San Francisco, CA  |  October 12-13, 2016

Precision Medicine 2.0: Evolving Partnerships, Ongoing Lab Hurdles and Developing Infrastructure


DAY ONE – October 12, 2016 

7:45 am Registration and Continental Breakfast 

8:30 am Opening Remarks
Felix Frueh, Ph.D., Executive Partner, Opus Three, LLC
8:45 am Big Data in Cancer Care, Hopes, Dreams and Hard Realities
The convergence of molecular diagnostics, targeted therapies and advanced computational platforms has the potential of substantially improving cancer care. The ubiquity of electronic health record systems offers the hope that we can access unprecedented amounts of real world clinical evidence. This real world evidence (RWE) has the potential to reveal many important insights such as disease progression in subpopulations of patients and off-target effects of new therapies. There exists however many obstacles to realizing the benefits of RWE. These impediments include data fidelity issues, lack of interoperability between HER’s as well perceived commercial and regulatory barriers to data sharing. This presentation will focus on the progress of the ASCO CancerLinQ program and the strategies that we have employed to overcome many of these barriers.
Kevin Fitzpatrick, Chief Executive Officer, CancerLinQ
9:15 am Simplifying and Accelerating Precision Medicine with In-Memory Computing
Despite the incredible potential, organizations have struggled with leveraging rich data sets, diverse in data type and disparate in location, to harness precision medicine. In-memory computing enables dramatic acceleration of analysis while simplifying the ingestion, storage and in-situ analysis of large, complex data sets. As the leader in enterprise in-memory computing, SAP is uniquely positioned to apply this transformative technology to precision medicine. Dr. Delaney will illustrate how leading initiatives, such as ASCO’s CancerLinQ, are using SAP’s Connected Health Platform to power next generation precision medicine applications.
David Delaney, MD, Chief Medical Officer, Healthcare Sector, SAP
9:45 am Illumina Global Screening Array: A high-powered, Economical Tool for Large Population Scale Genomics
As human genomics enters the era of big data there is a rise in large global biobanks, DNA repositories and clinical institutions with a breadth of phenotypic data readily available. While these cohorts are not limited by access to phenotype data, budget constraints can hinder their ability to generate relevant genetic data for discovery and analysis using large number of samples. To remedy this limitation and create opportunities for large-scale genomic analysis, Illumina has developed the Multiethnic Global Array and the new Global Screening Array (GSA) which is specifically designed to enable low cost yet powerful, large scale global genotyping programs. Dr. Rosenow will discuss how Illumina has partnered with leading institutions for research, health care, biobanking, genotyping service and consumer genotyping, such as Sanford Health, Avera, 23&me, Vanderbilt University, University of Colorado at Anschutz Medical Campus, Partners HealthCare, UCLA and Montreal Heart Institute, to use its technology, to advance personalized medicine and improve health care.
Carsten Rosenow, Ph.D., Director Global Sales Applied Markets, Illumina

10:15 am Refreshment/Networking Break
10:45 am Panel Session: Big Data and Precision Medicine
Carsten Rosenow, Ph.D., Director Global Sales Applied Markets, Illumina
David Delaney, MD, Chief Medical Officer, Healthcare Sector, SAP
Kevin Fitzpatrick, Chief Executive Officer, CancerLinQ

11:25 am Effective Strategies for Accessing Phenotypic Outcomes Data
Access to high-quality phenotypic outcomes data is an ongoing challenge for precision medicine research. In this session, Mr. Astorino will review strategies employed across the industry to gather phenotypic outcomes, with a special focus on clinical level data locked in medical records. The session will include a case study from PicnicHealth's experience gathering phenotypic outcomes data from medical records without the need to rely on intermediary clinical sites. He will also discuss ongoing barriers to both accessing this data and making it useful in the research and drug development context.
Troy Astorino, Co-Founder and Chief Technology Officer, PicnicHealth
11:55 am Challenges Associated with the Commercialization of Companion and Complementary Diagnostics – Recent Experience with PD-L1 Assays
The objective of this talk will be to discuss challenges associated with the commercialization of companion/ complementary diagnostics in the US. Dr. Fikry will use his team’s recent experience with PD-L1 assays as a case study. Specific topics to be addressed will include:

♦ Fragmentation in the market – partnering with a range of diagnostic partners in the marketplace
♦ Problems/ opportunities in educating physicians (aligning oncologists and pathologists)
♦ Reimbursement hurdles
♦ Coordinating efforts with pharmaceutical partners
♦ Novel options/ best practices for approaching the commercialization of companion dx in the future

 Christopher Fikry, MD, Vice President, Oncology, Quest Diagnostics

12:25 pm Luncheon
1:25 pm Integration and Outcomes: Shifting Precision Medicine from the Future to Now
Many in healthcare today consider precision medicine and pharmacogenomics something that will be of benefit in the future, especially outside of oncology. Healthcare systems are juggling multiple implementations and making major process changes to address the shift to value-based care. All this with a careful eye on the associated and constantly evolving regulatory and quality initiatives. The only way to rise above the noise is to provide proven clinical and financial benefits AND answer the key questions – who do we test and how do we act on it – within the clinical workflow. See new research that puts pharmacogenetics on the priority list in a value-based world, and learn how cumulative and gene-based interaction risk is being identified and managed in the EHR.  
Kristine Ashcraft, MBA, Chief Executive Officer, YouScript

1:55 pm Clinical Pharmacogenetics: A Case Study In Personalized Medicine
This presentation will survey the last 5 years of diagnostic PGx in the U.S., highlighting the conflicting guidance from the FDA as compared to the payer perspective as well as the role of cost, or more accurately...the lack of market based pricing for diagnostics. 
Jami Elliott, Chief Executive Officer, QuantiGen LLC 

2:25 pm Challenges (and Solutions?) for Pharmacogenomics: A Payer Perspective
The promise of personalized medicine in general and pharmacogenomics in particular is significant, but more recently, so too are the challenges, especially with respect to achieving payer coverage and reimbursement. This presentation will review both the challenges and some potential solutions for pharmacogenomics providers from the perspective of the MolDX program at the Medicare Administrative Contractor Palmetto GBA.
Girish Putcha, MD, Ph.D., Directory, Laboratory Science, Palmetto
2:55 pm Refreshment/Networking Break

3:25 pm Panel Discussion – Pharmacogenomics Value and Realities
Kristine Ashcraft, MBA, Chief Executive Officer, YouScript
Jami Elliott, Chief Executive Officer, QuantiGen LLC
Girish Putcha, MD, Ph.D., Directory, Laboratory Science, Palmetto
4:05 pm Why Integration of Genomics Into Drug Development is Essential for Delivery of Precision Medicine
Regulatory authorities and payers will increasingly rely on genomic and non-genomic biomarkers to understand differences between patient subgroups and their response to medicine. Our data show that sponsors are increasingly leveraging genomics in all phases of clinical development. As pharmaceutical companies and their CRO partners integrate genomics throughout the medicine development process, they must navigate a complex environment that includes rapidly advancing technologies, evolving regulatory expectations, and uncertain ethics requirements. This presentation will explore strategies for integrating genomics in clinical development, common challenges and best practices to overcome these obstacles to successfully integrate genomics to aid decision making.
Anita Nelsen, Senior Director and Head, Genomic Medicine, Parexel International
4:35 pm End of Day's Proceedings
DAY TWO – October 13, 2016
8:15 am Continental Breakfast

8:45 am What's Hot in Personalized Medicine
In this presentation, Dr. Hwang will highlight the latest findings in the personalized medicine space, including recent financing and merger/acquisition activity.
Stuart Hwang, Ph.D., Managing Partner, Mavericks Capital
9:15 am Opportunities and Challenges with Complementary Diagnostics
Complementary diagnostics have recently been recognized by the FDA as its own diagnostic category. Distinct from traditional companion diagnostics, complementary diagnostics are broader in application and with significant opportunity to shape precision medicine. However, complementary diagnostics come with their own set of regulatory and commercial challenges. This presentation will provide an overview of the differences between companion and complementary diagnostics and will highlight the many ways complementary diagnostics can drive precision medicine. In addition, it will address the unique challenges of complementary diagnostics and offer potential solutions that both diagnostic companies and  pharmaceutical companies should consider for successful launch and commercialization. The presentation will cover:

· Complementary Diagnostics definition and comparison with companion diagnostics
· Applications of Complementary Diagnostics
· Recent regulatory developments
· Role of Complementary Diagnostics in driving precision medicine
· Commercial opportunities associated with Complementary Diagnostics
· Key challenges for complementary diagnostics, including, regulatory, reimbursement, funding and adoption 
· Discussion on ways to address the key challenges and enable success with Complementary Diagnostics
Peter Hoehn, JD, Global Business Leader, Janssen Diagnostics
9:45 am Commercial Innovation in Pharmacogenomics
Increased research and investment in pharmacogenomics is testament to the value of personalized medicine. Once developed, genetic-based tools require an innovative commercial strategy – accounting for a unique set of new obstacles and stakeholders. This presentation will focus on past, present, and future barriers for commercializing pharmacogenomic diagnostics; and strategies to achieve commercial success.
Mark Verratti, Senior Vice President, Chief Sales and Business Development Officer, Assurex Health
10:15 am Refreshment/Networking Break
10:45 am Democratizing Access to Precision Medicine in Community Healthcare Systems
Precision medicine is revolutionizing the practice of oncology as well as many other service lines. Until recently, the use of genomic and other molecular information to improve care has been practiced primarily by academic medical centers. In this talk we will discuss how Syapse is democratizing precision medicine, allowing community healthcare systems to implement and scale precision medicine programs across their network of physicians, and allowing providers to share anonymized patient data to improve care.
Jonathan Hirsch, President and Founder, Syapse
11:15 am Patient Engagement and Technology in Genomic Medicine
Patient engagement is key to keeping patients involved with their healthcare. The use of technology helps to increase patient engagement and allows patients the opportunity to have a hands on approach to their own care. This hands on approach is key to Precision Medicine.
Michael J. Smith, MHS, MS, Research Analyst, Geisinger Health System
11:45 am Contradiction of Precision Medicine Drugs
In 2015, ~29% of new drugs approved by the USA Federal Drug Administration were "Precision Medicine Drugs." This fast emerging new type of therapeutic agent appears to be fraught with contradictions. We will discuss the major critical issues associated with precision medicine drugs, including the time, cost, risk and complexity of bringing such entities to market.
Stephen Naylor, Ph.D., Chairman & Chief Executive Officer, MaiHealth Inc.

12:15 pm Luncheon

1:15 pm The Need for Precision Dosing of Biologic Therapeutics 
Biologic drugs are among the most powerful and expensive drugs available for many chronic and serious illness. Yet they are often dosed in a "one size fits all" manner, despite extensive literature showing significant variability in pharmacokinetics and exposure in treated populations. An overview of the problem as well as specific case studies will be presented along with a short overview of technologies that can be used for dose monitoring.
Bradley Messmer, Ph.D., Chief Executive Officer, Abreos Biosciences
1:45 pm Panel Discussion: The Challenges and Progress of Developing a Universal Test Next-Generation Sequencing-Based Companion Diagnostic Designed to Support Multiple Drug Development Programs
Novartis, Pfizer and Thermo Fisher have entered into a long term partnership to develop and commercialize a multi-marker, universal next-generation sequencing (NGS) oncology test that will serve as a companion diagnostic (CDx) for non-small cell lung cancer (NSCLC) across multiple drug development programs. The collaboration, focused on a universal testing approach, could also accelerate the development and registration of several new NSCLC drugs and drug indications, with the ultimate goal of providing patients greater access to more targeted treatments and appropriate clinical trials as quickly as possible. The panel will discuss the challenges and progress of the approach.
Mark Stevenson, MBA, Executive Vice President and President of Life Science Solutions, Thermo Fisher
Anne-Marie Martin, Ph.D., Senior Vice President, Global Head of Precision Medicine, Novartis
Hakan Sakul, Ph.D., Vice President and Head of Diagnostics, Pfizer
2:45 pm Unraveling Why Some People Have Drug Side Effects, A Pharmacodynamics Perspective
Pharmaceuticals have had an immense positive impact on modern medicine. However, they often trigger unintended and injurious side effects. Most discovered pharmacogenomics biomarkers related to drug safety pertain to pharmacokinetics. However, recent advances in both experimental and computational biology are revolutionizing how we understand both individual patient physiology and pharmaceutical compounds, providing an opportunity to unravel the pharmacodynamics mysteries of why drug side effects occur and why some people have drug side effects and others do not. In this presentation, I will discuss our recent advances in personalized network models and high-throughput data analysis for assessing drug safety.
Aarash Bordbar, Ph.D., Co-Founder and Chief Technology Officer, Sinopia Biosciences
3:15 pm End of Conference

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