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Academia – Industry – Military
Biomedical Research Collaboration
John W. Sanders, MD MPHTM
Professor of Medicine
Chief, Section on Infectious Diseases
• Disclaimer: The views expressed in this article
are those of the authors and do not
necessarily reflect the official policy or
position of Wake Forest Baptist Health, the
Department of Veterans Affairs, or the U.S.
Government.
Navy Medicine's Research and
Development Enterprise
Why Should the Military and Industry
Collaborate with Academia?
Haven’t we always?
America’s History of Institutional
Collaboration in Innovation
• In build-up to WWII, Vannevar Bush, President of
the Carnegie Institution, presented to President
Roosevelt a proposal to combine government
funding with private enterprise
– public grants for defense research issued to
private institutions in order to accelerate
progress
• Science The Endless Frontier, A Report to the
President, July 1945
– the blueprint for America’s post-war
technological dominance
– Led to creation of National Science Foundation,
etc.
Vannevar Bush,
Director of the Office of
Scientific Research and
Development
Historically Perceived Disadvantage
• Academics:
– “research for the sake of
research”
– “hobby research”
• Basic Science
– research for years to disprove
hypothesis
versus
• Applied Science
– we’ve got to make decisions and
get to something that works
Concern Not Unique to Military
• ~37% of our federal
research budget (of about
$150 billion) goes to
universities
• Industry is only investing
~7% of its total
development spending to
buy research conducted by
universities.
• NIH is pumping about ten
times more money into
universities annually than
the market value of the
research generated
Why does Academia want to collaborate
with Industry and the Military?
• Large cutbacks in
research programs
– declines in philanthropic
support
– cuts of reimbursements
related to the Affordable
Care Act
– cuts to the National
Institutes of Health (NIH)
research grants.
“Because that’s where
the money is!”
How to Fix the Problem
• Increase focus on technology transfer and
commercialization
• Government policies
– 1980 Bayh-Dole Act allows federally-funded
universities to own the research and innovations
• New style partnerships
– Pfizer and the University of California, San Francisco
(UCSF) created the Center for Therapeutic Innovation
in 2010 to enable cross-sector collaboration for
identification and development of promising drug
candidates
It is working
• Total patents are increasing
• Startups zooming up!
Rank Academic institution
Source: Nature Biotechnology/AUTM
1 University of California system
2 University of Pennsylvania
3 University of Washington/Wash. Res. Fdn.
4 University of Utah
5 University of Minnesota
6 Columbia University
7 New York University
8 Northwestern University
9 Duke University
10 University of Massachusetts
11 University of Florida
12 Mount Sinai School of Medicine
13 University of Rochester
14 Wake Forest University
15 Princeton University
Academia-Industry-Military Collaborations
Benefits
• Efficient Implementation of Contract Research
– Resourceful academic institutions to facilitate the execution
of preclinical and clinical research
• Extended Networks
– Ability to build specialized teams from multidisciplinary
focus areas to combine skills
• Specialized Capabilities
– State-of-the-art technologies
– Clinical Capabilities
• Clinical Trials
• Training
– Laboratory Animal Facilities
Wake Forest Innovation Quarter
Research, Business, Education
Biomedicine, Information Technology, Materials
Basic
•GRAD 704 (Principles of Intellectual Property Development)
•GRAD 701 Seminar in Professional and Career Development*
•GRAD 702 Industry Internships
•GRAD 713, 714 Scientific Professionalism and Integrity*
Intermediate
•ENT5450 Commercializing Innovation
•GRAD 703 Industry Internships
Advanced
Professional
•Certificate in Science Management (Stackable certificate)
•PhD/MBA Program (Dual professional credential)
Wake Forest Graduate School Innovation Curriculum
Years 1-2
Years 2-3
Years 3-5
* Required of all 1st year students
Armed Forces Institute of
Regenerative Medicine (AFIRM)
• A multi-institutional, interdisciplinary network working to develop
advanced treatment options for our severely wounded servicemen
and women.
• AFIRM is dedicated to repairing battlefield injuries through the use of
regenerative medicine technology
• AFIRM II is composed of ~30 institutions
– Academic institutions (led by Wake Forest Baptist Medical Center)
– Military treatment and research facilities
Major Extremity Trauma Research
Consortium (METRC)
• Collaboration of
civilian trauma centers
and the Military
Treatment Facilities
(MTFs)
• Unified to identify and
address critical issues
challenging the
recovery of combat
and civilian trauma
patients
– 22 Core Civilian
Centers (including
Wake Forest Baptist
Medical Center)
– 4 Core MTFs
– 30 Satellite Centers
https://metrc.org/clinicalsites
The Concussion Assessment,
Research and Education
(CARE) Consortium
• 3-year, $14.6 million
initiative, funded jointly by
NCAA and DoD
• 30 Universities involved
• The most comprehensive
investigation of sports-
related concussion ever
conducted
XCEL (EX VIVO CAPABILITIES FOR EVALUATION & LICENSURE)
ECHO CONSORTIUM
• Mission: Accelerate development of
countermeasures to chemical and
biological attacks
• Focus: “Body on a chip” to model
response to harmful agents and
develop potential therapies
• XCEL funded by Defense Threat Reduction Agency
• Contract management through Space and Naval Warfare
Systems Center, Pacific
• Contract (not grant) funding mechanism
• Contract awarded to ECHO consortium
• Wake Forest School of Medicine, Institute for
Regenerative Medicine, prime contractor
17
XCEL / ECHO Consortium Roles
WFIRM
Wake Forest University
Institute for Regenerative
Medicine
Principal Investigator: Anthony Atala,
MD
Brigham and
Women's Hospital
Sub PI: Ali Kahdemhosseini
University of
Michigan
Sub PI: Shuichi Takayama
Johns Hopkins
University
Sub PI: Thomas Hartung
U.S. Army Edgewood
Chemical Biological Center
Sub PI: Harry Salem
Microreactors/Sensors Sensors/Scalability Biomarkers Study Design/Testing
Management/ Organoids/ Printing
18
Wake Forest Clinical and
Translational Science Institute
• Sustainable research
infrastructure to
accelerate translating
scientific discoveries
to impact patient care
• Funded by a Clinical
and Translational
Science Award (CTSA)
from the NIH
“Be Involved in Clinical Research”
Wake Forest Baptist Medical Center
Wake Forest Primate Center:
Extensive Facilities for Housing Monkeys, Rodents, Pigs, Sheep; A
Nationally Recognized Research Resource
Questions

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COBRA/Omnibus 4 Industry Day 2016- Academia Focus Group

  • 1. Academia – Industry – Military Biomedical Research Collaboration John W. Sanders, MD MPHTM Professor of Medicine Chief, Section on Infectious Diseases
  • 2. • Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Wake Forest Baptist Health, the Department of Veterans Affairs, or the U.S. Government.
  • 3. Navy Medicine's Research and Development Enterprise
  • 4. Why Should the Military and Industry Collaborate with Academia? Haven’t we always?
  • 5. America’s History of Institutional Collaboration in Innovation • In build-up to WWII, Vannevar Bush, President of the Carnegie Institution, presented to President Roosevelt a proposal to combine government funding with private enterprise – public grants for defense research issued to private institutions in order to accelerate progress • Science The Endless Frontier, A Report to the President, July 1945 – the blueprint for America’s post-war technological dominance – Led to creation of National Science Foundation, etc. Vannevar Bush, Director of the Office of Scientific Research and Development
  • 6. Historically Perceived Disadvantage • Academics: – “research for the sake of research” – “hobby research” • Basic Science – research for years to disprove hypothesis versus • Applied Science – we’ve got to make decisions and get to something that works
  • 7. Concern Not Unique to Military • ~37% of our federal research budget (of about $150 billion) goes to universities • Industry is only investing ~7% of its total development spending to buy research conducted by universities. • NIH is pumping about ten times more money into universities annually than the market value of the research generated
  • 8. Why does Academia want to collaborate with Industry and the Military? • Large cutbacks in research programs – declines in philanthropic support – cuts of reimbursements related to the Affordable Care Act – cuts to the National Institutes of Health (NIH) research grants. “Because that’s where the money is!”
  • 9. How to Fix the Problem • Increase focus on technology transfer and commercialization • Government policies – 1980 Bayh-Dole Act allows federally-funded universities to own the research and innovations • New style partnerships – Pfizer and the University of California, San Francisco (UCSF) created the Center for Therapeutic Innovation in 2010 to enable cross-sector collaboration for identification and development of promising drug candidates
  • 10. It is working • Total patents are increasing • Startups zooming up! Rank Academic institution Source: Nature Biotechnology/AUTM 1 University of California system 2 University of Pennsylvania 3 University of Washington/Wash. Res. Fdn. 4 University of Utah 5 University of Minnesota 6 Columbia University 7 New York University 8 Northwestern University 9 Duke University 10 University of Massachusetts 11 University of Florida 12 Mount Sinai School of Medicine 13 University of Rochester 14 Wake Forest University 15 Princeton University
  • 11. Academia-Industry-Military Collaborations Benefits • Efficient Implementation of Contract Research – Resourceful academic institutions to facilitate the execution of preclinical and clinical research • Extended Networks – Ability to build specialized teams from multidisciplinary focus areas to combine skills • Specialized Capabilities – State-of-the-art technologies – Clinical Capabilities • Clinical Trials • Training – Laboratory Animal Facilities
  • 12. Wake Forest Innovation Quarter Research, Business, Education Biomedicine, Information Technology, Materials
  • 13. Basic •GRAD 704 (Principles of Intellectual Property Development) •GRAD 701 Seminar in Professional and Career Development* •GRAD 702 Industry Internships •GRAD 713, 714 Scientific Professionalism and Integrity* Intermediate •ENT5450 Commercializing Innovation •GRAD 703 Industry Internships Advanced Professional •Certificate in Science Management (Stackable certificate) •PhD/MBA Program (Dual professional credential) Wake Forest Graduate School Innovation Curriculum Years 1-2 Years 2-3 Years 3-5 * Required of all 1st year students
  • 14. Armed Forces Institute of Regenerative Medicine (AFIRM) • A multi-institutional, interdisciplinary network working to develop advanced treatment options for our severely wounded servicemen and women. • AFIRM is dedicated to repairing battlefield injuries through the use of regenerative medicine technology • AFIRM II is composed of ~30 institutions – Academic institutions (led by Wake Forest Baptist Medical Center) – Military treatment and research facilities
  • 15. Major Extremity Trauma Research Consortium (METRC) • Collaboration of civilian trauma centers and the Military Treatment Facilities (MTFs) • Unified to identify and address critical issues challenging the recovery of combat and civilian trauma patients – 22 Core Civilian Centers (including Wake Forest Baptist Medical Center) – 4 Core MTFs – 30 Satellite Centers https://metrc.org/clinicalsites
  • 16. The Concussion Assessment, Research and Education (CARE) Consortium • 3-year, $14.6 million initiative, funded jointly by NCAA and DoD • 30 Universities involved • The most comprehensive investigation of sports- related concussion ever conducted
  • 17. XCEL (EX VIVO CAPABILITIES FOR EVALUATION & LICENSURE) ECHO CONSORTIUM • Mission: Accelerate development of countermeasures to chemical and biological attacks • Focus: “Body on a chip” to model response to harmful agents and develop potential therapies • XCEL funded by Defense Threat Reduction Agency • Contract management through Space and Naval Warfare Systems Center, Pacific • Contract (not grant) funding mechanism • Contract awarded to ECHO consortium • Wake Forest School of Medicine, Institute for Regenerative Medicine, prime contractor 17
  • 18. XCEL / ECHO Consortium Roles WFIRM Wake Forest University Institute for Regenerative Medicine Principal Investigator: Anthony Atala, MD Brigham and Women's Hospital Sub PI: Ali Kahdemhosseini University of Michigan Sub PI: Shuichi Takayama Johns Hopkins University Sub PI: Thomas Hartung U.S. Army Edgewood Chemical Biological Center Sub PI: Harry Salem Microreactors/Sensors Sensors/Scalability Biomarkers Study Design/Testing Management/ Organoids/ Printing 18
  • 19. Wake Forest Clinical and Translational Science Institute • Sustainable research infrastructure to accelerate translating scientific discoveries to impact patient care • Funded by a Clinical and Translational Science Award (CTSA) from the NIH “Be Involved in Clinical Research”
  • 20. Wake Forest Baptist Medical Center Wake Forest Primate Center: Extensive Facilities for Housing Monkeys, Rodents, Pigs, Sheep; A Nationally Recognized Research Resource

Notes de l'éditeur

  1. While university research can produce very important discoveries, it often falls short when it comes to translating those discoveries into actual impact and return on investment.
  2. there is a difference in what the government and industry spends their dollars on. In medical R&D, the government is focused on research (R) and industry on development (D), i.e., taking an idea to market through the costly FDA process. Indeed, research is increasingly shifting from “big pharma” to other entities such as universities, which are often the start of the compound discovery process.
  3. A Foundation of Academic and Clinical Excellence Technology licensing by Wake Forest Innovations builds on the academic and clinical research expertise that have been the hallmarks of Wake Forest Baptist Medical Center for more than 70 years. This includes: Scholarship in basic medical, materials and engineering science that attracts about $200 million in annual funding Nationally recognized expertise in clinical research and practice More than 1,095 Wake Forest School of Medicine faculty working in a diverse range of biomedical sciences A Successful Track Record in Technology Licensing Wake Forest Baptist Medical Center has a successful track record in technology licensing and is recognized as one of the top five U.S. academic technology transfer offices for licensing income by the Association of University Technology Managers. It also is top ranked by Forbes.com for return on research investment.