Biobetters: Challenges and Opportunities

The market of biologics is growing at a nearly twice the rate of pharma as a whole. Biobetters are the next big opportunity for biopharma to benefit from this growth. This podcast will explore the regulatory and scientific considerations for the development of biobetters.

Thought Leader: Hazel Gorham, Ph.D., Director, Biosimilars Development, PRA

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Risk-Based Monitoring for Late Phase: Implementation Strategies

In this episode, Ms. Harrison discusses the past, present, and future of Risk-based Monitoring. She also covers challenges and solutions, as well as a real-life example of RBM in a clinical study.

Thought Leader: Maria Harrison, Vice President, Late Phase Services, PRA

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Global Biosimilar Development

Thought Leader: Rodeina Challand, Executive Director, Biosimilars Development, PRA International

In this episode, Rodeina Challand clears up some of the murkiness among the many terms associated with biosimilars. Then, we cover the legislation and guidelines affecting biosimilars, we discuss the possibilities of one global program, and finally talk about the future for a global standard.

For more information about PRA International, visit www.prainternational.com.

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For more information on how you can be featured in a podcast, contact Dan Limbach at dlimbach@pharmavoice.com or call him at (847) 594-0157.