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Never before have humans been so readily connected. And while global connectivity is great for staying in touch with friends or family or working from home, it also allows for profound jumps in innovation resulting from data exchange, global collaboration, and much more.
Case in point: Accumulus Synergy, “a global, nonprofit organization developing a transformative data exchange platform that aims to enable enhanced collaboration and efficiency between life sciences organizations and global health authorities, while also affording users the ability to extract dynamic, data-driven insights.”
The recent launch of the company’s cloud-based, first-in-kind information and data exchange platform is helping to realize that goal by supporting real-time information and data exchange between drug developers and regulators—a first step in the organization’s mission “to dramatically accelerate critical therapies to citizens of the world,” said Chief Executive Officer Frank Nogueira in an interview with Bio.News.
Connecting those who develop new drugs with those who approve them
Accumulus Synergy arose from a question posed during a pre-competitive gathering of the heads of R&D from major pharmaceutical companies, global regulators, and other industry parties: How do we modernize interaction between those who develop new medicines and those who review and approve them?
The work group began investigating whether they could leverage cloud solutions to answer that question. Yet building the resources and industry-wise cooperation needed would be a multi-year task.
“First, you need to convince those who develop new medicines that our direction and our strategy and our plans make sense from an overall governance perspective,” Nogueira explained. “But then we also had to work closely with the health authorities around the world and continually engage with them to make sure that what we’re building is also fit for their purposes.”
“We understood that we really needed to work with industry and regulators to adopt a platform that could support harmonized policies and processes—which we know doesn’t exist now,” said Khushboo Sharma, Chief Regulatory Innovation Officer at Accumulus Synergy. “Every country has their own requirements, which can make it challenging, especially for small to mid-sized biotechs, to get a product approved efficiently.”
While large biotechs have entire teams and sections of the company committed to navigating the regulatory environment, small and mid-sized biotechs, and especially startups, often don’t have those resources. This means their new drugs are often only able to reach one market at a time, slowly.
“Whether you’re a small or mid-sized biotech, or whether you’re a large pharma, there’s a lot of complexity and overhead in working globally,” adds Nogueira. “There’s a lot of complexity and overhead for agencies globally to deal with as well. So I think what we’re trying to tackle is almost agnostic to the size of the organization. The value should be derived by all, meaning everyone on the sponsor side and everyone on the health authority side, as well.”
But it was not just partnerships that Accumulus Synergy needed to cultivate; they also needed to build the infrastructure for the technology.
“We had to build a whole engineering team, a whole product team, and a security team, because we’re dealing with both sensitive patient-level data and IP-level data,” says Nogueira. “And our system has to be secure both in transit and at rest. It also needs to meet the needs of the regions where we operate.”
After 18 months of development, Accumulus Synergy is seeing the fruits of its labor bear fruit. But how exactly does the platform work?
Smoothing the regulatory process
As the idea of Accumulus Synergy was explored by a few leading pharmaceutical companies, it was soon clear that it needed to become an independent nonprofit to become financially self-sustaining and “avoid concerns among drug sponsors and health agencies that it is exploiting its role as an intermediary to generate profits that could limit its use,” explained an Accumulus Synergy white paper.
This operational detail is small but important. It has never been the mission of Accumulus Synergy to act as a “pay for play” or rather “pay for faster play” entity. Rather, the organization functions like a mycelium network, growing and improving connections and communication for the betterment of the whole. And while participating organizations will pay to use the platform, Accumulus Synergy can set pricing at levels that meet this financial goal while not inhibiting access to the platform for any organization that wishes to use it (as a result of its nonprofit status).
Indeed, Accumulus Synergy’s vision is to ensure that patients globally get the medicines and treatments they need faster. That happens, in part, through the democratization—as well as the security and delineation—of data, which, in turn, creates a system aimed at regulatory harmonization.
The Accumulus Synergy platform
The cloud submission platform has three distinct workspaces: the drug developer space, the shared developer-regulatory space, and the regulatory-only space. Both regulators and drug developers have private and shared spaces in which they can interact with appropriate partners at any given time.
Per an Accumulus Synergy white paper, in the sponsor-only space (the drug developer space), companies “work with robust privacy and data security protections. Drug developers [are] able to share information with collaborators in the biopharma-only space to facilitate co-development approaches.” In the regulatory-only space, regulators “can review and interpret the data as a single regulator, as well as exchange information and collaborate securely with other regulators.”
The two sides also have a shared space, which allows for developers and regulators to “communicate in a controlled environment. This space will enable a more efficient exchange of questions and answers on review via the platform, but access rules [is] robust and companies will no longer be able to access regulator authored assessment documents unless the regulator releases them.”
The balance between security and interconnectivity aims to create a multi-directional collaboration within the confines of a secure system.
“Collaboration between regulators is not new,” states the white paper. “Consolidating the interactions between drug developers and health authorities in a single cloud environment would create a single source of up-to-date referenceable truth for the exchange of information, data, and all aspects of the dialogue, including information requests, post-market requirements and commitments, and tracking of audit findings.”
The platform is an exciting achievement with great potential, but Accumulus Synergy understands that its larger goals will not be achieved overnight, noting the need for “a sustained effort on harmonization and convergence of regulatory requirements around the world.”
The art of the possible
Accumulus Synergy is still young, so its potential is yet to be seen. A critical mass of sponsor and health authority buy-in is needed. However, it is poised to profoundly change the global healthcare ecosystem for the better.
“I believe what we’ve started to trigger for those in the healthcare ecosystem to see the art of the possible,” says Nogueira.
“The concept for a reliance program, or work sharing, has existed for a while,” adds Sharma. “The WHO has published guidelines for years, but what this pilot did was show that it can be operationalized in a sustainable and scalable way.”
The long-term goals include expansion into medical devices regulation, the expansion of technology-aided and real-time decision-making, and the expansion of global collaboration.
“Re-designing the paradigm from a document centric mindset to a data centric approach is a bold, transformative, multi-year endeavor and will ultimately touch all aspects of research, development and life cycle management,” says the white paper. “Journeying towards this will unlock efficiencies not yet available to drug developers and regulatory authorities.”
“And what we’re seeing today is enthusiasm,” says Nogueira, “not only from those who submit the application for new medicines for the sponsors, but health authorities worldwide”
“I remember the days when we used to have pallets of paper that we would generate from our studies, and we would pick them up with a forklift and put them on an 18-wheeler truck and send them to the FDA for a review,” recalls Nogueira. Within our lifetime, that process will become so efficient that everyone from industry to regulatory agencies can be directly and collaboratively connected.
As a result, patients have access to medicines and treatments faster. Drug shortages can be addressed faster. More people in the biotech industry gain proficiency in the regulatory space. Regulatory agencies have a wider set of resources for review. And more lives are ultimately saved.
“Ultimately, our mission is to dramatically accelerate critical therapies to citizens of the world,” repeats Nogueira. “We talk about that mission at Accumulus Synergy daily.”
