Thursday, October 20, 2016

FDA/CMS: New Administration, New Challenges?

Knect365 FDA/CMS Summit, photo on-site
photo credit: @KimTweetsDC

For over 20 years we have been working hard on delivering you with first-hand insights into one of the most heavily-regulated industries in the world.

With recent debates over drug pricing, the FDA is faced with some challenges over regulation policies to ensure the healthy balance of big pharma companies on the market.


Here are the main three questions that are bugging the minds of the Top Biopharma Executives today:


• What does the future hold for the Affordable Care Act and health reform in the post-Obama landscape?
• What is the state of biosimilars in the US, and how these medicines may impact the cost curve for biologics as more reach the market and uptake becomes measurable?
[read an excerpt from the panel discussion with experts from Mylan, Pfizer and Momenta Pharmaceuticals “Biosimilars are here. Now what?”.]
• Transparency around pricing.

Do these topics keep you up all night as well?

Be the first one to learn the updates directly from CDER and CMS right in the heart of DC, the political epicenter of the United States at the 11th Annual FDA/CMS Summit.


Some of the themes to be discussed at the Summit include:


• An overview of regulatory and policy news;
• Regulatory & reimbursement expertise from KaloBios Pharmaceuticals Inc., FDA, REGENXBIO, Aimed Alliance, Acorda Therapeutics, Beth Israel Deaconess Medical Center, and many others;
• The state of biosimilars and revisions to BSUFA;
• Drug Development Innovation including regulatory strategies of pandemics such as Ebola and Zika.

For the full range of topics download the brochure here.

Join an open dialog over the industry issues with other health care professionals from the FDA and CMS regulatory agencies, including Janet Woodcok, Gerald Dal Pan and John Jenkins at the FDA/CMS Summit, this December, 14 – 15th in Washington, DC.

As a valued member of our community you can register with a special discount of $100 OFF the current rate using this code: PFDA16SOCIAL.

Secure your spot and the best rate here.



Stay tuned:



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