The House Brazeryen: 22NOV2022 🐉
Merry Thanksgiving 🙏🏽
Gm Brazeryens. Who would like a slice of our biotech TurDuckEn? 🔪🦃🦆🐓
[Welcome to Issue Number 19 of The House Brazeryen, where we break down the latest Brazen Bio, Brazen Capital, and bio-startup-related news for you fortnightly, in roughly 5 minutes.]
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BRAZEN BRY: Wassup in Gene and Cell Therapy?
Contributed by Bry Reinhardt — Hallmark legislation for drug development was signed into law on September 30th, 2022, which aims to accelerate review of new drug and biologic license applications. This includes the FDA User Fee Reauthorization Act of 2022 and renewal of the Prescription Drug User Fee Authorization Act (PDUFA) VII.
But why is this important?
According to the American Society for Gene and Cell Therapy, the gene and cell therapy pipeline has expanded by 16% since 2021, including 3,579 therapies in development. Yet in the US this year, only one CAR T-cell therapy was fully approved along with two gene therapies which received accelerated approvals.
Sure, drug development is a slow and arduous process, but why is it this slow, and at the expense of patients who are dying due to the severity of their orphan diseases?
A major bottleneck is the funding, staffing, organizational structure, and relatively traditional mindset of FDA.
CBER—a center within FDA overseeing biologics—lacks subdivisions organized by therapeutic area and thus many specialists who can provide specific guidance.
FDA continues to look for clinical outcomes over surrogate biomarkers for most trials, delaying development.
BRAZEN BREAKDOWN
At a high level, what do you need to know?
The gene and cell therapy market is growing rapidly and FDA is trying to innovate their processes while keeping up with the volume of submissions.
Gene and cell therapies are largely deployed for orphan diseases with high unmet medical need. As such, they require an accelerated drug development process to reach patients before it’s too late.
The President signed into law PDUFA VII, which aims to address the above, in part, by increasing the FDA budget as well as establishing programs such as the Split Real Time Application Review (STAR) pilot designed to decrease review time for biologics.
Science Communicators Unite ✨IRL✨
Our very own #BrazenCreator, Ben Rein, PhD, co-hosted a #SciComm meetup last week during the Society for Neuroscience meeting in San Diego, CA. The event was sponsored by the Mind Science Foundation and was super packed with students and some of our favorite creators including @stina.biologista, @dr_inna, and #BrazenCreator @Chemis.te. Great job, Ben!
IRL ALPHA: A Very Brazen Holiday Party!
BCLA (aka, Biotech Connection, Los Angeles) is hosting their annual holiday party in early December at none other than our own Brazen House. I didn’t get permission from them to drop this alpha so stay tuned for more information.
BRAZEN BREAKDOWN
If you aren’t already on their e-mail list please remedy the situation HERE.
VC CORNER: WTFFTXNOBOD?!!?!
Contributed by Scott Alpizar, PhD — A huge news story recently has been the collapse of FTX, a cryptocurrency exchange platform started by Sam Bankman-Fried in 2019 and once valued at $32 billion (yes, with a ‘B’). If you’re not up to speed, catch up here.
What does a cryptocurrency company have to do with biotech? Well, in reality, not much (yet). But one of the places FTX failed was in its board of directors (BOD)—mostly in the fact that it didn’t really have one.
A BOD is intended to oversee management. It should include a company insider (usually the CEO) as well as external, and eventually, independent members. A strong BOD is critical for an early-stage biotech (n.b., prior to a significant funding round, it is typically just the cofounder[s]).
Once you’re on board with that concept, here are some best practices to follow:
Choose Wisely. The main job of the BOD is to hire/fire/assist the CEO.
Size Matters. You don’t need or want a large BOD early—find a group that is productive and can respond at the rapid pace that you’re developing. At the seed round, it is common to have just one investor and two cofounders on the BOD.
Fill Gaps. Once you’re large enough to include an independent director, you should intentionally be identifying your weak spots and trying to find people who can provide unique perspective.
Communicate often. You should have a constant line of communication open with your BOD—you don’t only need to stick to quarterly meetings. Typically, the most important work happens outside the board room.
It’s critical to have the proper checks and balances in place. The BOD should always be acting in the best interests of the shareholders—they have a fiduciary duty to do so. It’ll also ensure that future investors are more comfortable when they perform due diligence. This is something that should have been a red flag for the investors involved in FTX—many of whom are facing scrutiny themselves. Thanks FOMO.
Finally, BODs are a great way to increase diversity. It’s certainly something that’s important to consider for all hires as increased diversity can lead to more successful companies.
BRAZEN BREAKDOWN
HAVE A PROPER BOARD OF DIRECTORS.
😋 Brazen Snax
🩸 Elizabeth Holmes got too much—or not enough—jail time?
🧫 Microbiomes gone wild: even tumors have one?!??!
✍🏽 The architect behind the viral SAFE vehicle (NOT SAFE NOTE)
⚡️ Another science dogma bites the dust in vivo: mitochondrial edition
🦠 Are we getting closer to an understanding of anosmia after COVID?
🎂 December brings 200th birthday for this pre-Nobel scientist
🐻 The solution to loneliness is creepy as fuck and yours for only $160
📶 The epic startup story you’ve likely never heard before: Qualcomm
⏰ TikTokCrak: Imma let you speak, but first a word about Women in STEM
🔪 Carveout
We the Best AirBnB: After Art Basel, stay overnight in DJ Khaled’s Miami sneaker closet!
🙏🏽 A Dose of Gratitude
During this Thanksgiving week, we are grateful for all 812 of you subscribers. So many tell me IRL how much they enjoy this cheeky lil’ newsletter (even though most don’t mash that like button 😇). We just built diff’rent. Thank you for your support!
🙃 Brazen Meme
✍️ Feedback
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