FDA/CMS: New Administration, New Challenges?

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:

Twitter: @healthcarebiz ; #FDACMS

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Last Chance to Save $200 for FDA/CMS Summit for BioPharma Executives | Early Bird Rate Ends Friday

What do payors want when it comes to biopharma policy? Come to the FDA/CMS Summit for BioPharma Executives, December 11-12, 2014 in Washington, DC to hear payor perspectives on biosimilars, drug pricing, FDA reforms and drug coverage under Medicare, Medicaid and in the new Affordable Care Act Exchanges.

Take advantage of our Early Bird Rate, a savings of $200 off the standard registration rate. Register now.


Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

• The commercial outlook for biopharma under the new health care exchanges

• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"

• The future of drug safety at FDA - both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes

• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.

• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit

• What the mid-term Congressional elections will mean for the biopharma industry.


P.S. Maximize your investment by also attending the co-located FDA/CMS Summit for Payers. If you purchase the All Access Pass you will be able to not only collaborate with biopharm exeuctives, but rub elbows with C-Level health plans executives as well. Register now so you can double the speakers, double the content, and double the value for only an additional $800! Use the code XP1917BLOG when getting your All Access Pass to save $100, making it only an additional $700!

Register Here.

If you have any questions about the event, please reach out to Ryan Geswell at rgeswell@iirusa.com

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