Day Two

20th June, 2013

07:30 Registration and breakfast

08:00 Chairman’s opening remarks

PLENARY SESSION: THE SCIENCE OF REIMBURSEMENT FOR MDX

08:15 Clinical trial design in the age of personalized medicine

  • Pivotal trial designs, old and new
  • Rethinking the old paradigms
  • Can pivotal trials accommodate uncertainty?

Vince O’Neill, Global Head, Personalized Medicine, Sanofi

08:45  CDx – and evolving value proposition

  • As the shift in the payer space moves more towards outcomes and less on services, being able to demonstrate predicative outcomes for patients will become increasingly more important
  • CDx are well positioned to facilitate this transition to outcomes based reimbursement
  • Drug development companies who understand how competition increases reliance on PHC and have a clear understanding of the competitors PHC strategy will have an edge

Cyrus Arman, Principal, Deallus Consulting

9.15 Current trends and challenges facing innovation and commercialization of personalized medicine

  • Promoting and enabling personalized medical treatment through PPPs
  • Successfully leveraging the expertise and capacities of partners
  • Collaborating and partnering with stakeholders in personalized medicine including physicians, patients and investors to enable clinical development

Katherine Bonter, Director of Promotion & Advocacy, Cepmed (Center for Excellence in Personalised Medicine)

9.45 Regulatory and partnering considerations in companion diagnostics

  • Key challenges facing both the pharma and diagnostics partner in companion diagnostics development
  • Options available for execution in this evolving and complex area
  • What can we expect for the next decade of partnerships?

Ron Mazumder, Global Head, Research & Product Development, Janssen

10.15 Panel session: Allaying fears and ending uncertainties regarding reimbursement - What does the industry need in terms of knowledge and support?

  • Payment reform and current considerations
  • Capturing test value more successfully
  • Updating archaic and flawed payment protocols

Carol Berry, Sr. Vice President & GM Pharmacogenomics Services Division, Asuragen

Benjamin Eckert, Director, Global Health Economics and Pricing, Novartis

Christine Gathers, Senior Director, US Regulatory Affairs, Diagnostics, Eli Lilly

Scott Kahn, Chairman, Biomarkers Council, International Cancer Advocacy Center (ICAN)

10:45 Morning refreshments and networking

STREAM 1: OPTIMIZING MDx CLINICAL TRIALS

11.15 Phospho flow pharmacodynamic assays for clinical trials

  • Advantages over traditional assay systems
  • The role of signalling pathways
  • Evaluating assays to increase understanding of drug sensitivity

Shidong Jia, Scientist, Oncology Biomarker Development, Genentech

11.45 A roadmap for ensuring the highest standards of performance in MDx clinical trials

  • The evolution of trial design: Are we seeing a more definite move towards adaptive?
  • How industry can overcome sample shortages in order to conduct the most effective trials
  • Adapting to issues such as outlier patients, resistance and biomarker negative populations

Tharak Rao, Head of Medical Group, Novartis Molecular Diagnostics

12:15 Networking Lunch

1.15 Designing and conducting trials using predictive diagnostic PET-imaging agents

  • Overcoming early challenges in trial design
  • Advantages of PET versus other diagnostic imaging tests for cancer
  • Trial data and future promises of PET use in the clinic

Thomas Wickham, Vice President of Research & Development, Merrimack

1.45 I-SPY-2 & the role of imaging biomarkers in the clinical setting

  • An adaptive trial design to accelerate decision-making about candidate new agents
  • Accelerating the advancement of Phase II drug evaluation to Phase III confirmation of efficacy\
  • Determining whether adding experimental agents to standard neoadjuvant paclitaxel and AC therapy increases the probability of pCR over standard neoadjuvant chemotherapy

Sonia Pearson-White, Director, The Biomarkers Consortium

2.15 Using DNA methylation of specific genes as molecular diagnostics

  • The power and the promise of DNA methylation as a personalized medicine tool
  • The latest MDx applications of DNA methylation technology
  • Promising candidate molecular markers for non-invasive diagnostics

David Shames, Scientist, Genentech

2:45 Afternoon refreshments and networking

STREAM 2: THE GENETICS OF MDx

11.15 Bridging genomics and cancer diagnostic development: What gaps still remain?

  • Functional genomics strategies to define disease mechanisms at a molecular level
  • Novel technologies driving the role of genomics in personalized cancer drug development
  • Examples of how genomic advancements are increasing disease understanding and discovery in the clinic

Towia Libermann, Associate Professor of Medicine, Beth Israel Deaconess Medical Center

11.45 Applying novel genomic techniques and methodologies in development of novel diagnostics for breast cancer

  • Dividing efforts between genomic and proteomic methodologies
  • Novel high throughput methodology to detect germline DNA alterations in genes that are involved in risk of early onset cancer or somatic changes that impact tumor initiation, genesis and response to therapy
  • Development of techniques to facilitate detection of rare protein biomarkers that indicate the presence of breast cancer

Alexander Miron, Assistant Professor, Cancer Biology, Dana Farber Cancer Institute

12:15 Networking Lunch

1.15 Winning the genomic technology arms race: A technical and commercial perspective

  • Overcoming economic uncertainties preventing widescale adoption of sequencing and other genomic techniques
  • The new ‘Moore’s Law? Ensuring commercial success in an era of rapid technology advancement
  • How will the arms race be won? 
Matt Hawryluk, Director of Business Development, Foundation Medicine

1.45 Developing multi-gene molecular panels using next generation sequencing platforms

  • Multigene panel approaches and high throughput microarray analyses for molecular oncology
  • Using novel approaches to complement traditional molecular approaches
  • Practically applying to drug development programmes

Marina Nikiforova, Associate Professor of Pathology, University of Pittsburgh Medical Center

2.15 Supporting personalized cancer patient care in and behind the trenches

  • ICAN: History, mission, early support for a personalized approach to cancer treatment
  • Molecular profiling from the late stage cancer patient perspective - Barriers and breakthroughs
  • Thinking proactively: Bringing together stakeholders and an immediate need to streamline efforts to reimburse whole genome sequencing

Scott Kahn, Chairman, Biomarkers Council, International Cancer Advocacy Center (ICAN)

2.45 Afternoon refreshments and networking

PLENARY SESSION: SUCCESSFULLY BRINGING MDX TO THE PATIENT

3:15 The vital importance of increasing patient access to personalized therapies: A physician’s roadmap

  • An overview of recent PM advances, and what this has meant for the patient
  • Building and maintaining a strong network of cancer centres: Challenges and future aspirations
  • How can caregivers prepare for the next ‘wave’ of personalized therapies?

Timothy Yeatman, Director, Gibbs Cancer Center

3.45 Adapting patient care to the personalized medicine environment

  • Looking at the science in the context of the patient
  • Successfully storing and sharing patient data with industry and physicians
  • From bench to bedside: How can we build a more streamlined system?

Len Lichtenfeld, Deputy Chief Medical Director, American Cancer Society

4.15 Chairman’s closing remarks and close of conference