FDA regulation of LDTs : Evolution or Disruption?


“On July 31, 2014 the FDA notified Congress of the Agency’s intent to issue a draft oversight framework for LDTs based on risk to patients rather than whether they were made by a conventional manufacturer or a single laboratory.”

In this context, Tecan and Vermillion have jointly organized a symposium, held on Monday August 1.

“FDA regulation of LDTs : Evolution or Disruption?”

The speakers have shared their view on LDT versus FDA approved tests. Key questions such as patient safety, innovation, economical aspects (reimbursement and development costs of test) as well as regulatory acceptance have been discussed in an open discussion format, with audience Q&A as well.

All the content is available here below

 

Speaker profiles and topics

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Alan Mertz, President ACLA (American Clinical Laboratory Association)

Alan Mertz became the President of ACLA in 2003. During his tenure as President, ACLA’s membership has grown, the organization has greater visibility in Congress and the Administration, and ACLA’s advocacy programs have been successful.

During Mr. Mertz’s tenure, ACLA has become a leader on advocacy issues dealing with laboratory reimbursement, regulation and coding. Most recently, ACLA led the industry in working with Congress on alternatives to across the board cuts and other reductions to the Medicare Clinical Laboratory Fee Schedule (CLFS). In April 2014, Congress passed The Protecting Access to Medicare Act which incorporated some of the key provisions advocated by ACLA.

In recent years, ACLA was instrumental in stopping legislation that would have instituted coinsurance for laboratory services in Medicare, in repealing the Medicare Competitive Bidding Demonstration program, and heading off a proposal for imposing a new federal tax on all laboratory revenue. In 2013, ACLA led a successful advocacy campaign in opposition to a CMS proposal that would have cut Medicare payments for common anatomic pathology services by as much as 80%.

ACLA is recognized as being in the forefront of advocacy efforts to ensure that regulatory changes do not stifle innovation in genetic and molecular testing. ACLA has also been a leader on molecular coding and reimbursement issues.

In 2007, ACLA launched the “Results for Life” educational campaign aimed at promoting the value of laboratory services. In 2009, ACLA started its Associate Member program for non-laboratory health care companies and organizations as a means of broadening education and communication with the laboratory industry’s health partners.

From 1998-2003, Mertz was Executive Vice President of the Healthcare Leadership Council (HLC) and served as Acting President at HLC for one year. From 1980 to 1998, he served in three senior staff positions in the House and Senate, and was selected as a John C. Stennis Congressional Fellow in 1996. Mertz was an adjunct professor at George Washington University from 1997-1999. He holds a Masters Degree in American Politics from American University and a BA in Government from Monmouth College (IL).

James H. Nichols, Chair, AACC Gov't Affairs comm.

James H. Nichols, Ph.D., DABCC, FACB is a Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry and Point-of-Care Testing at Vanderbilt University School of Medicine.

Dr. Nichols received his B.A. in General Biology/Premedicine from Revelle College, University of California at San Diego.

He went on to complete a Masters and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign.

Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN.

He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry.

Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions.

Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine.

Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.
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Randy Prebula, Hogan and Lovells

Whether describing complex science in straightforward terms to lawyers or translating premarket and compliance regulatory requirements to scientists, Randy Prebula focuses practical experience and a deep understanding of FDA regulations to help clients navigate the intersections of science, policy, and law.

Victoria Pratt, Director of the Pharmacogenomics Laboratory at Indiana University School of Med

Victoria M. Pratt, Ph.D., FACMG, Associate Professor, Director of Pharmacogenetics Laboratory, Indiana University School of Medicine

Dr. Pratt is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics. She is the Director of the Pharmacogenomics Laboratory at Indiana University School of Medicine. Prior to joining Indiana University, she was Chief Director, Molecular Genetics, for Quest Diagnostics Nichols Institute.

In addition to her work, Dr. Pratt is currently serving on the Centers for Medicare and Medicaid Services Clinical Diagnostic Laboratory Tests Advisory Panel. Dr. Pratt continues to serve on the CDC’s GeT-RM program for reference materials for Molecular Genetics. She is currently serving on the Institute of Medicine/National Academy of Medicine’s Roundtable on Translating Genomic-Based Research for Health. She also served on the U.S. Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society for the Oversight of Genetic Testing and the Advisory Committee on Hereditary Disorders in Newborns and Children. She also participated in the preparation of the Morbidity and Mortality Weekly Report for Best Practices in Molecular Genetic Testing for the Centers for Disease Control and Prevention (CDC) and the Institute of Medicine/National Academy of Medicine’s Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies.

Dr. Pratt is Past Chair of the Clinical Practice Committee and is currently a member of the Professional Relations committee, and is the chair of the Program committee for the Association of Molecular Pathology. She is a former advisor of EurogenTest for genetic test validation. Dr. Pratt serves on the American Medical Association’s (AMA’s) Molecular Pathology Current Procedural Terminology (CPT) Advisory committee.

Dr. Pratt has authored over 50 peer-reviewed manuscripts and book chapters. She is also an Associate Editor for the Journal of Molecular Pathology.

Dr. Pratt graduated with a Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine, Indianapolis, IN in 1994. Her fellowship training was in Ph.D. Medical and Clinical Molecular Genetics at Henry Ford Hospital, Detroit MI. icine

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Luann Ochs, Senior Project Manager at CLSI (Clinical and Laboratory Standards Institute)

Luann Ochs is Senior Project Manager for the Clinical and Laboratory Standards Institute since October 2015, having previously been CLSI’s Senior Vice President of Operations.

With over 35 years in the in vitro diagnostics industry, Ms. Ochs previously worked at BD Diagnostics Women’s Health and Cancer, where she was the Vice President for Regulatory Affairs, Clinical Operations, and Quality Management; Roche Diagnostics, Boehringer Mannheim Corporation; and American Monitor Corporation, having held positions in Regulatory Affairs, Research & Development, and Quality.

She previously served on the American National Standards Institute’s (ANSI) Board of Directors. She previously held volunteer positions with AdvaMed, the Center for Disease Control and Prevention's Clinical Laboratory Improvement Advisory Committee (CLIAC), the International Standards Organization (ISO), and the Clinical and Laboratory Standards Institute (CLSI), including serving on CLSI's Board of Directors, and receiving their highest volunteer honor, the Russell J. Eilers Memorial Award.

Ms. Ochs holds a Master's Degree in Chemical Pathology from the Indiana University School of Medicine.

Andrew Fish, Executive Director of AdvaMedDx

Andrew Fish is Executive Director of AdvaMedDx, the U.S. trade association representing leading manufacturers of medical diagnostic tests. AdvaMedDx operates as a division of AdvaMed, the medical device manufacturers association, where Mr. Fish holds the title of Senior Executive Vice President. Mr. Fish has extensive government relations, legal, regulatory, and policy background in food, drug, health, and agriculture issues. Prior to joining AdvaMedDx in 2010, Mr. Fish was Senior Vice President of Legal and Government Affairs, General Counsel, and Secretary for the Consumer Healthcare Products Association (CHPA), representing manufacturers of non-prescription medicines.

Mr. Fish also worked for the American Cancer Society as Senior Director of Federal Government Relations. Earlier in his career, he served in the Senate-confirmed post of Assistant Secretary of Agriculture for Congressional and Intergovernmental Affairs, after twice working for the U.S. Senate Agriculture Committee, first as a professional staff member and later as deputy chief counsel. Mr. Fish’s work in private practice focused on biotech regulation, as well as on a wide range of food, drug and agriculture issues.

Mr. Fish is a graduate of Yale University and Stanford Law School.

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Moderator

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Bob Schroder, Vice President for Global Business Development of Vermillion

Bob Schroder is Vermillion’s Vice President for Global Business Development. He has over 25 years of leadership and industry experience and most recently worked as an independent laboratory consultant.

Previous to that Bob served as Senior Vice President for Strategy & Implementation at Sonic Healthcare USA (SHUSA). In that position Bob’s responsibilities included government public policy and serving as SHUSA’s ACLA representative in Washington, D.C. While at SHUSA other positions held by Bob were General Manager of the Mid-Atlantic Division and Mid-Atlantic’s Vice President for Sales & Marketing.

Before SHUSA Bob served in a variety of positions at CBLPath, including Vice President for Strategic Initiatives and later Chief of Staff. Prior to entering the civilian workforce, Bob served as an active duty officer and helicopter pilot in the U.S. Army, rising to the rank of Captain and serving in a variety of positions, including a helicopter company commander in the 101st Airborne Division.

He is a graduate of the Army’s Flight, Airborne, Air Assault and Jungle Warfare Schools. Bob holds an Executive MBA degree from George Mason University and a Bachelor of Science degree with a major in Diplomatic and Strategic History from the United States Military Academy at West Point.


 

Please note: In order to ensure adequate opportunities for networking and in-depth discussion, attendance is limited. As such, attendance at the Tecan symposium is by invitation only. Tecan does not charge any registration fees for attending the symposium

 

To learn more about Tecan partnering expertise in OEM development visit our website.