Annual Meeting, 2014 - MDICmdic.org/wp-content/uploads/2014/06/MDIC-Overview.pdf · Computer...
Transcript of Annual Meeting, 2014 - MDICmdic.org/wp-content/uploads/2014/06/MDIC-Overview.pdf · Computer...
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Bill Murray, President & CEOMDIC Annual Meeting
June 2014
A Public-Private Partnership collaborating on Regulatory Science to make patient access to new medical device technologies faster, safer and more cost-effective
38 Members5 Members
2012 2013 Q1 2013 Q2 2013 Q3 2013 Q4 2014 Q1 2014 Q2
CM&S Executives & Fellows Meeting
Nationwide Rollout
Articles of IncorporationBy-laws; Business Plan
Key Accomplishments
1st Board Meeting
15 Members 24 Members 33 Members 35 Members
Computer Modeling & Simulation Patient Centered Benefit-Risk Clinical Trial Innovation & Reform
MDIC conducted two brainstorming sessions
with ODE and OSEL
• 30+ participants identified 50+ ideas
Executives and Fellows meeting at FDA including
70 members from industry, nonprofits, NIH, and
FDA
• Pre-meeting survey
Six working groups initiated
• Clinical trials powered by simulation & bench
• Library of models and data
• Orthopedics
• MR heating
• Blood damage
• Leads and human heart
Three priority deliverables established:
• Catalog of methods to assess patient preferences
• Framework for incorporating patient preferences
to benefit/risk assessments of new technology
• Agenda for future research regarding the
incorporation of patient preference information
into medical device regulatory approvals
Applied for and received $500K FDA contract
to conduct patient-centered benefit-risk assessment
methodology research
Catalog and Framework working groups established,
bringing together member organizations and
academic experts to collaborate on project goals.
• Held inaugural MDIC Chief Medical
Officer workshop at FDA to discuss
medical device clinical trials and
opportunities for innovation
• Conducted landscape analysis prior to
Chief Medical Officer workshop to
understand member organization
priorities for innovation in the medical
device clinical trial enterprise
• Formed project working groups to
collaborate on innovations in Clinical Trial
Design and Early Feasibility / First-in-
Human studies
3 Initial Projects:
Organizational Highlights
• 501(c)(3) status granted in 2014
• 43 Member Organizations to date
• $500K PCBR BAA Award
• Project teams: staffed and plans developed
Project Framework in place
Fully Staffed
3 Initial Projects Approved
MDIC.org launched
Full-time CEO onboard
43 Members
Pre-revenue
4
Large
Company
10
Government &
Non-profit
14
Small
Company
15
June 2014
43 Members
CTIR / CMO survey
$500K BAA Award
501(c)(3)granted
Umbrella Cooperative Research Agreements
(CRADA) w/ FDA1st Annual Meeting
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What is Regulatory Science?
The science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated 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 trials
Faster, Safer, More Cost-effectiveFDA Strategic Plan, August 2011Advancing Regulatory Science at FDA
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Why is it Important?
Increasing rate of innovations, diversity of applications & complexity of innovations have challenged traditional development and assessment systems
• More rigorous clinical trial proof is not only a regulatory expectation, it is a societal expectation
• Evidence of value will become part of premarket clinical trial considerations
• Informed patient preferences incorporated into benefit-risk decision framework; push for earlier access to potentially life saving technologies
• Balance of premarket and post market data collection through a Total Product Lifecycle framework is necessary
• Incorporation of state-of-the-art regulatory grade modeling and simulation tools to increase confidence and quality of product assessment is essential to support the pace of innovation
• Stakeholder collaboration is the most effective way to advance regulatory science
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The MDIC is uniquely
focused on the medical device
industry
• Preferentially focused on medical devices and
regulatory science• Industry led• Close partnership with FDA• National in scope
There are other public private partnerships focused on regulatory science
• Center of Excellence in Regulatory Science and Innovation (CERSI)-Georgetown
• CERSI-University of Maryland
There are many public-
private partnerships in the healthcare
space
• Medical Device Innovation, Safety and Security Consortium
• Biomarkers Consortium• Critical Path Institute• National Bone Health
Alliance• Observational Medical
Outcome Partnership• International Consortium
for Innovation and Quality in Pharmaceutical Development
Public Private Partnerships Have Worked Before:The MDIC is Uniquely Medical Device
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“Faster, Safer, More Cost-effective”MDIC Vision
Align
Achieve Accelerate
Bring together the expertise and resources of industry, government and non-profit
organizations
Invest in regulatory science to keep pace with technology
advances
Increase the throughput of medical device innovation
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FDA 2014-15 Strategic Prioritiesfor Regulatory Science
Center for Devices and Radiologic Health Strategic Priorities 2014-15
MDIC: Integral part of FDA Strategic Priorities
The Center for Devices and Radiological Health’s (CDRH) 2014-2015 Strategic Priorities describe the most important areas that they will focus on:
• Strengthen the clinical trials enterprise;*
• Strike the right balance between premarket and postmarket data collection; and
• Provide excellent customer service.
*MDIC collaboration through our Clinical Trial Innovation and Reform Project identified as a key aspect to strengthening the clinical trial enterprise strategic priority.
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MDIC: FDA:Board Champion | TBD Acting Primary Contact |Michelle McMurry-Heath, MD, PhD |Acting Program Manager | Steve Binion, PhD | Associate Director for Science | Office of the Center Director | Director, Reg Affairs/Clinical Development | BD Center for Devices and Radiologic Health (CDRH)
Project Initiatives
Clinical DiagnosticsGoal: Identify one or more opportunities to improve Diagnostic trials approach/
infrastructure that will be of value to both the regulated industry and government
stakeholders, and is consistent with MDIC’s mission and project structure.
MDIC: FDA:Board Champion| Rick Kuntz, MD Primary Investigator | Bram Zuckerman, MD | Supervisory MedicalSenior VP & Chief Scientific, Clinical & Regulatory Officer | Office of Device Evaluation (ODE)Officer| Medtronic Primary Investigator | Kathryn O’Callaghan | Health Scientist|
Program Manager | Stephanie Christopher | MDIC Office of the Center Director | Center for Devices and Radiologic Health (CDRH)
Clinical Trial Innovation & ReformGoal: Streamline the clinical trial process, increasing efficiency and safety over the
total product lifecycle of medical devices
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Project Initiatives
MDIC: FDA:Board Champion | Ross Jaffe, MD Primary Investigator | Randall Brockman, MD | Chief Medical Officer | Director | Versant Ventures, and Office of Device Evaluation (ODE)Managing Director | National Venture Capital Association Primary Investigator | Robert Becker, MD | Medical Officer | OfficeProgram Manager | Stephanie Christopher | MDIC of In Vitro Diagnostics & Radiological Health (OVD)
Patient Centered Benefit-Risk AssessmentGoal: Develop a framework for including patient views on benefit/risk in device
development and regulatory assessment
Computer Modeling & SimulationGoal: Increase confidence in device safety and efficacy, reduce clinical trial size,
and accelerate device review through regulatory-grade models and simulations
MDIC: FDA: Board Champion| Randy Schiestl Primary Investigator | Kyle J. Myers, PhD | Director, Division of Imaging
VP, Global Operations & Technology | Boston Scientific & Applied Mathematics | Office of Science & Engineering Laboratories Program Manager | Dawn Bardot, PhD | MDIC (OSEL)
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Team Structure Framework
Project Manager
Steering Committee
Workgroup 1
Sub-team leadTeam members
Task Team ChairTeam Members
Grant Review Task Team
Workgroup 2
Sub-team leadTeam members
Workgroup 3
Sub-team leadTeam members
Project manager works with Steering Committee, MDIC staff, and sub-team leads to develop project scope and manage project resources, timelines,
and deliverables
Board Champion & CEOplus representatives from Membership Organizations:
Industry, Government,Non-profit, Patient groups
MDIC Staff
President & CEOProgram AdministrationEducation & Project Support
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Board of DirectorsExecutive Committee
Full Board
Allan Coukell | The Pew Charitable TrustsDirector of Drugs and Medical DevicesMDIC Vice-Chair
Vincent Forlenza | BDPresident, CEO and Chairman
William A. Hawkins III | Immucor, Inc. President and CEO MDIC Board Chair
Michael R. Minogue |Abiomed, Inc.President, CEO and ChairmanMDIC Secretary; Membership Committee Chair
William V. Murray | MDICPresident & CEOMedical Device Innovation Consortium CEO
David Perez |Terumo BCT President and CEOChairman, Blood Management Business Division, Terumo CorporationMDIC Finance Committee Chair
Jeffrey Shuren, MD, JD | CDRH, FDADirector, Center for Devices and Radiological HealthFood and Drug AdministrationMDIC Membership Committee Vice-Chair
Glenn L. Criser | Biomet, Inc.Senior VP, Quality/Regulatory/Clinical Affairs
Kathy Hudson, PhD | NIHDeputy Director for Science, Outreach, & Policy
Ross Jaffe, MD | NVCA, Director and Versant Ventures, Managing Director
Richard E. Kuntz, MD, MSc | Medtronic, Inc.Sr. VP and Chief Scientific, Clinical & Regulatory Officer
Bryan Luce, PhD | PCORIChief Science Officer
Aran Maree, MD |Johnson & JohnsonChief Medical Officer, Medical Devices & Diagnostics
Bryan Olin, PhD| Cyberonics, Inc.VP, Clinical, Quality & Regulatory
Michael Rousseau |St Jude Medical Group President
Peter Saltonstall | NORDPresident & CEO
Randall Schiestl | Boston Scientific CorporationVP, Global Operations and Technology
Tamara Syrek Jensen, J.D. |CMSDeputy Director, Coverage and Analysis Group
Michael Tarnoff, MD | CovidienChief Medical Officer
Dale Wahlstrom |LifeScience Alley and The BioBusiness Alliance of MNPresident & CEO MDIC Finance Committee Vice-Chair
Nadim Yared |CVRxPresident & CEO
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MDIC Membership Roster
1. Abbott Vascular
2. Abiomed, Inc
3. AdvaMed
4. ANSYS
5. Aptiv Solutions
6. B. Braun Medical
7. BD
8. Biomet, Inc
9. Boston Scientific
10. Cardiovascular Research Foundation, SkirballCenter
11. CD-adapco
12. CMS
13. Cook Group, Inc
14. Covidien
15. Creganna-Tactx Medical
16. CVRx
17. Cyberonics
18. DesignWise Medical
19. Edwards Lifesciences
20. FasterCures
21. FDA
22. HeartFlow, Inc
23. Holaira
24. IT’IS-USA
25. Immucor, Inc
26. Johnson & Johnson
27. LifeScience Alley
28. MDMA
29. Medtronic, Inc
30. NIH
31. NORD
32. NVCA
33. NAMSA
34. Novartis Pharmaceutics
35. NxThera, Inc
36. PCORI
37. The Pew Charitable Trusts
38. SIMULIA
39. St Jude Medical
40. Sysmex Americas, Inc
41. Terumo BCT
42. Vital Images, Inc
43. W.L. Gore & Associates
Updated 6/6/2014
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Membership
Membership and participation in the MDIC is open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or who have expertise in regulatory science.
• Membership is offered at several levels based on organization type and, if applicable, annual revenue
• Membership has not been offered to academic groups
• Membership has not been offered to individuals
Contact: Bill Murray, [email protected]
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Tamara Syrek Jensen, JDActing Director, Center for Coverage and Analysis
CMS
Role of Regulatory Science/ MDIC in Molecular Diagnostics: A CMS Perspective