Understanding biosimilar study challenges and strategies to reduce supply-related costs and delays
The use of biosimilars in clinical trials is on the rise. Often tightly controlled or in short supply, sourcing the necessary drugs can be challenging. Given the variability of biosimilars, even within different batches of the same product and often limited or tightly controlled availability, studies using these products are particularly at risk for supply-related delay and cost overruns unless proactively managed from the beginning.
Unfortunately, clinical supply considerations are often overlooked until it is too late and the study timeline is in jeopardy. This webinar will explore common challenges and the strategies that can be employed to overcome them and keep your study on track.
Working with a partner who can analyze the clinical supply needs early and develop and appropriate sourcing plan is essential for staying on track, especially when biosimilars are involved. As a fully integrated clinical trial supply partner, Catalent provides the services you need including direct sourcing and analytical testing to packaging and ultimately distribution into clinical sites. This approach, when properly executed, enables tighter control of the supply chain and reduces supply-related risks related to biosimilar product availability, expiry, cost and quality.
Whether you are planning for your first biosimilar trial or have already experienced first-hand the complexity of running a biosimilar study, this webinar will help you build strategies to reduce or avoid clinical supply challenges. Register for FREE today.
Presented by
Kristen DeVito,
Global Director, Clinical Supply Services Business Solutions
Kristen DeVito is Global Director, Clinical Supply Services Business Solutions at Catalent Pharma Solutions. In this role, she is lead for internal business improvement initiatives/projects as well as lead for the Clinical Supplies Management function of the business. With twenty years of industry experience, she previously held the positions of General Manager of the CSS site in Mt. Laurel, NJ and Director, Project Management with Aptuit and Quintiles Clinical Supplies. Kristen is a committee member and former Chair of the ISPE Investigational Products COP Steering Committee and former instructor for the Center for Professional Advancement Course, Clinical Trial Materials.
Vincy Abraham, Ph.D.,
Senior Manager, Large Molecule, Analytical Chemistry Department, Catalent, KCM
Vincy Abraham joined Catalent in 2001. Before joining Catalent, she was the Manager of the Mass Spectrometry Facility at Midwest Research Institute, Kansas City, MO. She has a Ph.D. in Analytical Chemistry (Mass spectrometry) from University of Miami and Mississippi State University and completed her Post-Doctoral Research at Mississippi State Chemical Laboratory, Mississippi State University. She has ~23 years of experience in mass spectrometry including both GC/MS and LC/MS and has worked on various types of mass spectrometers.
