21st century medicine and technology has seen exciting advancements at a pace and scale so remarkable that it exceeds the medical trajectory as compared to all of human history combined. This evolution, marked by preventative measures in healthcare, has improved the longevity and quality of life for patients, which also equates to a rising incidence and prevalence of chronic disease, especially chronic kidney disease (CKD). Indeed, chronic kidney disease is now the 10th leading cause of mortality compared to the early 1990’s when it was over the 35th leading cause, with projections over time placing it much higher on the ranking in the future. Historically, however, those with chronic kidney disease have represented a population traditionally excluded from clinical trials, especially those in cardiovascular disease despite the improved understanding of its implications related to comorbid diseases.
Despite the inherent complexities of chronic kidney disease, with its intricate bidirectional cardiovascular effect, along with being one of the strongest risk factors for cardiovascular death, there has never been a more important time to include those with chronic kidney disease in clinical trials, especially those related to cardiovascular disease. An understanding of integrated approaches toward expanding this population in clinical trials will ultimately benefit not only both patients and Sponsors alike, but also will have a positive global impact on disease burden while also continuing to evolve the thinking on chronically ill populations.
Join this webinar to learn about integrated approaches to include patients with chronic kidney disease in cardiovascular clinical trials, benefiting both patients and improving disease burden worldwide.
Dr. Ajay Srivastava, MD, FASN, Sr. Vice-President, Medical Department, Medpace
Dr. Ajay Srivastava is a board-certified nephrologist with an extensive background in both clinical and academic medicine. Specializing in adult nephrology, he brings over 20 years of experience in both the common and rare conditions of the kidney, renal replacement therapies, ICU nephrology including IV fluid resuscitation and management and comorbid conditions such as cardiorenal syndrome and hypertension. As an interventional nephrologist, he also provided education, assistance and evaluation regarding matters of dialysis vascular access including the performance of interventional procedures to preserve, optimize and salvage these hemodialysis accesses. Dr. Srivastava has also held several other leadership positions including Director of Nephrology Fellowship Training, the Medical Directorship of dialysis facilities, Division Chief of Nephrology and Interim Chair of Medicine, and has served on a number of departmental, hospital and university committees.
Dr. Nicholas Alp, MD, PhD, FACC, Sr. Vice-President, Medical Department, Medpace
Dr. Nicholas Alp is a board-certified interventional cardiologist and clinician scientist with more than 30 years of clinical research experience. Dr. Alp trained in medicine at the University of London and the University of Oxford. He completed his PhD in immunology at Cambridge University with a further postdoctoral DM degree in vascular biology at Oxford University. He held senior clinical academic appointments in cardiovascular medicine at Oxford University. Prior to joining Medpace, Dr. Alp was Head of Cardiovascular Drug Development at another global CRO. He has authored more than 75 original papers, chapters and books, and has established himself as a thought leader in the industry.
Heather Lohr, Sr. Director, Clinical Trial Management, Medpace
Ms. Heather Lohr has a Bachelor of Arts in Physical Anthropology and has over 17 years of operational experience in the clinical research industry with nine years in clinical trial management at Medpace. Ms. Lohr has been both a CTM and a Lead Clinical Research Associate (CRA) on multiple complicated oncology/hematology, cardiovascular, nephrology (rare renal/glomerular diseases) and rheumatology studies.
Who Should Attend?
This webinar will appeal to VPs, directors, managers and department heads working within:
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Outsourcing
- Clinical Operations
- Regulatory Affairs
- Medical Affairs
What You Will Learn
Attendees will be introduced to a medical perspective on:
- Chronic kidney disease (CKD) overview with comorbid and cardiovascular implications
- A cardiorenal overview
- The historical exclusion of CKD from clinical trials
- Considerations and reasons to increase the CKD population in clinical trials
- The value of integrated approaches to clinical trials including cardiorenal
- Cardiorenal case studies to exemplify how cross collaboration and integration lead to overall clinical trial success
- Specific considerations for a “One Team” approach
And an operational perspective on:
- The value of therapeutically aligned clinical operations teams
- Feasibility and optimization of enrollment through integrated teams
- Operational lessons learned from cross collaboration
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective.
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