Modernizing Oncology Endpoints: Pathways for Evidence and Policy – Speaker Biographies
Learn more about panelists and keynote speakers from Friends of Cancer Research’s public meeting Modernizing Oncology Endpoints: Pathways for Evidence and Policy. Click here to view the agenda and access the white papers.
SESSION 1 – ctDNA: Lessons Learned and Future Directions
Névine Zariffa, M.Math.
Principal and Founder
NMD Group, LLC
Névine is a highly accomplished thought leader in the fields of biostatistics and data science with extensive experience across all phases of drug development. Névine had a 25-year career in senior roles at GlaxoSmithKline and AstraZeneca where she also led the Enterprise Data & Analytics initiative. She has been a key contributor to development strategies for over 200 drug projects across oncology, cardiovascular, metabolic, respiratory, inflammation, and renal diseases. She has been a reviewer for The Lancet and has over 30 peer reviewed publications to her name. She is currently a strategic consultant to several organisations including scientific data consortia such as ctDNA. She advised FDA (Office of the Commissioner) on the application of real-world evidence to COVID19. She serves on the Scientific Advisory Board of ANOVA, ZS Associates, Beaconcure and Intelligencia (Chair). She is a Board member of Ephicacy and served on the Board of CDISC for 6 years. She recently published her first novel, Sisters Pieced Together and her short stories appear in @nevine.storyteller.
Jon Baden
Executive Director and Head of Precision Medicine
Bristol Myers Squibb
Jonathan (Jon) Baden is the Executive Director and Head of Precision Medicine at Bristol Myers Squibb (BMS) in Lawrenceville, New Jersey. He has over 20 years of experience developing companion and standalone diagnostics across molecular, immunohistochemistry, and nextgeneration sequencing platforms. Since joining BMS in 2017, Jon has led enterprise diagnostic strategy and delivery, overseeing technical development, clinical validation, regulatory execution, and external partnerships that support key therapeutic programs. He represents BMS as a senior diagnostic expert across health authorities, industry partners, and scientific consortia. Previously, Jon spent 16 years at Janssen and Johnson & Johnson in diagnostic innovation, assay development, and program leadership. He contributes actively to BLOODPAC, Friends of Cancer Research, and broader efforts advancing liquid biopsy, ctDNA, and precision medicine adoption.
Shibing Deng
Data Sciences and Analytics, La Jolla, CA
Pfizer
Shibing Deng, PhD, is a Senior Director and biomarker statistician at Pfizer in La Jolla, CA, where he leads a team of statisticians supporting translational biomarker research in oncology drug development. Since joining Pfizer in 2004 after earning his PhD in Biostatistics from UNC Chapel Hill, Shibing has contributed to statistical analytics across preclinical research and all phases of clinical development. Prior to Pfizer, he held roles at UNC Chapel Hill, SAS Institute, and Pharsight Corporation. He has authored over 100 peer-reviewed publications, and his research interests include statistical methods in genomics, preclinical studies, and translational biomarkers.
Minetta Liu, M.D.Minetta Liu
Chief Medical Officer of Oncology
Natera
Dr. Minetta Liu, M.D., is the Chief Medical Officer of Oncology at Natera. She previously served as professor of oncology and chair of research in the Department of Oncology at Mayo Clinic in Rochester, MN. In her role at Mayo, she also held a dual appointment in the Department of Laboratory Medicine and Pathology and served as co-leader of the Genomics in Action Strategic Priority for the Center of Individualized Medicine. Dr. Liu brings a wealth of experience in developing blood-based biomarkers to predict treatment benefit and outcomes in solid tumors and in developing novel therapeutics to improve survival, with a particular focus in breast cancer. She chaired the Circulating Biomarker Working Group of the Alliance for Clinical Trials in Oncology. She also co-chaired the Correlative Science Working Group and led several multi-institutional clinical trials through the Translational Breast Cancer Research Consortium. Dr. Liu received her B.A. from Princeton University, her M.D. from Jefferson Medical College and completed her residency and hematology/oncology fellowship at Georgetown University Medical Center.
Paz Vellanki, MD, PhD
Supervisory Associate Director
Division of Oncology 2/ Center for Drug Evaluation Research
U.S. FDA
Paz Vellanki is a medical oncologist and Supervisory Associate Director for the Division of Oncology 2 at the U.S. Food and Drug Administration (FDA). In this role, she focuses on the regulation of drugs and drug approvals for patients with lung and head and neck cancers. At the FDA, she is also involved with efforts related to ctDNA and drug development. She continues to care for patients with head and neck cancer as a Clinical Assistant Professor at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center.
Prior to working at the FDA, she received her MD/PhD at the University of Maryland. She completed her residency in Internal Medicine at the Wake Forest, School of Medicine, and her fellowship in Oncology at Johns Hopkins.
SESSION 2 – AI-Enabled Tumor Assessments: Opportunities and Challenges for Incorporation into Clinical Trials
Ariel Bourla
Executive Director, Head of Solid Tumor Oncology
Johnson & Johnson
Dr. Ariel Bourla, MD, PhD, serves as Executive Director, Head of Solid Tumor Oncology on Johnson & Johnson R&D’s Data Science and Digital Health team. In this role, she leads efforts to apply real-world data, AI, and other innovative technology solutions to advance and accelerate Oncology clinical programs in both early and late development.
Prior to her tenure at Johnson & Johnson, Dr. Bourla spent 6 years at Flatiron Health as a Medical Director and Clinical Trials Lead. In this role, she oversaw research teams executing prospective real-world studies, methodologic and observational research projects, and development of new technologies for sites and sponsors participating in clinical trials.
Dr. Bourla received her MD from the Mount Sinai School of Medicine and her PhD in Immunology from a combined program with the Mount Sinai School of Medicine and the NIH. She completed her subsequent internship and residency at New York Presbyterian-Columbia University Medical Center, and pursued a Medical Oncology fellowship at Memorial Sloan Kettering Cancer Center. She earned a BA in English Language and Literature from Yale University.
Felix Baldauf-Lenschen
CEO
Altis Labs
Felix Baldauf-Lenschen is the CEO and Founder of Altis Labs, a computational imaging company accelerating drug development with AI-powered clinical trial endpoints. Under his leadership, Altis built the industry’s largest real-world cancer imaging database to train AI models that predict long-term patient outcomes. Leading biopharmaceutical companies, including AstraZeneca, Bayer, and J&J, use these models to go beyond traditional imaging endpoints and achieve earlier readouts with more precise estimations of clinical benefit. Felix has worked at the forefront of AI in radiology and oncology since 2016. Driven by AI’s potential to unlock insights within medical imaging, he founded Altis to accelerate evidence generation and help patients access novel, effective treatments sooner.
Lauren Brady
Director of Translational Data Science
Genmab
Lauren K. Brady, PhD is a Director of Translational Data Science at Genmab, where she applies multimodal biomarker approaches to inform oncology drug development. Her work focuses on leveraging machine learning across diverse biomarker modalities, including medical imaging, to characterize tumor phenotype, predict treatment response, and improve response assessment in oncology clinical trials.
Dr. Brady holds a PhD in Cellular and Molecular Biology from the University of Pennsylvania School of Medicine and has a background spanning genetics, computational biology, tumor microenvironment, and immuno-oncology research. Prior to joining Genmab, Lauren served as both a Biomarker Lead and Computational Biologist in Oncology Translational Research at Janssen. At Genmab, she leads the collaboration strategy for the Translational Data Science team and co-founded the Medical Imaging Research group, which develops and validates imaging-derived biomarkers with a focus on interpretability and clinical applicability.
Nathaniel Braman
Co-founder/VP of AI Research & Development
Picture Health
Nathaniel Braman is the co-founder and VP of AI Research & Development at Picture Health, where he leads the development and real-world deployment of AI imaging biomarkers at the intersection of radiology, oncology, and drug development. His work focuses on AI for clinical trials, including automation of standard imaging readouts (ai.RECIST) and next generation novel radiomic endpoints, to make response assessment more scalable, consistent, and actionable. He spearheads efforts to build interpretable, AI-enabled radiology biomarkers for treatment prediction and longitudinal monitoring by targeting tumor biology linked to therapeutic response. In partnership with biopharma teams, he embeds AI imaging biomarkers across study design, execution, and endpoint generation, while advancing these technologies toward clinical adoption. Most recently, he led the launch of QVT Score, an interpretable radiomic biomarker that quantifies tumor vascular complexity/chaotic angiogenesis from routine CT imaging and was selected as a scientific highlight of the 2025 Society for Immunotherapy in Cancer (SITC) meeting.
Nathaniel earned a PhD in Biomedical Engineering from Case Western Reserve University (Doctorate Excellence Award). Supported by NIH predoctoral fellowships (NCI, NIBIB), his dissertation research on treatment-response prediction and multimodal data fusion became the technical foundation for Picture Health. Previously, he worked at IBM Research and Tempus Labs on incidental disease detection and multimodal outcome prediction. He has 20+ peer-reviewed publications and 15+ patents spanning medical image analysis, precision oncology, and multimodal data fusion.
Lia Ridout
Friends Advisory Advocate
Lia Ridout was diagnosed with non-small cell lung cancer in 2017 and has since become a passionate advocate. She uses her lived experience to promote biomarker testing, patient-centered research, and cancer treatment that reflects the needs of patients and their families. Lia regularly brings the patient perspective into conversations about research, care, and survivorship, focusing on what matters most to patients.
Larry Schwartz
Chairman, Department of Radiology
Memorial Sloan Kettering Cancer Center
Lawrence H. Schwartz, M.D. is the Chairman of the Department of Radiology at Memorial Sloan-Kettering Cancer Center. In his capacity as Chairman, Dr. Schwartz oversees a 164 clinical member department and directs its patient care, research, and educational initiatives.
Dr. Schwartz is a graduate of Boston University School of Medicine. He completed his residency at New York-Presbyterian Hospital/Cornell University Medical Center and his Fellowship in Cross Sectional Imaging at Brigham and Women’s Hospital/Harvard Medical School.
Before returning to Memorial Sloan-Kettering Cancer Center 2023, Dr. Schwartz was the Vice Chair at Columbia University. Dr. Schwartz’s academic interests are in the development of novel imaging biomarkers in oncology, both clinical care and drug discovery. He is an active member of the Quantitative Imaging Biomarker Alliance and the Oncology Biomarker Qualification Initiative.
Alain Silk, Ph.D.
Senior Director of Regulatory Affairs
Tempus AI, Inc.
Alain Silk is a Senior Director of Regulatory Affairs at Tempus AI, a technology company focused on accelerating cancer research and providing data-driven insights for clinical care through the use of clinical and molecular data and analytical tools. Dr. Silk was trained as a cancer cell biologist at the University of California, San Diego and at Oregon Health & Science University, and has more than a dozen years experience as a medical device regulatory professional focused on diagnostic testing, encompassing chemistry, toxicology, diabetes, cardiology and oncology devices. He served as a scientist and regulator at the US Food and Drug Administration prior to moving to Tempus, where he has been working since 2020 to support regulatory authorization of innovative laboratory-based molecular oncology tests and AI-based software diagnostics.
SESSION 3 – Modernizing Regulatory Frameworks: Future Policies & Priorities
Tala H. Fakhouri, Ph.D., M.P.H.
Vice President Consulting: AI & Digital Policy, Real-World Research
Parexel
Tala H. Fakhouri, Ph.D., M.P.H., is the Vice President Consulting: AI & Digital Policy, Real-World Research and will consult in these three key innovation areas. Most recently, Dr. Fakhouri was the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). In this role, Dr. Fakhouri led a team focused on advancing medical policy related to the use of AI in drug development. Her work included overseeing FDA’s AI policy efforts in drug development, engaging with external stakeholders, and driving regulatory science initiatives to ensure the responsible and effective use of AI across the drug development lifecycle. During her FDA tenure, she led the development of the first draft CDER AI Guidance, established the CDER AI Council, and contributed to the development of policy on real-world evidence and digital health technologies, including leading the publication of the first RWE guidance for FDA. Her leadership in statistical methodology has been recognized through her selection to serve on the Federal Committee for Statistical Methodology in 2023.
Prior to joining FDA, Dr. Fakhouri served as Senior Health Scientist and Chief Statistician for the CDC’s National Health and Nutrition Examination Survey (NHANES), the nation’s premier source of nationally representative health and nutrition data. At NHANES, she provided leadership on epidemiologic, statistical, and methodological issues, with a focus on selection bias, data linkage, and data quality. She also led efforts to improve study design, enhance participant recruitment strategies, and increase population representativeness. Dr. Fakhouri’s previous roles include Epidemic Intelligence Service Officer at CDC, deputy lead for health surveys at ICF Macro, and contributor to cross-agency efforts such as the Cancer Moonshot. She has authored more than 30 government reports, peer-reviewed publications, and book chapters.
Dr. Fakhouri holds a Ph.D. in Oncological Sciences from the Huntsman Cancer Institute at the University of Utah, an M.P.H. in Epidemiologic and Biostatistical Methods from the Johns Hopkins Bloomberg School of Public Health, and a postdoctoral fellowship in molecular biology and genetics from Harvard University. She earned her BSc in Medical Technology from the Jordan University of Science and Technology.
Michael Montalto, Ph.D.
Vice President of Precision Medicine, Global Development
Amgen Inc.
Michael Montalto is Vice President of Precision Medicine, Global Development at Amgen Inc. where he leads the strategy and execution of translational and precision medicine across all global therapeutic areas in support of discovery biology, clinical development, and companion diagnostics.
Dr. Montalto brings 25 years of transformational leadership in pharmaceutical and diagnostic device companies, with deep expertise in digital pathology and artificial intelligence applications for biomarker discovery. Throughout his career, he has directed large multidisciplinary teams across the full lifecycle from innovation through commercialization, holding senior roles spanning research, development, clinical, medical, regulatory, business development, and commercial functions for in-vitro diagnostic devices.
Before joining Amgen, he served as Chief Scientific Officer of PathAI, a leading technology company developing AI-powered digital pathology and software platforms for biopharmaceutical and diagnostic healthcare industries.
Dr. Montalto actively contributes to the scientific community through various leadership positions. He currently serves on steering committees for the FNIH Biomarkers Consortium, the editorial board of the Journal of AI in Precision Oncology, and as a member of the Friends of Cancer Research Digital Pathology Working Group. His previous service includes NIH Study Sections for In Vivo Molecular Imaging Centers and the Digital Pathology Association Executive Committee, where he served as President and long-standing Board member. He has also provided scientific advisory support to Leica, Perkin Elmer/Akoya, and various digital pathology startups, and holds ten US patents.
Dr. Montalto earned his Ph.D. in tumor biology from Albany Medical College and completed postdoctoral fellowship training in cardiovascular anti-inflammatory drug discovery at Brigham and Women’s Hospital and Harvard Medical School.
John Stone
Principal
BGR Group
John Stone leads the FDA and Public Health Working Group within BGR’s Health and Life Sciences Practice, helping FDA-regulated clients navigate congressional and administration policy development processes that impact their products and commercial activities.
John joined the firm after spending nearly seven years with the House Energy and Commerce Committee (E&C), first as a Counsel on the Oversight and Investigations Subcommittee and then as a Senior Counsel on the Health Subcommittee primarily handling issues under the jurisdiction of the FDA.
Working for Chairman Fred Upton (R-Mich.) he played a leading role in developing, negotiating and ultimately passing numerous bipartisan bills, including the Drug Quality and Security Act (DQSA), the Safe and Accurate Food Labeling Act and the landmark 21st Century Cures Act (Cures)—widely considered one of the most comprehensive biomedical research and FDA reform bills ever signed into law. Under subsequent Chairman Greg Walden (R-Ore.), John facilitated timely passage of the Food and Drug Administration Reauthorization Act (FDARA) in the midst of a very challenging political environment.
Prior to joining the Committee in February 2011, John spent two years in the Washington office of Sanofi. He received his undergraduate degree from Miami University in Oxford, Ohio, and his law degree from American University in Washington, D.C.
Lowell M. Zeta, J.D.
Deputy Commissioner for Strategic Initiatives and Special Counsel
U.S. FDA
Lowell M. Zeta, J.D., is the Deputy Commissioner for Strategic Initiatives at the U.S. Food and Drug Administration and serves as Special Counsel for FDA in the Office of the Chief Counsel (OCC), which is the Food and Drug Division of the U.S. Department of Health and Human Services’ (HHS) Office of the General Counsel.
In this dual role, Mr. Zeta provides legal and strategic counsel to the FDA Commissioner and Agency leadership to advance strategic regulatory initiatives, drive cross-agency innovation, and strengthen oversight across all FDA-related product areas including drugs, biologics, food, medical devices, cosmetics, veterinary products, and tobacco products. He serves as the point-person ensuring that strategic initiatives and priorities, at all levels of the organization, are authorized under the Federal Food, Drug, and Cosmetic Act (FDCA) and other applicable laws and regulations, and are in line with the FDA Commissioner’s priorities and the broader goals of HHS and the Administration.
Mr. Zeta is responsible for collaborating with the FDA Commissioner to identify opportunities to improve regulatory programs, to develop innovative strategies to emerging and ongoing issues, and to implement new programs and solutions to achieve the FDA’s mission objectives. He works closely with FDA leadership and provides executive oversight for operations and regulatory process improvements. His responsibilities include providing analyses and recommendations on innovative regulatory initiatives and programs, ensuring the alignment of the key functions of strategy planning, and driving change and overseeing change management during implementation to maximize efficiency and public health benefit.
As Special Counsel for FDA, Mr. Zeta provides legal counsel and strategic counsel on high-priority regulatory and administrative actions and cross-cutting legal issues involving emerging technologies such as artificial intelligence, domestic manufacturing and foreign inspections, and risk management for regulations, guidance, and policy development, which often involves complex legal analyses of intricate statutory provisions. He works closely with OCC litigators and counselors to advise FDA officials on strategy planning and risk mitigation approaches, new and pending regulations and draft legislation, and complex compliance and enforcement matters to advance FDA’s mission of promoting and protecting the public health.
Mr. Zeta was previously with the FDA (2020-2021), serving as a Senior Advisor to the Commissioner, and provided leadership on key public health initiatives, including the Pandemic Recovery and Preparedness Plan (PREPP) initiative to strengthen the FDA’s response to public health emergencies. Prior to his return, Mr. Zeta was a senior partner at a global law firm in Washington, D.C., focusing on regulatory and commercial strategies, enforcement and administrative matters, compliance and investigations involving the pharmaceutical and biotech industries. In addition, he has extensive experience, and is a frequent speaker and published writer on FDA and healthcare priorities. Mr. Zeta previously served as a Food and Drug Law Journal advisory board member where he was responsible for peer-review of publications in the Food and Drug Law Journal, covering scholarly work on legislation, regulations, court decisions, and public policies affecting FDA regulated industries. Mr. Zeta completed his undergraduate studies at the University of Iowa and earned his juris doctor and postgraduate degree in law and health policy from Creighton University and Georgetown University, respectively.