Cambridge Healthtech’s 10th Annual
Companion Diagnostics: Strategy and Partnerships
Winning Strategies for Drug-Diagnostics Co-Development
August 20-21, 2019
The co-development of drugs and diagnostics, i.e. companion diagnostics development, is delivering significant patient benefits, healthcare cost savings, and revenue opportunities. Historically, it carries out most technological advances both as IVD products
and as laboratory developed tests with gene panels and whole exome sequencing playing a role of companion tests. The space of companion diagnostics is highly sensitive to the regulatory and reimbursement fluctuations, and it requires specific market
access strategies. Cambridge Healthtech Institute’s Tenth Annual Companion Diagnostics: Strategy and 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.
Final Agenda
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Recommended Short Course*
SC2: Discover How Machine Learning Can Complement Diagnoses through Medical Imagery
Helen Lam, Software Developer, Developer Advocate, IBM Watson
Nicholas Bourdakos, Software Developer, IBM Watson
In this hands-on session, learn how to train your own custom classifier using medical images to help augment your diagnoses. We will first cover the overview of available technologies for medical imagery in diagnosis, then will show examples by utilizing
Watson Machine Learning and Tensorflow, an open source software library for high performance numerical computation to create a custom model.
SC8: Tumor Mutation Burden: Unloading the Latest Challenges and Developments
Susan J. Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center
Larissa V. Furtado, MD, Medical Director, Molecular Oncology, ARUP Laboratories; Associate Professor of Pathology, University of Utah School of Medicine
Ahmet Zehir, PhD, Director, Clinical Bioinformatics, Memorial Sloan Kettering Cancer Center
In this short course, we will review the current state of the field for tumor mutational burden (TMB), a biomarker predictive of response to immunotherapy agents. This course will cover concepts including the clinical utility of measuring TMB, technical
considerations and challenges in validating and measuring TMB in a clinical laboratory, issues surrounding clinical TMB interpretation, and future directions and applications of TMB testing.
*Separate registration required.
TUESDAY, AUGUST 20
7:30 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
Jonathan Beer, MBA, Director of Disruptive Technologies, Oncology Precision Medicine, Novartis
8:40 Companion Diagnostics in the Era of Consolidation and Globalization: Multiplexed Biomarkers Across Therapeutic Areas and Around the Globe
Omar Perez, PhD, RAC, Head of Precision Medicine and Diagnostics, R&D, GSK
Although biopharmaceutical pipeline products increasingly incorporate companion diagnostics into their clinical development efforts, commercial launch plans often do not adequately address the diagnostic component. Early planning and collaboration between
biopharma and diagnostic companies can better support an optimal launch.
9:10 Companion and Complementary Diagnostics: Regulatory Challenges and Opportunities
Pamela Gallagher, PhD, Scientific Reviewer, FDA
Companion diagnostics are essential for the safe and effective use of therapeutic products and promise to deliver a clearer understanding of disease development at the individual patient level. The companion diagnostics industry is rapidly progressing
along with rapid advances in technology and healthcare demands leading to unique regulatory complexities. The strategies for successful codevelopment (for companion and complementary diagnostic devices) will be reviewed and the FDA regulatory review
process for some approved companion diagnostic devices will be discussed.
9:40 Liquid Biopsies Enabling Precision Medicine
Jonathan
Beer, MBA, Director, Disruptive Technologies, Oncology Precision Medicine, Novartis
Blood-based detection of tumor-associated variants is advantageous in the era of Precision Medicine due to the non-invasive nature of sample collection and has demonstrated effectiveness as a Companion Diagnostic assay in lung cancer. However, this sample
type still has challenges to overcome before ctDNA assays reach their full potential.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
John Lubniewski, President, CEO, HTG Molecular Diagnostics
11:00 Going Global – Setting Up a European Subsidiary
John Lubniewski, President, CEO, HTG Molecular Diagnostics
The speaker will provide a high level and lighthearted walk through the thinking behind (and the process and actual work of) setting up your first European entity. In HTG’s case, we evaluated setting up in the UK, the Netherlands, Germany or France.
We chose France. Buckle up.
11:30 Integrating China in Global Clinical Trials with a Companion Diagnostic: Challenges and Opportunities
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Marielena Mata, PhD, Director and Diagnostic Lead, Oncology Programs, Pfizer
The health challenges of China offer big opportunities for multinational pharma companies. Cases of chronic diseases are on the rise in the region, as are lung, gastric and liver cancers. China alone is likely to be the world’s third-largest pharmaceutical
market with sales of more than $50 billion. While the unmet need for oncology drugs in the China market represents a large opportunity, conducting the clinical trials needed for registration presents a number of challenges. Changing regulations, restrictions
for the exportation of samples, IP requirements and availability of CROs represent a few of the obstacles that need to be overcome to successfully conduct global registration studies in China. In this talk, we will discuss in more depth these challenges
and potential solutions.
12:00 pm Presentation to be Announced
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:00 Cookie & Refreshment Break in the Exhibit Hall with Poster Viewing
1:30 Chairperson’s Remarks
John Sninsky, PhD, Consultant, Translational Sciences
1:35 Evolving Trends in Respiratory Infections Diagnostics and the Impact in Drug Development
Jorge Villacian, MD, Medical, Digital and Technical Solutions Leader, Janssen Pharmaceutica
Accurate and reliable diagnostics are important in assessing the etiology of acuter respiratory infections. This has great impact in drug development for viral respiratory diseases. New trends in diagnostic development include home testing. The interaction
of these elements will be discussed in the presentation.
1:55 ctDNA Utility and Challenges
J. Carl
Barrett, MD, Vice President, Oncology Translational Sciences, AstraZeneca
Circulating tumor DNA (ctDNA) is becoming increasingly used in clinical practice and clinical/translational research. Examples of this utility will be given for patient selection, monitoring disease response and elucidating mechanisms of resistance to
targeted therapies. Despite the common use in many commercial and academic labs , issues remain with sensitivity and specificity of some assays and this will be discussed in this and other talks from our laboratories.
2:10 PANEL DISCUSSION: Precision Medicine Beyond Oncology
Moderator: John Sninsky, PhD, Consultant, Translational Sciences
Panelists: Speakers of the Session
Flora Berisha, Director, Companion Diagnostics, Translational Sciences, Global Oncology R&D, Daiichi-Sankyo, Inc.
Scott Patterson, PhD, Vice President, Biomarker Sciences, Gilead Sciences, Inc.
It’s been 20 years! Why so little success for a great idea (right drug, right patient, right time)? What are we doing wrong? Are health care providers outside of Oncology actually ready to implement Personalized Medicine? Where is the value for
Co-Dx outside of oncology? Prediction of R? Prediction of NR? Prognosis? How good would a Co-Dx need to be to change care paradigms from requiring patients to fail “cheaper” drugs first? Is there a robust value proposition?
2:35 Presentation to be Announced
3:05 Presentation to be Announced
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing
4:25 Chairperson’s Remarks
Carolyn Hiller, Program Director, Clinical Diagnostics Initiative, Medical Device Innovation Consortium (MDIC)
4:30 Precision Medicine: Innovation Focused on Patients
Hisani
Madison, PhD, MPH, Associate Director, Diagnostics Expert, Oncology, AstraZeneca
With the steady decrease in costs for genome/targeted sequencing and the rapid adoption of next generation sequencing (NGS) within clinical laboratories, we find ourselves in the midst of a revolution in precision medicine. With rapid uptake comes room
for innovation, but also highlights a need to keep patients as the central focus. Ensuring that patients receive the best and most effective treatment for their respective diseases is the goal of precision medicine. This presentation will explore
the innovative ways in which AstraZeneca is approaching precision medicine in a patient-centric manner and highlight the strategic implementation of diagnostics in clinical development.
4:50 Panel Discussion: Somatic Reference Samples for NGS Dx
Moderator: Carolyn Hiller, Program Director, Clinical Diagnostics Initiative, Medical Device Innovation Consortium (MDIC)
Panelists:
Barbara Zehnbauer, MD, Editor in Chief, ASIP/Journal of Molecular Diagnostics
Timothy K. McDaniel, PhD, Senior Vice President of Emerging Opportunities, TGen
J.D. Alvarez, MD, PhD, Vice President, Oncology Diagnostics, Janssen Pharmaceutical Companies
Zivana Tezak, PhD, Associate Director for Science and Technology, Personalized Medicine Staff, Office of in vitro Diagnostic Device (IVD) Evaluation and Safety (OIR), Center for Devices and Radiological Health, FDA
Clinical oncology is being transformed by the use of next-generation sequencing (NGS) based diagnostics. NGS lays out a promise for personalized medicine in other therapeutic areas. However, lack of agreed upon, well-characterized and community-validated
reference samples and data benchmarks creates a potential challenge for the efficient development of these critical tests and for understanding their results. The ultimate goal of this effort is to develop properly consented, widely shareable reference
samples that can be made available to the public and scalably produced in order to enable efficient development and improve the accuracy, reliability and transparency of NGS-based oncology tests.
5:30 Presentation to be Announced
6:00 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
7:00 Close of Day
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WEDNESDAY, AUGUST 21
7:15 am Registration
7:30 Problem Solving Breakout Discussions with Continental Breakfast
8:25 Chairperson’s Remarks
Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition
8:30 Influence of Genomic Tests on Decision Pathways for Reimbursement Practices for Oncological Therapeutics
Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation & Medical Policy, Claim Payment Policy Department, Facilitated Health Networks, Independence Blue Cross
Achievement of optimal clinical care must be driven by multiple objective factors. Understanding and establishing the confidence in these contributing factors are essential due to their impacts on any proposed net improvement in relevant health outcomes.
Development, advancement, integration, and routine clinical usage of options in oncological therapeutics are closely tied to availability, reliability, and acceptance of certain aspects of genomics. We will explore the impact of different facets of
genetic testing on multiple phases of oncological therapeutics, and payment considerations based on these relationships.
8:45 Humana’s Perspective on Personalized Medicine
Kristine Bordenave, MD, FACP, Corporate Medical Director, NMCARE, Healthcare Services, Humana
9:00 PANEL DISCUSSION: Funding Common Ground with Payers and Policy Makers to Advance Personalized Medicine in Oncology and Beyond
While emerging personalized medicine technologies and platforms have the potential to make drug development more economical and make health systems more efficient by targeting treatments to only those who will benefit, they are also challenging reimbursement
systems accustomed to one-size-fits-all medicine. Indeed, personalized medicine has led payers to think differently about coverage and reimbursement of high-value diagnostics and novel cell-based and genetic therapies that have the potential to cure
diseases with one or only a few treatments. The approval of tissue-agnostic drugs such as Keytruda and Vitrakvi, for example, will force payers to figure out policies for pan-cancer indications and associated genetic testing, while the approval of
cellular-based CAR-T therapies and gene therapies such as Luxturna, Kymriah, and Yescarta are challenging the traditional way that high-cost therapeutics can be reimbursed.
Moderator:
Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition
Panelists:
Kristine Bordenave, MD, FACP, Corporate Medical Director, NMCARE, Healthcare Services, Humana
Robert Dumanois, Manager, Reimbursement Strategy, Thermo Fisher Scientific
Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation & Medical Policy, Claim Payment Policy Department, Facilitated Health Networks, Independence Blue Cross
Katherine B. Szarama, PhD, Presidential Management Fellow, CMS
Topics to be Discussed:
- What are the key reimbursement challenges for advanced diagnostic tests?
- What strategies are emerging for the coverage and reimbursement of cell-based and genetic therapies?
- What evidence is necessary to demonstrate the value of personalized medicine technologies to payers and providers?
How can practice-based evidence be developed in an environment of limited reimbursement and reduced access?
10:00 Global Commercial and Partnership Considerations for Companion Diagnostics
Joseph Ferrara, President & CEO, Boston Healthcare Inc.
Key commercialization considerations for drug and test innovators, including balancing test access and quality, and embedding CDx global commercial considerations in pharma and diagnostic company partnerships will be highlighted.
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
11:30 Plenary Keynote Session
11:30 Chairperson’s Remarks
Charles Mathews, Principal, ClearView Healthcare Partners
11:40 Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future
Tim Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and
Drug Administration
Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.
12:10-1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)
Moderator:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition
- How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
- How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
- How are policymakers addressing the role of CMS and CLIA in the VALID Act?
- How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
- What impact will changes in diagnostics regulation and oversight have on patient care?
Panelists:
Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)
Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings
Susan Van Meter, Executive Director, AdvaMedDx
1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:35 End of Companion Diagnostics: Strategy & Partnerships
Day 1 | Day 2 | Download Brochure