Adaptive Trial Expertise
Aptiv Solutions is the only CRO to offer design, simulation and execution of adaptive clinical trials – and the only partner that brings together the people, knowledge, software and systems to make fully functional adaptive trials a reality.
Aptiv Solutions is the market leader in the provision of global adaptive trial services with more than a decade of experience in successfully planning and managing over 100 adaptive clinical trials. This experience is directly accessible through our Innovation Center comprising the world’s leading experts in the design and execution of adaptive trials. Many of these individuals have been directly involved in the regulatory agency debate on adaptive design trials which has led to the release of agency guidance for the conduct of adaptive trials.
With Aptiv Solutions as your partner, you have access to the world’s leading adaptive trial experts who will work with you to apply the power of adaptive techniques to your own drug and medical device trials.
- 850 Professionals at 23 offices in 16 countries
- More than 110 adaptive trials for over 30 sponsors in the last 10 years
- Locations in the USA, Switzerland, Austria, Czech Republic, France, Germany, Hungary, Italy, Israel, Netherlands, Poland, Russia, Spain, Ukraine, United Kingdom, & Japan with strategic partners in India, Asia & South America
Innovation Center for Adaptive Clinical Trials
The Aptiv Solutions Innovation Center comprises the world’s leading experts in adaptive trial design and execution. Through this team Sponsors have access to first class expertise to ensure that adaptive trials are designed and implemented successfully.
Key areas of leadership include:
- Design, simulation and execution of adaptive trials across all phases of development
- Development of innovative trial methodologies
- Customized training in adaptive trial statistical methodology
- Advice and guidance on the logistical and operational requirements for successful adaptive trial execution
Click on each name for more information.
Reinhard Eisebitt | EVP, Head of Innovation Center
Reinhard Eisibitt is the EVP and Head of the Aptiv Solutions Innovation Center, where he oversees the US and European team that provides our global services for adaptive trials.
Most recently, Reinhard Eisebitt was Managing Director of ClinResearch GmbH from 1999 to June, 2010. ClinResearch has been founded by Reinhard together with Michael Fischer. Clin-Research was a leading European full service CRO with 140 employees and offices in Germany, Russia, Ukraine, and Australia. ClinResearch was specialized in the planning, execution and reporting of adaptive clinical trials and has conducted more than 100 adaptive studies. In 2001, Reinhard has founded ADDPLAN GmbH, together with Gernot Wassmer. ADDPLAN have created the first commercial software package ever for the design, simulation, and analy-sis of adaptive clinical trials. Prior to ClinResearch and ADDPLAN, Reinhard spend 9 years as a Director Biostatistics for IFNS, a German CRO. He started his career in the CRO business in 1987 as a clinical biostatistician. Reinhard holds a Master degree in Mathematics from Albertus-Magnus-University, Cologne, Germany.
Andy Grieve, PhD | Senior Vice President, Clinical Research Methodology
Andy Grieve is currently Senior Vice President for Clinical Trials Methodology in the Innovation Center, based in Cologne. He joined the company having spent four years as Professor of Medical Statistics at King’s College London.
Prior to joining King’s he spent over 30 years in the pharmaceutical industry. Between 1975 and 1989 he was a statistician working for CIBA-GEIGY Pharmaceuticals both in the UK and Switzerland. From 1989 to 1994 he was the head of ICI Pharmaceuticals pre-clinical statistics group in the UK. From 1995 to 2006 he worked at Pfizer taking on increasingly senior roles and ending as Executive Director and World-Wide Head of the Statistical Research and Consultancy Centre at Pfizer’s research facility in Sandwich, UK.
Andy is a Fellow and Chartered Statistician of the Royal Statistical Society, of which he is a former President, is a Fellow of the American Statistical Association and a member of Statisticians in the Pharmaceutical Industry of which he is a past-Chairman and founder-member.
His research has been primarily concerned with the application of statistics to the pharmaceutical industry, and in particular he has concentrated on the implementation of Bayesian ideas and techniques. Latterly he has been involved in the development and implementation of Bayesian Adaptive Designs. He has published over 80 articles and is the author of a book for non-statisticians involved in clinical trials: FAQ’s on Statistics in Clinical Trials, Brookwood Medical Publications, 1998.
Andy received his MSc in Statistics from Southampton University in the UK in 1975, a Ph.D. in Statistics from Nottingham University in the UK in 1992 and an Honorary Doctorate from Kingston University for Services to Statistics in 2006.
Judith Quinlan (MSc) | Senior Vice President, Adaptive Trial Design & Implementation
Judith Quinlan is Senior Vice President, Adaptive Trial Design & Implementation at the Aptiv Solutions Innovation Center. Judith has always been a strong advocate for adaptive designs and has become a regular speaker on this topic at conferences. She has also played an active role as a member of industry’s Adaptive Design Working Group (ADWG) where she co-chaired the case study workstream that collected industry experience on the use of adaptive designs, the drug supply workstream, and currently co-chairs the monthly KOL lecture series on adaptive designs, which attracts a large audience from industry, academia and agencies.
Prior to joining Aptiv Solutions, Judith worked for companies such as Cytel and GSK. At GSK she held the position of Director Statistics for the early phase Neurology and GI therapeutic areas and more latterly the position of Director Statistics for Bio-Pharmaceuticals. In this role she managed a global team of statisticians supporting biology, assay validation, clinical development out to and including POC, process development and manufacturing for GSK’s early phase biopharmaceutical portfolio.
Educated in Australia, Judith began her career in statistics as a biometrician for the Department of Agriculture in Western Australia.
Vlad Dragalin, PhD | Senior Vice President, Software Development & Consulting
Vlad Dragalin has recently joined Aptiv Solutions. Previously he was at Quintiles where he led the adaptive trial design center. Prior to that Vlad was at Wyeth Research (now part of Pfizer) where he was an Assistant Vice President and Research Fellow. He was the Head of Statistical Research and Applications Group in the Division of Global Biostatistics and Programming – a small team of statisticians that worked on implementing innovative approaches to drug development in “Learn and Confirm”: Proof-of-Concept, dose-ranging, confirmatory trials with adaptation, improving clinical development planning on a strategic level through interactions with project teams across all therapeutic areas, enabling real time learning in clinical drug development, through a culture open to innovative, model-based drug development, and adaptive approaches in the design, implementation and execution of clinical trials.
Previously he was a Senior Director, Research Statistics in the Division of Biomedical Data Sciences at GlaxoSmithKline. Prior to joining GSK in 1999, Vlad was a Research Assistant Professor at the University of Rochester, NY. Before that, he had a record of distinguished service for more than 15 years in various positions at prestigious research institutions in Moldova, Russia, Italy and Germany. Vlad received his Ph.D. in Probability Theory and Mathematical Statistics from the Steklov Mathematical Institute, Moscow in 1988.
Vlad is an elected member of PhRMA Biostatistics and Data Management Technical Group. He is a Member of the American Statistical Association, the Institute of Mathematical Statistics, the Drug Information Association, and an Associate Editor of Journal of Biopharmaceutical Statistics. Vlad was actively involved in the PhRMA Working Group on Adaptive Designs and the PhRMA Working Group on Adaptive Dose Ranging Studies.
Gernot Wassmer, PhD | Senior Vice President, Chief Software Architect ADDPLAN
Gernot is currently Senior Vice President and Chief Software Architect in the Innovation Center, based in Cologne. He created and developed the ADDPLAN software, and was a co-founder of the ADDPLAN Software Corporation, together with Reinhard Eisebitt. He is also an adjunct Professor for Biostatistics at the Institute of Medical Statistics, University of Cologne, Germany.
Procedures for group sequential and adaptive designs in clinical trials are Gernot’s major statistical interests. He has authored over 40 methodological and another 40 application articles, as well as one book. Since 1995, he has been developing statistical methods for confirmatory adaptive designs. Many of these adaptive methods are now widely used in practice.
Formerly, Gernot has also served as a Research Fellow at the Institute of Statistics, University of Munich, at the Institute for Epidemiology, GSF Neuherberg, and at the Institute of Medical Statistics, University of Cologne. He has worked as a statistical consultant for the pharmaceutical industry for over 20 years.
Gernot received both his Masters in Statistics (1987) and his PhD (1993) from the University of Munich, Germany. In 1999, he earned his professorial standing (habilitation) from the University of Cologne.
Silke Jörgens, PhD | Senior Statistical Consultant
Silke works as a statistical consultant in the Innovation Center. Her main focus lies on Adaptive Design Clinical Trials and on the relevant software for this type of trials.
Silke has more than 10 years experience in statistical consulting. She holds a Master in Statistics from the University of Dortmund, Germany, and a PhD in Biostatistics from the University of Cologne, Germany.
Martina Elze, PhD | Senior Statistical Consultant
Martina works as a statistical consultant in the Innovation Center. Her main focus lies on Adaptive Design Clinical Trials and on the implementation of this type of trials.
Martina has more than 10 years experience in statistical consulting. She holds a Master in Mathematics from the University of Leipzig, Germany, and a PhD in Biostatistics from the University of Frankfurt/Main, Germany.
Tobias Mielke | PhD, Statistical Consultant
Tobias Mielke joined Aptiv Solutions in 2013 and works as a statistical consultant in the Innovation Center. His main focus is on dose-response trials and the relevant statistical methodology and software for these type of trials.
Before joining Aptiv Solutions, Tobias served as a Research Fellow at the Institute of Statistics at the University of Magdeburg. He was actively involved in projects on the development of optimal designs for clinical studies and on multivariate equivalence and non-inferiority testing.
Tobias has 5 years of experience in statistical consulting. He holds a Master in Mathematics (2008) from the University of Dresden. Tobias received his PhD in Mathematical Statistics (2012) at the University of Magdeburg for his work on optimal experimental designs for population pharmacokinetic studies.
Philip T. Lavin, PhD | Executive Vice President, Device Programs
Dr. Lavin co-founded Boston Biostatistics, Inc. (acquired by Aptiv Solutions) in 1983 while a Biostatistics faculty member at the Harvard School of Public Health. Dr. Lavin led the company from a group of Boston-based biostatistics consultants into a full-service contract research organization, which, in 2001, changed its name to Averion Inc. and became Averion International Corp. in 2006 through a series of mergers.
Dr. Lavin has participated in the design, analysis, presentation and publication of clinical studies since 1974. He authored or co-authored over 150 publications and is internationally recognized for his methodology contributions to developing biomarkers, assessing prognostic factors using multivariate models, developing longitudinal models to detect shifts and trends, standardizing efficacy and safety for oncology studies, designing clinical studies to reduce sample size, devising composite endpoints to jointly assess compliance, safety, and efficacy, and extending labeling claims through a closed testing procedure as well as his clinical contributions to developing biomarkers (CA-125 and PSA), establishing the importance of performance status and weight loss for GI cancer, utilizing tumor dimensions to more efficiently assess new oncology agents, employing cardioplegia during open heart surgery, optimizing kidney transplants, characterizing infertility, defining composite endpoints for periodontology and orthopedic studies, and identifying the value of limited weight loss. He has successfully supported many IDEs and INDs and has personally represented clients, leading to over 60 FDA product approvals to date. Dr. Lavin has been the senior biostatistician for 42 FDA approvals including 31 PMA/HDE approvals, more than any biostatistician. Over the past twenty years, Dr. Lavin has served on multiple FDA advisory panels. He has also served as the Principal Investigator for Data Coordinating Centers for multiple government sponsored clinical studies. He is an active speaker at industry and professional society meetings. He is the first person to be named a fellow of both the American Statistical Association and the Regulatory Affairs Professional Society. Dr. Lavin received his PhD in Applied Mathematics at Brown University in Providence, Rhode Island in 1972. He remains available to help design, present, analyze, and defend studies for regulatory and reimbursement bodies.