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Master Protocol Workshop


  • Daniel  Millar, MBA

    Daniel Millar, MBA

    • Senior Director, Strategic Business Transformation Quantitative Sciences
    • Janssen Research & Development, United States

    Daniel Millar leads Strategic Business Transformation in Quantitative Sciences at Janssen R&D. He is an advocate for utilizing quantitative innovation to advance patient-centric R&D while simultaneously delivering transformational efficiencies. Daniel is a founding leader and champion for multi-stakeholder engagement in the recently launched Innovative Medicines Initiative (IMI) public-private partnership for Integrated Research Platforms. Daniel obtained a MBA from the University of Chicago Booth School of Business and a BA in Mathematics from the University of Pennsylvania. He lives in Manhattan and enjoys traveling. His current “country number” is 115.

  • Abby  Bronson, MBA

    Abby Bronson, MBA

    • Vice President, Patient Advocacy and External Innovation
    • Edgewise Therapeutics, United States

    Abby Bronson is the Vice President of Patient Advocacy and External Innovation at Edgewise Therapeutics where she leads patient advocacy and external relationships within the Muscular Dystrophy community. Previously she was Senior Vice President of Research Strategy at PPMD, focusing on Duchenne Muscular Dystrophy. She has experience from a variety of areas, including NIH, Children's National Medical Center and MedImmune. She holds an MBA from the Wharton School of Business at the University of Pennsylvania and a BA from the University of Vermont.

  • Amy  Burd, PhD

    Amy Burd, PhD

    • Vice President, Research Strategy
    • Leukemia & Lymphoma Society, United States

    Amy Burd, Ph.D., is vice president of research strategy for The Leukemia & Lymphoma Society. Dr. Burd first began working with LLS in 2009 as senior director of LLS’s Therapy Acceleration Program. In her current role, Dr. Burd provides strategic planning and oversight for mission special initiatives. She also leads LLS’s Beat AML initiative, a significant multi-institution collaboration to change the paradigm of treatment and improve outcomes for patients with acute myeloid leukemia (AML).

  • Michelle  Detry, PhD

    Michelle Detry, PhD

    • Director, Adaptive Trial Execution & Senior Statistical Scientist
    • Berry Consultants LLC, United States

    Michelle Detry, PhD, is the Director of Adaptive Trial Execution and a Senior Statistical Scientist for Berry Consultants. Dr. Detry’s expertise is in the implementation of adaptive clinical trials, including platform trials. As part of her role in implementing Berry Consultant’s trial designs she is a member of numerous statistical analysis committees that conduct the interim analyses. In addition, she has expertise in clinical trial design, reporting for Data Monitoring Committees, and also serves on Data Monitoring Committees.

  • Sudheer  Doss, PhD

    Sudheer Doss, PhD

    • Chief Data Officer and Head of Business Development
    • Pancreatic Cancer Action Network, United States

    As Chief Data Officer of the Pancreatic Cancer Action Network (PanCAN), Sudheer is responsible for the health data generated from PanCAN’s scientific and clinical initiatives. Prior to joining PanCAN, Sudheer worked as a management consultant for over a decade where he led a variety of strategic initiatives, including market entry strategies, deals-related operational / commercial due diligence, and business launch strategies, all related to genomic medicine. Sudheer completed his doctorate and post-doctoral research at UCLA in the Department of Human Genetics where his research combined areas of network theory with genetics and global gene expression data to elucidate the genetic underpinnings of disease

  • AnnCatherine M. Downing, PharmD

    AnnCatherine M. Downing, PharmD

    • Chief Operating Officer - Lilly Research Laboratories
    • Eli Lilly and Company, United States

    AnnCatherine Downing received her Doctor of Pharmacy degree from Butler University in Indianapolis, Indiana. She has over 17 years of pharmaceutical industry experience across all phases of clinical development. She is currently a Sr. Clinical Research Advisor in Eli Lilly and Company's Design Hub responsible for clinical trial design across the neuroscience portfolio.

  • Kimberly Ann Fisher, MA

    Kimberly Ann Fisher, MA

    • Project Manager for Master Protocol Project
    • Clinical Trials Transformation Initiative (CTTI), United States

    Ms. Fisher manages the development and implementation of CTTI projects. In collaboration with team leaders, she creates project plans and budgets, and manages the implementation of those plans. Ms. Fisher has over 7 years of project management experience in diverse research, clinical, and community settings. Prior to working at CTTI, her research and advocacy efforts largely focused on community-driven health education and research initiatives with low-income communities. She has served as a lead coordinator for research studies and community health education initiatives funded by the NIH, public health departments, pharmaceutical companies, and private foundations.

  • Scott M Berry, PhD

    Scott M Berry, PhD

    • President and Senior Statistical Scientist
    • Berry Consultants LLC, United States

    Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests are in Bayesian Analysis, Design of Innovative Trials, Platform Trials, Clinical Trial Simulation, and Hierarchical Modeling.

  • Lisa  LaVange, PhD

    Lisa LaVange, PhD

    • Professor and Chair, Department of Biostatistics
    • University of North Carolina At Chapel Hill, United States

    Lisa LaVange, PhD, is Professor and Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill and former director of the department’s Collaborative Studies Coordinating Center (CSCC). From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and was the 2018 ASA President.

  • Randall J. Bateman, MD

    Randall J. Bateman, MD

    • Charles F. and Joanne Knight Distinguished Professor of Neurology
    • Washington University School of Medicine, United States

    Randall Bateman, MD is the Charles F. and Joanne Knight Distinguished Professor of Neurology. His research focuses on the pathophysiology and development of diagnostics and treatments of Alzheimer’s disease. His lab accomplishments include pioneering central nervous system Stable Isotope Labeling Kinetics (SILK) measurements in humans, furthering insights of human circadian patterns of amyloid-beta and soluble APP, and developing a blood test for brain amyloid plaques. Dr. Bateman directs the DIAN-TU, which launched the first prevention trial in families with early onset Alzheimer’s disease. The DIAN-TU trial is a global adaptive trial platform testing the most advanced therapeutics targeting Alzheimer’s disease.

  • Heather  Dobbins, PhD

    Heather Dobbins, PhD

    • Lead Results Analyst, NCBI/NLM
    • National Institutes of Health (NIH), United States

    Dr. Heather Dobbins holds a Staff Scientist position in the National Center for Biotechnology Information (NCBI) at the National Library of Medicine, where she serves as the Lead Results Analyst for In this capacity she oversees the submission, quality review process and investigator assistance services for the Basic Results Database. Dr. Dobbins earned a B.S. in Physics, a B.S. in Biology and a Ph.D. in Neuroscience. She held a dual appointment as a Postdoctoral Research Associate and Howard Hughes Medical Institute Teaching and Learning Fellow in the Physics Education Research Group at the University of Maryland. She has been a member of the Results Team since 2009.

  • Gregory  Levin, PhD

    Gregory Levin, PhD

    • Deputy Director, DBIII, OB, OTS, CDER
    • FDA, United States

    Greg Levin is a supervisory mathematical statistician at the Center for Drug Evaluation and Research within FDA. He joined FDA after receiving a PhD in biostatistics from the University of Washington in 2012. At FDA, Greg has helped regulate products across a wide range of therapeutic areas. His research interests include missing data, adaptive design, labeling, and making real-world inferences from clinical trials.

  • Sabrina  Paganoni, MD, PhD

    Sabrina Paganoni, MD, PhD

    • Assistant Professor
    • Harvard Medical School, Healey Center for ALS at Mass General, United States

    Sabrina Paganoni, MD, PhD is a physician investigator at the Healey Center for ALS at Mass General, Co-Director of the Neurological Research Institute at the Massachusetts General Hospital and Assistant Professor at Harvard Medical School. Dr Paganoni’s research focuses on clinical trials and therapy development for ALS. She has served as the Principal Investigator of many ALS clinical trials and has been using novel neuroimaging techniques, bio-fluid biomarkers and digital technology as measures of target engagement in these trials. Currently, she is the co-Principal Investigator of the HEALEY ALS Platform Trial. Her research has been funded by the NIH, several ALS Foundations and non-profits, and industry.

  • Dionne  Price, PhD

    Dionne Price, PhD

    • Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
    • FDA, United States

    Dr. Price is the Director of the Division of Biometrics IV providing leadership of analytical assessments in a regulatory setting. On the Senior Leadership Team and Statistical Policy Council, Dr. Price promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section and on the Regional Committee of the Eastern North American Region of IBS. She is a Fellow of the ASA and an elected VP. With an MS in Biostatistics from UNC, and PhD from Emory, her research interests focus on clinical trial designs. She has co-authored papers in Statistics in Medicine, Clinical Trials, and Statistics in Biopharmaceutical Research.

  • Robin M. Weinick, PhD

    Robin M. Weinick, PhD

    • SVP/Managing Director Americas and Global Program Officer
    • DIA, United States

    Robin M. Weinick, PhD. brings 25 years of experience to her DIA role as Senior Vice President & Managing Director, Americas, and Global Program Officer.Robin joins DIA from RTI International, a large, nonprofit research institute dedicated to improving the human condition. She also has served as Associate Director for Health at the RAND Corporation, a premier U.S.-based think tank, and on the faculty of Harvard Medical School and Massachusetts General Hospital. She began her career in federal service with the U.S. Department of Health and Human Services. She holds a B.A. in Health and Society from the University of Rochester and a Ph.D. on Population Dynamics from Johns Hopkins University.

  • Shanna  Allen, MPH

    Shanna Allen, MPH

    • Clinical Operations Regional Lead
    • Global Coalition for Adaptive Research, United States

    Shanna Allen is a Clinical Operations Regional Lead at the Global Coalition for Adaptive Research (GCAR) with over 15 years of experience in managing, leading, monitoring, and coordinating domestic and global Phase I-IV clinical trials across various therapeutic areas. As a Clinical Operations Regional Lead, she oversees the operational activities of master protocols, focusing on establishing processes for the appropriate handling of data. Prior to GCAR, Shanna served in management roles at pharmaceutical and biotechnology companies responsible for leading multidisciplinary teams in the execution of clinical trials from initiation through close-out.

  • Donald A Berry, PhD

    Donald A Berry, PhD

    • Professor, Department of Biostatistics
    • M.D. Anderson Cancer Center, United States

    Donald Berry is a professor in the Department of Biostatistics of the University of Texas M.D. Anderson Cancer Center. He has held endowed faculty positions at Duke University and at M.D. Anderson. Dr. Berry has authored over 400 publications. He is listed by as one of The World’s Most Influential Scientific Minds in Clinical Medicine in 2014. Through Berry Consultants he has designed innovative clinical trials in all therapeutic areas for industry and international consortia.

  • Marianne K Chase

    Marianne K Chase

    • Senior Director of Clinical Trial Operations
    • Neurological Clinical Research Institute, Massachusetts General Hospital, United States

    Marianne Kearney Chase is currently the Senior Director of Clinical Trial Operations for the Neurological Clinical Research Institute, and the Healey Center for ALS Research at MGH. She is an active member of the Clinical Trial Transformation Initiative (CTTI) and has over 25 years of experience in both investigator initiated NIH/ foundation funded, and industry sponsored research including protocol development, regulatory strategy and compliance, and project management. She also serves as an adjunct faculty member for the NINDS funded Clinical Trials Methodology Course and has developed and presented course on a variety of topics.

  • Lennie  Derde, MD, PhD

    Lennie Derde, MD, PhD

    • Intensivist and Clinician Researcher
    • UMC Utrecht, Netherlands

    Dr. Lennie Derde is a clinician-researcher focussing on sepsis and severe infections in ICU and innovative trial design. She works at the UMC Utrecht as ICU consultant. She obtained a PhD on antibiotic resistance in the ICU in 2013 . She has been involved in REMAP-CAP since 2015, chairs the European RMC and is a member of the ITSC and various expertise groups. She recently obtained a Dutch grant (ZonMw) to investigate anakinra treatment of COVID-19 patients. Lennie chairs the Dutch ICU Taskforce for Infectious Threats.

  • Benjamin  Hofner, PhD

    Benjamin Hofner, PhD

    • Head of Section Biostatistics
    • Paul-Ehrlich-Institut, Germany

    Benjamin Hofner is Head of Section Biostatistics at the Paul-Ehrlich-Institut (PEI). In this role he is involved in the assessment of Marketing Authorisation Applications and Clinical Trial Applications and provides Scientific Advice to stakeholders. He is observer at the EMA Biostatistics Working Party and Adjunct Lecturer for Biostatistics at the medical school at FAU Erlangen-Nuremberg. Benjamin is involved in the IMI project EU-PEARL on patient centric research platforms as regulatory task lead. Benjamin graduated in Statistics from the LMU Munich where he also obtained his PhD.

  • Jane  Perlmutter

    Jane Perlmutter

    • Patient Advocate, United States

    Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of research questions, design of trial protocols, and encouraging innovation to increase the speed of developing new treatments. She is also involved in health research policy, including projects with CTTI, RUF and PCORI.

  • Janet  Woodcock, MD

    Janet Woodcock, MD

    • Acting Commissioner
    • FDA, United States

    Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER, overseeing the center’s work that is the world’s gold standard for drug approval and safety. In that position, she has led many of the FDA’s groundbreaking drug initiatives. She has also served in other leadership roles at the FDA, including as Deputy Commissioner and Chief Medical Officer.With the onset of the COVID-19 public health emergency last year, Dr. Woodcock was asked to lend her expertise to “Operation Warp Speed” the initiative to develop therapeutics in response to the pandemic. Dr. Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021.

  • Janice  Chang

    Janice Chang

    • Chief Operating Officer
    • TransCelerate Biopharma Inc., United States

    Janice Chang is the Executive Vice President at TransCelerate BioPharma Inc. In her position, Janice works closely with the CEO and the Board of Directors to shape the long-term strategic vision and objectives for the organization and its 30+ initiatives. Janice defines and guides TransCelerate’s overall external engagement strategy with international regulatory bodies, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 nations. She has accountability overseeing TransCelerate’s corporate operations and the ongoing delivery of the initiatives’ tools and deliverables. In her role, Janice also actively serves in ongoing cross-stakeholder discussions to help evolve our R&D paradigm. She is passi

  • Philip John Green

    Philip John Green

    • Patient Advocate
    • Person Living With ALS, United States

    Phil was diagnosed with ALS in August of 2018 and immediately dedicated himself to making a difference in the fight against ALS. Phil is active with multiple ALS organizations and institutions (Team Gleason, I AM ALS, Augie’s Quest, ALS TDI, ALS Cure Project, UW Medicine, ALSA) with promoting ALS legislation and policies, increasing awareness and raising funds to find effective treatments and cures, and bringing the patient voice to biopharma companies on clinical trial design. He was a Patient Fellow at the 2019 International Symposium on ALS/MND and has also served as a Consumer Reviewer for the DoD ALS Research Program. Phil is a graduate of the University of Washington where he was on the 1991 National Championship UW Football team.

  • Raj  Malathker

    Raj Malathker

    • Senior Manager, Quantitative Sciences IT
    • Janssen Pharmaceutical , United States

    Raj Malathker is currently the Sr. IT Manager (Business Technology Leader) within Pharma R&D IT at The Janssen Pharmaceutical Companies of Johnson & Johnson. Raj joined J&J in 2011 and his key responsibilities have been to define strategies and enable innovative technology solutions around Adaptive Clinical Trials, High Performance Computing for Pharmacometrics and Statistical Programming, in liaison with Pharma R&D groups such as Quantitative Sciences, Clinical Pharmacology & Pharmacometrics. Raj has a Computer Science & Engineering degree from Mysore University, India.

  • Lindsay  McNair, MD, MPH, MS

    Lindsay McNair, MD, MPH, MS

    • Chief Medical Officer
    • WCG, United States

    Lindsay McNair, MD, MPH, MS in Bioethics is the Chief Medical Officer for the WIRB-Copernicus Group (WCG). She oversees the physician team within the WCG IRB, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design, regulatory compliance, human subject protection, and ethical policy development. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical oversight of all phases of clinical trials.

  • Gustavo  Mendes Lima Santos, MPharm

    Gustavo Mendes Lima Santos, MPharm

    • General Manager of Medicines and Biological Products
    • ANVISA, Brazil

    General Manager of Medicines and Biological Products at ANVISA, Brazil. Responsible for the management of drug and biological product registration submission evaluation teams, authorization to conduct clinical trials in Brazil, and certification of bioequivalence centers. I have been working at ANVISA, Brazil since 2003 mostly with bioequivalence / biowaiver studies and clinical trial evaluations. I'm a pharmacist with specialization in public health, I also holds a Master of Toxicology.

  • Susan  Mills

    Susan Mills

    • Senior Director, Clinical Operations
    • Washington University School of Medicine, DIAN Trials Unit, United States

    Susan Mills is the Senior Director, Clinical Operations within the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University in St. Louis, School of Medicine. She has a BS in both Chemistry and Biology from the University of California, Irvine, and while starting at the bench in cellular gastroenterology, she quickly found her passion in clinical research management, which proved to be a far more engaging and vocal subject matter. Over the past 20 years, she has both managed and directed global clinical trials over a broad therapeutic range of programs, including Phase II through IV trials contributing to approvals of NDAs, ANDAs, and BLAs.

  • Jay JH Park, MSc

    Jay JH Park, MSc

    • Director of Trials Research
    • Cytel, Canada

    My research interests include adaptive trial designs and master protocols and their application to low- and middle-income countries for global health. I currently act as the Director of Trials Research at Cytel. Prior to Cytel, I was an Associate Director of Trials Research at MTEK Sciences (acquired by Cytel in December 2019), a boutique analytics firm specializing in innovative clinical trial designs and data analyses for global health. He is part of the Clinical Trials Unit that provides consulting services to the Bill and Melinda Gates Foundation. I currently teach a graduate-level course on adaptive trial designs and master protocols (HRM 732) at the Department of Health Research Methods, Evidence, and Impact at McMaster University.

  • Cecile  Spiertz, MSc

    Cecile Spiertz, MSc

    • Senior Director, External Innovation Clinical Trial Platforms
    • Janssen, Netherlands

    Cecile Spiertz is a senior director at J&J, Head External Innovation, Clinical Trial Platforms and current project lead for the IMI Project EU-PEARL. She has a strong operational track record in successful delivery of global clinical development programs for Janssen Immunology R&D in her most recent positions as Global Operations Head and Strategy&Operations Lead for the Immunology clinical development organisation. She brings > 25 years of experience in phase 1, 2, 3 of drug development in various scientific and operational leadership roles, in different companies and is highly skilled in leading global cross-functional teams and innovation projects.

  • Tina  Gislimberti, MA

    Tina Gislimberti, MA

    • CNS Project Management
    • IQVIA, United States

    Tina Gislimberti is a Project Manager Director with considerable experience in oversight, management and coordination of multi-centre international clinical projects and project teams. Experience includes over 20 years within clinical project management. Tina's responsibilities have included customer project/program oversight, escalation point, primary key contact, budget and finance management, study document management, overall study conduct.

  • Sundeep Surendra Sethi, MD, MBA

    Sundeep Surendra Sethi, MD, MBA

    • Vice President, Safety Operations
    • AbbVie, Inc., United States

    Dr. Sethi is VP Safety Operations at AbbVie. In 15 years in the pharmaceutical industry he has held roles in clinical development, regulatory affairs, medical affairs, and pharmacovigilance. Prior to industry Dr. Sethi worked at the Boston Consulting Group. His passions are transforming business process, technology, and organizations to realize higher performance and cross-company collaborations to advance industry capabilities. In 2019 Dr. Sethi was diagnosed with ALS, a progressive and fatal neurodegenerative disorder. While it has taken a significant toll he remains active in driving advocacy and research efforts for all patients and families stricken by this challenging disease. Dr. Sethi earned his BS, MBA, & MD from UCLA.

  • Sumithra  Mandrekar, PhD

    Sumithra Mandrekar, PhD

    • Biostatistician
    • Mayo Clinic, United States

    Dr. Mandrekar is a Professor of Biostatistics and Oncology as well the Group Statistician for the Alliance for Clinical Trials in Oncology and Section Head for Cancer Center Statistics at Mayo Clinic. Her primary areas are lung cancer and leukemia. She is the faculty statistician for the national adjuvant lung cancer trial, ALCHEMIST, which is part of the NCI precision medicine initiative. Her research interests include adaptive dose-finding trial designs for Phase I trials, designs for predictive biomarker validation, and general clinical trial methodology related to identification of alternative Phase II cancer clinical trial endpoints. Dr. Mandrekar has co-authored140+ original papers, several book chapters and editorials.

  • Phyllis Barkman Ferrell, MBA

    Phyllis Barkman Ferrell, MBA

    • Global Head, External Engagement, Alzheimer's Disease and Neurodegeneration
    • Eli Lilly and Company, United States

    Phyllis Ferrell is the Global Head of External Engagement for Alzheimer’s disease and Neurodegeneration at Lilly. Ferrell has been an industry leader in Alzheimer's R&D for a decade and has been with Lilly for more than 25 years. Ferrell received a BA in economics from DePauw University and received an MBA in general management and a healthcare public management from Stanford. Phyllis was recognized as a Rising Star from the Healthcare Businesswomen’s Association and the Indianapolis Star Top 40 Under 40. Phyllis is a current member of the World Dementia Council and is on Executive Boards for the Indiana Alzheimer's Association, EdoN, the Indianapolis 500 Festival, and is co-chair of the Women Against Alzheimer's Leadership Council

  • Stephen  Finger, PhD

    Stephen Finger, PhD

    • ALS Patient Advocate
    • HEALEY ALS Platform Trial Patient Advisory Committee, United States

    Stephen Finger was diagnosed with ALS in 2013. A vocal advocate, Stephen actively participated in drafting the ALS Community Developed Guidance Document submitted to the FDA and served as a panelist at the ALS Guidance Workshop in 2018. He was a Patient Fellow during the 2017 ALS/MND International Research Symposium. He was awarded the 2014 Stephen Milne Adventurous Spirit Award by the ALS Therapy Development Institute. After earning degrees from Princeton and Duke, Dr. Finger was an economics professor at the Moore School of Business at the University of South Carolina. He now resides in Atlanta with his wife and two kids.

  • Tobias  Mielke, PhD

    Tobias Mielke, PhD

    • Janssen Pharmaceutical
    • Scientific Director, Germany

    Tobias Mielke is a Scientific Director in Janssen's internal Quantitative Science consulting group, where he supports compound development teams with his expertise on adaptive designs. Prior to joining Janssen in 2018, Tobias worked at ICON Clinical Research, where he specialized on adaptive designs through numerous adaptive design consultancy projects. In his role at ICON, Tobias led the methodological development of ADDPLAN DF, a software for the design, simulation and analysis of adaptive dose-finding studies. Tobias applies this experience currently in the IMI project EU-PEARL as a co-lead for the development of a platform trial design & simulation software.

  • Roger J. Lewis, MD, PhD

    Roger J. Lewis, MD, PhD

    • Professor and Chair, Department of Emergency Medicine
    • Harbor-UCLA Medical Center, United States

    Dr. Lewis is Professor and Chair in the Department of Emergency Medicine at Harbor-UCLA Medical Center and the Senior Medical Scientist at Berry Consultants, with expertise in the design and oversight of adaptive clinical trials. He is a member of the National Academy of Medicine, the Board of Directors for the Society for Clinical Trials, and the Blood Products Advisory Committee of the FDA/CBER. He has served as a member of the Medicare Evidence Development & Coverage Advisory Committee for CMS and chaired numerous data and safety monitoring boards (DSMB) for both federally-funded and industry-sponsored clinical trials. He has authored or coauthored over 240 original research publications, reviews, editorials, and chapters.

  • Geoffrey  Kerchner, MD, PhD

    Geoffrey Kerchner, MD, PhD

    • Global Development Leader
    • F. Hoffmann-La Roche, Ltd., Switzerland

    Geoffrey A. Kerchner, MD, PhD is a neurologist and neuroscientist and Global Development Leader at F. Hoffmann-La Roche, Ltd., in Basel, Switzerland. He graduated summa cum laude from Harvard University, completed MD and PhD degrees at Washington University School of Medicine, and completed a residency, postdoctoral fellowship, and behavioral neurology fellowship at the University of California, San Francisco. He was on the faculty of Stanford School of Medicine before joining Genentech/Roche in 2015, where he led early-stage clinical development teams in Alzheimer's disease and ALS. He moved to Basel in 2018 to lead the late-stage clinical development team for gantenerumab in Alzheimer's disease.

  • Nicholas  Richardson, DO, MPH

    Nicholas Richardson, DO, MPH

    • Clinical Team Leader, Division of Hematologic Malignancies 2, OND, CDER
    • FDA, United States

    Nicholas C. Richardson DO, MPH, is a pediatric oncologist in the Division of Hematologic Malignancies 2 within the Office of Oncologic Diseases, at the Food and Drug Administration (FDA). Prior to joining the FDA, he completed his pediatric residency and chief residency at A.I. duPont Hospital for Children/Thomas Jefferson University and fellowship in pediatric hematology and oncology at Vanderbilt University Medical Center. Dr. Richardson’s is currently a clinical team leader for lymphoma drug development and his clinical interest include Hodgkin and non-Hodgkin lymphoma, pediatric drug development in oncology, patient advocate engagement, and innovative trials designs such as master protocols.

  • Vivek  Subbiah, MD

    Vivek Subbiah, MD

    • Executive Director, Cancer Medicine Research
    • UT MD Anderson Cancer Center , United States

    I am an Associate professor in the Department of Investigational Cancer Therapeutics, Associate Professor in Division of Pediatrics, the Center Clinical Medical Director of the Clinical Center for Targeted Therapy ( Phase 1 Clinical Trials Program) and Executive Director of Cancer Medicine Research, MD Anderson Cancer Network. I serve as the Principal Investigator in over 50 Phase I/II trials. My research interests are drug development in rare cancer. I have led several first-in-human and practice changing novel basket trials leading to FDA approval in rare diseases in BRAF V600E and RET inhibitor space. Published several prestigious journals eg. NEJM, JCO, Cancer Discovery, Lancet Oncology & JAMA Oncology

  • Gene  Vinson

    Gene Vinson

    • Executive Director
    • Syneos Health, United States

    Gene Vinson has over 15 years’ experience in a clinical research organization (CRO) and is currently the Senior Director of Global Data Technologies in Biometrics at Syneos Health. Gene has lead the implementation of multiple EDC Systems and is an expert in the implementation of Electronic Data Capture. Gene is currently working with eSource systems, wearables and the integration of Electronic Health Record data into EDC systems and the integration of clinical data into the Syneos Health Data Lake, development of reporting and analytics data for analysis and trial management.

  • Kert  Viele, PhD

    Kert Viele, PhD

    • Director and Senior Statistical Scientist
    • Berry Consultants, United States

    Kert Viele is a leader in clinical trial implementation of Bayesian hierarchical modeling, with expertise in platform and basket trials as well as clinical trials incorporating the use of historical information. Prior to joining Berry Consultants in 2010, he was a faculty member at the University of Kentucky, where he received the Provost’s Award for Outstanding Teaching and was an investigator for NSF and NIH funded research. A former editor of the journal Bayesian Analysis, Dr. Viele is also an author of FACTS, clinical trial simulation software currently licensed to multiple pharmaceutical, academic, and government organizations.