"We've deepened our bench of experts by adding some of the most experienced REMS professionals to our team, including Melissa Landers," said Howard Miller, CEO of Two Labs.
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.
Emerging manufacturers have a strength in how close to and how passionate they are about the science they are developing. But because they are hyper-focused on the groundbreaking science they're working on, it can be hard to come up from the weeds to put together the launch support that their product needs. And often, one of the most underestimated parts of that launch plan is medical communications.
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.
As the cell and gene therapy market has exponentially grown in recent years — with some reports predicting it will reach $24.4 billion with 54 to 74 approvals by 2030 — many manufacturers are learning the hard way just how complex it can be to launch these products.
It’s no surprise that putting together a successful launch strategy for an oncology product is a complex process. And we’ve heard from many of our emerging pharma clients that it’s intimidating to see how saturated and competitive the landscape is.
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.
In a market where most medical affairs and medical communications service providers are built to support large pharma, Two Labs is aiming to fill the gap for small and emerging biopharma and biotech manufacturers with the launch of Medical Affairs & Communications.
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.
