As many as 26 million Americans have chronic kidney disease (CKD) and more than 570,000 have kidney failure. Worldwide, around 200 million people have CKD. Prevalence is forecast to rise with continuing increases in hypertension and diabetes. CKD can progress to end stage renal disease (ESRD), which requires dialysis or a kidney transplant. There is no cure for CKD, with current treatment strategies depending on controlling blood pressure by blockade of the renin–angiotensin system.
Patients with advanced kidney disease represent less than 0.5% of the adult U.S. population, yet health care expenditures for this population have increased to more than $47 billion dollars per year, representing over 7% of the Medicare budget. Kidney disease is also responsible for a large individual and social burden. African Americans, Hispanics, Native Americans and some Asian Americans are disproportionately affected. Nonetheless, research in this area is underfunded.
The level of unmet need among these patients is high, and new therapies are urgently needed to combat and cure chronic kidney disease. After a period of stagnation and negative trial results, new life is being breathed into the R&D pipeline in this therapeutic category.
Recently, several novel mechanisms involved in development of CKD have been identified, including vascular changes, loss of renal epithelial cells and podocytes, matrix deposition, metabolic dysregulation, and inflammation. These have revealed new potential therapeutic approaches for CKD.
This webinar will examine new and more advanced and personalized precision medicine approaches to kidney disease research, including both potential drugs and technologies:
- Novel biologic targets in areas such as immunology/inflammation, fibrosis, tubular injury, ischemic injury, and podocytopathy
- Genetic manipulation, including gene therapy, immunomodulation, and approaches to genetic diseases
- Regenerative approaches using stem cells, including their potential to generate whole kidneys, prevent transplant rejection, and create hemodialysis filters.
The Clinipace expert – respected nephrologist Eric B. Grossman, MD – will provide an overview of the current R&D pipeline, including major players in big pharma, smaller biotech companies, and academia – including collaborations between multiple players. Participants will hear that finally, the needle is moving on nephrology R&D.
Eric B. Grossman, MD, Vice President and Medical Director, Clinipace Worldwide
Eric B. Grossman, MD, is Vice President and Medical Director of Clinipace Worldwide, a global contract research organization based in Morrisville, NC. An eminent nephrologist with over 30 years of industry and clinical experience, Dr. Grossman brings almost two decades of experience designing and conducting clinical studies for FDA submission and top-tier journal publication. In addition to his work in nephrology, Dr. Grossman has conducted studies across a broad range of therapeutic areas including cardiovascular, diabetes, urology, women’s health and oncology. He is Board Certified in Internal Medicine and Nephrology. Prior to joining Clinipace in April 2017, Dr. Grossman was most recently a consultant to the pharmaceutical industry with Bexon Clinical Consulting. Before that, he held positions with Reata Pharmaceuticals, Keryx Biopharmaceuticals, the New York Organ Donor Network and Pfizer. Dr. Grossman received an MD from the University of Chicago Pritzker School of Medicine. He completed his residency at the Tufts-New England Medical Center and his nephrology fellowship at Harvard Medical School’s Brigham and Women’s Hospital in Boston.
Clara Li, VP, Regulatory and Strategic Development, Global Consulting, Clinipace Worldwide
Clara has over 25 years of regulatory affairs experience and is an expert in US, European, Asia Pacific, and Canadian biotechnology and drug development (Phases I-IV). She works with all Divisions of CDER and the OTAT (Office of tissues and Advanced Therapeutics) in CBER and has lead strategic regulatory roles in the development of therapeutics for a wide range of disease areas including: biotechnology, gene therapy, cell and tissue therapy, small molecule, and combination products.
Who Should Attend?
Senior level professionals from pharmaceutical and biotechnology companies involved in the planning or administration of Phases I, II and III clinical trials.
- Clinical Affairs
- Clinical Operations
- Clinical Pharmacology
- Clinical Research & Development
- Clinical Trial Management
- Scientific & Medical Affairs
- Project Management
- Regulatory Affairs
- Trial Recruitment & Retention
- Clinical Monitoring
Clinipace Worldwide, a global full-service clinical research organization (CRO) serves the unique needs of venture-backed, mid-tier and strategic pharmaceutical, biotechnology and medical device firms, helping them advance drug candidates to deliver successful stakeholder and patient outcomes. The company leverages extensive therapeutic knowledge, clinical trial expertise, and their proprietary eClinical platform TEMPO™ to support life science firms in achieving some of their most important goals: Executing regulatory strategies, optimizing clinical development timelines and completing high quality trials.
Clinipace has completed more than 1,500 clinical trials and 1,500 regulatory and statistical consulting projects and operates in North America, South American, Europe, and Asia. To learn more, visit http://www.clinipace.com/