Adaptive Experts

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 nearly 200 adaptive clinical trials for over 30 sponsors. By partnering with us you have access to:

  • The Aptiv Solutions Innovation Center – a group of world leading experts in adaptive design and execution
  • Experts with direct involvement in regulatory agency adoption of adaptive design trials and subsequent agency guidance
  • Operational teams and technologies to apply the power of adaptive techniques to your own drug and medical device trials

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

Bios

Click on each name for more information.

Reinhard Eisebitt | Executive Vice President, Head of Innovation Center

Reinhard Eisibitt is the Executive Vice President 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.

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.

Tobias Mielke, PhD | Statistical Consultant

Tobias Mielke joined Aptiv Solutions in 2012 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.