What Is the Role of the Accelerating Medicines Partnership?

What Is AMP?

For context, the FNIH is a nonprofit entity separate from the NIH but works alongside researchers and leaders at the NIH to support the government organization’s overall mission by bridging the gap between patient advocacy organizations, academic and government research, and industry leaders.

“The Accelerated Medicines Partnership is a signature platform started a decade ago and has progressed through more than 10 therapeutic areas, explained Gerberding. “It's not one project; it's a set of projects that continue to evolve.”

Some of the programs have been around for a long time. For example, the AMP Alzheimer’s Disease program was founded to understand the condition's pathways and targets. The original program was a five-year project, and after meeting its five-year goals, both private and government partners on the team pitched a 2.0 AMP for this condition, renewing it for an additional five years.

Goals

“The goal is obvious: it's to define treatments and cures for diseases faster than any single company, NIH institute, or academic research center could accomplish,” Gerberding reinforced. “By putting the wise crowd together, AMP creates the platform where data are shared, insights are explored, and cohorts of patients can be followed longitudinally to identify the precision needed to detect new targets and, in some cases, test new therapies.”

Over the past decade, 10 mature AMP programs have been in full swing, and new ones are continually being launched. Gerberding told PharmaNewsIntelligence that the FNIH had raised nearly a billion dollars to support these programs. Alongside funding, the programs collectively have over 30 industry or private sector partners and almost 40 nonprofit partners.

“It's an extensive distribution of partners,” she noted. “Of course, the NIH part of the investment funds the academic investigators who are the best and brightest in their field. That is the [critical] characteristic of the FNIH. We have the smartest people at NIH working with the smartest people in life science companies, the smartest people in academia, and the smartest people in the patient research world. They all work collaboratively on a common therapeutic area or a common problem.”

For example, one of the most recent launches that AMP announced is the Bespoke Gene Therapy Consortium, which included 33 partners and 10 NIH institutes to study best practices for launching gene therapies and get them past approval hurdles.

Launching AMPs

“We get the AMP started in many different ways,” said Gerberding, addressing how disease or research areas are chosen for each program. “One common way is that we, the leaders of FNIH, sit down with the heads of the NIH institutes to understand what they see as the important unmet needs.”

She shared that she serves on the National Health Council Executive Board, allowing her to interact with leaders across multiple groups, including patient organizations.

“First and foremost, it must be an area of unmet need that's important to patients and others in the ecosystem,” she explained.

The second thing they look for in an AMP partnership is a problem that, to date, seems unsolvable. The organization has a unique ability to develop collaborative, multi-faceted teams that take advantage of various skill sets and capabilities, meaning they can tackle the most challenging problems.

Finally, the program also looks at feasibility. They want to ensure enough interest in each topic to garner the resources and support they need to sustain funding and attention to the program for its duration. One of the FNIH’s primary goals is to ensure patient-centric approaches that heavily consider patient experiences.

“To that end, we've started a patient advisory council to the FNIH that has several wise and influential patient leaders, patient organization leaders, and patients with lived experience,” noted Gerberding. “We also have patient ambassadors who have some of the conditions that we're working hard to address who explain to others in the community why clinical research is important or why participating in a scientific collaboration is valuable and brings meaning.”

She included that these efforts include attempts to ensure a diverse patient population. They have structures and strategies to include a broad spectrum of individuals representing the patient population instead of just those conveniently near the major medical centers.

“Those are the kinds of things that we think about, and when we think we have an area, we could come together and create a collaborative that accelerates progress in this area,” she revealed. “[Then,] we move through a process of designing the program with our stakeholders and establish a governance steering committee, which is shared across different partner groups and the specific scientific subcommittees that take on the more scientific detailed protocols, et cetera, to make sure that we maintain the highest standards of scientific integrity and quality as we go forward.”

Horizontal Planning, Vertical Execution

“The overarching key to success is that shared agenda. If [we’re] going to have a team science [approach] or a collaboration, the partners need to agree on the overarching reason that they're coming together and what success looks like.”

Gerberding describes the structure as planning horizontally but executing vertically. In other words, the team looks across the concern, bringing together people with varying expertise and differing sub-agendas under the same overarching agenda. The teams execute vertically after painting a lateral view of the bigger picture. Gerberding maintains that it is ineffective to execute in a swarm. Together, the team decides what needs to be done, who will do it, when it will be delivered, and metrics for measuring success. 

“That actual execution step gets distributed across the consortium in a way that allows the right people [to contribute to] the execution so that [the team] knows who's accountable and who has the expertise and the capability to accomplish their piece of the action.”

Gerberding closed by telling PharmaNewsIntelligence that the key to successful multi-disciplinary research approaches, like the ones executed by the AMP program, is to “Agree on the overarching goal, plan horizontally, execute vertically, measure progress, and above all, maintain transparent and open communication because inevitably there'll be delays or there'll be a funding glitch or the study won't go as planned, and we have to maintain that agility and the flexibility to solve the problems and continue to move forward.”