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.
Understand the various priority review voucher programs and their respective eligibility requirements
Navigate the changing regulatory landscape and effectively anticipate the future of the program
Discuss the various valuation models to utilize before buying or selling a priority review voucher
Examine the challenges of clinical study design, operational logistics and patient engagement for developing rare disease therapeutics
Comply with regulatory requirements by composing and submitting compliant documentation
Professionals in biotech and pharmaceutical companies with responsibilities in the following areas:
This event is also of interest to: