Biomarkers Consortium:
Leadership + Governance

As CTO and Director of ImmunoScience at Nordic Bioscience, I oversee the biomarker development pipeline, from discovery to product launch. With over 20 years of experience, I lead a team of five dedicated and fantastic leaders for in RND (Rheum, Gastro, Derm), biomarker development and production. Each of the leads and their teams are committed to developing, validating, and clinically translating blood-based biomarkers for fibro-inflammatory diseases, including osteoarthritis, rheumatoid arthritis, and gastrointestinal disorders. An important recent highlight in my career is our close collaboration with Roche Diagnostic, which provide us with platforms for automization and in vitro diagnostic development and launch. Thus, bringing ROU biomarkers to clinical diagnostics.

In addition, I have a small research team (Rheum) focused on joint diseases, leading to the development of biomarkers for bone, cartilage, and connective tissue destruction for use in precision medicine, such as prognosis and treatment prediction. I believe it is important stay in touch with science, when leading part of a biotech company.

I hold a master’s degree in Biochemistry and Immunology, a PhD in Tissue Pathology, and a Leadership Certificate (CBA). Throughout my career, I have actively collaborated with international researchers and served on various EU consortia and committees within organizations like OARSI, EULAR, and FNIH. This has led to 260 peer-reviewed publications on my pub list, including >20 first-authored papers in high-impact journals.

Dr. Benzinger earned medical and doctoral degrees from the University of Chicago. She completed both her diagnostic radiology residency and neuroradiology fellowship at Washington University. Dr. Benzinger’s research focuses on novel neuroimaging tools in the study of aging, neuroinflammation, Alzheimer disease (AD), and related disorders. The laboratory pioneers translational PET and MR imaging to investigate biomarkers for Alzheimer Disease. Her group also serves as the imaging core for the Knight Alzheimer Disease Research Center, and for the international studies of autosomal dominant AD, the Dominantly Inherited Alzheimer Network (DIAN) and its clinical trials unit, DIAN-TU. Dr. Benzinger co-chairs the Radiological Society of North America (RSNA) Quantitative Imaging Committee (QuIC) and the American Society for Neuroradiology (ASNR) Alzheimer Disease, ARIA and Dementia Study Group.

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.

Hearn Jay Cho MD, PhD is Clinical Professor of Medicine at the Icahn School of Medicine at Mt. Sinai and an Attending Physician with the Multiple Myeloma Center of Excellence at the Mt. Sinai Tisch Cancer Institute. Dr. Cho’s laboratory is investigating novel therapies for multiple myeloma in two areas. First, they are investigating immunologic therapies with a focus on using cutting-edge genomic and immunologic assays to map the interaction between myeloma and the immune system in the tumor microenvironment. These projects illuminate the mechanisms of action of novel immune therapies in both laboratory models and clinical trials and will inform the design of rational combinations. This program has a special focus on immunologic therapy in the setting of autologous stem cell transplantation for myeloma. Second, Dr. Cho’s group discovered that two of the type I Melanoma Antigen GEnes (MAGE), MAGE-A3 and MAGE-C1, are commonly expressed in multiple myeloma and are correlated with progression of disease and proliferation. The group demonstrated that type I MAGE plays a critical role in conferring resistance to chemotherapy and inhibition of apoptosis in myeloma cells through regulation of Bcl-2 family proteins and the tumor suppressor p53. Dr. Cho’s group is conducting biochemical and structural studies to identify novel pharmacologic strategies for inhibition of type I MAGE activity in myeloma.

In 2019 Dr. Cho joined the Multiple Myeloma Research Foundation (MMRF) as Chief Medical Officer. Dr. Cho is responsible for the MMRF’s clinical research strategy. Health Equity is a core value of the MMRF mission, and equitable access and participation in MMRF clinical trials are guiding principles. MMRF clinical trials are conducted through the Multiple Myeloma Research Consortium, a group of 21 leading research centers dedicated to advancing treatment options for multiple myeloma patients.

Dr. Cho received his MD and PhD in Immunology from Cornell University Medical College (now Weill Medical College), was a resident in the Internal Medicine Investigator Track at UC San Diego Medical Center, and did his clinical fellowship in Hematology and Medical Oncology at New York-Presbyterian Hospital/Weill Cornell Medical Center. He did post-doctoral studies at UCSD and The Rockefeller University in New York City. Dr. Cho is on the Board of Directors of Solving Kids Cancer, a pediatric cancer non-profit foundation, he serves on the Biomarker Consortium Executive Committee of the Foundation for the National Institutes of Health, and is an expert reviewer in multiple myeloma for the Cancer Research Institute.

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.

Dr. Michael Montalto Ph.D., Vice President of Precision Medicine, Global Development since February 2024.

Dr. Montalto is a transformational research and development leader with 25 years of experience in both diagnostic device and pharmaceutical companies including a strong history of leading large multidisciplinary teams from innovation to development and commercialization. He is considered an industry leader in digital pathology and artificial intelligence applications for biomarker discovery and has further served in several senior functional leadership roles for in-vitro diagnostic devices including research, development, clinical, medical, regulatory, business development and commercial organizations. In his current role as Vice President of Precision Medicine at Amgen, Dr. Montalto is responsible of the strategy and execution of translational and precision medicine in support of discovery biology, clinical development, and companion diagnostics, across all global therapeutic areas.

Prior to Amgen, Dr. Montalto served as the Chief Scientific Officer of PathAI, a leading start-up technology company developing AI-powered digital pathology and software platforms for biopharmaceutical and diagnostic healthcare industries. Under his leadership, the company launched over 25 AI-based product applications, received multiple IVD regulatory clearances in the US and EU, established biopharma laboratory clinical trial services/CLIA certification, published several high impact journal articles including Nature Medicine and Nature Communications, and helped establish record growth of their sales funnel.

Prior to PathAI, Dr. Montalto led the Translational Sciences Organization as a Vice President at Bristol Myers Squibb, comprising all clinical biomarker platform laboratories, as well as pathology, radiology, sample operations and biobank in support of all therapeutic areas and companion diagnostic development. During his tenure, his team supported flagship biomarker testing programs such as PharmDx 28-8 (PD-L1/Agilent), Tumor Mutational Burden (Roche/Foundation Medicine), ctDNA/MRD (Illumina, ThermoFisher) for drug program Opdivo (Nivolumab), Yervoy (Ipililumab) and Opdualag (Relatlimab).

Dr. Montalto has significant entrepreneurial experience leading teams to invent and develop novel spatial multiplexing (MxIF) technology platforms within General Electric Global Research (GE GRC) Division, which are currently on the market through Danaher/Cytiva (CellDive™) and Neogenomics (Multiomyx™). Additionally, he led teams that pioneered novel digital pathology imaging and software technologies (Dynamx™; VL4/120™) that served as the basis for a joint venture that he co-founded between GE Healthcare and the University of Pittsburgh Medical Center (Omnyx, LLC) that was sold to Inspirata Inc in 2018 and subsequently Fuji, Inc in 2023.
Dr. Montalto is currently serving on several steering committees 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. Dr. Montalto has previously served on NIH Study Sections for In Vivo Molecular Imaging Centers, as well as, serving on the Digital Pathology Association Executive Committee as President and a long-standing member of their Board of Directors. He has served as a scientific advisor to Lieca and Perkin Elmer/Akoya and various start-up companies in the digital pathology sector. He also holds ten US issued patents. He received his PhD from Albany Medical College in tumor biology and post-doctoral fellowship training at Brigham and Women’s Hospital and Harvard Medical School in Cardiovascular Anti-inflammatory drug discovery.

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.

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.