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Webinar Recording: RDCA-DAP Collaboration with Clinerion for Real World Data Solutions

Date: Wednesday, October 27, 2021
Time: 7 am PT | 10 am ET | 4 pm CET

This webinar was run in collaboration with the Critical Path Institute.

The Rare Disease Cures Accelerator–Data and Analytics Platform (RDCA-DAP®) is launching a new webinar series with the goal of sharing with the community examples of the use of rare disease person-level data in drug development and regulatory decision making. The series will feature 1-hour webinars highlighting analyses that have been done in individual disease areas, how they informed drug development, and how similar approaches could be applied to common drug development issues encountered in rare diseases. After each presentation time will be allowed for discussion with a panel of Quantitative and Regulatory experts around why the solutions presented were informative, lessons learned and how similar approaches could be applied to related problems.

The Rare Disease Cures Accelerator-Data and Analytics Platform is an FDA-funded initiative that provides a centralized and standardized infrastructure to support and accelerate rare disease characterization, with the goal of accelerating therapy development across rare diseases.
Find out more, here >

Speakers

Jeff Barrett, PhD, FCP
Senior Vice President; RDCA-DAP Lead
Critical Path Institute 

Dr. Jeff Barrett is Senior Vice President at C-Path and serves as the lead for its Rare Disease Cure Accelerator-Data and Analytics Platform (RDCA-DAP) initiative. As SVP, Dr. Barrett guides all operational and scientific activities for RDCA-DAP. These activities include continuing outreach and collaboration with the rare disease community to optimize data usability and availability, as well as transforming such data into actionable knowledge to advance drug development for rare and orphan conditions. He was previously Senior Advisor serving as a critical liaison between C-Path and the pharmaceutical industry, foundations, and other key stakeholders, helping grow C-Path’s portfolio in drug development solutions, with a focus, but not limited to model-informed drug development (MIDD) and real-world data (RWD) technologies. Prior to coming to C-Path, he was Head of Quantitative Sciences at the Bill & Melinda Gates Medical Research Institute. In this role he was responsible for implementing model-based drug development, employing PK/PD modeling, statistics, and clinical trial simulations to advance the discovery and development of new medicines and vaccines. Prior to MRI, he was Vice President, of Translational Informatics at Sanofi Pharmaceuticals. He led various aspects of model-based decision-making spanning and provided leadership for Sanofi’s cloud-based, high-performance computing and “big data” initiatives. Jeff spent more than 10 years at the University of Pennsylvania where he was Professor, Pediatrics and Director, Laboratory for Applied PK/PD at the Children’s Hospital of Philadelphia. Jeff received his B.S. in Chemical Engineering from Drexel University and Ph.D. in Pharmacokinetics from University of Michigan. He has co-authored over 175 manuscripts, is fellow of ACCP and AAPS and the recipient of numerous honors including ACCP awards for Young Investigator (2002) and Mentorship in Clinical Pharmacology (2007) and the AAPS Award in Clinical Pharmacology and Translational Research (2011). Dr. Barrett was awarded for Exceptional Innovation and Advancing the Discipline of Pharmacometrics at the International Society for Pharmacometrics (2013) and elected ISOP Fellow (2017). He is co-Specialty Chief Editor of Frontiers in Obstetric and Pediatric Pharmacology Journal and an active member of the Child Health and Human Development Pediatrics Subcommittee as a study section reviewer. He was a past acting chair of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; a voting member of the committee for eight years. 

Alexandre Bétourné, PhD, PharmD
Scientific Director, RDCA-DAP
Critical Path Institute 

 

Alexandre Bétourné, PhD, PharmD, is Scientific Director for the Rare Disease Cures Accelerator-Data and Analytics Platform initiative. Dr. Bétourné works with the RDCA-DAP team to expand its reach into new diseases areas accessing new data and enhancing C-Path’s relationships within the rare disease community. Dr. Bétourné holds both a PhD and a PharmD from the University of Toulouse in France. He holds three patents and has written multiple papers that intersect with several different rare disease areas. Before joining C-Path, he led a team of senior U.S. scientists, CMC and regulatory consultants at a small company developing therapies for amyotrophic lateral sclerosis (ALS). 

Douglas Drake
Senior Director, Customer Solutions
Clinerion

Douglas Drake, MS, MBA, is originally a life science researcher with a passion for digital enablement of better patient care. For over 30 years, Douglas has worked in various aspects of diagnostics, therapeutic research, drug discovery and global business development. He has broad experience in transformative technologies, data sciences, digital healthcare and applying these to improving patient engagement and the patient journey.

 

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