AdamJButler

We can make clinical research better for everyone!

[AdamJButler @AdamJButler]

@bijans This is about to become the hot new target indication in CNS - not even joking.

[AdamJButler @AdamJButler]

@RKouzyMD @PavlosMsaouel @ebludmir The most Stanford thing I’ve ever seen

[AdamJButler @AdamJButler]

@RecoveryDoctor These guys are hilarious - won’t even link the original research. “Secondary outcomes generally favored psilocybin over escitalopram, but the analyses of these outcomes lacked correction for multiple comparisons.”

[AdamJButler @AdamJButler]

@PaulAustin3w This paper clearly shows a negative outcome for psilocybin in this design?? “Secondary outcomes generally favored psilocybin over escitalopram, but the analyses of these outcomes lacked correction for multiple comparisons.” https://t.co/o7Tc7sXRmP

[AdamJButler @AdamJButler]

@bijans Crazy thing to take public without evidence!

[AdamJButler @AdamJButler]

Also a racist who went to the grave believing that Charles Murray’s race science was real. The late Sharon Begley’s obituary tells the story quite well. https://t.co/PSEDEiHbir

[AdamJButler @AdamJButler]

James Watson was a bad guy and carried himself terribly, especially around female peers, and that’s how he should be remembered.

[ISCTM @isctm]

Join academic, industry, and regulatory global leaders at the ISCTM/ECNP Joint Autumn Conference to address challenges and future directions in CNS trials! Amsterdam, Netherlands 9-11 October https://t.co/E4V6CHHNzz

#ISCTM #ECNP #CNS #trials #methodology

[AdamJButler @AdamJButler]

@RefiningValue @matthewherper Another data solution built around medical records, claims, EHR. The value proposition for these kinds of data sources is pretty limited and we’ve had hundreds of startups try to show value here in the past 5 years.

[AdamJButler @AdamJButler]

@Sports_bios DELIVER is an interesting use case on a new wearable outcome measure - SV95c. It’s been qualified in EMA as a replacement primary for NSAA in this patient pop. FDA is evaluating it. Good exploratory data in this study could be enough for them to switch in ph3.

[AdamJButler @AdamJButler]

@ysingh_hopkins Really good paper. There has been similar consolidation of specialty clinics that exclusively serve as clinical trial sites into PE umbrellas. It would be interesting to see if returns have been better or worse than these practices.

[AdamJButler @AdamJButler]

@erinbrodwin It will be interesting to see if Otsuka can figure out how to combine an app and a small molecule and get the same payor to reimburse for both. The efficacy doesn’t look great compared to existing options.

[AdamJButler @AdamJButler]

@erinbrodwin @holdspacefree Babylon had peer reviewed data and started as an NHS pilot 🥴

[Ken Klippenstein @kenklippenstein]

Instead of an election let’s just see who can draw a clock better

[AdamJButler @AdamJButler]

@matthewherper It begs the question - why isn’t the FDA requiring the use of the CSSR-S in these studies? They utilize this tool broadly (and sometimes punitively) in other indications but I’m not aware of any glp-1 studies that are prospectively measuring this.

[AdamJButler @AdamJButler]

@matthewherper @23andMe The company is betting the farm on therapeutics. They shut down telehealth earlier this year and personal genome testing revenue is now declining YoY.

[AdamJButler @AdamJButler]

@Sports_bios One of the key secondaries in this study (SV95c) has been qualified as a primary by the EMA for the same patient population, and is under consideration by FDA. If this separates it could be compelling evidence in support of this application. Patients and families hate the NSAA.

[AdamJButler @AdamJButler]

@Sports_bios @BiotechObserver I recently rewatched the ALNY adcom. FDA had specific and pointed critique for choice of KCCQ as an endpoint in this patient group. “We are not aware of any evidence of what a clinically meaningful change on the KCCQ is.” All of these other companies have KCCQ as 2nd endpoints.

[AdamJButler @AdamJButler]

@bijans 13% revenue CAGR and it wasn’t enough - the scale these guys must have been expecting is high!

[AdamJButler @AdamJButler]

Today I learned that “Versorgungsrealität” is the German word for standard of care.