This June, Mikko Neimi, ITC member, will meet with European industry experts at Pharma IQ’s Clinically Relevant Drug Transporters congress to discuss the ITC Whitepaper and the imminent FDA guidelines.
Mikko Neimi, ITC member, will lead the panel Clarification of the ITC Whitepaper and its Uses in Drug Development and Evaluating the Forthcoming Guidelines. This interactive session will examine the advent of guidelines on transporters, drug-drug interactions and what is required for approval. The session will be the chance for delegates to speak directly to the experts from the regulatory field, ITC and industry to get a full perspective on what is expected.
The new regulation discussions will be enriched by the case study from GSK. John Keogh, GSK, will provide the audience with an overview of the paper and its impact on the role of transporters in clinical development and ensuring safety and efficacy. He will also present working examples of good and bad practice illustrating how GSK managed to overcome the challenges.
ITC session, Clarification of the ITC Whitepaper and its Use in Drug Development and Evaluating the Forthcoming Guidelines, will be part of the 2nd Annual Clinically Relevant Drug Transporters, taking place 29th June-30th June 2011 in London.
Other key sessions include:
- Does Polymorphism of the P-gp Transporter Impact Treatment Response in Major Depressive Disorder (MDD) by Mads Kreilgaard, Head of Department, Discovery ADME, H. Lundbeck A/S
- Studying the Interplay Between CYP 3A and Drug Transporters Using Knockout Mice by Robert van Waterschoot, Laboratory Head DMPK Abbott Laboratories|
- Interactive Session: Transporter Relevance: A Question of Data? run by Dr Constance Höfer, Director Non-Clinical Drug Development from Medigene AG
- Case Study: In Vitro and In Vitro Pharmacokinetic Profile of a Novel a4b1/a3b7 Integrin Receptor Antagonistpresented byJean-Marie Nicolas, Director of ADME from UCB