring that their heavy R&D investment translates into new drugs. In 2000, the global pharmaceutical industry was projected to have invested US$58 billion in R&D (1). In recent years, there has been an increasing emphasis on clinical trials and this has been reflected by a steady rise in R&D costs. For example, the proportion of industry R&D expenditure allocated to clinical studies increased between 1996 and 1998 from 32.5% to 39.5%, respectively (1). Dealing with development times The development time to first market for each new drug is an important time period for the marketing company since its duration determines the period of marketing exclusivity (patent cover) available to the company to attempt to recoup R&D expenditure. The time taken to develop new pharmaceuticals has quadrupled since the 1960s (1). The pharmaceutical industry has made tremendous efforts to reduce drug development times. However, despite the heavy investment in R&D and the use of newer technologies only a few companies appear to have consistently shown improvement. Generally, mean development times to first market remain between 10 and 12 years (1). Nevertheless, several companies have publicly stated their intention to reduce development times further. GlaxoSmithKline is aiming for a development timeline from the discovery of a novel target to new drug application (NDA) filing (in the USA) to be as little as five years (2). Similarly, AstraZeneca has set tough targets for itself. AstraZeneca intends to add more than 15 drug candidates to the pipeline every year by 2003 and double its project success rate from candidate drug to launch to 20%, whilst reducing the time to market of new drugs to six years (3). Successes in clinical development When it comes to clinical development, some companies appear to be making real progress. A recent survey by CenterWatch suggested that during the past five years, the top quartile of pharmaceutical companies had developed their new chemical entities almost 50% faster than their peers in the bottom quartile (4). Companies that were particularly highlighted for being successful in moving drugs from IND approval to NDA approval were Roche, Schering-Plough, Merck, Novartis, Johnson & Johnson, Pharmacia and AstraZeneca (4). Room for optimism? Some industry observers have predicted that by 2008 the major pharmaceutical companies will have increased the number of new chemical entities entering clinical development by 65% (5). As part of this, companies will have reduced the time products spend in the discovery/preclinical phase by 46%, the time spent in Phases I/IIa by 40% and the time spent in Phases IIb/III and awaiting approval by 27% (5, 6). Some of the improvements in clinical development times will be driven by more proactive use of CROs. It has been estimated that project sponsors are now using CROs on more than 60% of their clinical projects and this has driven growth of the CRO sector by 10-12% (4, 7). Outsourcing allows companies to control the escalating costs of trials and benefit from the CRO’s expertise in this area of drug development. References 1. Kermani F and Findlay G (2000). The Pharmaceutical R&D Compendium. http://www.cmr.org 2. Anon. Drug Development Time is Five Years from Target to NDA, Glaxo’s Sykes Says. The Pink Sheet 24 January 2000; p20. 3. Anon. AstraZeneca Unveils Promising Portfolio with 57 NCEs. Pharma Marketletter 20 December 2000; p18. 4. Breaking the Development Barrier (2002). CenterWatch. http://www.centerwatch.com 5. Anon. Rapid Rise in NCEs in Trials by 2008. Scrip 2530, 2000, p12. 6. Anon. Speed to Value: Delivering on the Quest for Better Medicines. Andersen Consulting Executive Briefing 2000. 7. Mathieu M. (2002). Parexel’s Pharmaceutical R&D Statistical Sourcebook.