Cambridge Healthtech Institute’s Inaugural

Companion Diagnostics for Immuno-Oncology

Accelerating Innovative Therapies to the Clinic

8-9 May 2019

 

Innovation in immuno-oncology is rapidly advancing cancer treatment, but significant challenges remain with patient selection and treatment monitoring. Companion diagnostics have the potential to improve immunotherapy efficacy, ensure greater safety, shorten product lifecycles, and increase availability to the patient. The development of robust assays is urgently needed for successful implementation and expediting immunotherapies to the market. CHI's Companion Diagnostics for Immuno-Oncology will facilitate partnerships between pharma and diagnostic companies and bring together clinicians in immuno-oncology with diagnostic developers and translational experts to review the tools and strategies to advance immunotherapies.

Final Agenda

WEDNESDAY 8 MAY

PLENARY SESSION

11:35 Moderator’s Remarks

Charlotte Ryckman, Associate, Covington & Burling LLP, Belgium

11:45 Precision Diagnostics in Oncology: Expanding Roles of Liquid Biopsies

Nitzan Rosenfeld, PhD, Senior Group Leader, Cancer Research UK Cambridge Institute, University of Cambridge; CSO, Inivata Ltd., United Kingdom

Effective clinical management relies on accurate diagnostic information, which requires effective techniques and the right samples. Next generation sequencing can provide a wealth of information, but implementing innovative technologies into clinical routine can be a challenge. We’ll examine how analysis of cell-free DNA can provide an opportunity to re-examine many of the current clinical decision points, and a test case for adoption of new diagnostic tools.

12:15 Legal and Regulatory Developments in Precision Medicine and Diagnostic Devices

Erik Vollebregt, Partner, Axon Lawyers, The Netherlands

  • What changes will be brought about by the IVDR?
  • What is the impact of the GDPR in the field of precision medicine and diagnostic devices?
  • What are the practical implications of implementation of new European regulations?
  • What are the consequences of the interplay of the IVDR and the GDPR?


12:45
PANEL DISCUSSION: Challenges and Opportunities in European Diagnostic Investments

Moderator:

Philippe Peltier, Partner, Kurma Partners, France






Panelists:

Florian Kainzinger, PhD, Managing Partner, Founder, Think.Health Ventures, Germany





Makinen_SeppoSeppo Mäkinen, Partner, Pathena Investments


  • What is different in Europe versus other markets (e.g., US and Israel). How do different European markets compare?
  • What has changed in the landscape of European investments over the past few years? What can be improved?
  • The role of regulators and governments
  • How can start-ups stand out and get attention in the current landscape?


 

OPENING KEYNOTE SESSION

14:30 Chairperson's Remarks

Charlotte Ryckman, Associate, Covington & Burling LLP, Belgium

14:35 The EU IVD Regulation and CDx: What Will Change?

Charlotte Ryckman, Associate, Covington & Burling LLP, Belgium


15:05 Bring Forward the “Intrinsic” Value of Diagnostic Information and the Drive to Value-Based Procurement

Yves Verboven, Director, Market Access & Economic Policies, MedTech Europe, Belgium


15:35 Scientific-Regulatory Challenges for Co-Development of Drug and CDx during Clinical Trials Up to Clinical Routine

Jörg Engelbergs, PhD, Scientific Expert and Assessor Biomedicines (Quality, Non-Clinic & Personalized Medicine), Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany

In opposite to the US in Europe, the legislations for marketing of medicinal products (MP) and predictive biomarker-based diagnostic assays (i.e., companion diagnostics, CDx) are not directly linked, which is challenging for its co-development. The new in vitro diagnostic regulation (IVDR) involves for the first time, drug regulators in the CDx review process for CE marking. The presentation will outline from the perspective of drug regulators, the scientific-regulatory challenges for clinical co-development addressing also technical CDx validation aspects (e.g. differences between exploratory assays and assays used for patient stratification) and discusses finally the assurance of diagnostic assay quality during clinical drug-Dx co-development and post-authorization clinical routine testing.

 

16:05 Refreshment Break in the Exhibit Hall with Poster Viewing

BIOMARKERS FOR COMPANION DIAGNOSTICS

17:00 Chairperson’s Remarks

Michael Oellerich, MD, Hon MD, FAACC, FAMM, FFPath (RCPI), FRCPath, Distinguished Research Professor of Clinical Chemistry, Department of Clinical Pharmacology, George-August-University, University Medical Center Goettingen (Umg), Germany

17:05 Comparative Tumor Mutation Burden Testing for Companion Diagnostics

Arriola_EdurneEdurne Arriola, PhD, Head of Lung Cancer Division, Medical Oncology Department, Hospital del Mar, Spain

Tumor mutational burden (TMB) might represent a useful biomarker to select cancer patients that will benefit from immunotherapy. Currently, many platforms are being validated to assess TMB in solid tumors. However, there is no data about the consistency of results and the clinical validity across the different platforms that are being developed. International efforts are currently ongoing to assess reproducibility and standardization of these techniques.

17:35 Circulating Cell-Free DNA – Diagnostic and Prognostic Applications in Personalized Cancer Therapy

Oellerich_MichaelMichael Oellerich, MD, Hon MD, FAACC, FAMM, FFPath (RCPI), FRCPath, Distinguished Research Professor of Clinical Chemistry, Department of Clinical Pharmacology, George-August-University, University Medical Center Goettingen (Umg), Germany

High-quality genomic analyses are essential for precision medicine approaches to cancer patient management. Tumor-specific genomic alterations can be identified in cell-free tumor DNA (ctDNA) from patient blood samples and complement biopsies for real-time molecular treatment monitoring, early recurrence detection, resistance tracking, and identification of candidates for targeted therapies. ctDNA allows for the identification of specific mutations selected by treatment, such as EGFR T790M or C797S in NSCLC patients treated with tyrosine kinase inhibitors. ctDNA can also detect mutations such as KRAS G12V in colorectal cancer and BRAF V600E/V600K in melanoma. Chromosomal aberration pattern analysis by low coverage whole genome sequencing is a new broader approach based on genomic instability and can be used to compute a genomic copy number instability (CNI) score. Change in CNI can serve as an early predictor of therapeutic response to chemo/immunotherapy in many cancer types and for prediction of recurrence-free survival.

18:05 Breakout Discussions View Details

19:05 Close of Day

THURSDAY 9 MAY

08:30 Registration and Morning Coffee

PAYING FOR IMMUNOTHERAPY

09:00 Chairperson's Remarks

Edward Abrahams, PhD, President, Personalized Medicine Coalition, United States

09:05 Immunotherapy in Europe: A Landscape Analysis

Greuel_JoachimJoachim M. Greuel, PhD, MBA, Managing Director, Bioscience Valuation BSV GmbH, Germany

The recent rejections of Gilead’s Yescarta and Novartis’ Kymriah CAR-T cancer cell therapies by UK’s NICE have spurred debates whether expensive, personalized immunotherapies may achieve reimbursement in Europe. The presentation will review current reimbursement policies in key European countries with particular emphasis on immunotherapies. Furthermore, it will highlight major economic challenges and will suggest concrete measures that may facilitate reimbursement in the future.

09:35 The Innovative Medicines Initiative – A Model for Accelerating Access to Medical Innovation

Meulien_PierrePierre Meulien, PhD, Executive Director, Innovative Medicines Initiative, Belgium

The Innovative Medicines Initiative is a large-scale public private R&D partnership between the European Commission on the public side and the European Federation of Pharmaceutical Industries and Associations. With a long-term commitment and a budget of over €5 billion, this partnership seeks to accelerate and make more efficient the medicines development process. This new way of working changes practices and cultures across the public-private divide ultimately benefitting society.

10:05 Streamlined CDx™ - A Proven Strategy to Accelerate Drug Approvals

Andreia de Albuquerque, PhD, Senior Manager, Strategic Business Development, Invivoscribe, USA

Invivoscribe Streamlined CDx™ approach has been shown to collapse the development timelines of biomarker assays, and proven successful in approval of the first ever AML companion diagnostic – The LeukoStrat® CDx FLT3 Mutation Assay, helping accelerate FDA and PMDA approvals of targeted therapies for the most deadly form of leukemia.

10:35 Coffee Break in the Exhibit Hall. Last Chance for Poster Viewing.

11:20 Aligning Value and Payment of Immunotherapy and Companion Diagnostics 

Sheppard_ElizabethElizabeth Sheppard, MBA, Senior Director, Global Market Access, Roche Tissue Diagnostics, United States

The access plans for immuno-oncology therapies and companion diagnostics have become increasingly complex, mostly due to the misalignment and the lack of a clear definition of “value” for a diagnostic combined with an innovative drug.  This program will discuss the companion diagnostic reimbursement variations among funding decision makers and the impact to prioritize cost-based pricing over value-based pricing in contrast to the therapy.   

 

BostonHealthcare 11:50 Companion Diagnostics in Immuno-Oncology: Global Commercial and Partnership Considerations

Ferrara_JosephJoseph Ferrara, CEO, Boston Healthcare Associates, USA

The testing paradigm in immuno-oncology is growing increasingly complex, moving beyond PD-L1, to include mismatch repair, microsatellite instability, tumor mutational burden, and others. The presentation will highlight 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.

12:20 PANEL DISCUSSION: How Will Countries across Europe Pay for Immunotherapy?

Moderator: Edward Abrahams, PhD, President, Personalized Medicine Coalition, United States

Panelists: Joachim M. Greuel, PhD, MBA, Managing Director, Bioscience Valuation BSV GmbH, Germany

Pierre Meulien, PhD, Executive Director, Innovative Medicines Initiative, Belgium

Elizabeth Sheppard, MBA, Senior Director, Global Market Access, Roche Tissue Diagnostics, United States

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

13:20 Session Break

EXECUTIVE SESSION: CONSIDERATIONS FOR Rx/Dx Development IN COMPANION Dx

13:50 Chairperson's Remarks

Michael Roehrl, MD, PhD, Director, Precision Pathology Biobanking Center, Memorial Sloan Kettering Cancer Center, United States


14:00 KEYNOTE PRESENTATION: New Challenges of CDX Development into the Commercial Marketplace

Omar Perez, PhD, Head of Precision Medicine and Diagnostics, GlaxoSmithKline, United States



14:30 Companion Diagnostics in a Not-So-Flat World

Emancipator_KenKenneth Emancipator, MD, Executive Medical Director and Head of Companion Diagnostics, Translational Medicine, Merck, United States

This program discusses the challenges of introducing companion diagnostics into the not-so-flat world of the highly regulated, global pharmaceutical industry. The need to market globally almost instantaneously, the complex global regulatory framework, and the variable global delivery models for clinical laboratory services favor the few large, established diagnostic companies. This obviously is a problem for the small, innovative diagnostic company, but it presents challenges for big pharmaceutical companies as well.

15:00 Transforming Pathology in the Immuno-Oncology Space: Precision Pathology in the Theranostics Frontier

Roehrl_MichaelMichael Roehrl, MD, PhD, Associate Professor of Pathology and Laboratory Medicine, Weill Cornell Medicine, United States

Precision Health Care puts Pathology as the key theranostic discipline front and center, especially in oncology. We will discuss examples of new approaches for immunomonitoring and cutting-edge theranostic assays in the I-O space, including multiplex imaging, proteomics, and functional assays. We will also discuss how the Precision Pathology Center is instrumental in the next generation of clinical trials in immunooncology.

15:30 Strategies for Development of Companion Diagnostics for Immuno-Oncology

Pantano_SerafinoSerafino Pantano, PhD, Director, EMEAC Biomarker & Diagnostics Leader, Oncology Global Medical Affairs, MSD International GmbH, Switzerland

This presentation will discuss strategies for development of companion diagnostics in the immuno-oncology space. Successful examples of immuno-oncology companion diagnostics development will be presented and discussed, with a special focus on the CDx clinical validation. Practical aspects that should be considered when designing a CDx development strategy will also be discussed.

16:00 Biomarkers in Immuno-Oncology and Transitioning Them to an IVD – Opportunities and Challenges

Adya_NeerajNeeraj Adya, PhD, Director, Pharmacodiagnostics Research and Development, Bristol-Myers Squibb, United States

Precision medicine continues to transform treatment paradigms through development of new biomarkers and interpretation of clinical data. Immuno-Oncology biomarkers, such as PD-L1, and emerging ones, such as TMB and GEP, may help optimize treatment decisions, individually or in combination. The advancement of increasingly complex biomarkers also brings a need for advanced diagnostic tools. We will discuss biomarkers and their transition to an IVD in the evolving field of pharmacodiagnostics.

16:30 Close of Conference