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Adaptive Designs in Clinical Trials conference 2019, 1st – 2st April 2019, Holiday Inn Kensington Forum, London, UK

Adaptive Designs in Clinical Trials conference 2019, 1st – 2st April 2019, Holiday Inn Kensington Forum, London, UK

Supplier: SMi Group

Description

SMi Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new FDA draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.

Hosting in depth presentations from regulatory agencies, researchers and biostatisticians, the meeting will cover how personalized medicine, platform trials, response-adaptive randomization, signature designs, estimand framework, Bayesian methods and digital innovation are revolutionizing the drug development process both in Europe and North America.

The benefits of attending:
At this year’s conference there will once again be an array of networking opportunities:
•    Meet and network with key industry and thought leaders shaping state of the art adaptive design techniques
•    More than 4 hours of networking during the conference days
•    Engage with an array of vendors, with leading solution providers, Mevia and GCE Solutions among those exhibiting last year

Key reasons to attend:
•    See how the regulatory environment for adaptive drug design is shifting across the continent with insights from the MHRA, Amgen, AstraZeneca and Berry Consulting
•    Explore the therapeutic potential of adaptive designs with real-world examples from H.Lundbeck, GSK Vaccines, Pfizer and Novartis
•    Listen to how the latest platform trial case studies – such as that of the EPAD project and the MS Society initiative, are impacting pharmaceutical development
•    Delve into the long-standing discussion of Bayesian vs. frequentist designs
•    Discover the latest research in response-adaptive designs: trials for rare diseases and looking forward
Chairs for 2019:
Alex Sverdlov, Director, Statistical Scientist, Novartis
Tom Parke, Director of Software Solutions, Berry Consulting

Featured Speakers:
• Sandeep Menon, Vice President and Head of Early Clinical Development, Pfizer
• Simon Wandel, Associate Director, Statistical Methodology and Consulting, Novartis
• Solange Corriol-Rohou, Senior Director Regulatory Addairs & Policy, Europe, AstraZeneca*
• Christine Fletcher, Executive Director Biostatistics, Amgen
• Philip Hougaard, Vice President Biometrics, H. Lundbeck
• Beatrice Panico, Medical Assessor, MHRA
• Kaspar Rufi bach, Principal Statistical Scientist, Roche
• Andrea Callegaro, Senior Manager, Biostatistician, GSK Vaccines

Post conference - Workshops 3rd April

The FDA – a new guidance on adaptive designs

Workshop Leader: Tom Parke, Director of Software Solutions, Berry Consulting

Overview of the workshop:
The new FDA draft guidance on Adaptive Trials is a significant change from the 2010 version of the draft guidance. This workshop will look at the changes and what it means for submitting proposals for adaptive trials to the FDA.

The workshop will cover:
• How to submit adaptive designs to regulators
• What the contents of the documents should be
• What simulation details need to be submitted
• What problems to expect
• How to submit simulation results
• How to submit simulation software

Why you should attend?
• Attend this workshop if you would like to understand:
• How the new guidance reflects changes at the FDA
• How to justify the use of an adaptive design to the FDA
• How to document an adaptive design
• How to organise, perform, and report the clinical trial simulations necessary to support an adaptive design
• How to report the results of an adaptive design
 
Post – conference Workshops 3rd April
Design and analysis of clinical trials evaluating novel digital technologies

Workshop Leaders:
Alex Sverldlov, Director, Statistical Scientist, Novartis
Yevgen Ryeznik, PhD, Uppsala University
Overview of the workshop
Digital technologies (such as wearable devices, smartphone apps) are increasingly used in clinical research and development. Despite numerous pilot clinical studies evaluating merits of digital technologies, there is still little knowledge on how to properly design and run such studies, and how to analyse the collected experimental data. The current course will cover several important statistical aspects of clinical trials evaluating digital technologies.

Why you should attend?
Attend this workshop if you would like to understand:
• Potential challenges and benefits of utilizing digital technologies in clinical research
• What trial designs are available for evaluating digital technologies
• How to analyze data generated by digital technologies
• Current regulatory pathways to the approval of digital therapeutics

EARLY-BIRD RATE:

BOOK BY 14H FEBRUARY AND SAVE £100
Targeted Keywords
MAMS, Response-adaptive randomization, Biomarkers, Bayesian and Platform trial
Additional Contact Info:
T: +44 (0)20 7827 6088
E: hsidhu@smi-online.co.uk

LinkedIn: @SMi Pharma
Twitter: #SMi & #smiadaptivedesigns