Faculty – Adaptive Clinical Trials Symposium


Amer Alghabban, Quality Assurance Director,

Amer Alghabban
Managing Director , GXP COMPLIANCE AND TRAINING PARTNERS LIMITED

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Amer completed his M.Sc in pharmacology at Bradford University, his postgraduate studies in medical sciences at University College Hospital, his diploma in biological sciences at Salford University and his postgraduate certificate in clinical research at Surrey University.

Amer is a frequently invited speaker at international congresses. He has presented and chaired at more than 68 international congresses and academic institutions, as well as the World Health Organization. He has a track record spanning more than 25 years in the pharmaceutical industry (clinical development, quality assurance, pharmacovigilance, medical information and medical communications). For some time, he was the Assistant Editor for 11 medical and pharmaceutical journals. He contributed further to these disciplines by writing “The Pharmaceutical Medicine Dictionary” in April 2001 and “The Dictionary of Pharmacovigilance” in May 2004. He is currently writing his third book, “Dictionary of Clinical & Pharmaceutical Development.”

Amer is currently the VP GxP QA, Compliance and Training at Karyopharm Therapeutics. Prior to joining Karyopharm, he was the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies and academic institutions and others with expertise and preparation with regulatory inspections to achieve compliance with GCP, GVP and GLP as well as providing a variety of trainings and support with regulatory inspections.

Prior to his current role, he was Director, Global Head of Quality Assurance and Audit Management at Merck Serono, Geneva, Switzerland. His previous positions include: Global Head of GxP (GCP, GMP, GLP and GPP) Quality Assurance at Arpida Ag., Switzerland and Senior International Clinical Quality Assurance Audit Manager at Novartis Pharma Headquarters in Switzerland. He was the first Pharmacovigilance Compliance Coordinator of the MHRA (UK Department of Health).


Divya Chadha Manek
Business Development Manager, NATIONAL INSTITUTE FOR HEALTH RESEARCH


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.


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


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


Feng Liu
Manager Statistics, GLAXOSMITHKLINE


Susan Lubin
Director, Clinical Safety Monitor, Clinical Pharmacology Medical and Operations Group, BRISTOL-MYERS SQUIBB

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Susan has 25 years of experience in clinical research with a focus in early development phase 1 trials. She is currently the Director of Marketed Products and Late Stage Clinical Pharmacology Operations at Bristol-Myers Squibb. Susan has extensive experience working in the outsourcing arena with major CROs in the roles of outsourcing manager for operations and clinical safety. Early in her pharmaceutical experiences, Susan was the administrator of the BMS Clinical Pharmacology Unit. Susan is a RN with a master’s degree in health care administration from Rider College.


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.


Ramses Sadek, Ph.D.
Director of Biostatistics Core, Georgia Cancer Center, AUGUSTA UNIVERSITY MEDICAL COLLEGE OF GEORGIA


Alex Sverdlov
Director, Statistical Sciences, NOVARTIS


Chad Swanson
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.


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.