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Wednesday, May 18

11:00 am Conference Registration

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

12:45 Dessert Break in the Exhibit Hall with Poster Viewing

Diagnostics to Guide Cancer Immunotherapy

1:30 Chairperson’s Opening Remarks

Marisa Dolled-Filhart, Ph.D., Director, Pathology and Companion Diagnostics, Translational Biomarkers, Merck

1:35 Development of PD-L1 as a Companion Diagnostic for Pembrolizumab

Marisa Dolled-Filhart, Ph.D., Director, Pathology and Companion Diagnostics, Translational Biomarkers, Merck

The rapid clinical development of pembrolizumab required rapid development of a PD-L1 immunohistochemistry assay. This talk will focus on Merck’s determination of whether or not PD-L1 was a predictive biomarker, use of the assay to enrich in clinical trials, and partnership to develop the assay as a companion diagnostic, which was subsequently approved by the FDA.

2:00 PD-L1: A Complementary Diagnostic for Nivolumab Checkpoint Therapy in Advanced Cancer

Julie Dixon, Ph.D., Group Director, Global Regulatory Sciences, Bristol-Myers Squibb

2:25 Comparing CDx Tests: What’s a Pathologist to Do?

David Rimm, M.D., Ph.D., Professor, Pathology, Yale University

Q2 Solutions2:50 From Eligibility to CDx: Developing and Implementing Effective Biomarker Strategies for Immuno-Oncology Trials

Patrice Hugo, Ph.D., CSO, Q² Solutions

Patrick Hurban, Ph.D., Senior Director and Global Head, Genomic Development/Esoteric Assays, Q² Solutions

By capitalizing on fundamental cancer and immunology research, Immuno-Oncology (I-O) has led to exciting breakthroughs. A deep understanding of the tumor and the anti-tumor immune response is needed to fully exploit this strategy, requiring a fresh perspective on biomarker strategies and a comprehensive toolkit for biomarker testing. I-O trials face particular challenges, and we will discuss how we have engaged Pharma and focused critical tools—anatomic pathology, flow cytometry, and genomics—on these challenges, as well as how we have leveraged this knowledge to facilitate transitioning to companion diagnostic development.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing

4:25 Diagnostic Strategies for Cancer Immune Therapies

Andy Williams, Ph.D., Companion Diagnostics Group Leader, Cancer Immune Therapies, Genentech

Current and future opportunities for diagnostics for cancer immune therapies will be covered. This will include companion diagnostics as well as other informative tests.

4:50 FDA Regulatory Review of Companion Diagnostics in Cancer Immunotherapy

Shyam Kalavar, MPH, CT(ASCP), Scientific Reviewer, Diagnostic Devices, Center for Devices and Radiological Health, US Food and Drug Administration

This talk will focus on regulatory considerations for companion diagnostics that guide cancer immunotherapy. The talk will cover issues related to the use of diagnostics in biomarker-related drug trials with a focus on immunohistochemistry assays. FDA regulatory review of these diagnostics for approval purposes will also be discussed.

5:15 Supporting CAR T Trials in GBM through NGS: Patient Selection and Monitoring

Jennifer J.D. Morrissette, Ph.D., Assistant Professor, Clinical Pathology & Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania

5:40 ThinkTank Registration

6:00-9:00 pm Dinner ThinkTank*

SC3: PD-L1 Assays for Biomarkers and Companion Diagnostics

*Separate registration required or all access

Thursday, May 19

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

Companion Diagnostics Implementation

8:25 Chairperson’s Remarks

Steven Gutman, M.D., MBA, Strategic Advisor, Myraqa/Illumina

8:30 Regulatory Update on Companion Diagnostics

Aaron Schetter, Ph.D., Senior Staff Fellow, Center for Devices and Radiological Health, US Food and Drug Administration

Companion diagnostics are tests that are essential for the safe and effective use of a therapeutic product. This talk will provide an overview of the FDA companion diagnostic approval process. It will provide a summary of recent approvals by the FDA and other policy developments for companion diagnostics.

8:55 Companion Diagnostics: Pot of Gold or Money Pit

Steven Gutman, M.D., MBA, Strategic Advisor, Myraqa/Illumina

Companion diagnostics are now commonly used to ensure the clinically effective and cost effective use of new drugs. FDA review of these products appears to be flexible and “least burdensome” and third party payers generally have been willing to pay for these tests although not at the same premium as for drugs. While there is growing evidence these tests are cost effective, there is less evidence they are cost savings. Understanding the economic impact of these new products is imperative if we are to make well informed health care choices.

9:20 Blood-Based Companion Diagnostics

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

Future Diagnostics9:45 Future Diagnostics as a Solution Provider to AroCell for Their New Biomarker – TK 210 ELISA

Mike Martens, Ph.D., Managing Director, Future Diagnostics Solutions B.V.

Helena Wensman, Product Manager, AroCell

Oncologists need to monitor tumor growth during cancer treatment. Future Diagnostics has developed the TK 210 ELISA for AroCell AB. TK 210 ELISA is a robust, blood based test that measures the proliferation marker Thymidine Kinase 1. Thymidine kinase is a stable protein, so the sampling procedure is reliable. Research results show that TK 210 ELISA can detect tumor growth which promises great clinical value for the future.

10:15 Networking Coffee Break

Companion Diagnostics beyond Oncology

10:45 Beyond Oncology: Implementing Precision Medicine and Companion Diagnostics Principles in Other Therapeutic Areas – A Case Study

Marielena Mata, Ph.D., Head of Precision Medicine and Companion Diagnostics, GlaxoSmithKline

Precision medicine is often associated with oncology where the ability to screen and select patients based on a particular mutation is critical for use and efficacy of many new cancer drugs. Yet, the use of stratification tools, companion and complementary diagnostics can be applied to better identify the patients that will most benefit from the safe and efficacious use of therapies in other chronic diseases where extended use may be needed. In this talk, we will review several case studies outside of oncology.

11:10 Companion Diagnostics for Gene Therapy Vectors: Defining the Problem and the Scope of Possible Solutions

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

Gene therapy technology has begun to show significant promise to alter the course of disease in many therapeutic areas. Delivery of the gene payload frequently utilizes a viral vector, which introduces the issue of previous patient exposure to the virus. An understanding of the impact and prevalence of exposure, and the likely requirement for screening of patients will create a new field in companion diagnostics. With this comes an opportunity to systematically establish the science, requirements and standards necessary to provide the optimal strategy for patient management and benefit to the health care system.

Partnering and Collaborations to Drive Innovation

11:35 Chairperson’s Remarks

Daniel Forler, Ph.D., Alliance Management, Global External Innovation & Alliances, Bayer AG

11:40 Strategic Partnerships for CDx – Challenges and Opportunities

Daniel Forler, Ph.D., Alliance Management, Global External Innovation & Alliances, Bayer Pharma AG

Companion diagnostics are a key component of many drug development programs. They promise great benefits for patient safety and drug efficacy. However, they come with additional challenges for drug as well as CDx manufacturers and typically require close alignment and merging of two distinct development programs. Different business models, requirements and philosophies have to come together to successfully launch and commercialize the CDx-drug tandem.

12:05 Partnering to Deliver Personalized Medicine

Nicole D. St Jean, MBA, Personalized Healthcare, Corporate Business Development, Global Product & Portfolio Strategy, AstraZeneca

This presentation will cover AstraZeneca's model for partnering with diagnostic companies and strategy to deliver targeted therapies.

12:30 Close of Conference