TY - JOUR
T1 - Translation to Practice
T2 - Accelerating the Cycle of Innovation to Impact
AU - Anderson, Jeff R.
AU - Chung, Thomas D.Y.
AU - Clark, Leon
AU - Weis, Jennifer A.
AU - Danielsen, Andrew J.
AU - Khosla, Sundeep
AU - Gores, Gregory J.
AU - Badley, Andrew D.
N1 - Funding Information:
Additional processes have necessarily accompanied the efforts of the OTP. These processes are exemplified by the concept of OTP-led, project-specific management teams ( ). As products progress on the developmental pathway, various specialists may be required to advise and participate in product development. The OTP provides a nexus for organization and management of project-specific management teams that respond agilely to fluctuating and evolving team needs. Additional team members brought on by the OTP augment the core scientific teams that the OTP services. Figure 4 To facilitate the population of these teams, the OTP team leaders partner with the various internal offices and support services at Mayo Clinic and also have curated a list of external consultants. External consultants include, among others, experts in regulatory affairs, reimbursement strategy, and business intelligence ( ). Table 2 Project-specific management teams have been used extensively in an additional success of the OTP, co-administering the Translational Product Development Fund (TPDF) with the University of Minnesota (UMN) Office of Discovery and Translation. The TPDF is a competitive funding mechanism established by the CCaTS and the UMN Clinical and Translational Science Institute in conjunction with the Minnesota Partnership for Biotechnology and Medical Genomics. 28 Similar to the main Minnesota Partnership, the TPDF leverages the generous support of the State of Minnesota to position Minnesota as a world leader in biotechnology, stimulate the regional economy and industry, and realize breakthrough therapies. 29 Ultimately, the intent of the program is to “impact the lives of Minnesotans by translating research discoveries into new therapies and treatment approaches for patients.” 28 It does this through milestone-based, tiered funding of translational projects at the UMN and Mayo Clinic. For each project on which the lead principal investigator or co–principal investigator is from Mayo Clinic, the OTP provides oversight and assembles a project-specific management team. The OTP advises and coordinates when additional team members are needed and assists as appropriate to help teams realize their milestone goals. Since June 2015, more than 150 letters of intent have been received for the TPDF, resulting in 15 tier 1 ($50,000 for 1 year) and 2 subsequent tier 2 awards ($400,000 over 2 years) committed. Awarded projects have been distributed across different types of products, including drugs and biological agents, medical devices, biomarkers and diagnostics, and software. Many of these TPDF projects continue to progress toward commercialization, and resources for additional rounds of funding of the TPDF have been secured. Recently, based on its successes, the TPDF received a 1-time $2.5 million bolus of additional funding, above its current support from the Minnesota Legislature, through a bill championed by Rep. Matt Dean, chairman of the Minnesota State House Health and Human Services Finance Committee. 30 A standout example of the innovation supported by the TPDF is seen in the work of Mayo Clinic's Dr Barry Borlaug to develop new tools and procedures to treat heart failure with preserved ejection fraction (HFpEF), a subtype of heart failure that is currently untreatable. Using TPDF funding, Dr Borlaug has prototyped and tested novel, minimally invasive surgical tools for a completely new surgical intervention for HFpEF: percutaneous pericardial resection. This work has been partly captured in a recent publication that was recognized as a “best paper” by the Heart Failure Society of America at their yearly conference in September 2017. 31 Through the TPDF award, the new surgical tools have been prototyped over multiple iterations, acute and further chronic testing in an animal model of HFpEF has been performed, and proof of principle mechanistic studies in humans have been performed. These activities have significantly derisked this new product that is intended to assist a significant population that currently has no viable treatment options. 31 The TPDF mechanism has had such great success that in 2018 Mayo Clinic decided to develop a similar program on an institutional level. The Advance the Practice Research Award provides critical support in the form of interaction with the OTP product-specific project management teams as well as a $50,000 award. Projects are limited to either development of an early-stage product or transformative practice initiatives or pilots. Although just in its infancy, it is expected that this critical infusion of focused support at an early stage of product development will have great impact.
Funding Information:
Grant Support: Research reported in this publication was supported by award numbers UL1TR002377 and UL1TR002494 from the National Center for Advancing Translational Sciences of the National Institutes of Health and by the Minnesota Partnership for Biotechnology and Medical Genomics through the Translational Product Development Fund.
PY - 2019/3
Y1 - 2019/3
N2 - The Office of Translation to Practice (OTP) is housed in the Center for Clinical and Translational Sciences at Mayo Clinic. Established in 2015, the office was tasked with developing and managing novel tools, mechanisms, and processes to facilitate and accelerate the translation of products, such as drugs, biological agents, and medical devices, into practice. Since its inception, the OTP is credited with creating valuable services through several strategic alliances and active scientific and project management involvement. The OTP continues to move forward to assist Mayo Clinic physicians and scientists to interact effectively with internal and external collaborators to advance translational projects that will benefit patients. Best practices, innovations, and nascent successes of the OTP are presented and discussed herein.
AB - The Office of Translation to Practice (OTP) is housed in the Center for Clinical and Translational Sciences at Mayo Clinic. Established in 2015, the office was tasked with developing and managing novel tools, mechanisms, and processes to facilitate and accelerate the translation of products, such as drugs, biological agents, and medical devices, into practice. Since its inception, the OTP is credited with creating valuable services through several strategic alliances and active scientific and project management involvement. The OTP continues to move forward to assist Mayo Clinic physicians and scientists to interact effectively with internal and external collaborators to advance translational projects that will benefit patients. Best practices, innovations, and nascent successes of the OTP are presented and discussed herein.
UR - http://www.scopus.com/inward/record.url?scp=85061044686&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85061044686&partnerID=8YFLogxK
U2 - 10.1016/j.mayocp.2018.08.008
DO - 10.1016/j.mayocp.2018.08.008
M3 - Review article
C2 - 30738605
AN - SCOPUS:85061044686
VL - 94
SP - 490
EP - 499
JO - Mayo Clinic Proceedings
JF - Mayo Clinic Proceedings
SN - 0025-6196
IS - 3
ER -