Cambridge Healthtech Institute’s Ninth Annual
Companion Diagnostics: Strategy and Partnerships
Diagnostics and Pharma: Reaching for Common Ground and Profitability
August 20-21, 2018 | Grand Hyatt Washington | Washington, DC
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 Ninth 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
Recommended Short Course*
SC1: Liquid Biopsy: Technology, Applications, Regulations and Reimbursement
Hatim Husain, MD, Physician, Medical Oncology, University of California, San Diego
John Simmons, PhD, Director, Translational Science & Diagnostics, Personal Genome Diagnostics
Živana Težak, PhD, Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH/FDA
Girish Putcha, MD, PhD, Director of Laboratory Science, MolDx, Palmetto GBA
*Separate registration required
MONDAY, AUGUST 20
12:00 pm Main Conference Registration (Independence Foyer)
1:30 Chairperson’s Opening Remarks
Eric Lai, PhD, Partner, Personalized Science, LLS; Former Senior Vice President, Takeda Pharmaceuticals
1:40 PANEL DISCUSSION: Companion Diagnostics: Lessons Learned and New Approaches
Companion diagnostics have been critical to the success of many cancer and viral therapies, but have still not been broadly implemented, particularly in other therapeutic areas. In this panel, we will hear new approaches to developing companion diagnostics.
- Lessons learned from successful CDx development
- Untold stories of CDx un-development
- Non-traditional, novel and successful approaches of CDx development and implementation
- The importance of new and creative CDx business models
- What we've learned from the past and moving forward
Moderators: Eric Lai, PhD, Partner, Personalized Science, LLS; Former Senior Vice President, Takeda Pharmaceuticals
Myla Lai-Goldman, MD, CEO, GeneCentric Therapeutics
Panelists: Eric Peters, PhD, Director, Head, Companion Diagnostics, Genentech
Jason Christiansen, Vice President of Diagnostics, Ignyta
Matthew Hawryluk, PhD, Executive Vice President and Chief Business Officer, Gritstone Oncology
John Lubniewski, Chief Business Officer, HTG Molecular
Nicholas Dracopoli, PhD, Senior Vice President, Translational Science, Personal Genome Diagnostics
3:10 Almac Diagnostics Solutions for Multi-Arm Clinical Trial Designs
Katarina Wikstrom, PhD, Head, US Operations, Almac Diagnostics
In this presentation, you will learn about Almac’s: novel strategy for patient stratification in Basket & Umbrella trials; solution to enable multiple biomarkers to be evaluated from one sample; forthcoming product launches involving cancer panels for both DNA & RNA; unique product offering for Immuno-Oncology; and customised patient reporting enabling simple interpretation of molecular data.
3:40 Networking Coffee Break (Independence Foyer)
4:15 pm Chairperson’s Remarks
Charles Mathews, Principal, ClearView Healthcare Partners
4:25 - 5:45 pm Global Dx Insights: Policy and Prediction for Diagnostics
Moderator: Cecilia Schott, PhD, Former Former Vice President, Precision Medicine, AstraZeneca
- Will value-based medicine replace fee-for-service?
- PAMA impact on reimbursement
- Changes in LDT oversight policy
- Changing landscape of IVD regulation in U.K. and Europe after Brexit
- What is the future of molecular diagnostics in medical care?
- How will these policy changes affect the patient?
Panelists:
Dennis J. Dietzen, PhD, DABCC, FAACC, President, AACC; Professor of Pathology & Immunology and Pediatrics, Washington University School of Medicine; Medical Director of Laboratory Services, St. Louis Children’s Hospital
John Leite, PhD, Vice President, Strategic Partnerships, Corporate and Business Development, Illumina
J. Leonard Lichtenfeld, MD, MACP, Deputy CMO, American Cancer Society, Inc.
Victoria M. Pratt, PhD, FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Department of Medical and Molecular Genetics, Indiana University School of Medicine (AMP President-Elect)
Susan Van Meter, Executive Director, AdvaMedDx
Ian S. Young, MD, PhD, Chief Scientific Advisor, Department of Health (Northern Ireland) and President, Association for Clinical Biochemistry and Laboratory Medicine (ACB), UK
5:45 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing (Independence Ballroom)
7:00 Close of Day
TUESDAY, AUGUST 21
7:15 am Registration (Independence Foyer)
7:30 Problem Solving Breakout Sessions with Continental Breakfast (Independence F-I)
This session features various discussion groups that are led by a moderator/s who ensures focused conversations around the key issues listed. Attendees choose to join a specific group and the small, informal setting facilitates sharing of ideas and active networking. Continental breakfast is available for all participants.
Companion Diagnostics Outside Oncology
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Mark Curran, PhD, Vice President, Companion Diagnostics, Janssen R&D
Jorge Villacian, MD, CMO, Janssen Diagnostics
Brad Nohe, MBA, Head of Lupus, Global Product and Portfolio Strategy, AstraZeneca
- 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?
- Changing clinical practice is very hard –potential synergies between stakeholders (Pharma, Dx co’s, payors, providers)?
- Future utility of AI/ML in biomarker discovery – areas of low lying fruit?
- What does it take to change clinical practice in order to implement precision medicine?
- Are there examples outside oncology where precision medicine is currently being practiced?
- What has led to the success of these approaches and can it be extrapolated to other disease areas?
- Is the concept of precision medicine well understood across the board?
- How will personalized medicine in other therapeutic areas be different than in oncology?
- How attractive is personalized medicine to non-oncology patients?
Solutions for Supporting Companion Diagnostic Commercialization
Moderator: Gary Gustavsen, Partner, Health Advances
- Typical barriers to CDx adoption
- Split of roles and responsibilities across partners
- Marketing, reimbursement, logistics support, and field force strategies
8:30 Chairperson’s Remarks
Jorge Villacian, MD, CMO, Janssen Diagnostics
8:35 KEYNOTE PRESENTATION: Companion Diagnostics in Autoimmune Disorders: Improving Outcomes through Personalized Medicine
Mark Curran, PhD, Vice President, Companion Diagnostics, Janssen R&D
Despite advances in treatment options for severe autoimmune disorders there remains a significant unmet clinical need for new therapies and integrated treatment solutions. We are applying systems pharmacology, precision medicine and developing companion diagnostics to create new treatment paradigms. Our objective is to deliver higher response rates, deeper remission, early interception and eventually prevention of these diseases. Progress and strategy toward these objectives will be discussed.
9:05 Bringing Precision Medicine to the Clinic
Jorge Villacian, MD, CMO, Janssen Diagnostics
Therapeutic solutions including drugs and diagnostics are evolving to target narrow populations to improve results. The challenges of bringing precision medicine approaches to the clinic from early biomarker discovery to development and commercialization will be addressed.
9:35 Partnering for Success: Biopharma and Diagnostics
Brad Nohe, MBA, Head of Lupus, Global Product and Portfolio Strategy, AstraZeneca
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.
10:05 Coffee Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
11:00 NEW: ctDNA Utility and Challenges
Benoit Destenaves, PharmD., Director, Precision Medicine Lead, Precision Medicine and Genomics, Innovative Medicines and Early Development, 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.
11:30 Breakthrough Genomic Cancer Testing from a Single Blood Draw
Jessica Riley, PhD, Senior Director, BioPharma Business Development, Guardant Health
12:00 pm Implementing Personalized Medicine: Overcoming Practice Challenges in CDx
Joseph V. Ferrara, MS, CEO, Boston Healthcare Associates
The number of approved drugs and combinations with companion diagnostics in clinical practice continues to increase, generating unique challenges to implementing personalized medicine. This presentation will highlight key practice-level barriers to CDx implementation and approaches that pharma and diagnostic partners can deploy to address these challenges and achieve commercial success.
12:30 Luncheon Presentation: Beginning with the End in Mind: Starting with a CTA to the Development and Commercialization of a CDx
Fritz Eibel, MBA, Senior Vice President, MolecularMD
Precision medicine efforts are yielding breakthrough therapy designations with accelerated approvals. Many clinical trial assays are likely to become a companion diagnostic with proper design and upfront planning. Experience and insight on MolecularMD’s MRDx Test, a companion diagnostic used for the initiation and monitoring of Treatment-free Remission in eligible CML patients, will be shared with the NextGen Dx audience.
1:00 Refreshment and Cookie Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
1:30 Chairperson’s Remarks
Debra J Rasmussen, Global Regulatory Affairs Diagnostic Leader, Johnson & Johnson Company
1:35 Use of Diagnostics Guiding Pharmaceutical Treatments: Regulatory Challenges and Opportunities
Debra J Rasmussen, Global Regulatory Affairs Diagnostic Leader, Johnson & Johnson Company
With the continued growth of precision medicine, an increasing number of pharmaceuticals are using diagnostic (Dx) devices to detect, measure, or monitor biomarkers and other individual characteristics to guide patient management. In some cases, the pharmaceutical company will develop the biomarker test or work with a Dx company(s) with the aim for co-approval of an in vitro companion diagnostic device that is essential to the safe and effective use of the pharmaceutical. This session will explore the new global regulatory landscape changes and dynamics of Dx and pharmaceutical companies planning for a high quality diagnostic test accessible to patients and physicians upon approval of the therapy.
2:05 Companion and Complementary Diagnostics: Regulatory Challenges and Opportunities
Soma Ghosh, PhD, Scientific Reviewer, CDRH, 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.
2:35 Next-Generation Companion Diagnostics: A Public Payer Perspective
Joseph Chin, MD, MS, Deputy Director, Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)
Next generation companion diagnostics hold potential to identify targeted therapies for patients with cancer yet may present challenges to patients, providers, and payers when tests do not have sufficient evidence for specific populations. The presentation will discuss coverage considerations for advanced diagnostic tests using next generation sequencing for Medicare patients with advanced cancer.
3:05 Global Regulatory Strategy for a Companion Diagnostic: A Diagnostic Company’s Perspective
Chris Bray, Director Regulatory Affairs, QIAGEN Manchester
As the regulatory landscape for companion diagnostics continues to develop around the world, what is the regulatory strategy for the global roll-out of a companion diagnostic? The session will include the approach and key challenges that are commonly encountered.
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)
4:20 Chairperson’s Remarks
Cecilia Schott, PharmD, MBA, Former Vice President, Precision Medicine, Global Product & Portfolio Strategy, AstraZeneca
4:25 Business Models for Working with Existing Tests: Managing Life Cycle and Labels of Drugs and Multiplexed Companion Assays
Cecilia Schott, PharmD, MBA, Former Vice President, Precision Medicine, Global Product & Portfolio Strategy, AstraZeneca
Precision medicine has been defining healthcare. In addition to providing clinically meaningful benefits to patients, it offers budgetary efficiencies reducing the costs, clinical time and ineffective treatment associated with, ‘one-size-fits-all’ approach. From an initial start of a handful of oncology drugs with corresponding diagnostics, the field has expanded to include multiple therapeutic areas, and the number of combinations has grown exponentially. The revolution in biology and high-throughput technology has provided an opportunity to develop a new wave of companion and complementary diagnostics. The future and growth of companion diagnostics rely upon a thriving ecosystem which requires multiple players to come together to be successful. These include drug developers that continue to develop targeted therapies based on biomarkers, diagnostic developers with the capability to integrate innovation to create new diagnostic tests, regulators and payers who see the value in reimbursing targeted therapies and diagnostics.
4:55 CDx Patient Leakage Mapping
Gary Gustavsen, MS, Partner, Precision Medicine, Health Advances
As pharma and diagnostics companies continue to place more focus on the success of their companion diagnostics, novel commercialization strategy techniques continue to evolve. One such analytical technique is the concept of CDx patient leakage mapping, which is an objective means of segmenting and monitoring leakage points throughout the patient/tissue journey. This session will review this concept through the lens of a case study in oncology.
5:25 The Evolution of the Commercial CDx Landscape: A Broad Companion Diagnostic Case Study
John Truesdell, Senior Director and Life Cycle Lead, FoundationOne CDx, Marketing, Foundation Medicine
New considerations around companion diagnostic (CDx) partnership and commercialization have recently emerged with the approval of new next-generation companion diagnostic tests. This talk will focus on partnering and commercialization considerations of the evolving CDx landscape. Topics will include commercializing the first FDA-approved broad CDx incorporating claims across multiple tumor types and targeted therapies, globalization of a centralized CDx model, and successful Rx/Dx commercial partnerships.
5:55 The New Paradigm and Challenges of CDX Development into the Commercial Marketplace and Community Setting
Julie Ramage, National Account Director, Diagnostics, Pfizer Oncology
Robert Dumanois, Manager, Reimbursement Strategy, Thermo Fisher Scientific
As one of the pioneers in CDX, Pfizer has developed a unique partnership between developing our companion group and our commercial group through our diagnostics subject matter expert. By collaborating months to years in advance, we identify challenges in the form of lab uptake for platforms and reagents and look at current and future landscapes in reimbursement and regulatory challenges to assist in early and more seamless adoption of new companion diagnostics to the commercial labs and to the community oncologists being served by these labs.
6:25 End of Companion Diagnostics: Strategy and Partnerships
6:00 Dinner Short Course Registration (Independence Foyer)
6:45 - 9:15 pm Recommended Dinner Short Course*
SC8: Commercialization Boot Camp: Manual for Success in Molecular Diagnostics
Harry Glorikian, Healthcare Consultant
Stan Skrzypczak, Vice President, Corporate Development and Reimbursement, Guardant Health, Inc.
*Separate registration required