Measuring the Value of DCTs and Hybrid Models for Ultimate Trial Success

Kenneth A. Getz, MBA, is the Executive Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Mr Getz has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors including WCG and ORA and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science.  Mr Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Mr Getz is the founder of CenterWatch, a leading publisher in the clinical trials industry.

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.

Shayna Lambert, Head of Strategy and Business Transformation, Global Clinical Operations (GCO) at Janssen R&D, has been in the pharmaceutical industry for 19 years, with various roles.  In her current role, Ms Lambert is responsible for leading a robust ‘Future Ready’ strategy and global business transformation tactical plan for GCO, considering the evolutions in the execution of clinical trials. Prior to her current role, she led Janssen’s Digital Health CoE where she has shaped the organization to be set up to meet the increasing demands and ever-evolving digital landscape.

Anna Yang, PharmD, is a Clinical Innovation and Technology Leader at Genentech’s US Medical Affairs Innovation Hub. In this role, Ms Yang collaborates with study teams to spearhead decentralized clinical trial (DCT) initiatives and drives innovation across the company’s portfolio. She contributes to the Decentralized Trials and Research Alliance, specifically focusing on DCT Key Performance Indicators/Metrics. She holds a PharmD degree from Rutgers Ernest Mario School of Pharmacy and has completed a postdoctoral fellowship within Genentech’s BioOncology Medical Science Liaisons team.

Brandon Maggio is a Director of Digital, Analytics & Performance, within Global Clinical Operations at GSK. Mr Maggio holds degrees in Biotechnology and Biochemical Pharmacology from the University at Buffalo and has dedicated 20 years to the pharmaceutical industry. He leads a diverse group of global innovators responsible for developing Digital Health strategies, implementing technology and innovative trial designs, optimizing processes to standardize new ways of working, and utilizing data to improve performance.