Jacob Staudhammer

Pre-DHC expertise?

Viral vectors/gene therapy through early- and late-stage process development.

How would you describe the culture at Dark Horse?

It allows each of us to be in a position where we’re challenged and pushed. We’re given the necessary resources and the whole team is rooting for you, so as long as you’re up to the challenge, you will succeed.

It’s an environment where everyone is helping everyone else to do their best, and where you’re surrounded by extremely impressive people who are able to leverage their background and diverse ways of thinking to help support you.

How did you end up working in cell and gene therapy?

My mom is an oncology nurse practitioner and my dad’s work background is as a science teacher and so, probably not unexpectedly, I found myself to be both good at and drawn to an overlap of science and medicine.

I didn’t want to administer the medicine, though…I wanted to be on a team that could develop something that could help a wide swath of people. In college I discovered that bioengineering was an excellent way to bridge those two strong suits and while I was studying, I did a lot of work in various research labs and companies. I found myself really enjoying the process development side of things and then had a work opportunity in a spin-out from a lab I was involved with. I had the pre-requisites and base knowledge necessary to be eligible for it, so I jumped at the chance.

How did you have all those necessary skills when you were still in college?

Throughout college I always had an internship in industry or a lab position and I was able to take on progressively increasing responsibilities. By the time I was done with school, I had quite a bit of hands-on experience. I would absolutely recommend this to anyone else just starting out, because the more real-world knowledge and experience you gain early, the more prepared you are when a future opportunity presents itself.

What changes have you seen in process development recently?

Process development in gene therapy used to take place with a mindset most similar to that of academic development (in that the developer would typically go with what works the first time), but it has rapidly changed to a Quality by Design (QbD) approach, which relies on designing for robustness over the long-term.

What do you see as the current weak points in process development?

Definitely scalability: We’re still in the early stages of scalability with the standard transient transfection process. We’re seeing developers start to shift towards stable cell lines or a more scalable option like the Baculovirus/SF9 system for larger volumes, but it’s not yet scalable to the degree that biologics have reached which allowed the massive production scales that are currently in use.

As for common indications and systemic diseases that require large quantities of vector, it’s currently very difficult to generate enough vector material at a reasonable cost to meet the demand of patient populations.

Dark Horse hires from all over the place and encourages remote work. What does the opportunity to work from anywhere in the world mean to you?

I’m in the process of moving to Bellingham, WA, because I’m a mountain biker and skier and that’s a quiet town with everything I love to do right there in my backyard! I grew up in Eugene, OR (a similarly sized town), and I don’t think it felt like a small town when I was growing up but now, looking back, I see that it definitely was! Maybe that’s partly why I’m drawn to Bellingham? It’s sort of my chance to recreate that experience in a way that’s all my own…plus Bigfoot and murder hornets, of course!

Would you consider yourself an “outdoorsy” person?

YES! (Not to mention, being outside has been a balm during the pandemic.) I camp and backpack in addition to biking and skiing and in the past year I took up fly-fishing. That brings in more of a grounding experience; it’s almost meditative. It teaches me patience, which can be the polar opposite of some of the more adventurous activities I do.

How do your outdoor activities complement your job?

Well, first, exercising and being outside really clears my mind after a long day. I’ve discovered that without regular exercise, I’m a shadow of my usual self. But also, nature draws parallels to work for me in some ways: focusing in closely on an element of something and then pulling back, stopping for a minute, and taking a look at the bigger picture, then diving back in. Getting distance from anything, whether it’s the work you’ve focused on all day or the house that you’re now able to look down on from the mountain trail, helps you see the shape of your experiences from the outside. And then when you dive back into real life or the problem in front of you, it’s easier to dig in even deeper than you were before with a new perspective.

Which of your activities have you been doing the longest?

My parents have both been road cyclists, so biking was a part of my world from a very early age, though I did end up gravitating towards mountain biking instead of road biking. I was put on my first bike when I was 3 years old, with no training wheels. [ed. note: NO TRAINING WHEELS?!] One of my earliest memories is of being on that bike. It was rainy nearly all the time in Eugene and there was a gravel track near our house where I was learning to ride. My parents got me on the bike and give me a push to get me going…I was doing just fine except that I didn’t know how to brake or turn yet so when I tried to go around the corner of the track I did a pretty impressive fall into a very, very large and very, very wet puddle!

Process development is one of your specialties, right? Are there others?

In addition to process development, I’ve also specialized in statistical/data analysis at Dark Horse, and it’s immensely enjoyable for me. I love using statistical analysis tools to tease out information from data that we might not otherwise see at first glance. It allows us to identify patterns, experience another view of the same picture, or take a deeper dive. Finding something interesting and unexpected when running an analysis is one of the most satisfying things I’ve encountered. It allows us to answer questions from a scientific POV and from a statistical POV, simultaneously. Combining those two viewpoints gives a much more complete picture of the problem at hand.

Do you find that most clients are aware of the possibility of a statistical view being run in tandem with their work?

A lot of early-stage companies (and even some late-stage companies!) overlook data trending because it can seem easier or faster to just keep running experiments, full steam ahead, than to take what sometimes feels like a risk in pausing to look at the data and learn which direction it’s telling you to go. But, when you’re following QbD, it’s particularly important to pay attention to what your data is telling you and understand the limitations of the process.

How early in the process do you recommend that a client begin to consider a statistical review of their data?

Well, two [data] points make a line…so…! In other words, it’s never too early to ensure that your decision-making is taking the data you’ve worked to generate into consideration.

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