ARW's C&G Manufacturing Must-Reads (Holiday Edition!)

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

So, here’s a “permanent” copy of my C&G Manufacturing Must-Reads newsletter that was delivered on December 16th, for all you practical people who, like Carlin, abhor the question, “Where is it?”

“On The First Day Of Christmas, Scott Gottlieb Told To Me”
* To be sung to the tune of “The Twelve Days Of Christmas.” If you didn’t do that automatically, go back and try again.

• When I met Dr. Scott Gottlieb at a recent meet-the-press event, I told him I was going to be the “black sheep” in the room because I didn’t want to talk to him about COVID. Instead, we revisited his famous 2018 quote on how CGTs — and CMC in particular — challenge the traditional FDA review paradigm and his expectations for that 80/20 ratio in the future. I’m thrilled to share with you this article from our 10 minute back-and-forth, which proves to me daily this interaction wasn’t actually a dream.

“O Outlook Thoughts, O Outlook Thoughts, How Lovely Are Thy Insights”
*Yeah, yeah, your tree looks great too.

• Call my colleagues Erin Harris of Cell & Gene and Rob Wright of Life Science Leader magazine Santa — they’re delivering the goods this holiday season in both of their Life Science Leader 2022 outlook articles that include several CGT leaders — including a few of your fellow C&G Collaborative manufacturing counterparts! (Free registration required to read both. #JustDoIt)
  • Here’s looking at you, Charles Calderaro (Kite); Howard Bernstein (SQZ Biotech); Sadik Kassim (Vor Biopharma); Kee-Hong Kim (Tenaya); & Kim Raineri (AVROBIO)
  • Hear from Andre Choulika, CEO of Cellectis, and Michael Mehler, director, global site operations, Immatics, in Harris’ outlook; there’s something for everyone here — whether it be clinical improvements, COVID-19, manufacturing, FDA regs., and more!
• This piece from Pharma Boardroom was published a little earlier than true “outlook season,” but I think you’ll agree that this look at how CGT manufacturing needs to change (or already is changing for the better) has a positive “new year, new…zeal for old resolutions” feel to it.
• If there’s a lesson to be learned from the CGT CMC stumbles from the past few months, it’s that %^&* happens. This blog post highlights several recent CMC stumbles and shares a piece of advice that seemed particularly relevant given some of this news.

“All I Want For Christmas Is You”
*The CGT industry to Mariah Carey: “Hold my beer”

• CGT companies are facing a steep growing curve (or at least want to be growing, if only there were more people). In the fourth installment of our “choose your own manufacturing adventure,” our favorite manufacturing director protagonist finds themselves (post-ice cream) craving some coffee and further education on talent management best practices for their growing organization.
• Speaking of people, turns out this industry wants to snag experts as ferociously as Bumble, the Abominable Snowmonster of the North. The Cell & Gene Therapy Catapult released its 2021 Skills Demand Survey Report forecasting headcount needs through 2026. Manufacturing & quality people, you’re more in demand than (thrice-) spiked eggnog.

“Jingle Cells, Jingle Cells, We Built A Facility. It’s A Place For Our Folks To Invest In GMP”
*I’m not spelling this one out for you.

• If you’re working on autologous cell therapies, ISPE has released a new guide on autologous ATMP facility design. It’s not a cheap date (for members or non-members), but it would look really nice under that corporate Christmas tree — and then, eventually, on your/your teammates’ desk.

“O Holy Hell, Outsourcing Costs Are Rising”
*Apologies for the blasphemy, O Holy Night fans — of which, I am one, btw.

• Given all the talk on inflation, I found this Outsourced Pharma article by my colleague Louis Garguilo to be an insightful look into how rising salaries in the pharma industry and supply constraints are going to impact outsourcing costs over the next two years (at least!) This article also highlights how several companies are structuring their CMO partnerships to reduce the harmful effects of inflation.

• Alas, nothing good in this world is free. But Industry Standard Research Reports has released its Cell & Gene Therapies Market Outlook giving you a glimpse into the CGT outsourcing expectations/competitive dynamics through 2026. Psst…there’s a free preview!

“I’m Dreaming Of A Wise [FDA] Guidance”
*I could take or leave a white Christmas.

• Though “N of 1” gene therapies are being developed more regularly within the academic realm, the FDA just released a CMC draft guidance a few weeks ago for these “N of 1” individualized therapies. (Just try to say antisense oligonucleotides five times fast…) RAPS wrote a nice “wrap-up” here; the draft guidance can be found here.

“I Caught Mommy Coding Tardigrade, Logged Into The VPN Last Night”
*After the make-out sesh with Santa Clause, obviously.

• Omicron aside, a new strain of Windows malware aka “Tardigrade” began making the rounds of biomanufacturing facilities in 2021. So far, two biomanufacturing facilities have been impacted over the last year, but this threat shouldn’t be taken lightly; BIO-ISAC is urging all companies to make cybersecurity reviews a New Year’s resolution.

“I Want A Hippopotamus For Christmas”— And Other Ancillary Materials
*The rock under which I was born kept me from knowing that this is an actual Christmas song. Until 12/14/21.

• There’s this nifty song lyrics generator, which allowed me to come up with a very bizarre CGT-centric song entitled “A Cheery & Optimistic Manufacturing Director” to the tune of “Last Christmas, I Gave You My Heart.” But the link to the song expired so… create your own?
• Nothing says “Have a festive holiday season” like: unusual deaths through history; a feral hog suburb invasion; night blooming cacti; and (sometimes violent) snowball fights through the ages. Merry. Merry.
• I love Endpoints’ annual Women In Biopharma series. Their 2021 Top 20 class is chock-full of great leadership advice, including from leaders within the AAV and CAR-T space.