In 2015, the U.S. government passed the 21st Century Cures Act. In it was a provision called the ‘Open Act,’ designed to increase drug pricing transparency by requiring manufacturers to submit clinical trial results and detailed information on production and R&D costs.
Based on Two Labs’ experience supporting 280+ pharmaceutical new product launches, our experts will walk you through the most critical questions to answer when planning a pharma launch strategy.
We’ve entered a new era in the U.S. healthcare system with the passage of the Inflation Reduction Act’s (IRA) landmark policy changes. And whether you are an emerging manufacturer bringing your first drug to market or more seasoned about the whole launch process, it’s important to make sure that your strategy includes a focused public policy element.
Given the complexities that an emerging manufacturer is managing when developing a new product for launch, it might sound like medical communications is just one more thing on the list. But this couldn’t be further from the truth.
Thousands of rare diseases affect hundreds of millions of people globally, and hope for treatment is on the rise in the form of cell and gene therapies. While only 9 cell and gene therapies are currently FDA-approved in the U.S., that number is soon expected to grow exponentially. With such drastic change on the horizon, the industry needs to be prepared.
A pharma client came to Two Labs for patient services mock launch testing prior to their first product commercialization in the U.S. market. Here’s how we helped ensure their patient services program successfully went live upon FDA approval.
