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Wednesday, February 6 • 16:45 - 18:00
#S0404: Study Design and Innovative Statistics

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Component Type: Session

Having “got the questions right” (Session 0403 Change is Coming… Getting the Questions Right in Clinical Development), trial designs and analytical approaches are needed that are able to give reliable answers to those questions while being efficient in terms of costs and burdens to patients and the healthcare system. This session will explore novel approaches that are working in practice.

Chair

Robert Hemmings, MS, MSc

Speaker

Innovation in Clinical Trial Design – Why Embracing Novel Approaches is Important and Where We Go from Here
Chrissie Fletcher, MSc

New Precision R&D Models in Oncology – Complex Clinical Trials to Investigate Histology-Independent Indications
Sacha Wissink, PhD

Adaptive Trial Designs: Delivering the Unicorn of Clinical Trials in the UK
Matt Cooper, PhD

Panel Discussion
Kirsty Wydenbach, DrMed, MSc



Speakers
avatar for Matt Cooper

Matt Cooper

Business Development and Marketing Director, NIHR Clinical Research Network
Matt has been Business Development & Marketing Director at the Clinical Research Network Coordinating Centre since 2014, having been part of the Network structure for a decade. In a previous roles he was a member of the leadership team of the National Cancer Research Network and before... Read More →
avatar for Chrissie Fletcher

Chrissie Fletcher

Executive Director, Biostatistics in Global Biostatistical Science, Amgen Ltd
Chrissie is an Executive Director Biostatistics in Global Biostatistical Science at Amgen. She is the Global Biostatistics TA Head for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology disease areas, the EU Regional Head for Biostatistics and leads a Health... Read More →
avatar for Robert Hemmings

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
Rob has been with MHRA for 16 years and heads up the team of statisticians and pharmacokineticists. Much of Rob’s time is spent educating colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a co-opted member of the... Read More →
SW

Sacha Wissink

Exec. Director Regulatory Affairs Europe, MSD
Dr. Wissink joined Regulatory Affairs Europe MSD in January 2014 to lead the company’s oncology efforts, including the registration of the PD-1 inhibitor, Keytruda® as well as its developmental activities. Prior to joining Regulatory Affairs Europe, Dr. Wissink was Director, Global... Read More →
avatar for Kirsty Wydenbach

Kirsty Wydenbach

Deputy Unit Manager, Clinical Trials Unit, MHRA
Joined MHRA in 2009, as the Senior Medical Assessor and Deputy Unit Manager in the Clinical Trials Unit. Involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for chemical and biological products, Advanced Therapy... Read More →


Wednesday February 6, 2019 16:45 - 18:00
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session