Redesign Dialysis Phase I

Redesign Dialysis Phase I

KidneyX's inaugural prize competition, Redesign Dialysis, asks innovators to accelerate the development and commercialization of next-generation dialysis products. Redesign Dialysis is a two phase prize: Phase I asks participants to design possible solutions or solution components that can replicate normal kidney functions and improve patient quality of life. For Phase I, we're awarding up to 15 prizes of $75,000 each. Phase II (planned to open in late April 2019) will ask participants to develop and demonstrate prototype solutions. Phase II will have up to three awards of $500,000 each. You can participate in Phase II even if you didn't participate in Phase I.

In Phase I, we sought designs of solutions that will address at least one of the following areas:

  • Replicating Kidney Functions (Blood Filtration, Electrolyte Homeostasis, Fluid Regulation, Toxin Removal and Secretion, and/or Filtrate Drainage and Connectivity)
  • Improving Patient Quality of Life (e.g., minimizing burden on the family and care partner(s), reducing disease and treatment complications, increasing mobility and physical activity)
  • Improved renal replacement therapy access (vascular or peritoneal access)
  • Addressing engineering challenges (e.g., preventing clotting, bleeding, and infection in vascular circuit and associated devices)
  • Ancillary technologies
  • Biomaterials development
  • Biological and Immunological modulation
  • Biosensor development and other safety monitoring functions

For more specifics about current technical and scientific needs in the field, you can review Section F on the prize announcement or the Kidney Health Initiative's Technology Roadmap for Innovative Approaches to Renal Replacement Therapy.

Winning Solutions

Awardees will be announced at the Inaugural KidneyX Summit, taking place April 29-30, 2019.

Review Process

Redesign Dialysis Phase I has a multi-stage review process:

  1. KidneyX team members will triage submissions, validating that they meet eligibility requirements and distributing valid submissions to technical reviewers.
  2. Technical reviewers will review submissions to score and provide comments (3 reviewers per submission). The 25 highest-scoring submissions will be sent on to the judges.
  3. Judges will review the top 25 scored submissions and make final recommendations of winners. Note: Judges will also have access to all submissions, and may review and recommend any to be added to the judging discussion even if that submission was not selected by the technical reviewers as a 25 highest-scoring submission.
  4. ASN Council and the HHS Chief Technology Officer will certify the winners. Winning solutions will be announced at the Inaugural KidneyX Summit, taking place April 29-30, 2019.

KidneyX appreciates the confidentiality associated with submissions. All judges, reviewers, and staff signed a Non-Disclosure Agreement (NDA). Read the Statement Regarding KidneyX's Multi-Stage Review Process and Safegaurds for Participants' Intellectual Property and Reviewers' Conflict of Interest.

Judges

A diverse group of subject matter experts are reviewing all of the KidneyX: Redesign Dialysis Phase I submissions.

Joseph Hamel

Mr. Hamel currently serves as a Strategic Innovation and Emerging Technology Manager for the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services. The office of the ASPR leads the nation in preventing, responding to and recovering from the adverse health effects of manmade and naturally occurring disasters and public health emergencies. As such, Mr. Hamel works across HHS, other federal agencies, and state and local officials responsible for emergency preparedness and the protection of the civilian population from public health emergencies. Mr. Hamel has spent more than 16 years leading health security initiatives within the both the public and private sectors, and has deployed all-hazard defense technologies and enhanced facility security and laboratory safety practices worldwide. Mr. Hamel previously served as a Program Manager within the Johns Hopkins University Applied Physics laboratory, where he led environmental health research initiatives, including the development of novel toxicant exposure detection capabilities. Mr. Hamel also was responsible for the successful execution of the US Department of Homeland Security (DHS) protective security officer program. To this end, Mr. Hamel implemented an approximate $1B/year program focused upon enhancing protective security operations to ensure the safety of over one million occupants and visitors to Federal facilities on a daily basis. Prior to joining DHS, Mr. Hamel served as a program manager within the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD). In this role, Mr. Hamel lead Department of Defense (DoD) and international initiatives to deploy novel global biological surveillance and response capabilities. Earlier in his career, Mr. Hamel lead initiatives for both the Pentagon Force Protection Agency and US Army to improve safety and surety practices for effective all-hazard screening operations to counter chemical, biological, radiological, nuclear and explosive (CBRNE) threats in the wake of 9/11. Mr. Hamel received his undergraduate degree in Molecular Biology from Colgate University, and his M.S. in Biotechnology from Johns Hopkins University. He is also the recipient of the U.S Army Achievement and Commendation Medals for Civilian Service for his contributions towards the establishment of global biosecurity initiatives.

Ken Kim

Dr. Hyong (Ken) Kim is a board certified internal medicine hospitalist. He is currently the chief medical officer of Center for Medicare and Medicaid Innovations Center (CMMI). Prior to joining CMMI, Dr. Kim served as the CMO and co-founder of Alignment Healthcare and CareMore Health.

His focus is management of chronically ill patients and clinical innovations for Medicare Advantage, global risk and fee-for-service (FFS) patients.

Emily Levy

Emily is the former Head of Fresenius Medical Care Ventures. She has over 30 years of experience in biotechnology, including new product assessment, venture investment, strategy and business development, and held roles with the Diagnostics Division of Abbott Laboratories and Genzyme Corporation. While at Genzyme, she managed the early development of Ceredase®, and participated in the successful raising of the R&D Limited Partnership to fund the drug's development. At Abbott, she was responsible for global business unit product management for immunoassay, CNS diagnostics, and high-volume automation products. Emily, as a founding principal of Synergy Partners, consulted to pharmaceutical and biotechnology companies, venture capital firms, and academic institutions in product development, licensing, and for interim general management positions. She invested in early-stage biotechnology and diagnostics companies for a mission-driven corporate life science venture fund of a healthcare system. Emily served on the Board of Directors and as an Officer of HBS Health, and was a board member of Mitomics, Inc. Emily was the volunteer President of the FTD Disorders Registry LLC, a web-based research-oriented patient registry, and served for six years on the Board of the Association for Frontotemporal Degeneration. She holds an MBA from the Harvard Business School and a BA in chemistry from Swarthmore College.

Meda Pavkov

Dr. Pavkov is a physician scientist with research centering on complications of diabetes. After completing a five-year post-doctoral research fellowship with the National Institutes of Diabetes and Digestive and Kidney Diseases in Phoenix, Arizona, she joined the Division of Diabetes Translation at the Centers for Disease Control and Prevention, Atlanta, Georgia, as senior medical epidemiologist. Current projects center on the progression of early kidney disease in diabetes, and include The Longitudinal Study of Markers of Kidney Function, a project initiated in 2009 based on an agreement between CDC and the National Institute Health, studies of the association of persistent organic pollutants with diabetes and kidney disease, development of simulation models of kidney disease progression, racial/ethnic survival disparities and renal replacement therapy. Other national and international research projects include the CKD Surveillance project and Global and country-specific rates and trends in incidence of diabetes and chronic kidney disease.

Dr. Pavkov published articles, reviews and book chapters that focused on the relationship between kidney and cardiovascular disease, changes in the pattern of diabetes in a high risk population, the impact of youth-onset diabetes on development of kidney complications, and the epidemiology of kidney disease in diabetes.

Krishna Polu

Dr. Polu is a nephrologist and clinical development executive whose experience in the kidney space has spanned the development and approval of a number of a products in renal diseases and complications of kidney failure. He currently serves as chief medical officer at Equillium, a public biotech company focused on developing novel therapies for autoimmune and inflammatory diseases. Previously, he was an entrepreneur-in-residence at Frazier Healthcare, a life science-focused venture capital firm, and founded Expedition Therapeutics, a search company focused on identifying and in-licensing assets in the kidney and autoimmune therapeutic areas. Dr. Polu has also served in executive and management level roles at Raptor Pharmaceuticals, CytomX Therapeutics, Affymax, and Amgen. He received his B.A. in Human Biology from Stanford University and M.D. from the University of Texas Health Science Center, San Antonio. He completed his residency at the University of Colorado followed by a clinical and research fellowship in nephrology at Harvard Medical School at the Brigham and Women's Hospital and Massachusetts General Hospital.

Danilo Tagle

Dan Tagle is associate director for special initiatives at NCATS. He also recently served as the Center's acting deputy director, as well as the acting director of NCATS' Office of Grants Management and Scientific Review and as executive secretary to the NCATS Advisory Council and Cures Acceleration Network Review Board. Prior to joining NCATS, Tagle was a program director for neurogenetics at the National Institute of Neurological Disorders and Stroke (NINDS), where he was involved in developing programs concerning genomics-based approaches for basic and translational research in inherited brain disorders.

Prior to joining NINDS in 2001, Tagle was an investigator and section head of molecular neurogenetics at the National Human Genome Research Institute and has been involved in the highly collaborative effort toward the positional cloning of genes for Huntington's disease, ataxia-telangiectasia and Niemann-Pick disease type C. He has served on numerous committees and advisory boards, including the editorial boards of the journals Gene and the International Journal of Biotechnology .

Tagle obtained his Ph.D. in molecular biology and genetics from Wayne State University School of Medicine in 1990. He was an NIH National Research Service Award postdoctoral fellow in human genetics in the laboratory of Francis S. Collins, M.D., Ph.D., at the University of Michigan. Tagle has authored more than 150 scientific publications and has garnered numerous awards and patents.

Joseph Vassalotti

Dr. Vassalotti is the Chief Medical Officer of the National Kidney Foundation (NKF) and Associate Clinical Professor of Medicine in the Division of Nephrology, at Icahn School of Medicine at Mount Sinai. He received his medical degree with Distinction in Research from the SUNY Stony Brook School of Medicine and completed an Internal Medicine Residency and Nephrology Fellowship at the Johns Hopkins Hospital. At NKF, his major focus is implementation of evidence-based clinical practice guidelines in chronic kidney disease (CKD), including the NKF's Kidney Disease Outcomes Quality Initiative (KDOQI), particularly through guidance of the NKF's primary care initiative, called CKD intercept. He has served as co-PI for the CDC Demonstration Project "CKD Health Evaluation and Risk Information Sharing (CHERISH)", which aimed to identify individuals at high risk for CKD in the U.S. and as an investigator for the NIH-sponsored clustered practice randomized trial entitled, evidenced-based primary care for CKD. Leadership also includes multiple roles over the last decade with the CMS Fistula First national quality improvement initiative for hemodialysis, including as Lead Physician Consultant from 2013 through 2015. He has served on numerous committees that shape innovation and health policy in kidney disease for the CDC, the NIH and CMS. Currently, he serves as Principal Investigator for the Kidney Score Platform an NKF educational project funded by the Veterans Administration Center for Innovation to improve awareness and education among Veterans with and at risk for CKD in the primary care setting. Dr. Vassalotti has over 80 publications in peer-reviewed journals and has been featured in Castle Connolly's Top Doctors and Best Doctors in America.

John Watson

John T. Watson is Professor of Bioengineering (BE) and a Founder of the William von Liebig Center for Entrepeneurism and Technology Advancement at the University of California, San Diego. For the BE Department he Directs the Master of Engineering Program, Co-Directs the professional degree Masters of Advanced Studies for Medical Device Engineering Program and Directs the Whitaker Center for Biomedical Engineering. As Professor, his research interests include: 1) engineering design principles that improve outcomes for combined assisted circulation and adjunct agents; and 2) innovations in existing public policy that decrease the timeline for clinical use of new medical technologies. He also oversees the BE student outreach activities for community service and developing leadership opportunities and experience.

Dr. Watson attended the University of Cincinnati (M.E. '62) and later received his M.S.M.E from Southern Methodist University while working as a Systems Engineer on the Ling-Temco-Vought XC-142 Vertical Takeoff Transport. He contributed to the design of the hydraulic system that controlled vertical and horizontal flight. To his surprise the XC-142 was mentioned as a key advance in history celebrating the Wright Brothers and worldwide aviation.

He received his Ph.D. in Physiology from the University of Texas Southwestern Medical School in1972. At Southwestern, Dr. Watson served as an Assistant Professor in the Departments of Surgery and Physiology and Chairman of the Graduate Studies Program in Biomedical Engineering. In 1976, he was appointed Chief of the Devices and Technology Branch of the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. There, he oversaw research and development of cardiovascular imaging systems such as MRI, ultra-fast CT, and Ultrasound; implantable materials used in cardiovascular implants and devices; ventricular assist systems and the total artificial heart. He then served as Acting NHLBI Deputy Director and Director of Clinical and Molecular Medicine until 2003, with oversight of 60 major clinical trials, genomics and proteomics, tissue engineering and regeneration, computational biology and informatics, and adult and pediatric circulatory support programs. Dr. Watson played a major role in introducing the Small Business Innovation Research (SBIR) program at the NIH.

Dr. Watson was the first NIH scientist/engineer elected to the National Academy of Engineering (NAE) and was an invited member of the nominating committee for the Japanese Kyoto Prize and the NAE Draper Prize. He was also a member of the NAE Committee selecting the greatest engineering achievements of the twentieth century.

Caroline Wilkie

Caroline Wilkie is a nocturnal home hemodialysis patient of 9 years, who is heavily involved in volunteer work with the National Kidney Foundation, and Kidney Health Initiative. Caroline is a member of the National Kidney Foundation's (NKF) Kidney Advocacy Committee and the NKF PEERS program. She is a member of the Kidney Health Initiative's (KHI) Patient and Family Partnership Council. She has worked on numerous research projects with both KHI and PCORI with the aim of improving the patient quality of life.

She and her husband, Jeff reside in Southwest Florida and travel every chance they get.

Redesign Dialysis Phase I FAQ

In order to clarify the Redesign Dialysis prize competition process, FAQ have been drafted and can be accessed here.