Workshop 2: Digital Clinical Development: Tutorial, Case Studies, and Future Readiness

MONDAY, APRIL 6 | 2:30 – 5:30 PM

ABOUT THIS WORKSHOP:

We live in an incredible time where the rate of technological advancement is accelerating now more than ever before.  Our industry is at a critical juncture for disruption and opportunity to change the clinical trials execution model. Pharmaceutical companies are now undergoing massive transformation driven by entrepreneurs and technologists, as well as the evolving role of patients themselves. Sponsors and CROs – large and small – are investing in initiatives to help them modernize and embed technology and bring their processes to the 21st century.
Today, we have the opportunity to re-define digital clinical trials from the point of view of Patients, Sites, Sponsors and Regulators:

• What is a digital clinical trial?
• What are the strengths and limitations of digitization?
• What has been implemented and what has been learned?
• What are the obstacles to successful implementation?
• How can we advance digital clinical trials as a community together?
• What are the practical steps that you can take back and apply?

Participants in this workshop will understand the role of digital in impacting end-to-end clinical development inclusive of recruitment, engagement, ongoing data collection, and the predictive models to reduce the research cycle time, reduce the number of participants and lowers the cost of bringing medicine to market.

INSTRUCTOR BIOGRAPHIES:

Munther Baara, Vice President, Product Strategy and Innovation, EDETEK, Inc.

Munther Baara is the product strategy and innovation lead as well as EDETEK's major industry partnerships. Munther has 25 years of experience in leading the development of numerous clinical systems and business solutions. He has held roles of increased seniority in biotechnology and in the world's largest pharmaceutical companies, leading global teams and technology implementations. Munther's experience has been focusing on innovation, trends and emerging technologies in support of the paradigm shift in the execution of clinical trials. Munther was most recently the head of New Clinical Paradigm at Pfizer where he led and/or contributed to transformative technological breakthroughs. Munther also worked on mClinical patient journey (mobile and sensor), blockchain, returning data to patients, Shared Investigator Platform (SIP), clinical aggregation layers, eSource (Industry-Pioneering EHR Data Transfer) and TransCelerate BioPharma Projects. Also, he was awarded the 2018's Top 20 Innovators in clinical trial advancements by CenterWatch.

Craig Lipset, Independent Adviser, Former Head of Clinical Innovation, Pfizer

Craig Lipset was Head of Clinical Innovation within Global Product Development at Pfizer. Craig’s team impacted clinical research through digital tools, innovative research approaches and game-changing collaborations. Craig previously served as Venture Partner in Pfizer Venture Investments (Pfizer’s VC arm), where he focused on diversifying the company’s $50M annual budget for private investments in the areas of diagnostics and health technology. Craig was also Senior Director in Molecular Medicine, where he spearheaded initiatives driving innovation in clinical research and personalized medicine by drawing upon tools from health information technology, telemedicine, and eHealth. Craig brings over 15 years of leadership and innovation in the field of drug development. He previously served as Associate Vice President of Program Management at Adnexus Therapeutics (acquired by Bristol-Myers Squibb), and on the founding management team for Perceptive Informatics (now part of PAREXEL International). Craig has been listed among the PharmaVOICE most inspiring people in the life sciences, Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top Innovators, and AlleyWatch Who's Who in eHealth. He serves on the Editorial Board for Therapeutic Innovation & Regulatory Science. Outside of Pfizer, Craig serves on the Board of Directors for the People-Centered Research Foundation, Foundation for Sarcoidosis Research and MedStar Health Research Institute, and is a Mentor at health tech accelerator Blueprint Health.