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.
After downloading on the goals and priorities of the patient services program, Two Labs provided Account Directors to serve as ‘Hub and Patient Services’ representatives.
These representatives assisted with the design and implementation of the patient support program and served as stakeholder-facing subject matter experts on the program.
To optimize their program performance, the client needed a deeper and broader understanding of the patient services space, as well as an objective evaluation of their program and data capabilities. Two Labs took a two-step approach that combined benchmarking of the market competition, as well as an assessment and gap analysis of current operational processes, performance, and reporting.
Whether you’re an emerging manufacturer putting the finishing touches on a new product launch or a small to mid-sized company whose products are outgrowing the post-launch support infrastructure you have in place, Two Labs provides expert consultative services to ensure your product can keep pace with constantly changing market dynamics.
In its simplest form, an order set is like a decision tree for healthcare providers. At the top of the tree are the diagnostics and tests, and based on the results and disease state, physicians can follow specific branches of treatment that best match the patient’s needs, including scans, care procedures, and drugs.
Patient Services have become a must-have for any specialty product launching today. Many pharmaceutical clients are looking to expand their reach and offer enhanced services to their patients, particularly in a competitive landscape.
As the world’s largest single pharmaceutical market, the US should – at least at first glance – provide a simplified pathway for companies looking for a stateside translation of their successes in Europe’s patchwork quilt of countries.
