Modeling and Simulation (M&S) - MDIC

1 1 Modeling and Simulation (M&S)Steering Committee Conference Call Agenda November 19, 2013 ALIGN | ACHIEVE | ACCELERATEA genda1)Welcoming Remarks Michelle McMurry-Heath, Assistant Director for Science, FDA2)Introductions of the Steering Committee Members 2-4 sentence introduction by each member3)Regulatory Science at the FDA Kyle Myers, MDIC CM&S FDA PI, Office of Science and Engineering Laboratories, FDA4)MDIC Overview Dale Wahlstrom, MDIC Emeritus Executive Director & Board Member, Life Science Alley5)Motivation and Vision of the M&S Program Randy Schiestl, MDIC CM&S Board Champion, Boston Scientific5)M&S Current Activities Dawn Bardot,MDIC CM&S Program Manager6)Q&A2CM&S Steering CommitteeRandy Schiestl, Board ChampionDawn Bardot, Program ManagerKyle Myers, FDA PIMedical Device ManufacturersMatt Waninger, Cook MED InstituteDavid Flynn, Boston ScientificMorrisMilton, CyberonicsDave Anderson, St.

2 Jude MedicalAnita, Bestelmeyer, BDTBD, MedtronicNon Profits and CM&S Expert OrganizationsCheryl Liu, PhD, SIMULIAMarc Horner, PhD, ANSYSG race Peng, PhD, NIBIB/NIHN iels Kuster, PhD , IT ISFDATina Morrison, Office of Device EvaluationDonna Lochner, External RelationshipsAldo Badano, Imaging PhysicsGerry Gray, Office of Surveillance and BiostatisticsMatthew Myers, Computational ModelingPrasPathmanathan, Computational Biology3 CDRH Vision Patients in the have access to high-quality, safe, and effective medical devices of public health importance first in the world.

3 The is the world s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance. Devices are legally marketed in the and remain safe, effective, and of high-quality. Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions.

4 4 What is Regulatory Science? Provides the tools, standards, and approaches needed to evaluate the safety, effectiveness, performance, and quality of medical products Benefits patients by speeding the rate of important technologies reaching market Reduces time and resources needed for device development, assessment, and review. For example: Can lead to quicker, more efficient device approvals Can decrease the size and duration of pre-market clinical trialsFaster, Safer, More Cost-Effective5 ComputationalModelingFrom: The Virtual Physiological Human Academic, hypothetical Catalogue of normal human anatomy European Union Constructed by: AcademicsTo.

5 The Virtual Physiological Patient Practical, applied to device design and testing Catalogue of normal human variation and disease physiology/structure FDA Constructed by Academics, Industry, FDA6 Limited federal government investment in regulatory science Private sector investments generally have been proprietary High cost of engaging in scientific collaborations due to administrative inefficiencies and legal issues Risk of legal liability when competitors collaborateOpportunity: Establish a public-private partnershipChallenges7T h e o n e p l a c e w h e r e i n d u s t r y, n o n-p r o f i t s & F D A c a n c o l l a b o r a t e t o m a k e p a t i e n t a c c e s s t o n e w m e d i c a l d e v i c e t e c h n o l o g i e s f a s t e r, s a f e r a n d m o r e c o s t-e f f e c t i v Strategy.

6 Create a Public-Private Partnership between Industry, FDA and Non-profits9 PPP GoalsAlign ResourcesAccelerate ProgressAchieve ResultsWorking cooperatively with FDA to re-engineer pre-competitive technology innovation Reducing the time and resources needed for new technology development, assessment, and review Helping patients benefit by gaining access tonew medical technologies soonerMDIC Public-Private Partnership10 OSEL/ODE/OIR/OSB are Fully Engaged on the Board, Committees & Working Groups NIH/Other Government Research Project Support Collaborative Leadership on Board & Steering Committee from all 3 core groups Key technical/clinical/scientific members on working groups Focused on common pre-competitive needs Large & Small Company Representation Exclusively Medical Device Project Support Patient Organizations Clinical Research Scientific ResearchFDA & other GovernmentIndustryThought LeadersFDA Leadership Commitment"This consortium is truly ground-breaking.

7 It creates a safe space to collaborate on early-stage regulatory science efforts that will eventually benefit the entire industry: the advancement of innovation and ultimately, and most importantly, patients. -FDA Commissioner Margaret Hamburg, MDMPRNews, December 3, 2012"What we've lacked is a structure like the Medical Device Innovation Consortium that allows for a larger number of parties to come together to develop these projects on an ongoing basis -a significantly more effective way to do research. -CDRH Center Director Jeffrey Shuren, MD, JDMedPage Today, December 4, 2012 11 Patient Centeredness and Benefit-Risk AssessmentMDIC Board Champion: Ross Jaffe, MD | Versant VenturesProgram Manager: Kelly Slone (acting) Stephanie Christopher (11-11-13)Goal: Develop a framework for incorporating patient preferences into B/R assessmentClinical Trial Innovation and ReformMDIC Board Champion: Rick Kuntz, MD | MedtronicProgram Manager: Stephanie Christopher (11-11-13)Goal.

8 Improve the function of the clinical trial process while increasing efficiency and utility through a Total Product Lifecycle (TPLC) frameworkComputer Modeling and SimulationMDIC Board Champion: Randy Schiestl | Boston ScientificProgram Manager: Dawn Bardot, PhDGoal: Increase confidence in safety and efficacy, reduce clinical trial size and accelerate device review through regulatory grade computer models & simulationsMDIC Initial Projects12 Board of Directors13 Allan Coukell | The Pew Charitable TrustsDirector of Drugs and Medical DevicesMDIC Vice-ChairVincent Forlenza|Becton, Dickinson and CompanyPresident, CEO and ChairmanMDIC Finance Committee, Vice-ChairWilliam A.

9 Hawkins III | Immucor, Inc. President and CEO MDIC Board ChairMichael R. Minogue |Abiomed, , CEO and ChairmanMDIC Secretary; Membership Committee ChairWilliam V. Murray | MDICP resident & CEOM edical Device Innovation Consortium CEOD avid Perez |Terumo BCT President and CEOC hairman, Blood Management Business Division, Terumo CorporationMDIC Finance Committee ChairJeffrey Shuren, MD, JD | CDRH, FDAD irector, Center for Devices and Radiological HealthFood and Drug AdministrationMDIC Membership Committee Vice-ChairGlenn L.

10 Criser|Biomet, VP, Quality/Regulatory/Clinical AffairsKathy Hudson, | NIHD eputy Director for Science, Outreach, & PolicyRoss Jaffe, MD |Versant VenturesManaging DirectorRichard E. Kuntz, , |Medtronic, Chief Scientific, Clinical & Regulatory OfficerTamara SyrekJensen, |CMSD eputy Director, Coverage and Analysis GroupKaren Licitra|Johnson & JohnsonWorldwide Chairman, Global Medical SolutionsDee Mellor |GE HealthcareChief Quality OfficerDaniel J. Moore | Cyberonics, & CEOM ichael Rousseau |St Jude Medical Group PresidentPeter Saltonstall| NORDP resident & CEOJoe Selby, , MPH |PCORIE xecutive DirectorRandall Schiestl | Boston Scientific CorporationVP, Global Operations and TechnologyNadim Yared |CVRxPresident & CEODale Wahlstrom |LifeScienceAlley and The BioBusinessAlliance of MNPresident & CEO Executive CommitteeFull BoardALIGN| ACHIEVE| ACCELERATEMDIC Member Logos14 ALIGN| ACHIEVE| ACCELE