Vishal Bhatnagar, MD (@vishalbmd) header
Vishal Bhatnagar, MD (@vishalbmd) profile picture

Vishal Bhatnagar, MD

@vishalbmd

Associate Director for Patient Outcomes, Oncology Center of Excellence. FDA. Interested in MM and patient focused drug development. Opinions/tweets are my own

 Washington, DC
Joined November 2017
  • Tweets28
  • Following115
  • Followers255
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Photo by Vishal Bhatnagar, MD (@vishalbmd)Photo by Vishal Bhatnagar, MD (@vishalbmd)Photo by Vishal Bhatnagar, MD (@vishalbmd)Photo by Vishal Bhatnagar, MD (@vishalbmd)Photo by Vishal Bhatnagar, MD (@vishalbmd)
Listen in to two fantastic sessions moderated by @FDAOncology deputy director @pkluetz!
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An important draft guidance for those interested in rigorous measurement of PRO in oncology trials!
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Excited for this workshop, focused on better characterizing patient-reported physical function! @FDAOncology
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Exciting areas for meaningful #PFDD research! #PROs #RareDisease @FDAOncology
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Vishal Bhatnagar, MD retweeted
NFL on ESPN (@ESPNNFL) profile picture
NFL on ESPN
@ESPNNFL22 Nov 2020
Mo Gaba, who battled cancer and was blind, became part of the fabric in the Baltimore sports community and made a lasting impact on the Ravens. Mo died on July 28, 2020, but his legacy continues to carry on.
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Vishal Bhatnagar, MD retweeted
NEJM (@NEJM) profile picture
NEJM
@NEJM7 Oct 2020
Why has the United States handled this pandemic so badly? The Editors note that although we came into this crisis with enormous advantages, our current political leaders have demonstrated that they are dangerously incompetent.

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FDA’s professional staff have acted with a sense of high urgency during Covid, driven by a shared sense of public health mission; issuing over 60 guidances on accelerating Covid innovation, 750 drugs in mid or late stage trials, a huge review team focused on Covid therapeutics.
Image from Scott Gottlieb, MD 🇺🇸 (@ScottGottliebMD)
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Vishal Bhatnagar, MD retweeted
Paul Kluetz (@pkluetz) profile picture
Paul Kluetz@pkluetz21 Aug 2020
Informative visualization of the timing of FDA review when multiple expedited programs are put in place. A lot goes into hastening the availability of novel treatments for patients with cancer...
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Patient-reported overall side effect bother is key to assessing tolerability. Listen to @pkluetz moderate a discussion w/ @unbiasedlaura @GitaThanaMD @JFreemanDaily @SpiveySandra @pre_ryan, Dr Sandra Mitchell and Dr David Cella. Tune in now! #OCEOutcomes20
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Vishal Bhatnagar, MD retweeted
Paul Kluetz (@pkluetz) profile picture
Paul Kluetz@pkluetz17 Jul 2020
Like this panel, trial design for #PRO needs clinician, psychometrician, statistician and patient input! Expected toxicity and timing, right tool, strong analysis methods and objectives that are meaningful to patients. #OCEOutcomes20
Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD) profile pictureIshwaria Mohan Subbiah, MD MS FASCO
@IshwariaMD17 Jul 2020
Replying to @IshwariaMD
Folks you can't ask the right question at the wrong time! Timing of #PRO measurements must adapt as #cancer treatments (esp. their mechanisms, targets, etc) evolve!! @FDAOncology's Sundeep Agrawal tackles the timing challenge at @ASCO @FDAOncology #OCEOutcomes20!
Image from Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD)
Image from Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD)
Image from Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD)
Image from Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD)
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Vishal Bhatnagar, MD retweeted
Mel Calvert (@drmelcalvert) profile picture
Mel Calvert@drmelcalvert17 Jul 2020
Why timing really matters in #pro assessment. @BellKingKal describes how we may miss important side effects if we assess #PROs day 1 of treatment cycle -are frequent brief assessments the way forward? #OCEOutcomes20 @pkluetz @vishalbmd @FDAOncology @CPROR_UoB
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Vishal Bhatnagar, MD retweeted
Ramez Kouzy, MD (@RKouzyMD) profile picture
Ramez Kouzy, MD@RKouzyMD17 Jul 2020
Really excited to hear about project patient voice which will allow healthcare providers to access PRO data collected from cancer trials. This will allow providers to be armed with information that can guide treatment expectations #OCEoutcomes20 #PROs
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Folks you can't ask the right question at the wrong time! Timing of #PRO measurements must adapt as #cancer treatments (esp. their mechanisms, targets, etc) evolve!! @FDAOncology's Sundeep Agrawal tackles the timing challenge at @ASCO @FDAOncology #OCEOutcomes20!
Image from Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD)
Image from Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD)
Image from Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD)
Image from Ishwaria Mohan Subbiah, MD MS FASCO (@IshwariaMD)
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Happening now: @FDAOncology @ASCO COA-CCT workshop Session 2, moderated by @BellKingKal - and important discussion about PRO assessment frequency #OCEOutcomes20
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Vishal Bhatnagar, MD retweeted
Julia Maués (@itsnot_pink) profile picture
Julia Maués@itsnot_pink23 Jun 2020
Replying to @lisaksheldon @DarcyBurbage @pkluetz @vishalbmd
This team 100% walks the walk of listening to and including patients
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Registration now open! FDA-ASCO Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop : July 17, 2020 (virtual format) #OCEOutcomes20 @pkluetz @BellKingKal @FDAOncology @ASCO fda.gov/drugs/news-events-hu…
2020 Clinical Outcome Assessments in Cancer Clinical Trials

2020 Clinical Outcome Assessments in Cancer Clinical Trials

In this workshop, we will consider a hypothetical case example of a trial in which the investigational arm is a tyrosine kinase inhibitor (TKI) and the control arm is traditional cytotoxic chemothe...

fda.gov
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The @FDAOncology-AACR #MyelomaDiversity Workshop is underway! Looking forward to a series of important panel discussions focused on racial disparities in MM drug development. Drs. Gormley and Fashoyin-Aje kicking things off
Image from Vishal Bhatnagar, MD (@vishalbmd)
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Vishal Bhatnagar, MD retweeted
FDA Drugs and Biologics (@FDADrugs) profile picture
FDA Drugs and Biologics
@FDADrugs30 Sep 2019
#FDA issues draft guidance on Patient-Focused Drug Development (#PFDD) to describe methods to identify what matters most to patients regarding burden of disease and burden of treatment to guide medical product development, including endpoint development: go.usa.gov/xVGwq.
Image from FDA Drugs and Biologics (@FDADrugs)
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Excellent discussion re: Estimand framework. If you aren’t sure what that is or what it means for PRO, tune into the live webcast of the FDA-ASCO Clinical Outcome Assessments in Cancer Clinical Trials Public Workshop. #OCEOutcomes19 @BellKingKal @johnsonll @pkluetz @ASCO
Image from Vishal Bhatnagar, MD (@vishalbmd)
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Link to webcast: fda.gov/drugs/news-events-hu…
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