Industry to Meet as Regulators Set Direction on Transporter-Mediated Drug Interactions
In the wake of both FDA and EMEA meetings on the subject, industry leaders are to converge in London on June 30th to discuss the implications of the united front represented by their recommendations.
On March 17th, the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology met to discuss four areas where adjustments may be considered in the process of submitting NDAs, with one of these being transporter-mediated drug interactions. It was concluded that the way transporters are assessed needs to be looked at and carefully defined by the FDA. As a result, it has been recommended that transporter information be included in all new NDAs.
Only a month later on 22nd April, the EMEA Committee for Human Medicinal Products issued a revised version of their draft guideline on the investigation of drug interactions. The CHMP draft concurred with the FDA recommendations in that it agreed increased focus on this important area was necessary in the immediate future and to that end released the draft guidelines for consultation until 31st October 2010.
Pharma giants such as AstraZeneca, Pfizer and GlaxoSmithKline are meeting at the end of the month at Pharma IQ's Clinically Relevant Drug Transporters meeting in London to discuss these recent developments and to share information on the latest developments, technology and techniques being developed by leaders of the field. The conference also addresses the recent International Transporter Consortium (ITC) paper, along with new methods of predicting drug-drug interactions, specific transporter-related substrates and inhibitors, the FDA stance on clinical interaction studies and labelling and new effective modelling and IVIVE techniques.
“The publication of the ITC whitepaper and the EMEA guidelines is a very significant step forward in standardising transporter research in drug discovery and development” says Peter Krajcsi, CSO of leading assay provider SOLVO Biotechnology. “It will help scientists to decide which transporters they should study and when”.
For more information about the upcoming Clinically Relevant Drug Transporters Conference visit www.drugtransporters.com or
phone + 44 (0) 20 7368 9300
Media contact: Nicole Abbott, Marketing Manager, Pharma IQ/IQPC
Ph: 0207 368 9807 or email Nicole.email@example.com