31 - “Advancing In Silico Clinical Trials from Concept to Practice”
Host:
Jeffrey Bischoff
Research Director (Biomechanics) at Zimmer Biomet.
Abstract:
The concept of an in silico clinical trial (ISCT) has been proposed as a means to utilize computational modeling across a virtual patient cohort, in order to provide evidence in support of a novel medical device, drug, or therapy. Evidence from an ISCT can potentially be used in various ways to enrich data acquired via a traditional clinical study, such as providing data on rare anatomies, pathologies, or device configurations that are difficult to acquire clinically. Putting the concept of an ISCT into practice within a medical device environment introduces a number of challenges: (1) developing a quality systems framework for ensuring appropriate credibility of the modeling approach(es) that can support technical and regulatory review, (2) identifying appropriate patient outcomes of interest that have the potential to be addressed within an ISCT, and (3) demonstrating sufficient credibility of models for each of the identified patient outcomes through benchtop and/or clinical validation activities. In this talk, a strategy for addressing these challenges will be presented, using a case study of an ISCT intended to support a novel shoulder arthroplasty system.
Short bio:
Jeffrey Bischoff is Research Director (Biomechanics) at Zimmer Biomet. He received his Ph.D. from the University of Michigan with a specialization in soft tissue biomechanics, held a post-doctoral position at the Bioengineering Institute at the University of Auckland, and served as Assistant Professor at the University of South Carolina in Mechanical Engineering. In his current role at Zimmer Biomet, he provides with his team biomechanical support for a wide variety of development and research projects connected with musculoskeletal health. Jeff is currently Chair of the ASME VVUQ40 Subcommittee , and Chair of the Implants Section of the Orthopaedic Research Society (ORS).
