Day One

 

27th March 2012

8.00 Registration, coffee and networking

9.00 Chairman’s opening remarks

Dr Richard Buller, Vice President, Translational Oncology, Pfizer

9.05 Development, Approval and Commercialisation of CDx for Xalkori® (crizotinib)

• CDx development for low prevalence of disease populations
• Kicking off: LDT or IUO and which one?
• Dual labeling, marketing, and other post approval issues

Dr Richard Buller, Vice President, Translational Oncology, Pfizer

Strategies for Successfully Implementing Companion Diagnostics

9.35 Considerations for Finding Biomarkers and Translating into Diagnostics Along Side Drug Development

• Finding biomarkers early is preferable but is the technology used for discovery best for an IVD? How do you evaluate this?
• Choosing the Dx partner and model for availability and accessibility: Key considerations
• How early should commercial , development and regulatory teams with Dx expertise be incorporated into drug development?

Dr Peter Collins, Vice President, Diagnostics, GlaxoSmithKline

10.05 Speed networking session

11.00 Morning refreshments

11.30 Roche Personalised Healthcare: Identifying Key Factors for the Success of a Personalised Medicine Approach

• Driving the business case for personalised healthcare and key considerations to take into account
• Implementing personalised healthcare: Interplay between pharma and diagnostics divisions throughout the drug lifecycle
• Experiences from marketed medicines and their companion diagnostics in oncology and virology
• Late-stage personalised healthcare–related drug pipeline overview

Dr Gerd Maass, Vice President, Global Head of Strategic Initiatives, pRED, Roche

12.00 Successful Strategies in Personalised Medicine: Learning from a Global IVD Company

• Understanding the companion diagnostic model of drug development: From biomarker evaluation to commercialisation of a companion IVD
• How a dx partner fits into the drug development lifecycle
• Examples of CDx implementation

Dr Jörgen Dahlström, Senior Manager, Marketing and Scientific Support, Phadia, Now Thermo Fisher Scientific

12.30 Lunch

13.30 Drug-Diagnostic Co-Development: Why is it Important?

• What is driving the process toward a more individualised pharmacotherapy?
• Overcoming the challenge of disease heterogeneity
• Integrating companion diagnostics and drug development: Overcoming the key challenges

Dr. Jan Trøst Jørgensen, Director, Dx-Rx Institute 

 Predictive Biomarker and Companion Diagnostic Clinical Case Studies across Multiple Therapeutic Areas

14.00 Issues and Prospects for Companion Diagnostics in Oncology

• Review of recent successes
• What can we learn from the failures?
• What does oncology personalised medicine development look like at Celgene?

Dr Rajesh Chopra, Vice President, Translational and Early Drug Development, Executive Research, Celgene

14.30 Infectious Diseases: Implementing New Host Biomarker Research Findings into Clinical Development of New Hepatitis C Treatment Options

• Identifying biomarkers for use in drug discovery and development research of viral diseases
• Integrating host genetic and serum biomarkers predictive of HCV therapy response
• Investigating the clinical application of host biomarkers for newly developed HCV compounds

Dr Jeroen Aerssens, Research Fellow, Head, Translational Genomics & Genetics, Janssen Pharmaceuticals

15.00 Afternoon refreshments

15.30 Personalised Healthcare in Oncology Drug Discovery & Development at Roche

• Ensuring timely diagnostic co-development
• Integrated and iterative development of drugs and diagnostics
• Recent examples of PHC in Roche Oncology R&D

Dr Martin Steegmaier, Senior Biomarker & Experimental Medicine Leader, Roche

16.00 Analysis of Intrasubject Variability in CSF Biomarker Levels from Clinical Trials for Alzheimer’s Disease

• Identification of CSF Abeta as a viable biomarker for Alzheimer’s disease to monitor disease progression or efficacy of drugs
• Identifying factors that contribute to the variability of intrasubject levels of Abeta, taking into account clinical protocol
• Designing clinical trial protocols that minimise the variability

Dr Jeff Waring, Senior Group Leader, Associate Research Fellow, Pharmacogenetics, Abbott

16.30 Stratified Medicine Approaches in Fertility and Endocrinology Therapeutic Areas: Implementation of Clinical Biomarker and Pharmacogenomics Strategy

• Non-invasive biomarkers in fertility
• Biomarker approaches in endocrinology: Use of biomarkers for response to Kuvan (BH4) in PAH and predicting response to GH prior to treatment in GHD and TS

Dr Benoit Destenaves, Director, Head of Clinical Biomarkers & Pharmacogenomics, Global Clinical Development Fertility & Endocrinology, Merck Serono

17.00 Trials and Tribulations - Biomarkers and Diagnostics in Clinical Development

• Challenges and opportunities: Patient segmentation and diagnostic investigation in autoimmune indications
• Lessons learned: What does the data tell us so far?
• Providing meaningful tools to patients and physicians

Dr Fabio Magrini, Senior Director, Inflammation & Autoimmunity, MedImmune

17.30 Chairman’s closing remarks

19.30 Networking dinner

The summit dinner will take place in a local venue. Share discussions with your peers and enjoy a relaxing and informal dinner in comfortable surroundings. Good food, good wine, good company.