Speakers
Amin Yehya (GEP member)
Program Director of the Cardiovascular Disease Fellowship, Associate Professor of Medicine, Director of Heart Failure Research, Medical Director of the Durable Mechanical Circulatory Support Program
Eastern Virginia Medical School, Old Dominion University, Senatra Health
Dr Amin Yehya, MD, MS, FACC, FHFSA, ISHLT-F is an advanced heart failure and heart transplant cardiologist and Medical Director of the Durable Mechanical Circulatory Support Program at Sentara Health, Norfolk, USA. He also serves as Associate Professor of Medicine at Macon & Joan Brock Virginia Health Sciences at Old Dominion University (ODU), Director of Heart Failure Research at Sentara Health and Program Director of the Cardiovascular Disease Fellowship, Eastern Virginia Medical School, ODU.
Dr Yehya completed his medical degree and Master of Science in Biochemistry at the American University of Beirut, followed by internal medicine residency at Emory University, Atlanta. He pursued his cardiovascular disease fellowship at the Medical College of Georgia and advanced training in heart failure and transplant cardiology at Stanford University. An Alpha Omega Alpha Honor Medical Society member, Dr Yehya has received numerous distinctions, including Top Transplant Cardiologist in Virginia (2022–2024), Best in Virginia – Heart Transplant Cardiologist (2025) and recognition as being among the top 5% physicians publishing leading-edge research in cardiology for 2025 compiled by Avant-garde Health.
He actively contributes to national committees and serves as a representative on the United Network for Organ Sharing Adult Heart Regional Review Board. He currently chairs the Heart Failure Society of America (FHFSA) Educational Committee and serves on multiple HFSA committees, among others. He is an active member of ISHLT, ACC, AHA and the Medical Society of Virginia. At Sentara, he has led quality initiatives in advanced heart failure, mechanical circulatory support protocols, hypertension and heart failure pathways and frailty assessment.
He has served as principal investigator or sub-investigator on numerous landmark heart failure and transplant trials, advancing therapies in heart failure and left ventricular assist device management, to name a few. Dr Yehya is a peer reviewer for reputable medical journals and has published widely.
Anne Rygaard
Anne Rygaard is currently the Global SRR Lead in studyprogrammes at Novo Nordisk headquarters in Søborg, Denmark. She heads up the Scientific Recruitment and Retention Program for the liver trial portfolio. Anne received her MSc in Public Health from Copenhagen University in 2007 and holds a diploma degree in Strategic Communication.
Prior to joining Novo Nordisk, Anne worked in international health for the Danish Ministry of Health. After graduation, Anne first joined WHO’s Disaster Preparedness Department, working in country offices in Kosovo, Macedonia and Albania. She then moved on to United Nations High Commissioner for Refugees (UNHCR) in Geneva, leading a large study on the spread of HIV in conflict zones in Africa.
Upon her return to Denmark, Anne held different positions inthe Danish Ministry of Health, ultimately serving as a chief advisor in the Danish National Covid Response Team with responsibility for national vaccine communication efforts. Anne is an external lecturer and external examiner in public health at Copenhagen University.
Assen Goudev (GEP member)
Professor & Head of Department of Cardiology
University Multi-profile Hospital for Active Treatment “Tsaritsa Yoanna–ISUL” EAD, Sofia
Professor Assen Rachev Goudev, MD, PhD, is a cardiologist and Head of the Department of Cardiology at the Clinic of Cardiology, University Multi-profile Hospital for Active Treatment “Tsaritsa Yoanna–ISUL” EAD, Sofia, Bulgaria.
Prof Goudev earned his Medical Doctor degree from the Medical University of Sofia and subsequently completed specialties in internal medicine and cardiology. He obtained his cardiology PhD in 1997, became Associate Professor in 1998, and was appointed Professor in 2009, Medical University, Sofia His professional experience includes serving as Head of the Department of Cardiology at UMHAT “Tsaritsa Yoanna–ISUL” since 2004, and previously as Head of the Department of Cardiology at the University Hospital in Pleven.
He has also led the Clinical Centre of Emergency Medicine at the Medical University, Sofia, and has experience as a practicing physician. Prof Goudev has participated as principal investigator and sub-investigator in 14 Phase III trials in areas including atrial fibrillation, heart failure, arterial hypertension, coronary artery disease, dyslipidaemia and anaemia.
He is a fluent in English, German and Russian.
Audrey Auclair (GEP member)
Research Coordinator
Institut Universitaire de Cardiologie et de Pneumologie de Québec
After graduating as a kinesiologist in 2009, Audrey Auclair completed a master’s degree and a doctorate at Université Laval (Quebec City, Canada). Her research focused on the role of ectopic adipose tissue deposition in the resolution of comorbidities following bariatric surgery, as well as on the effects of a supervised exercise training program after bariatric surgery on cardiometabolic health.
Audrey Auclair is an author or coauthor of more than 25 scientific papers in peer-reviewed journals, 150 abstracts and 30 presentations, most of which are in the area of severe obesity, bariatric surgery, physical activity and ectopic fat deposition. Since 2016, she has been a research coordinator working with cardiologist Dr Paul Poirier at the Institut Universitaire de Cardiologie et de Pneumologie de Québec – Université Laval (Quebec, Canada). She has worked as the lead study coordinator for more than 27 pharmaceutical studies, including five studies conducted with Novo (SELECT, STEP HFpEF, STEP-HFpEF DM, STRIDE, REDEFINE 3).
She has also successfully coordinated a non–for-cause FDA audit for the SELECT trial for which her site was the biggest recruiter in Canada. She has been appointed national study coordinator for Canada for the first time and will also serve as a member of the Global Expert Panel for the HF-POLARIS study.
Carla Vicente (GEP co-chair)
Clinical Trial Manager
Instituto de Pesquisa Clínica de Campinas
Carla Vicente is a pharmacist and Clinical Trial Manager at the Instituto de Pesquisa Clínica de Campinas (IPECC), Brazil. She graduated from the Pontifical Catholic University of Campinas in 2008 and holds postgraduate degrees in People Management and Project Management, with a strong focus on leadership within the healthcare environment.
Since the very beginning of her career, Carla has worked closely with patients, prioritising patient care, emotional support and well-being as central elements of clinical research. Her professional journey in clinical research started in 2008, and in 2009 she became a Study Coordinator, building solid expertise in regulatory affairs, patient support, staff training and overall research site operations.
In 2013, Carla joined Novo, where she contributed to the LEADER trial and further developed her experience in large, multicentre clinical studies. In 2018, she was appointed National Study Coordinator for the SELECT and SOUL trials, playing an active role in developing and implementing recruitment and retention strategies across Brazil. In this position, she worked closely with the sponsor, supported and engaged research sites and shared experiences and best practices at national and international meetings.
In 2024, Carla was invited to join the Global Expert Panel (GEP) of the ARTEMIS study, expanding her involvement in global clinical research initiatives. Throughout her career, Carla has managed more than 100 clinical trials in cardiology, endocrinology, pneumology and vascular diseases. Her work reflects a consistent commitment to scientific excellence, patient-centred care and the advancement of clinical research that meaningfully improves patient outcomes.
Carolyn Lam (Steering Committee co-chair)
Senior Consultant Cardiologist, Professor
National Heart Center, Duke-National University, Singapore
Carolyn Lam is a Senior Consultant Cardiologist at the National Heart Center in Singapore and a Professor at the Duke-National University of Singapore. She is recognised globally for her expertise in heart failure with preserved ejection fraction (HFpEF). She is a world-renowned clinical triallist, having contributed to the first approved treatments for HFpEF through her roles on the global steering committees of the PARAGON, DELIVER, FINEARTS-HF, and EMPEROR-Preserved trials.
She served on the 2021–2022 European Society of Cardiology Heart Failure Guidelines Task Force and has published over 750 articles in leading journals, including the New England Journal of Medicine, the Journal of the American Medical Association, Lancet, Circulation, and European Heart Journal, earning recognition as a Clarivate Highly Cited Researcher in Clinical Medicine (2021–2024). Dr Lam serves as a Senior Consulting Editor for the Journal of the American College of Cardiology and is the recipient of the prestigious 2025 National Outstanding Clinician Scientist Award from the Singapore Ministry of Health.
In medicinal technology, she is a co-founder of Us2.ai, an award-winning startup applying artificial intelligence to echocardiography to advance the fight against heart disease.
Casper Bang
International Medical Director
Novo
Casper Bang is currently an International Medical Director at Novo, responsible for designing, driving and providing input into cardiovascular trials at Novo. Casper is a medical doctor and board-certified specialist in internal medicine and cardiology, has a PhD in cardiovascular medicine and was previously a Postdoctoral Researcher at Cornel University, New York, NY, USA.
Casper has authored more than 70 scientific publications in international peer-reviewed journals. At Novo, Casper has been responsible for the clinical scientific evaluation of due diligence, leading scientific input to cardiovascular trials, heading the Event Adjudication Team responsible for scientific event adjudication of clinical trials across Novo, and driving the Novo portfolio of cardiovascular endpoints and drug development.
Before joining Novo, Casper worked as a Chief Cardiologist and Associate Professor at Copenhagen University in Denmark.
Cathrine Mechlenburg
Senior Clinical Project Lead
Novo
Cathrine Mechlenburg is a Senior Clinical Project Lead within Clinical Operations at Novo, with over 20 years of experience spanning the full spectrum of clinical trial execution.
Cathrine has an MSc in pharmacology and extensive expertise in large-scale trial operations, particularly cardiovascular outcomes trials.
Elise Ryan
Senior Global SRR Professional
Novo
Elise Ryan is a Senior Global Scientific Recruitment & Retention Professional in Study Programmes at Novo, based in Copenhagen, Denmark. She joined the HF-POLARIS team in mid-2025, where she leads engagement and operations for the HF-POLARIS Global Expert Panel and overseas country-specific recruitment and retention activities across participating countries. Prior to her role with HF-POLARIS, Elise was a key member of the SOUL and FLOW trial teams, supporting the achievement of trial targets and successful trial execution through close collaboration with expert panel members and cross-functional affiliate colleagues.
Elise holds a Bachelor’s degree in Applied Science (Occupational Therapy) from the University of Sydney, Australia, and has 1.5 years of experience in the rehabilitation field. After relocating to Denmark, she completed her Master’s in Business Administration and Innovation in Healthcare at Copenhagen Business School. During her studies, Elise began her career at Novo as a student assistant and has since held roles of increasing responsibility within global clinical trial operations.
Frida Belhage
Senior Statistician
Novo
Frida Belhage joined Novo in October 2021 as a student assistant on the concizumab and growth hormone projects. She has an MSc in statistics from the Copenhagen University (2023) and started in the chronic kidney disease and atherosclerotic cardiovascular disease (CKAD) area in March 2023 as the Trial Statistician for the outcome trial ZEUS and a phase 1 trial, and she has also supported Novo teams across other trials, including heart failure with preserved ejection fraction (HFpEF) trials and SELECT.
Frida is part of the team planning the large zenagamtide outcome trials and will be taking on the statistical responsibility for the heart failure trial. She is also a team member preparing for the heart failure Advisory Committee and will be providing strong statistical insights from the large outcome trials SELECT, FLOW and SOUL. Furthermore, she will be taking on a key role in handling the complex mediation analyses of these large outcome trials.
Grzegorz Gajos (GEP co-chair)
Professor of Medical and Health Sciences & Vice-Dean for Research and Development
Jagiellonian University Medical College
Prof Grzegorz Gajos, MD, PhD, is Professor of Medical and Health Sciences and serves as Vice-Dean for Research and Development at the Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland. Clinically, he works at the Department of Coronary Artery Disease and Heart Failure, John Paul II Kraków Specialist Hospital, where he combines patient care with academic research and clinical trial leadership. Prof Gajos’ scientific work focuses on coronary artery disease, heart failure, cardiometabolic risk and the interface between cardiovascular disease and lifestyle factors, including nutrition.
His research has addressed mechanisms and clinical implications of atherosclerosis, thrombosis and coagulation abnormalities — particularly in patients with obesity and/or diabetes — and has contributed to the broader discussion on residual cardiovascular risk. He has authored a substantial body of peer-reviewed publications and has contributed to high-impact international literature in cardiovascular medicine. His publication in JACC was recognised with the Polish Cardiac Society Award for the best scientific publication in Poland and has achieved broad international reach.
Prof Gajos holds key editorial roles in major Polish medical journals, and has contributed to professional societies and academic governance, supporting the development of cardiovascular research and education programmes. Over more than two decades, Prof Gajos has been actively involved in multicentre, randomised clinical trials across cardiometabolic and cardiovascular disease, serving as principal investigator and national coordinator.
Prof Gajos is a member of the HF-POLARIS Global Expert Panel (GEP) and serves as Vice Chair of the GEP, contributing to scientific strategy, expert guidance and practical implementation insights from high-volume cardiovascular care. He is also a GEP member for the SELECT and ZEUS trials and serves on the Steering Committee of the MARITIME-CV trial. Prof Gajos is a highly regarded educator, has received multiple student-voted awards for teaching excellence and has mentored physicians in internal medicine and cardiology training pathways.
Gustavo Méndez (GEP member)
Head of Cardiology, Honorary Research Fellow
Hospital Angeles Xalapa, Imperial College London
Dr Gustavo Francisco Méndez Machado is Head of cardiology/clinical research at the Hospital Angeles Xalapa, Mexico, works at the MH Integrative Medical Clinical Research SC (cardiology/clinical research), worked at the Cardiology/Head Health Research Department, Medica del Este, Xalapa, and was Medical SubDirector physician at the Hospital General de Zona No 11, Xalapa.
Dr Méndez Machado is Honorary Research Fellow at the Health Services Research Group, Department of Clinical Cardiology, National Heart & Lung Institute, Imperial College London. He obtained his medical degree from the Universidad de Guadalajara, School of Medicine, and has a Master Degree, Medical Sciences (Honors) in “Acetyl CoA and Dilated Cardiomyopathy Bioenergetics” from the Universidad Nacional Autonoma de México, before which he also qualified as a consultant cardiologist.
He is a Fellow of the American College of Cardiology and Heart Failure Association, and received the Alere Latin-American award POCT 2015 Premio ALERE for the project “Utilidad clínica de la proteina C reactiva (PCR) en la prescripcion de antibioticos para el tratamiento de infeccions en la vias respiratorias”. He has also been Special Visiting Professor at the Northwestern University, Feinberg School of Medicine, Chicago, USA, among other acknowledgements & achievements.
Jonathan Purnell (Steering Committee co-chair)
Professor of Medicine, Director
Oregon Health & Science University, OHSU Knight Cardiovascular Institute Center for Preventive Cardiology
Jonathan Purnell is Professor of Medicine at Oregon Health & Science University (OHSU), Portland, OR, USA, with board certification in both endocrinology and obesity medicine. His research areas of interest include understanding the causes and consequences of obesity, dyslipidaemia and diabetes in humans. He is the Director of the OHSU Knight Cardiovascular Institute Center for Preventive Cardiology, which integrates management of obesity, lipids, and diabetes to reduce and prevent cardiovascular disease.
Dr Purnell is Co-Editor of the Obesity section for the online textbook EndoText (www.endotext.org), Assistant Editor for Diabetes Careand the Journal for Lipid Research, and President Elect of The Obesity Society.
Megha Patel (GEP member)
Head of Department of Clinical Research
Rhythm Heart Institute
Megha Patel is a senior clinical research professional with over 15 years of progressive experience in Phase II–IV clinical trials, ensuring operational alignment, regulatory compliance and high-quality study execution in accordance with ICH guideline for good clinical practice (GCP) and global sponsor standards. She holds a Bachelor of Pharmacy degree and a Master’s degree in Clinical Research from Cranfield University, UK.
Her academic foundation in pharmaceutical sciences, combined with advanced clinical research knowledge, enables her to bridge scientific rigor with operational excellence. Ms Patel has contributed to more than 80 clinical trials across cardiovascular, respiratory, metabolic, infectious, neurological and orthopaedic therapeutic areas. She has been closely involved in heart failure trials for various national and multinational sponsors, including Novartis, Novo Nordisk, AstraZeneca and Bayer, supporting the execution of complex protocols aimed at improving long-term cardiovascular outcomes.
Her experience spans multi-centre studies conducted across diverse patient populations. Ms Patel played a pivotal leadership role during multiple concurrent Phase II–III COVID-19 and other indication trials, maintaining regulatory rigor and operational stability during periods of heightened research demand. As site in-charge and Head of Department of Clinical Research, she has trained and mentored research coordinators and site personnel in good clinical practice, regulatory frameworks, protocol adherence and institutional standard operating procedures. Her structured leadership initiatives enhanced operational consistency and contributed to a 60% increase in participant retention through thoughtfully designed follow-up and patient engagement strategies.
Beyond clinical operations, Ms Patel actively mentors postgraduate students and clinical fellows in thesis development and research methodology and has conducted academic seminars at various colleges, contributing to the advancement of clinical research education and capacity building. She remains engaged in advancing regulatory and research excellence through participation in national conferences and professional forums, including the Indian Society for Clinical Research and other regulatory workshops.
Michael Søberg Christensen (MLSC)
Global Portfolio Vice President
Novo
Michael Søberg Christensen holds an MSc and a PhD from the Technical University of Denmark. He is currently Global Portfolio Vice President for Zenagamtide at Novo, where he oversees all development activities aimed at achieving global marketing authorisations. Since joining Novo in 1996, he has held several senior leadership roles, including Head of Global Regulatory Affairs, Corporate Project Vice President for Inflammation & Growth Hormone, Head of Nonclinical Development and Project Vice President for early-phase projects within diabetes, obesity, and rheumatoid arthritis.
Before joining Novo, Michael was an Assistant Professor at the Technical University of Denmark and gained international research experience in Australia and the USA. Throughout his career, he has developed extensive expertise in global drug development and lifecycle management across research, clinical development, regulatory affairs and manufacturing.
Pernille Auerbach
Senior Director, Medical
Novo
Pernille Auerbach is Senior Director and Head of the Cardiovascular Disease Department, Global Medical Affairs, Novo. She joined Novo in 2016, and during 2021–2024, led the Cardio-Renal and Alzheimer’s Diseases unit in Medical Affairs, Novo Canada, supporting the readout of SELECT, STEP HFpEF and STEP HFpEF DM trials and the initiation of the ziltivekimab clinical development programme.
Before her current role, she worked in various clinical settings and also as International Medical Director in the Global Development. She is a Steering Committee member of HERMES/ATHENA (ziltivekimab) and HF-POLARIS. Pernille holds an MD and PhD from the University of Copenhagen and is co-author of several publications in international peer-reviewed journals.
Renee Baxely (GEP member)
Nurse Manager, Clinical Trials
Medical University of South Carolina
Renee Baxley is a highly accomplished registered nurse with 17 years of extensive experience in clinical care and research management. Her distinguished career is marked by a deep commitment to cardiovascular health and a versatile background in both adult and paediatric patient care. For the past decade, Renee has been a cornerstone of the Medical University of South Carolina (MUSC) within the Division of Cardiology and the Clinical Trials Program.
Her clinical foundation includes serving as a charge nurse in the Pediatric Cardiac Intensive Care Unit at MUSC and as a clinic nurse for the Children’s Hospital of Philadelphia. These roles honed her expertise in managing complex cardiac care across diverse patient populations. In the latter half of her career, Renee transitioned her focus to the advancement of medical science through clinical research.
Starting as a nurse coordinator, she demonstrated a natural aptitude for the intricacies of trial oversight and regulatory compliance. Her leadership and strategic vision led to her advancement as the nurse manager of the clinical trials team within MUSC’s Division of Cardiology. Currently, Renee manages a robust team of 18 professionals who support more than 100 active clinical trials.
Under her guidance, the team ensures the highest standards of patient safety and data integrity while pushing the boundaries of cardiovascular innovation. Renee’s blend of nursing experience, administrative leadership and focus on interdisciplinary collaboration makes her an invaluable asset to the medical community, dedicated to improving patient outcomes through both direct care and groundbreaking research.
Sanaz Gabery
International Medical Director
Novo
Sanaz Gabery serves as the International Medical Director within the Medical & Science Clinical Drug Development team at Novo, Denmark. With a focus on the clinical development of obesity-related therapies, she brings extensive expertise in clinical and preclinical research. Sanaz holds an MD, PhD and MSc from Lund University in Sweden.
Her academic work spans over 18 years, exploring the central neuronal circuits involved in metabolic and emotional control, primarily in proteinopathies associated with neurodegenerative disorders covering both preclinical and clinical research. She has also contributed to understanding glucagon-like peptide-1 actions in the brain and authored over 25 peer-reviewed articles.
Sheldon Litwin (GEP co-chair)
Alicia Spaulding-Paolozzi Professor of Cardiology, Medical Director of Echocardiography Laboratory
Medical University of South Carolina, Ralph H. Johnson VA Medical Center
Dr Sheldon E. Litwin is the Alicia Spaulding-Paolozzi endowed Professor of Cardiology at the Medical University of South Carolina (MUSC). His major focus is on the diagnosis and treatment of heart failure with preserved ejection fraction (HFpEF). He is very involved in clinical trials studying interventional therapies for HFpEF such as atrial shunts and GSN ablation as well as treatments for obesity-related HFpEF. He is the medical director of the echocardiography laboratories at MUSC and the Ralph H. Johnson VA Medical Center.
He has published over 200 original scientific articles and served on multiple study sections, national committees and editorial boards. He served a 5-year term as an associate editor of the Journal of the American Society of Echocardiography. Dr Litwin is an avid recreational athlete/exerciser and has a lifelong interest in the cardiovascular effects of physical activity and exercise.
Sidsel Gamborg Møller (SGXM)
Associate Medical Director
Sidsel Høier Gamborg Møller is an Associate Medical Director in the Incretins Cardiovascular Disease and Coramitug Team within Global Medical Affairs at Novo Nordisk A/S, Denmark. She focuses on incretins in cardiovascular disease, with a particular focus on heart failure and the zenagamtide development programme. Previously, she worked on the ATTR-CM (transthyretin amyloid cardiomyopathy) and coramitug development programme. She completed her medical degree at the University of Copenhagen, Denmark, in 2016 and completed her PhD in cardiology in 2021. Following clinical positions in cardiology, she joined Novo Nordisk in 2022.
Sille Esbjerg
Statistical Director
Novo
Sille Esbjerg is Statistical Director at Novo with more than 20 years of experience in biostatistics. She has played a central role in the development of glucagon-like peptide-1 therapies for type 2 diabetes and obesity, shaping the statistical strategy and overseeing execution of late‑stage and cardiovascular outcomes trials. Sille holds an MSc in statistics from the University of Copenhagen (1997).
Sofie Føns
Global Trial Manager
Novo
Sofie Føns is a Global Trial Manager in Clinical Operations at Novo, with 6 years of experience in clinical trial roles at the company. She has managed complex studies, including a mode‑of‑action Alzheimer’s disease study, from their set up to the generation of clinical study reports, and has strong vendor management experience. She gained her MSc in molecular biomedicine from the University of Copenhagen, Denmark.
