Dearest Brazeryens: Sam Altmanâs birthday was on Earth Day. Coincidence?
[Welcome to Issue Number 55 of The House Brazeryen, where we break down the latest #ScientistCEO-related news for you fortnightly, in roughly 5 minutes. Brought to you by Brazen Bio, Brazen Capital and brainsurgerydropout.]
Was this forwarded to you? Mash this subscribe button, homie.
FOUNDERâS LENS: FDA Orphan Drug Resignation
by W. Shawn Carbonell, MD, PhD â My startup has successfully obtained THREE Orphan Drug Designations (ODD), but no one cares (esp. investors).
Little Orphan Druggie
Here is the tl;dr on the FDA Orphan Drug Act (ODA) of 1983:
âwen market smol, farma no likey.â âanonymous
The ODA aims to encourage the development of drugs for rare diseases that affect fewer than 200,000 people in the United States. It does this through:
tax credits (50% credit on all clinical trial-related expenses!)
no fee to submit a New Drug Application (in FY24 a savings of ~$4M!)
7 year market exclusivity (even more powerful than patent protection!)
This all seems pretty sweet. HoweverâIMHOâthe ODA fails to incentivize the entities most likely to pursue orphan indications: startups.
Is ODA an ODB?
To date, there have been over 6,000 orphan designated drugs (ODDs) and over 1,000 of those have ultimately entered the market. Great, but hereâs the problemâŚ
âŚuntil a drug is FDA approved there is basically ZERO BENEFIT for the company (usually a startup) who obtained the ODD other than an opportunity for people (including investors) to ignore your stupid press release.
And it gets worse⌠if you successfully obtain an ODD but a competitor beats you to market approval *THEY*âNOT YOUâGET THE ODA BENEFITS!!!!!!! WTF?!??!?
Holy UNO Reverse Card.
You Down with ODV?
What are some ways to improve this?
Taking a cue from the highly successful FDA Priority Review Voucher (PRV) programs, I believe the ODD should be a voucher system as well⌠letâs call it âODVâ. This gives the program teeth as rather than a mere trophy on the shelf it becomes a valuable asset for young struggling startups.
BRAZEN BREAKDOWN
Donât get me wrong, an ODV likely wonât have the insane nine-figure value of a more versatile PRV, but it would mitigate risk, increase collaboration, attract investment, and enhance flexibility for companiesâagain largely small startupsâinvesting in orphan drug research.
Major downside of an ODV? Having drafted two successful ODD applications in collaboration with the former Director of the Office of Orphan Products Development, I can tell you it is almost too easy. The process should be much more rigorous to avoid creating an arbitrage economy (i.e., filing and flipping).
That said, if any startups are interested in obtaining an ODD as it stands today feel free to hit me up.
BrazenGPT: Llama 3 Update
Our AI chatbotâEmilia (hosted on Hugging Face)âjust got a Face-lift! Woo!
After fucking around with Metaâs newest releaseâLlama 3âwe found out that we were really impressed with the outputs (especially to sanity-check questions like âIs it morally right to kill mosquitos?â).
So, we swapped out the prior LLM (Mixtral) for Zuckâs GPT-4 killer. Additional tweaks are ongoing as Hugging Face adds more functionality (including web access); please pardon our dustâŚ
BRAZEN BREAKDOWN
Ask Emilia all your burning questions at bit.ly/brazengpt. Registration is required, but itâs totally FREE.
đ BRAZEN SNAX
đ Unexpected solution for cancer: put it in rice
đĽľÂ Imagine your sweat being so potent it prevents Lyme disease
đ¨đŚ Grad studs and postdocs finally get a national pay raise in Canada
đşđ¸ Grad studs and postdocs finally get a national pay raise [NIHâs version]
đ Become a Brazen Capital LP! Rich folks need only apply (by law đ)
đ¤ The startup we all knew was coming: CRISPR + LLMs
đŚ Fossilized remains of the giant fish lizard of the Severn discovered
đŚ Force-fed bat feces: what could go wrong?
𼺠Fighting back against the ongoing normalization of burnout
â° TikTokCrak:Â The health teacher we all wish we had
đŞ CARVEOUT
An oldie but goodie⌠eBoysâby Randall Strossâis the first ever journalist peek deep inside the workings of a Silicon Valley venture capital firm. Not just any VC firm, but the legendary Benchmark.
Published in 2000, it was waaaaay ahead of its time. Given there hasnât been another book like it since is all the more reason you should savor every delicious morsel of it rn!
đđ˝ A DOSE OF GRATITUDE
We are grateful for Liam Lewis, a grad of our Junior Venture Fellow program who kicked ass and sourced our latest portco, DrĹŤl (who also is kicking ass).
đ BRAZEN MEME
đ BRAZEN THOUGHTS
âRemember when you are offended you are complicit in taking the offense.â
âEpictetus
âď¸ FEEDBACK
>98.5% of you donât smash the like button and even fewer leave a comment! Be the change we need! And letâs continue the convo @brazencapital