The team

Mike joined Sepul Bio as the Chief Operating Officer. He brings over 25 years of experience in different aspects of drug development including Project Leadership, Project Management, Clinical, Clinical Operations and Regulatory. Prior to joining Sepul Bio, Mike worked as VP, Global Project Leader & Head Portfolio and Project Management at ProQR Therapeutics and was actively involved in developing treatments for inherited retinal eye diseases such as Leber congenital amaurosis 10 and Usher syndrome. Prior to ProQR, Mike spent over 15 years at GlaxoSmithKline Pharmaceuticals, focusing mainly in the Ophthalmology space. Mike has been a consultant for multiple Ophthalmology Biotech companies in roles such as CEO advisor, project leadership and clinical development. He is a biopharmaceutical executive with extensive multi-disciplinary experience and a science-centric approach to R&D program strategy and execution. He has a strong track record in leading large teams through project management, portfolio management, clinical development strategy, clinical operations, therapeutic area strategic planning and organizational development. Mike holds a Master’s Degree in Pharmaceutical Sciences with an Executive Pharmaceutical Marketing MBA.

Dr. Zuhal Butuner has over 25 years of experience in the biotech and pharmaceutical sectors in clinical development and medical affairs, mainly in ophthalmology. Early in her career she worked at Biogen for the development of drugs in multiple sclerosis, glioma and idiopathic pulmonary fibrosis. She then joined Bausch & Lomb where she served as the Medical Director responsible for the global development, approval and launch of Retisert for posterior uveitis. She joined QLT to develop a sustained release punctual plug delivery platform for glaucoma, ocular allergy and dry eye, and holds several patents in sustained drug delivery. She took a sabbatical from pharma for four years where she joined McMaster University as an Associate Professor in Ophthalmology in the Department of Surgery. Her research area included the use of stem cells to develop novel in vivo screens for new drug candidates for inherited retinal diseases including Stargardts and Bests disease. She then joined Novartis Pharma as the Worldwide Brand Medical Affairs Director for retinal diseases. Most recently she worked as the VP, Clinical Development for ProQR for the development of mRNA technologies for Inherited Retinal Diseases. She holds a Doctor of Optometry, a Masters of Science and a Master’s of Business Administration. Dr. Butuner’s passion is bringing novel treatment options for patients to treat eye diseases.

Divya D'Souza, MD is an ophthalmologist, bringing over 13 years of industry experience in retina clinical development and medical affairs. She has worked extensively with anti-VEGFs including Lucentis, Eylea, and Beovu, as well as Izervay, a novel complement inhibitor recently approved for the treatment of geographic atrophy secondary to age-related macular degeneration. She joins us from Iveric Bio, an Astellas company, where she held the position of Executive Director of Clinical Development, supporting ongoing clinical trials, regulatory submissions, and evidence generation. Her prior experience includes roles at Novartis, Bayer, and GSK. At the core of her work is a passion for keeping patients safe and improving their outcomes. Dr. D'Souza earned her M.D. in Ophthalmology from the All India Institute of Medical Sciences in New Delhi and her MBBS from St. John's Medical College in Bangalore.

Ursula Garczarek, Ph.D. is Senior Director Statistics at Sepul Bio a Théa Business Unit. She has the overall responsibility and accountability for the biostatistical strategy and its implementation to all stages of development for Sepul Bio's pharmaceutical products. Prior to Sepul Bio, Ursula was Research Principal at the Therapeutics Development Team Strategic Consulting in Cytel and provided guidance to trial sponsors on optimizing their development strategy, and successfully implementing trial design innovations. She applied new and pragmatic methodologies to address the needs and requirements of the sponsor within the regulatory environment. Prior to Cytel, Ursula was the Program Leader Data Science at Unilever R&D (NL), and Biostatistician at Roche Diagnostics GmBH (DE) developing multi-marker diagnostics based on proteomics and metabonomics approaches. She received her Ph.D. from the University of Dortmund (DE), in context of a collaborative research center on complexity reduction in high-dimensional data spaces on Machine Learning and Statistics.

Wilma joined Sepul Bio as Director Clinical Operations early 2024 and is responsible for the execution and delivery of our clinical trials. She has nearly 20 years of global biopharmaceutical experience and has spent her career in different clinical operation roles. She has worked across multiple geographies in a range of small and large disease therapy areas. In one of her previous roles, Wilma worked on rare ophthalmic diseases at ProQR Therapeutics. Her passion lies in contributing to the growth and success of Sepul Bio, and work collaboratively to bring novel therapies to market and make a positive impact on patients in need. Wilma holds a Master of Science degree in innovation management in medical biotechnology.

Dan joined Sepul Bio as Director of Clinical Operations. Dan brings over 25 years of clinical operations experience in driving global clinical trials and development programs forward. Prior to joining Sepul Bio, Dan worked as Senior Director of Clinical Operations at Oxular Limited and was instrumental in initiating trials of a combination drug and device product for diabetic macular edema. Prior to Oxular, Dan was Director of Clinical Operations at Gyroscope where he was actively involved in developing a gene therapy for dry age-related macular degeneration. Prior to Gyroscope, Dan spent 3 years with Teva Pharmaceuticals leading global pediatric asthma trials and 13 years with Shire Pharmaceuticals leading large cross-functional teams to completion of multiple global studies and development plans mostly in the CNS space. Dan has a proven track record of success. Under his direction and leadership multiple global studies have been delivered and in turn led to successful submissions leading to new product approvals, new indications, and/or desired label changes. Dan holds a bachelor’s degree in biology.

Marloes joined Sepul Bio in the role of Project Management Director. She brings over 15 years of experience in different aspects of drug development. Prior to joining Sepul Bio, she worked as Head of Project Management at ProQR and was actively involved in developing treatments for Leber congenital amaurosis 10 and Usher syndrome. Marloes specializes in carrying all aspects of a project from conception to execution and feedback. She enjoys being involved in all phases of the project and works alongside people in the team to ensure successful target completion. Marloes holds a Batchelor’s degree in Biotechnology.

Blanca joined Sepul Bio as Project Manager. She brings five years of diverse project management experience in drug development from preclinical to late phase at ProQR Therapeutics. Her professional journey extends beyond project management, encompassing researcher roles in university, startup, and big pharma environments, as well as pharmacist roles in both retail and hospital settings. Her diverse background has afforded her valuable insights into the complexity of drug development, spanning from research to the ultimate beneficiaries of medical advancements. Blanca holds a Master of Pharmacy (MPharm) and a Master of Science in Applied Research in the Biotechnological Industry. Dedicated to accelerating medicine development, Blanca serves as the Project Manager for the sepofarsen program, playing a pivotal role in its advancement and ensuring its alignment with Sepul Bio mission to pioneer breakthroughs in the treatment of inherited retinal diseases.

Corentin joined Sepul Bio in the role of Clinical Data Manager, SAS programmer and Data Analyst. He has more than 10 years of experience in Clinical Data Management after studying statistics and business intelligence. Corentin has worked in different countries and for companies of varying sizes, including, bioMerieux a mid-size company, Teoxane a Swiss start-up, Sanofi Pasteur and ProQR a Dutch biotech. He has performed hands-on activities as well increasing responsibilities of oversight and project management activities. During his last experience he has worked exclusively on Sepofarsen and Ultevursen programs on all the data management activities as well as all the clinical data investigation.