Driving Momentum Towards Approval of New Therapies
December 14-15, 2015 Washington, DC


Join THE biopharma event that facilitates direct dialogue between biopharma executives, investors and FDA/CMS regulators to explain complex regulatory and reimbursement policy.

The year has seen new leadership at FDA and CMS, and the legality of the Affordable Care Act once again affirmed by the Supreme Court. The 21st Century Cures Act – currently being shaped and debated against the backdrop of industry’s considerable regulatory and commercial success of the past two years – was designed to better fund translational science and speed the development and approval of new therapies. We’ll discuss the legislative ideas that have captured the imaginations, and sometimes provoked the ire, of industry, regulators, and patient advocates alike.

Reauthorizing industry’s Prescription Drug User Fee Act has moved to the front burner and PDUFA VI negotiations have kicked off. Which biotech and pharmaceutical industry proposals will make the cut? We’ll hear how has FDA’s drug review “Program” improved regulatory efficiency, and how can the FDA improve on the breakthrough successes of FDASIA’s Breakthrough Therapies and patient-focused drug development programs in the next iteration of the law. Patient groups are indeed seeking greater involvement in the drug review and approval process, and working with the agency and sponsors to craft best practices for patient reported outcomes. Read more ▼

Meanwhile, drug prices – even in oncology settings – continue to face pressure from payers, providers, and the public alike, all while the 2016 election cycle gathers considerable steam. How are efforts to contain costs shaping up, and will industry feel the sting of payer-generated competition in new drug categories like PCSK9 therapies? We’ll explore whether the approvals of the first biosimilar drugs in the US helped to reduce drug costs in those categories, and whether patients and providers are adopting their use. We’ll examine the Center for Medicare& Medicaid Services’ episode-of-care payment programs and how industry is faring with these bundling experiments. We’ll also discuss how quickly industry and payers can move to embrace new, outcomes-based reimbursement models.

As FDA and stakeholders debate new pathways that will shorten review times and move drugs to the market faster, drug safety is sure to remain a concern. What will come of FDA’s discussions with companies like Google who want to put their algorithms to work spotting drug-related adverse events? We will explore how conventional means of monitoring new drugs are performing, and the opportunities and limitations for industry and regulators in using social media to track AEs and other drug trends.

FDA/CMS Summit will cover the implications of the following topics:

  • Affordable Care Act
  • The 21st Century Cures Act
  • Breakthrough Therapies
  • Patient-focused drug development programs
  • Patient reported outcomes
  • Drug pricing
  • The impact of the 2016 election cycle
  • Payer-generated competition
  • Approvals of the first biosimilar drugs in the US
  • Center for Medicare & Medicaid Services' episode-of-care payment programs
  • Outcomes-based reimbursement models
  • FDA's discussions with companies like Google
  • Monitoring of new drugs' performance

Key Benefits for Attending FDA/CMS Summit:

  • Hear about critical trends and changes so you can create successful strategies for dealing with FDA and CMS
  • Walk away with practical, real life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles
  • Get face-to-face access to the top regulatory thought leaders and policy makers
  • Benchmark your regulatory strategy against all the major pharmaceutical and biotech companies

View the agenda



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