Role of membrane transporters in drug interactions

Abstract

e122 Volume 35 Number 8S ACAdemiA iSN’T So bAd eiTher N.D. Moore Pharmacology, Univ Bordeaux, Bordeaux, France Summary: Drug development follows a very specific path, from preclinical safety and quality ascertainment to clinical development to market authorization and postmarketing surveillance. The whole process is geared to the pharmaceutical industry, which indeed has all the know-how and experience to bring a drug to market, especially when it is also the originator of the future drug. When the product is derived from academic research, can academia initiate drug development, and at what stages? This will depend on the availability of the appropriate resources in the academic and/or private sectors, and the funding for these. Preclinical drug development is not overly expensive, especially for the basic elements needed to pursue drug development and to bring the drug to clinical testing. If the quality issues can be controlled (drug synthesis, stability testing), basic toxicity testing can be outsourced to any of many specialized companies. Obviously, academic laboratories should have all the required resources for pharmacodynamic testing and demonstration. Clinical trials can be done in the appropriate clinical investigation centers, and the academic hospitals of course have all the patients needed for the clinical trials, because this is usually where industry actually does them. Therefore, academia (including public hospitals and research centers) has all the required knowledge and resources needed to develop a drug and bring it to market. What may be most lacking at the premarket phase is financing, and finding this is not easy, especially at the later-phase clinical trials, which are usually multicenter and require heavy logistical resources. Recently developed networks and structures (E-CRIN, F-CRIN) aim to help these large multicenter studies. Increasing awareness by the public research-financing bodies of the need to be able to develop alternatives to industrial development, especially for certain types of drugs (drugs for rare diseases or new uses for old drugs), may also increase the involvement of academia in de novo drug development. Of course, public–private partnerships should continue, both through involvement of industry expertise during academia-initiated development and through the increasingly evident involvement of academia during later-phase clinical development of major new drugs, if only to avoid unnecessary suspicions of industrial misconduct, much as is done in the postmarketing arena with the ENCEPP code of conduct. Disclosure of Interest: None declared.