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Posted 03 October 2013
BOSTON - If you haven't heard regulators-and the US Food and Drug Administration (FDA) in particular-talking about regulatory science in recent years, well, you haven't been paying attention.
The terminology has come up time and again, with respect to drugs, medical devices, biologics and food products.
The goal, said Susan Alpert, formerly Director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health (CDRH), is that scientific advances can afford regulators and industry a better sense of the safety and efficacy of a product before it reaches the market, and even before it comes to be used in patients.
But that raises a higher-level question, said Alpert during a session at the 2013 RAPS Regulatory Convergence conference in Boston on 1 October 2013. If everyone stands to benefit from advances in regulatory science--and she made the case that regulators, industry, patients, payers and academia all do--how can incentives be aligned to promote its development?
Alpert, of course, was asking somewhat hypothetically, as the answer to that question was the focus of remarks made by Bill Hawkins, former CEO of Medtronic and now CEO and President of Immunocor and a new public-private venture known as the Medical Device Innovation Consortium (MDIC).
The goal of the MDIC, said Hawkins, is to drive the development of answers to common development hurdles capable of being addressed through regulatory science.
"There's a real need for industry, FDA and academia to work together to find alignment and agreement on the best methods or tools to be using to evaluate risk and performance and get those understood before industry goes to FDA," Hawkins told the audience of regulatory professionals.
Hawkins said he believed the rapid pace of technological change had put industry out too far ahead of regulatory science, forcing industry to anticipate what FDA is thinking instead of being able to collaborate with the agency. He added that in some cases, companies seeking approval for innovative devices now have to get approval for the regulatory science testing methods they used to validate a device's safety and efficacy-an issue that can bog down the eventual approval of their device.
FDA, for its part, has thrown its support firmly behind the MDIC from the start. When the initiative launched in the waning months of 2012, Jeff Shuren, director of CDRH, tied it to the future of healthcare product regulation in the US.
"If the US wants to remain the leader in medical device innovation, we also must be the leader in regulatory science," he said in a January 2012 meeting before members of the medical device industry. Shuren quipped that he wanted to create a sort of regulatory "Switzerland"-a neutral body where regulatory science could be freely shared.
"We want to be safer, faster and more cost-effective," Hawkins said. "The right technologies really will make a difference in patient care."
Hawkins noted the difficulties of working together outside of safe spaces in his speech, saying competitive and antitrust issues had proven intransigent in the part.
But now, nearly a year after MDIC was formed, it's attracted what Hawkins called a "pretty interesting group of stakeholders."
Right now, those stakeholders include FDA, the Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), the Patient-Centered Outcomes Research Institute (PCORI), the Pew Charitable Trusts, the National Organization for Rare Diseases, the National Venture Capital Association, AdvaMed, and many of the largest companies in the medical device space (and plenty of smaller ones as well).
On the topic of FDA's involvement, Hawkins said he has been "incredibly impressed with Shuren's involvement."
"He is completely committed to this."
Hawkins went on to describe an array of benefits that MDIC promises to deliver if it succeeds. For regulators, it will give access to the same tools, understanding and state-of-the-art regulatory science now used in industry. For industry, it will allow refinements in regulatory science and more informed input from FDA earlier on in the regulatory process, as well as access to validated tools at a lower cost. For academics, it will grant access to more training and research opportunities. And for patients, it will lead to safer devices that are approved more quickly.
Hawkins said MDIC is already involved in starting up three major projects: Benefit-risk guidance and patient centeredness; clinical trial innovation and reform; and computer modeling and simulation.
The first will seek a structured way to work patient input into ultimate approval criteria. "We need to do this in a very methodical way," Hawkins said. FDA has been investing heavily into this space in recent years, and stands to do even more under the terms of the FDA Safety and Innovation Act of 2012. These models could account for different risk-acceptance paradigms among different sub-groups, Hawkins said, but the goal is to have a deliverable that will allow FDA to work a model into the regulatory process itself.
The second will look to reform how clinical trials are conducted. Hawkins remarked that under current paradigms, regulators want to eliminate as much risk as possible during pre-market trials. "Instead, maybe there are things we can shift things to the postmarket environment," Hawkins mused. The question was one of balancing the risks of not knowing enough and unnecessarily delaying access to patients, he said.
The third will meanwhile focus on computer modeling and simulation, creating virtual patients which could be utilized during the preclinical testing process. The goal is to have testing technologies which are better suited to understanding how a device would actually function in a human, as opposed to making the best possible guesses in animal models. Hawkins explained that this area of testing would actually constitute a network of individual models, and not just one single one.
Whatever the outcome of those projects, Hawkins said he was optimistic about the overall efforts of MDIC thus far. "MDIC is this place to make positive change to the benefit of industry and patients," he said. "I think we have a real opportunity here with the FDA. The FDA has been extraordinarily receptive to our efforts. They know they need help in developing regulatory science, and have reached across the aisle-and we've reached back. There's a lot of work to be done, but there's a real opportunity here."
And while MDIC is for now only focused on the US, he explained in response to a question that he wants to eventually invest in making it a global initiative. "There's a hope that any benefits in the US will be recognized elsewhere," added Alpert.
"That will eventually happen, but it's not our first priority," Hawkins said.
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