On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.

While at this year’s BioProcess International (BPI) show in Boston, I was very fortunate to make new acquaintances and catch up with some industry friends. One of those friends was Carl Schoellhammer, Ph.D., a partner at DeciBio. I had the chance to get Schoellhammer on the record between sessions to ask him questions about his time at Biotech Week, as well as where he anticipates growing pains for the industry.

The following transcript has been edited for clarity.

How have you been enjoying BPI?

Schoellhammer: It's been great! I think it's an interesting time in biotech, especially looking at bioprocessing. You still kind of have this tale of two cities where the advanced modalities still have a lot of cutbacks, lean times, thinking through priorities, and then you have the biologics — ADCs, bispecifics, traditional mAbs — that are largely kind of business as usual. And so, when you think about the tools and all the bioprocessing like we're seeing that feed into it, I think you see that similar story sort of emerge.

What are your biggest takeaways from the week? Have you been getting a general sense of where people are falling, especially in terms of technology adoption?

Schoellhammer: Yeah, I mean you saw outside of this meeting, the recent news from Lilly opening up their AI pipeline, effectively. Good data in leads to better models, so that's a really exciting development. I think the other piece is just thinking through the solution portfolio, the sample-to-answer type menu offering from tools providers and bioprocessing stakeholders, in that Pharma needs to advance their programs, they need to advance the ball down the field, get into clinical, etc. And so, it's opening up the start of slightly greater flexibility in terms of the CDMOs they engage with, the vendors and vendors’ tools they look at to adopt— looking for more flexible, more fluid, faster answers so that biopharma can now really try and develop things in a much leaner way. I think that's going to be a trend that continues. And I think you're seeing kind of the start of it here.

What do you think are the biggest challenges biopharma faces in the coming years in terms of bringing advanced therapies to commercial?

Schoellhammer: I think it's to the point where it's really all about commercial viability. If it can get approval and then see sufficient market uptake, a strong market launch, I think that'll solve everything. But that's a big if. There are a couple of programs we're watching and keeping eyes on that I think could be exciting, but I think it all goes back to patient access, payer considerations, and very careful forecasting while still in clinical development.

On a recent episode of “Better Biopharma,” Dr. Nicole Paulk from Siren was talking about the asset and platform cycle we see in the industry. She believes we're due for it to swing back to platforms soon, where she thinks it's going to stay. I'm curious how that resonates with you. Do you agree?

Schoellhammer: I appreciate Dr. Paulk's thoughts. She's doing very exciting things in terms of broadening the potential impact of AAV beyond rare disease. I think it's maybe twofold: From a delivery standpoint, regulators in the FDA have their platform designation for tools like what Sarepta got, despite some of their recent issues. That could be one where the delivery vehicle, like an AAV capsid that Siren's developing, could become that platform, and then you load different cargoes in it, and that's a multi-asset strategy within a singular product.

I think I would disagree with that from a broad platform standpoint. I think platforms just went out of vogue, mid-2023/end of 2023. We're still in that. Biotech — particularly U.S. Biotech — needs to figure out how to materially advance programs that are market viable, and with a reasonable amount of money. And so, I think we need to do some market correction and figure out how to do exactly that; get something into the clinic for less than $50-100 million, and that means, I think, very sharp focus on specific products as opposed to broad platforms.