Meet the Speakers -Complex Innovative Trial Design Series

The morning symposium will be covering Bayesian design methods, real world evidence and software for trial design. There will also be an opportunity for Q&A after each presentation for further discussion. During lunch, software experts will be available to demo EnForeSys, Cytel's user-friendly decision tool for forecasting patient enrollment. The afternoon will be dedicated to an East® training session.

Click here to view the full agenda

London Registration Tuesday 25 February 

Copenhagen Registration Thursday 27 February

James Halle
VP Europe, Sales and Business Development

A Decade for Innovation at Cytel

About the Speaker

JamesJames Halle is Vice President of Sales at Cytel and leads a team responsible for building strategic partnerships by using sophisticated analytical approaches to solve our clients toughest challenges.

James and his team are subject matter experts who cover a range of capabilities from industry leading software, pioneering trial design services and enhanced regulatory approval and patient access through the use of Real Word Data.

Prior to joining Cytel in 2019, James held senior positions at IQVIA, Reed Elsevier and IBM and has an extensive background in life sciences and technology.

James holds a Masters in Computing Science from the University of Cardiff, UK.

Grace Hsu

Survival Network Meta-analysis in Practice

About the Speaker

GraceGrace Hsu is a trained statistician specialising in consulting and working with real world evidence. She is experienced in clinical trial simulations using frequentist and Bayesian methods, and statistical modelling using traditional regression and machine learning techniques. Grace also researched fast model emulation and calibration for large computer experiments. 

Radek Wasiak
CHief Data Officer

Optimising Clinical Trials in the Era of Big Data

About the Speaker

rw_smallRadek Wasiak, PhD is a Chief Data Officer, Head of Europe at Cytel. In this role, he is driving Cytel’s data strategy to include all types of data and transferring them to insight via advanced analytics approaches or software. Prior to his current position, he led multiple business lines at Evidera/PPD, including Peri- and Post-Approval Studies, RWE and Meta Research and working with clients on generating and synthesizing real-world and clinical evidence. Before joining Evidera, Radek was a research scientist at the Liberty Mutual Research Institute for Safety, where he developed an extensive expertise with multi-level claim and secondary databases.

Radek holds a PhD and an MA in economics from the University of Connecticut, as well as an MSc in finance and banking from the University of Economics, Poznan, Poland. He has held adjunct appointments at Trinity College (USA) and the Harvard School of Public Health.

Natasha Muhlemann
VP, Strategic Consulting

How to Optimise your Clinical Trial Program

About the speaker

Natasha frameNatalia "Natasha" Muhlemann has over 15 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. 

Natalia combines medical and strategic expertise enhancing business value through clinical and real world evidence generation, medical & scientific interactions and stakeholders' engagement. Natalia has years of experience in direct-to-patient marketing.

A passionate advocate for adaptive approaches to trial design, Natalia has been leading the integration of adaptive designs into comprehensive evidence development strategies that combine clinical, regulatory, market access and commercial plans. 

Leveraging the FDA's move to modernize clinical trials by adaptive designs, the integration of adaptive approaches into strategy for the development of new technologies reduces time to marketing, limits the risk of uncertainty, maximizes returns on investments and improves patient access to innovations. 

Natalia graduated from IMD, Lausanne, Switzerkland (MBA , 2002) and Russian State Medical University, Moscow, Russia (1996).

Rajat Mukherjee
Principal, Strategic Consulting

Bayesian Borrowing from Historical Data: Case Studies

About the Speaker

RajatRajat Mukherjee is Principal, Strategic Consulting at Cytel. He has more than 20 years of professional experience as an industry and academic statistician, and brings a range of expert knowledge to Cytel’s customers. This includes work in Pattern Recognition problems for devices and biomarker discovery, Bayesian clinical trials, adaptive designs, and design and analysis of complex epidemiological studies.

Pantelis Vlachos
Principal, Strategic Consulting

Overview of EnForeSys and Examples of Clinical Trial Design Using East

About the Speaker

Pantelis Vlachos photo on black 2018Pantelis Vlachos is a Principal, Strategic Consulting  for Cytel based in Geneva. He joined the company in January 2013. Before that, he was a Principal Biostatistician at Merck Serono as well as a Professor of Statistics at Carnegie Mellon University  for 12 years. His research interests lie in the area of adaptive designs, mainly from a Bayesian perspective, as well as hierarchical model testing and checking although his secret passion is Text Mining. He has served as Managing Editor of the journal “Bayesian Analysis” as well as  editorial boards of several other journals and online statistical data and software archives.