Sponsors must understand how many different factors play a role in enabling more efficient development and reducing the time to market.
June 29, 2020
With 26 biosimilars having been approved by the FDA through the 351(k) pathway and over 50 biosimilar applications approved through the CHMP under the EMA, the global biosimilars market has grown rapidly. Despite these successes, many challenges remain in developing, analyzing, manufacturing and obtaining regulatory approval for these biotherapeutic products.
Defining a sound global strategy requires a complete understanding of today’s development landscape. Sponsors must understand how many different factors play a role in enabling more efficient development and reducing the time to market.
This webinar will feature scientific thought leaders who will discuss lessons learned and case studies from supporting unique biosimilars across the development spectrum. Participants will hear about Chemistry, Manufacturing and Controls (CMC) characterization and the use of CMC analytical master files to support the assessment of bio-similarity and reduce downstream development risks. The presenters will also cover regulatory and clinical trial execution strategies, including the use of virtual trials for long-term follow-up studies.
Participants will gain a better understanding of how to handle common challenges faced and insights on how to design an efficient biosimilar development strategy that encompasses key considerations from early development through commercialization.
The presenters from Covance include:
Siân Estdale BSc, MPhil, PhD, Head of Science and Innovation, Clinical Trials Testing Solutions
- Joan Meyer, MS, PhD, Executive Director, Strategy & Planning Inflammation, Infectious Disease and General Medicine
- Alicia M. Baker McDowell, DRSc, MS, Executive Strategist, Head of Biosimilars Center of Excellence, Strategic Product Development Consulting
For more information or to register for this event, visit Strategic Considerations for Successful Biosimilars Development.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
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