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“Physicians and researchers often have new ideas for medical devices, drugs, biologics, or other products that they want to deliver to patients, but they don’t know how to bring those discoveries to life,” says Jeff Anderson, Ph.D., Mayo Clinic Office of Translation to Practice. Taking the next steps in product development may require access to additional resources or know-how. That’s the critical moment where the Mayo Clinic Office of Translation to Practice can step in to help bridge the gap.
The Office of Translation to Practice recently shared what it has learned in its first three years—best practices, innovations, and early successes—in a paper published in Mayo Clinic Proceedings.
Jeff Anderson, Ph.D.: Patent agent and manager of OTP strategic alliances. Doctorate in physical chemistry. Bharath Wootla, Ph.D.: Specialty in biopharma product development. Doctorate in biochemistry. Nathan Wiedenman, Ph.D.: Specialty in medical device product development. Doctorate in mechanical engineering.
The Office of Translation to Practice specializes in helping Mayo researchers assemble the best possible scientific teams to facilitate product development.
Office staff members are “bridge building specialists”—with expertise in business, law, sales and other areas—that makes them uniquely suited to help researchers find resources and assemble the teams that will help them move effectively between medicine and the marketplace.
Sanford Burnham Prebys offers Mayo researchers access to sophisticated drug screening capabilities, vast drug libraries, and medical chemistry expertise.
The Office of Translation to Practice has established a variety of strategic alliances with organizations outside the walls of Mayo Clinic, providing access to specialized resources and expertise.
The first of these strategic collaborations was a drug development research agreement established with Sanford Burnham Prebys (SBP) Medical Discovery Institute in 2012. Together, SBP and Mayo scientists have applied for and received numerous grants, resulting in a nearly six-fold return on investment.
Guidance from Translation Boards has already led to the product development success, including the formation of startup companies. One such company is Qrativ, a collaboration between Mayo Clinic and an analytics company called ‘nference’ that focuses on identifying the best clinical indications for new drugs.
Product development sometimes fails due to inadequate safety or toxicity assessment, incorrect patient populations selected for study, inappropriate study endpoints, and flaws in the design and implementation of clinical trials.
To help researchers avoid these pitfalls, Office of Translation to Practice offers researchers the opportunity to receive feedback and guidance from Translation Boards composed of physicians and scientists from a wide variety of specialties. In addition, the Boards are able to easily pull in additional experts from inside or outside Mayo Clinic, as needed.
A standout example of the support offered by project-specific management teams is seen in the work of Barry Borlaug, M.D., a Mayo Clinic cardiologist. With the help of specialists identified by the Office of Translation to Practice, Dr. Borlaug prototyped and tested new tools and procedures to treat a previously-untreatable type of heart failure. Dr. Borlaug’s research and product development is ongoing, but these activities have significantly de-risked the product.
As products move along the developmental pathway, the needs of research teams evolve. At different points along the journey, a research team may need access to experts in specific areas, such as regulatory affairs, reimbursement strategy, or business intelligence.
When these needs arise, the Office of Translation to Practice stands ready to supply the expertise, drawn from inside and outside Mayo Clinic.
In addition, the Office of Translation to Practice provides project management advice to help teams reach milestone goals.
“No success of the Office of Translation to Practice would be possible without the strong partnership that exists between the Office and Mayo Clinic Ventures.”
- Jeff Anderson, Ph.D., Office of Translation to Practice
The Office of Translation to Practice partners with Mayo Clinic Ventures on a continual basis as discoveries are translated into treatments with commercial potential.
Mayo Clinic Ventures provides legal and commercial expertise, negotiating and managing all contracts and agreements. The Office of Translation to Practice focuses on scientific strategy, creation and management of partnerships, and project execution.
”Discovery, product development, and the dissemination of knowledge and tools are deeply rooted in the ethos of Mayo Clinic, beginning with Drs. Charles and William Mayo. In today’s more complex scientific and regulatory environment, those tasks have become increasingly difficult. OTP’s mission is to simplify and provide navigation support for Mayo investigators that enables product development for the benefit of our patients.”
- Andrew Badley, M.D., director of the Office of Translational to Practice
As the Office of Translation to Practice enters its third year of existence, more and more Mayo Clinic researchers are reaching out, eager for specialized assistance to translate their discoveries into products that will meet the unmet needs of patients
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Tags: Andrew Badley, Barry Borlaug, Bharath Wootla, Center for Clinical and Translational Science, Jeff Anderson, Mayo Clinic Ventures, Nathan Wiederman, News, People
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