Monday, December 30, 2013

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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How Working Together Effectively on a Clinical Trial is Like Doing a Successful Skydive

In this episode, Ms. Ruby discusses how clinical trials are like skydiving, what some of the key challenges are in clinical trials, solving unexpected challenges, and creating a productive and collaborative relationship between CROs and sponsors.

Thought Leader: Barbara Ruby, Project Director, SynteractHCR, Inc.

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Risk-based monitoring (RBM): A shift in paradigm from the traditional experimental design

In this episode, Mr. Penniston and Ms. Taber talk about risk-based monitoring what it is, why it's important, what are the components, what skill sets or tools are necessary, and the challenges and opportunities related to risk-based monitoring.

Thought Leaders: Mark Penniston, Senior Vice President and General Manager, Clinical Analytics, Theorem Clinical Research and Alison Taber, Vice President of Global Data Management, Theorem Clinical Research