Biomarkers can be multi-faceted and play important roles in disease diagnosis, prognosis, and monitoring; as companion diagnostics, they are important for predicting response to therapy. Possible clinical biomarker applications seem almost infinite, yet there are still significant obstacles for broad adoption in the clinic, including technical, regulatory, and reimbursement challenges.

More at: Personalized Medicine World Conference (PMWC) 2015 Silicon Valley, co-hosted with Stanford Health Care on January 26-28, 2015 http://2015sv.pmwcintl.com/emails/4LinkedIn.html

Featuring Key Opinion Leaders, including:

Ralph Snyderman, MD, Chancellor Emeritus, Duke University Medical Center
Craig Venter, PhD, Founder & CEO, JCVI
Margaret Hamburg, MD, FDA Commissioner
Richard Klausner, CMO & Interim General Manager, Oncology, Illumina
George Church, PhD, Co-developer, Human Genome Project
Dennis Lo, MD, PhD, Director, Li Ka Shing Inst. of HS, Chinese Uni. of HK
Krishna Yeshwant, MD, General Partner, Google Ventures
Ron Davis, Ph.D., Director, Stanford Genome Technology Center
Anne Wojcicki, CEO and Co-Founder, 23andMe
Michael Pellini, MD, President & CEO, Foundation Medicine

ATTENDEES

>35% CEOs, Presidents and Managing Directors
>15% VPs and Directors
>10%Genomics Services
>30%Researchers and Clinical researchers
>8% MDs
>2% Regulators and Payers

Where Attendees Come From?

Academia, Research

Johns Hopkins Uni., Oxford Uni., Duke Uni., Harvard Uni., Weizmann Inst., McGill Uni., Kyoto Uni., Uni. of Florida, Leiden Uni., Uni. of Pittsburgh, Technion, Korea Uni., Michigan Uni.

Pharma and biotech

Gilead Sciences, Merck, Genentech, Janssen, Pfizer, Abbott, Roche, Onyx, Novartis, Metabolon, Amgen, AstraZeneca

Commercial

L’Oreal, Google, Bosch, Hitachi, Sony, Riken Genesis, Samsung, Amazon, HP, Intel, Agilent, Siemens

Genome centers

Genome Quebec, New York Genome Center, Oxford, Wellcome Trust, BGI, Israel National Center for PM, UCSC

Medical centers & Labs

Stanford Health Care, Harvard Medical School, Mayo Clinic, Broad Institute, PAMF, Guro Hospital, CTCA, Sutter Health

Payors & Regulators

FDA, Aetna, Palmetto GBA, Mubadala Healthcare, Intermountain Health, Tidewater Physicians Multispecialty Group

Commercial and DTC diagnostic

CareDx, AltheaDx, 23andMe, Ancestry, Counsyl, Natera, Quest Labs, LabCorp, Genotox, Clontech, CRL

Life Science tools and reagents companies

Illumina, WaferGenBiosystems, DNAnexus, ThermoFisher, Applied Microarrays,Trovagene, Affymetrix, Qiagen, Complete Genomics

Licensing and Financial

KP Ventures, Warburg Pincus, McDermott Will & Emery, Mitsui Global Investment, GE Ventures, KPCB, Telegraph Hill Partners, Domain Associates, Google Ventures, Aberdare Ventures

Overall Themes and Scope of PMWC2015 – January 26-28, 2015

Personalized Medicine World Conference 2015 (PMWC2015) is the 7^th annual gathering of key opinion leaders and all stakeholders who constitute the personalized medicine field—researchers, industry participants, clinicians, regulators, payors, and emerging companies in this space, making it “a must attend event”. Highlights range from research-related topics such as Next Gen Sequencing (NGS) and its clinical utilization and prenatal Diagnostics to regulatory and commercially focused presentations. This conference brings together all the key decision-makes in personalized medicine for three days of intensive scientific exchange, partnering activities as well as networking opportunities. PMWC2015 will highlight the following topics:

Research/Technical Perspective

Prenatal Diagnostics
Streamlining of Clinical Trials Through Personalized Medicine
Translational Next-Generation Sequencing (NGS) and Genomic Profiling

Regulatory and Commercial Perspectives

Clinical Decision Support and the Role of Personalized Medicine in Stratification
Coverage and Reimbursement in the Era of Personalized Medicine
Ethical and Legal Framework of Personalized Medicine
Developing a Robust Regulatory Strategy for Personalized Medicine

The Research Arm of Personalized Medicine

The strong interest in prenatal and newborn diagnostics is being addressed in an opening lecture by Dennis Lo, Li Ka Shing Institute, followed by presentations by companies that operate in this space. Another key topic area well addressed at PMWC2015 is the deployment of NGS addressed by practitioners such as Illumina, Thermo Scientific and Trovagene, that offer tools and technologies allowing the deployment of NGS into clinical practice. Content-focused companies such as Foundation Medicine frame the opportunity for cancer care through NGS. Genomic profiling in routine clinical care enabled by companion diagnostics is discussed by Amgen’s Scott Patterson, along with speakers from Abbott and Thermo. PMWC brings to light the emerging themes in the migration of NGS toward the clinic. The adoption of Personalized Medicine is being driven by the pervasiveness of NGS. It is estimated that 50% of academic oncologists currently refer their patient samples for NGS-based genomics testing—of course this is only a small fraction of the total patient population since a vast majority of cancer patients receive care in community hospitals without access to NGS and other molecular medicine tools. Frank Ong, Associate Director of Medical Affairs at Illumina, chairs a session focusing on the impact of NGS in clinical care beyond cancer as it is gaining traction in many other therapeutic areas. Indeed, NGS is bigger and far-reaching beyond merely oncology. In the cardiovascular area the discovery and development of biomarkers for more precise diagnosis and treatment is the focus of a session chaired by Gil Omenn, from the University of Michigan. The streamlining of clinical trials through the utilization of personalized medicine to stratify and target responder patient populations is addressed at PMWC, highlighting the advantage of cost-effectiveness to pharmaceutical companies and clinical value to patients and payers.

Regulatory and Reimbursement Trends in Personalized Medicine

PMWC2015 offers a forum for the US FDA Commissioner, Margaret Hamburg to comment on evolving FDA regulation on laboratory developed tests (LDTs) – key area of change in this industry and of paramount importance to personalized medicine. George Lundberg from CollabRx chairs an important session on ethics and public law in personalized medicine—an area gaining interest as personalized medicine begins to permeates all aspects of the practice of medicine. Without reimbursement personalized medicine will not prevail. Palmetto GBA will give an update on the evolving reimbursement trends in personalized medicine. The regulatory and commercial framework of personalized medicine is absolutely critical to its deployment and acceptance industry-wide, and PMWC brings together the FDA and legal experts such as Hank Greely from Stanford to comment on the ethical and legal framework surrounding patient privacy and confidentiality, as well as moral perspectives of personalized medicine.