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Nephrology Times:
doi: 10.1097/01.NEP.0000423999.16766.4d
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ASN–FDA Partnership Focuses on Innovation, Patient Safety

Coleman, Matthew

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The American Society of Nephrology (ASN) and the US Food and Drug Administration (FDA) have created a formal collaboration designed to foster better communication between the kidney care community and the agency—the Kidney Health Initiative (KHI).

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“Up to 26 million Americans have chronic kidney disease and well over 500,000 actually have kidney failure, but far, far, far too few new therapies to treat or even prevent those conditions are coming onto the market and ultimately into patients' hands,” said Rachel Nell Shaffer, ASN Manager of Policy and Government Affairs. “KHI hopes to change that.

“Our ultimate goal is that by increasing communication between the Food and Drug Administration, patients, industry, and researchers, we can make it more feasible for innovators to develop new products that are safe, effective, and meet the needs of patients that frankly are currently unmet for many, many types of kidney disease.”

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Part of that patient safety work will include a focus on non-nephrology products.

“One point that ASN made was that a lot of products that FDA regulates are not necessarily developed to treat kidney diseases but have impact on the kidneys,” said Patrick Archdeacon, MD, Medical Officer in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA.

“With oncology products, a lot of times those could have nephrotoxicities, but they're being reviewed in an oncology division by oncologists, and ASN wasn't sure there was always a nephrology perspective.” The FDA is open to conversations with the society about the review of such products, he added.

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Building Infrastructure

The concept for this initiative was broached when the American Society of Nephrology, under current President Ronald Falk, MD, reached out to the FDA last year, leading to a meeting between representatives of both parties.

“There was a discussion about all sorts of different interactions that were possible between FDA and outside stakeholders,” Dr. Archdeacon said.

“One prominent area where nephrology products get reviewed in FDA is the Division of Cardiovascular and Renal Products. They had cited some previous experience they had, something called the Cardiac Safety Research Consortium (CSRC). That was an engagement that FDA and Duke founded, and then others joined, where they were able to talk about cardiac safety issues.

“We said that could be a model where we could do similar work in the area of nephrology, and that was the option that got a lot of traction.”

The Kidney Health Initiative could promote the development of new nephrology therapies by helping build infrastructure, which would take some of the burden off innovators.

“One reason why large kidney trials are not being done the way cardiac trials are done is the difficulty in identifying patient networks,” Dr. Archdeacon said. “This might be the type of forum where we can bring together patient groups and start putting together infrastructure that will really help serve patients' needs.

“If we can start forming these patient registries of people interested in being in trials, that reduces one of the barriers to entry as people are looking at where they're going to invest their energies.”

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Streamlining the Approval Process

Another current challenge in the development of new therapies is the complicated FDA approval process.

“KHI needs to make the approval process for products that treat the kidney in the nephrology space more facile and easier to navigate for innovators, for start-ups, for industry in general,” Ms. Shaffer said. “We don't necessarily have well-defined endpoints that the FDA, industry, and researchers all agree upon that should be used in a trial.

“The FDA is bringing together all of those components—the patients, the research community, the FDA, industry—into a forum so that we can identify in a manner that everyone agrees is scientifically valid what those endpoints are and then write a white paper to get the word out into the public space so that every innovator, every company with a concept in AKI [acute kidney injury], diabetic nephropathy, etc., has access and a well-defined process to follow.”

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Other objectives of the Kidney Health Initiative include establishing expert consensus around common terminology and definitions related to kidney health, coordinating think tanks to promote discussion on topics in nephrology, and establishing systems to optimize post-market surveillance of products that affect the kidney.

“We, meaning both ASN and the folks we were working with at FDA, really thought it was vitally important that the Kidney Health Initiative's Memorandum of Understanding—the actual document that we signed with FDA to establish the Kidney Health Initiative—cover not only drugs but also devices, biologics, as well as food safety, and that ultimately is where we wound up, with an MOU that encompasses the entire scope of what the FDA does,” Ms. Shaffer said. “That really will give us the flexibility to work on a significant variety of projects.”

The initiative is expected to be fully up and running by January.

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‘Revolution in Our Field’

Leaders in nephrology expressed enthusiasm and optimism when asked to share their opinions of the ASN–FDA endeavor.

“The initiative is overdue,” said Richard J. Glassock, MD, Emeritus Professor of Medicine at the David Geffen School of Medicine at UCLA and a member of the American Association of Kidney Patients (AAKP) Medical Advisory Board.

“There has been a lack of dialogue between the scientific community, as represented by the ASN, and the internal bureaucracy of the FDA, and this has led to some delay in the development of promising new drugs.”

Ruben Velez, MD, President of the Renal Physicians Association (RPA) and President and CEO of Dallas Nephrology Associates, also praised the collaborative spirit of the KHI.

“When you look at the purpose of the initiative, I would say all stakeholders would be in support of it,” he said. “There has always been fractionation in our community, and this initiative might bring a more inclusive way to attack some of the issues.”

This dialogue can help the FDA and ASN concentrate on solutions for a central member of the kidney care community—the patients.

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“To me, this is almost a revolution in our field to really become focused on real problems of real people, and focusing on putting the patient at the center of the work that we do,” said Katherine R. Tuttle, MD, Executive Director for Research at the Providence Sacred Heart Medical Center and Professor of Medicine at the University of Washington School of Medicine. “I think it's the first step down a long road, but I think that's where we'll end up.”

One drawback of this type of initiative could have been conflicts of interest (COIs), but the ASN and FDA have developed a plan to address this concern.

“We have finalized that the Kidney Health Initiative will proactively establish a conflict-of-interest management committee that will involve FDA staff and ASN members,” Ms. Shaffer said. “The FDA is considering the personnel who will serve on that committee, and we will tap some of our volunteers and leadership.

“Individuals representing organizations that have conflicts related to a specific activity can participate in that project only in an advisory capacity; they will not have a leadership role in the group that is working on that project, nor will they have voting privileges.”

Dr. Glassock does not anticipate conflicts of interest representing a major concern for the initiative.

“ASN has sufficient integrity as a scientific organization to manage that potential quite well, and so far I have not seen any signs that this is an attempt on the part of the pharmaceutical industry to exploit the ASN's ability to influence FDA decisions,” he said.

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Membership Structure

Membership in the KHI is geared toward all stakeholders in the kidney community. Target groups include patient organizations; health professional groups, including those not necessarily focused on nephrology but having similar interests, such as the JDRF and the American Heart Association; pharmaceutical and biotechnology companies; device manufacturers; dialysis providers; government agencies (international and national); and foundations.

According to Dr. Velez, the RPA anticipates becoming a member of the initiative. Dr. Glassock does not know if AAKP will become a member, but he does believe a patient voice would be “highly desirable in this dialogue,” he said. Nephrology Times has also received confirmation that DaVita will become a member of the initiative.

“We have received several applications for membership that represent a diverse swath of organizational types,” Ms. Shaffer said. “We've heard from well over 30 other organizations that anticipate applying.”

The KHI will be financed exclusively through member dues that vary by organization size. A large organization, as defined by market capitalization greater than $3 billion or yearly gross sales exceeding $1 billion, will have annual dues of $30,000, for example, while small organizations, as defined by market capitalization less than $250 million or yearly revenue below $50 million, will have annual dues of $5,000.

In terms of whether the Kidney Health Initiative will accomplish its goals, Dr. Tuttle said, “More likely than not, it will succeed. I think we will move forward from where we are. I don't know how far we'll go, but hopefully a long ways.”

Dr. Velez agreed that the initiative has the potential to improve patient safety and promote new therapies.

“The proof is in the pudding,” he said. “How all the parts will be able to work and collaborate together is going to be the key aspect here.”

But when collaboration occurs between two large entities, there is movement in the right direction, Dr. Glassock said.

“Any time you can get people from one side of the table talking with the people on the other side of the table with a common interest, I think we are going to be better off.”

© 2012 Lippincott Williams & Wilkins, Inc.

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