Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health from Johns Hopkins University. After seven years in the medical device practice at Hogan Lovells, she joined Amgen as a Senior Counsel for Health Regulatory. For four years, she counseled Amgen on drug, device, combination product, digital health, and companion diagnostic matters. Currently, she is a Director in Amgen’s Global Regulatory and R&D Policy group, where she is the Global Policy Lead for Oncology and Medical Device-related matters.

Susan has worked in both the in vivo and in vitro diagnostic industries holding executive management positions in regulatory, clinical, and quality for IVD, medical device, and biologic products. She has been with Hogan Lovells for the last 22 years, assisting clients with FDA strategies and obtaining marketing clearances and approvals for diagnostic tests and other medical devices, working with companies throughout the life cycle of product development. She has deep insight into the FDA’s biologics and medical device regulation of in vitro diagnostics assays and related instruments, accessories, laboratory developed tests, and drug companion diagnostics as well as CLIA waiver applications and has been involved with many COVID-19 EUAs.

Maria Orr is currently Head of Precision Medicine for Biopharmaceuticals in AstraZeneca. In this role she leads the delivery of precision medicines and their associated companion diagnostics for drugs across a diverse range of therapeutic areas including cardiovascular, renal, metabolism (CVRM), respiratory and immunology (R&I), microbial science and neuroscience. Maria has extensive experience in the field of precision medicine and companion diagnostic development. She has contributed to the successful launch of three personalised treatments in oncology and the delivery of over 30 companion diagnostic assays to the market to date.

Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments in the fastest and safest way possible. Mark leads the development and implementation of the organization's research and policy agenda as well as overseeing the conduct of research projects to inform ongoing policy discussions. He regularly participates in policy discussions and meetings throughout the year to help catalyze meaningful change for oncology healthcare and patients.

Lakshman Ramamurthy PhD manages a team responsible for diagnostic and digital regulatory strategy working closely with clinical development teams in GSK and diagnostic partners externally. Previously he was Global Regulatory Lead at Foundation Medicine Inc prior to which he worked for over five years at the US FDA’s Center for Devices and Radiological Health (Office of In Vitro Diagnostics) as Senior Reviewer, Associate Director and later as Policy Advisor to the Commissioner of US FDA. He led the FDA-CMS Parallel Review pilot project in CDRH. He has a PhD in Molecular Biology from the University of North Carolina and has co-authored over 20 publications speaking at international conferences on regulation of diagnostics and devices.

Donna Roscoe is the Deputy Director for the Molecular Genetics Branch in the Division of Molecular Genetics and Pathology in FDA’s Office of In Vitro Diagnostic Device Evaluation and Radiological Safety having previously served as Chief of the Molecular Genetics Branch in the Division which is responsible for reviewing IVDs principally in the area of oncology, companion diagnostics and hereditary genetics. Prior to coming to the FDA, Dr. Roscoe worked for various CROs and the National Center for Biotechnology Information (NCBI) after completing a post-doctoral fellow in the clinical cancer research Laboratory of Molecular Biology at the National Cancer Institute (NCI) at NIH.

Dr. Granville provides insight, guidance, and a collaborative approach to build DIA’s thought leadership, research and content strategy to support innovation and building efficiency in drug, device and diagnostics development. She brings 2 decades of regulatory science-related research experience to her role at DIA. Her research career focused on developing data to support regulatory decision making in the fields of tobacco regulatory science, preclinical and molecular toxicology, nonclinical drug development, and public health. She holds a BS in Biology from Yale University, an MSPH in Environmental Health from UNC Chapel Hill and a PhD in Biochemistry and Molecular Genetics from George Washington University.

A geneticist by training, Claudia Dollins served in regulatory leadership roles located both in the USA and Europe. She held multiple roles of increasing responsibility in US FDA’s CDRH/Office of In Vitro Diagnostics and Radiological Health before transitioning to the pharmaceutical industry. In prior pharmaceutical industry roles, she has built global Digital Health, Companion Diagnostics, Medical Devices, and Combination Product Regulatory organizations within Merck Healthcare KGaA and Bristol-Myers Squibb. She is currently the VP, Precision Medicines, Global Regulatory Affairs at GSK.

Andrea is the President and Chairman of LUNGevity Foundation, the nation's leading lung cancer non-profit. Andrea's strong business background combined with her connections to the worlds of research and advocacy have enabled her to build the preeminent patient advocacy organization in the lung cancer space. LUNGevity funds translational research into both early detection and more effective treatments of lung cancer. LUNGevity also conducts research on patient needs through Patient FoRCE, LUNGevity's patient focused research center. LUNGevity empowers patients and their families by providing education, support and survivorship programs and the largest grassroots events network in the country.

JEFFREY SHUREN, MD, JD is the Director of the Center for Devices and Radiological Health (CDRH) at FDA. He previously served as Acting Center Director. He received both his BS and MD degrees from Northwestern University under its Honors Program in Medical Education and his JD from the University of Michigan Law School.

Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As a thought leader on many issues related to Food and Drug Administration, regulatory strategy and healthcare policy, he is regularly published in prestigious medical journals and policy publications, and has contributed his expertise to the legislative process on multiple occasions. Dr. Allen received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelors of Science in Biology from Bowling Green State University.

John Bertrand brings over a decade of healthcare technology experience to Digital Diagnostics, previously holding a variety of executive roles at Epic Systems. During his 12-year career with Epic, Bertrand led cross-functional teams in a variety of product, customer success, and business development roles with a focus on growth. Most recently Bertrand served as Executive in Residence at 8VC, a Silicon Valley venture capital firm focused on healthcare technology. His time in this space focused on the application of artificial intelligence and computer vision in healthcare.

Carolyn Hiller is Clinical Dx Program Director at the Medical Device Innovation Consortium (MDIC). Drawing on diverse experiences, she uses logic and intuition to achieve success at leading virtual teams that are often comprised of members from competing organizations. Carolyn works at the intersection of the medical device industry, federal agencies, and non-profit groups to bring innovative technology to patients faster, safer, and more cost effectively by contributing regulatory science tools, standards, and methods, for both the IVD development process and the review process.

Seamus Kearney is CEO and Principal Consultant at ARC Regulatory and with more than 22 years’ experience in the medical device industry; has considerable expertise in all areas of regulatory, clinical, and quality assurance for in vitro diagnostic and companion in vitro diagnostic medical devices. Seamus held various senior roles in development, quality, regulatory and clinical operations before founding ARC Regulatory in 2010. ARC supports pharma and their Dx partners in implementing CTA and candidate CDx devices in to clinical development programmes, including study management, laboratory study monitoring, regulatory compliance and study reporting, ensuring that local Dx requirements are being met for global precision medicine trials.

Dr. Patterson joined Gilead in 2015 to lead biomarker discovery and development across all therapeutic areas (aside from direct acting antivirals), Inflammation, Oncology, Liver Fibrosis and host HBV/HIV Cure efforts; including responsibility for biomarkers which transition to in vitro diagnostics. Previously he was at Amgen, where he established the biomarker and IVD groups from 2003-2015 and had led proteomics and apoptosis efforts from 1993-2000. From 2000-2003 he was Vice President, Proteomics at Celera Genomics Group and Chief Scientific Officer at Farmal Biomedicines, LLC. He was a Staff Investigator at Cold Spring Harbor Laboratory, New York after gaining his degrees and working at The University of Queensland, Australia.

Dr. Wendy Rubinstein is a physician-scientist who is Director of Personalized Medicine at FDA / CDRH. She co-discovered the SDHD gene for hereditary paraganglioma syndrome and directed academic cancer genetics programs for 15 years at three NCI-designated Comprehensive Cancer Centers (UPMC, Northwestern, University of Chicago). From 2011 to 2017 Dr. Rubinstein was a Senior Scientist at the NIH where she launched and directed the NIH Genetic Testing Registry (GTR), co-created ClinVar, and ultimately served as Chief of Medical Genetics and Human Variation at NCBI. Subsequently, she was Deputy Medical Director of CancerLinQ, ASCO’s real world data platform aimed at improving the quality of care for patients with cancer.

Sherie Lou Santos, MPH, MCHES is currently the Health Policy Director for Congresswoman Diana DeGette (D-CO-01), the Chairwoman of the Oversight and Investigations Subcommittee and a Member of the Energy and Commerce Committee. She leads and manages a very robust health care portfolio. She was previously an American Public Health Association Congressional Policy Fellow for Sen. Patty Murray (D-WA), then Ranking Member of the Senate Health, Education, Labor and Pensions Committee. She served as key staff in legislative negotiations as well as advised on FDA-related, drug pricing, and public health policies. Ms. Santos is a Master Certified Health Education Specialist (MCHES) and earned her dual MPH at the Loma Linda University.

Cynthia A. Bens, Senior Vice President, Public Policy at PMC, leads the Coalition’s policy development and government relations efforts and serves as its primary liaison with the U.S. Congress and federal regulators. In collaboration with PMC’s Senior Vice President, Science Policy, Bens is responsible for implementing research, regulatory and reimbursement policy strategies that promote the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system.

Rob Berlin is Head of U.S. Regulatory Policy at GlaxoSmithKline (GSK). Rob leads a team focused on driving U.S. regulatory policy, advocacy, and intelligence activities, to ensure optimal advancement and lifecycle management of GSK’s product portfolio. Rob came to GSK from the FDA where he most recently served as the Director of the Division of Clinical Policy within the Office of New Drug (OND) Policy, an office he helped to establish as a founding member of the leadership team. Prior to joining OND Policy, Rob worked in CDRH, FDA’s Office of Policy, and in the Office of Chief Counsel. He began his career at Hogan & Hartson (now Hogan Lovells) after completing his law degree and M.P.H. in Epidemiology at the University of Minnesota.

Santiago Gonzalez is the Senior Policy Advisor for Senator Michael Bennet (D-CO), a member of the Senate Finance Committee. He advises the Senator on health and immigration policy, including Medicare, Medicaid, FDA, public health, and disparities. Previously he worked as Policy Advisor to Representative Jason Crow (D-CO) and Legislative Aide to Senator Heidi Heitkamp (D-ND). Prior to working in Congress, Santiago was a Health Policy Research Associate at FBR Capital Markets and Research Assistant at The George Washington University's Milken Institute School of Public Health. He received his MPH, focusing on Health Policy, from the George Washington University and has a BA in Biochemistry and Chemistry from the University of Colorado Boulder

Dr. Mansfield is the Vice President of Regulatory Policy, Foundation Medicine

Jude is responsible for regulatory compliance for the development, validation and use of in vitro diagnostic devices within Almac Diagnostic Services. Since joining Almac Diagnostic Services, Jude has acted as Team Leader and Program Manager for the development and validation of a series of in vitro diagnostic clinical trial and companion diagnostic assays on behalf of Almac and Almac’s global pharmaceutical and biotechnology partners. Prior to joining Almac Diagnostic Services, Jude obtained a PhD in molecular oncology from Trinity College Dublin and subsequently completed a postdoctoral fellowship on the role of BRCA1 in chemotherapy response at Queen's University Belfast.

Dr Nicola Normanno is Director of the Cell Biology and Biotherapy Unit of INT Fondazione “G. Pascale” and from 2006 he is the Chairman of the Translational Research Department of the same institute. Dr. Normanno leads a research group involved in both pre-clinical and clinical studies, with particular regard to the identification of biomarkers associated with sensitivity/resistance to target-based agents in clinical development. He is President of the International Quality Network for Pathology (IQN Path) and President of the Italian Cancer Society (SIC). Dr. Normanno is author of more than 250 publications in peer-reviewed journals and he is a reviewer for many scientific journals.

Ivana Silva joined the European Medicines Agency (EMA) in 2010. She is part of the Stakeholders and Public engagement team where she coordinates all activities related to EMA’s interaction with healthcare professionals and learned societies and support to activities aimed to align EMA overall stakeholder engagement practices. These include the secretariat of the healthcare professionals’ working party (HCPWP), support to multi-stakeholder activities and, management of the EMA stakeholders’ database. Ivana was an Adviser for Pharmaceuticals and Professional Affairs (2006-2010) in the Pharmaceutical Group of the European Union (PGEU) in Brussels. Previously, she work for the National Board of the Portuguese Pharmaceutical Society.

Sue Spencer - IVD Lead and Principal Consultant Sue leads Qserve’s IVD service, she has over 30 years’ experience in the Medical Device and IVD industries including extensive notified body experience. Sue has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing and quality assurance. Sue worked for 3 notified bodies establishing two from scratch. Sue chaired the European IVD Notified Body Working Group coordinating the notified body responses to the regulations. Sue also participated in the Commission IVD Technical Work Group for many years.

Prior to accepting her post as CEO for the FDA’s Foundation in May of 2020, she served as President of Leavitt Partners Solutions. She advised corporate executives on policy and business matters. As CEO of the Food & Drug Law Institute, she provided attorneys, regulators, industry leaders, and consumers with a neutral forum to address domestic and global issues. As FDA Chief of Staff from 2007-2009, Ms. Winckler managed the Commissioner’s office; served as his/her senior staff adviser; analyzed policies; and represented FDA before myriad government and external stakeholders. She simultaneously led FDA’s Offices of Legislation, External Relations, Public Affairs, and Executive Secretariat.

Noah Zimmerman is Vice President of Translational Science at Tempus, where he oversees research and development of novel digital biomarkers in cardiovascular disease. Tempus' disease agnostic platform is designed to aggregate de-identified data and develop insights to power intelligent diagnostic tests. Prior to Tempus, Noah was Assistant Professor and Director of the Health Data and Design Innovation Center at the Mount Sinai School of Medicine where his research focused on improving decision-making in healthcare by developing and deploying novel data-driven technologies. He received his PhD in Biomedical Informatics from Stanford University, and his bachelors degree in Computer Science and Philosophy from University of Maryland.

Alberto Gutierrez, PhD is a Partner with NDA Partners and has worked with the company as an Expert Consultant since 2017. He is an expert in preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices, premarket notifications of devices, applications for approval, and post-marketing surveillance and compliance. Dr. Gutierrez oversaw the Personalized Medicine Staff at the FDA and developed and managed the policies surrounding companion diagnostic devices. Dr. Gutierrez was also a member of the Center for Devices and Radiological Health committee that oversaw policies on Digital Health.

BAKUL PATEL was the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies. Mr. Patel, in 2013, created the term “software as a medical device”(SaMD) and under his leadership the International Medical Device Regulators Forum (IMDRF) established the globally harmonized definition of SaMD. Mr. Patel subsequently led global regulators at IMDRF to create and author the globally harmonized regulatory framework for SaMD.

Whether describing complex science in straightforward terms to lawyers or translating premarket and compliance regulatory requirements to scientists, Randy focuses on practical industry experience and a deep understanding of Food and Drug Administration (FDA) regulations to help clients navigate the intersections of science, policy, and law. As Director of the firm's FDA Medical Devices and Technology practice area and a key resource for medical device, drug, human tissue, and combination product manufacturers, Randy works seamlessly across borders with clients and internal teams to help bring innovative medical products to market and meet patient needs throughout each product's unique life cycle.

Dr. Lucy Yin is currently Head of Precision Medicine & BioSamples (PMB) China in AstraZeneca, who is leading Companion Diagnostics (CDx) development for R&D China clinical study. Prior to PMB function, Lucy was Head of biomarker department in research center of China, AstraZeneca, where she led biomarker study for both drug discovery and translational science in multiple Oncology and non-Oncology pre-clinical studies and early clinical trials. Prior to AstraZeneca, Lucy was a chief pathologist for clinical patient diagnosis. Lucy has broad expertise in clinical pathology, translational and clinical biomarker study. She holds M.D from China Medical School; Ph.D in Molecular Pathology and Post-doctor training in US.