Need, Potential Exist for Global Integrated Regulatory Approach in Cardiology

San Francisco, CA—In light of current challenges such as a depressed global economy and a problematic regulatory environment, there is a need for a global integrated regulatory approach to spur innovation in the cardiology market, according to a speaker at TCT 2013. 

Greg L. Kaluza, MD, PhD, from the Cardiovascular Research Foundation, New York, outlined many of the challenges facing biomedical innovation.  

“We are in a different world since the 2008 depression, and there is a powerful perception that innovation has stagnated, especially in the United States, as a consequence of that,” Kaluza said. 

Challenges to innovation

Among the challenges facing medical innovation today, in addition to the economic climate, are the stagnant growth in traditional CV markets, cost-sensitive reimbursement, less investment capital and patents, problematic regulatory environments, excessive governmental and media scrutiny and conflict-of-interest constraints placed on physicians, Kaluza said. 

He showed that compared with 2005, there has been a decrease in start-up valuation (–55%), health care funding (–52%), venture capitalists (–25%) and private equity funds (–65%).

“This has been called, quite dramatically, ‘the valley of death’: the widening chasm between scientific discovery and the doctor’s office,” he said, noting that renal denervation may take up to 6 years to be approved. 

“The investments necessary to get a novel product approved are also exponentially increasing due to increased device complexity, demand for performance and clinical evidence, and diverging and increasing regulatory demands,” he said. 

“One thing that is anticipated is that outside U.S. markets will meet and exceed U.S. markets.”

Adaptation mechanisms

Kaluza outlined what he called adaptation mechanisms necessary for CV innovation to re-emerge. There must be a clear regulatory approval pathway, evidence-based clinical data, a global strategy from the outset and cost sensitivity in respect to diverse economic environments. 

Kaluza cited a need for a global integrated approach. Basic regional differences he identified include the process to approve human research, the process to approve and make a treatment commercially available, reimbursement and post-market surveillance.

It is anticipated that what will eventually happen is “reverse innovation” where emerging economies may become the generators of new technology and developed nations will become the adopters, validators and followers, he said. 

In order to overcome these challenges, there is a need for what he described as areas of global harmonization in research.

“It would be great to have uniform technical dossier requirements for each level of approval, uniform reasonable preclinical data requirements for first in-human studies, uniform preclinical and first-in-human data portfolio minimum for a pivotal trial and eventually global post-market surveillance, which is enabled by contemporary information technology and is extremely cost effective,” he said. 

‘Harmonization by Doing’

Although currently we are “anything but integrated” globally, Kaluza believes this is possible and cited the ongoing “Harmonization by Doing” initiative between the United States and Japan. 

“It was begun in 2003, by dedicated, passionate people who felt that it would be great to close the regulatory gap between these two systems,” he said. “It is based on very personalized relationships and mutual trust. It features pre-competitive collaboration. The companies that compete, theoretically, to market the same technology are interested in diminishing these hurdles.” 

He said that the structure of Harmonization by Doing resembles a public-private partnership. 

Disclosures:

Kaluza reports conflicts of interest with several device and pharmaceutical manufacturers.