Virtual Hill Briefing: Strengthening FDA’s Biomarker Qualification Program – Speaker Biographies
Click here to learn more about the Virtual Hill Briefing and explore the agenda.
Opening Keynote
The Honorable Tim Kaine
U.S. Senator (D-VA)
Senator Tim Kaine was elected to the Senate in 2012 and serves on the Armed Services; Budget; Foreign Relations; and Health, Education, Labor, and Pensions (HELP) Committees.
Tim has made boosting job opportunities for everyone a top priority. As co-chair of the
bipartisan Career and Technical Education (CTE) Caucus, Tim focuses on expanding access to job-training programs to ensure that students of all ages are prepared with the skills they need for the jobs of the modern economy. Tim has also led successful efforts in the Senate to reduce unemployment for military families and veterans.
As a senator from one of the states most closely connected to the military and the father of a Marine Reservist, Tim is focused on crafting smart defense strategy and reducing the risk of unnecessary war. He works to ensure that the military has the resources it needs to keep the country safe and that service members and veterans receive the benefits and care they have earned. He has also been the leading voice against presidents starting wars without a vote by Congress.
Tim believes that health care is a right, not something reserved just for those who can afford it, and has consistently pushed for reforms to expand access to quality care. This includes legislation to give Americans more options for affordable health insurance and to combat the opioid abuse epidemic.
Tim grew up working in his father’s ironworking shop in Kansas City. His parents taught him the value of hard work and showed him how small businesses and technical skills strengthen this country every day. After graduating from the University of Missouri, he started his public service career by running a technical school founded by Jesuit missionaries in Honduras. He trained teenagers to become carpenters and welders, equipping them with skills to lift up themselves and their communities.
He was first elected to office in 1994, serving as a city council member and then Mayor of Richmond. He became Lieutenant Governor of Virginia in 2002 and was inaugurated as Virginia’s 70th Governor in 2006. He is married to Anne Holton, who served as Virginia Secretary of Education from 2014 until 2016 and as the Interim President of George Mason University from 2019 until 2020; she now teaches education policy at GMU. They both revel in the adventures of their three grown children and live in Richmond.
Panel Discussion: Strengthening the Biomarker Qualification Framework
Rasika Kalamegham, PhD
Head, US Regulatory Policy
Genentech, a member of the Roche group
Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy and Intelligence at Genentech, a member of the Roche Group. She joined Genentech in 2015 bringing considerable, scientific, regulatory and policy experience to her role. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy.
Steve Hoffmann, MS
Vice President, Science Partnerships
Foundation for the National Institutes of Health
Steve Hoffmann is Vice President of Science Partnerships at the Foundation for the National Institutes of Health (FNIH), where he leads strategic planning and programmatic oversight across major public–private partnerships, including the Biomarkers Consortium and Accelerating Medicines Partnership. He has longstanding involvement in the development, validation, and regulatory qualification of translational biomarkers and endpoints to support drug development and clinical practice. His work spans a broad range of therapeutic areas, including neuroscience, rare diseases, organ toxicity, infectious diseases, and autoimmune and inflammatory conditions. Steve has a broad background in the academic, government and industry sectors in the field of translational biomarkers, molecular immunology and precision medicine. Prior to FNIH, he supported diagnostic development at Meso Scale Discovery and led translational research efforts in transplantation and autoimmunity at NIDDK. Steve holds a Master of Science degree in Pathology and Laboratory Medicine from the University of North Carolina at Chapel Hill and a Bachelor of Science degree in Biochemistry and Biophysics from the University of Pittsburgh.
Michael Montalto, PhD
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.
Lauren Oliva, PharmD
US Regulatory Policy Lead
Biogen
Lauren Oliva is the U.S. Lead for Regulatory Policy at Biogen, where she develops and implements policy strategies to support innovation in drug development. Her work focuses on aligning science, regulation, and advocacy to better serve patients and ensure their needs are reflected in how new therapies are developed. She’s driven by a belief that good policy should be clear, collaborative, and focused on delivering value to the people it’s meant to serve.
With 15 years of experience in the pharmaceutical industry, Lauren has contributed to multi-stakeholder efforts through the Critical Path Institute, Duke-Margolis Institute for Health Policy, the Clinical Trials Transformation Initiative (CTTI), the National Academies’ Drug Forum, and serves on the Program Committee for the Drug Information Association (DIA). She earned her Doctor of Pharmacy from Rutgers University and has served as adjunct faculty at MCPHS University in Boston.
Katy Wack, PhD
SVP, Clinical Science
PathAI
Katy Wack, PhD is Senior Vice President and Head of Clinical Science at PathAI, where she leads clinical development and diagnostic strategy for AI-powered pathology tools. Since joining PathAI in 2019, she has been at the forefront of integrating artificial intelligence and digital pathology into regulated medical contexts — most notably spearheading the AIM-NASH Drug Development Tool qualification effort that resulted in the first-ever AI-based Drug Development Tool qualified by both the FDA and EMA in 2025. She also led the clinical submissions that secured 510(k) clearance for PathAI’s AISight Dx viewer across four whole slide imaging scanners, and achieved the first Pre-Determined Change Control Plan (PCCP) for a digital image management (IMS) system — a landmark in adaptive regulatory frameworks for AI/ML-based devices.
Katy brings decades of experience spanning drug development, digital pathology, and translational science. Prior to PathAI, she served as VP of Development at an immunotherapeutics company where she led assay, preclinical, and process development, and as Lead Clinical Scientist at a digital pathology company, where she directed a four-site PMA clinical study for primary diagnosis and published and patented novel analytical methods. She has served as board member of the Digital Pathology Association and has been a longstanding voice in advancing the field at the intersection of science, technology, and regulation. She holds a BS from Carnegie Mellon University, an MS from MIT, and a PhD from the University of Pittsburgh in Cell Biology and Pathology.