Unlocking ctDNA's Potential for Prognostic Stratification, Tumor Evolution Insights & Accelerated Drug Development

Jeff Allen, PhD, is President and CEO of Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy and regulation that speed life-saving treatments to patients. For more than two decades, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible.For over 10 years, Dr Allen has been a driving force in the growth and success of the organization. Under his leadership, Friends has evolved into a nimble, forward-thinking policy, public affairs and research organization. As President and CEO, he leads the strategic development and implementation of Friends’ scientific, policy, research and legislative initiatives, as well as overseeing Board governance and organizational operations.As a thought leader on many issues related to the Food and Drug Administration, regulatory strategy and healthcare policy, he is regularly published in prestigious medical journals and policy publications. In addition to participating in major scientific and policy symposiums around the country each year, Dr Allen has had the honor to be called to testify before Congress on multiple occasions and regularly contributes his expertise to the legislative process. Recent Friends initiatives include the establishment of the Breakthrough Therapies designation and the development of the Lung Cancer Master Protocol (Lung-MAP), a unique partnership that will accelerate and optimize clinical trial conduct for new drugs.Dr Allen has the privilege to also serve on a variety of influential committees, boards and advisory councils including the Alliance for a Stronger FDA (Board Member, Past President), the Medical Evidence Development Consortium (MED-C; Board Chair), Lung-MAP Senior Leadership Team Member and a participant on working groups convened by the National Academies of Medicine and President’s Council of Advisors on Science and Technology (PCAST).Prior to joining Friends, Dr Allen was an endocrinology researcher at the National Institutes of Health. His background in cancer research focused upon molecular changes associated with cancer formation as well as treatments to prevent cancer progression. Dr Allen received his PhD in cell and molecular biology from Georgetown University and holds a Bachelor’s of Science in Biology from Bowling Green State University.

Reshma Patel, BSc, brings more than 25 years of extensive regulatory experience to her current role as Senior Director of Global Regulatory Affairs at Janssen. Ms Patel's experience spans across all phases of drug development, advancing small molecules and biologics to global markets. Her in-depth knowledge and diverse experience of the global regulatory environment accumulated by leading multiple global submissions through to approval for key compounds including Breakthrough Therapies to treat hematologic malignancies. Currently, Ms Patel leads the global regulatory strategy for principal Janssen Hematology assets in Early Development. Ms Patel also co-leads the MRD Partnership and Alliance in AML Clinical Treatment (MPAACT), an industry and academic alliance founded in 2018 working to establish MRD surrogacy based on clinical trial data generated in acute myeloid leukemia (AML). She is also the Regulatory lead for Janssen strategic goal to establish MRD as a surrogate endpoint in multiple myeloma for PFS.

Matthew Silver, PhD, serves as Head of Oncology Precision Medicine and Companion Diagnostics at Takeda. Dr Silver established and built the centralized CDx function at Takeda, where he and his team are accountable for global diagnostic strategy development and execution across the Oncology pipeline. Before joining Takeda, Dr Silver was with EMD Serono where he was Director of Companion Diagnostics and Immuno-Oncology CDx Team Lead. In this role, Dr Silver had broad responsibility for Immuno-Oncology CDx strategy and served as CDx Lead for multiple late-stage programs. Prior to EMD, Dr Silver led the translational assays group at Cell Signaling Technology where he was responsible for product development to support their growing translational portfolio and external collaborations. Dr Silver earned a PhD in Biochemistry from the University of New Hampshire, which was followed by a postdoctoral fellowship at Wyeth Research. Dr Silver also holds a BS in Molecular and Cell biology from the University of Connecticut.

John Simmons, PhD, currently leads oncology biopharma partnerships at Natera. Before joining Natera, Dr Simmons completed his postdoctoral fellowship at the National Cancer Institute (NCI) and served as Vice President of Translational Medicine at Personal Genome Diagnostics (PGDx). He received his PhD in Tumor Biology from Georgetown University.