What Statisticians Wish They Could Tell Their Chief Medical Officers

Dr Jeffrey Bornstein has served as the Chief Medical Officer of Eledon Pharmaceuticals since April 2021. Prior to joining Eledon, he served as Vice President, Head of Clinical Sciences, Gastroenterology at Takeda Pharmaceuticals, and he has previously led development programs at Biogen, Gilead Sciences, Elan Pharmaceuticals and several early stage biotechs. Dr Bornstein earned his Doctor of Medicine and completed his residency in internal medicine at McGill University. He also completed a fellowship in gastroenterology at Duke University Medical Center where he subsequently served on the faculty as an Assistant Professor of Medicine.

Dr Sheela Kolluri is currently the Global Head of Clinical & Real World Evidence Statistics in the Specialty R&D organization at Teva Pharmaceuticals. She has been part of pharmaceutical statistics & data science organizations for the past 20 years, during which time she also held an academic teaching position in Statistics. Prior to Teva, she was the Head of Statistical & Quantitative Sciences-Gastroenterology at the Data Sciences Institute in Takeda Pharmaceuticals (Cambridge, MA). Before transitioning to organizational leadership roles, Dr Kolluri spent the majority of her career as a Statistician at Pfizer, in roles of increasing responsibility, across multiple disease areas and stages of drug-development. Given her passion for teaching, during her time at Pfizer, Dr Kolluri also taught Statistics courses at Columbia University (New York, NY), as an adjunct faculty member in their Department of Statistics. At Teva, Dr Kolluri leads a global Statistics organization responsible for providing quantitative insights and data analysis for their innovative (non-generic) clinical development programs in Immunology, Pain, Oncology, Neuroscience, Psychiatry, GI and Respiratory. Her responsibilities include functional leadership for evidence-generation using real world data sources. A primary focus for her role at Teva is to drive innovation in trial design, evidence-generation and quantitative decision-making. Previously, at Takeda, in addition to functional leadership for the GI Statistics organization, Dr Kolluri’s experience included a foray into providing strategic guidance on machine learning-related initiatives driven by Takeda’s Data Sciences Institute.Dr Kolluri received her PhD in Biostatistics at University of Iowa (Iowa City, IA), following which she began her career in drug-development at Pfizer. During her long tenure at Pfizer, she provided statistical leadership on drug-development programs in both early and late stages, including regulatory submissions. Her work at Pfizer spanned numerous TAs including Rare Diseases, Neuroscience, CNS, Inflammation and Immunology. She was also part of Pfizer’s large marketed medicines Statistics organizations, with a focus on medical evidence generation for approved products. Dr Kolluri’s industry experience includes development of functional SOPs/process, matrix oversight of data-management and statistical programming functions and representing Statistics on clinical operations initiatives (implementation of risk-based monitoring).

Dr Marcia Levenstein was at Pfizer for over 30 years. Her most recent role at Pfizer was VP, Statistics with responsibility for clinical development in the CVMET therapeutic area and global sponsorship of Pfizer’s China Research & Development Center (CRDC) Statistics organization.She is currently Senior Advisor to Vivli, a global clinical research data sharing platform which is dedicated to helping researchers share and access data from clinical trials to advance science. Previously Marcia led the global biometrics organization for Pfizer’s marketed medicines clinical research programs and established regional biometrics centers for Latin America, Europe, Asia, and China. She worked in numerous therapeutic areas and has extensive experience in design, analysis, and interpretation of clinical trials data, particularly in demonstrating medical value and benefit-risk of medicines. She served as the statistical leader for regulatory submissions with the responsibility of ensuring biometrics business support of the global pharmaceutical product portfolio.In addition to leading Biometrics and Statistics groups, As a member of Pfizer’s team for the clinical trial disclosure policy, she played a key role in defining Pfizer’s disclosure policy. She was a member of Pfizer’s internal steering committee for their Bioethics Advisory Panel and a member of Pfizer’s Clinical Trials Policy Group. She is a member of the Stevens Institute Business Intelligence & Analytics Program Advisory Board. She was a member of the ASA Committee on Professional Ethics. Marcia holds BS degrees in Mathematics and Life Sciences from MIT, an MS in Biostatistics from UNC, and an ScD in Biostatistics from Harvard University. She received a MBE (Bioethics) from U Penn in 2012.

Natalia Mühlemann has over 18 years of experience in General Management, International Marketing, Business Development and Clinical Development in Life Sciences across several therapeutic areas, including intensive care, surgery, oncology, neurology, rehabilitation and diabetes. Dr Mühlemann combines medical and strategic expertise enhancing business value through clinical and real world evidence generation, medical & scientific interactions and stakeholders’ engagement.In her recent positions of Global Business Manager, Medical Devices and Global Category Head, Acute Care – Oncology – Devices at Nestle Health Sciences (NHSc), Dr Mühlemann have been leading cross-functional team of marketing, business development, R&D, clinical, medical, regulatory, market Access and Operations.  Dr Mühlemann led due diligence and played a key role in deal negotiations as part of negotiation committees, resulting in several deal closures. She led financial evaluation, business plan development, technical and clinical development, regulatory plans and market access strategy for medical technologies licensed or acquired in early stage.Dr Mühlemann has been invited to European MedTech meetings as panel speaker and expert jury member. Natalia also acts as an Expert Jury member for the European Commission’s European Innovation Council (EIC).Dr Mühlemann holds MD and MBA and continues her professional development through medical conferences and Executive Education programs. Dr Mühlemann's specialization in medical cybernetics and instrumental methods of diagnostics enable her to effectively connect medical, engineering and data science specialties. Dr Mühlemann has Stanford certification in Medical Statistics, IBM Data Science Professional Certification and executive education in Machine Learning from MIT and Digital Transformation in Healthcare from Harvard Medical School.