Short Courses*

*Separate registration required. Short courses are complimentary and are available for in-person attendees (or delegates) only. However, registration is still required.

Tuesday, August 24, 2021   4:05 - 5:35 PM |

SHORT COURSE 1: Reimbursement Challenges and Pathways Forward Under PAMA

Detailed Agenda
This course will describe the reimbursement landscape under PAMA, including how it has shifted during the course of the COVID-19 Public Health Emergency and the challenges expected for 2022 and beyond. Understanding this complex legislation is critical in ensuring that patients have widespread access to diagnostic testing. We will provide a background of this legislation and its genesis, review current timelines and processes, explain which labs are required to report and how often, and examine how new laboratory tests are priced under Medicare.

Paul Gerrard, MD, Vice President, McDermott+ Consulting

Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

Nicholas Halzack, Senior Manager, Federal Health Policy & Reimbursement, Roche Diagnostics

Chandra N. Branham, JD, Vice President, Payment & Health Care Delivery Policy, AdvaMed

Tara Burke, PhD, Senior Director, Public Policy & Advocacy, Association for Molecular Pathology

INSTRUCTOR BIOGRAPHIES:

Paul Gerrard, MD, Vice President, McDermott+ Consulting

Paul is a highly regarded physician and healthcare executive with deep experience in both the academic and patient care spaces. He offers clients critical insights across a wide range of clinical areas and healthcare technologies, and provides guidance on Medicare policy and regulatory requirements. Paul also has significant experience in health outcomes research and scientific computing. Before joining McDermottPlus, Paul had a varied career spanning academia, private practice, and Medicare policy. After leaving academia, he established and ran his own medical practice serving patients in addition to advising large institutions on utilization management and quality improvement before becoming a chief medical officer at Palmetto GBA and MolDX director of clinical science leading coverage and payment determinations for new molecular medicine technologies. In this role, he was instrumental in forging consensus among Medicare contractors on emerging and sometimes controversial areas of medicine in a highly visible program, and served as a primary point of contact between MolDX and the Centers for Medicare & Medicaid Services. Paul now works for McDermott+ Consulting assisting manufacturers and health care providers in bringing innovative patient care products to market.

Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

Ester Stein is Director of Corporate Reimbursement and reports into Abbott’s Government Affairs’ office which is based in Washington DC. Ester has been employed at Abbott since 2003. Ester is highly knowledgeable in diagnostic reimbursement strategies for traditional diagnostics, molecular and point of care. In her capacity, she has spearheaded efforts to ensure that there is appropriate coverage, coding and payment by public and private insurers for Abbott products in the United States. Ester has also been involved in healthcare economics in the area of oncology, specifically breast and bladder cancer. She Chaired AdvaMed’s Payment Work Group and serves on the AMP Economic Affairs Committee. Ester earned her M.B.A. from Loyola University of Chicago.

Nicholas Halzack, Senior Manager, Federal Health Policy & Reimbursement, Roche Diagnostics

Nick is the Senior Manager of Federal Health Policy & Reimbursement at Roche Diagnostics Corporation. He believes that diagnostics are one of the most crucial elements to improving public health, and that broad access to new diagnostic technologies is based on a solid foundation of reimbursement and access policies. Prior to Roche, Nick worked on federal health policy at the American Society of Anesthesiologists and Nemours Children's Health System. He holds a M.P.H. in Health Policy from The George Washington University and a B.S. in Biological Sciences from Cornell University.

Chandra N. Branham, JD, Vice President, Payment & Health Care Delivery Policy, AdvaMed

Chandra N. Branham, JD, Vice President, Payment & Health Care Delivery Policy The Advanced Medical Technology Association (AdvaMed) Chandra Branham, J.D., joined the Advanced Medical Technology Association (AdvaMed) as Vice President, Payment and Health Care Delivery Policy, in 2011. Ms. Branham leads AdvaMed’s policy work in a number of areas, including diagnostics payment, coverage issues, value of medical technology and comparative effectiveness. Prior to joining AdvaMed, Ms. Branham was an associate at large D.C. law firm where she focused on healthcare regulatory and legislative issues involving Medicare coverage, coding, reimbursement and quality for providers and suppliers of Medicare items and services. Ms. Branham previously was a senior legislative analyst at the Centers for Medicare & Medicaid Services (CMS) Office of Legislation; and early in her career, served as associate director of regulatory affairs at the National Association for Home Care. Ms. Branham has a Bachelor of Science from Drexel University and a J.D. from the George Mason University School of Law.

Tara Burke, PhD, Senior Director, Public Policy & Advocacy, Association for Molecular Pathology

Tara Burke, PhD joined the Association for Molecular Pathology (AMP) staff in 2014 and currently serves as AMP’s Senior Director of Public Policy & Advocacy. Her areas of expertise focus on the regulatory and reimbursement issues affecting molecular pathology. She has a PhD in Biochemistry and Molecular Genetics from The University of Virginia, and completed a postdoctoral fellowship at the NIH. Her training and research in molecular genetics showed her the hope and promise that genetics can bring to improving human health, and she is proud to be able to work towards the realization of this goal.

Wednesday, August 25, 2021   5:30 - 7:00 PM |

SHORT COURSE 2: Navigating the EUA Process for Diagnostics

Detailed Agenda
This course will cover:
• Access to samples
• Real world data
• CLIA status for POCT
• Lessons learned and transition period after Pandemic
• Serological testing
• Importance of reliance on international regulatory oversight
• Need for transparency, metrics and predictability
• What is the impact on everything else and how the agency will deal with the back-log

Jamie Wolzson, JD, Associate Vice President, Technology & Regulatory Affairs, AdvaMed

Melina Cimler, PhD, CEO & Founder, PandiaDx LLC

Alberto Gutierrez, PhD, Partner, NDA Partners LLC

Navigating the EUA Process for Diagnostics: Practical Advice, Education and POCT

Co-organized with AdvaMedDx

Jamie Wolzson, JD, Associate Vice President, Technology & Regulatory Affairs, AdvaMed

  • Access to samples
  • Real world data
  • CLIA status for POCT
  • Serological testing
  • Lessons learned and transition period after Pandemic
  • Importance of reliance on international regulatory oversight 
  • Need for transparency, metrics and predictability 
  • Assessing the impact on everything else and how the agency will deal with the back-log​

Talk Title to be Announced

Melina Cimler, PhD, CEO & Founder, PandiaDx LLC

Talk Title to be Announced

Alberto Gutierrez, PhD, Partner, NDA Partners LLC

INSTRUCTOR BIOGRAPHIES:

Jamie Wolzson, JD, Associate Vice President, Technology & Regulatory Affairs, AdvaMed

Jamie Wolszon is Associate Vice President, Technology & Regulatory Affairs at the Advanced Medical Technology Association (AdvaMed). Prior to AdvaMed, she worked for several years, first as Associate and later as Of Counsel, at Hyman, Phelps & McNamara, P.C., where she advised diagnostic companies on FDA regulatory matters. She also worked at Heller, Ehrman, While & McAuliffe. While at law school, she had multiple internships at government agencies, including the office of former U.S. Federal Communications Commission (FCC) Commissioner Michael Copps, the Federal Emergency Management Agency, Office of Chief Counsel and HHS Office of General Counsel, Public Health Division. She received her J.D. from Catholic University, Columbus School of Law, and her B.A. from Grinnell College. She is licensed to practice law in Maryland and the District of Columbia.

Melina Cimler, PhD, CEO & Founder, PandiaDx LLC

Melina Cimler is the CEO and Founder of PandiaDx LLC. She has over 30 years of experience in the life science and regulated diagnostic industry leading regulatory, quality systems, clinical affairs, research, and product development organizations with a focus on precision medicine. Dr. Cimler served as Senior Vice President of Regulatory & Quality at Adaptive Biotechnologies until April 2018. In her role, she developed the regulatory strategy for NGS-based immunosequencing products and led regulatory interactions with pharma partners to allow use of NGS-based minimal residual disease tests in oncology drug trials and submissions. She was previously Head of Global Quality and Vice President of Quality, Regulatory, Clinical and Government Affairs at Illumina Inc. She defined and executed on the regulatory strategy resulting in the first next generation sequencing platform (Illumina’s MiSeqDx) receiving FDA marketing authorization. She serves on the Board of Directors of Nanostics, Inc., and as a member of the Scientific Advisory Board of Athira Pharma. She also currently serves as an Expert Consultant at NDA Partners. Previously, she held leadership positions in quality, regulatory and government affairs as Senior Vice President at Beckman Coulter Inc (now Danaher). She also served in senior quality, clinical and regulatory roles at Abbott Molecular, Gen-Probe Inc. (now Hologic), C.R. Bard, and Epitope, Inc. (now OraSure Technologies). Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.

Alberto Gutierrez, PhD, Partner, NDA Partners LLC

Alberto Gutierrez, Ph.D., is a partner with NDA Partners, a FDA regulatory consultant firm. Dr. Gutierrez retired from the FDA in 2017, after 25 years of working in research and regulation. Dr. Gutierrez was the director of FDA’s Office of In Vitro Diagnostics and Radiological Health for 8 years, responsible for the pre-market review and post-market regulation of in vitro diagnostics and radiology devices, as well as responsible for FDA’s regulation of radiation emitting products and regulation of mammography facilities in the US. Dr. Gutierrez received a bachelor’s degree from Haverford College, and master and doctorate degrees in Chemistry from Princeton University. Dr. Gutierrez research experience is in structural organic and organometallic chemistry. Dr. Gutierrez joined the FDA in 1992 as researcher and reviewer in FDA’s Center for Biologics Evaluation and Research working on vaccine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he joined the Office of In Vitro Diagnostic Device Evaluation and Safety as a scientific reviewer, joining management in 2003. Dr. Gutierrez moved up the management chain finally reaching Executive Service level as Director of the Office of In Vitro Diagnostics in 2009. Between 2009 and 2017 the Office grew and acquired the responsibility for regulating Radiological Health devices and products and the oversight of the mammography program. By 2017, the Office had more than 300 employees. Dr. Gutierrez retired from the FDA in September 2017 joined NDA Partners LLC as an expert consultant, becoming a Partner in May 2018.