Events

6th Annual Diagnostics Summit

Thermo Fisher Scientific

DX2FinalFINALThe diagnostics industry is changing rapidly, fueled by basic scientific advances in genomics and molecular genetics, along with technological innovations in areas like gene sequencing. It’s clear that policy and regulation have not kept pace with this fast-moving field. To build a better understanding of the complex environment facing diagnostics innovators, CHI organizes this annual summit to bring together industry executives, policymakers, regulators, as well as policy experts to discuss topics such as coverage and payment, regulation of laboratory-developed tests and regulatory approaches to sequencing.

Location:Thermo Fisher Scientific 180 Oyster Point Boulevard South San Francisco, California 94080

Date & Time: September 23, 2014 Summit: 9 a.m. – 5 p.m.* PST Reception: 5 – 6 p.m. PST

* There will be a private, invitation-only session from 9 a.m. – 11 a.m. The general public is invited to register for the summit commencing at 11 a.m.

Speakers

Private Diagnostics Working Group meeting
FDA regulatory briefing by Lakshman Ramamurthy, Director of FDA Strategy and Regulatory Policy, Avalere

Welcome and Opening Remarks
Ronnie Andrews, President of Medical Sciences, Thermo Fisher Scientific

Regulatory Approaches to Diagnostics Innovation
Eric Zimmerman, Partner, McDermott Will & Emery (moderator)
Lakshman Ramamurthy, Director of FDA Strategy and Regulatory Policy, Avalere
Ronnie Andrews, President of Medical Sciences, Thermo Fisher Scientific

21st Century Cures Initiative
Eric Zimmerman, Partner, McDermott Will & Emery

Driving Toward Value: Ensuring Access to Innovation in New Payment Models
Bruce Quinn, M.D., Ph.D., Senior Health Policy Advisor, Foley Hoag LLP
Danielle Scelfo, Senior Director of Government Affairs & Public Policy, Genomic Health

Keynote: Public Investment in Early-Stage Diagnostics Research
Wendy Rubinstein M.D., Ph.D, Director, NIH Genetic Testing Registry

Gene Sequencing: Early Signals for Clinical Relevance
James Ford, Director, Stanford University Clinical Cancer Genetics Program
Phil Febbo, M.D., Chief Medical Officer, Genomic Health

Patient Perspective
Laurie Levin, breast cancer survivor

Speakers

Regulatory Approaches to Diagnostics Innovation

EZEric Zimmerman
Partner, McDermott Will & Emery
Eric Zimmerman is a partner in the law firm of McDermott Will & Emery LLP based in the Firm’s Washington, D.C. office.  Eric also serves as a principal of McDermott+Consulting LLC.  Eric is a recognized Medicare law and policy authority and registered lobbyist who represents clients before Congress and administrative agencies, and helps clients navigate federal legislative and regulatory processes related to Medicare coverage, coding, reimbursement and compliance.  Eric primarily counsels and represents hospitals and health systems, ambulatory surgery centers, clinical laboratories, pharmaceutical, biotechnology and device manufacturers and suppliers, medical trade associations and professional societies.

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Lakshman Ramamurthy, Ph.D
Director of FDA Strategy and Regulatory Policy, Avalere
Lakshman Ramamurthy, Director of FDA Strategy and Regulatory Policy, advises clients on medical device regulation and how to incorporate FDA regulatory strategy in business planning. He also aids clients on product life cycle management and evidence planning, including how best to leverage evidence generation for regulatory and reimbursement approval. Lakshman has a PhD in Molecular Biology from the University of North Carolina at Chapel Hill. He is a member of FDA’s strategic team guiding the Entrepreneurs in Residence program at FDA CDRH, and a member of the Clinical Lab Standards Institute. Lakshman serves as faculty at the NCCN (National Comprehensive Cancer Network) Academy of Excellence and Leadership in Oncology.

AndrewsRonnie Andrews
President of Medical Sciences, Thermo Fisher Scientific

Mr. Ronald A. Andrews, Jr., also known as Ronnie, has been the President of Genetic & Medical Sciences Organization at Life Technologies Corporation since June 26, 2013. Mr. Andrews also oversees Ion Torrent business. He has more than 25 years of experience in the diagnostics industry. He served as the President of Medical Sciences at Life Technologies Corporation from February 2, 2012 to June 26, 2013. Mr. Andrews served as the Chief Executive Officer of Clarient Inc. (formerly Chromavision Medical Systems Inc.) since July 22, 2004. He served as Chief Executive Officer of GE Molecular Diagnostics. Mr. Andrews served as the President of Clarient Inc. from July 22, 2004 to April 2008. From August 2002, he served as Senior Vice President Global Marketing and Commercial Business Development at Pleasanton, CA-based Roche Molecular Diagnostics, where he developed and led the strategic execution for all diagnostic commercial operations.

Driving Toward Value: Ensuring Access to Innovation in New Payment Models

QuinnBruce Quinn M.D. Ph.D, Senior Health Policy Specialist
Foley Hoag LLP

Bruce Quinn, MD PhD, is a national expert on Medicare policy, the impact of health reform on innovation, and the crafting of successful business strategies within the US healthcare reimbursement system.  Dr. Quinn has worked successfully with both large and small companies in overcoming hurdles to commercialization through negotiation, understanding insightful ways to use the existing system to advantage, and the mechanisms of policy change.

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Danielle Scelfo
Senior Director of Government Affairs & Public Policy,Genomic Health

Danielle Scelfo is Senior Director, Government Affairs and Public Policy for Genomic Health Incorporated and is based out of Genomic Health’s company headquarters in Redwood City and her San Diego office. Ms. Scelfo is the current co-chair of the Diagnostics Workgroup for the California Healthcare Institute, former founder and co-chair of the Coalition for 21st Century Medicine’s Reimbursement and Policy Workgroup and contributes to molecular diagnostic workgroups with American Clinical Lab Association (ACLA), Personalized Medicine Coalition (PMC), California Healthcare Institute (CHI), California Clinical Lab Association (CCLA) and BayBio. She has also been an active participant in the AMA’s Molecular Diagnostic Workgroup, Tier 1 and the Multiple Analyte Assay with Algorithms sub teams and serves on the editorial faculty for the journal Personalized Medicine in Oncology.

Public Investment in Early-Stage Diagnostics Research

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Wendy Rubinstein M.D., Ph.D.
Director, NIH Genetic Testing Registry 

Wendy Rubinstein, M.D., Ph.D., FACP, FACMG, is a Senior Scientist at the NIH and Director of the NIH Genetic Testing Registry in the National Center for Biotechnology Information. Dr. Rubinstein earned her Ph.D. in Biomedical Sciences from the City University of New York and her M.D. from Mount Sinai School of Medicine. She was a Clinical Associate Professor at the University of Chicago Pritzker School of Medicine and Chief of the Division of Genetics at NorthShore University HealthSystem. Recently named a Top Doctor by U.S. News, her clinical and research expertise is on hereditary cancer syndromes, computerized family history, and quantitative genetic risk assessment.

Gene Sequencing: Early Signals for Clinical Relevance

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James Ford, M.D.
Director, Stanford University Clinical Cancer Genetics Program

Dr. Ford is a medical oncologist and geneticist at Stanford, devoted to studying the genetic basis of breast and GI cancer development, treatment and prevention. Dr. Ford graduated in 1984 Magna Cum Laude (Biology) from Yale University where he later received his M.D. degree from the School of Medicine in 1989. He was a internal medicine resident (1989-91), Clinical Fellow in Medical Oncology (1991-94), Research Fellow of Biological Sciences (1993-97) at Stanford, and joined the faculty in 1998. He is currently Associate Professor of Medicine (Oncology) and Genetics, and Director of the Stanford Cancer Genetics Clinic, at the Stanford University Medical Center.

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Phil Febbo, M.D.
Chief Medical Officer, Genomic Health

After 20 years as a physician scientist at leading Institutes throughout the country, Phil Febbo, joined Genomic Health as Chief Medical Officer in 2013. Immediately prior to Genomic Health, Phil served as Professor of Medicine and Urology at the University of California, San Francisco where his laboratory focused on using genomics to understand the biology and clinical behavior of prostate cancer and his clinical practice focused on genitourinary oncology.

Patient Perspective 

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Laurie Levin
Cancer Survivor and Patient Advocate 

Laurie Levin holds graduate degrees in Anthropology from Harvard University and the University of California, Los Angeles. She has published two commercial non-fiction books as well as several corporate histories of some of the country’s most prestigious healthcare institutions. More than three decades following her successful treatment for lymphoma, she was diagnosed with breast cancer in 2005. Genomic testing made it possible for her to personalize her treatment and forgo chemotherapy. Twice a cancer survivor, she has traveled throughout the United States as a health ambassador, promoting breast cancer treatment awareness and offering peer-to-peer coaching through personal appearances, talk radio shows, print interviews and digital media, including blogs, webinars, and webcasts. For more biographical information: www.laurielevin.net

 

Agenda

9:00-11:00 a.m. 

Private Diagnostics Working Group meeting (invitation only)

FDA regulatory briefing by Lakshman Ramamurthy, Director of FDA Strategy and Regulatory Policy, Avalere

11:00 a.m.-Noon

Buffet Luncheon

12:00-12:10 p.m.   

Welcome and Opening Remarks

  • Ronnie Andrews, President of Medical Sciences, Thermo Fisher Scientific

12:10-1:10 p.m.

Regulatory Approaches to Diagnostics Innovation

  • Eric Zimmerman, Partner, McDermott Will & Emery (moderator)
  • Lakshman Ramamurthy, Director of FDA Strategy and Regulatory Policy, Avalere
  • Ronnie Andrews, President of Medical Sciences, Thermo Fisher Scientific

1:10-1:30 p.m.

Keynote: 21st Century Cures Initiative

  • Eric Zimmerman, Partner, McDermott Will & Emery

1:30-2:30 p.m.

Driving Toward Value: Ensuring Access to Innovation in New Payment Models

  • Bruce Quinn, M.D., Ph.D., Senior Health Policy Advisor, Foley Hoag LLP
  • Danielle Scelfo, Senior Director of Government Affairs & Public Policy, Genomic Health

2:30-3:00 p.m.

Afternoon Networking Break

3:00-3:30 p.m.

Keynote: Public Investment in Early-Stage Diagnostics Research

  • Wendy Rubinstein M.D., Ph.D, Director, NIH Genetic Testing Registry

3:30-4:30 p.m.

Gene Sequencing: Early Signals for Clinical Relevance

  • James Ford, Director, Stanford University Clinical Cancer Genetics Program
  • Phil Febbo, M.D., Chief Medical Officer, Genomic Health

4:30-5:00 p.m.

Patient Perspective

  • Laurie Levin, breast cancer survivor

5:00-6:00 p.m.

Closing Reception

Register Today! CHI Members: $59.00 Non-CHI Member: $129.00

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