June 26, 2019

Vineti joins the leadership of the Standards Coordinating Body

Posted in Commercial Scale by Amy DuRoss

At Vineti, we’re pushing every day to help the field of advanced therapies — cell therapy, gene therapy, personalized cancer vaccines, and more — grow.

That means supporting our biopharmaceutical clients as they develop and launch their transformative treatments. And it also means working on behalf of the entire industry wherever we can.

So we’re honored and humbled to be able to help in a whole new way, by joining the leadership of the Standards Coordinating Body. With this expanded role, we’re excited to provide even more support to the organization’s FDA-funded work.

April Lynch, Vineti’s Senior Vice-President of Product Marketing, has been selected to serve as Secretary of the SCB’s Executive Committee. With April’s extensive background in the commercialization of personalized medicine, and Vineti’s involvement in the leadership of the SCB, we’re deepening our commitment to the growth of advanced therapies.

We’re encouraging everyone to join us in supporting the SCB. Here are just a few of the reasons why this type of cross-industry collaboration matters more than ever.

More than 1,000 advanced therapy clinical trials are underway, according to the Alliance for Regenerative Medicine.
The FDA expects to receive more than 200 new cell and gene therapy INDs (Investigational New Drug applications) per year beginning in 2020, and to approve 10 to 20 such therapies per year beginning in 2025.
As an organization formed specifically to help advance standards for regenerative, the SCB has drafted a new 62-page Needed Standards in Regenerative Medicine report that outlines six major functional areas that need new or updated standards. It came as no surprise to us that existing standards are relatively lacking in an area of direct concern to patient safety — logistics and compliance. In fact, this functional area — an area of focus for Vineti — ranked second-to-last in SCB’s tally of existing standards.

Standards are crucial to making all of this amazing transformative science work on behalf of all patients. How else will we make personalized therapies available to all who need them? We need to bring standardized, industrial rigor to these deeply individual therapeutics.

We’re excited to provide this new level of support to the SCB! With April’s input, we’ll be using our blog to provide regular updates on the SCB’s work. If you have questions about standards or how to get involved, please send a message. You can also see standards development in action, by downloading slides from our SCB webinar on in-process labeling standards or reading our recent SCB case study. Thank you!

Amy DuRoss is the CEO and Co-founder of Vineti. If you’d like to learn more about how Vineti’s Personalized Therapy Management (PTM) is helping to standardize and industrialize workflows for personalized therapies, please contact us.