Precision medicine has continued to progress immensely in the last decade with flourishing discoveries in clinical genetics and genetic epidemiology. These successes have enabled the identification of therapeutic strategies for patients more accurately than ever. Our 4th Annual Precision Medicine program will once again bring together experts in the field to share their knowledge and approaches in moving precision medicine toward routine practice. We will showcase cutting edge technologies and workflows on how to implement precision medicine in different settings, along with the adoption of bioinformatics and clinical decision support tools for precision medicine.

Final Agenda

Monday, March 11

10:30 am Conference Program Registration Open (South Lobby)

OPENING KEYNOTE PRESENTATIONS - PERSONALIZED MEDICINE IN ACTION
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11:50 Chairperson’s Opening Remarks

Edward Abrahams, PhD, President, Personalized Medicine Coalition

12:00 pm A Digital Platform Integrating Disease and Risk Factor Surveillance, Genomics and Continuous Glucose Monitoring (CGM) to Estimate Personalized 10-Year Mortality Risk

Bradley A. Perkins, MD, Co-Founder & CEO, Sapiens Data Science, Inc.

There are converging macro-trends including better disease and risk factor surveillance data, personal control of health-related data (e.g., Apple iPhone), increasing availability of affordable genomics data and devices providing continuous streams of important physiologic data (e.g., CGM) which create new opportunities to protect and improve health. We have built a digital platform providing personalized 10-year mortality risk which has the potential to incorporate new science more rapidly than existing mechanisms for translation of clinical evidence into broad scale adoption and use.

12:30 Harnessing Patient Biology and Artificial Intelligence to Enable a Biomarker-Driven Personalized Medicine Approach

Niven R. Narain, PhD, Co-Founder, President & CEO, BERG

Leveraging its proprietary intelligence platform, Interrogative Biology®, BERG is mapping disease to identify critical biomarkers that can accelerate the discovery and development of treatments aimed at the most promising therapeutic targets and pathways. This Back to Biology™ approach, combined with AI, has advanced understanding of disease and enabled biomarker-guided approaches to better personalize treatments and improve patient outcomes. Through this network approach to discovery, BERG is able to eliminate much of the ‘guess and check’ from drug discovery to accelerate the development of critical new treatments more cost-effectively.

1:00 Session Break

1:10 Luncheon Presentation: Beyond Genomics−Protein Drug Target Activation Mapping to Change the Paradigm in Precision Medicine Based Cancer Therapy

Emanuel (Chip) Petricoin, PhD, Co-Director, Center for Applied Proteomics and Molecular Medicine (CAPMM), George Mason University

The field of precision oncology now is extending beyond genomics to proteomic activation analysis since it is the protein activation machinery that contains nearly all of the drug targets. The reverse phase protein array platform can measure the activation state (phosphorylation) of the drug targets for nearly every targeted agent in the clinic, and produce a population-based portrait of functional activity or a patient-specific circuit diagram that can be used for treatment decision making.

1:40 Session Break

PERSONALIZED MEDICINE IN THE 116TH CONGRESSCo-organized with

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2:30 Chairperson’s Remarks

Edward Abrahams, PhD, President, Personalized Medicine Coalition

2:40 Progress in Washington to Advance Personalized Medicine

Cynthia Bens, Senior Vice President, Personalized Medicine Coalition

Although U.S. policymakers are increasingly recognizing the benefits of personalized medicine, the future of key regulatory and reimbursement policies that will help determine the pace at which personalized medicine tests and treatments are brought to market remains in flux. This presentation will highlight evolving federal policies that are essential to continued advancement of the field.

3:00 The Impact of the November Mid-Term Elections on Precision Medicine Landscape

Hannah Murphy, Executive Director, Coalition For 21st Century Medicine

I will discuss the political landscape for precision medicine, especially the changes due to the November mid-term elections, pending precision medicine legislation, and access to diagnostic testing.

3:20 External Impacts on Medicare Policy

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates LLC

Coverage and reimbursement at CMS is frequently influenced by external factors, such as PAMA for pricing, AMA CPT for code categories, and FDA policies for product review and approval. In addition, Medicare preventive services are usually contingent on USPSTF endorsement, so USPSTF funding cuts narrow that route to coverage. We discuss how these impact labs, investors, and patients based on the latest updates.

3:40 PANEL DISCUSSION

Understanding the future environment of personalized medicine following the 2018 election including discussions of regulation, reimbursement and other policies.

4:40 Refreshment Break and Transition to Plenary Session

5:00 Plenary Keynote Session   (Room Location: 3 & 7)

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:30 Close of Day

Tuesday, March 12

7:30 am Registration Open and Morning Coffee (South Lobby)

8:00 Plenary Keynote Session   (Room Location: 3 & 7)

9:15 Refreshment Break in the Exhibit Hall with Poster Viewing

IMPLEMENTATION OF PRECISION MEDICINE
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10:15 Chairperson’s Remarks

Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition

10:20 Why Hospitals & Labs Can’t Afford Not to Have a Precision Medicine Program

Kiran Ganda, Director, Product and Precision Medicine Marketing, Sunquest Information Systems

Why Hospitals & Labs Can’t Afford Not to Have a Precision Medicine Program

10:50 Implementing Precision Medicine in an Academic Medical Center

David B. Roth, MD, PhD, Director, Penn Center for Precision Medicine; Chair, Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania

Penn’s Center for Precision Medicine provides infrastructure and programmatic support for a variety of precision medicine efforts in our health system. I will present an overview of our activities, with particular focus on implementation of precision medicine approaches into routine clinical practice.

11:05 Implementing a Molecular Tumor Board in the Community Hospital Setting

Timothy Cannon, MD, Gastrointestinal Malignancies, Clinical Director, Inova Schar Cancer Institute Molecular Tumor Board; Assistant Professor, Virginia Commonwealth University

The promise of precision medicine for advanced cancer has excited patients and physicians, yet most patients in the United States still receive only conventional chemotherapy for advanced cancer. With most patients being treated outside of large academic centers, molecular tumor board is being cited as a way to bring better tolerated and potentially more effective treatments to patients in the community. Still, much improvement in our understanding of molecular medicine is necessary for all patients to receive the benefits of improving molecular diagnostics and targeted treatments.

11:20 The Future of Cancer Care through Biologic Profiling and Big Data

Thomas Brown, MD, MBA, Executive Director, Swedish Cancer Institute; Co-Chair, PSJH Personalized Medicine Program, PSJH Cancer Leadership Council

The Swedish Cancer Institute (SCI) embarked on an integrated program of Personalized Medicine in 2014. The resultant emerging data set is used for three primary purposes: 1-Prioritization of on and off-label therapies; 2-Prioritization of clinical trial options; and 3-Data mining research. This integrated program can contribute to sharing de-identified data across health system boundaries, as exemplified by SCI’s participation in AACR Project GENIE. This approach underscores the shift of defining illness in a new manner, focused on risk of illness on an individual or population basis.

11:35 PANEL DISCUSSION

• What are the key challenges to implementing a precision medicine program?
• What strategies can be employed to overcome implementation challenges?

12:25 pm Enjoy Lunch on Your Own

1:35 Refreshment Break in the Exhibit Hall with Poster Viewing

PERSONALIZED STRATEGIES FOR IMMUNOTHERAPY
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2:05 Chairperson’s Remarks

Eric Konnick, MD, MS, Assistant Professor; Associate Director, Genetics and Solid Tumors Laboratory, University of Washington

2:10 Current Landscape of Biomarkers for Anti-Cancer Immunotherapy

Kurt A. Schalper, MD, PhD, Assistant Professor, Pathology and Medicine (Medical Oncology); Director, Translational Immuno-Oncology Laboratory, Yale Cancer Center

Immunostimulatory anti-cancer therapies targeting the PD-1 axis are well tolerated and can induce lasting clinical responses in patients with advanced malignancies. However, the majority of patients treated with such agents do not receive clear benefit, highlighting the need for biomarkers to identify subjects with the highest potential of response and resistance. Current status and recent developments in genomic and phenotype immunotherapy biomarkers will be discussed with focus on lung cancer.

2:40 Development of Multi-Parameter Assays to Predict Therapeutic Response and Toxicity Risk in Immunotherapy

George Poste, DVM, PhD, Director, Complex Adaptive Systems, Arizona State University

The clinical benefits of immune checkpoint inhibitors in a variety of malignancies are unprecedented. Unfortunately, the level of positive therapeutic response is not consistent across different tumor classes and even in responsive tumor lineages, non-responders still dominate. The need for comprehensive immunophenotyping to identify the mechanisms underlying these differential responses and better predict responder patients and reduce toxicity is an urgent clinical and economic imperative.

3:10 Updates on PD-L1 Biomarker Testing

Larissa V. Furtado, MD, Medical Director, Molecular Oncology, ARUP Laboratories, Associate Professor of Pathology, University of Utah School of Medicine

Immunotherapies targeting the PD-1/PD-L1 pathway represent a promising treatment option across numerous types of solid tumors. Understanding the advantages and limitations of PD-L1 biomarker testing in immuno-oncology practice is, therefore, critical to appropriate patient care. This course will review practical uses, clinical utility, indications, interpretation, limitations, implementation approaches, and challenges of PD-L1 biomarker testing. Correlation between PD-L1 and other immuno-oncology biomarkers will also be discussed.

3:40 DEPArrray^TM Enables Isolation of Pure Tumor Cells from FFPE Samples for Precise Genomic Analysis

Arielle Ginsberg, MSc, Scientific Affairs Liaison, Menarini Silicon Biosystems

 DEPArray^TM technology identifies, isolates, and recovers pure single-cells and pure populations of cells from heterogeneous samples. It is the only technology to combine microfluidics with microelectronics and microscopy to isolate pure tumor and pure stromal cell populations from FFPE.

3:55 Enablement of Genomics and Business Insights for Diagnostic Assay Manufacturers and Clinical Laboratory Workflows

Naomi Thomson, Director, Business Development, BlueBee

Case examples will illustrate fit-for-purpose, genomics data-to-report through knowledge management workflows. BlueBee is a configurable, secure and scalable private cloud-based data solution. This talk will share how global assay manufacturers and clinical end users put genomics data in action as part of their go-to-market strategy.

4:10 St. Patrick’s Day Celebration in the Exhibit Hall with Poster Viewing

5:00 Breakout Discussions in the Exhibit Hall

6:00 Close of Day

Wednesday, March 13

7:30 am Registration Open and Morning Coffee (South Lobby)

8:00 Plenary Keynote Session   (Room Location: 3 & 7)

10:00 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall

HIGH-THROUGHPUT SCREENING AND MODELS FOR PERSONALIZED MEDICINE
1 & 2

10:50 Chairperson’s Remarks

David B. Roth, MD, PhD, Director, Penn Center for Precision Medicine; Chair, Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania

11:00 Precision Oncology in AML: Choosing the Right Drugs to Treat

Sara Cherry, PhD, Professor of Microbiology, Scientific Director, High-throughput Screening Core; Director, Program for Chemogenomic Discovery, University of Pennsylvania

Acute myeloid leukemia (AML) is the most common form of adult acute leukemia, with ~16,000 new cases per year in the US and 10,000 deaths. Despite intensive treatment regimens the 5-year survival is ~35%. New targeted therapies have shown promise, but are not curative, and only available to subsets of patients. We developed a new pipeline to directly screen patient tumor cells for sensitivity to 3000 clinically actionable drugs and are currently developing this into a diagnostic for personalized therapies in AML.

11:30 Personalized Cancer Models for Target Development and Precision Oncology

Christopher Kemp, PhD, Full Member, Human Biology, Fred Hutchinson Cancer Research Center

A major goal of precision oncology is to utilize genomic information to inform patient care. While there are spectacular examples of success, for the great majority of cancer patients, genomic information is insufficient to guide patient care or select effective therapeutic options. We have developed an approach that employs high-throughput functional testing with both siRNA and drugs using patient tumor cell cultures. This functional data combined with genomic analysis is used to distinguish driver from passenger mutations and identify novel drug targets and potentially effective drugs specific to a given patient.

12:00 pm Functional Approaches to Define Tumor Intrinsic and Extrinsic Targets for Personalized Therapeutic Regimens

Jeffrey Wallace Tyner, PhD, Associate Professor, Developmental & Cancer Biology, Oregon Health & Science University (OHSU) Knight Cancer Institute

To overcome these obstacles in delivery of precision medicine based on genomic-only approaches, my research program has developed a pipeline of functional tools for analysis of primary cells from patients with hematologic malignancies. This pipeline is comprised of siRNA, CRISPR/Cas, and small-molecule libraries to interrogate the genes and signaling pathways required for cancer cell growth. Simultaneous application of these functional approaches with genomic data has accelerated our understanding of pathways that contribute to neoplasia. In addition, these assays are completed in a clinically relevant time frame of three days, such that the data from these assays can be used to directly inform therapeutic strategies, even in the absence of genomic information.

12:30 Enjoy Lunch on Your Own

1:10 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

HOW TO MOVE TOWARD NETWORK-BASED MEDICINE
1 & 2

1:50 NEW: Chairperson’s Remarks

Thomas P. Conrads,  PhD, Associate Director of Scientific Technologies, Inova Schar Cancer Institute, Inova Center for Personalized Health; Chief Scientific Officer, Gynecologic Cancer Center of Excellence, John P. Murtha Cancer Center, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences

2:00 Multi-Omic Network Analysis in Complex Disease

Kimberly Glass, PhD, Assistant Professor of Medicine, Channing Division of Network Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School

Networks provide a powerful approach for modeling biological mechanisms. Our group has developed a suite of methods for: (1) integrating multi-omic data through gene regulatory network reconstruction; (2) analyzing networks to identify changes in disease state; and (3) modeling patient-specific networks to link regulatory alterations with disease phenotype. We have applied these approaches to discover new disease features and to understand alterations in biological processes across patients with lung disease.

2:30 Dissecting Proteomic Heterogeneity of the Tumor Microenvironment

Thomas P. Conrads, PhD, Associate Director of Scientific Technologies, Inova Schar Cancer Institute, Inova Center for Personalized Health; Chief Scientific Officer, Gynecologic Cancer Center of Excellence, John P. Murtha Cancer Center, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences

This lecture will highlight cutting edge applications in applying laser microdissection and microscaled quantitative proteomics and phosphoproteomics to uncover exquisite intra- and inter-tumor heterogeneity. The paradigm-shifting results offer unprecedented opportunities to speed progress in identifying novel molecular sub-types of cancer, therapeutic targets, prognostic signatures, and companion diagnostics.

3:00 A Cloud-Based Asynchronous Virtual Tumor Board Facilitates Treatment Recommendations for Patients with Advanced Cancers Based on Molecular and Clinical Data

Subha Madhavan, PhD, Director, Innovation Center for Biomedical Informatics (ICBI); Associate Professor, Oncology, Georgetown University Medical Center

We developed a cloud-based, asynchronous virtual tumor board (VTB) that integrates multi-modal patient data to formulate, discuss, and rank treatments. The VTB utilizes 8 linked databases, a treatment scoring model based on the AMP/ASCO variant interpretation guidelines and an AI-based treatment recommender. The VTB provides a scalable platform for integration and asynchronous team communication for facilitating case review with no geographical and time/attendance restrictions. We anticipate that further development of such clinical decision support tools will be important for widespread adoption of cancer precision medicine.

3:30 Session Break

PERSONALIZED MEDICINE STRATEGIES FOR CLINICALLY ACTIONABLE DATA
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3:40 Chairperson’s Remarks

Funda Meric-Bernstam, MD, Chair, Executive, Investigational Cancer Therapeutics, MD Anderson Cancer Center

3:45 Precision Oncology Decision Support

Funda Meric-Bernstam, MD, Chair, Executive, Investigational Cancer Therapeutics, MD Anderson Cancer Center

Molecular profiling is increasingly utilized in the management of cancer patients. Decision support for precision oncology includes guidance of optimal testing, interpretation of test results including interpretation of functional impact of genomic alterations and therapeutic implications. We will review strategies for decision support and resources for identifying optimal approved or investigational therapies.

4:15 High-Performance Integrated Virtual Environment (HIVE) and BioCompute Objects for Regulatory Sciences

Raja Mazumder, PhD, Associate Professor, Biochemistry and Molecular Medicine Georgetown Washington University

Advances in sequencing technologies combined with extensive systems level -omics analysis have contributed to a wealth of data which requires sophisticated bioinformatic analysis pipelines. Accurate communication describing these pipelines is critical for knowledge and information transfer. In my talk I will provide an overview of how we have been engaging with the scientific community to develop BioCompute specifications to build a framework to standardize bioinformatics computations and analyses communication with US FDA. I will also describe how BioCompute Objects (https://osf.io/h59uh/) can be created using the High-performance Integrated Virtual Environment (HIVE) and other bioinformatics platforms.

4:45 Integrating Genomic and Immunologic Data to Accelerate Translational Discovery at the Parker Institute for Cancer Immunotherapy

Danny Wells, PhD, Scientist, Informatics, Parker Institute for Cancer Immunotherapy

Immunotherapy is rapidly changing how we treat both solid and hematologic malignancies, and combinations of these therapies are quickly becoming the norm. For any given treatment strategy only a subset of patients will respond, and an emerging challenge is how to effectively identify the right treatment strategy for each patient. This challenge is compounded by a concomitant explosion in the amount of data collected from each patient, from high dimensional single cell measurements to whole exome tumor sequencing. In this talk I will discuss translational research at the Parker Institute, and how we are integrating multiple molecular and clinical data types characterize the tumor-immune phenotype of each patient.

5:15 Close of Conference Program