opmizingpaentcarethrough) management)of)conflicts)of)interest · optimizing patient care through...
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Op#mizing Pa#ent Care Through Management of Conflicts of Interest
June 2, 2015
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David Johnson, President & CEO,
Central Indiana Corporate Partnership and BioCrossroads
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Thank You
Official Printer for Frameworx
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@BioCrossroads
#patientinnovation #patientoutcomes #conflictofinterest
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David Johnson, President & CEO,
Central Indiana Corporate Partnership and BioCrossroads
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Optimizing patient care through management of conflicts of interest
Michael E Berend, MD Midwest Center for Joint Replacement
Joint Replacement Surgeons of Indiana Research Foundation
Rose Hulman Institute of Technology
Indianapolis, Indiana
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Disclosure Research Funding, Intellectual
Property Transfer, Consulting
• Biomet, Stryker, DePuy, Wright
• St. Francis Hospital • National Science Foundation
• Orthalign
• Pacira
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Interesting Hypothesis
“Scrutiny on physician-industry relationships are
handicapping innovation in
translational medicine and
marring the current
healthcare environment…”
affirm
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How does patient care improve?
Ideas New Discovery
Clinical Trials
Collaboration Industry
Physicians
Training Education
Data
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Value in Knowledge and Experience
• Experience: More joint replacements than any other group in Indiana ~ >34,000
• Largest clinical database in the state
• Local, regional, national, and international educators
• Research, teaching, and developers focused on clinical outcomes and cost reduction
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Improving Patient Care with Industry Development Pathways
1. Basic Science and Clinic Research
2. Intellectual Property Transfer
3. Consulting
4. Independent IP development and
licensing and sale
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Basic Science Research Funding
• Surgeon and Industry initiated
• Collaboration with Rose Hulman Institute of Technology & JRSI Foundation 501(c)(3)
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Knee Replacement Technique 5mm resection
15mm resection
Small, Berend et al, JOA 2010
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Component Mismatch - TKA
Berend et al, JOA 2010
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Biomechanics of Alignment
neutral varus
Green, et al, JOA, 2002
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Is there additional fruit? • 17 journal publications
• 22 conference presentations
• 37 nameable projects
• $486,309 in grants and gifts
• $414,460 in industry projects
• 42 undergraduate student research internships
• 12 masters student theses 18
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• Student alumni currently in graduate school (MS and PhD): Florida (2), Clemson, Oxford, Illinois, Colorado (2), Cornell, Michigan, New Jersey, Purdue, Grace College (2).
• Alumni employees: Biomet, Zimmer, Depuy, Stryker, OrthoPediatrics, Paragon Medical, Cook, Boston Scientific, Covidien, Invacare, Beckman Coulter, MPS Precimed.
• MD students: IU Med (2) and Michigan State
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Clinical Research ~ Patient Safety
Multicenter study comparing early complications (< 90 days) between TKA and UKA. ~3,000 knees.
Brown, et al, JOA, 2012
Is A Compartmentalist Approach Safer ?
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Results : Total Complications
p < 0.001, Odds 2.8
252 of 2290
27 of 629
TKA 11.0%
UKA 4.3%
VS.
Brown, et al, JOA, 2012
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Are the Patients More Satisfied?
Patient Satisfaction Residual Symptoms
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Contributions: Publications
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IP Transfer: Patent Assignment
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Outpatient Joint Replacement Clinical Innovation ~ Pathways and Processes
Cost savings, early return to function and work, higher satisfaction
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Medicine is Dynamic
• EMR • “Meaningful” use • SGR • Payment advisory board • Medicare reducMons • Regulatory “oversight”
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Timeline of Arthroplasty Length of Stay
From Keith R Berend, MD, JIS, Inc
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Outpatient Joint Replacement Center Development
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Perspective on Scrutiny
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Department of Justice
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Additional Scrutiny The Indianapolis Star
November 12, 2007
Docs bristle at suggestion of kickbacks; Feds probe orthopedic surgeons' fees from artificial device makers
“Federal prosecutors call them bribes and kickbacks. Orthopedic surgeons call them legitimate consulting fees for their hard work and expertise.”
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Physician Financial Transparency Reports
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Management ~ Disclosure Patient Consent Form
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End Result
www.mcjr.com
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Thank You
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Laura Lyons, Vice President of Clinical, Quality and Regulatory Affairs,
SonarMed, Inc.
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Inventor, this is my “baby”
Early collaboraMon with Regulatory experts increases chance of success
! Inventors partner with a regulatory resource early in the process – Ensures they are documenMng the work being done so this can be
used in the regulatory submission process
– SomeMmes the path is easier or more difficult than the company originally thinks
– Provides the company with the valuable informaMon they need on cost of the regulatory process
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Conflicts of Interest
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Investor-‐It costs how much and takes how long??
Proper funding for the regulatory process ! Investors need clear communicaMon from the inventor or
company on the costs of the regulatory process – Company needs understanding and again partnering with regulatory
early on is essenMal
! Investors need to understand that the regulatory process changes subtly (or not so subtly) and they need to remain flexible – Regulatory bodies do not typically communicate or guarantee
Mmelines, and their Mmelines are not the same as the company anyway
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Conflicts of Interest
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! Take the Mme to find out what the user really wants – This is not always what the people closest to the product see
– Involve the clinicians who will use the product early and o^en
Clinical
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Inventor/Company Needs Clear User Requirements
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Start Up Company
59
It takes longer than you expect
! And that means you probably need more money than you think – Hiring seasoned execuMves is expensive but worthwhile and may shorten the process
! The work is rewarding – Though o^en Mmes it is daunMng (wear lots of hats) knowing you are bringing a product to market that will improve or save lives is extremely saMsfying
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Anantha Shekhar, MD, PhD, Director,
Indiana Clinical and TranslaMonal Sciences InsMtute
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Op#mizing Pa#ent Care Through Management of Conflicts of Interest
June 2, 2015
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Thank You
Official Printer for Frameworx
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@BioCrossroads
#patientinnovation #patientoutcomes #conflictofinterest