Addressing the Clinical Operations Workforce Gap in the Journey towards Patient Flexibility

Shoibal Datta is Head, Digital Health Sciences within the Data Sciences Institute at Takeda. His team focuses on the incorporation of digital health technologies within clinical development specializing in decentralization of clinical trials, remote sensing and measurement and the development of digital health products for post-launch use. Prior to Takeda he was Vice President of PPD Digital where he set the strategy of working with external platform partners and device manufacturers to create compliant, globally scalable approaches to conduct decentralized trials and their integration into conventional clinical research and data management processes. Prior to that, he spent 13 years at Biogen in roles within translational informatics, data sciences and as part of an innovation hub that launched MS PATHS, a learning healthcare system that utilizes technology to capture high quality data as standard of care for over 10,000 MS patients globally supporting RWE and value-based medicine initiatives.

Kim Hawkins has 30 years of operational experience managing all phases of the drug development process. Kim started her career at Boston Medical Center as a Research Assistant working on pediatric AIDS and Oncology trials. After working in academia, Ms Hawkins moved into industry and held various clinical operations positions at Boston-area biotechnology/pharmaceutical companies including Genzyme, Antigenics, and Novelos Therapeutics where she was the Vice President of Clinical Development. She joined Sanofi 9 years ago and is currently the Global Head of Clinical Project Operations & Dossier Delivery, the team of clinical operations leads responsible for the management of all clinical programs across the portfolio as well as the submission dossiers. She is a graduate of Boston University with a Bachelor’s degree in Human Physiology and a Master’s degree in Public Health.In addition to her project responsibilities, Ms Hawkins is leading several projects focused around the evolving clinical trial model to build innovation and digital technology into our programs to further optimize clinical research for Sanofi and patients. In this role, she has led the integration of decentralized approaches into trials at Sanofi and is currently the co-lead  for the IMI Trials@Home Project.

John Wilbanks is the Former Head of Data at Biogen Digital Health, leading a team that builds products and services making clinical study data findable, accessible, interoperable, and reusable inside the company. Mr Wilbanks was formerly chief commons officer at Sage Bionetworks, where he led efforts in data governance for cloud science and informed consent for phone and wearable driven clinical research. He also serves as a Senior Fellow at the Milken Institute’s FasterCures program.Previously, Mr Wilbanks worked as a legislative aide to Congressman Fortney “Pete” Stark, served as the first assistant director at the Berkman Center for Internet & Society, founded and led to acquisition the bioinformatics company Incellico, Inc., and was vice president of science at Creative Commons. He also served as a senior fellow at the Ewing Marion Kauffman Foundation, on the National Advisory Board for PubMed Central at the National Institutes of Health, and as a senior advisor for big data to the National Coordination Office at the National Science Foundation. In February 2013, in response to a We the People petition that was co-led by Wilbanks and signed by 65,000 people, the U.S. government announced a plan to open up taxpayer-funded research data and make it available for free. Wilbanks graduated with a BA in philosophy from Tulane University.