Faculty – Adaptive Clinical Trials Symposium

Divya Chadha Manek

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Divya has worked for the NIHR CRN for the past nine years. She has hands experience of delivering clinical research from both a site-level and national perspective.

Divya’s current role is to maintain strategic relationships with global and UK life sciences companies. Within this role, Divya provides advice and works collaboratively with companies to optimize how companies utilize government-funded support services to ensure clinical studies are set up quickly and efficiently and recruit to time and target.

Divya also leads on keeping the NIHR CRN abreast of study delivery innovations. In doing so she helps to ensure that the services we provide continually evolve meet the needs of the life sciences industry.

Divya has a degree in Clinical Psychology, a Masters in Clinical Research and is currently undertaking a Ph.D. in Dementia Care.

Mark Chang, Ph.D.
Senior Vice President, Strategic Statistical Consulting, VERISTAT

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Dr. Chang provides statistical and adaptive design support to Veristat’s clients who are looking to design and simulate their trials for optimal success. He is experienced with NDA submissions and working collaboratively with the regulatory agencies throughout the clinical trial and submission process. He has more than 20 years of experience as a statistician at both biopharmaceutical firms and CROs, including AMAG Pharmaceuticals, Millenium/Takeda Pharmaceuticals, PAREXEL, and MTRA. Dr. Chang is also an adaptive design expert, having authored and co-authored dozens of books and peer-reviewed journal publications on adaptive design methodologies and implementation in clinical trials.

In addition to his role at Veristat, Dr. Chang is a fellow of the American Statistical Association and an adjunct professor of Biostatistics at Boston University. He is a co-founder of the International Society for Biopharmaceutical Statistics, co-chair of the Biotechnology Industry Organization (BIO) Adaptive Design Working Group, and a member of the Multiregional Clinical Trial (MRCT) Expert Group. Throughout his career, he has frequently held advisory posts for numerous industry committees and served as an associate editor for many peer-reviewed publications. He has given over 50 lectures, short courses, and invited speeches at national and international conferences and has been invited twice to present at the FDA.

Vladimir Dragalin
Vice President and Scientific Fellow, Head of ACT CoE, JANSSEN

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Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at the Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is leading the Adaptive Clinical Trial Center of Excellence. He is a well-known adaptive design expert with 25 years of experience in developing the statistical methodology of adaptive designs and more than 15 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles and Aptiv Solutions. He has more than 75 publications in peer reviewed journals and books. Vlad is a fellow of the American Statistical Association; a member of the Drug Information Association, the Society for Clinical Trials, and the International Society for CNS Clinical Trials and Methodology; and an Associate Editor of the Journal of Biopharmaceutical Statistics.

Chitra Edwin, Ph.D., RAC
Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION, INC.

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Dr. Chitra Edwin is the Senior Vice President of Regulatory Affairs and Compliance at Spotlight Innovation Inc. She has over two decades of experience in the biotechnology and diagnostics private sector and has been a key member in the development of infectious disease, oncology, and cardiology products that have secured regulatory approval. Her areas of expertise include product development, regulatory affairs, regulatory strategy, regulatory compliance and quality systems. Dr. Edwin earned a Ph.D. in Medical Microbiology and Immunology from the University of Minnesota and then trained at the Harvard Medical School as a Research Fellow at the Brigham and Women’s Hospital, and as an Instructor in Medicine at the Dana Farber Cancer Institute. She holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society. She is an Adjunct Associate Professor of Pharmaceutical Sciences at the College of Pharmacy, University of Cincinnati, and was the Director, Capstone Project, Masters in Drug Development Program.

Balazs Flink
Head of Clinical Trial Analytics, Business Insights and Analytics, BRISTOL-MYERS SQUIBB

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Balazs is a key R&D contributor to the company’s efforts to integrate analytics, strategy and insights capabilities to drive key decisions that generate greater outcomes for patients. His team provides predictive analytics, clinical trial design validation, general and operational feasibility and forecasting capabilities together with tracking, benchmarking and metrics generation for the R&D organization.

Graduated as a physician, explored medicine from the academic perspective before he joined BMS in 2005. Balazs held roles of different functions in R&D before taking over the leadership of the Clinical Trial Analytics group in the newly formed Business Insights and Analytics organization in February 2016. His main goal in this new integrated corporate wide analytics organization is to establish common consciousness in R&D and to connect strategy and execution through data and insights. Most recently he is driving work streams in a companywide initiative to connect the advanced solutions surfacing from the digital health space and precision medicine in to the ongoing pharma drug development process to enhance outcomes for patients in need of innovative drugs for their diseases.

Lance Hill
Chief Executive Officer, WITHIN3

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As Chief Executive Officer of Within3, Lance Hill brings his own brand of energy, leadership and vision to the company.

With the belief that deeper engagement among healthcare professionals results in improved healthcare and better patient outcomes, Lance strategizes with global healthcare decision makers on how to integrate digital collaboration solutions into their businesses as an effective new channel of communication.

Prior to joining Within3, Lance served as the Vice President and General Manager of the worldwide Service Oriented Architecture business unit for the webMethods Corporation, an international leader in enterprise software. With annual revenues exceeding $200 million, webMethods was acquired in 2007 by German giant, Software AG, for $546 million.

Recruited directly from the University of Toledo by tech giant IBM, Lance led the design and implementation of global telecommunication networks for Fortune 500 businesses and major healthcare organizations, as well as consulted and lectured on worldwide technology strategies. He also developed training, methodology and best practices for Global Services consultants. Lance subsequently joined a top 10 U.S. financial services firm where he served as the Vice President of Enterprise Engineering and founded its Fusion Technology Group, dedicated to accelerating corporate adoption of new technologies and business processes.

A veteran in the technology industry, Lance dedicates himself to work he strongly believes in — improving healthcare by providing an easy-to-use, always accessible, digital collaboration solution for healthcare professionals and industry leaders to connect, communicate and collaborate.

Mingxiu Hu
Senior Vice President, Head of Data Science and R&D Systems, NEKTAR THERAPEUTICS

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Mingxiu Hu recently joined Nektar Therapeutics as the Senior Vice President responsible for Data Science and Systems. Before joining Nektar, Dr. Hu was a Vice President at Takeda Pharmaceuticals. In his 12.5 years at Takeda, he was critical in the successful approval of several important medicines, especially Entyvio® and Ninlaro®. He is an Adjunct Professor of Biostatistics at Yale University and a Fellow of the American Statistical Association (ASA) and served on the board of directors for multiple statistical organizations including ASA and ICSA. His research interest focuses on statistical methodologies and applications in drug development, including clinical trial designs and analysis methodologies, development decision making, and biomarker strategies. He has published over 20 scientific articles, edited one book, and co-authored another.

Dr. Hu received his Ph.D. in Statistics from George Washington University, M.S. in Statistics from Beijing University, and M.A. in Biology from Brown University.

Feng Liu
Manager Statistics, GLAXOSMITHKLINE

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Feng Liu is a Statistical Leader at GlaxoSmithKline, Inc. He held master degrees in Statistics and biochemistry, biophysics and molecular biology from Iowa State University and Ph.D. at medical statistics from the University of Sheffield. He has more than 15 years of experience in nonclinical, early- and late-phase of clinical trials in multiple therapeutic areas including oncology, CNS, maternal and neonatal health, RA, OA etc. Dr. Liu has extensive experience in statistical application of adaptive design and his expertise areas include NDLM model, missing/imputed data, predictive inference etc. He has been serving as associate editor and book review editor in Pharmaceutical Statistics Journal since 2006. He is also a member of ASA ACOP, and PSI.

Inna Perevozskaya
Senior Director and U.S. Team Lead, Statistical Innovation Group, GLAXOSMITHKLINE

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Inna Perevozskaya has 16 years of pharmaceutical industry experience, working at GSK, Pfizer, Wyeth and Merck supporting various projects and serving as an internal adaptive design expert and consultant. She received her Ph.D. in statistics from the University of Maryland, where she specialized in novel dose-escalation designs for oncology. More recently, as a member of Statistical Research and Consulting Center at Pfizer and DIA Working Group on Adaptive Designs, she continues to pursue her research interests while building expertise in other types of adaptive designs and their application.

Elizabeth Presson
Patient Engagement and Digital Strategy Lead, OTICON MEDICAL, LLC

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Liz Presson works at the intersection of patient engagement, innovation, and digital strategy with pharmaceutical and medical device companies. She’s led innovation initiatives for Fortune 500 Pharma organizations, built advocacy programs for medical device companies that doubled the bottom line, and has helped transform influential healthcare organizations into digital leaders. Liz takes the stage at conferences like Stanford’s Medicine X, Technori, World Maker Faire, Internet Summit, and others. She contributes articles on company culture, entrepreneurship, and technology to publications like Fast Company, Forbes, Inc., and Mashable.

Ramses Sadek, Ph.D.
Professor of Biostatistics, Department of Population Health Sciences, DEPARTMENT OF POPULATION HEALTH SCIENCES

Director of Biostatistics Core, Georgia Cancer Center, AUGUSTA, UNIVERSITY

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Dr. Sadek joined Augusta University in 2013 as the Director of Georgia Cancer Center Biostatistics Core and Professor of Biostatistics, Department of Population Health Sciences. Previously, Dr. Sadek served as the Global Senior Director of Biostatistics and Data Management at BioMerieux Inc. (2009-13), Senior Director of Biostatistics and Data Management at the NCI-funded Radiation Therapy Oncology Group (2007/08), team leader at Centers for Disease Control and Prevention (1999-2008). Dr. Sadek’s academic interests include oncology research, clinical trials, epidemiology and healthcare disparity and QoL.
Dr. Sadek has a Ph.D. and an MS from the University of Georgia (Athens, GA) and MSc. and BS from Cairo University (Egypt). He has received several awards from the CDC, an Outstanding Teamwork Award from the American College of Radiology, and the Education excellence award from the Augusta University. He serves in several scientific journal editorial boards and the AU Senate.

Alex Sverdlov
Director, Statistical Sciences, NOVARTIS

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Alex Sverdlov has worked as a statistical scientist in biopharmaceutical industry since 2007 at Bristol-Myers Squibb, Merck Serono, and Novartis. He handled clinical trials in neurodegenerative diseases, metabolic disorders, ophthalmology, immunology, and oncology. Alex has been involved in active research on adaptive designs for clinical trials to improve efficiency of drug development. He edited a book “Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects” which was published by CRC Press in 2015. Alex’s most recent work involves design of proof-of-endpoint clinical trials evaluating digital technology (including wearable devices) in neuroscience.

Chad Swanson, Ph.D.
Director, Clinical Neuroscience, EISAI

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Dr. Swanson is currently Director of Neuroscience Clinical Development, Neurology Business Group, Neurodegenerative Diseases at Eisai, Inc, where he serves as the study director for a large, highly novel Phase 2b proof of concept study of a monoclonal antibody (BAN2401-G000-201) in Early AD. Before joining Eisai, Dr. Swanson held clinical research positions in neurodegeneration at Merck and Schering Plough. Prior to his tenure in clinical research and development, Dr. Swanson was Senior Scientist and US Head of Neurochemistry, Target Discovery and Assessment, at Lundbeck, Inc, where he led a number of discovery programs and ran a lab devoted to discovery and preclinical research in psychiatric disease. Dr. Swanson received his Ph.D. from the Medical University of South Carolina in Physiology and Neuroscience, and his BS degree from the University of Wisconsin – Madison in Zoology with Neurobiology emphasis.

Yuehui Wu
Director Statistics, GLAXOSMITHKLINE

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Yuehui Wu is Statistics Director in Oncology Clinical statistics, GSK. She got her Ph.D. in Biostatistics from the University of Pennsylvania in 2004. After graduation, she joined GSK in Research Statistics Unit focus on developing methodologies and implementing adaptive designs for clinical trials. Later she joined Oncology clinical stats group and since then has been the statistical lead for several oncology compounds where she keeps promoting and implementing innovative/adaptive designs.

Peter Zhang, Ph.D.
Head of Biostatistics Department, OTSUKA

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Peter Zhang, Ph.D. has over 25 years of experience in the Pharmaceutical Industry with a diverse experience in Drug Development including preclinical, Phase I/II/III/IV and also life cycle management (LCM). He has also supported more than 15 NDAs/sNDAs/MAAs/NDS/PMDA. and several INDs across various therapeutic areas including CNS (Alzheimer’s disease, MDD, Schizophrenia, Bipolar, ADHD), Cardiovascular (BP, ACS, Intermittent Claudication), Respiratory disease (Asthma, COPD, RDS), Gastrointestinal Disease (Ulcerative Colitis, IBD, Crohn’s Disease), Anti-Infection (UTI, LRTI, MDR-TB), Oncology (Advance colorectal cancer, MDS, AML, Cancer Pain, and CML), and Ophthalmology (Dry eye, Dry AMD). The hallmark of his career is his successful leadership in biostatistics, programming, quantitative analytics, statistical reporting, global drug development, and global medical affairs/HEOR, and CMC & QC at several pharmaceutical companies in the United States such as Procter & Gamble Pharmaceuticals, Novartis Pharmaceuticals, Forest Laboratories (now Allergan), and Otsuka Pharmaceutical Development and Commercialization, Inc. Peter is currently Head of Biostatistics Department at Otsuka Pharmaceuticals (US) that focusses on collecting, integrating, analyzing, interpreting and providing insight from the many data sources that exist across various functions.

Peter has published over 110 abstracts and manuscripts in various international statistical and medical Journals. He has also written several book chapters. His research interest areas are the nonparametric Bayesian method, meta-analysis/network meta-analysis, missing data, enrichment clinical trial design, and SPCD/re-randomization design. He graduated with a Ph.D. in Statistics from Purdue University, an M.S. in Computing Statistics from Chinese Academy of Sciences, and a B.S. in Mathematics from Peking University.

Seth Zuckerman
Senior Director of Biostatistics, CYTEL

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Seth Zuckerman, M.Sc., has been working in the pharmaceutical industry for more than 20 years. In addition to working as a Statistician for 17 years, he also has experience working in Clinical Data Management and Clinical Trial Management. Seth attended Temple University for Graduate School and Gettysburg College for his undergraduate studies where he received a B.S. in Biology and Minors in Mathematics and Spanish Language Studies.