By Patrice L. Jackson-Ayotunde and Annette Bak
Over the past decade, there has been a decrease in the number and rate of new drug candidates that are being translated into effective therapies for clinical use. Approximately only five out of every 10,000 new chemical entities make it into phase I clinical trials. In addition, approximately only one out of these five is approved for the marketplace. Underlying scientific causes of attrition are mainly lack of efficacy, toxicity, and pharmacokinetics/formulation related events. Therefore, in order to select drug development candidates effectively, it is important that the discovery and preclinical disciplines collaborate on selecting a candidate with good probability of success in clinical development. This will be a drug candidate with compelling efficacy and a suitable physicochemical, formulation, ADME, and toxicology profile.
Scientific quality is obviously a “must have” for discovery and early development clinical candidates. However, recently, there has also been significant debate about discovery portfolio management, or in other words, what data is really needed at what stage gates of the process in order to achieve the scientific quality yet still keep the lean timelines that have become an industry “must have.” This balancing act has been known for a while, and collaboration around drug candidate selection is typically taking place within pharmaceutical companies and academic institutions. To provide a forum for AAPS DDDI section members to discuss these topics, the DDDI section will be hosting their Inaugural Regional Meeting on May 29, 2015, in Upper Gwynedd, Pa., at the Merck & Co. site.
The meeting objective and agenda have been strategically assembled to address current, novel, and future strategies for drug candidate selection, and speakers have been selected to cover all discovery (chemistry and pharmacology) and preclinical (ADME, pharmaceutical sciences, and toxicology) disciplines, and multiple sectors (industry, academia, and regulatory agencies). This diverse strategy—the organizers hope—will allow for sharing of best practices and strategies across organizational borders and hence contribute positively to the scientific field of drug candidate selection.
Learn more about the event, the speakers, the organizing team, and online registration (by May 22, 2015) on the AAPS DDDI website. Feel free to respond to this blog with comments or questions regarding the meeting or drug candidate selection in general. We look forward to your participation!