Templates for Success: Speeding the Formation of Public-Private Partnerships

Public-private partnerships are an important way to accelerate translational science. Each party brings its unique expertise and assets to the table to solve a common challenge. But establishing this kind of partnership can be its own kind of challenge — one that can delay scientific progress for a year or more.

NCATS’ Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program is an innovative effort that focuses on establishing public-private partnerships to advance the development of promising therapeutic candidates. It is designed to bring together partners from the pharmaceutical industry and academic institutions to crowdsource ideas for new uses of existing molecules. These molecules are proven to be safe in humans but were not effective against the diseases they were developed to treat. NCATS’ goal is to repurpose these drugs and speed the development of new therapies.

NCATS knew that one major roadblock to success was time: It takes a while to set up a collaborative research agreement between the company that owns a molecule and the academic institution of the researchers proposing a new use. This legal agreement describes how intellectual property such as patents will be handled in the project. Agreement negotiations can take a long time — sometimes a year or more — and a “new uses” project cannot start until they are completed.

“Protracted agreement negotiations can be a bottleneck in public-private collaborations, significantly delaying research progress,” said Lili Portilla, M.P.A., director of NCATS’ Office of Strategic Alliances.

Portilla and others at NCATS saw an opportunity to speed the negotiation process, so they created template legal agreements that academic institutions and pharmaceutical companies could use as a launching point for negotiations. A pilot test of these was impressive.

“Most of the pilot project agreements were formed within three to four months instead of a year or more,” Portilla said. “For patients who are sick now, cutting six to nine months off the time it takes to get a study started is a big deal. These template agreements really kick-started negotiations.”

The template agreements are an example of the kind of operational research hurdles NCATS is addressing. Developing solutions that streamline the processes of carrying out translational science speed not just a project or research on a specific disease, but the overall process of translating discoveries into interventions and therapies for patients.

When successful, NCATS’ efforts can also result in dissemination and adoption by the wider research community to effect broad, lasting changes for patients’ benefit. In this case, the templates proved so successful that others within and outside NIH have adapted them to jump-start a wide range of innovative research initiatives.

Negotiating a Strong Foundation

To create the New Therapeutic Uses template agreements, NCATS’ Office of Strategic Alliances worked closely with the NIH Office of the General Counsel, the NIH Office of Technology Transfer and pharmaceutical companies experienced in forming agreements with academic researchers. Not everyone in the academic community was initially supportive of the idea, since NIH had not previously been involved in agreements between academia and industry at this level. But skepticism decreased once it was clear the templates can be modified to fulfill the needs of both the company and the academic institution, and most important, that the templates are accelerating agreements. They also help a company and an institution to reach an agreement before NIH funding is awarded, allowing projects to begin more quickly.

“The availability of the templates helped facilitate a very rapid turnaround of a collaborative research agreement with AstraZeneca,” said Mark Dransfield, M.D., a professor of medicine at the University of Alabama at Birmingham. Dransfield and his team became involved with the New Therapeutic Uses program in 2018 to test an AstraZeneca drug as a treatment for lung damage in patients with the rare genetic disease Alpha-1 antitrypsin deficiency.

“AstraZeneca has participated in the New Therapeutic Uses program since its inception in 2012,” said Kumar Srinivasan, vice-president of Scientific Partnering and Alliances for AstraZeneca’s Innovative Medicines and Early Development (IMED) Biotech Unit. “The template agreements simplified the contracting process, enabling our project teams and investigators to move forward more expeditiously to initiate the programs.”

Disseminating Solutions that Work

The benefits of the New Therapeutic Uses templates did not go unnoticed in the NIH community.

The NIH BRAIN Initiative, launched in 2014, is an ambitious effort to revolutionize scientists’ understanding of the brain to find new ways to treat, prevent and cure related disorders. One approach is to use medical devices that stimulate the brain to treat various disorders or record brain activity to learn more about a disease. Increasingly, more of these devices are being approved for patients. Similar to the New Therapeutic Uses program, the BRAIN Initiative team wanted to capitalize on their work by funding researchers to test the medical devices for potential new uses. BRAIN Initiative staff worked with medical device companies and the academic community to adapt the New Therapeutic Uses template agreements for their unique needs.

“NCATS’ New Therapeutic Uses program served as a model for our efforts,” said Nick B. Langhals, Ph.D., M.S.E., program director of neural engineering at the NIH National Institute of Neurological Disorders and Stroke and a scientific program team member for the BRAIN Initiative. “The success of the program’s templates in facilitating negotiations between industry and academia made us optimistic that we could create a similar framework for central nervous system devices.”

Medical devices also have been approved to stimulate peripheral nerves, which are the nerves that connect the brain and spinal cord to the rest of the body, to treat conditions such as obstructive sleep apnea and chronic pain. The NIH Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program focuses on understanding peripheral nerves and how their electrical activity controls organ function. Through SPARC, NIH funds researchers to test these medical devices for new conditions ranging from diabetes to irregular heart rhythms to gastroparesis, also called delayed stomach emptying. When the SPARC program launched in 2016, the New Therapeutic Uses template agreements were used to enable studies on the devices to start sooner.  

“SPARC investigators were able to complete collaborative research agreements very quickly,” said Siavash Vaziri, Ph.D., a SPARC program manager at NCATS. “This does not usually happen in academia and was made possible through the templates.”

Sharing Tools to Speed Progress

The template agreements from the New Therapeutic Uses program are free and publicly available for researchers or companies to adapt to their own needs. As expected, downloads of the templates spike when NCATS announces new funding opportunities, but even when there are no related funding opportunities, the templates are popular. This suggests that those in the broader research community are finding the templates useful in negotiating public-private partnerships and demonstrates how NCATS is disseminating solutions as part of its mission to get more treatments to more patients more quickly.

Posted September 2018