Exclusive Interview with Sanofi - New Developments Sanofi Envisioned for Adaptive Designs in 2015

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SMi’s 7th annual Adaptive Designs in Clinical Trials conference will be taking place on the 20th & 21st April 2015 in London, UK

Set to take place on 20th & 21st April in Central London, 2015 will gather together a global audience of leading scientists and key decision makers, academia in the healthcare industry, as they address key topics from Novel Response-Adaptive Randomization Designs for multi-armed survival trials to Covariate-Adjusted Response-Adaptive Randomization Designs. The agenda will highlight group Sequential Response-Adaptive Designs, multi-Armed Bayesian Bandit Models in rare disease and Seamless Adaptive Designs for estimating treatment effects.

Breaking new ground with real–world patient data: Attendees will hear comprehensive discussions on adaptive approaches for implementing real-world patient data that could reinforce the quality of adaptive clinical trials. Learn how to spearhead through the EMA’s Medicines Adaptive Pathways for Patients (MAPPS) that is gathering pace this year in our featured presentation, and increase stakeholder engagement!

Attendees can expect to hear novel clinical trials designs and developments on current challenges surrounding topics such as the Ebola crisis and clinical attrition rates in Alzheimer's and Cancer Treatment. Alex Sverdlov, Associate Director of Biostatistics, EMD Serono commented:

"In 2015, the trend for a broader use of adaptive designs in clinical trials will continue. The Health Authorities recognize the challenges the modern R&D is facing and therefore innovation in drug development is encouraged. One example of a new paradigm in drug development is the Master Protocol—a tool which can optimize the infrastructure, the clinical trial process and the use of valuable patient resources by having multiple sub-studies and evaluating multiple products under one overarching protocol. The BATTLE1 trial in advanced non-small cell lung cancer and the I-SPY2 trial in early breast cancer are two good examples of the Master Protocols. More of these protocols are underway. Disease areas where such protocols are appropriate include anti-infective/anti-bacterial, cancer, Alzheimer’s disease, etc. The common denominator is high unmet medical need. Ebola is another example where a Master Protocol could be appropriate."

A brochure with a full list of speakers and presentations is available to download online.

Keynote speakers will include, Norvatis, Quintiles, EMD Serono & Sanofi who will discuss ongoing efforts in adaptive designs. Loic Darchy, Head of Statistical Methodology Group, Sanofi Aventis speaks exclusively on new developments Sanofi envisions for 2015, he commented:

"Adaptive designs do have a very broad range of applications. The main developments envisaged at Sanofi over the next 2 years are: Biomarker-based enrichment designs, Bayesian dose escalation designs including a placebo arm and optimization of dose selection."

This conference will appeal to those looking to understand regulatory submissions across the international landscape, including parallels and discrepancies between the FDA, EMA and PDMA methods of regulation, not to mention MAPPs and Adaptive Licensing!

Organisation who have confirmed their attendance include: UCB, Janssen Pharmaceutical, Sanofi, EMD Serono, Eisai inc, UCLH NHS Foundation Trust, Synthon BV, National Institute of Pharmacy Hungary, NDA Group AB, plus many more.

For further information or to book a place, visit http://www.smi-online.co.uk/2015adaptivedesign59.asp

7th annual Adaptive Designs in Clinical Trials conference
20th & 21st April 2015
Marriott Regents Park Hotel, London, UK
http://www.adaptivedesigns.co.uk

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About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk

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Sonal Patel
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