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.
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.
Speakers
Siân Estdale BSc, MPhil, PhD, Head of Science and Innovation, Clinical Trials Testing Solutions, Covance
Siân Estdale is the head of science and innovation within clinical trials testing solutions at Covance where she has worked since 2002. Her expertise is in methodologies to support drug development of molecules, especially biologics from R & D to market in CMC and BioA and now patient care analysis. She has worked with biosimilars for over 12 years and worked with the CMC team to develop biosimilar master files for key targets. Previous to Covance, Estdale was an academic, lecturing in Biomedical Sciences at Bradford and Sheffield Hallam Universities with 14 years research experience in diverse areas: recurrent miscarriage, ischemia-reperfusion and skin research. She has a PhD in organic chemistry.
Message Presenter
Joan Meyer, MS, PhD, Executive Director, Strategy & Planning Inflammation, Infectious Disease and General Medicine, Covance
Dr. Joan Meyer is the executive director, inflammation, infectious disease & general medicine at Covance. She has more than 30 years of experience in basic research and clinical development, which includes more than 20 years at Procter & Gamble and spans both consumer products and pharmaceuticals. She has taken two compounds from the bench through Phase III clinical development and designed and/or led clinical studies in a variety of indications across many therapeutic areas as well has launched new products, developed Phase IV studies and led an FDA Advisory Committee presentation. Dr. Meyer received her PhD in Neuroscience from the University of Illinois.
Message Presenter
Alicia M. Baker McDowell, DRSc, MS, Executive Strategist, Head of Biosimilars Center of Excellence, Strategic Product Development Consulting, Covance
Alicia Baker McDowell is an executive strategist and the head of the Biosimilars Center of Excellence based in Princeton, NJ. Baker has over 24 years of drug development experience including over 21 years in global regulatory strategy. Baker 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.
Baker 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.
Message PresenterWho Should Attend?
- Chief Medical Officer
- Chief Executive officer
- Clinical Operations
- Clinical Development Manager/ Director
- Clinical Director/ Senior Clinical Director
- Commercial and Sales
- Medical Affairs
- Medical Director/ Senior Medical Director
- Operational Director/ Senior Operational Director
- Physicians
- Project Management
- Procurement Manager
- Regulatory Specialist
- Research Director/ Research and Development Director
- Scientist/ Senior Scientist
- Senior Medical Science Liaison
What You Will Learn
In this webinar, participants will:
- Hear about recent lessons learned in the development of biosimilars
- Learn about regulatory and clinical trial execution strategies
- Get insights on CMC requirements and its role in reducing downstream risks
- Gain an understanding of challenges in today’s development landscape
- Get insights on CMC characterization and its role in reducing downstream risks
Xtalks Partner
Covance
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.
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