Faculty – Nephrology Clinical Trial Best Practices Master Class

Wayne Bowden
Vice President, Program Development, BIORASI

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Wayne is an accomplished researcher and executive, combining his scientific knowledge and business experience to optimize clinical development pathways and shepherd the clinical trials to success. Prior to spearheading Program Development at Biorasi, Wayne led the execution of numerous nephrology clinical studies as a project Director and continues to support Biorasi’s nephrology studies as an executive resource today, with experience in both pre-dialysis and dialysis patient populations. He has overseen programs in primary and secondary glomerulopathies, renal anemia, hyperphosphatemia and uremic pruritis, among others. Prior to joining Biorasi, Wayne authored multiple peer-reviewed publications in oncology and cancer epigenetics including prostate cancer and uterine leiomyomas. Wayne received his undergraduate degree in Neurobiology from the University of Texas at Austin and his Master’s in Business Administration from Florida International University in Miami, FL.

Courtney Cordaro
Clinical Project Manager, FRENOVA RENAL RESEARCH

Barbara Gillespie
Vice President, Therapeutic Head, Nephrology, COVANCE

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1. Board Certified Nephrologist; fellowship in nephrology at Duke University Medical Center, and residency in internal medicine at the University of North Carolina.
2. Serves on Board of Directors for the Kidney Health Initiative (a public-private collaboration between the FDA and American Society of Nephrology) and active on several Workgroups (Endpoints for IgAN, Endpoints for FSGS, CKD Patients in CV Outcome Trials) with the goal of facilitating CKD drug development
3. Clinical Nephrologist as an Adjunct Professor at University of North Carolina, Division of Nephrology (CKD Clinic) and Assoc. Medical Director at a local Dialysis Unit
4. Serve on multiple Stakeholder and Advisory Boards (e.g. National Kidney Foundation, PCORI, SONG) and invited faculty speaker at several global Nephrology Conferences (e.g. ASN, KHI, KDCT, CVCT CKD Panel, VASA, PCORI)
5. Invited Co-Leader of FSGS Workgroup Session co-sponsored by FDA and NephCure Kidney International (Nov 2018)
6. 14+ years of Clinical Research experience, including 12 years in Industry; Experience in 16+ CKD indications across CKD and non CKD Dialysis

Mandeep S. Grewal, M.D.

Jonathan Kornstein
Senior Director, Project Management, PPD

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Jonathan Kornstein is a Senior Director, Global Project Management in the General Medicine Division at PPD and oversees programs and clinical trials. Jonathan has over 23 years of experience in the Pharmaceutical and CRO industry; and is responsible for the oversight of clinical trial services contracted by PPD. Jonathan has demonstrated a depth of project management and clinical operations experience in a multitude of full service global clinical studies on the sponsor and CRO side. Jonathan provides oversight for all Nephrology and Women’s Health studies at PPD. Jonathan has recent extensive experience in overseeing global Nephrology programs and understands the issues in running these programs.

Jonathan has a B.A. in Biology from Hamilton College. Prior to joining PPD, Jonathan held positions of increasing responsibility in both clinical monitoring and project management at both large CROs and sponsor companies. Jonathan has experience in complex therapeutic areas including: Chronic Kidney Disease, Chronic Kidney Disease with Anemia, Cardiology, Diabetes Type 1 and 2, Diabetic Nephropathy, Obesity, Dermatology, Alzheimer’s disease, Cerebrovascular Dementia, Oncology, Pain, Liver Fibrosis, NASH, PSC, Overactive Bladder, Nocturia and Women’s health.

Steven Malahias
Manager, Clinical Development, STIEFEL LABORATORIES

Kurt Mussina
General Manager, FRENOVA

Vice President, Clinical Studies Operations, FRESENIUS MEDICAL CARE NA

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Chemist, executive, and entrepreneur, Kurt Mussina leads FMCNA’s contract clinical research services organization, Frenova, the world’s leading network of renal research assets including more than 450 principal investigators across 260 research sites. Under Kurt’s leadership, Frenova has enjoyed consistent market leading financial performance and growth. A former analytical chemist and research and development scientist for some of the world’s leading pharmaceutical and biotech companies, he holds a bachelor’s degree in chemistry from Montclair State University and a master of business administration from the Fuqua School of Business at Duke University.

Kim Norwood

Christopher Poole

Angela Rose
Senior Director, Clinical Development, HUMACYTE

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Angela Rose is Senior Director, Clinical Development at Humacyte, a regenerative medicine biotech company that develops human vascular tissue based investigational products for vascular disease and replacement of anatomical conduits. Angela is a clinical project management professional with over 15 years of experience in medical device, biologics, pharmaceutical and CRO industry with a focus on global cross-functional clinical trial management (Phase 1 – 4). Currently, Angela manages the global clinical development program at Humacyte and provides leadership and operational oversight and delivery of all clinical trials. Angela has experience in a variety of complex therapeutic areas and orphan indications including: Infections Diseases (HCV, HIV, HBV, Sepsis Flu, Ebola), Immunology/Genetic disorders (Hereditary Angioedema (HAE)), Pulmonary (Alpha-1 Antitrypsin Deficiency (AATD), Emphysema) (Metabolic disorders (NASH, obesity) and Vascular Surgery (AV Access, Peripheral Arterial Disease (PAD) and Trauma). Angela holds a BS in Medical Technology from Concord University and an MBA from Elon University.

Katrin Uhlig
Senior Medical Director, Clinical Development Lead, KERYX BIOPHARMACEUTICALS

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Dr. Katrin Uhlig, MD, MS is a Senior Medical Director and Clinical Development Lead at Keryx where she provides medical and scientific leadership anddirects a multi-disciplinary team responsible for the design and execution of clinical studies supporting Auryxia. Dr. Uhlig is board certified in Nephrology, and Rheumatology and holds a Master of Science degree in Clinical Care Research.

Prior to transitioning to industry, she worked as an academic nephrologist and clinician scientist in evidence appraisal for nephrology clinical practice guidelines. She is a member of the Board of Directors for the Kidney Health Initiative (KHI), a co-chair for the KHI workgroup on ‘Overcoming barriers to drug development in children with chronic kidney disease’ and an Adjunct Associate Professor at Tufts University School of Medicine, Boston.

Liron Walsh
Vice President, Clinical and Translational Nephrology, GOLDFINCH BIO

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Liron Walsh leads the translational and clinical development efforts at Goldfinch Bio. Liron is a nephrologist by training and has held multiple clinical development leadership roles in both the Nephrology therapeutic area and the rare disease space.

Prior to joining Goldfinch, Liron served as a Senior Medical Director at BioMarin overseeing clinical development for two rare-disease programs; enzyme replacement therapy for Pompe’s Disease and gene therapy for Hemophila A. Liron was integral in advancing both programs, serving as the clinical lead for early and late phases of development. Prior to BioMarin, Liron was a Medical Director in the Nephrology therapeutic area at Amgen involved in the development of cinacalcet and etelcalcetide, calcimimetic agents for patients with chronic kidney disease. Liron oversaw multiple clinical studies at various stages of development, most notably, as the clinical lead for two phase 3 etelcalcetide clinical studies, which ultimately led to a successful approval in the US and the EU.

Liron received his MD from the University of Toronto and completed his Nephrology fellowship at Mount Sinai in NY in 2010.

Amy Young
Vice President, General Manager, DAVITA CLINICAL RESEARCH