Academia – Industry – Military Biomedical Research Collaboration

John W. Sanders, MD MPHTMProfessor 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 institutionSource: Nature Biotechnology/AUTM

1 University of California system2 University of Pennsylvania3 University of Washington/Wash. Res. Fdn.4 University of Utah5 University of Minnesota6 Columbia University7 New York University8 Northwestern University9 Duke University10 University of Massachusetts11 University of Florida12 Mount Sinai School of Medicine13 University of Rochester14 Wake Forest University15 Princeton University

Academia-Industry-Military CollaborationsBenefits

• 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 QuarterResearch, 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

AdvancedProfessional

•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 contractor17

XCEL / ECHO Consortium RolesWFIRM 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