Kidney Health Initiative Aims to Spur Innovation in Kidney Sphere Through Collaboration With FDA, Others

By ASN Staff

KHI_Logo-Horizontal-Color.jpgThe Kidney Health Initiative (KHI) hosted a stimulating session entitled, “The Time Is Now: Using Partnerships to Spur Innovation” which described some lessons on bringing communities from the perspective of the US Food and Drug Administration and KHI.

The session speakers included:

  • Raymond C. Harris, MD, FASN – former ASN President 2016-2017 and is the current Co-Chair for the Kidney Health Initiative
  • Celia Witten, MD, PhD – Deputy Director of the Center for Biologics Evaluation and Research (CBER) at FDA
  • Murray Sheldon, MD – Associate Director of Technology and Innovation at the Center for Devices and Radiologic Health at FDA
  • Aliza Thompson, MD, MS - Deputy Director Division of Cardiovascular and Renal Products at FDA
     

Dr. Raymond Harris began the session by explaining that since the partnership began between ASN and FDA, which created KHI, 105 organizations have joined the initiative. 14 major projects have been completed and 8 are currently ongoing, in addition to 18 publications. He expressed the current relevant issues for KHI as the following: Patient Preference Survey, a commitment to developing an artificial kidney, conducting more clinical trials and increasing patient inclusion, supporting future KidneyX prize competitions, and the FDA organ preservation policy.

The goals for the next evolution of KHI for 2019-2021 are envisioned as:

  1. Working closely with CDER, CBER, CDRH from FDA
  2. Supporting an on-study culture and promote mechanisms to better support clinical trials and development of innovative trial design
  3. Technology roadmapping to develop further innovation and increase guidance on clinical trial endpoints to aid in meeting the goals of the AAKD, while continuing to partner with KidneyX to develop more prize competitions
  4. Eliciting, measuring, and incorporating patient preference information at all stages in order to drive both innovation and acceptance by patients.
     

Later in the session, Murray Sheldon, MD tackled the question of what it will take to get the job done of redesigning dialysis. In relevant surveys of patients, it’s notable that patients want a major disruptive change, such as a wearable kidney, rather than incremental improvements to current therapies, like dialysis. Especially as the cost to fund dialysis in the US is ever-growing, only 20% of US dialysis patients receive a transplant, and a projection in 2030 of 14.5 million people internationally suffering from ESRD, the time is now for radical change. Dr. Sheldon’s vision is the development of an artificial kidney by an international consortium and to provide it free to people around the world as a worldwide humanitarian effort for peace. He compared it to the example of the International Space Station, which was a combined effort of 15 different nations to accomplish a shared mission, as proof that international efforts can be successful and achieve more than any one group acting solo. With KidneyX providing a great starting point, and the Advancing American Kidney Health initiative encouraging the development of an artificial kidney, we all now have the opportunity to pursue this end with fervor and more support than ever.

The subject of patient engagement was further supported by Celia Witten, MD, PhD who expressed the necessity for patient stakeholders to share their needs, experiences, perspectives, and priorities in order for new therapies and biologics being developed to be better suited for patients. The subject of xenotransplantation was also addressed, which has grown in relevancy due to the AAKH initiative’s emphasis on increasing the supply of organs for transplant. She expressed that it is on the horizon, but they are not yet sure when it will be applicable. There are many challenges they are encountering, such as animal sourcing, how to test success, study endpoint determination, the immunosuppression regimen necessary, the appropriate patient population to begin testing, infectious disease prevention, and of course, ethical issues.

The session demonstrated the overall goal for KHI, which is to continue to make KHI relevant and responsive to the renal community, help new therapies and new innovation come to market, engage the membership of KHI to provide guideposts to transform clinical trials and outcomes, and to test new therapeutic interventions with the ever-present goal of improving the lives of kidney patients.

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KHI_Logo-Horizontal-Color.jpgThe Kidney Health Initiative (KHI) hosted a stimulating session entitled, “The Time Is Now: Using Partnerships to Spur Innovation” which described some lessons on bringing communities from the perspective of the US Food and Drug Administration and KHI.

The session speakers included:

  • Raymond C. Harris, MD, FASN – former ASN President 2016-2017 and is the current Co-Chair for the Kidney Health Initiative
  • Celia Witten, MD, PhD – Deputy Director of the Center for Biologics Evaluation and Research (CBER) at FDA
  • Murray Sheldon, MD – Associate Director of Technology and Innovation at the Center for Devices and Radiologic Health at FDA
  • Aliza Thompson, MD, MS - Deputy Director Division of Cardiovascular and Renal Products at FDA
     

Dr. Raymond Harris began the session by explaining that since the partnership began between ASN and FDA, which created KHI, 105 organizations have joined the initiative. 14 major projects have been completed and 8 are currently ongoing, in addition to 18 publications. He expressed the current relevant issues for KHI as the following: Patient Preference Survey, a commitment to developing an artificial kidney, conducting more clinical trials and increasing patient inclusion, supporting future KidneyX prize competitions, and the FDA organ preservation policy.

The goals for the next evolution of KHI for 2019-2021 are envisioned as:

  1. Working closely with CDER, CBER, CDRH from FDA
  2. Supporting an on-study culture and promote mechanisms to better support clinical trials and development of innovative trial design
  3. Technology roadmapping to develop further innovation and increase guidance on clinical trial endpoints to aid in meeting the goals of the AAKD, while continuing to partner with KidneyX to develop more prize competitions
  4. Eliciting, measuring, and incorporating patient preference information at all stages in order to drive both innovation and acceptance by patients.
     

Later in the session, Murray Sheldon, MD tackled the question of what it will take to get the job done of redesigning dialysis. In relevant surveys of patients, it’s notable that patients want a major disruptive change, such as a wearable kidney, rather than incremental improvements to current therapies, like dialysis. Especially as the cost to fund dialysis in the US is ever-growing, only 20% of US dialysis patients receive a transplant, and a projection in 2030 of 14.5 million people internationally suffering from ESRD, the time is now for radical change. Dr. Sheldon’s vision is the development of an artificial kidney by an international consortium and to provide it free to people around the world as a worldwide humanitarian effort for peace. He compared it to the example of the International Space Station, which was a combined effort of 15 different nations to accomplish a shared mission, as proof that international efforts can be successful and achieve more than any one group acting solo. With KidneyX providing a great starting point, and the Advancing American Kidney Health initiative encouraging the development of an artificial kidney, we all now have the opportunity to pursue this end with fervor and more support than ever.

The subject of patient engagement was further supported by Celia Witten, MD, PhD who expressed the necessity for patient stakeholders to share their needs, experiences, perspectives, and priorities in order for new therapies and biologics being developed to be better suited for patients. The subject of xenotransplantation was also addressed, which has grown in relevancy due to the AAKH initiative’s emphasis on increasing the supply of organs for transplant. She expressed that it is on the horizon, but they are not yet sure when it will be applicable. There are many challenges they are encountering, such as animal sourcing, how to test success, study endpoint determination, the immunosuppression regimen necessary, the appropriate patient population to begin testing, infectious disease prevention, and of course, ethical issues.

The session demonstrated the overall goal for KHI, which is to continue to make KHI relevant and responsive to the renal community, help new therapies and new innovation come to market, engage the membership of KHI to provide guideposts to transform clinical trials and outcomes, and to test new therapeutic interventions with the ever-present goal of improving the lives of kidney patients.

Date:
Saturday, November 9, 2019