Newsletter | November 22, 2022

11.22.22 -- Business of Biotech Newsletter

Insight from Merck, Stemline, NIIMBL, and more!

Business of Biotech Newsletter

If I had a dollar for every time I read a story about a biotech builder and thought, I gotta get them on the podcast…

Eventually, I’ll interview everyone in the business, or retire trying. In the meantime, I’m launching this newsletter to bring you more experiences and ideas from the personalities moving biopharma forward. It’s only monthly, it’s ad-free, and everything herein is hand-picked by yours truly, because I think you’ll like it and learn something from it.

Got a biotech topic you’d like us to cover? An interesting guest I should consider? Feedback on what we’re doing here? I’m at


- Matt Pillar, chief editor, Bioprocess Online and host, Business of Biotech podcast


Biotech Beat

November 22, 2022

White Paper On Wheels


This will be a long one, but worth your time if you’re not familiar with or involved with NIIMBL. What a resource to biologics manufacturers. Institute director Kelvin Lee, Ph.D., is an industry treasure. He took us on a verbal tour of NIIMBL’s work during a recent keynote. These are the highlights.


Whose Facility Is This, Anyway?


Build? Buy? Both? Something better? What does “outsourcing” even mean anymore? Outsourced Pharma chief editor Louis Garguilio takes us behind the manufacturing story of Keytruda, the granddaddy of mAbs, in a story that begs the question, “Whose manufacturing facility is it, anyway?”


6 Steps To Patient-Focused Drug Dev


It’s said that startup biotech businesses should “begin with the end in mind.” Do drug developers follow suit, beginning with the patient in mind? Alycia Shilton-Lloyd, Ph.D., VP of medical affairs at Imago BioSciences, explores the nuances between biomarkers and patient experience — and what defines “effective” — in this Clinical Leader exclusive.


Blueprint To BTD


From The Archives: This was a particularly constructive conversation on successfully applying for Breakthrough Therapy designation with the FDA, with two women who have been there and done that. Drs. Ganeshan and Gupta are both now at Stemline Therapeutics (talent sticks together), but their experience and wisdom are evergreen.



Quotes Of The Month

Dr. Rob Ross

"We're taking big swings, but almost certainly, not all those swings are gonna work. How do we deal with that? We bring a bunch into the clinic."

― Rob Ross, M.D., CEO, Surface Oncology, episode 122

Dr. Anat Binur

"Diversity doesn’t mean inclusion. It’s not about counting numbers. Inclusion means being thoughtful about building an organization that gives space to everyone, and leveraging those diverse opinions."

― Anat Binur, Ph.D., cofounder and CEO, Ukko, episode 120

Rachelle Jacques

"They would take the tick’s salivary glands, remove them, and purify and isolate the proteins. That was an arduous process, not at all suitable for what we’re doing now in clinical trials and our ambitions for commercialization.”

― Rachelle Jacques, president and CEO, Akari Therapeutics, episode 123

Business of Biotech Podcast

Created exclusively for the leaders of new and emerging biopharma firms, the Business of Biotech podcast tackles organizational, funding, HR, regulatory, production, and CMC considerations with insight from peer founders who have taken biologic therapies from an idea to clinical success. Check out our episode archive. The Business of Biotech podcast is produced in partnership with Cytiva.


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