As part of Sarcoma Awareness Month, we are featuring our colleagues working to support the afami-cel BLA and commercialization process. If approved, we would have the first TCR T-cell therapy on the market as well as providing a new and meaningful treatment option for people with synovial sarcoma!

Lane Jaeckle-Santos is based in the Navy Yard, in the US. Lane is Associate Director, CMC Submissions and works in the Manufacturing Science and Technology, in the Manufacturing Technical Operations team. In the interview below, Lane shares her passion for being directly involved in a diverse array of projects supporting our manufacturing processes, and particularly working toward the BLA.

Tell us about what inspires you in your job as Associate Director, CMC Submissions at Adaptimmune

I’m part of the Manufacturing Technical Operations branch of our CMC department in MS&T. Our role is to assist Manufacturing and Quality with the monitoring, improvement, and ultimate validation of our manufacturing process. We do everything from transferring in new technologies to improve the robustness of our manufacturing processes, to investigations when something goes wrong, to updating our CMC content with the FDA and other Health Authorities. I love that our group always has our hands in what feels like hundreds of different projects.

Most people in our department also know me as the person with a Squirrel iPhone case, I love squirrels and grew up with them as pets! Here I am age 5 with our first squirrel, Fröhlich.

One of the most inspiring things about my job is when my colleagues in the CMC department pull together to tackle complex projects and problems. There’s never discussion about if something should be done, just how to best accomplish it so that we can keep making products for our patients.

We have these coins for CMC members that highlight our mission statement and ethos. The coins state, “One Patient, One Batch,” and on the reverse, the behaviours that we focus on to achieve our mission. The behaviours are “Collaborative, Innovative, Accountable, and Resilient.” Every time we as a department come together to solve a complicated problem, we do it by embodying those behaviours. Our CMC folks are some of the most dedicated people in our organization and I’m incredibly proud of what we accomplish each day.

July is sarcoma awareness month – what do you think we should all be aware of when it comes to this cancer?

As much we all hate to think about it, no one is immortal and our lifetimes are finite. When someone is given a sarcoma diagnosis it’s terrifying, and easy for them to feel like they are being robbed of the remainder of their life. While reading one of the many forums online for sarcoma support groups, the message I saw again and again was how much people wanted to just get back a few more months, a year, or 2 years to spend time with their loved one and to finally do the things they had always dreamed of doing. It’s a heart-breaking situation for these patients and their loved ones.

One of the things that I think is so very powerful about our therapies is that they give people back some or all that lost time. When these patients are faced with having only a year left and our therapies give them an additional year or years it makes a huge difference. We are giving back the time that our patients were robbed of with their diagnosis. I cannot imagine a more inspiring mission.

What is your role in the BLA and commercialization process (with focus on CMC)? Why is this important?

I’m the Sub-team Lead for T cell BLA study planning, preparation, and execution of these studies. My group is also the ones writing all the CMC content for this BLA in partnership with Regulatory. We are the middle and last legs in a marathon relay race for commercialization.  We live and breathe the BLA every day, all day long. It’s very nearly the only thing that we are working on!

This virtual BLA tattoo represents our group’s devotion and love of this marketing application. When I say we live and breathe the BLA - it's true! It is all we think about day in and day out.