About to watch @realrickpazdur on @statnews #ASCO21 recap.

Pazdur is one of thoe FDA voices that silences the room when he pipes up. When he speaks, you listen.
@realrickpazdur @statnews .@realrickpazdur: People want to put regulations that don’t exist on us. For exmaple, we have to demonstrate that drug is safe and effective not that it is better than what we approved yesterday.
@realrickpazdur @statnews .@realrickpazdur: People must undersatnd we have to move on from the traditional overall survival endpoint to meet patients needs. #ASCO21
FDA's Paul Kluetz said he sees his work as colloborative with industry not confrontational as he thinks some of the public precieves it. to be.

Though FDA's Harprett Singh then chimes in to note it does sometimes get tense. Agency and company are not always on the same page.
.@realrickpazdur I think these 3 (his colleagues on panel) have been too politically correct for him.

says FDA is often confrontational. Companies often want path of least resistance and FDA is there pushing back.

"There is this inherent tension that always exists."
@realrickpazdur .@realrickpazdur: what we really want companies to do is do randomized studies looking at different doses before they go into pivotal study. very difficult to retrofit afterwards. --- relates to $AMGN's recently approved KRAS drug for lung cancer.
said FDA will be less forgiving in less refractory settings.
as an aside @realrickpazdur seems to be trying to make conscious effort to not dominate and let his colleagues weigh in. nice to see a manager do this.
@realrickpazdur .@realrickpazdur re dose finding: One of the other things we are emphasizing is to start including diverse populations early to figure out are there differences here (elderly, ethnic, gender, differences)

I've heard this from FDA folks at other times during #ASCO21.
.@realrickpazdur Unforutnate situation I have been railing on during proliferation of pd1 drugs, despite my admonitions there is not less there is more & we have to start asking do we need all of these drugs that are competeting against each other instead of advancing the field
@realrickpazdur Pazdur seems like he wants head to head trials but doesn’t expect to get them.
then we had a conversation on endpoints and debate around whether some non-OS endpoints are really OK -- Pazdur seems very set on idea can't hold things to standards haven't held other drugs/ cancer areas -- but this seems like slipperly slope????
Paul Kluetz - defending FDA accelerated approval program and FDA's commitment to reviewing drugs granted AA ---- I think the data doesn't quite back that up though. Lots of drugs linger forever with no confirmed clinial benefit.
.@realrickpazdur notes June will be the 10 year anniversary of the Avastin public hearing around revoking its accelerated approval in breast cancer.... this my first FDA advisory committee meeting coverage experience.
@realrickpazdur .@realrickpazdur re PD1/L1 accelerated approvals seems to be saying that PD1s generally very similar and often differences has been trial designs in whether drug succeeded or failed in one indication or not.

A failed trial is not a failed drug, he says.
Pazdur says FDA would be failing patients if they pullled good drugs because of poorly designed studies.
and here comes the accelerated approval and $BIIB question.....

@adamfeuerstein says he heard @realrickpazdur was brought in by FDA to help with situation.
@adamfeuerstein @realrickpazdur .@realrickpazdur: emphasizes that if you believe amloiyd beta is apprpriate surrogate marker then you can approve....

But isn't issue many studies seem to indicate it is not a good marker???
@adamfeuerstein @realrickpazdur .@realrickpazdur expresses openness to discloses complete response letters.

Poeple put their lives on the line in these studies, we owe it to the patients to make those disclosures.
FDA's Paul Kluetz says advisory committees are often used so FDA can be more transparent with a troubled application.
.@realrickpazdur says he favors keeping safety and efficacy determinations away from cost effectiveness determinations like QALY. its hard enough to do safety/efficacy and then cost can change on dime.
@realrickpazdur .@realrickpazdur says when he came to FDA in 1999 he said he didn't plan to stay at FDA more than 3 years. indicates has no financial motivation to move to higher paying gig now and doens't seem like he plans to retire.
@realrickpazdur and that is a wrap folks. This was a jammed packed interview. I might get assigned a story per minute.

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More from @SarahKarlin

10 Jun
#FDA's vaccine advisory committee about to discuss COVID-19 vax approvals and emergency use authorizations in children. Key thing will be whether they think EUAs are OK for younger children.

FDA's Dorian Fink emphasizes they are asking the committee to focus on safety for this panel (agency feels confident with their established efficacy process).
CDC now presenting some data on inital safety surveillance of use of $PFE vaccine in adolescents.

also on myocarditis and pericarditis w/ mrna vaccines.
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Here's a run down of some of our stories on $BIIB's Aduhelm approval for Alzheimer's (and then I'll try to stop tweeting about this for a bit :)

@brendasandburg on the unexpectedly BROAD label that doesn't align with trial population.

@brendasandburg .@PinkSheetSutter looks at the implications of FDA approving the drug via the accelerated approval pathway, including what it means for future FDA decisions.

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CDC's ACIP now talking about what data would be needed to inform delaying the 2nd dose of mRNA vaccines or single dose of mRNA vaccine for individuals w/ prioir confirmed SARs-coV-2 infection.
Sanchez - said have to go with what the RCTs showed us for timing of 2nd dose.

for single dose for peope w/ past infection -- he thinks need more data but could see this being a possibility down the line.
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I'm watching the second day of CDC's ACIP meeting today. This meeting if focused more broadly on COVID-19 vaccines than yesterday's.
ACIP going to discuss possibility of delaying 2nd dose of mRNA vaccines as well as whether people who already had COVID-19 only need 1 dose. $BNTX $PFE $MRNA
CDC's Dooling says in Phase I/2 trials neutralizing antibodies did not show large increases until after 2nd dose of mRNA vaccines.
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screams into the abyss becuase people just don't get it!!!

.@NateSilver538 please please please please please call some people who understand the FDA and vaccine review.
@NateSilver538 1. the US needs to stop pretending that vaccines are our ONLY tool. There are many and we need to do a lot better job using the other ones while the vaccine deveolpment does its thing.
@NateSilver538 2. I don't think people appreciate how much data FDA is going to pour through and how understaffed and overworked they are.

again read @KatherineEban's piece which will break your heart about the toll this pandemic has taken on some of its reviewers.
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