Engage with ITC and Regulatory Representatives



Explore and Understand the Forthcoming Regulations in order to Develop Transporter Assays, Identify Substrates, Establish IVIVC and Evaluate their Clinical Implications

The arrival of last year’s ITC whitepaper has brought many changes to both preclinical and clinical investigations and has meant that transporter data is now essential for regulatory approval.

So, what are your strategies for identifying whether your compound is a substrate or inhibitor of a transporter?

Our industry-wide survey has highlighted that the biggest challenges include:

  • Identifying which transporters to study
  • Understanding regulatory requirements
  • Developing assays and screening techniques
  • Prediciting IVIVC and clinical implications from preclinical data

Do you agree?

Download the Drug Transporters Programme here for all the details and full speaker line up.

The event takes place on 29-30 June 2011 in London and is the only event in Europe that provides a regulatory focused evaluation of the forthcoming FDA and EMA guidelines and you can hear directly from the ITC about the whitepaper and its impact.

Mikko Niemi from the ITC will also be sharing his expertise on the ITC whitepaper and you have the perfect chance to get clarification on the aims, impact and future implications of the paper. Ask your questions on decision trees, different transporter families and integrating these studies into your drug development plan.

Exclusive Case Study

One of the latest approaches to understanding and studying transporters is actually to visualise their functionality and expression through the magic of Positron Emission Tomography (PET)! Oliver Langer, University of Vienna will be providing you with the latest in his research into developing imaging probes to achieve this and how these probes can facilitate dose-finding. Not to be missed!

What the event will discuss:

  • The ITC Whitepaper and forthcoming EMA and FDA regulations – what does the future hold?
  • How to reduce attrition rates due to toxicity and inefficacy through correct understanding of intercellular transportation
  • Investigating the use of knockout mouse models and how you can make clinical predictions form this data
  • Bridging gaps in clinical methodologies for assessing transporter based DDIs
  • Establishing IVIVC and speeding time to market through predicting DDIs at a preclinical stage

Top 10 Reasons to Attend

1. Exclusive regulatory panel session; get clarification of the whitepaper and forthcoming regulations!

2. Hear how last year’s theory has been put into practice and learn from our expert speaker panel to ensure successful transporter studies and regulatory approval

3. Investigate hepatotoxicity through DDIs with transporters

4. Learn how to characterise in vitro/in vivo systems to identify P-gp substrates

5. Interactive session – take a hands on approach to compare and contrast a preclinical and clinical study

6. Apply risk factors for DDI determination and get it right first time!

7. Discuss the risks and advantages of outsourcing

8. Understand and apply the use of PET imaging to speed up studies

9. Get the academic’s perspective on the role of ABC transporters in the development of multidrug resistance in cancer and hear how their polyspecificity is a key factor in ADMETox profiles

10. Get to grips with interspecies variability and differing PK profiles

What others say about Pharma IQ's events?

I learned a lot at this conference-the topics were interesting.
Janssen
A good mix of functional areas. For training purposes it has been enlightening.
ONO Pharmaceutical UK
Informative, examples from daily practice.
Medigene AG
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