Amgen Lead Discussion on Successful Launch Strategy Under New FDAAA Guidelines

/EIN News January 13th, 2009/

With FDA guidelines likely to become more stringent under the Obama administration, Pharma oncology companies are meeting to look at how to develop and execute a Risk Evaluation and Mitigation Strategy (REMS).

Led by industry expert, Max Colao, Executive Director, Oncology Marketing, Amgen, the discussion will take the audience through the implications of the new FDAAA guidelines on oncology launch strategy.
Drawing key learnings from, Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding, Max and other leading industry names will share best-practice on how to plan for and deliver successful REMS, particularly for products without a black box.

With the regulatory environment more uncertain than ever and a fast-evolving domestic and global healthcare landscape, it’s never been more important to best-practice insights on how to stay ahead of the curve.

Max and other industry big-hitters will deliver their insights to the Oncology Summit USA. The Summit runs March 30-31 at the Boston Park Plaza hotel.

To learn more about how to become one of the first in the world to get the insight track on the future of the oncology space going forward, and benefit from the other expert sessions at this industry-leading, 150+ delegate event, view the website:

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