October 17 – 19 2017 | Boston, MA

Hyatt Regency Boston

2016 Speakers

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DRUG DEVELOPERS

Dr. Chris Womack
Medical Pathologist and and Past President
British Association for Tissue Banking

Dr. Womack is a medical pathologist and past president of the British Association for Tissue Banking. He was a Consultant diagnostic pathologist in the UK National Health service for 20 years before taking the post of principal clinical histopathologist at AstraZeneca (AZ) Oncology Translational Science UK. At AZ he was head of the oncology molecular pathology group responsible for the development of tissue-based assays until his retirement in Dec. 2014

Carl Barrett
Vice President, Translational Science
AstraZeneca

Day 2

Thursday October 20th, 2016

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

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

George Bashirians
Director, Diagnostics Lead
Pfizer

Roy Baynes
Senior Vice President & Head Global Clinical Development
Merck

Abdel Halim
Vice President, Translational Medicine, Biomarkers & Diagnostics
Celldex Therapeutics

Martin Armstrong
Senior Director of Molecular Genetics
UCB Pharma

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

Steven D. Averbuch, M.D.
Vice President, Development, Oncology & Pharmacodiagnostics
Bristol-Myers Squibb

Dr. Averbuch is Vice President, Development, Oncology & Pharmacodiagnostics, Bristol-Myers Squibb.  In this role, Dr. Averbuch is responsible for the execution of external clinical collaborations for the company’s immuno-oncology pipeline.  Dr. Averbuch also leads the Pharmacodiagnostics Center of Excellence, whose mission is to drive biomarker strategy, optimize biomarker knowledge and tools across all of R&D and execute on the integrated co-development and co-commercialization of diagnostic tests as companions to Bristol-Myers Squibb medicines. Dr. Averbuch joined Bristol-Myers Squibb in 2006.  Prior to his current role, he co-led the Oncology early strategy team and he was the executive sponsor for Oncology Transition Teams for the execution of Phase 2 Oncology programs.  He has made significant Global Clinical Research contributions to business development and he has participated in multiple successful licensing and acquisition deals. Dr. Averbuch previously held positions at Merck Research Laboratories, AstraZeneca, and Mount Sinai School of Medicine.  He received his M.D. and Internal Medicine training from the University of Illinois, Chicago and his Medical Oncology training at the National Cancer Institute in Bethesda, Maryland.   Dr. Averbuch has authored over 60 peer reviewed publications and book chapters and he is a co-author on one patent.  He is currently on the Personalized Medicine Coalition Board of Directors, the Steering Committee of the National Biomarker Development Alliance, the Advisory Board for the University of Kansas Institute for Advancing Medical Innovation, and he is a member of the American Society of Clinical Oncology and the American Association for Cancer Research having served on multiple committees for both organizations.  Dr. Averbuch is the 2014 recipient of the University of  Illinois College of Medicine Distinguished Alumnus Award.    

Day 1

Wednesday October 19th, 2016

10.25 | Immuno-Oncology Targeting Therapies: Developing Diagnostics to Meet Patient Needs

14.15 | Panel Session hosted by Roche Diagnostics: What are the Places of Complementary and Companion Diagnostics in Immuno-Oncology?

David Kaufman
Executive Director, Translational Immuno-Oncology Lead
Oncology Clinical Research, Merck

Gavin MacBeath
Co-Founder & Senior Vice President
Merrimack Pharmaceuticals

Jean-Claude Marshall
Director, Clinical Pharmacogenomics Lab
Pfizer

Day 1

Wednesday October 19th, 2016

17.30 | Panel Session: Achieving Drug, Diagnostic and Tech Regulatory Approval in the U.S. and Other Leading Geographies

Huifeng Niu
Director, Translational Medicine
Takeda

Steven Pirie-Shepherd
Director, Oncology Translational Research
Pfizer

Sangeetha Ramsagar
Director, Strategic Business Improvement
Johnson & Johnson

Day 3

Friday October 21st, 2016

09.00 | Chairman’s Opening Remarks

Eric Rubin
Vice President & Therapeutic Area Head, Oncology Early Development
Merck

Day 1

Wednesday October 19th, 2016

14.15 | Panel Session hosted by Roche Diagnostics: What are the Places of Complementary and Companion Diagnostics in Immuno-Oncology?

09.05 | Predictive Biomarkers for Pembrolizumab

Hakan Sakul
Vice President & Head of Diagnostics
Pfizer

Day 2

Thursday October 20th, 2016

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

09.00 | Chairman’s Opening Remarks

Stefan Scherer
Vice President, Global Head, Correlative Sciences
Novartis

Day 1

Wednesday October 19th, 2016

15.00 | Liquid Biopsies: Changing Treatment Paradigms for Patients

Cecilia Schott
Head, Personalized Healthcare, Corporate Development & Ventures
AstraZeneca

Zhen Su
Vice President & Head, Global Medical Affairs, Oncology
EMD Serono

Day 1

Wednesday October 19th, 2016

14.15 | Panel Session hosted by Roche Diagnostics: What are the Places of Complementary and Companion Diagnostics in Immuno-Oncology?

11.40 | The Art of Oncology: How to Utilize Biomarker Tests for Immuno-Oncology Treatments in the Real-World

Meena Subramanyam
Vice President, Translational Sciences & Technology
Biogen

Miro Venturi
Global Head, Diagnostics, Biomarkers
Roche

Day 1

Wednesday October 19th, 2016

14.15 | Panel Session hosted by Roche Diagnostics: What are the Places of Complementary and Companion Diagnostics in Immuno-Oncology?

10.00 | Diagnostics for Cancer Immunotherapies: Present and Future Outlook in Healthcare and Precision Medicine

David Weaver
Vice President, Translational Research
Verastem

DIAGNOSTIC & TECHNOLOGY DEVELOPERS

Andrew Beard
Head of Companion Diagnostics & Strategic Biomarker Group
& Molecular Marketing, Siemens Healthcare Diagnostics

Chris Womack
Senior Consulting Pathologist
TriStar Technology Group LLC

Daniel O’ Shannessy
Translational Diagnostics

"With today’s technology, the success or failure of a companion diagnostics program is governed less by imagination but more by the samples available for analysis." Translational medicine/diagnostics is a passion, not a job. I have proven ability to take diagnostics from bench to bedside, both IVDs and CDx and in depth knowledge and demonstrated success across multiple diagnostic platforms, commercialization and novel regulatory strategies.

Erik Faulkner
VP, Precision & Transformative Technology Solutions
Evidera

Kathryn Becker
Franchise Director Oncology & Companion Diagnostics,
Global Strategic Marketing, Abbott Molecular

Karina Kulangara
Scientific Manager, Companion Diagnostics, R&D
Agilent Technologies

Brian Burke
Director, Business Development
Horizon

Mark Landers
VP Translational Research
Epic Sciences

Mark Landers has 20 years of experience developing and commercializing molecular assays to drive translational and clinical research. In his current position as VP of Translational Research at Epic Sciences, he is leading the development of assay’s to characterize CTC by genotype and phenotype at the single cell level. These assays can be utilized to develop clinical tests to drive patient care decisions. Prior to his tenure at Epic Sciences, Mark was Head of R&D at AltheaDx where he developed several companion assays for targeted therapies. He has also held several senior level scientist positions in the San Diego biotech community, at companies including LifeTechnologies, Ceregene and Vical.

Sean Ferree
Vice President, Diagnostic Development
NanoString Technologies

Day 1

Wednesday October 19th, 2016

09.30 | Decentralized Multiplexed Companion Diagnostics on the NanoString nCounter Analysis System

Day 2

Thursday October 20th, 2016

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

Jay Foust
CDx Partnering
Roche Tissue Diagnostics (Ventana)

Day 1

Wednesday October 19th, 2016

12.05 | Fast to Pivotal: An Approach to Cut-Off Determination to go Directly to Pivotal Trial

Kaylan Handique
President & Chief Executive Officer
Celsee Diagnostics

Bob Holt
Companion Diagnostic Development Manager
Hologic

Olga Potapova
Founder, CEO and Scientific Director
Cureline

Richard Heichemer
Senior Scientific Advisor, CDx
Q2 Solutions

Christopher Bunker
Vice President Business Development
Advanced Cell Diagnostics

Dr. Christopher Bunker is the Vice President of Business Development at Advanced Cell Diagnostics (ACD) in Newark, California.  Dr. Bunker did his doctoral research in the laboratory of Dr. Robert E. Kingston at Harvard University, investigating oncoprotein function in regulating gene expression and chromatin structure in cancer model systems.   Dr. Bunker continued work in cancer biology with a Leukemia Society of America postdoctoral fellowship in the laboratory of Dr. Patrick O’Farrell at the University of California, San Francisco, where he investigated developmental cell cycle control mechanisms.  Following his postdoctoral research, Dr. Bunker joined Genome Therapeutics Corporation (GTC) as a senior scientist in cancer functional genomics, where he established a gene expression profiling platform to cancer target discovery.  Dr. Bunker also has an M.B.A from Boston University. Dr. Bunker has put his scientific knowledge to use in business development activities for ten years at Cell Signaling Technology (CST) and for the past six years at Advanced Cell Diagnostics.

Bruce Jordan
Vice President, International Business Leader, Companion Diagnostics
Roche Diagnostics

Day 1

Wednesday October 19th, 2016

14.15 | Panel Session hosted by Roche Diagnostics: What are the Places of Complementary and Companion Diagnostics in Immuno-Oncology?

Brian Kelly
Director, Diagnostic Partnering
Thermo Fisher Scientific

Day 2

Thursday October 20th, 2016

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

Peter Kerr
Vice President, Companion Diagnostic Development
Almac

Rudi Pauwels
Chief Executive Officer & Co- Founder
Biocartis

Steven Anderson
CSO
Covance

Day 1

Wednesday October 19th, 2016

12.35 | How to Maximise the Value of Biomarkers in Immuno-Oncology: A Role for Companion and Complementary Diagnostics

14.15 | Panel Session hosted by Roche Diagnostics: What are the Places of Complementary and Companion Diagnostics in Immuno-Oncology?

Dan Snyder
President & CEO
MolecularMD

Mr. Snyder assumed the role of MolecularMD President and CEO in 2014. With more than 15 years of experience in the life science research and diagnostic fields, Mr. Snyder has worked extensively in supporting new product introductions and rapid market adoption for novel proteomic and genomic technologies. Mr. Snyder received a BA in Economics from the University of Virginia, and an MBA from the College of William and Mary.

Day 3

Friday October 21st, 2016

10.15 | A Pragmatic Approach for the Successful Co-Development of Drugs and Diagnostics: Case Studies with Focus on Mitigating Risk in Oncology Drug Development

Mark Roberts
Director, Diagnostic Development
Covance

Day 2

Thursday October 20th, 2016

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

Vishal Sikri
Vice President, Commercial Operations
Sysmex Inostics

Theresa Zhang
Vice President, Research Services
Personal Genome Diagnostics

Eric Faulkner
Vice President, Precision and Transformative Technology Solutions
Evidera

Eric Faulkner, MPH, is the Vice President, Precision and Transformative Technology Solutions covering Value Demonstration, Access and Commercial. He brings approximately 20 years of experience in the healthcare industry focusing on value demonstration, product commercialization, and market access/reimbursement. At Evidera, he focuses on health technologies with significant disruptive potential which have complex access issues or requirements such as personalized medicine, diagnostics, orphan drugs, combination products, cell therapy and regenerative medicine, immuno-oncology and vaccines, and e-connectivity technologies. Eric is a recognized global thought leader in emerging technology market access, with extensive publication and over 70 global panel sessions on these topics. He has recently served as an expert advisor to the Personalized Medicine Subcommittee of the President’s Council of Advisors on Science and Technology and serves on the Leadership Committees of the HTA and the Medical Devices Special Interest Groups, as Co-Chair of the Diagnostics Special Interest Group, and formerly as the Chair of ISPOR’s Personalized Medicine Special Interest Group (now a Leadership Committee member). He has also served on the Leadership Committee for Reimbursement and Business Models for the International Society for Cellular Therapy (ISCT). Mr. Faulkner’s prior project work has included global market access and commercial strategy analysis, qualitative and quantitative research, evidence-based practice and policy, design of clinical trials to meet third-party decision requirements, real-world evidence strategy and implementation, life sciences portfolio due diligence, and modeling/decision support. Faulkner has also led health policy assessments, including CMS’s Coverage with Evidence Development (CED) and Clinical Trial Policy, value-based purchasing, competitive bidding, cost-effectiveness, comparative effectiveness, and pharmacogenomics for life sciences manufacturers, industry and medical professional associations, and government agencies, including CMS, HHS, NIH, FDA, CDC, and ASPE. He has also served as a global payer expert for emerging technologies for various global industry and EU government groups. Mr. Faulkner also serves as an adjunct Assistant Professor for the Institute for Pharmacogenomics and Individualized Therapy at the Eshelman School of Pharmacy of the University of North Carolina at Chapel Hill and as the Executive Director of the Genomics Biotech and Emerging Medical Technology Institute of the National Association of Managed Care Physicians, one of the largest US payer leadership bodies which includes a 90 commercial payer Executive Leadership Council and approximately 25 manufacturer members from all health technology sectors.

Day 3

Friday October 21st, 2016

09.35 | Panel Session: How do we Improve the Integration of Precision Medicine & Multi-Biomarker Diagnostic Tests in Healthcare Systems?

ACADEMICS, ADVOCATES & ASSOCIATIONS

Andrew Nixon
Associate Professor of Medicine
Duke University

Dr. Nixon is Associate Professor of Medicine at Duke University and Director of the Duke Phase I Biomarker Laboratory, a credentialed Molecular Reference Laboratory for the evaluation blood-based biomarkers within the Alliance oncology cooperative group.  He is a nationally recognized expert regarding the development of biomarkers and brings together clinical, translational and basic research to pursue the development of novel biomarkers defining mechanisms of sensitivity, resistance, and toxicity to given therapeutic drug classes, particularly anti-angiogenic agents. Our research focuses on the interrogation of circulating markers found in the blood, referred to as the 'liquid biopsy'. Overall, Dr. Nixon brings extensive experience in coordinating multi-investigator and multicenter analyses, having operational experience ranging from biomarker kit development, to assay development, including all aspects of sample handling, processing, inventory management, data cleaning, and statistical analyses.

Chris Anderson
Editor in Chief
ClinicalOMICs

Day 1

Wednesday October 19th, 2016

09.00 | Chairman’s Opening Remarks

Jennifer Dickey
Senior Scientific Reviewer, CDRH, OIR
FDA

Day 1

Wednesday October 19th, 2016

17.30 | Panel Session: Achieving Drug, Diagnostic and Tech Regulatory Approval in the U.S. and Other Leading Geographies

Mark Oldroyd
Senior Director, Regional Payer Relations & Reimbursement
Foundation Medicine

Suzanne Belinson
Executive Director, Center for Clinical Effectiveness
BlueCross and BlueShield Association

Day 3

Friday October 21st, 2016

14.35 | Panel Session: Securing Evidence-Based Drug, Diagnostics & Tech Reimbursement in Precision Medicine

14.05 | Evidence Street™: Where the Market Meets Evidence

Darrell Borger
Director, Biomarker Laboratory
Massachusetts General Hospital

Paul Radensky
Partner
McDermott, Will & Emery

Louis Fiore
Executive Director
MAVERIC US Department of Veterans Affairs

Day 3

Friday October 21st, 2016

09.35 | Panel Session: How do we Improve the Integration of Precision Medicine & Multi-Biomarker Diagnostic Tests in Healthcare Systems?

Michael Heller
Professor
University of California, San Diego

Kenna Mills Shaw
Executive Director, Institute for Personalized Cancer Therapy
MD Anderson Cancer Center

Day 3

Friday October 21st, 2016

09.35 | Panel Session: How do we Improve the Integration of Precision Medicine & Multi-Biomarker Diagnostic Tests in Healthcare Systems?

Edmund Pezalla
Vice President, National Medical Director, Pharma Policy & Strategy
Aetna

Day 3

Friday October 21st, 2016

14.35 | Panel Session: Securing Evidence-Based Drug, Diagnostics & Tech Reimbursement in Precision Medicine

13.35 | Deciphering Drug and Diagnostic Reimbursement: Who’s Paying for What?

09.35 | Panel Session: How do we Improve the Integration of Precision Medicine & Multi-Biomarker Diagnostic Tests in Healthcare Systems?

Girish Putcha
Director, Laboratory Science
Palmetto GBA

Day 1

Wednesday October 19th, 2016

17.30 | Panel Session: Achieving Drug, Diagnostic and Tech Regulatory Approval in the U.S. and Other Leading Geographies

17.00 | The Regulatory & Policy Landscape of Precision Medicine’s and Diagnostics: What have we Accomplished?

Day 3

Friday October 21st, 2016

14.35 | Panel Session: Securing Evidence-Based Drug, Diagnostics & Tech Reimbursement in Precision Medicine

Claudia Hille
PhD Student
University Medical Center Hamburg - Eppendorf (UKE)

Day 1

Wednesday October 19th, 2016

15.30 | Epitope-Indpendent Capture and Harvest of CTCs from Blood

David Roth
Director, Penn Center for Precision Medicine
University of Pennsylvania

Day 3

Friday October 21st, 2016

09.35 | Panel Session: How do we Improve the Integration of Precision Medicine & Multi-Biomarker Diagnostic Tests in Healthcare Systems?

Jack Whelan
From Research Analyst to Research Advocate
Patient Advocate

Day 3

Friday October 21st, 2016

09.35 | Panel Session: How do we Improve the Integration of Precision Medicine & Multi-Biomarker Diagnostic Tests in Healthcare Systems?

09.15 | How Can we Improve Patient Access to Testing for Earlier Diagnosis?