Day One

19th June, 2013

07:45 Registration and breakfast

08:30 Chairman’s opening remarks

PLENARY SESSIONS: TRANSITIONING BIOMARKERS INTO ROBUST DIAGNOSTICS

8.45 Navigating the commercial landscape of personalized oncology drug development 

  • How do we define current market access pathways for cancer MDx and how can they be improved?
  • Maximizing efficiency in partnerships between pharma and Dx
  • Building a culture of strong communication: Ending the ‘disconnect’ between science and commercial

Cynthia Brogdon, Group Director, Oncology Medical Strategy, Global Development Lead, Erbitux, Bristol Myers Squibb

9.15 Companion diagnostic success: Biomarker discovery to global commercialization

  • Making the transition from a biomarker to a CDx Solution
  • Collaborative partnerships that drive results
  • Models for successful market acceptance

Chris Jowett, Companion Diagnostics Global Commercial Head, Abbott Molecular

9.45 Big Data + analytics = precision diagnoses and better outcomes

  • Commercial versus health outcomes arising from big data
  • Overcoming the challenges faced in storage, platforms and costs
  • How big a role does big data really have to play in the future of personalized healthcare?

Mark Boguski, Associate Professor, Harvard Medical School

10:15 Speed networking

11:15 Morning Refreshments

STREAM 1: GAME-CHANGING TECHNIQUES IN MDx DEVELOPMENT

11.45 Molecular Dx in cancer drug development: Why it’s challenging

  • What are the biggest challenges currently facing MDx advancement, from biomarker to bedside?
  • Overcoming economic unsuitability of novel diagnostic tools
  • Tackling questions around reproducibility and standardization of novel technologies for MDx

Abdel Halim, Director, Clinical Biomarkers, Daiichi Sankyo

12.15 The importance of building a technology infrastructure andworkflow for the optimization of MDx development

  • Technology assessment and implementation: Deciding what’s best for your pipelines
  • Regulatory compliance in the context of MDx technology infrastructure
  • Breaking down barriers associated with emerging market operations and workflows

Jonathan Pan, Director, Oncology Companion Diagnostic & Disease Strategy, GSK

12.45 Networking lunch

1.45 Examining the effects of optimized validation strategies on clinical development study size and timeframes

  • Best practice in discovery, development and execution of biomarker strategies across early and late stage development
  • The role of successful translational research strategies
  • Biomarker discovery and development in clinical studies: Now and in the future

Ian McCaffery, Oncology Biomarker Development, Companion Diagnostics, Genentech

2.15 Molecular imaging in oncology: Will it deliver the goods?

  • Examining the growing list of molecular imaging probes targeting all the hallmarks of cancer in small, single institution studies
  • The need for larger studies in multiple institutions
  • Meeting the challenges of bringing cost effective MI to the clinic

Peter Choyke, Senior Investigator, National Cancer Institute, NIH

2.45 Best practice in integration of state-of-the-art biomarker strategies

  • Setting the standard in developing and validating assays for biomarkers
  • Coordinating biomarker labs to ensure healthy diagnostic pipelines
  • Mapping the future of disease profiling and application of biomarker diagnostics

Bob Beckman, Executive Director, Clinical Research Oncology, Daiichi Sankyo

3.45 Progression-free survival (PFS) in patients with short tumor telomere length: Subgroup analysis from a randomized phase II study of the telomerase inhibitor imetelstat as maintenance therapy for advanced NSCLC

  • Using novel qPCR and FISH technologies for candidate biomarker measurements
  • Lessons learned from retrospective data analysis
  • How can a candidate biomarker help us choose the right indication for the drug?

Katia Bassett, Associate Director, Geron

4:45 Afternoon refreshments and networking

STREAM 2: BIOMARKER DISCOVERY & VALIDATION

11.45 Harnessing signalling pathways for biomarker discovery

  • Pathways to predict drug response and aid patient stratification
  • Best practise in target discovery
  • Evaluation of new systems and techniques to uncover the potential of signalling pathways

Joerg Heyer, Director of Cancer Biology, AVEO Pharmaceuticals

12.15 Biomarker selection in the development of two novel compound combinations

  • Case study from a recent development program
  • Overcoming the challenges associated with traditional biomarker selection
  • From selection to efficient biomarker translation

George Naumov, Senior Research Biologist - Oncology, Merck

12.45 Networking lunch

1.45 Challenges and opportunities for drug development with biomarker negative populations

  • What is a biomarker negative population?
  • How do we get the data?
  • Ramifications of exclusion and issues with inclusion

Richard Buller, VP, Translational Oncology, Pfizer

2.15 Tackling the verification and validation bottlenecks: Why are we still facing challenges?

  • Overcoming cost barriers associated with screening and imaging systems
  • Sample shortages and lack of relevant predictive biomarkers:
  • What are the next steps to tackling these issues?
  • Using more non-invasive methods to minimize clinical attrition

Chris Coughlin, Medical Director, Morphotek

2.45 Incorporating biomarker strategies early on in oncology programs

  • Evaluation, development, and implementation of biomarker
  • assays for both preclinical studies and clinical trials
  • Pharmocodynamic and patient stratification biomarkers
  • Best practise in working across multiple assay platforms

Tammie Yeh, Oncology Biomarkers Team Lead, Merck

3:15 Panel session: Mass spectrometry technique advancement & what this means for biomarker validation

  • Mass Spec as a driver of clinical cancer diagnostics: Present and future
  • Bridging the gap between early-stage discovery and next-stage using Mass Spec
  • Mass Spec as an essential verification tool

Michael Hodsdon, Associate Professor of Laboratory Medicine and Pharmacology, Yale University

George Naumov, Senior Research Biologist - Oncology, Merck

3:45 Afternoon refreshments and networking

4:15 Integrating Data Mining with Image Analysis to increase productivity and accelerate the development of tissue-based biomarkers

  • Definiens’ revolutionary technology provides unprecedented accuracy in identifying and quantifying biological attributes within images
  • Providing end-to-end software solution for tissue-based research
  • Integrating data mining and image analysis to generate new knowledge and better decisions

Alan Jerusalmi, Director of Technical Field Operations, Definiens

PLENARY SESSIONS: UNDERSTANDING & RESPONDING TO REGULATORY GUIDELINES FOR MDx

4:45 Examining routes and options for regulatory approval success in personalized medicine

  • How can industry work with regulators to smooth the approval process?
  • End to end marketing: when does the approval process start?
  • Anticipating the next wave of regulation for medical devices, in-vitro diagnostics and clinical trials

Keith Fournier, Director, Global Regulatory Affairs, AbbVie

5:15 Charting the true effects of recent healthcare legislation on personalized medicine

  • How healthcare legislation is having a profound effect on PM: An overview
  • Legal considerations in pharmacodiagnostic collaborations
  • Pre-empting legislative hurdles: staying ahead of the curve

Mark Kass, Partner, Nixon Peabody

5:45 Ensuring product quality standards across FDA/CLIA labs for MDx tests and IVD systems

  • Systems integration and what the true effect new CLIA guidelines will have on MDx development
  • Successful coordination of multiple cross-functional IVD development programs
  • Working with regulators to ensure compliance and efficiency

Devon Campbell, Director, Engineering & Systems, Novartis

6:15 Chairman’s closing remarks and end of day one

6:30 Networking drinks reception