Session Information:
Title: Ensuring Rich Evidence in DCTs in a World that Demands Trial Anywhere™
Date: Thursday, May 5th, 2022
Time: 12:00 p.m. CET
With only 5-10% of clinical trials expected to be fully de-centralized and 70-80% expected to be hybrid, sponsors, sites and CROs need to continue to solve the challenges of generating rich evidence in this decentralized reality. During this session, speakers will discuss:
- Capturing high-quality data that meets regulatory standards and using rich evidence to determine the safety and efficacy of a medicine, medical device, or therapy.
- Fusion of scientific and technological excellence to generate rich, gold-standard evidence.
- How therapeutic area and domain expertise augments evidence-generating technologies and methodologies.
- The impacts of decentralized and hybrid trials on clinical evidence generation including: the influences of patient accountability, how science drives rich evidence, and the impact of rich evidence on studies.
Speakers
Bryan McDowell
VP, eCOA Science & Consulting at Clario
In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma wide industry necessity for smarter drug & device development and life cycle management.
Phil Lake, PhD
Senior Director, Respiratory Solutions at Clario
Phil Lake is a respiratory specialist who supports clients all around the world and has held various roles in drug development for more than 22 years, predominantly focused on respiratory trials. Previously, he held positions at SmithKline Beecham and GlaxoSmithKline within respiratory drug development, working on respiratory drug development in a range of drug mechanisms and trial designs including landmark studies such as exacerbations, mortality, and mechanistic studies focusing on biopsy and sputum biomarkers. Phil has concentrated extensively on understanding drivers for variability to reduce the risk of study failure that included traditional respiratory indications as well as generic bioequivalence studies and the use of lung function as a biomarker within many rare diseases. He has focused on understanding potential safety signals within drugs which could have negative impacts on lung health. Phil has been pivotal in early centralized over read studies and is committed to driving improvements in lung function testing within decentralized trials.
Guillem Serra Autonell
C.E.O. & Founder, mediQuo
Guillem is the Founder and CEO of MediQuo as well as the Founder of MeetingDoctors. Investor and board member of more than 30 startups including: Singularu, Cuidum, Landbot, Demium, Homyspace, Hannun, Taiga Agile, Swipcar, Catevering, Dental Residency, Brickbro, Twenix, The Wild Curl, Shimoku, Spathios, Trialing, Pulpo, Rebag, Impossible Bakers, Incapto and Buscoresi among others. He is a physician and mathematician with an MBA from IESE Business School and has deep knowledge in the eHealth market, MedTech and early seed startups. Guillem’s technical knowledge includes the areas of data-mining, signal processing, artificial intelligence and product development.