Speakers

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Aliza Thompson
Clinical Team Leader, Division of Cardiovascular & Renal Products
FDA

Day Two

Wednesday 15 July 2020

9:00 am | Talk Details to be Revealed

Andrew King
Head of Renal Discovery & Translational Medicine
Chinook Therapeutics

Day One

Tuesday 14 July 2020

4:30 pm | Panel Discussion: Executing Precision Medicine in Clinical Trials

Day Two

Wednesday 15 July 2020

10:00 am | Selective ETA receptor antagonist ATRASENTAN for the Treatment of Primary Glomerular Diseases

Anjali Pandey
SVP of Nonclinical R&D & Chemistry
twoXAR Pharmaceuticals

Beno Freedman
Assistant Professor, Nephrology
University of Washington

Dr. Freedman became fascinated by stem cells as an undergraduate at the University of Pennsylvania, and learned the art of minimal reconstitution in vitro as a doctoral student at U.C. Berkeley. Members of Dr. Freedman's family suffer from kidney disease, which prompted him to investigate the potential of stem cells and CRISPR for this fascinating organ. As a postdoc at Harvard Medical School, Dr. Freedman generated and characterized iPS cells from patients with polycystic kidney disease, revealing a molecular phenotype in these cells. Dr. Freedman subsequently developed protocols directing differentiation of iPS cells into kidney organoids that functionally model morphogenesis, physiology, and injury. Combining this with CRISPR-Cas9 genome editing, he established the first organoid models of genetic disease. Dr. Freedman is currently an Assistant Professor of Medicine at the University of Washington, where his group is combining iPS, organoids, and genome editing to model disease and, ultimately, regenerative therapy.

Colin Meyer
Chief Research & Development Officer
Reata Pharmaceuticals

Day Two

Wednesday 15 July 2020

3:00 pm | Talk Details to be Revealed

Dorothee Oberdhan
Associate Director, Health Outcomes
Otsuka Pharmaceuticals

Day One

Tuesday 14 July 2020

1:45 pm | Panel Discussion: Advantages & Disadvantages of Targeting Trials to Specific Orphan Indications Versus Larger Public Health Problems

Day Two

Wednesday 15 July 2020

2:15 pm | Panel Discussion: Navigating Enrolment of Minority Patients

Frank Czerwiec
Chief Medical Officer
Goldfinch Bio

Dr. Czerwiec joined Goldfinch Bio from Otsuka Pharmaceutical Development & Commercialization, Inc. where he was most recently Vice President, Global Clinical Development leading their Cardio-Renal and Metabolic/Medicine group. During his 20-year tenure at Otsuka he was a key contributor to multiple drug approvals and led the global tolvaptan program in autosomal dominant polycystic kidney disease (ADPKD). During his career Dr. Czerwiec has been an active supporter of kidney disease-related research including the Critical-Path’s PKD Outcomes Consortium, Kidney Drug Development Tools Summit and ADPKD Summit. He has contributed to the National Kidney Foundation's Patient Reported Outcome Initiative and ASN’s Kidney Health Initiative. Dr. Czerwiec earned his M.D. and a Ph.D. in Biochemistry and Molecular Biology and conducted his internal medicine residency at the University of Miami Miller School of Medicine before completing his post-doctoral training in translational research through a fellowship in Adult Endocrinology and Metabolism at the National Institutes of Health (NIH) (NICHD & NIDDK).

Fredrik Erlandsson
Global Clinical Lead for Verinurad
AstraZeneca

Day Two

Wednesday 15 July 2020

9:30 am | Phase 2a Results, Phase 2b Study Design, & Investigations into the Mechanism of Action of Verinurad, a URAT1 Inhibitor, in Development for CKD & Heart Failure

Harry Alcorn
Chief Medical Officer
Diamedica

Dr. Alcorn has over 30 years of clinical research experience working with public and private biotech and pharmaceutical companies in studies of kidney diseases and diabetic, hepatic and cardiovascular patients. He has designed, authored and been a consultant to a multitude of companies in the industry on protocol development, clinical execution and regulatory guidance. He has served as Principal Investigator or Sub Investigator in over 450 clinical studies and has assisted many biotech and pharmaceutical companies in negotiating protocols and presenting results to the FDA. Dr. Alcorn has presented at numerous international meetings and industry seminars discussing the critical challenges in conducting patient studies.

Prior to joining DiaMedica, Dr. Alcorn served as Chief Scientific Officer at DaVita Clinical Research (DaVita), a company that provides clinical research services for pharmaceutical and biotech companies.During this time, he also served on the Board of Directors for The Association of Clinical Pharmacology Units and on the Board of Directors of MedTox Laboratories. In 2000 Dr. Alcorn started the US Renal Network, the first organization to coordinate clinical trial sites for the conduct of kidney studies. Prior to DaVita he held the position of Executive Director and led the clinical trials at GalaGen Inc, a biopharmaceutical company developing therapeutics to target life-threatening and emerging pathogens.

Dr. Alcorn obtained his Bachelor of Pharmacy from Creighton University and his Doctor of Pharmacy from University of Nebraska Medical Center. He currently holds clinical faculty appointments with the University of Minnesota, Creighton University, University of Nebraska Medical Center, Virginia Commonwealth and the University of Colorado, Denver.

Workshop Day

12:45 pm | CKD DM199 Research Update

Hitesh Soni
Renal Fibrosis Gene Therapy Lead
Renascent Biosciences

After completion of Masters’ in Industrial Pharmacology, Dr. Hitesh Soni joined Zydus Research Center, a research wing of Zydus Cadila, Ahmedabad, India - the 6 th largest pharma company with revenue of $1.7 billion in 2019. He has more than eight years of experience working in drug discovery small molecule research, beginning in his home country. The company has launched the first new chemical entity (NCE) named Saroglitazar (LipaglynTM) for diabetic dyslipidemia where Dr. Soni has significantly contributed to preclinical evaluation of the molecule. Another molecule ZYAN1 (Desidustat), a PHD2 inhibitor for renal anemia where Dr. Soni has performed proof-of-concept (POC) preclinical studies as project coordinator and created a strong foundation for the project. Recently (Jan, 20th, 2020) this molecule has been licensed to China Medical System in Greater China (China, Hong kong, Macau, Taiwan) after completion of the Phase II trial in India. He has contributed significantly to diabetes, cardiovascular, metabolic, renal anemia, thrombosis, and inflammation drug discovery projects as well as bioassay development for generic biologics at Zydus Research Center. He published several research articles in peer-reviewed journals such as vascular pharmacology, thrombosis research, toxicology and applied pharmacology, two of which were awarded as best papers and also published one international patent (WO2011132201) while working at Zydus Research Center.

In 2011, following completion of his Ph.D., Dr. Soni moved to the USA to pursue his research aspirations. He worked for almost eight years as an instructor at University of Tennessee Health Science Center, Department of Physiology, Memphis, TN, USA, assisted in the laboratory of Dr. Adebowale Adebiyi and focused on research projects related to the role of renovascular physiology and pathophysiology using piglet and mouse models of kidney injury. Recently (Dec 2019), he has completed his professional MBA degree with a GPA of 4 out of 4 from the University of Memphis, Memphis, TN. He has published more than 20 research papers (80% of research papers as the first author) and contributed to one patent (20% contribution) as well as numerous abstracts from UTHSC, Memphis, TN. He has also received Leonard Share Young Investigator Award in 2014 by the University of Tennessee Health Science Center (UTHSC), Memphis, TN, USA in recognition of outstanding basic research in the Cardiovascular-Renal field. Dr. Hitesh Soni is currently working as Senior Scientist and group leader of kidney fibrosis project at Renascent Bioscience LLC., a gene therapy-based start-up in Lexington, MA.

Day Two

Wednesday 15 July 2020

1:30 pm | Panel Discussion: Understanding Renal Fibrosis as a Hallmark of CKD & Debating if Targeting TGF is Best to Reverse it

Workshop Day

11:30 am | Role of Vascular Smooth Muscle Cell (SMC) TRPV4 Channel in IschemiaReperfusion-Induced Renal Insufficiency in Neonatal Pigs

Jeremy Duffield
Global Head of Human Biology
Vertex Pharmaceuticals

Jeremy is the Global Head of Human Biology at Vertex Pharmaceuticals, where he oversees all research programs. Formerly, he was Vice President of R&D at Biogen Inc., where he oversaw early target discovery in immunological and fibrotic diseases of lung, kidney and liver. He also oversaw drug discovery programs for mitochondrial diseases and cell stress pathways. He graduated from Oxford and Edinburgh Universities in the UK with MD PhD, and currently practices Nephrology part-time at Massachusetts General Hospital. From 2003, he directed the laboratory of inflammation research at Harvard Medical School, then expanded his lab at the Institute for Stem Cell and Regenerative Medicine at the University of Washington in Seattle. His laboratory focused on the role of innate immune response cells in injury and repair and on the role of pericytes and fibroblasts in microvascular remodeling and fibrosis, and has published more than 120 articles. He is a recipient of scientific awards including: Young Investigator Award from the British Renal Association (2001); Medical Research Society (2002); NIDDK Young Investigator/Scholar Award (2010); and the American Society of Nephrology Young Investigator Award (2013). In 2011, he became an elected member of the American Society for Clinical Investigation. He also serves on scientific study sections at the NIDDK/NHLBI. He is a cofounder of Muregen, and has served on advisory boards for Genzyme, Takeda, Promedior Inc. and Regulus Therapeutics. In his ‘spare’ time he rides bicycles, climbs mountains, skis, plays tennis, grows organic vegetables, looks after children (his own), and fixes things that are broken.

Day One

Tuesday 14 July 2020

4:30 pm | Panel Discussion: Executing Precision Medicine in Clinical Trials

2:45 pm | APOL1 – A Genetic Driver of Kidney Disease: From Concept to Clinical Trials

Jonathan Himmelfarb
Director of the Kidney Research Institute & Professor of Medicine
University of Washington

Jonathan Himmelfarb, M.D., is a board certified physician, director of UW Medicine’s Kidney Research Institute, the UW’s Joseph W. Eschbach Endowed Chair in Kidney Research, president-elect of the American Society of Nephrology and a UW professor of Medicine and Nephrology and adjunct professor of Medical Bioengineering.
Dr. Himmelfarb's research interests involve metabolic complications of kidney disease. He has also been involved in creating statewide, community-based research into healthcare disparities related to chronic kidney disease. The total patient experience is his primary concern and he provides care that is personal and friendly.
Dr. Himmelfarb earned his M.D. at George Washington University in Washington, D.C. He is board certified in both General Internal Medicine and Nephrology.

Joseph Stavas
Senior Vice President, Clinical Development
inRegen

Senior Vice President of Clinical Development at inRegen, LLC. Dr. Stavas has been in clinical health care and research for 30 years, as an Interventional Radiologist, serving as Department Chair and on national committees. At inRegen, he is involved in trial development of autologous kidney cell implantation therapy with promise for CKD stability, renal regeneration and disease reversal. He currently oversees Phase I-II trials.

Josh Tarnoff
Chief Executive Officer
NephCure Kidney International

Josh Tarnoff is the Chief Executive Officer for NephCure. He came to NephCure in early 2018 when he fulfilled a long-held desire to more closely serve the rare disease patient community. Josh spent over 30 years working in the pharmaceutical and biotechnology community moving new therapies closer to reality. Personal contact with NephCure families drives his passion to achieve the goals of our mission and he always appreciates directly speaking with our community. Likely due to a snake bite, he also has personal insights into renal disease having been a patient. Josh lives in PA where he enjoys backpacking while also trying to avoid further contact with venomous snakes.

Day One

Tuesday 14 July 2020

1:45 pm | Panel Discussion: Advantages & Disadvantages of Targeting Trials to Specific Orphan Indications Versus Larger Public Health Problems

Jyothis George
Vice President, Clinical, Medical & Regulatory
Novo Nordisk

Jyothis is an entrepreneurial physician-scientist with a track-record in global leadership. Leading clinical development of BI’s cardio-metabolic portfolio (which includes two blockbusters – Empagliflozin and Linagliptin) His global outcome-trial leadership includes the pragmatic trial EXSCEL, the active-comparator trial CAROLINA, the CARMELINA trial with a renal-enriched population and the EMPEROR Heart Failure Program. This decade-long experience in clinical development (>40,000 patients from >40 countries), helped design a lean global registration programme in CKD, with world-leading university partners (EMPA-KIDNEY). He has dozens of publications in prestigious journals and multiple award-winning presentations complement >15 years of clinical practice -including senior roles in world-renowned tertiary hospitals. This foundation helped consolidate a team delivering high-impact publications in cardiology and diabetes, enabling the clinical implementation of Empagliflozin (EMPA-REG OUTCOME). Regulatory interactions (FDA, EMA and PMDA) range from pre-IND to approvals, including FDA Advisory Committee and CHMP Oral Examination. Addressing evidence needs of payers, HTAs and guideline providers is also a key focus.

Day One

Tuesday 14 July 2020

9:30 am | Panel Discussion: Demonstrating Opportunity in Renal to Support a Business Case:

8:30 am | Interplay Between Diabetes, Heart failure & CKD: What Can we Learn from Novel Drug Development?

Kevin Fowler
President
The Voice of the Patient

Kevin Fowler worked in the pharmaceutical industry for over 25 years both commercial and R&D . His career has encompassed a breadth and depth of skills and experiences. During his career, he demonstrated leadership in sales management, training, public affairs, global marketing, patient advocacy, and patient marketing. He formed his own patient advocacy and patient engagement consulting business in 2014, “The Voice of the Patient, Inc. His clients have included: CareDx, Inc., Hansa Medical, Chiesi, Bayer, TapCloud LLC, Otsuka, Retrophin, Protalix Biotherapeutics, and Gilead. In 2020 Kevin was invited to be a member of the Kidney Health Initiative, Board of Directors. Based upon his personal experiences of having a pre-emptive kidney transplant in 2004, he has a deep passion for patient advocacy and patient engagement.

Day One

Tuesday 14 July 2020

8:20 am | Chair’s Opening Remarks: The Value Proposition of Early Identification & Intervention of Kidney Disease

Day Two

Wednesday 15 July 2020

2:15 pm | Panel Discussion: Navigating Enrolment of Minority Patients

Liron Walsh
Vice President of Translational & Clinical Nephrology
Goldfinch Bio

Liron Walsh comes to Goldfinch Biopharma with a Nephrology and Clinical Development background. Liron 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.

Day One

Tuesday 14 July 2020

4:30 pm | Panel Discussion: Executing Precision Medicine in Clinical Trials

4:00 pm | Targeting FSGS as an Entry Point in CKD: Expanding From a Smaller Market

Maria Chiara Magnone
Vice President Kidney Diseases & Boston Site Head
Janssen R&D

Matt Breyer
Distinguished Scientist
Janssen

Matthew D. Breyer, MD, CSO BioTDR Lead Generation Eli Lilly & Company (retired): Dr. Breyer received his M.D from Harvard, Internal medicine Residency at Michael Reese Hospital, and training in Nephrology at Parkland Hospital, University of Texas Health science center Dallas. From 1985-2007 he was Professor of Medicine in the division of Nephrology at Vanderbilt University Medical Center where his work focused on the study of transgenic mouse models to study diabetic kidney disease and hypertension. Dr. Breyer held numerous NIH and VA awards and from 2001-2006 headed the nephropathy sub-group of the NIH Animal Models of Diabetic Complications Consortium (AMDCC). As a result of his interest in developing treatments for diabetic nephropathy he moved to Eli Lilly in 2007 to oversee a program to develop bio-therapeutics for diabetic kidney disease. In 2009 he was appointed to his current position at Eli Lilly as Chief Scientific Officer Lead Generation Biotechnology Discovery Research, where he oversaw preclinical target identification and validation of biologics for metabolic, neurologic, oncologic and chronic kidney diseases.

Day Two

Wednesday 15 July 2020

1:30 pm | Panel Discussion: Understanding Renal Fibrosis as a Hallmark of CKD & Debating if Targeting TGF is Best to Reverse it

Matt Devalaraja
Chief Scientific Officer, Head of R&D
Corvidia Therapeutics

In addition to being one of Corvidia Therapeutic’s founders, Matt Devalaraja is Head of Research and Development. Matt is an inflammation biologist with more than 19 years of experience in drug discovery and development across multiple therapeutic areas. Prior to founding Corvidia, Matt was Director of Emerging Innovations Unit at AstraZeneca, where he enabled multiple clinical studies and developed the core hypothesis of precision cardiovascular therapeutics that formed the basis for Corvidia. He also was Head of Immunology Research, Pharmacokinetics and Toxicology groups at Human Genome Sciences, and was integral to the approval of Benlysta for Lupus and Raxibacumab for Anthrax. He started his career at Pfizer Ann Arbor and brought forth the first biologic program for Pfizer’s Global Immunology portfolio. As Head of Biologics Discovery at Pfizer Ann Arbor, he initiated multiple programs across various therapeutic areas including immunology and cardiovascular space—many of which are currently in various stages of clinical development. Currently, he is on the board of P2D Biosciences and is a founder of multiple startup biotech companies. Matt received his Ph.D. from the University of Kentucky and Post-Doctoral training at Vanderbilt University.

Workshop Day

10:30 am | Inflammation at the Heart of Chronic Kidney Disease Patients: Anti-Interleukin Therapy?

Matthias Kretzler
Professor of Medicine Nephrology/ Internal Medicine & Bioinformatics
University of Michigan

Dr. Kretzler is the Warner-Lambert/Parke-Davis Professor of Internal Medicine/Nephrology and Computational Medicine and Bioinformatics. The overarching goal of his research is to define chronic organ dysfunction in mechanistic terms and use this knowledge for targeted therapeutic interventions. To reach this goal he has developed a translational research pipeline centered on integrated systems biology analysis of renal disease. He leads the U54 Nephrotic Syndrome Research Network (Neptune) in the Rare Disease Clinical Research Network II, is a Principle Investigator (PI) of the Coordinating center of the CureGN research network, the Director of the Applied Systems Biology Core, PI in the R24 “Integrated Systems Biology Approach to Diabetic Microvascular Complications” and site PI in the NIH Acceleration of Medicine (AMP) program in lupus.

He has 20 years of experience in integration of bioinformatics, molecular and clinical approaches in more than 210 publications. He has a track record on interdisciplinary data integration of large-scale data sets in international multi-disciplinary research networks in the US, Europe, China and sub-Saharan Africa. These studies enable precision medicine across the genotype-phenotype continuum using carefully monitored environmental exposures, genetic predispositions, epigenetic markers, transcriptional networks, proteomic profiles, metabolic fingerprints, digital histological biopsy archive and prospective clinical disease characterization. The molecular mechanism identified have result in new disease predictors and successful phase II trial of a novel therapeutic modality in diabetic kidney disease.

Matthias Kretzler was born in Bruchsal, Germany close to Heidelberg (and France). He received his medical training at the University of Heidelberg, Germany; Newcastle upon the Tyne in the U.K.; and at the University of Michigan.

Taking full advantage of Germany’s medical training system, Matthias enrolled in an MD/PhD structured program working Wilhelm Kriz’s Anatomy and Cell Biology research team on the mechanism of glomerular filtration barrier failure. The fascination of the aesthetic beauty of glomerular filters has become the central theme of his research for the past 20 years. Beginning with ultrastructural morphology, he expanded his research efforts to modern molecular biology tools during a post-doctoral fellowship with Josie Briggs, MD, Juergen Schnermann, MD, and Larry Holzman, MD and the University of Michigan.

After returning to Germany he built, under the mentorship of Detlef Schlondorff, MD, a molecular nephrology laboratory at the Medizinische Poliklinik in Munich. Using the unique research team network around the European Renal Cell Study Group, he initiated what is now a worldwide network of kidney research centers to define molecular mechanism of renal disease in humans. For this personalized medicine approach to Nephrology he found an ideal environment at his old alma mater – the University of Michigan – and is now embedded in the fascinating collaborative network of molecular biologists, clinician-scientists, mathematicians, bioinformaticians, and systems analysts at work in Ann Arbor. The love of his life, Annette, and his two children Katharina and Johannes, are very effective counterbalances to his busy life as a clinician-scientist and ensure he enjoys the wonders and beauties of Michigan’s nature.

Day One

Tuesday 14 July 2020

4:30 pm | Panel Discussion: Executing Precision Medicine in Clinical Trials

2:15 pm | Pathway Driven Patient Stratification in Glomerular Disease: A Report From the Trenches

Nick LaBella
Chief Scientific Officer
ZyVersa Therapeutics

Mr. LaBella is an experienced pharmaceutical executive with extensive expertise and core competency that spans over 34 years in Regulatory Affairs and Clinical Operations. His background includes hands-on experience in small molecule pharmaceutical development providing corporate leadership; strategic assessments; FDA interactions; preparation, submission and approval of NDA, ANDA and IND applications; and compliance with cGMP, cGCP, and cGLP. He has successfully designed, developed and executed pharmaceutical development programs in multiple therapeutic areas leading to NDA approvals. These therapeutic areas include cardiovascular, CNS, women’s health, anti-diabetic and anti-infective products. He managed a full spectrum of R&D departments; and served both on Executive Management Teams and as a Board of Director. Management experience includes growth and operations of a CRO organization with over 200 individuals.

Mr. LaBella most recently served as Chief Scientific Officer at Insmed, Inc. (merged with Transave), VP of Development and Regulatory Affairs at Cardiokine, Inc, VP of Operations, Phase IV Division at Pharmanet (previously Medex Clinical Trail Services), VP of New Drug Development at Watson Laboratories (formally Circa Pharmaceuticals, where he was VP, Director of Research and Development, Director of Regulatory Affairs, and Director of Regulatory Investigational New Drugs). Mr. LaBella began his career at Sandoz Research Institute as a Senior Project Coordination Manager, followed by Associate Director of Regulatory Affairs at Lorex Pharmaceuticals. Mr. LaBella received his Bachelor of Science in Pharmacy from the University Of Connecticut School Of Pharmacy and his Master of Science in Drug Information and Communication from Arnold and Marie Schwartz College of Pharmacy, Long Island University. Mr. LaBella is a licensed Pharmacist and has published various publications and patents.

Workshop Day

11:00 am | Renal Lipids as a Potential Therapeutic Target for Kidney Disease

Pernille Hansen
Senior Director & Head of Bioscience
AstraZeneca

Prof. Hansen has over 20 years of experience in Chronic kidney Diseases. She holds a PhD in physiology from the University of Southern Denmark. After a postdoc from the National Institutes of Health, National inst. of Diabetes, Digestive and Kidney Diseases, USA she later became Professor and Deputy Department Head of Cardivascular and Renal Research at the University of Southern Denmark. Prof. Hansen has significant experience from the field of renal hemodynamics and thorough experience in in vitro and in vivo systems as well as translational approaches. Prof Hansen is now working at AstraZeneca, Gothenburg, Sweden as Head of CKD, CVRM, IMED and also holds an adjunct professorship at Gothenburg University.

Ravi Kumar
Senior Vice President & Chief Scientific Officer
Acceleron Pharma

Dr. Kumar joined Acceleron in March 2004 and is currently Senior Vice President and Chief Scientific Officer. Dr. Kumar established and currently leads Acceleron discovery research. Previously, Dr. Kumar worked for 12 years at Genetics Institute and Wyeth Pharmaceuticals. At Genetics Institute, Dr. Kumar was a key member of the Small Molecule Drug Discovery group and was responsible for cell biology. Following the integration of discovery functions from GI and Wyeth Pharmaceuticals, Dr. Kumar served as Senior Scientist in the Biological Chemistry group. Dr. Kumar is the author of several key scientific manuscripts in the area of protein glycosylation and is named as an inventor of several patents. Dr. Kumar received his BS in chemistry from Rohilkhand University, his MS in chemistry from Meerut University, his Ph.D. from University of New Brunswick and he completed his post-doctoral fellowship at Albert Einstein College of Medicine, in Bronx, NY.

Day Two

Wednesday 15 July 2020

1:30 pm | Panel Discussion: Understanding Renal Fibrosis as a Hallmark of CKD & Debating if Targeting TGF is Best to Reverse it

Richard Nkulikiyinka
VP, Head of Therapeutic Area Cardiology & Nephrology
Bayer Pharmaceuticals

Day One

Tuesday 14 July 2020

9:30 am | Panel Discussion: Demonstrating Opportunity in Renal to Support a Business Case:

Robert Edwards
Clinical Project Scientist
Janssen Pharmaceuticals

Robert Edwards, MPH, joined Janssen in early 2012 and is currently a Director, Clinical Project Scientist, supporting the Cardiovascular and Metabolism (CVM) therapeutic area. Robert’s tenure with CVM began with responsibilities on several late-stage clinical trials supporting the original submission packages leading to the approval of Invokana® (canagliflozin) and Invokamet® (fixed dose combination of canagliflozin and metformin) prior to being named the Study Responsible Scientist for CREDENCE when the trial was first conceived.  Today, Robert continues to support CREDENCE-related activities including regulatory interactions and publication initiatives.  After obtaining a BS in Biotechnology with a focus in Applied Microbiology from Rutgers University, Robert worked as a bench scientist at two biotechnology start-ups.  Robert next spent nearly 10 years at Merck, Inc., supporting the potency testing platforms for the M-M-R®II and Gardasil® vaccine programs prior to joining the clinical development program supporting Januvia® (sitagliptin) and several other late-stage compounds. Robert obtained his MPH from Drexel University in 2018.

Day Two

Wednesday 15 July 2020

2:30 pm | A Blueprint for Success: Janssen's CREDENCE Clinical Trial

Ron Perrone
Scientific Director, Clinical & Translational Research Center; Professor
Tufts University School of Medicine

Dr. Perrone is a member of the Division of Nephrology at Tufts Medical Center, Scientific Director of the Clinical and Translational Research Center, and Professor of Medicine at Tufts University School of Medicine. He has had a long-standing and wide-ranging interest in ADPKD, focusing recently on clinical trials and use of total kidney volume as a potential regulatory endpoint. Dr. Perrone has a large clinical practice focused on PKD. He served as the co-founder and clinical lead of the PKD Outcomes Consortium whose work led to qualification of total kidney volume as a prognostic biomarker by FDA and EMA.

Workshop Day

12:15 pm | Research Update in Polycystic Kidney Disease

Scott MacDonnell
Associate Director, Cardiovascular & Fibrosis Research
Regeneron Pharmaceuticals

Dr. Scott MacDonnell obtained his undergraduate and master’s degrees in exercise physiology from the University of Delaware and completed his doctoral work in cardiovascular physiology at Temple University in Philadelphia, PA. He completed a post-doctoral fellowship at Temple University Medical School in the lab of Dr. Steve Houser. Scott worked for 8-years as a principal scientist at Boehringer Ingelheim within the department of CardioMetabolic Disease Research where his research focused on identifying novel therapeutic treatment options for chronic kidney disease, heart failure, and fibrosis. Scott currently works at Regeneron Pharmaceuticals in the cardiovascular, renal, and fibrosis therapeutic focus area where he leads an in-vitro and histology group supporting both screening and functional assay development for heart failure, systemic hypertension, pulmonary fibrosis and hypertension, and both acute and chronic renal indications. His groups recent publication defined a disease associated fibroblast gene signature and challenged both the use of smooth muscle actin to delineate activated fibroblasts and the central role of TGFb in early fibrotic events.

Day Two

Wednesday 15 July 2020

1:30 pm | Panel Discussion: Understanding Renal Fibrosis as a Hallmark of CKD & Debating if Targeting TGF is Best to Reverse it

Sibylle Hauske
Senior Medical Director & Global Clinical Development Lead - Empagliflozin in CKD
Boehringer Ingelheim

Day One

Tuesday 14 July 2020

9:30 am | Panel Discussion: Demonstrating Opportunity in Renal to Support a Business Case:

Tzu-Ling (Karen) Tseng
Chief Executive Officer
Bio Preventive Medicine Corp

Dr. Tseng founded Bio Preventive Medicine Corp. (BPM) with more than 20 years of biomedical research experiences and leadership in Taiwan and US. BPM is an innovative and clinical-staged biotech company, focusing on developing novel biomarker-based diagnostic products. She previously served as Head of a National Biomarker Research Program and Deputy General Director of Biotech and Pharmaceutical Research Laboratories at ITRI, which is a national institute in Taiwan and listed as one of the Top 100 Global Innovators. She has started developing biomarkers since she worked at National Cancer Institute, NIH, in US. Dr. Tseng received her doctoral fellowship training in molecular biology at Cold Spring Harbor Laboratory and a Ph.D. in Genetics from the State University of New York at Stony Brook in New York, US. She is the inventor of a series patents in biomarker area, including biomarkers for detecting diabetes complication, auto-immune disease, renal disease, liver fibrosis and cancer.

Uptal Patel
Executive Director of Clinical Research & Head of Nephrology
Gilead

Uptal Patel, MD, Senior Director, Inflammation & Respiratory Therapeutics, Gilead Sciences. Dr. Patel attended medical school at UCSF and completed residency and fellowship training at the University of Michigan. He also received advanced training in health services research and epidemiology, and has been board certified in internal medicine, pediatrics, adult nephrology, and pediatric nephrology. He was faculty in the adult and pediatric nephrology divisions at Duke University and a member of the Duke Clinical Research Institute where he was interested in developing and applying strategies to reduce the burden of kidney disease in populations. There, he directed several multidisciplinary translational research efforts, and led a broad-based research program focused on improving the detection and management of kidney disease, as well as understanding the inter-relationships between kidney disease and cardiovascular disease. He also served on a number of national committees related to clinical research, health policy, and public health issues related to kidney diseases, as well as a several editorial boards, grant review panels and national committees. Despite the promise of scalable interventions on the horizon to improve population health for patients with kidney diseases, these experiences also highlighted the dire need for new, more effective therapies. As a result of his interest in developing new treatments to prevent the progression of kidney diseases, he moved to Gilead Sciences in 2016 to lead clinical development programs for kidney diseases. He remains active in efforts to improve population health for patients with kidney diseases as an Adjunct Professor at Duke.

Day One

Tuesday 14 July 2020

1:45 pm | Panel Discussion: Advantages & Disadvantages of Targeting Trials to Specific Orphan Indications Versus Larger Public Health Problems

9:30 am | Panel Discussion: Demonstrating Opportunity in Renal to Support a Business Case:

Vishal Vaidya
Translational Omics Group Head
Pfizer

Vishal S. Vaidya is the Global Lead for Biomarker Analytics at Pfizer and a Principal Investigator at Brigham and Women’s Hospital, Harvard Medical School. Vishal’s laboratory is responsible for discovering, qualifying and implementing translational safety biomarkers to support drug development. Vishal has authored more than 90 publications and serves as a primary editor for the book "Biomarkers in Medicine, Drug Discovery and Environmental Health". Vishal’s work has been recognized by the NIH/NIEHS Outstanding New Environmental Scientist award, Burroughs Wellcome Fund’s Innovation in Regulatory Science Award, Society of Toxicology’s Leading Edge in Basic Science Award and the Achievement Award.

Wenjun Ju
Associate Research Scientist of Internal Medicine
University of Michigan

Dr. Wenjun Ju is an associate research scientist in the Department of Medicine and Department of Computational Medicine and Bioinformatics at the University of Michigan. She is the Michigan Kidney Translational Core Center Deputy Director. Dr. Ju has extensive experience on integration of patients’ kidney biopsy transcriptomics, plasma and urinary proteomics, highly granular morphometrics data, cross-sectional and longitudinal clinical data to determine critical molecular networks and pathways for risk stratification, molecular subgrouping, and targeted therapy followed by identification of non-invasive surrogates and final validation in the global research network. Her long term goal is to translate these mechanism-based molecular markers into clinically implementable tools for kidney precision medicine.

Yshai Yavin
Director, Cardiovascular & Metabolism Development
Janssen Pharmaceuticals

Yshai Yavin, MBChB MFPM, is Director in Cardiovascular and Metabolism Development  and has been the Study Responsible Physician for the CREDENCE study since joining Janssen in March 2016. He received his medical degree from the University of Pretoria, South Africa, where he qualified in General Medicine and practiced in several fields. He subsequently completed specialist training in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine, UK. Before joining Janssen, Yshai worked at Bristol-Myers Squibb in Medical Affairs as well as Clinical Development. Before his career in industry, Yshai worked for several years as a clinical research fellow and co-investigator at Kings College Hospital, London.

Day Two

Wednesday 15 July 2020

2:00 pm | Rationale & Results of Subgroup Analyses of the CREDENCE Study