Exclusive Interview with Cinfa BiotechGmbH released ahead of Biosimilars and Biobetters

LONDON - Aug. 3, 2015 - PRLog -- SMi’s 6th annual Biosimilars and Biobetters conference will provide the ideal platform to engage in scientific discussions and debate the best practices and solutions to improve industry performance through technical case studies and practical advice from leading biosimilar and regulatory players including Harvest Moon Pharmaceuticals USA Inc, GfK, MHRA, Selecta Biosciences, Cinfa Biotech GmbH, Norwegian Medicines Agency and more. Unique perspectives will be shared on:
• Evolving biosimilar regulatory landscape
• Market access and product commercialisation barriers
• Global marketing developments, including a focus on emerging market trends
• In-depth protein characterisation and analytical comparability to efficiently and effectively collect data

When asked about what his presentation 'Clinical Development Strategies for Biosimilars - A Mid-Size Pharma Perspective' will offer, Karsten Roth, Director Clinical Operations  from Cinfa Biotech GmbH said:

"Attendees will take away from my presentation insight on a new approach for the clinical development of Biosimilars, aligned with national health authorities and central EMA advice"
Furthermore when asked about the conference programme as a whole, Karsten said:
"The conference programme has a good balance of speakers from the regulators and industry; I am especially looking forward to hearing more about the regulatory view on guideline updates"

Read the full interviews with Cinfa Biotech GmbH, Harvest Moon Pharmaceuticals USA, Inc. and Schwegman, Lundberg & Woessner at http://www.smi-online.co.uk/2015biosimilars1.asp

Speaker Panel includes:
• Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.
• Shahin Kauser, Senior Scientific Assessor, MHRA
• Chris Teale, Vice President Europe, GfK NOP Ltd
• Bracha Timan, Director, Israel Site Head, Global Bioassays & Technology, Global R&D, Teva
• Takashi Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
• Karsten Roth, Director Clinical Operations, Cinfa Biotech GmbH
• Alan Sheppard, Principal, Global Generics and Biosimilars, IMS Health
• Steinar Madsen, Medical Director, Norwegian Medicines Agency

View the full speaker line-up and conference programme at http://www.smi-online.co.uk/2015biosimilars1.asp

Plus, don’t miss two half-day interactive conference workshops on:

A: Assessing the Regulatory Framework for Europe and the US – Developing Future Biologics
Led by: Lincoln Tsung, Daniel Kracov, Jennifer Sklenar, Partners, Arnold & Porter (UK) LLP
29th September 2015, 13.30 - 17.30

B: Biosimilars – Understanding the Regulatory Processes and the Commercial Realities
Led by: Peter Wittner, Senior Consultant, Interpharm Consultancy
2nd October 2015, 08.30 - 12.30