October 18 – 19 2017

Boston, MA

Day 1
Wednesday October 19th, 2016

Day 2
Thursday October 20th, 2016

Day 3
Friday October 21st, 2016

Workshops
Tuesday October 18th, 2016

Synopsis

We’re busy building the agenda for 2017

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08.00
Breakfast & Networking

How Far Have We Actually Come with Precision Medicine & Companion Diagnostics?

09.00
Chairman’s Opening Remarks

  • Hakan Sakul Vice President & Head of Diagnostics, Pfizer

09.10
Changing the Paradigm for the Development of Multiple Biomarker Companion Diagnostic Tests

  • Brian Kelly Director, Diagnostic Partnering, Thermo Fisher Scientific

Synopsis

  • The challenges of analyzing increasing numbers of biomarkers in the era of targeted therapy and precision genomics
  • Applying the advantages of Ion Torrent next-generaion technology to the development of future companion diagnostics outlook in the future – applications for liquid biopsy and immune response
  • Outlook in the future – applications for liquid biopsy and immune response

09.40
State of Address: What has been our Journey Along the Precision Medicine Timeline to this Point?

  • Carl Barrett Vice President, Translational Science, AstraZeneca

Synopsis

  • Understand what have been the key breakthroughs in precision medicine up to this point
  • A look at how the successes of the field have further fuelled and accelerated our journey
  • Discussion around what lessons have been learnt from our successes and failures

10.10
Panel Session: What have we Achieved with Precision Medicine and Companion Diagnostics and Where are we Going?

  • Hakan Sakul Vice President & Head of Diagnostics, Pfizer
  • Carl Barrett Vice President, Translational Science, AstraZeneca
  • Mark Roberts Director, Diagnostic Development, Covance
  • Sean Ferree Vice President, Diagnostic Development, NanoString Technologies

Synopsis

  • Have we delivered on our initial promises to the drug development and healthcare industries?
  • Why has there been a recent slow down in drug-diagnostic deals signed over the last few months?
  • If there was a bubble around precision medicine, has this burst and are we over the peak of hype curve?
  • As an industry how do we look to deliver true value to classical drug development?
  • As drug, diagnostic and tech developers, how do we look to deliver true value to unmet patients in the need?
  • What needs to change moving forward for us to really deliver the potential of this field?

10.45
Morning Refreshments & Networking

Chair: Daniel O’Shannessy, Translational Diagnostics
Liquid Biopsies

11.30 Circulating Tumor DNA: Applications and Challenges

  • This talk will discuss novel applications of ctDNA analysis in clinical and pharmaceutical research settings and highlight the major challenges encountered
  • Recent studies have demonstrated that ctDNA can be effective pharmacodynamics and early response markers for drug development
Theresa Zhang, Vice President, Research Services, Personal Genome Diagnostics

12.00 Prognostic and Predictive Relevance of ctDNA and CTC’s in Patients with Advanced Small Cell Lung Cancers

  • Understand the rational behind undertaking a single center prospective study in patients with relapsed refractory SCLC for profiling circulating tumor cells and circulating tumor DNA
  • These results can inform treatment options and disease progression, and provide valuable tools for identification of prognostic or predictive biomarkers
Huifeng Niu, Director, Translational Medicine, Takeda

12.30 Liquid Biopsy for Clinical Diagnostic Use: Development and Commercialization of the OncoBEAM Platform

  • Laying the Groundwork—Transforming a Service-Based RAS Test to a Commercial IVD System
  • Goal: Establishing Global Centers of Excellence to Standardize Testing
  • Results: Concordance with Tissue in Multi Center Studies
Vishal Sikri, Vice President, Commercial Operations, Sysmex Inostics

13.00 Networking Lunch in Exhibition Room

13:00 Invited Workshop Lunch Hosted by Cancer Genetics Inc.

Speaker: Daniel Duncan, Medical Director MD,Cancer Genetics, Inc.
  • Overcoming Challenges in Companion Diagnostic Development – CGI insights into Multiple Myeloma, Renal Cell Carcinoma, and Lymphoma
  • A series of case studies demonstrating capabilities in hematologic and solid tumor testing will be used to highlight the importance of well planned clinical studies

Emerging Assays & Tech

14.15 Understanding Disease Heterogeneity Through Liquid Biopsies

  • A look at how the real-time application of liquid biopsies allows us to understand different patient populations at a more sophisticated level
  • Case studies around how liquid biopsies are currently being used in exploratory studies to improve scientific understanding of disease progression
Michael Heller, Professor, University of California, San Diego

14.45 Prediction of Homologous Recombination Deficiency (HRD) Phenotype Utilizing a Liquid Biopsy for PARP Inhibitor Patient Selection and Monitoring

Mark Landers, VP Translational Research, Epic Sciences

15:15 Pivotal Role of Tissue Samples in CDx Development

Chris Womack, Senior Consulting Pathologist, TriStar Technology Group LLC 

15.25 Expanding the CDx Strategy Options with RNAscope – A clinically-validated, Quantitative in situ RNA Biomarker Expression Platform

Christopher Bunker, Vice President Business Development, Advanced Cell Diagnostics

15.35 Innovation Presentation – Cureline

Olga Potapova, Founder, CEO & Scientific Director, Cureline

 

15.45 Afternoon Refreshments

Data, NGS & Multi-Omic Approaches

16.30 The VA Precision Oncology Program (POP)

  • Description of how precision oncology is being delivered across the VA healthcare system nationally
  • Implementation of learning healthcare system activities of the VA POP
  • Research activities of the VA POP
Louis Fiore, Executive Director, MAVERIC, US Department of Veterans Affairs

17.00 Companion Diagnostic Harmonization: Making a Difference for Patients

  • Personalized medicine can be highly effective when the correct patients are diagnosed accurately
  • How do we best standardize complementary diagnostics and/or companion diagnostics clinical assays?
  • Here we will showcase the continually evolving PDL1 story
Brian Burke, Business Development Director, Horizon

17.30 Using Next Generation Sequencing to Direct Patients to the Right Study

  • Understand the infrastructure being used for robust access to patients with key focus on implementation on selection methodologies
  • A look at the data challenges that are being overcome with these studies and how this is improving study design moving forward
  • Results from recent studies will be showcased
David Roth, Director, Penn Center for Precision Medicine, University of Pennsylvania

Chair: Mark Oldroyd, Senior Director, Regional Payer Relations & Reimbursement, Foundation Medicine
Accessing Patients

11.30 Developing and Validating Patient Selection Assays

  • Understand the thought process and execution of methodically developing and validating tissue morphology assays
  • The importance of accessing high quality human tumor samples in the development and deployment of Tissue Morphology Assays
Steven Pirie-Shepherd, Director, Oncology Translational Research, Pfizer

12.00 Accelerating the Adoption of Companion Diagnostics and Therapeutic Uptake with Decentralized Testing Models

  • Understand how improvements in patient quality of life can be achieved by connecting stakeholders in the healthcare community and providing broad access to molecular testing
  • Abbott and Biocartis are partnering to simplify multiplex PCR-based testing to the local community to drive adoption of testing linked to therapeutic prescription
Kathryn Becker, Franchise Director Oncology & Companion Diagnostics, Global Strategic Marketing, Abbott Molecular

12.30 Getting the Right Patient(s) the Right Drug(s) at the Right Time(s)

  • Matching patients to appropriate targeted agents must consider not only the gene or genes mutated but also the specific mutation; not all mutations are created equally
  • We must improve selection of patients for “matching” to clinical trials by proactive, large-scale functional genomics in lieu of in vivo experiments that are not feasible
  • Just in time precision oncology decision support required for optimal utilization of molecular testing data for oncology
Kenna Mills Shaw, Executive Director, Institute for Personalized Cancer Therapy, MD Anderson Cancer Center

13.00 Networking Lunch in Exhibition Room

13:00 Invited Workshop Lunch Hosted by Cancer Genetics Inc.

Speaker: Daniel Duncan, Medical Director MD,Cancer Genetics, Inc.
  • Overcoming Challenges in Companion Diagnostic Development – CGI insights into Multiple Myeloma, Renal Cell Carcinoma, and Lymphoma
  • A series of case studies demonstrating capabilities in hematologic and solid tumor testing will be used to highlight the importance of well planned clinical studies

Clinical Trial Design

14.15 Combining Molecular and Histological Techniques to Effectively Stratify Patients to Cancer Therapies

  • NGS provides a cornerstone for directing targeted therapy choices in the treatment of cancer
  • Integration of slide-based techniques can refine clinically-relevant signatures
  • Emphasis will be placed on clinical case studies that highlight the benefits of multi-platform approaches in guiding and adapting therapy
Darrell Borger, Director, Biomarker Laboratory, Massachusetts General Hospital

14.45 Development and Commercialization of Companion Diagnostic Tests

  • This presentation will expand on some of the diagnostics developed and delivered by Almac Group including case studies of where successes have been achieved and what has been needed to achieve it
Peter Kerr, Vice President, Companion Diagnostic Development, Almac

15.15 Immuno-Oncology Therapeutic and Companion Diagnostic Co-Development: A Match Made in Heaven?

  • Understand the current thought process when looking to develop diagnostics alongside immune-oncology therapies
  • Case studies contrasting the companion and complementary diagnostic approach using PDL-1 as an example
Roy Baynes, SVP and Head, Global Clinical Development and Chief Medical Officer, Merck Research Laboratories

15.45 Afternoon Refreshments

Refining Clinical Drug-CDx Co-Development

16.30 A Biomarker-Driven Approach to Combating EGFR Inhibitor Resistance in Colorectal Cancer

  • Understand how genetic and non-genetic biomarkers can be used for prospective patient selection as early as Phase 1
  • Discussion will focus around design of a biomarker-driven multi-arm Phase 1 study of novel-novel combinations designed to combat resistance to EGFR inhibitors in late-stage CRC
Gavin MacBeath, Co-Founder & Senior Vice President, Merrimack Pharmaceuticals

17.00 Improving Patient Access to High Precision Diagnostics

Rudi Pauwels, Chief Executive Officer & Co-Founder, Biocartis

17.30 Combination Trials for Cancer Immunotherapy Development

  • Understand the decision making processes when analyzing how to undertake combination trials in cancer immunotherapy development
  • Case studies from trials in current clinical development will be showcased and analyzed
David Weaver, Vice President, Translational Research, Verastem

Chair: Sangeetha Ramsagar, Director, Strategic Business Improvement, Johnson & Johnson
ROI vs. Patient Population Size

11.30 How can Companion Diagnostics Robustly Add Value to Targeted Drug Development?

  • Understand the attributes for robust and successful drug-diagnostic co-development
  • Discussion will focus around the critical but overlooked challenges facing CDx case study demonstration
  • An in-depth look at how limitations can be mitigated in building towards successful programs
Abdel Halim, Vice President, Translational Medicine, Biomarkers & Diagnostics, Celldex Therapeutics

12.00 Is CDx development a Win/Win for Pharma and Diagnostic Companies?

  • Pharma and Diagnostic partners have different priorities when it comes to CDx development – is a cultural shift in the relationship required to secure the long term future of companion diagnostics? This interactive session will highlight these differences, their effect on the development process and offer potential solutions.
Bob Holt, Companion Diagnostic Development Manager, Hologic
Martin Armstrong, Senior Director of Molecular Genetics, UCB Pharma

12.30 Commercial Trade-Off vs. Helping Small Populations of Patients: What’s the Right Thing to do?

  • Understand the dilemma’s facing drug and diagnostic organizations when deciding how small of a patient population size to target with biomarkerdriven therapies
  • Discussion will be lead around how patient-centric business models and approaches can improve product development
Cecilia Schott, Head, Personalized Healthcare, Corporate Development & Ventures, AstraZeneca

13.00 Networking Lunch in Exhibition Room

13:00 Invited Workshop Lunch Hosted by Cancer Genetics Inc.

Speaker: Daniel Duncan, Medical Director MD,Cancer Genetics, Inc.
  • Overcoming Challenges in Companion Diagnostic Development – CGI insights into Multiple Myeloma, Renal Cell Carcinoma, and Lymphoma
  • A series of case studies demonstrating capabilities in hematologic and solid tumor testing will be used to highlight the importance of well planned clinical studies

Aligning Drug-CDx Co-Development

14.15 Ultra-Sensitive Protein Multiplex Arrays – Going Where No One Has Gone Before

Andrew Nixon, Associate Professor of Medicine, Duke University

14.45 Best Practice in Partnering With Your Laboratory for Successful Companion Diagnostic Development

  • Top partnership models to optimize your CDx clinical trials
  • Lessons learned for CDx projects: a lab perspective
  • Is the LDT route still the best option?
Richard Heichemer, Senior Scientific Advisor, CDx, Q2 Solutions

15.15 How is Companion Diagnostics Adding Value Outside of Oncology?

George Bashirians, Director, Diagnostics Lead, Pfizer

15.45 Afternoon Refreshments

The Fit of Precision Medicine in Pharma

16.30 Overcoming the Challenges and Harnessing the Opportunities of Drug- Diagnostic Partnering

  • Understand how to harness the latest technologies and diagnostics to improve targeted therapy development and patient care
  • A look at complementary diagnostics as an emerging class of important diagnostics in precision medicine. Real world examples will be showcased, analyzed and discussed
Andrew Beard, Head of Companion Diagnostics & Strategic Biomarker Group & Molecular Marketing, Siemens Healthcare Diagnostics

17.00 Title TBC

Meggan Czapiga, Precision Medicine and Companion Diagnostics Leader, R&D ImmunoInflammation, GSK

17.30 Title TBC

18.00
Close of Day Two