2015 Next Generation Dx Summit

Cambridge Healthtech Institute’s Sixth Annual
Companion Diagnostics
Strategy, Partnership, Technology and Adoption
August 18-19, 2015 | Capital Hilton | Washington, DC


The co-development of drugs and diagnostics, i.e. companion diagnostics development, is promising, and in some cases already delivering significant patient benefits, healthcare cost savings, and revenue opportunities. It requires a new business model to fit the emerging strategies in the marketplace. It also carries out most technological advances both as IVD products, and as laboratory developed tests with gene panels and even whole exome sequencing playing a role of companion tests. Cambridge Healthtech Institute’s Sixth Annual Companion Diagnostics: Strategy & Partnerships conference is designed to facilitate knowledge and opinion exchange between pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine. Case studies of successful collaboration between pharmaceutical and diagnostics companies’ researchers and executives will be presented.

Day 1 | Day 2 | Short Courses | Download Brochure 

TUESDAY, AUGUST 18

7:30 am Main Conference Registration & Morning Coffee


FROM BIOMARKERS TO DIAGNOSTICS

8:20 Chairperson’s Opening Remarks

Kenneth Emancipator, M.D., Executive Medical Director, Molecular Biomarkers and Diagnostics, Merck Research Laboratories


8:30 Extracting Added Value from Clinical Trials through Systematic Pharmacogenomic Research

Kenneth Emancipator, M.D., Executive Medical Director, Molecular Biomarkers and Diagnostics, Merck Research Laboratories

Rebecca Blanchard, Ph.D., Executive Director, Genetics and Pharmacogenomics, Head, of Clinical Pharmacogenomics, Merck & Co., Inc.

Clinical development activities provide drug companies with opportunities to identify genomic variants associated with disease, pharmacological mechanisms and biomarkers predictive of drug response. This genomic information can be leveraged to identify new drug targets, optimize drug leads, determine patients most likely to benefit from drug treatment, and to develop companion diagnostics. This presentation will focus on a systematic approach to identifying predictive biomarkers of drug response, possible impact of such findings on drug development strategy, and ultimate development of companion diagnostics.


9:10 Creating and Managing the Multiple Interfaces of Drug/Diagnostic Co-Development

George A. Green IV, Ph.D., Group Director, Pharmacodiagnostic Center of Excellence, Bristol-Myers Squibb

Andrea H. Lauber, Ph.D., Executive Director, Business Development, Clinical Biomarkers and Pharmacodiagnostics, Bristol-Myers Squibb

BMS works closely with external partners to co-develop diagnostic products for our pipeline therapies. The pharmacodiagnostic strategy for each therapeutic asset is developed based on medical need, biomarker science, assay performance and value creation. Partnering facilitates access to the diverse capabilities needed to execute on this strategy. Key partner capabilities considered include biomarkers, technologies, manufacturing and commercialization expertise, and up-to-date regulatory and reimbursement policies; aimed at providing benefits of companion products to clinical practice. We will explore some of challenges and benefits that Rx/Dx collaborations bring to the industry.

9:40 Achieving Personalized Medicine through successful Rx-Dx Partnerships: From Biomarkers to Commercialization

Carolina Rizo, Ph.D., MBA, Director, Business Development, Roche Molecular Systems

Companion Diagnostics enable the safe and effective use of targeted therapies, facilitating Personalized Medicine. This talk will describe strategies to overcome intrinsic challenges and achieve successful partnerships between pharma and diagnostics, from Biomarkers to Commercialization, based in real world experience.

10:10 Coffee Break in the Exhibit Hall with Poster Viewing


EARLY VS. LATE STAGE DRUG/DIAGNOSTICS CO-DEVELOPMENT

10:55 Chairperson’s Remarks

William Pignato, Founder and Principal, W.J. Pignato & Associates, LLC

11:00 From One Biomarker, One Test, to Multiple Biomarkers, One Test: NGS and CDx Development to Support the Pipeline

Anne-Marie Martin, Ph.D., Head, Molecular Medicine and Precision Medicine & Diagnostics, GlaxoSmithKline

I will discuss the limitations of developing assays for one biomarker and how leveraging newer technologies, such as next generation sequencing, we can maximize assay development to support multiple biomarkers supporting multiple drugs.

11:20 Challenges with Early Co-Development of Rx/CDx: A Companion Diagnostics Perspective – From a Large Pharma Point of View

Peggy Carter, Ph.D., Global Head, Drug Regulatory Affairs, Novartis Companion Diagnostics

In the ideal situation, the therapy and the companion diagnostic would be co-developed starting as early in the development process as possible; but there are challenges. I will discuss some of these challenges and some strategies that have been employed to overcome them.

11:40 Strategic Considerations of Which Clinical Development Stage To Start Selecting Patients

Jocelyn A. Holash, Ph.D., Vice President, Translational Sciences, BioClin Therapeutics, Inc.

I will discuss the pros and cons of implementing patient selection strategies early or late in the drug development process, how this decision will affect the development of a CDx and why small companies might make different decisions than larger companies.

12:00 pm PANEL DISCUSSION: Challenges and Opportunities in Drug/CDX Co-Development: Early vs. Late Stage Development

Moderator: William Pignato, W.J. Pignato & Associates, LLC

  • Designing Co-Development Strategy in Early Stages
  • Coordinating Drug and Diagnostics Development throughout the Process
  • Working with Regulators
  • Planning Out Market Access Strategies

Panelists:

Anne-Marie Martin, Ph.D.,GlaxoSmithKline

Peggy Carter, Ph.D., Novartis Companion Diagnostics

Jocelyn A. Holash, Ph.D., BioClin Therapeutics, Inc.

illumina NEW12:30 Partnering for Precision Oncology: From Companion Diagnostics to Companion Therapeutics 

Karen Gutekunst, Ph.D., Vice President, IVD Development, Oncology, Illumina

Precision for Medicine1:00 Luncheon Presentation

1:30 Refreshment Break in the Exhibit Hall with Poster Viewing


KEYNOTE SESSION: COMPANION DIAGNOSTICS IN THE CLINIC

1:55 Chairperson’s Remarks

Mitch Raponi, Ph.D., Senior Director, Molecular Diagnostics, Clovis Oncology

2:00 Testing for Cancer Heterogeneity

Marc Ladanyi, M.D., Chair, Molecular Oncology, Memorial Sloan-Kettering Cancer Center

NGS offers a powerful tool for assessment of molecular defects found in cancer. The utilization of NGS is becoming common practice in clinical laboratories. This complex technology requires a new level of analytical performance testing and validation. This discussion will focus on approaches used for analytical validation of the NGS clinical assay used for treatment selection in the NCI-MPACT Study.

2:30 Liquid Biopsies for Cancer Detection and Characterization

Victor E. Velculescu, M.D., Ph.D., Professor, Oncology; Co-Director, Cancer Biology, Johns Hopkins Kimmel Cancer Center

Analyses of cancer genomes have revealed mechanisms underlying tumorigenesis and new avenues for therapeutic intervention. In this presentation, I will discuss lessons learned through the characterization of cancer genome landscapes, challenges in translating these analyses to the clinic, and new technologies that have emerged to analyze molecular alterations in the circulation of cancer patients as cell-free tumor DNA. These approaches have important implications for non-invasive detection and monitoring of human cancer, therapeutic stratification, and identification of mechanisms of resistance to targeted therapies.


CO-DEVELOPMENT OF DRUGS AND MULTIPLEX COMPANION DIAGNOSTICS

3:00 Evolution of a Therapeutic and Its Companion Diagnostic: The Search For Improved Patient Outcomes Through Better Predictive Tests, A Case Study

Catherine Lofton-Day, Ph.D., Principal Scientist, Amgen

Predictive biomarkers are difficult to identify during the course of drug development but can provide great improvements in patient outcomes. Maintaining an active biomarker program after drug approval can further define patient response and provide data to support new therapeutic indications and more effective diagnostics. Monoclonal antibody therapies targeting EGFR and associated RAS biomarkers will be discussed as a case study for biomarker evolution and global management of drug/diagnostic pairs.

Randox_Biosciences3:30 Companion Diagnostic Assay Development: A Perspective from a Global IVD Company

chrismorChris Moriarty, Global Manager, Randox Pharma Sciences, Business Development, Randox Biosciences

The majority of IVD cleared diagnostics currently in routine clinical use utilize automated clinical chemistry or immunoassay platforms as they offer ease of use, low cost per test and widespread adoption in clinical labs…key features for any CDx. With this in mind the speaker will present an overview on technical considerations, regulatory pathway and platform solutions for CDx assay development.

Health Advances3:45 Positioning Your Companion Program for Global Success

GGGary Gustavsen, Vice President, Health Advances LLC

Based on experiences from recent companion programs, it is clear that a “one size fits all” approach is insufficient when commercializing a companion diagnostic worldwide. This dynamic field fundamentally requires complete drug-companion diagnostic commercialization strategies and this session will analyze several key methods to optimize your strategy.

4:15 Refreshment Break in the Exhibit Hall with Poster Viewing

4:50 Development and Application of a NGS-Based Companion Diagnostic for Prospective Identification of Ovarian Cancer Patients Likely to Respond to Rucaparib

Mitch Raponi, Ph.D., Senior Director, Molecular Diagnostics, Clovis Oncology

A uniquely integrated translational-clinical program (Assessment of rucaparib in ovarian cancer trials; ARIEL) is ongoing to identify endometrioid and HGSOC patients who may benefit from rucaparib treatment. A test for HRD that identifies both BRCA defects and genome-wide loss of heterozygosity (LOH), or “BRCAness”, has been developed in collaboration with Foundation Medicine and is being prospectively tested in the ARIEL2 study. The ARIEL program was developed to enable prospective validation of a novel NGS-based companion diagnostic for rucaparib in both the treatment (ARIEL2) and maintenance (ARIEL3) settings. This presentation will discuss the development of the HRD test and results from the ARIEL2 study.

5:20 NGS-Based Companion Diagnostics Assays – FDA Perspective

Eunice Lee, Ph.D., Division of Immunology and Hematology Devices, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA

The advent of next generation sequencing (NGS) has introduced new challenges to the existing regulatory paradigm for companion diagnostic devices in oncology. To date, all of the approved DNA-based companion diagnostics are single gene tests for specific indications. In contrast, NGS-based tests can identify variants, which may or may not be pre-specified, in numerous genomic regions for the therapeutic management of patients. To enable appropriate oversight of NGS tests in oncology, FDA is exploring new regulatory approaches.

5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

6:50 Close of Day

Day 1 | Day 2 | Short Courses | Download Brochure 

WEDNESDAY, AUGUST 19

7:15 am Registration

7:30 – 8:25 Problem-Solving Breakout Discussions with Continental Breakfast


FROM CO-DEVELOPMENT TO CO-COMMERCIALIZATION

8:25 Chairperson’s Opening Remarks

Peter Collins, Chief Commercial Officer, Premaitha Health

8:30 Foundation Medicine & Roche: Joining Forces to Transform the Field of Molecular Information in Oncology

Matthew J. Hawryluk, Ph.D., Senior Director, Corporate & Business Development, Foundation Medicine, Inc.

9:00 Understanding The Challenges in Companion Diagnostic Development

Ron Mazumder, Ph.D., MBA, Global Head, R&D and Operations, Janssen Diagnostics, Janssen Pharmaceutical Companies of Johnson & Johnson

Choosing the right sample type, platform, and partner and synchronizing companion diagnostic development are critical for enabling precision medicine. I will present various learnings gained from executing on our companion diagnostics programs. The incorporation of diagnostics into proof of concept studies and immuno-oncology studies will also be discussed.

ThermoFisher Scientific9:30 Presentation to be Announced

10:00 PANEL DISCUSSION: Co-Commercialization of Drugs and Diagnostics

Moderator: Peter Collins, Chief Commercial Officer, Premaitha Health

  • What is pharma looking for in a commercialisation partner for Dx
  • What are the critical issues in making a Dx product globally available
  • How to overcome the challenges of operating in a Parallel universes

Panelists:

Jonathan Pan, Ph.D., Head, Oncology Companion Diagnostic and Disease Strategy, Novartis Pharmaceuticals Corporation

Matthew J. Hawryluk, Ph.D., Foundation Medicine, Inc.

Ron Mazumder, Ph.D., MBA, Janssen

Panelist to be Announced, Thermo Fisher Scientific

10:30 Coffee Break in Exhibit Hall with Poster Viewing


PLENARY KEYNOTE SESSION: Click here for details 


12:40 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:10 Close of Companion Diagnostics


Day 1 | Day 2 | Short Courses | Download Brochure 

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2015 Brochure

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Premier Sponsor

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