Wednesday, May 6 11:00 am Conference Registration 12:15 pm Lunch on Your Own 1:30 Chairperson’s Opening Remarks Kenneth Emancipator, M.D., Executive Medical Director, Molecular Biomarkers and Diagnostics, Merck Research Laboratories 1:35 Making Disciplined Decisions in Companion Diagnostic Development Using Clinical Epidemiologic Techniques Kenneth Emancipator, M.D., Executive Medical Director, Molecular Biomarkers and Diagnostics, Merck Research Laboratories Choosing which biomarker to develop as a companion diagnostic, choosing a cutoff, and even deciding whether or not a companion diagnostic should be co-developed with a therapeutic often provokes spirited discussions within pharmaceutical companies. However, these discussions need not involve high drama. This presentation will demonstrate a few simple, well-established clinical epidemiologic techniques which can guide rational, disciplined decisions. Examples of the application of these techniques will also be presented. 2:00 The Role of Companion Diagnostics in Improving Patient Care Carolina Rizo, Ph.D., MBA, Director, Business Development, Roche Molecular Systems Companion diagnostics is becoming a key element in cancer treatment. In this talk, I will: 1) discuss the importance of standardized testing due to variability observed in EQA schemes, 2) review the differences in test methodologies and the resulting impact on patient selection, 3) describe the value of clinical validation with a CDx and advantages it may bring to the drug registration process, and 4) evaluate how future technologies (liquid biopsies) may play a role in patient selection and management. I will show how companion diagnostics is improving patient care and will continue doing so. 2:25 Dollars and Sense: Making the Most of Companion Diagnostics Steven Gutman, M.D., Myraqa Strategic Advisor, Illumina, Inc. Companion diagnostics are now commonly being evaluated early in the drug development process as important tools to reduce the cost of clinical trials and to improve study outcomes. These tests are also being 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. With this background in mind, this talk will address the gaps that exist in the value proposition for companion diagnostics. 2:50 Diagnostics Partnering to Realize Combined Drug-Diagnostics Strategies Rolf Ehrnström, Scientific Advisor, Diagnostics Partnering, Thermo Fisher Scientific 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing 4:25 Tissue and Time: Perspectives on Companion Diagnostic Development Ron Mazumder, Ph.D., MBA, Global Head, R&D and Operations, Janssen Diagnostics, Janssen Pharmaceutical Companies of Johnson & Johnson 4:50 Companion Diagnostics – Immunoassay and Other “Wet” Markers – Method Development and Choice of Platform – Challenges and Considerations John L. Allinson, FIBMS, Head, Biomarker Strategy, Drug Development Services, LGC Group This talk will look at potential development of companion diagnostics in the “wet” biomarker space. Consideration will be given to: 1) range of analytical platforms available and factors that influence their choice, 2) development program from original research method through to accredited diagnostic – the technical challenges and requirements, 3) different applications of the research and diagnostic assays during a drug development program, and 4) overall project design – requirements from the sponsor, diagnostic and contract research organization to deliver a successful outcome. 5:15 Regulatory Perspective on in vitro Companion Diagnostic Devices Eunice Lee, Ph.D., Division of Immunology and Hematology Devices, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA Since the approval of the HercepTest in 1998, significant strides have been made to establish a regulatory structure for companion diagnostic devices in the US. Companion diagnostics are defined as devices that provide information that is essential for the safe and effective use of a corresponding therapeutic. I will describe the current regulatory model for companion diagnostics, and share some lessons learned from successful co-development programs from the device perspective. My talk will also highlight considerations for validating the performance of in vitro diagnostics, and discuss potential challenges to the regulatory model for companion diagnostics in the future. Thursday, May 7  7:30 am Breakfast Presentation: Next Generation in Situ Hybridization (ISH) and Immunohistochemistry (IHC)
Sven Müller, Ph.D., Manager, R&D, ISH pharmDx, Dako - an Agilent Technology company The need for solid tumor biomarkers to be confirmed in context of tissue morphology calls for routine involvement of slide based techniques like IHC and ISH. The major drawbacks of these methods relates to a qualitative readout and a slow turn-around time, respectively. Based on Dako, an Agilent Technologies Company's long term IHC and ISH expertise we are bringing these technologies to the next level, enabling us to continue being a One Stop Shop in IHC and ISH solutions for pharma partners - from early development to IVD class III kits. The symposium focuses on game changing improvements of the ISH and IHC technologies. 8:25 Chairperson’s Remarks James Novotny, Ph.D., Group Director, Pharmacodiagnostics, Bristol-Myers Squibb 8:30 Translational and Companion Diagnostic Strategies: A Case Study of Development of a PI3K-Beta Inhibitor Monica Motwani, Ph.D., Director, Precision Medicine & Diagnostics, GlaxoSmithKline In the era of precision medicine, efficient development and implementation of biomarker and companion diagnostic strategies in clinical studies is a key to being successful. This talk will discuss the PI3K beta inhibitor development as an example to illustrate various steps in the development and implementation of these strategies in clinic. 8:55 Evaluation of PD-L1 as a Potential Companion Diagnostic for Nivolumab, a Novel Immune Checkpoint Inhibitor for the Treatment of Cancer James Novotny, Ph.D., Group Director, Pharmacodiagnostics, Bristol-Myers Squibb PD-L1 expression has been documented on a wide variety of solid tumors, and PD-L1 positivity may correlate with response from treatment with PD-1 pathway inhibitors. Nivolumab is a fully human IgG4 PD-1 immune checkpoint inhibitor antibody that selectively prevents interaction with PD-L1 and PD-L2, thereby inhibiting the downregulation of antitumor T cell function. BMS has engaged in a comprehensive analytical and clinical evaluation of PD-L1 expression by IHC in order to determine the association between expression and clinical outcome for Nivolumab. 9:20 A New Paradigm for Precision Oncology: A Shared Vision for Universal Oncology Testing John Leite, Ph.D., Vice President, Oncology Market Development, Oncology, Illumina 9:50 Coffee Break in the Exhibit Hall with Poster Viewing 10:45 Presentation to be Announced 11:10 Development of a Homologous Recombination Deficiency (HRD) Companion Diagnostic Test for Selecting High Grade Ovarian Cancer Patients Likely to Respond to the PARP Inhibitor Rucaparib Mitch Raponi, Ph.D., Senior Director, Molecular Diagnostics, Clovis Oncology PARP inhibitors are active in patients whose tumors exhibit homologous recombination deficiency (HRD), and pathogenic mutations in the tumor suppressor gene BRCA (a key player in the HR pathway) is a predictor of PARPi efficacy. However, multiple mechanisms can result in HRD, which in turn leads to a BRCAness phenotype. A comprehensive genomic sequencing-based HRD test has been developed to identify a patient population who will benefit from the PARP inhibitor Rucaparib. This approach is being prospectively tested in the ARIEL (Assessment of Rucaparib In ovarian cancEr triaLs) program and will be described. 11:35 Developing Biomarkers for Use in Patient Selection in Early Phase Clinical Trials Ann Kapoun, Ph.D., Vice President, Translational Medicine, OncoMed Pharmaceuticals This presentation will cover: 1) incorporating predictive biomarkers into early stage R&D to ensure each clinical candidate has a complimentary biomarker when it reaches the clinic, 2) embedding personalized medicine strategies into drug discovery to fast-track CDx programs, and 3) prospective and retrospective predictive biomarker case studies for Anti-Notch1 and for Tarextumab clinical programs. 12:00 pm Enjoy Lunch on Your Own 1:30 Chairperson’s Remarks George A. Green IV, Ph.D., Group Director, Pharmacodiagnostic Center of Excellence, Bristol-Myers Squibb 1:35 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 Many pharmaceutical companies are using an external partnering model to pursue co-development of drugs and diagnostic products. This approach provides access to diverse biomarkers, technology and platforms, as well as diagnostic manufacturing and commercialization expertise, thus maximizing diagnostic development capabilities. External partnering creates multiple interfaces of functions both within and between the drug and diagnostic companies. We will explore some of the challenges that accompany these interfaces, their management and implications, along with ideas for optimizing the “virtual diagnostic company” model for the Rx/Dx co-development environment. 2:25 Innovative Strategies and Progress in Translational Biomarkers in Clinical Oncology through Public-Private Partnerships Paula Eason, Ph.D., Scientific Program Manager, Cancer Division of Research Partnerships, Foundation for the National Institutes of Health The continual need for development of biomarkers with robust clinical utility is an ongoing challenge for all cancer types. Incorporation of prognostic and predictive biomarkers into clinical trial strategies and therapeutic decision-making is essential to disentangle the complexities of the pathogenic process, drug pharmacodynamics, and tumor heterogeneity. Success will require strategic partnerships and alliances between public and private sectors to share resources, risks, experience and expertise, and to align multiple stakeholder incentives to support and accelerate sustainable innovation. 2:50 Close of Conference | .png)