2nd Priority Review Voucher Summit -

2nd Priority Review Voucher Summit
October 26 - 27, 2017
Boston, MA

Understand the FDA's Priority Review Voucher Programs and Discuss the Challenges With Respect to Valuation, Market Access and the Regulatory Landscape

2nd Priority Review Voucher Summit – 2nd Priority Review Voucher Summit

The FDA’s Priority Review Voucher Programs are incentives meant to encourage the development of new treatments for diseases that lack commercial viability and do not typically garner development interest from companies. These incentives come in the form of special vouchers, which allow a company to have any one of their future drugs reviewed under the FDA’s priority review system.

The priority review process can be extremely beneficial for companies and patients. A quicker review process allows patients with serious conditions to gain access to potentially life-saving or -changing treatments. It also allows companies to market their product sooner and begin recouping their considerable development costs. Additionally, there is the option to sell a PRV, which can help offset development costs. A number of priority review vouchers have been sold to other drug sponsors for prices ranging from $67.5 million to $350 million, which has helped incentivize research for treatments of neglected tropical and rare pediatric diseases.

The 2nd Priority Review Voucher Summit is the leading event to understand the benefits and challenges of developing a drug that would be eligible for a PRV, and will provide attendees with the opportunity to network and engage with leaders from pharmaceutical companies, social enterprises, patient groups, government agencies and the investment community to create the best development strategy for your organization/portfolio.

Top Five Reasons to Attend

  1. Understand the various priority review voucher programs and their respective eligibility requirements
  2. Navigate the changing regulatory landscape and effectively anticipate the future of the program
  3. Discuss the various valuation models to utilize before buying or selling a priority review voucher
  4. Examine the challenges of clinical study design, operational logistics and patient engagement for developing rare disease therapeutics
  5. Comply with regulatory requirements by composing and submitting compliant documentation

Who Should Attend

Professionals in biotech and pharmaceutical companies with responsibilities in the following areas:

  • Strategic Planning
  • Business Development
  • Regulatory Affairs/Operations
  • Medical Information/Affairs
  • Strategic/Competitive Intelligence
  • R&D/Drug Development
  • Clinical Operations/Development
  • Rare/Orphan Program Management
  • Pipeline/Portfolio Management

This event is also of interest to:

  • Strategic/Management Consultants
  • Venture Capitalist/Private Equity/Financial Organizations
  • Law Firms
  • Regulatory Advisors
  • Valuation Experts
  • Drug Development Service Providers
  • Clinical Operations/CROs
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