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

Transcript of OpmizingPaentCareThrough) Management)of)Conflicts)of)Interest · Optimizing patient care through...

Page 1: OpmizingPaentCareThrough) Management)of)Conflicts)of)Interest · Optimizing patient care through management of conflicts of interest Michael E Berend, MD Midwest Center for Joint

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

Page 4: OpmizingPaentCareThrough) Management)of)Conflicts)of)Interest · Optimizing patient care through management of conflicts of interest Michael E Berend, MD Midwest Center for Joint

@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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video placeholder

Page 21: OpmizingPaentCareThrough) Management)of)Conflicts)of)Interest · Optimizing patient care through management of conflicts of interest Michael E Berend, MD Midwest Center for Joint

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  

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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  

Page 60: OpmizingPaentCareThrough) Management)of)Conflicts)of)Interest · Optimizing patient care through management of conflicts of interest Michael E Berend, MD Midwest Center for Joint

Anantha  Shekhar,  MD,  PhD,    Director,  

Indiana  Clinical  and  TranslaMonal  Sciences  InsMtute  

Page 61: OpmizingPaentCareThrough) Management)of)Conflicts)of)Interest · Optimizing patient care through management of conflicts of interest Michael E Berend, MD Midwest Center for Joint

Op#mizing  Pa#ent  Care  Through  Management  of  Conflicts  of  Interest  

June  2,  2015  

Page 62: OpmizingPaentCareThrough) Management)of)Conflicts)of)Interest · Optimizing patient care through management of conflicts of interest Michael E Berend, MD Midwest Center for Joint

Thank  You  

Official Printer for Frameworx

Page 63: OpmizingPaentCareThrough) Management)of)Conflicts)of)Interest · Optimizing patient care through management of conflicts of interest Michael E Berend, MD Midwest Center for Joint

@BioCrossroads

#patientinnovation #patientoutcomes #conflictofinterest


Johannes J. van Lieshout, Wilbert A. Wesselink, Berend E. Westerhof

Johannes J. van Lieshout, Wilbert A. Wesselink, Berend E. Westerhof

Fractal-Type Dynamical Behaviors of Complex Systemsdownloads.hindawi.com/journals/complexity/2018/8029361.pdf · Conflicts of Interest The editors declare that they have no conflicts

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Partisan conflicts and parliamentary dominance: the ...home.bi.no/a0111218/NorwayPBC.pdf · Partisan conflicts and parliamentary dominance: the Norwegian political business ...

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KITCHENS - Gerber Berend Design + Build...Susan worked closely with design guru and Gerber Berend co-owner Jeff Gerber on the interior structure and composition of the home. “My

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Fifty Shades of QE: Conflicts of Interest in Economic Research · Fifty Shades of QE: Conflicts of Interest in Economic Research * Brian Fabo1, Martina Janˇcokov a´2, Elisabeth

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CMBS and Conflicts of Interest: Evidence from a Natural ...realestate.wharton.upenn.edu/wp-content/uploads/2017/03/...1 Introduction Reducing conflicts of interest is central to

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in traffic conflicts

CORPORATE INFLUENCE OVER UNIVERSITY AGRICULTURAL … Resear… · create potential, perceived or actual conflicts of interest for land-grant research programs. Some research programs

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John Mulhall Berend de Jong Ivo Weterings DATA … · John Mulhall Berend de Jong Ivo Weterings PROFIT POOR ... opportunity to turn their valuable data and insights ... the intersection

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PERSONAL INFORMATION Berend · PDF fileCurriculum vitae PERSONAL INFORMATION Berend Wilffert WORK EXPERIENCE 1984–1986 Head of the laboratory in the Respiration Therapeutics Department

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Resolving Water Conflicts: A Comparative Analysis of ...water.columbia.edu/files/2011/11/Heikkila2009ResolvingWater.pdf · Resolving Water Conflicts: A Comparative Analysis of Interstate

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Mapping the nature of land conflicts in India

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Responsible Investment Policy … · D. Conflicts of Interest The Fidelity Conflicts of Interest Policy addresses the obligations of Fidelity and its subsidiaries carrying on regulated

Responsible Investment Policy … · D. Conflicts of Interest The Fidelity Conflicts of Interest Policy addresses the obligations of Fidelity and its subsidiaries carrying on regulated

Biased Recommendations from Biased and Unbiased Experts · Biased Recommendations from Biased and Unbiased Experts ... recommendation still be persuasive with such conflicts of interest,

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