(May 18, 2017)
Well designed and well conducted clinical trials are essential for every successful biopharmaceutical company to prove the efficacy and safety of their investigative products. These trials are typically designed based on similar prior trials or Clinical Trial Simulations (CTS) using assumed patient demographic and health profiles. Trials designed using these techniques may not accurately reflect actual patient populations leading to trial recruitment difficulties, erroneous trial outcomes or unexpected post-approval therapy performance.
Electronic Medical Records (EMR) provide a tremendous opportunity for biopharmaceutical companies to leverage patient-centric, longitudinal Real World Data (RWD) or Real World Evidence (RWE) to better understand their therapy targets and provide fact-based CTS assumptions leading to better informed clinical trial designs. However, RWD are often difficult to harmonize with clinical trial data constructs and often exceed the scale of most advanced analytics platforms.
A new and novel approach, based on the Cambridge Semantics Anzo Smart Data Lake (ASDL) graph-based technology, was piloted to demonstrate the feasibility of leveraging RWD to inform CTS. The outcomes and methods of this pilot will be discussed during this webinar. There will be an opportunity to ask pilot participants questions.
James T. LaPointe
MScEng, Managing Director of Life Sciences & Healthcare
Mr. LaPointe leads Cambridge Semantics Life Sciences and Healthcare practice to develop and implement transformational graph-based solutions for the industry across the entire R&D and commercialization lifecycle. Jim directs life sciences & healthcare business development and solution delivery based on Cambridge Semantics’ award-winning Anzo Smart Data Lake (ASDL) technologies. He identifies and implements high-value use cases for the biopharma industry based on accelerated insights from both structured and unstructured (text) ‘big data’ sources and immediate end-user advanced analytics. Jim is often seen presenting the ASDL technology at numerous industry conferences.
Over 20+ years before joining Cambridge Semantics, Mr. LaPointe provided disruptive information technology services for the life science industry and guided clients in the adoption, design, development, and implementation of information technology assets and processes that led to operational excellence and improve efficiency. Jim assisted clients in managing the entire solution deployment lifecycle including architectural assessments, strategic and tactical visioning, business case creation, business and system requirements definition, best-in-class vendor selection, development process management, systems integration with associated applications, application testing and user acceptance planning and support, GxP validation support, new system adoption planning and support, and post-deployment planning and support.
Jeffrey S. Barrett
MD, Vice President for Translational Informatics
Sanofi Pharmaceutical Company
Mr. Barrett leads Sanofi’s Translational Informatics (TI) group comprising Quantitative Systems Pharmacology, Bioinformatics & Data Integration, Drug-disease modeling and Clinical Trial Simulation team. The global group is led by quantitative scientists that participate in various aspects of model-based decision-making spanning drug discovery through commercialization. The group is positioned to provide strategic guidance to project teams and various decision-making bodies as well as senior management. Jeff provides leadership for Sanofi’s R&D’s cloud-based, high-performance computing and several big data initiatives in collaboration with IS and IT collaborators and external technology partners. Jeff serves as Global Head of Pediatric Clinical Pharmacology where he provides support to all pediatric clinical development plans and regulatory filing strategy and is co-lead of the Sanofi Pediatric Network.
As the Professor of Pediatrics & Pharmacology at The Children’s Hospital of Philadelphia, Mr. Barrett was Principal Investigator for the CHOP Pediatric Pharmacology Research Unit (PPRU) and the Director of the Penn/CHOP Kinetic Modeling and Simulation (KMAS) core of the CTSA for research focused on the investigation of sources of variation in pediatric pharmacokinetics. Jeff applied clinical pharmacologic investigation coupled with modeling and simulation strategies to pursue the development of rational dosing guidance in various pediatric populations for both marketed and exploratory compounds.
Mr. Barrett has served as the Global Head of Biopharmaceuticals at Aventis Pharmaceuticals and the Director of Clinical PharmacoKinetics at Dupont Pharmaceuticals.
Who Should Attend:
- Chief Medical Officers (CMO)
- Clinical Operations Leadership
- Therapeutic Area Leadership
- Real World Data (RWD) / Real World Evidence (RWE) Leadership
- Big Data IT Leadership