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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Introducing the FDA/CMS Summit for Biopharmaceutical Executives

Join us for the 10th Annual FDA-CMS Summit, for biopharmaceutical executives, December 11-12, 2014 in Washington, DC. 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.

 
Speakers Include:

o Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA)
o John Jenkins, MD, Director, Office of New Drugs, Food and Drug Administration (FDA)
o Leah Christl, Associate Director, Biosimilars Program, Office of New Drugs Food and Drug Administration (FDA)    
o Gerald Dal Pan, MD, Director, Office of Surveillance & Epidemiology, Food and Drug Administration (FDA)
o Jim Robinson, President, Astellas Pharma US    
o Sumant Ramachandra, MD, PhD, MBA, SVP & Chief Scientific Officer, Hospira
o Robert Clark, VP, US Regulatory Affairs, Novo Nordisk    
o Francois Nader, MD, CEO, NPS Pharmaceuticals
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Beier, Partner, Bay City Capital    
o John McHutchison, MD, Executive Vice President, Clinical Research, Gilead
o Mark McClellan, MD, PhD, Senior Fellow and Director, Health Care Innovation and Value Initiative, Brookings Institution    
o Niall Brennan , Acting Director, Office of Enterprise Management, Centers for Medicare & Medicaid Services (CMS)
o Tamara Syrek Jensen, JD , Deputy Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)    
o Mark McCamish, MD, PhD, Global Head Biopharm.& Oncology Injectables Development, Sandoz International GmbH
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Mott, General Partner, Biopharmaceutical Investments, New Enterprise Associates (NEA), Former CEO, MedImmune    
o Steven Nissen, MD, MACC, Chairman, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation

Register now for this can't-miss event! 

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