Johnathan Maher

Cancer biologist and biotech enthusiast

[Houman David Hemmati, MD, PhD @houmanhemmati]

I am witnessing a handful of biotech companies doing important work in rare diseases - blinding conditions, syndromes that kill children etc - on the verge of shutting down (some despite stellar Phase 3 data!) because investors are hesitant to invest $20-100M w/FDA uncertainties.

I therefore applaud Acting Commissioner @FDA_KyleD and other senior leaders' statements this week making it clear that FDA intends to adopt a patient-first approach that includes empowering career staff to do their jobs without interference, and to hold Advisory Committees (AdComs) again to put drugs under review "on trial" -- for the public to see and for the public to PARTICIPATE.

It's ESSENTIAL to hold more AdComs because the public needs to witness and have a say in regulatory decision-making that directly impacts the American people AND it gives the FDA more confidence in the decisions they make. A win-win.

There's a lot more to do, but this is a great start. Time is of the essence because uncertainties and lack of predictability at FDA have made it impossible for many small companies (the ones responsible for nearly all innovation) to survive due to the exceptionally expensive process of manufacturing & testing drugs.

Each day, more American patients will suffer & die, so let's encourage our leadership to give the public & the investment community more confidence.

[David Frum @davidfrum]

Today, childhood leukemia has a 90% survival rate, thanks to a sophisticated menu of treatments developed and sold by companies like Johnson & Johnson https://t.co/7nnwWToPmS, Novartis https://t.co/zi6LRjVTvE, and Pfizer. https://t.co/GkyJgY1Vs0 3/x

[Johnathan Maher @JCMaher75]

@BoitechB Amazing 😂

[Dana-Farber’s Breast Oncology Center @DFCI_BreastOnc]

Check out Dr. Ada Waks' & coauthor’s #SABCS23 poster on ACE-Breast-03: Phase 2 study of ARX788 a novel next-generation anti-HER antibody-drug conjugate in HER2+ #metastaticbreastcancer patients previously treated with trastuzumab deruxtecan @adawaksmd @hoperugo #DanaFarberSABCS23

[Urology Times @UrologyTimes]

Findings from the APEX-01 study: PSMA-targeting antibody-drug conjugate ARX517 demonstrated early efficacy signals with a strong safety profile in patients with mCRPC. #ESMO23 #urology #urologist #pcsm @johnshenmd @UCLAJCCC

Read more: https://t.co/VGHRwzM6Be

[OncLive.com @OncLive]

ARX517 Demonstrates Early Efficacy With Favorable Safety in Heavily Pretreated mCRPC @johnshenmd @UCLAJCCC @myESMO #ESMO23 #ESMO2023 #pcsm #oncology https://t.co/6oaORseJVq

[Targeted Oncology @TargetedOnc]

In the phase 1/2 APEX-01 study, ARX517 led to preliminary efficacy and displayed a strong safety profile when used as a treatment for patients with #mCRPC. #ESMO23 | @johnshenmd @UCLAJCCC

https://t.co/CcQ75cx4fa

[Johnathan Maher @JCMaher75]

@CharuAggarwalMD @PennMedicine @PennCancer @CoreyLangerMD @MMarmarelis @LovaSunMD @AditiSinghMD @CCiunci @PennMedNews @PC3Innovation @PennPrecisMed @PennMDForum @kevinbmahoney @PennMedEVDCSO Congratulations, Charu!

[josh_skowronski @skowronski_josh]

#2 of the forest acres classic.@PBR_SC @PBRMaryland @JNaill8 @UKBaseball @coachlowry301

[Peter Kolchinsky @PeterKolchinsky]

Nature, your view of how economy works would suggest that America's public schools should be getting royalties on everything its graduates accomplish. After all, taxpayers paid to make you smart and now their graduates have jobs and make a profit! Right, that what taxes are for.

[Brad Loncar @bradloncar]

$RCUS communication on calls and things over the last year has been some of the strangest I've seen in a while. Have to give them credit for getting it done, and then some. To partner one drug is hard in IO today...to partner three is really impressive.