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Challenges and Opportunities in Biosimilar Development and Commercialization
Jump to the Agenda for Each Day: Day One | Day Two | Day Three
When biosimilars first became available, their all-consuming struggle was establishing legitimacy as replacements for originator (“reference”) biologics. But now that biosimilars have achieved broad acceptance and market penetration, the rules of competition are in flux.
Now, with increasing competition and regulatory evolution occurring across the globe, the biosimilar market is ripe for innovation – and developing the optimal clinical development and commercial strategy is key to maximizing the value of your biosimilar asset.
This three-day symposium will provide an overview of the current challenges and opportunities in biosimilar development and commercialization, and discuss expectations and requirements from key stakeholders such as manufacturers, physicians, patients and payers.
In this symposium, attendees will:
- Understand the US and European landscape and how APAC developers can bring their biosimilar products to Western markets
- Learn how physician and patient expectations impact the clinical evidence needs critical to trial planning
- Explore the evolution of market demands that influence how we will commercialize biosimilars now and in the future
Day One | From Asia to the World – Global Biosimilar Development
October 26, 2021 (90 Mins)
4PM CST (Beijing) | 5PM JST (Tokyo) | 5PM KST (Seoul) | 1:30PM IST (New Delhi) | 4:00AM EDT (New York)
Welcome
Nick Kenny, PhD, Chief Scientific Officer, Syneos Health
Growing Impact of Asia in Biosimilar Development
Manfred Weiler, PhD, Senior Vice President, Medical & Scientific Strategy, Head of Biosimilars Consortium, Syneos Health
Designing a Global Biosimilar Program - Comparison of Regulatory Guidelines in US, EU, China, Japan
Zohra Lomri , Senior Director, Regulatory Consulting, Syneos Health
Manufacturing and CMC Comparability Programs
Sateesh Babu GSV, Senior Manager, Regulatory CMC, Syneos Health
Panel Discussion - Opportunities and Challenges for Asian Biosimilar Developers
Parisa Asvadi, Chief Development Officer, Neuclone
Dr. Sandeep Athalye, Chief Medical Officer, Biocon
Day Two | Clinical Evidence – Expectations from Physicians and Patients
October 27, 2021 (90 mins)
10:00AM EDT
Selection of Indications and Endpoints – Balancing Requirements on Patient Population, Treatment Effect and Marketing Needs
Angel Uriol, Vice President, Clinical Development, Syneos Health
Challenges from Extrapolation, Switching and Interchangeability
Anna La Noce, Executive Medical Director, Syneos Health
New MHRA Guideline: Dropping Clinical Efficacy Studies - The Future of Biosimilar Clinical Development?
Catherine Edwards, Senior Director, Regulatory Consulting, Syneos Health
Panel Discussion - Expectations From Key Stakeholders – What Clinical Data Is Required?
Wael Harb, Vice President, Medical Affairs, Syneos Health
Molly Schreiber, Community Manager, Savvy Cooperative
Dr. Jose-Luis López Lorenzo, Department of Hematology, Jiménez Diaz Foundation
Day Three | Biosimilar Commercialization
October 28, 2021 (90 Mins)
10:00AM EDT
Uptake of Biosimilars in US and EU – A Comparison
Michael Sarshad, Managing Director, Commercial Advisory Group, Consulting, Syneos Health
Current Challenges and Hurdles in Marketing Biosimilars – Feedback from the Industry
Michael Sarshad, Managing Director, Commercial Advisory Group, Consulting, Syneos Health
Branding of Biosimilars – It’s Time to Change
Justin Holloway, Head of Client Strategy, Communications Europe, Syneos Health
Panel Discussion – Expectations from Payers and Marketers
Andreas Reinbolz, Managing Director Communications, Syneos Health
Lisa Günther, Head of Global Business Insights, Sandoz
Shawn Davis, US Pharmacy Director, United Health
When
Tue, Oct 26, 04:00 am to Thu, Oct 28, 11:30 am
Additional Details
