San Francisco, CA  |  October 12-13, 2016

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

2015 Agenda

 
DAY ONE – OCTOBER 5TH, 2015
 
7:45 am Registration/Continental Breakfast
 
8:20 am Chairperson's Opening Remarks
Mollie Roth, JD, Managing Partner, PGx Consulting
 
8:30 am Finding Value in Pharmacogenomics
Inherited genetic variants affect a drug's uptake and metabolism between individuals. The genetics are complex, and are further complicated by drug-drug interactions and overlapping metabolic pathways. In addition, interpreting novel variants is difficult, particularly in the absence of a disease phenotype or symptoms. Nevertheless, testing for inherited variants before administering a drug reduces adverse events and predicts non-responsiveness. With new technologies, simultaneous testing of multiple variants and genes is feasible. Because such testing is expensive, payers and regulators are evaluating clinical utility for coverage and reimbursement decisions, yet, clinical utility has been difficult to demonstrate. This presentation will explore the challenges in demonstrating the value of pharmaocogenetic testing, provide examples of those with accepted clinical utility and review efforts to incorporate testing routinely to benefit patients.
Elaine Lyon, Ph.D., Section Chief, Molecular Genetics, Co-Medical Director, ARUP Laboratories, Associate Professor, University of Utah
 
9:00 am Public Policy Issues with Regulation and Reimbursement for Precision Medicine
The launch in 2015 of the President’s Precision Medicine Initiative and Congress’ legislation on 21st Century Cures are clear signals that policymakers are interested in promoting precision medicine. This attention could translate into new funding for basic research, stronger financial incentives for developers of precision diagnostics and drugs, and a more certain pathway to regulatory approval. But does the rhetoric match the reality? The prospect of more regulation of lab-developed tests and a slow response by payers to new codes for next-generation sequencing are concerning to investors and companies. This session will cover the current landscape for public policy in these important areas and how stakeholders can engage to move the debate forward.
Jen Madsen, MPH, Health Policy Advisor, Arnold & Porter
 
9:30 am The Challenge of Adopting NGS Panels: One Companies' Perspective
The adoption and clinical implementation of NGS technology has become the touchstone in precision medicine, but the realities of adopting it and obtaining reimbursement for the panels presently being offered are not easy.  This presentation will focus on one companies experience in adopting and offering NGS to its clients, including the need to help clients navigate the complexities of interpreting and understanding the tremendous amounts of data generated by NGS panels. 
Erick Lin, MD, Ph.D., Director of Medical Affairs, Ambry Genetics (formerly Senior Manager, Medical Affairs, Illumina)
 
10:00 am Precision Medicine in a Pay-for-Performance World
In today’s world, you need proof of both financial and clinical improvements to get the attention of busy risk managers, whether they’re payers, self-insurers, or ACOs. Find out about studies that got their attention and pilot proposals that worked, all involving pharmacogenomics, a core tenet of the precision medicine movement.
Kristine Ashcraft, Chief Operating Officer, Genelex
 
10:30 am Refreshment/Networking Break
 
11:00 am Barriers to the Advancement of Precision Medicine: Current Issues in the Regulation and Reimbursement of Diagnostics
This presentation will explore the current landscape of the regulation of diagnostics, and address issues affecting the coding, coverage and payment for laboratory services. The presentation will cover the evolving environment of the regulation of laboratory developed tests, with an eye towards a legislative solution to the FDA’s proposal to regulate them under the Federal Food, Drug, & Cosmetic Act. He will also explore implementation of the Protecting Access to Medicare Act(PAMA), which will establish a market-based system for setting payment rates. Finally, he will discuss the increasingly challenging coverage hurdles that diagnostics face before they are accessible to physicians to improve the care of patients.
Paul Sheives, JD, Vice President, Reimbursement & Regulatory Policy, American Clinical Laboratory Association
 
11:30 am Panel Discussion: State of Molecular Diagnostic Reimbursement
Moderator: 
Paul Sheives, JD, Vice President, Reimbursement & Regulatory Policy, American Clinical Laboratory Association
Participants: 
Elaine Lyon, Ph.D., Section Chief, Molecular Genetics, Co-Medical Director, ARUP Laboratories, Associate Professor, University of Utah
Jen Madsen, MPH, Health Policy Advisor, Arnold & Porter
Erick Lin, MD, Ph.D., Director of Medical Affairs, Ambry Genetics (formerly Senior Manager, Medical Affairs, Illumina)
 
12:30 pm Luncheon
 
1:30 pm Personalized Medicine in Practice: How Should It Work?
The Coriell Personalized Medicine Collaborative (CPMC) research study, which launched in 2007, partnered with leading national hospitals and the United States Air Force, is helping to accelerate the adoption of precision medicine in the clinic with its 8,000 study participants. Recent CPMC findings include the identification of novel sleep genes, an improved warfarin dosing algorithm, and preventative behavior changes made by participants with a genetic risk for melanoma. In 2013, in order to scale the clinical use of pharmacogenomics (PGx), Coriell launched a commercial entity in partnership with IBM called Coriell Life Sciences. Today, doctors in 25 states are bringing personalized medication management to their patients through Coriell Life’s “GeneDose” PGx testing, a decision support tool helping healthcare providers select the safest possible drugs at the safest possible doses. More than 150 FDA-approved drugs include PGx dosing guidance on the drug label and a 2008 survey by Medco indicated that most physicians are eager to use it, however, few are prepared.
Michael F. Christman, Ph.D., Presidient and Chief Executive Officer, Coriell Institute for Medical Research
 
2:00 pm Making RNA Sequencing Actionable in The Clinic
DNA panels have now successfully been commercialized and are making their way into standard of care in oncology. The panels are effective in predicting response to targeted therapies, however DNA sequencing cannot predict response to chemotherapy or the new immune therapies. RNA sequencing provides a potential solution, however a number of hurdles from paraffin to lack of read debt on the MiSeq platform prevents RNA sequencing from gaining traction as a diagnostic application in oncology. 
Gitte Pedersen, Chief Executive Officer, Genomic Expression
 
2:30 pm Healthy Ventures: A New VC Perspective
Healthy Ventures is a seed stage venture capital firm looking to discover and foster digital health startups. Perhaps not an unusual thing in the fast paced world of venture capital and its intense focus on healthcare, but this fund has a difference - it was started by two women. Anya Schiess and Enmi Kendall started Healthy Ventures after almost 20 years spent in healthcare and consumer technology, respectively, as entrepreneurs, executives, and investors. Frustrated by their inability to find an investment fund that dug deep into the emerging area of seed-stage healthcare technology start-ups, they formed Healthy Ventures. They aim to help startups that have graduated from accelerator programs but find themselves in the “valley of death" once they start looking for investments in the $1 million range. Anya will talk about Health Ventures key areas of interest - genomic services, infrastructure, and ad-tech healthcare – the trends they are seeing in these area and what and how they intend to fill this gap in the investing landscape.
Anya Schiess, MBA, General Partner, Co-Founder, Healthy Ventures
 
3:00 pm Partnering For A Universal NGS-Based Oncology Diagnostic
A case study on how the field of what has traditionally been termed “companion diagnostics” is evolving to multi-analyte tumor profiling to select for the right therapeutic. This session will explore the partnership between Merck Serono and Illumina to create an NGS-based universal cancer test that would be used in and approved for clinical practice alongside Merck Serono’s therapeutics.
Birgit Reitmaier, Ph.D., Head of Technologies & Biomarkers , Global Licensing & Business Development, Merck Serono division, Merck KGaA
Elaine Cheung, Director of Strategic Partnerships, Illumina
 
3:30 pm Refreshment/Networking Break 
 
4:00 pm The MedSeq Project: Integration of Whole Genome Sequencing into Clinical Medicine
Genome sequencing services are currently available to and being utilized by physicians and their patients in both research and clinical settings. However, the widespread availability and use of genome sequencing in the practice of clinical medicine is imminent. In the very near future, sequencing of individual genomes will be inexpensive and ubiquitous, and patients will be looking to the medical establishment for interpretations, insight and advice to improve their health. Developing standards and procedures for the use of sequencing information in clinical medicine is an urgent need with numerous obstacles to integrity and storage of sequencing data, interpretation, and responsible clinical integration. The MedSeq Project seeks to develop a process to integrate genome sequencing into clinical medicine and explore the impact of doing so.
Robert Green, MD, MPH, Director, Genomes2People Research Program, Associate Professor of Medicine, Brigham and Women's Hospital and Harvard Medical School
 
4:30 pm Precision Healthcare Platforms at the Arizona Health Sciences Center
A precision health initiative has been launched at the Arizona Health Sciences Center to advance academic and clinical programs that transform healthcare delivery in Arizona and beyond. A major focus has been the development of strategies to improve personal diagnostics and therapeutics in cancer and cardiopulmonary disorders, and the provision of healthcare to patients with conditions amenable to genome-based medical evaluations. Our clinical programs provide outstanding, state-of-the art patient care, match researchers with a patient base for enrollment in investigational studies and create an infrastructure for clinical trials. A major area of interest is the characterization of repetitive, long interspersed mobile elements as mediators of disease and specialized biomarkers for stratification of patients with pulmonary disease.  
Ken Ramos, MD, Ph.D., PharmB, Associate Vice President for Precision Health Sciences, Professor of Medicine, Arizona Health Sciences Center
 
5:00 pm Health Heritage: A New Personalized and Automated Family Medical History Tool
At a time when an individual’s genetic composition increasingly influences both medical care and prevention choices, the unique and complementary contribution of an accurate and detailed family health history are more important that ever. Unfortunately, they are seldom available. In May 2014, NorthShore University HealthSystem became the first healthcare system in the country to implement Health Heritage, a new online tool that enables individuals to easily obtain and securely share precise personal medical information with family members. This dynamic program links automatically to a person’s current and past electronic medical record. Health Heritage then analyzes very specific selected data and uses the latest scientific research and medical guidelines to provide individualized risk assessment and screening recommendations that help consumers and their physicians develop personalized plans. In 2015 Health Heritage is scheduled to become a key patient-facing gateway technology for NantHealth, a subsidiary of NantWorks, a group of companies founded and led by Dr. Patrick Soon-Shiong. Health Heritage’s capabilities are precisely aligned with NantHealth’s mission to build an integrated, evidence-based, genomically informed, personalized approach to the delivery of care and the development of next generation healthcare solutions.
William Knaus, MD, FACP, Director of Applied Genomics Research Informatics, Director, Health Heritage Family Medical History Project, Center for Biomedical Research Informatics, NorthShore University Research Institute
 
5:30 pm Cocktail Reception
 
DAY TWO – OCTOBER 6TH, 2015
 
7:45 am Continental Breakfast
 
8:15 am Genomics Informs Personalized Cancer Vaccine Design
Genomic alterations in cancer DNA encode novel proteins that have the potential to stimulate the host immunity against cancer cells. Genomics provides a facile way to explore the protein coding genes of an individual genome, and algorithms consider these novel peptides in the context of class 1 HLA to predict which novel peptides are neoantigens. My talk will describe the methods and application of personalized vaccines derived from genomic design and their use in patients with melanoma.
Elaine Mardis, Ph.D., Professor of Genetics and Molecular Microbiology, Co-Director, The Genome Institute at Washington University School of Medicine
 
8:45 am Personalizing Drug Development With the Incorporation of Patient Derived Xenograft (PDx) Models
Champions Oncology, Inc. is engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs. The Champions TumorGraft® (CTG) platform is a novel approach based upon the implantation of primary human tumors in immune-deficient mice followed by propagation of the resulting engraftments, or TumorGrafts, in a manner that preserves the biological characteristics of the original human tumor. In this presentation, Dr. Davies will discuss the advantages and limitations of using this PDX platform for drug development and discuss options for incorporating PDX models into clinical trial schemas.
Angela Davies, MD, FRCP (C), Chief Medical Officer, Champions Oncology
 
9:15 am Individualized Medicine: Next Generation Precision Cancer Medicine and Drug Positioning
This talk will describe an ‘Individualized systems medicine’ (ISM) platform run at the Institute for Molecular Medicine Finland (FIMM), University of Helsinki in collaboration with the Helsinki University Hospital Comprehensive Cancer Centre to optimize therapies for cancer patients. The ISM platform encompasses functional ex vivo drug sensitivity testing of patient cancer cells against over 450 approved and investigational anti-cancer compounds integrated with molecular profiles to uncover biology of disease, mechanism and biomarkers of drug sensitivity and resistance, and personalized therapeutic strategies for leukemia patients. In addition, the ISM strategy is a powerful tool to de-risk and position investigational compounds as well as reposition existing drugs to new indications.
Tea Pemovska, Doctoral Candidate, Lab of Krister Wennerberg, Institute for Molecular Medicine Finland, FIMM, University of Helsinki
 
9:45 am Refreshment/Networking Break 
 
10:15 am Trends, Models and Challenges in Bringing Stratified Medicine to Market and Making it Work - Interactive Perspectives
This interactive, audience participation presentation will explore some of the continued challenges of co-developing targeted therapies and companion diagnostics, including lessons learned, best practices and new discovered pitfalls.
Richard Watts, VP Business Development, Personalized Healthcare, Qiagen
 
11:15 am Balancing Public and Private Intellectual Property Interests in a Post Mayo-Myriad Age: What is Likely to Be Patentable in Diagnostics - and What Should Be Patentable - to Best Serve the Public Interest
There has always been a question as to what things should be eligible for the incentives provided by the patent system. Recent Supreme Court decisions (Myriad, Mayo, and Alice, for example) have intensified and focused this debate in medical diagnostics and software. How to leverage private sector rewards with public benefit is central to this discussion, and public outrage and legal controversy have called for rethinking IP strategies to balance these two interests. There is no clear consensus among PM stakeholders regarding how private sector providers can best serve the public, and their own interests, simultaneously. This panel will discuss recent contractions in available IP protection and how the likely impact on innovations in PM.
David Resnick, J.D., Partner, Nixon Peabody
 
11:45 am Genomic Privacy
With every new exciting development in genomics come the often under-appreciated ethical, legal and social concerns. Particularly with regard to issues of privacy, there are ultimate tradeoffs as the technology continues to develop and the real-life applications of genomics become more of a reality. Numerous technical solutions have been proposed, but every technical safeguard is accompanied by increased complications with analyzing and manipulating datasets. Moreover, technical solutions invite both white-hat and black-hat efforts of circumvention, making them less useful in the long run. Instead we propose a multi-prong approach to dealing with privacy issues in genomics that includes technical, regulatory and social advances that will create an environment that both safeguards privacy, prevents harms associated with a lack of privacy and promotes innovation in the fields of genomics and medicine.
Mark Gerstein, Ph.D., Professor of Biomedical Informatics, Yale University
 
12:15 pm Luncheon
 
1:15 pm Precision Medicine and Policy in The Making
While the expression “precision medicine” is more transparent and realistic as to the achievable goals of “personalized medicine”, achieving its lofty goals still lacks the necessary policy infrastructure. As precision medicine moves from populations, to sub-populations, to patients and back again, systemic ethical and legal issues may outweigh traditional policy frameworks centered as they are on the individual. The Global Alliance for Genomics and Health has adopted a Framework for Responsible Sharing of Genomic and Health-Related Data. It seeks to facilitate international data sharing by creating the principles, policies, and, procedures that will serve to achieve precision medicine. It has already built some of the innovative tools and policy norms that permit the refinements and modulation of the data trajectory. The purpose of this presentation is to elucidate and discuss the underlying rationale for a shift towards not only protection of research participants and patients but also promotion of their interests through more not less data sharing based on a human rights approach.
Bartha Knoppers, Ph.D., Director of the Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University
 
1:40 pm Changing the Privacy Conversation: From Protection to Participation
Privacy with regards to patients' genomic data gathered during clinical trials has long taken a solely protectionist view, based on foundational principles of law and ethics. With the rise of patients' voluntarily providing their data to direct to consumer diagnostic companies and websites like patientslikeme, perhaps it is time that the conversation shifted. The concept of privacy should afford a better balance in promoting research while not simply protecting patients’ data but being more transparent about what the real privacy risks are and letting the patients’ have a role in deciding what level of risk they're willing to accept. 
Laura Lyman Rodriquez, Ph.D., Director, Office of Policy, Communications and Education, National Human Genome Research Institute
 
2:05 Protection to Participation in Action: Engaging Patients for the Use of Their Clinical Remnants in Research
With the rise of precision medicine comes the need for high-quality, data-rich human biospecimens on which to conduct the research. Clinical remnants – leftover after patient care testing is complete – have long been utilized, often with little compliance oversight. While current law dictates that leftover specimens may be de-identified and used for research without patient consent, the precision medicine movement has re-opened the privacy and participation discussion. In this session, Dr. Ianelli will discuss current efforts to protect patients in the case of use of their remnant specimens, as well as where the industry appears to be moving in terms of patient engagement, informed consent, and ultimately, a shift from privacy to participation.
Christopher Ianelli, MD, Ph.D., Chief Executive Officer, iSpecimen
 
2:30 pm PANEL SESSION: Privacy in Precision Medicine
Laura Lyman Rodriquez, Ph.D., Director, Office of Policy, Communications and Education, National Human Genome Research Institute
Bartha Knoppers, Ph.D., Director of the Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University
Christopher Ianelli, MD, Ph.D., Founder and CEO, iSpecimen
 
3:15 pm End of Conference

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