Reimagining DCTs for Better Patient Experiences and Greater Inclusivity

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 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.

Hassan Kadhim is the Business Engagement Leader for Clinical Operations and Development for Vertex Pharmaceuticals. Prior to this role, he was the Global Head of Clinical Trial Business Capabilities & Clinical Innovation at BMS, where his team governed the business technology capabilities strategy within Global Development Operations, and drove changes and innovation towards better outcomes for clinical trial stakeholders. Mr Kadhim is passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patient-centric clinical trials, and is a firm believer of the need for clinical innovation grounded in strong business practices for sustainability, change management and adherence to compliance and regulatory commitments. Mr Kadhim regularly appears and speaks at industry events around improving the clinical trial experience with digital tools, and wrote “The Remote Clinical Trials Model” whitepaper in 2016, to formalize a new patient-centric clinical trial research model leading to what we know today as Decentralized Clinical Trials. Mr Kadhim actively collaborates across industry collaborations such as Transcelerate and others to advance relevant and high-value industry challenges.He has degrees in bioinformatics and pharmaceutical sciences, both from the University of Montreal in Canada.

Marie Rosenfeld is the Senior Vice President and Head of Clinical Science at Astellas and has responsibility for leading the global Clinical Science organization strategically planning and delivering high-quality clinical development programs to help bring innovative and reliable medicines to patients worldwide safely and quickly.Ms Rosenfeld is a drug development professional with more than 20 years of experience in R&D at large and medium size pharmaceutical companies and contract research organizations (CROs). Prior to her current role, Ms Rosenfeld held several positions in the Astellas clinical organization, managing clinical delivery teams, supporting regulatory filings and clinical inspection activities. At Astellas, Ms Rosenfeld also spent two years heading the Vendor Management function in the Outsourcing team, where she oversaw a team responsible for the management of all external vendor relationships, including sourcing, governance, performance assessment and issue resolution. Prior to joining Astellas, Ms Rosenfeld spent over eight years at Abbott Laboratories successfully overseeing the clinical delivery teams for the global Immunology Dermatology and Spondyloarthritis portfolio.Ms Rosenfeld’s drug development experience spans multiple therapeutic areas including: Immunology (Gastroenterology, Dermatology, Spondyloarthritis, Lupus), Oncology (Breast, SMLC, NSCLC, Solid Tumor, AML, Prostate), Hematology, Uveitis, Infectious Disease (Invasive Candidiasis), Renal Anemia, across all phases of development, including Phase 1– 4, Registries, PMOS/PASS, Investigator-Initiated Research and Compassionate Use.Ms Rosenfeld holds a Bachelor of Arts in Biology from Franklin and Marshall College.