Strategic Considerations for Successful Biosimilars Development
Sponsored by: Covance
Date: 17 October
Time: 4PM London/11AM New York
With 21 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. You will hear about Chemistry, Manufacturing and Controls (CMC) characterization and the use of CMC analytical master files to support the assessment of biosimilarity 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.
Join this informative webinar to 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.
SiÃ¢n Estdale BSc, MPhil, PhD,
Head of Science and Innovation, Chemistry
Dr. SiÃ¢n Estdale has spent the last 12 years as part of the Covance Biopharm CMC Solutions Team based in Harrogate, UK. Her area of expertise is in protein chemistry supporting the development and QA/QC of biologic and vaccine products. She received her PhD from the University of Sheffield and is a current member of the Scientific Advisory Board for the Biopharmaceutical Emerging Best Practices Association (BEPBA).
Alicia M. Baker McDowell, DRSc, MS,
Executive Strategist, Head of Biosimilars Center of Excellence, Strategic Product Development Consulting
Alicia Baker McDowell is an executive strategist and the head of the Biosimilars Center of Excellence based in Princeton, NJ. Alicia has over 23 years of drug development experience including over 20 years in global regulatory strategy. Alicia has registered products across the globe in over 90 countries and is experienced in direct agency interactions including FDA, EMA, MHRA, NMPA, PMDA, KFDA, TGA, and others. Her experience spans small molecules and biologics from both the innovator and biosimilar side of development.
Alicia has a BS in Biology from St. Joseph’s University, a MS in Regulatory Affairs/Quality Assurance from Temple University, a MS in Regulatory Science from the University of Southern California and a Doctorate in Regulatory Science from the University of Southern California.
Martin Knight BSc (Hons), Dip Clin Sci,
Senior Director, Strategy & Planning, Inflammation, Infectious Disease & General Medicine (iiGM)
Martin Knight is a senior director, Strategy & Planning, based in the UK, and has 30 years of experience within the pharmaceutical industry. Within his current role, Martin is responsible for supporting project teams in developing the appropriate strategy for conducting studies within the Inflammation (particularly autoimmune disease), Infectious Disease & General Medicine (iiGM) therapeutic area with additional focus upon biosimilars. This includes leading feasibility assessments, data analysis, subsequent data modelling, assessing study risks and challenges and ultimately recommending the geographic placement for clinical studies.
Martin obtained his degree in Pharmacology from the University of Manchester and a post-graduate diploma in Clinical Science from the University of Wales, Cardiff. Martin has a background in Project Management having held positions as a global project director, director of Clinical Operations, client relationship director and senior director, Project Management before moving into Strategy and Planning.
Key Learning Objectives
- Hear about recent lessons learned in the development of biosimilars
- Gain an understanding of challenges in todayâ€™s development landscape
- Get insights on CMC characterization and its role in reducing downstream risks
- Learn about regulatory and clinical trial execution strategies
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