Dale Butler, Managing Director, SMi Group, commented: “Biosimilars & Biobetters USA will be the first event of its kind to really tackle the creation of an innovate plan for the US Biosimilars market. The USA is at the heart of many modern medical breakthroughs so it’s logical to create a footprint in this region. We’re delighted to be providing the platform that will allow key figureheads in this marketplace to meet and discuss the strategies that will shape the future of the US Biosimilars market.”
Speakers were equally enthusiastic about the need for this type of event:
Peter Pitts, President, Center for Medicine in the Public Interest (Former FDA Associate Commissioner):
"Biosimilars are coming to the US market - and that's a good thing. But there remain many important issues to address from what biosimilarity really means to 21st bioequivilance, interchangeability, INN clarity, and pricing strategies - to name only a few. Nothing is more important in pursuing these urgent topics than a robust conversation amongst stakeholders and experts. "
Dominic Adair, Associate, Bristows LLP:
“The importance for the pharmaceutical industry of the shift towards biologic products cannot be ignored. How biosimilars and biobetters fit in with this is one of the most interesting issues we face today”
Kristopher Howard, NRL Enterprise Solutions
“I am very much looking forward to learning how other companies are preparing for the eventual launch of their biosimilar and biobetter products. Our panel discussion will specifically present opinions from experts on how companies should develop their manufacturing strategy ahead of these launches. The event promises to be a holistic exploration of the key requirements to successfully register, market and launch a biosimilar/biobetter product.”
The confirmed speakers SMi Group has attracted span the industry spectrum from academia to leading pharmaceutical institutions. They include:
- Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
- Dr John Pakulski, Senior Director, and Head US Biopharmaceutical Regulatory Affairs, Sandoz
- Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International
- Dr ShinJae Chang, Vice President, Research and Development, Celltrion Inc.
- Paul Ashton, President & CEO, pSivida
- Peter Pitts, President, Center for Medicine in the Public Interest (Former FDA Associate Commissioner)
- Douglas M. Long, Vice President, Industry Relations, IMS Health
- Dr Rakesh Dixit, Vice President, Research and Development Head, Global Biologics Safety Assessment, MedImmune (AstraZeneca Biologics)
Delegates attending can expect to:
- Get expert insights into the regulatory landscape and how it is affecting the industry
- Learn how to evaluate commercialization and development strategies to gain competitive advantage
- Understand how to identify potential revenue streams from biosimilar production and much more.
Two interactive post-conference workshops will also be held:
A. Differentiation Strategies for the Generics Industry. Workshop Leader: Asa Cox, Founder & CEO, Generic Pharma 2.0
B. Launching a Biosimilar in an Innovator v. Generic World. Workshop Leader: Kristie Kuhl, JD, Executive VP, Makovsky
Full event information can be found at http://www.smi-
Notes to editor
Sponsorship opportunities are available for this event, please contact Alia Malick on +44(0) 20 7827 6168.
About SMi Group
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-
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. We hold events in over 30 major cities throughout the world including London, Paris and Singapore and to date have welcomed over 200,000 participants from 80 countries.
More information can be found at www.smi-online.co.uk (http://www.smi-
+44(0) 20 7827 6197
+44(0) 20 7827 6197