Master Protocol Workshop

Speakers

• 

  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.

• 

  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.

• 

  Daniel Millar, MBA

  • Senior Director, Strategic Business Transformation
  • 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.

• 

  MaryAnn Morgan-Cox, PhD

  • Senior Director, Immunology Design Hub
  • Eli Lilly and Company, United States

  MaryAnn Morgan-Cox is a Sr Director and Leader of the Immunology Design Hub at Eli Lilly and Company, where she focuses on innovative approaches to drug development, clinical research, commercialization, and portfolio management.

• 

  Michael Krams, MD

  • Vice President, Global Head of Quantitative Sciences
  • Janssen R&D, Johnson & Johnson, United States

  Dr. Michael Krams is Global Head of Quantitative Sciences (QS) at Janssen R&D. Mike has created the vision, strategy and operating model for QS, a group of ~ 420 statisticians, modelers and clinical pharmacologists, to apply quantitative intelligence and model based drug development across all therapeutic areas. Mike 's ambition is to bring innovative approaches and “critical path philosophy” to drug development, to facilitate making the correct decision at the earliest timepoint, in the most efficient manner possible. Mike is recognized as an expert in adaptive designs, enabling real-time learning and decision making in Learn and Confirm studies.

• 

  Zoran Antonijevic, MSc

  • Vice President, Statistical Consulting
  • Abond CRO Inc., United States

  Zoran Antonijevic is Vice President of Statistical Consulting at Abond CRO. He held executive positions in Pharmaceutical Companies and CROs and has designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. Zoran is a long-time Chair and leader of the DIA Innovative Designs Scientific Working Group. He has authored numerous papers and scientific presentations and was editor of books “Optimization of Pharmaceutical R&D Programs and Portfolios” and, with Bob Beckman, “Platform Trials in Drug Development: Umbrella Trials and Basket Trials”.

• 

  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.

• 

  Victoria Manax Rutson, MD

  • Chief Medical Officer
  • Pancreatic Cancer Action Network, United States

  Dr. Victoria Manax is the Chief Medical Officer of the Pancreatic Cancer Action Network. She provides strategic direction and operational oversight to the organization’s high-priority clinical and medical initiatives, with emphasis on the Precision Promise initiative and its Clinical Trial Consortium. She works closely with cancer research institutions and biopharmaceutical companies to build a productive and collaborative team that will accelerate progress to improve patient outcomes. Dr. Manax joined PanCAN after holding many leadership positions in the pharmaceutical industry. Her areas of interest include drug development, precision medicine strategy, and innovative clinical trial design.

• 

  Rui (Sammi) Tang

  • Vice President, Global Head of Biometrics
  • Servier Pharmaceuticals, United States

  Rui (Sammi) Tang, PhD is currently the VP, Global Head of Biometric Oncology, leading Global biostatistics, statistical Programming and US Medical Writing Departments at Servier Pharmaceuticals US. Her research interests are primarily in adaptive clinical trial design and statistical issues in precision medicine. She authored more than 40 articles in peer-reviewed scientific journals on methodology, study design, data analysis and reporting and is a co-inventor of several patents. She is a co-founder of DahShu, a non-profit organization, founded to promote research and education of 5000 members. She is an active member in ASA and ICSA.

• 

  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.

• 

  Kristy Draper, PhD

  • Global Trial Lead for European Prevention of Alzheimer's Dementia Consortium
  • The University of Edinburgh, United Kingdom

  Kristy Draper currently works at The University of Edinburgh as the Global Trial Lead for EPAD. Kristy has 15 years experience working on phase I-III global clinical trials, predominantly in the field of Alzheimer's disease and other areas of neurology and oncology. This experience has come from a variety of roles such as a rater and study coordinator on site, a monitor in a CRO and operational study leader in the pharmaceutical industry in Australia and the UK. Kristy holds a Doctorate in Clinical Neuropsychology from Monash University during which she completed a PhD investigating the cognitive and psychosocial outcomes at 10-years post traumatic brain injury.

• 

  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.

• 

  Ditte Zerlang Andersen, PhD, MSc

  • EU Project Manager
  • Danish Medicines Agency (DKMA), Denmark

  Ditte Zerlang Andersen joined the clinical trial department at the Danish Medicines Agency (DKMA) in 2015. Starting as a clinical trial assessor, she now works as a project manager, leading European alignments in the regulatory clinical trial landscape and is chair for the ‘project and portfolio management’ sub-group of the Clinical Trial Coordination Group (CTCG). Ditte has been responsible for project management in the EMRN DCT project, which has delivered the EU harmonized recommendation paper on decentralized elements in clinical trials from the European medicines regulatory network (EMRN) in Dec 2022. Prior joining DKMA, Ditte worked 5 years in the pharmaceutical industry and have a PhD in neuroscience.

• 

  Patricia Noel

  • Project Officer for PrecISE, Lung Division, NHLBI
  • NIH, United States

• 

  Saira Ramasastry, MS, MSc

  • Partner
  • Life Sciences Advisory, United States

  Saira Ramasastry is managing partner of Life Sciences Advisory, LLC, a healthcare impact firm. Prior to founding LSA, Saira helped establish the life sciences group at Merrill Lynch and was responsible for biotechnology coverage. Saira serves on the industry advisory board of the Michael J. Fox foundation, is head of business and sustainability for EPAD, and was a special advisor for the G8 dementia initiatives. She is a guest lecturer for the bioscience enterprise program and serves on the advisory council of the Cambridge Judge Business School. Saira is a Fellow in the third class of the Health Innovators Fellowship and a member of the Aspen Global Leadership Network.

• 

  Mark Trusheim, MS, MSc

  • Strategic Director, NEWDIGS
  • Tufts Medical Center, United States

  Mark Trusheim is Strategic Director, MIT NEWDIGS where he also co-leads the Financing and reimbursement of Cures in the US (FoCUS) Project; and a Visiting Scientist at the MIT Sloan School of Management. Through MIT he has also served as a Special Government Employee for the FDA’s Office of the Commissioner. Mark’s research focuses on the economics of biomedical innovation, especially precision financing for patient access, precision medicine, adaptive pathways, platform trials and digital health advances.

• 

  Esther Arevalo, MS, MSc

  • EU-PEARL Project Management Strategy Unit
  • Vall d'Hebron Institute of Research (VHIR), Spain

  MSc Degree in Project Management by University of Barcelona and Postgraduate degree on R&D management by Universitat Politècnica de Catalunya, plus a bachelor degree in Veterinary Medicine. Over 6 years of experience in EU and national Research Projects (Vall d’Hebron Research Institute & IDIAP Jordi Gol Institute, Center for Research in Healthcare Innovation Management at IESE Business School, Agency for Health Quality and Assessment of Catalonia) and related competitive funding for health research. Also 7 previous years in industrial Pre-clinical Pharmaceutical Research Projects. Currently, Project Manager for EU-PEARL Project, funded by Innovative Medicines Initiative 2 JU, at Vall d'hebron Research Institute, the Project coordinator.

• 

  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

• 

  Anastasia Ivanova, PhD

  • Professor, Department of Biostatistics
  • University of North Carolina at Chapel Hill , United States

  Anastasia Ivanova, PhD, is Professor of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. Her primary interests are adaptive designs, designs for trials with high placebo response, subgroup discovery for biomarker trials and clinical trial simulation.

• 

  Nora Ku, MD

  • Executive Medical Director
  • Loxo Oncology, Inc-A Wholly Owned Subsidiary of Eli Lilly and Company, United States

  Nora is a native of Southern California and a graduate of the UCLA School of Medicine. She completed her residency in internal medicine at UT Southwestern/Parkland Memorial Hospital and her fellowship in hematology/oncology at UCLA. Nora has been an active clinical investigator in private and academic medical practice of hematology and oncology prior to joining Loxo Oncology, LP providing consulting services in drug development. In 2015, Nora joined Loxo Oncology, Inc as medical director for the phase 2 basket study of larotrectinib (Vitrakvi(R)). In Nov 2018, larotrectinib received FDA accelerated approval as the first drug initially approved for both adults and children and for a genomically defined, histology-independent indication

• 

  Peter P. Stein, MD

  • Director, Office of New Drugs, CDER
  • FDA, United States

  Dr. Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.