Biomarkers Consortium:
Leadership + Governance

Rachael Anatol, Ph.D., is Deputy Super Office Director, Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER), FDA, and Acting Chief of the Policy and Special Projects Staff.   OTP regulates cell and gene therapies, plasma protein therapeutics, xenotransplantation products, human tissues, devices, and combination products.    Rachael, together with the Super Office Director, Dr. Nicole Verdun, is responsible for all regulatory, policy, and research work conducted in OTP.

Between December 2022 and December 2023, Rachael served as Senior Vice President for Science and Regulatory Affairs at the Biotechnology Innovation Organization (BIO). In this role, Rachael led all aspects of BIO’s science and regulatory advocacy function, managed the BIO Board Regulatory Environment Committee, and advised executive and senior-level BIO staff on BIO’s science and regulatory agenda.

Prior to joining BIO in December 2022, Rachael spent 16 years at the Food and Drug Administration, where she took on roles of increasing responsibility in the CBER, culminating as Deputy Director of the Office of Tissues and Advanced Therapies (the predecessor office to OTP).

Rachael received her Ph.D. in molecular and cell biology from the University of Maryland, College Park, and completed her post-doctoral training at NIH’s National Heart, Lung, and Blood Institute.

Diana W. Bianchi, M.D., is the director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and head of the Prenatal Genomics and Therapy Section for the Medical Genetics Branch at NHGRI. She oversees the research on pediatric health and development, maternal health, reproductive health, intellectual and developmental disabilities, and rehabilitation medicine, among other areas. These efforts include managing a staff of approximately 1,400 people and an annual budget of approximately $1.5 billion. Dr. Bianchi serves as an ambassador and spokesperson for NICHD.

Dr. Bianchi received her B.A. magna cum laude from the University of Pennsylvania and her M.D. from Stanford University School of Medicine. She completed her residency training in pediatrics at the Children’s Hospital, Boston, and her postdoctoral fellowship training in both Medical Genetics and Neonatal-Perinatal Medicine at Harvard. She is board-certified in all three specialties and is a practicing medical geneticist with special expertise in reproductive genetics and genomics. Dr. Bianchi’s translational research focuses on two broad themes: prenatal genomics with the goal of advancing noninvasive prenatal DNA screening and diagnosis and investigating the fetal transcriptome to develop new therapies for genetic disorders that can be given prenatally.

Dr. Bianchi has published over 300 peer-reviewed articles, and she is one of four authors of Fetology: Diagnosis and Management of the Fetal Patient. This book won the Association of American Publishers award for best textbook in clinical medicine in 2000. The second edition was published in April 2010 and is in its third printing. It has been translated into Japanese, Mandarin and Spanish.

Dr. Bianchi is recognized widely for her leadership roles. She spent 23 years at Tufts Medical Center, where she was the founding executive director of the Mother Infant Research Institute, as well as the Natalie V. Zucker Professor of Pediatrics, Obstetrics and Gynecology at Tufts University School of Medicine. Dr. Bianchi also was the vice chair for Pediatric Research at the Floating Hospital for Children, Boston. From 2011 through 2015, she served on the National Advisory Council of NICHD. She is currently editor-in-chief of the international journal Prenatal Diagnosis and is a past president of the International Society for Prenatal Diagnosis and the Perinatal Research Society. She is a former member of the Board of Directors of the American Society for Human Genetics and a former council member of both the Society for Pediatric Research and the American Pediatric Society. She was elected to membership in the National Academy of Medicine (formerly the Institute of Medicine) in 2013.

Dr. Bianchi has received several major lifetime achievement awards. The Colonel Harland D. Sanders Lifetime Achievement Award in Genetics, given in 2017 by the March of Dimes, recognized her pioneering work on maternal and fetal cellular communication, including its significance in disease and diagnostics, and for exploring treatments of fetal disorders. The Maureen Andrew Award for Mentoring, given in 2016 by the Society for Pediatric Research, recognized her commitment to mentoring the next generation of clinician-scientists. The Landmark Award, from the American Academy of Pediatrics, was given in 2015 in recognition of her research and contributions to genetics and newborn care. The 2017 J.E. Wallace Sterling Lifetime Achievement Award recognized Dr. Bianchi’s achievements as an alumna of Stanford University School of Medicine. The Pioneer Award was given in 2019 by the International Society for Prenatal Diagnosis to acknowledge her transformative contributions to the practice, science and profession of prenatal diagnosis and therapy. In 2020 she received an honorary doctorate from the University of Amsterdam that recognized her contributions to the field of fetal cell microchimerism and noninvasive prenatal testing using DNA sequencing of fetal and placental DNA fragments.

Prior to joining NIAMS, Dr. Criswell was vice chancellor of research at the University of California, San Francisco (UCSF). A board-certified rheumatologist, Dr. Criswell was also a professor of rheumatology and a professor of orofacial sciences at UCSF. She has a bachelor’s degree in genetics and a master’s degree in public health from the University of California, Berkeley, and an M.D. from UCSF. She earned a D.Sc. in genetic epidemiology from the Netherlands Institute for Health Sciences, Rotterdam. She completed a residency in internal medicine and a fellowship in rheumatology.

Between 1994 and the time she became NIAMS director, Criswell was a principal investigator on multiple NIH grants and published more than 250 peer-reviewed journal papers. Her research focused on the genetics and epidemiology of human autoimmune disease, particularly rheumatoid arthritis and systemic lupus erythematosus. Using genome-wide association and other genetic studies, her research team contributed to the identification of more than 30 genes linked to these disorders.
In 2021, Criswell was elected to the Association of American Physicians, an honor extended to physicians with outstanding credentials in biomedical research. Criswell’s other honors include the Kenneth H. Fye, M.D., endowed chair in rheumatology and the Jean S. Engleman distinguished professorship in rheumatology at UCSF, and the Henry Kunkel Young Investigator Award from the American College of Rheumatology. She also was named UCSF’s 2014 Resident Clinical and Translational Research Mentor of the Year.

Dr. Hamilton is Vice President and Head of Precision Medicine, Early Clinical Development & Experimental Sciences at Regeneron Pharmaceuticals, Inc., leading a rapidly growing team. She has over 22 years of pharmaceutical industry research experience, 19 of which have been with Regeneron. She has research and/or development experience in inflammation/immune, neurology and oncology indications. As department head, Dr. Hamilton oversees the strategic application of biomarkers for clinical development, including target engagement and disease biomarkers, translational research, life cycle management, pharmacogenetics and predictive medicine, including companion diagnostics, across the entire Regeneron clinical development pipeline and research portfolio (~30 clinical candidates currently in development). The team she manages includes biomarker strategy leads, exploratory data analysts, clinical laboratory operations and companion diagnostic experts. In addition to departmental oversight, Dr. Hamilton also leads several cross-functional translational research initiatives. Dr. Hamilton is known for being an inspirational leader, her collaborative approach, scientific rigor and passion for translational research.

Prior to taking on the departmental leadership role in 2017, Dr. Hamilton led Precision Medicine strategies for a number of development programs, including dupilumab. She was the first person to hold a strategic biomarker position in Global Development at Regeneron, establishing the role and function. Dr. Hamilton’s strategic and scientific contributions include co-championing atopic dermatitis as the lead indication for dupilumab development, later co-leading the review and initiation of eosinophilic esophagitis as an additional indication for the program (now in phase 3). The translational research vision she implemented across the dupilumab program has provided insight not only into dupilumab mechanism of action in multiple indications, but also contributed to further understanding of the role of IL-4Ra (IL-4/IL-13) in disease. Most recently, she has been one of the leaders and contributors to Regeneron’s COVID-19 program strategy and execution.

Prior to joining Regeneron, Jennifer earned an Honors Bachelor’s of Science degree from Purdue University in Genetic Biology; a Ph.D. in Molecular, Cellular, Developmental Biology and Genetics from the University of Minnesota in the Dept. of Laboratory Pathology (studying the neurodegenerative disease spinocerebellar ataxia type 1); and completed a postdoctoral fellowship at Eli Lilly and Co. in Oncology Research (gemcitabine resistance in NSCLC).

Greg received his A.B. degree in biochemistry from Middlebury College and M.D. from New York Medical College. He completed his residency training in Internal Medicine at Dartmouth-Hitchcock Medical Center and his fellowship training in Hematology and Oncology at The University of Chicago Hospitals. As part of his training, he graduated from the University of Chicago Health Sciences Department Clinical Research Training Program specializing in clinical trial design and analysis. He joined the faculty of the University of Chicago thereafter joining the Phase I, Gastrointestinal, and Gynecologic oncology teams where he served as the PI for multiple early phase clinical studies. He published multiple research papers and reviews, and he was an active member of ASCO, the CALGB, and the GOG.

Greg joined Amgen in 2006 as an Associate Medical Director in Oncology Early Development. He served as the team lead for multiple early and mid-stage programs, shepherding molecules though IND filings, into initial human studies, and onto later development. Greg took over as group leader in 2011 and served for 3 years as Therapeutic Area Head, Oncology Early Development and later for 4 months as Early Development Head overseeing (Oncology, Inflammation, Neuroscience, and General Medicine/Bone). Starting in 2014, Greg served as the interim co-TA head for the Hematology / Oncology TA. In 2016 he served as the Global Product General Manager (GPGM) for the early hematology BiTE portfolio.

In 2017 Greg assumed the role of vice president and Therapeutic Area Head, Hematology / Oncology Global Development. In addition, in 2019 Greg assumed the TA Head responsibilities for the Bone franchise.

Dr. Gordon received his MD/PhD degree at the University of California, San Francisco and completed his Psychiatry residency and research fellowship at Columbia University. He joined the Columbia faculty in 2004 as an Assistant Professor in the Department of Psychiatry where he conducted research, taught residents, and maintained a general psychiatry practice. In September of 2016, he became the Director of the National Institute of Mental Health.

Dr. Gordon’s research focuses on the analysis of neural activity in mice carrying mutations of relevance to psychiatric disease. Dr. Gordon’s work has been recognized by several prestigious awards, including the The Brain and Behavior Research Foundation – NARSAD Young Investigator Award, the Rising Star Award from the International Mental Health Research Organization, the A.E. Bennett Research Award from the Society of Biological Psychiatry, and the Daniel H. Efron Research Award from the American College of Neuropsychopharmacology.

Dr. Iannone has been Jazz’s EVP, Research and Development since May 2019. Dr. Iannone oversees product development, clinical operations and regulatory affairs. Dr. Iannone brings more than 16 years of experience in clinical drug development, having worked on immuno-oncology programs at AstraZeneca and its biologics arm MedImmune. In 2021, Dr. Iannone was appointed to the board of directors for iTeos Therapeutics, a clinical-stage biopharmaceutical company pioneering the discovery and development of new generation immuno-oncology therapeutics. From April 2018 until May 2019, Dr. Iannone served as Head of Research and Development and Chief Medical Officer of Immunomedics, Inc., a biopharmaceutical company. Prior to that, from July 2014 to April 2018, Dr. Iannone served in the roles of Senior Vice President and Head of Immuno-oncology, Global Medicines Development and the Global Products Vice President at AstraZeneca plc, a global science-led biopharmaceutical company.

From 2004 to 2014, Dr. Iannone served in management roles at Merck Co., Inc., a global biopharmaceutical company, culminating in his role as Executive Director and Section Head of Oncology Clinical Development.
From 2001 to 2004, he served as Assistant Professor of Pediatrics and from 2004 to 2012 as Adjunct Assistant Professor of Pediatrics at the University of Pennsylvania School of Medicine. Dr. Iannone has been serving on the board of directors of Jounce Therapeutics, Inc., a clinical-stage immunotherapy company since January 2020 and on the Cancer Steering Committee of the Foundation for the National Institutes of Health since 2011.

Dr. Iannone received a B.S. from The Catholic University of America, an M.D. from Yale University and an M.S.C.E. from University of Pennsylvania and completed his residency in Pediatrics and fellowship in Pediatric Hematology-Oncology at Johns Hopkins University.

Dr. Shari M. Ling currently serves as the Deputy Chief Medical Officer for the Centers for Medicare and Medicaid Services (CMS), and Medical Officer in the Center for Clinical Standards and Quality (CCSQ). She assists the CMS Chief Medical Officer in the Agency’s pursuit of: empowering patients and doctors to make decisions about their health care, ushering in a new era of state flexibility and local leadership, supports innovative approaches to improve quality, accessibility and affordability and improving the CMS customer experience. Dr. Ling’s committed focus is on the achievement of meaningful health outcomes for patients and families through the delivery of high quality, person-centered care, across all care settings. Her leadership of the Agency’s clinician engagement efforts as part of this. Her clinical focus and scientific interest is in the care of persons with dementia, multiple chronic conditions, and functional limitations.

Dr. Ling represents CMS on several Health and Human Services (HHS) efforts. She leads the Clinical Services federal workgroup for the National Alzheimer’s Project Plan, and represents CMS on the workgroups to eliminate and prevent Healthcare Associated Infections (HAIs), the National Strategy to Combat Antimicrobial Resistance, and previously Vice President Biden’s Cancer Moonshot Initiative.

Dr. Ling earned a Master’s in Gerontology in Direct Service at the Leonard Davis School of Gerontology, an MD degree at Georgetown University School of Medicine, completed a rheumatology fellowship at Georgetown University Hospital followed by a Geriatric Medicine fellowship at Johns Hopkins University School of Medicine.

As Chief Medical Officer for Pediatrics and Special Populations at the U.S. Food and Drug Administration Center for Devices and Radiological Health, Dr. Peiris provides executive and clinical leadership. He serves as the Center’s senior clinical science and practice expert on pediatrics and pediatric medical device issues and provides executive leadership on Center policies and initiatives associated with medical devices intended for use in pediatric and special populations. As a systems architect, he leads the Center’s outreach for developing strategic initiatives which facilitate synergy among internal and external stakeholders and enhances the ability of the Agency and the medical device ecosystem to optimally serve the public health with respect to the needs of historically underserved populations at the FDA.

Prior to joining the FDA, Vasum was the Joon Park MD Endowed Chair in Medical Excellence, Associate Professor, and Chief of Pediatric and Adult Congenital Cardiology at Texas Tech University Health Sciences Center (TTUHSC) School of Medicine, the Graduate School of Biomedical Sciences, and University Medical Center (UMC), with appointments in both the Departments of Pediatrics and Internal Medicine. He served as the Medical Director of the Pediatric and Adult Congenital Imaging Laboratory and as Medical Director of the Pediatric and Adult Congenital Cardio-Respiratory Exercise Laboratory at TTUHSC/UMC. He provided senior leadership in the development of the TTUHSC Clinical Research Institute, promoting patient-oriented translational and outcomes research. Vasum helped develop the Department of Public Health from its inception, serving as inaugural faculty creating the curricula and program which offers a unique training that encompasses rural health.

Vasum is an accomplished researcher, author and speaker. He has been awarded First Prize-Young Investigator Award by the Section on Cardiology and Cardiac Surgery of the American Academy of Pediatrics. He has worked under grants from a number of major organizations including the Robert Wood Johnson Foundation, the American Federation for Aging Research, the Harvard Medical Scholars Program and has been awarded an Albert Schweitzer Fellowship. He is an author/editor of the FDA-NIH BEST (Biomarkers, EndpointS, and other Tools) Resource e-textbook and has been published in AIM journals. He has been an invited keynote speaker, served as the media lead speaker for FDA initiatives, and lectured as a visiting professor.
Vasum is triple-board certified in Pediatrics and Pediatric Cardiology by the American Board of Pediatrics and in Adult Congenital Cardiology by the American Board of Internal Medicine. He is a Fellow of the American Academy of Pediatrics, the American College of Cardiology, and the American Society of Echocardiography.

Vasum completed fellowship in Pediatric Cardiology and Cardiovascular Research at Harvard Medical School/Children’s Hospital Boston with senior fellowship training in Congenital Cardiovascular Magnetic Resonance Imaging at the Children’s Hospital and the Beth Israel Deaconess Medical Center at Harvard Medical School. He completed residency at the Yale School of Medicine/Yale-New Haven Hospital. Prior to achieving his Medical Doctorate at The University of Vermont College of Medicine, he earned his Master of Public Health ‘With Distinction’ at the Yale School of Medicine Department of Epidemiology and Public Health. Vasum earned his undergraduate degree in the honors major of Ethics, Politics and Economics at Yale University.

Dr. Strauss received both a B.A. in chemistry and medical degree (M.D.) from Duke University, and a Ph.D. in clinical physiology from Lund University, Sweden. He also completed a postdoctoral fellowship at Johns Hopkins University. He has led regulatory science research since joining FDA in 2010. He has published over 90 peer-reviewed journal articles and book chapters related to assessing the safety and effectiveness of drugs and medical devices and predicting individualized response to therapies.

Dr. Strauss currently serves as FDA’s Director of the Division of Applied Regulatory Science, which seeks to move new science into the CDER review process, closing the gap between scientific innovation and product review and improving public health by building and translating knowledge of drug response into science-based, patient-centered regulatory decisions of the highest quality. Dr. Strauss previously served as Senior Advisor for Translational and Experimental Medicine in the Office of Clinical Pharmacology, where he provided strategic, scientific, and operational leadership in several priority areas including early pharmacology studies, biomarker development and evaluation, disease and pharmacologic modeling, induced pluripotent stem cell research and silico modeling.

Additionally, Dr. Strauss oversees and coordinates FDA’s research activities supporting the Comprehensive In Vitro Proarrhythmia Assay (CiPA) Initiative, including the evaluation of ion channel pharmacology data, development and validation of an in silico computational model of the human ventricular myocyte, design and interpretation of induced pluripotent stem cell derived cardiomyocytes assays, and assessment of novel ECG biomarkers in phase 1 clinical trials. He has received multiple awards, including recently receiving the Secretary of Health and Human Services Award for Meritorious Service, the second highest award granted by the Department.

Dr. Tromberg is the Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH) where he oversees a portfolio of research programs focused on developing, translating, and commercializing engineering, physical science, and computational technologies in Biology and Medicine. In addition, he leads NIBIB’s Rapid Acceleration of Diagnostics (RADx Tech) innovation initiative to increase SARS-COV-2 testing capacity and performance. Prior to joining NIH in January 2019, he was a professor of Biomedical Engineering and Surgery at the University of California, Irvine (UCI). During this time, he served as director of the Beckman Laser Institute and Medical Clinic (BLIMC) (2003-2018) and the Laser Microbeam and Medical Program (LAMMP), an NIH National Biomedical Technology Center at the BLIMC (1997-2018). Dr. Tromberg specializes in the development of optics and photonics technologies for biomedical imaging and therapy. He has co-authored more than 450 publications and holds 24 patents in new technology development as well as bench-to-bedside clinical translation, validation, and commercialization of devices.

Dr. Vincent is Senior Vice President and Chief Scientific Officer of the Inflammation and Immunology Research Unit, leading the scientific pipeline for Rheumatology, Gastroenterology and Dermatology specialties from pre-clinical to phase 3 assets. Since joining Pfizer in 2011, he has held several scientific leadership roles, most recently as Clinical Head for Pharmatherapeutics in Cambridge, MA. Over this period, he has had responsibility for clinical and translational science in the Inflammation and Immunology, Rare Disease and the Cardiovascular and Metabolic Disease Research Units, and the Centers for Therapeutic Innovation. Dr. Vincent is an executive level physician scientist proficient in management of large and complex portfolios and large direct-line and matrixed teams toward strategic, timely delivery of drug development, portfolio or internal project milestones. He possesses a broad and diverse skillset including project leadership, management of multimillion direct and clinical trial budgets, management of biomarker research laboratories, fluency in advanced statistical and computational biology methods, breadth of scientific and drug development knowledge, including immunology, cell and molecular biology, biochemistry, clinical pharmacology, systems biology, regulatory science, health economics, quality assurance, inspection readiness, and insourced and outsourced pre-clinical and clinical development operational models.

Before joining Pfizer, Dr. Vincent held positions of increasing responsibility within Medical Sciences at Amgen. During his tenure, he acquired broad experience across protein and small molecule programs for inflammatory, neurologic and psychiatric diseases from preclinical to post-registrational phases of development, with a particular focus on characterizing pharmacodynamic activity in pre-clinical, early clinical, and proof-of-concept programs. Dr. Vincent earned his BA, PhD, and MD degrees from Indiana University. He completed his residency and began his post-doctoral and rheumatology training at the University of Vermont, completing his fellowship at Brigham and Women’s Hospital. His research while on faculty at Harvard centered on human T cell-dendritic cell interactions, and basic mechanisms of autoimmunity.

John A. Wagner, M.D., Ph.D. oversees clinical investment and strategy at Koneksa. With more than 20 years of drug development experience, Dr. Wagner has led more than 150 first-in-human studies and has been instrumental bringing numerous blockbuster programs to market. Prior to joining Koneksa, John was CMO of Cygnal Therapeutics, held senior leadership roles at Takeda and Merck, and was a venture partner at Foresite Capital. In addition, John is Editor-in-Chief of Clinical and Translational Science and an executive committee member of the Foundation for the National Institutes of Health Biomarkers Consortium.

Jeffrey Siegel is the director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research, regulatory, and clinical drug development. Jeff received his B.A. from Columbia University and M.D. from Yale University. He trained in internal medicine at University Hospitals of Cleveland. Then he did a fellowship in Immunology and Signal Transduction at NIH. He served at FDA from 1996-2010 as a medical officer and then Medical Team Leader. In 2010, he left FDA for industry and worked at Genentech/Roche as global lead for Rheumatology and Rare Diseases and subsequently at Gilead Sciences as Translational Medicine lead in Clinical Research/Inflammation before rejoining FDA in February, 2021.