Innovative Trial Designs to Reduce Patient, Site and Investigator Burden

Victoria L. Chiou, MD, is Head, Clinical Excellence and Innovation, Late Development Oncology at AstraZeneca, where she leads strategic development and implementation of global initiatives at the intersection of clinical cancer research, technology, and innovation. Dr Chiou is an oncology research physician with academic, industry, and regulatory experience in patient-centric drug development. Prior diverse clinical development experiences include GlaxoSmithKline in cell therapy, and MedImmune/AstraZeneca in novel immuno-oncology drug combinations for treatment of multiple cancers. Dr Chiou also served as a medical officer at the US Food and Drug Administration, Office of Hematology and Oncology products.Dr Chiou completed her BA in human biology and psychology as a Jefferson Scholar at University of Virginia, MD at Medical College of Virginia, internal medicine residency at Wake Forest University, and medical oncology fellowship at National Institutes of Health, National Cancer Institute. Multiple career recognitions include Conquer Cancer Foundation of ASCO Merit Award, ASCO/AACR Methods in Clinical Cancer Research Workshop, and SITC Women in Cancer Immunotherapy Network Leadership Institute.

Sheryl Jacobs is VP, Global Development Operations at Amgen. Ms Jacobs has nearly 30 years of industry experience and joined Amgen in 2008. As VP, Global Development Operations, Ms Jacobs is responsible for clinical operations activities associated with Phase 1-4 clinical studies and she previously served as the Vice President of Global Study Operations where she was responsible for the site and data management aspects of clinical studies. Prior to joining Amgen, Ms Jacobs served as VP, SOPs, Training & Processes at Pfizer. Ms Jacobs was the Head of Clinical Data Management at Searle and Pharmacia prior to their acquisition by Pfizer. Ms Jacobs’ background includes working in Government through the National Institutes of Health, working for a Japanese Pharmaceutical company, and starting a Data Management department for a Contract Research Organization (CRO). Throughout her career in the industry, Ms Jacobs has provided support to the successful filing and approval of over 50 life-changing medicines.

Daniel Millar leads Strategic Business Transformation in Statistics & Decision Sciences at J&J Innovative Medicine R&D and is an advocate for utilizing quantitative innovation to advance patient-centric R&D while simultaneously delivering transformational efficiencies. Mr Millar is a founding leader and champion for multi-stakeholder engagement in the Innovative Medicines Initiative (IMI) public-private partnership for Integrated Research Platforms, “EU PEARL.” Mr Millar was also a co-lead of the Clinical Trials Transformation Initiative (CTTI) project on Master Protocols together with leaders from FDA, academic research hospitals and patient advocacy. Daniel has served on and led DIA program committees for multi-stakeholder workshops focused on Complex Innovative Designs and Master Protocols. An important aspect of his focus has been generating a global discussion and knowledge exchange on innovative methods in clinical trial designs, including regulators in US, Brazil, Canada, Europe, UK, China and Japan, and bringing focus to the benefits of innovative designs for patients.Mr Millar obtained an 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.

Camilla Richmond, MD is a Medical Director of Translational Research in the Gastroenterology Drug Discovery Unit at Takeda. In this role, she oversees clinical development for early stage assets in the GI Cell Therapy and Neurogastroenterology/Motility portfolios. Dr Richmond has interest and experience in the design and implementation of decentralized clinical trial solutions and integration of novel digital tools as a mechanism to increase patient access to and diversity within clinical trials. Prior to joining Takeda, she was a physician-scientist at Boston Children’s Hospital and Assistant Professor at Harvard University Medical School. Dr Richmond continues to be a practicing pediatric gastroenterologist with a clinical focus in obesity medicine at Boston Children’s Hospital.