Fit Forum V- Successful Innovative Careers. Steven S. Brooks, MD MBA FACC Chief Innovation Officer Sage Growth Partners

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1 Fit Forum V- Successful Innovative Careers Steven S. Brooks, MD MBA FACC Chief Innovation Officer Sage Growth Partners

2 Disclosures: None

3 Background University of Pittsburgh School of Medicine 96 Sarnoff Fellowship Pitt Internal Medicine 99 Pitt General / Interventional Cardiology 03 Associate Professor University of Maryland Mid-Atlantic Cardiology JHU MBA Business of Medicine 2011 FDA Medical Officer Maryland Israel Development Center 2009-Present Sage Growth Partners 2014-Present

4 Why Not Medicine Medical Practice Lifestyle 3 Kids Who I never see Weekend Call Insurance Companies Malpractice Lawyers Decreasing Income

5 What Next? Industry Consulting Finance / Venture Capital MBA Johns Hopkins Stent Thrombosis Redux The FDA Perspective Andrew Farb, M.D., and Ashley B. Boam, M.S. N Engl J Med 2007; 356: February 12, 2007 FDA

6 From pacemakers... Division of Cardiovascular Devices and drug-eluting stents... to LVAD s

7 DCD Organization Eight branches Interventional Cardiology Devices Branch - ICDB Peripheral Interventional Devices Branch PIDB Cardiac Diagnostics Devices Branch - CDDB Cardiac Electrophysiology Devices Branch - CEDB Implantable Electrophysiology Devices Branch - IEDB Vascular Surgery Devices Branch VSDB Structural Heart Device Branch - SHDB Circulatory Support Devices Branch- CSDB

8 Role of FDA CDRH Establish reasonable assurance of the safety and effectiveness of medical devices marketed in the U.S.

9 What Does Regulation Involve Now? Product Review and Approval Approval of Clinical Studies Inspection of Manufacturing Facilities Post-Approval Monitoring Importing / Exporting Basic and Applied Scientific Research Education and Outreach

10 Premarket Submission Types Pre-Submission (Pre-IDE) IDE - Investigational Device Exemption 510(k) - Premarket Notification PMA - Premarket Approval HDE - Humanitarian Device Exemption

11 Additional Initiatives Physician Specialty Group Initiatives (ACC, VIVA, SVS, SIR) Intermittent Claudication (IC) Performance Goals CLI trial design performance goals RAS trial design performance goals Design of device registries DAPT Trial ASPECT Trial Harmonization By Doing with Japanese Ministry of Health and Welfare ISO Standards Standardized Definitions for CV Trials CDISC PARC CV Imaging Workgroup CMS Parallel Review Entrepreneurs-in-Residence CDRH Medical Device Reimbursement Taskforce

12 Maryland Israel Development Center Public Private Partnership Funding: Associated Jewish Charities, State of Maryland A non-profit organization promoting trade and investment between Maryland and Israeli businesses and research institutions

13 Sage Growth Partners CONSULTING Identifying opportunities and collaborating to enhance performance Strategic and business planning Operations improvement M &A Product development Thought leadership Strategic sourcing Scientific/Medical Development Regulatory and Reimbursement Strategy STRATEGIC MARKETING Identifying market opportunities and creating strategic communications campaigns to realize them Brand Audits Brand Positioning Messaging Media Planning and PR Advertising Social Media, Web, Interactive TECHNOLOGY Blending health care expertise and technology for growth IT strategic planning Business intelligence and analytics Implementation and Integration services Project management services Data and analytics Evidentiary Development Clinical Trial Design

14

15 Contact Information Steven S. Brooks, MD FACC Chief Innovation Officer Sage Growth Partners 3500 Boston Street, Ste 435 Baltimore, MD Phone: (410) FDA Web Site:

16

17 MDFP Fellows are FDA employees Fellows can be recent graduates, or individuals at the mid-career or senior career levels Full or Part-time Work On-site or off-site Examples Mayo Clinic Brigham and Women s Hospital University of North Carolina Cleveland Clinic

18 Commisioner s Fellowship For Health Professionals and Scientists 2 Year Commitment Preceptor Experience Class Curriculum Public Policy Regulatory Law Epidemiology Clinical Trials Statistics Applications: CommissionersFellowshipProgram. (January-March)

19 How Fellows Connect with MDFP Candidates may apply to the MDFP website Complete an online application: Send via a current CV and a Letter of Interest in our program. Candidates may be located through outreach efforts and other professional contacts

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