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.
TUESDAY, AUGUST 18
7:30 am Main Conference Registration & Morning Coffee
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 Successful Co-Commercialization of Companion Diagnostics: A Conversation between Pharma & Diagnostics
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Cecilia Schott, Head, Personalized Healthcare, Corporate Development & Ventures, AstraZeneca
Sushma Selvarajan, Head, Business Development & Strategy, Roche Diagnostics
Roche AstraZeneca (AZ) and Roche Diagnostics have a broad agreement to develop and commercialize companion diagnostics (CoDx) for AZ drugs. The speakers will share key learnings related to pre-commercial planning to enable the successful combined launch of a drug with its CoDx test, including early discussions around product requirements, target customers, educational efforts, reimbursement and co-promotion. The key message is to align early around shared commercial objectives to ensure long-term success.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
William Pignato, Founder and Principal, W.J. Pignato & Associates, LLC
11:00 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.
11:20 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.
11:40 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:
- Peggy Carter, Ph.D., Novartis Companion Diagnostics
- Jocelyn A. Holash, Ph.D., BioClin Therapeutics, Inc.
- Mark Monane, M.D., Chief Medical Officer, CardioDx, Inc.
12:10 Next Generation Sequencing in CDx Development
Leeona Galligan, Ph.D., Head, Laboratory Operations, Almac Diagnostics
The presentation will examine the potential use of NGS as a companion diagnostic and cover the development, validation and CLIA commercial delivery of a NGS based assay. A case study will be presented focusing on the development of a P53 sequencing assay.
12:30 Universal Testing for Actionable Genomic Variants in Cancer: A Paradigm Shift in Precision Oncology
Karen Gutekunst, Ph.D., Vice President, Diagnostic Development, Illumina
Dr. Gutekunst’s presentation will focus on the potential of Next Generation Sequencing to impact cancer care and will describe Illumina’s activities to enable broad adoption of the technology.
1:00 Luncheon Presentation: Accelerating NGS-based Diagnostic Development Using Strategic Science: Leveraging FDA’s Expedited Access Pathway Program
Kennon Daniels, Ph.D., Senior Consultant, In Vitro Diagnostics Regulatory Affairs, Precision for Medicine
Judi Smith, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine
The FDA’s Expedited Access Pathway (EAP) program presents a unique opportunity for companies developing innovative NGS-based diagnostics to accelerate market access. Successfully navigating the EAP requires an integrated, multi-disciplinary effort with expert knowledge in technology, science, regulatory and analytics to offer next-generation solutions. Using “Strategic Science” and leveraging the regulatory strategy from the Data Development Plan, companies can more easily link pre- to post-market clinical trial data leading to more efficient clinical trials – ultimately saving time and money.
1:30 Refreshment Break in the Exhibit Hall with Poster Viewing
1:55 Chairperson’s Remarks
Mitch Raponi, Ph.D., Senior Director, Molecular Diagnostics, Clovis Oncology
2:00 The MSK-IMPACT Program: Analytical Validation and Clinical Experience with High Volume Clinical Next-Generation Sequencing to Enable Personalized Oncology
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 and clinical experience in the MSK-IMPACT program.
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.
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.
3:30 Companion Diagnostic Assay Development: A Perspective from a Global IVD Company
Chris 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.
3:45 Positioning Your Companion Program for Global Success
Gary Gustavsen, Vice President, Personalized Medicine Practice, 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
4:45 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.
5:15 IncellPrep™, Liquid-Biopsy Technology Generates a Cell Suspension Sample Out of Fresh or FFPE Tissue
Bruce Patterson, M.D., CEO, Incell Dx, Inc.
IncellPrep™ creates a cell suspension from fresh or FFPE tissue that can then be used with IncellDx’s Cellular Multiplex™, a quantitative, flow cytometric diagnostic approach, that allows multiplexing of proteins using antibodies, mRNA by in situ hybridization,and DNA cell cycle. Morphologic measurements can be determined as well providing a multiparameter, quantitative alternative to IHC.
5:30 NGS-Based Companion Diagnostics Assays – FDA Perspective
Abraham Tzou, M.D., Medical Officer, Center for Devices and Radiological Health, Food and Drug Adminstration
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
WEDNESDAY, AUGUST 19
7:15 am Registration
7:30 – 8:25 Problem-Solving Breakout Discussions with Continental Breakfast
NGS-Based Companion Assays in Clinical Trials
Matthew J. Hawryluk, Ph.D., Senior Director, Corporate & Business Development, Foundation Medicine, Inc.
Mitch Raponi, Ph.D., Senior Director, Molecular Diagnostics, Clovis Oncology
- What type of NGS panels should be incorporated into clinical practice?
- What level of evidence should be required to implement NGS testing into standard clinical practice?
Lessons Learned from Recent Success and Failure Stories
Peter Collins, Chief Commercial Officer, Premaitha Health
Jonathan Pan, Ph.D., Head, Oncology Companion Diagnostic and Disease Strategy, Novartis Pharmaceuticals Corporation
- Understanding the technology roadmap (how to pick technologies)
- Navigating the Dx reimbursement landscape (US vs. Ex-US)
- Negotiating the right commercialization agreement with Dx partner (Who sells what and how?)
Navigating the Reimbursement Landscape for Personalized Medicine/CDx under PAMA
Barbara Cammarata, Counsel, Sidley Austin LLP
- How will PAMA reporting requirements impact payment rates for your CDx (or why the type of lab that performs your test, and retail and private payor prices and volumes matter)?
- Will your CDx be a "new test" or an "Advanced Diagnostic Laboratory Test" under PAMA and what does this mean in terms of required reporting and test prices?
- How do you proactively engage with MACs, CMS and Congress to influence, change or remove regulatory requirements to better address the special needs of Personalized Medicine/CDx within the larger PAMA laboratory reimbursement framework?
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., Vice President, 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.
9:30 A Unified Approach to NGS-Based Oncology Companion Diagnostics Development
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Dan Rhodes, Ph.D.,Head, Oncology Strategy, Thermo Fisher Scientific
There is significant interest for the development of a multi-marker companion diagnostic product to support the increasing number of potential targeted therapeutic candidates. Discussion will cover the development of a next-generation sequencing approach to change the paradigm from one test for one drug to one test for many targeted therapies in the future.
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
12:40 pm Luncheon Presentation: Rapid DNA Testing for Companion Diagnostics: Accelerating Clinical Trials and Expanding Markets
Paul Lem, CEO and Founder, Spartan Bioscience Inc.
To fulfill its promise, personalized medicine will require rapid, inexpensive genetic tests for companion diagnostics. For clinical trials, these tests could improve study outcomes and speed up patient enrolment. Following drug approval, rapid genetic testing would make it faster and easier for patients to be prescribed the right drug for their genotypes. Currently, it takes days to weeks to get genetic results from central labs. Rapid genetic testing is a new advance, and one of the leaders is Spartan Bioscience. Spartan’s on-demand DNA testing platform goes from sample to result in less than 1 hour. This presentation will discuss the benefits for patients, clinicians, and companies involved in drug commercialization.
1:10 Close of Companion Diagnostics