#BPC3: Become Trend on twitter at (2017-11-14 14:56)


People talking about #BPC3: - Kate_Rawson - Kate_Rawson - Kate_Rawson - Kate_Rawson - Laura_H - ZacharyBrennan - wendyselig - Ramsey_Baghdadi - ZacharyBrennan - Laura_H[...]
- wendyselig - Laura_H - wendyselig - CancerResrch - ZacharyBrennan - PinkSheetSutter - wendyselig - wendyselig - CancerResrch - CancerResrch - wendyselig - Laura_H - Laura_H - CancerResrch - ZacharyBrennan - BerrettDC - Ramsey_Baghdadi - BerrettDC - Laura_H - BerrettDC - BerrettDC - ZacharyBrennan - wendyselig - ZacharyBrennan - jennmcnary - CancerResrch - Laura_H - d2merino - d2merino - d2merino - d2merino - PDSA_ITP - wendyselig - PDSA_ITP - d2merino - wendyselig - d2merino - wendyselig - CancerResrch - Laura_H - Laura_H - wendyselig - d2merino - d2merino - ZacharyBrennan - wendyselig - d2merino - wendyselig - d2merino - d2merino - wendyselig - CT_Morrison - d2merino - wendyselig - CancerResrch - Laura_H - CancerResrch - ZacharyBrennan - CancerResrch - EladSharonMD - CancerResrch - EladSharonMD - CancerResrch - wendyselig - PinkSheetSutter - RevonSystems - wendyselig - RPMReportMike - RPMReportMike - wendyselig - CancerResrch - BerrettDC - BerrettDC - wendyselig - DonnaYoungDC - CancerResrch - Ramsey_Baghdadi - wendyselig - CancerResrch - wendyselig - ZacharyBrennan - CancerResrch - RPMReportMike - RPMReportMike - d2merino - CancerResrch - CancerResrch - d2merino

This Tag appearing in: United States: ( Cleveland - El Paso - Fresno - Greensboro - Harrisburg - Honolulu - Jackson - Jacksonville - Mesa - Miami - Milwaukee - Minneapolis - New Haven - Norfolk - Oklahoma City - Providence - Raleigh - Richmond - Sacramento - St. Louis - Tallahassee - Tampa - United States - ).
Popular tweets tagged with #BPC3:
#BPC3 Cancer Research @CancerResrchπŸ”Panel 2 on operationalizing patient input into approval decisions starts now #BPC3
loading...
Kate Rawson Powell @Kate_RawsonπŸ”Amazing panelists on stage to discuss PDUFA VI
Kate Rawson Powell @Kate_RawsonπŸ” Cole Werble's remark that FDA's office of tissues and advanced therapies w/in CBER might be more exciting than CDER oncology center of excellence generated several legit gasps and at least one "oh snap"
Kate Rawson Powell @Kate_RawsonπŸ”Corrected hashtag #BPC3 twitter.com
Kate Rawson Powell @Kate_RawsonπŸ”Talking about using drug reviews as a model for other diseases ’s Biopharma Congress
Laura Helbling @Laura_HπŸ”Woodcock: For medical products in the US the elephant in the room is the willingness of society to pay for new produc twitter.com ts. We're seeing the initial cracks in this construct because it’s not sustainable.
Zach Brennan @ZacharyBrennanπŸ”Woodcock on what keeps her up at night: "For medical products in the US, the elephant in the room is the willingness twitter.com of society to pay for the products. And that elephant is taking up most of the air in this room."
Wendy Selig @wendyseligπŸ”"We'd like sponsors to study the population that will be treated as part of registration trials." @FDAOncology #BPC3
Zach Brennan @ZacharyBrennanπŸ”Q on use of AI in regulations: Marks says FDA is engaged with IBM Watson and Quintiles to sort through spontaneous a twitter.com dverse event reporting
Laura Helbling @Laura_HπŸ”"They were born for one another" Marks says of RWE and vaccines. #bpc3
Wendy Selig @wendyseligπŸ”Any cancer patient with a solid tumor should be in a clinical trial. Yet only 3-5% of these pts enter trials. We have twitter.com to do better. Janet Woodcock
Laura Helbling @Laura_HπŸ”Marks says sponsors gather too much info as attempt to get a secondary endpoint or some insight if drug doesn't hit p twitter.com rimary. "The time to get insight into how your product works is Phase I or Phase II but not phase III." Prob need to consider streamlining Phase III trials.
Wendy Selig @wendyseligπŸ”We are falling systemically with unsustainable costs in clinical trials. Most barriers are cultural. @US_FDA Janet Woodcock #BPC3
Cancer Research @CancerResrchπŸ”Master protocols tend to be driven by patient groups; they're the people with a stake in getting outcomes @FDAOncology #BPC3
Zach Brennan @ZacharyBrennanπŸ”Woodcock repeats: clinical trial system is "broken – not sustainable, can’t answer the questions we want pre-market a twitter.com nd can’t figure out answers postmarket," need to commit to master protocols
Sue Sutter @PinkSheetSutterπŸ” Marks says CBER has received 34 RMAT designation requests, starting 12/14/17 -- the day after Cures was signed. #bpc3
Wendy Selig @wendyseligπŸ”2020 landscape for clinical trials: more exact definitions of Disease subtypes can lead us to better trial designs. twitter.com
Wendy Selig @wendyseligπŸ”Complicated issues of drug development engage many disciplines. Need excellence across the board. Janet Woodcock @US_FDA #BPC3
Cancer Research @CancerResrchπŸ”More to medical products than the clinical aspects; how do they all fit within the evolving science? - @US_FDA's Woodcock #BPC3
Cancer Research @CancerResrchπŸ”.@US_FDA's Pazdur: Need to focus on the excellence of people that work here & be integrated into the #cancer community #BPC3
Wendy Selig @wendyseligπŸ”Creating a dynamic regulatory environment at means focusing on the excellence of the people who work there and being twitter.com integrated into cancer community Dr. Pazdur
Laura Helbling @Laura_HπŸ” These are the people approving all the new medicine in the United States #BPC3 cc @CT_Morrison twitter.com
Laura Helbling @Laura_HπŸ”Marks says CBER has received 34 RMAT designation requests, starting 12/14/17 -- the day after Cures was signed. #bpc3
Cancer Research @CancerResrchπŸ” CBER Director Marks on RMAT designations – as of last Friday – 34 designation requests, acted on 31 and granted 11 #BPC3
Zach Brennan @ZacharyBrennanπŸ”CBER Director Marks on RMAT designations – as of last Friday – 34 designation requests, acted on 31 and granted 11 #BPC3
Berrett Stradford @BerrettDCπŸ” High priority for administration is bringing forward safe and effective treatments to patients - @US_FDA's Abram #BPC3
Ramsey Baghdadi @Ramsey_BaghdadiπŸ”These are the people approving all the new medicine in the United States #BPC3 cc @CT_Morrison twitter.com
Laura Helbling @Laura_HπŸ”CDER Director Woodcock discusses ways FDA is streamlining documentation:, like shorter guidance documents. Focus on h twitter.com aving up to date standards for diff disease areas, getting message out quickly.
Berrett Stradford @BerrettDCπŸ” CEO, Dr. Jeff Allen leads the discussion of FDA 2020 with leadership from the FDA. Drs. Pazdur, Woodcock, and Marks. twitter.com
Zach Brennan @ZacharyBrennanπŸ”FDA's Pazdur: Companies are now presenting pipelines to us – important for our reviewers to hear, rather than just h twitter.com ave a BLA dumped on your door…what are the selection criteria to move molecules forward, what are they looking at
Wendy Selig @wendyseligπŸ”"Rainforest, bottom of the sea and roulette wheels" the old ways of looking for Cancer drug targets. The world had c twitter.com hanged and so has Dr. Pazdur
Zach Brennan @ZacharyBrennanπŸ”FDA's Pazdur explaining change in cancer drug dev.: in 80s and 90s, we basically sent people to rainforests and the b twitter.com ottom of sea and used a roulette wheel of what would work...imatinib was the turning point
jenn mcnary @jennmcnaryπŸ”"Times have changed....huge changes, driven by the science" - (my personal hero) Janet woodcock #BPC3
Laura Helbling @Laura_HπŸ”On FDA having enough resources to attend the growing # of externally-led PFDD meetings, Principal Deputy Commissioner twitter.com Sherman: "This is not a place where we want to cut back."
Diana M Merino @d2merinoπŸ”Key example of the importance & influence of the #patientvoice in drug development. #BPC3 twitter.com
Diana M Merino @d2merinoπŸ”Bryan @US_FDA: patient focused drug development #PFDD mtgs help every1 understand range of concerns of ptsπŸ‘‰capture entire disease #BPC3
Diana M Merino @d2merinoπŸ”W. Bryan from @US_FDA: advocates should have a say early in drug developmentπŸ‘‰the earlier they voice concerns=greatest influence. #BPC3
Diana M Merino @d2merinoπŸ”Big S/O to @pkluetz from @FDAOncology & his great work in incorporating the #Patientvoice into drug development πŸ‘ Still + work ahead #BPC3
PDSA ITP SUPPORT @PDSA_ITPπŸ” Evaluating the meaningful-ness of certain outcomes? Patients can tell us and impact regulatory decisions. @US_FDA #BPC3
Wendy Selig @wendyseligπŸ”A well-deserved Paul Kluetz love-fest #BPC3 @FDAOncology
loading...
PDSA ITP SUPPORT @PDSA_ITPπŸ”PDSA Executive Director Caroline Kruse discussing importance of patient perspective with Principal Deputy Commission twitter.com er Rachel Sherman and Center for Drug Evaluation and Research's Wilson Bryan
Diana M Merino @d2merinoπŸ”Caroline Kruse from @PDSA_ITP advocating for #QOL endpoints in clinical trials: physical & emotional QOL measures to be considered #BPC3
Wendy Selig @wendyseligπŸ”Many points of entry at @US_FDA for Patient Engagement. Many shots on goal or too confusing to navigate? #BPC3
Diana M Merino @d2merinoπŸ”On to the use of the in approval decisions with twitter.com
Wendy Selig @wendyseligπŸ”Critical time to impact new treatments us during development. Patients must be engaged early in trials. @US_FDA #BPC3
Cancer Research @CancerResrchπŸ”Quality of life issues not normally taken into consideration, would like to see them incorporated into twitter.com - 'S Kruse
Laura Helbling @Laura_HπŸ”First theme at is aggressive piloting of RWE. FDA put a lot of resources behind it. Companies should come in with all kinds of proposals.
Wendy Selig @wendyseligπŸ”Bleeding disorders have multiple treatments but still much unmet need. Side effects of treatments can be severe. twitter.com Caroline Kruse.
Diana M Merino @d2merinoπŸ”Stein @US_FDA: space to use #RWD in decision-making framework, but 1st understand the limitations assoc w these data #BPC3 #RWE
Diana M Merino @d2merinoπŸ”P. Stein from @US_FDA: need to learn how to use observational trial data for drug approval processπŸ‘‰include in totality of evidence #BPC3
Zach Brennan @ZacharyBrennanπŸ”first I've hear an FDA Director say patient testimony at ad com had impact on approval decision. OTAT Dir. said a wom twitter.com an's testimony at an Ad Com over melanoma drug: "influenced heavily our decision to grant a regular approval"
Wendy Selig @wendyseligπŸ”Evaluating the meaningful-ness of certain outcomes? Patients can tell us and impact regulatory decisions. @US_FDA #BPC3
Diana M Merino @d2merinoπŸ”S Milligan @Merck: space for parallel studies on #RWE during trial devt,m. Need to assess whether this would be helpful & $efficient #BPC3
Wendy Selig @wendyseligπŸ”Externally led patient focused drug development meetings offer new ways to collaborate in bringing patient voice to @US_FDA #BPC3
Diana M Merino @d2merinoπŸ”Jeff Allen @CancerResrch: success in #RWE measured by whether study findings make into product #labels πŸ‘‰ leads to patient improvement #BPC3
Diana M Merino @d2merinoπŸ”S. Galson @Amgen on #RWE: learn how to collect high quality data more efficiently. Sponsors shouldn’t be waiting for @US_FDA guidance #BPC3
Wendy Selig @wendyseligπŸ”Grwat to be listening to @PDSA_ITP leader Caroline Kruse discussing efforts to engage with @US_FDA #BPC3
Chris Morrison @CT_MorrisonπŸ” Cole Werble's remark that FDA's office of tissues and advanced therapies w/in CBER might be more exciting than CDER twitter.com oncology center of excellence generated several legit gasps and at least one "oh snap"
Diana M Merino @d2merinoπŸ”Hukkelhoven from @bmsnews on #RWE, role for industry to propose study pilots, create smart protocols and validate data sources #BPC3
Wendy Selig @wendyseligπŸ”Public service commitment to patients runs deep at @US_FDA #BPC3
Laura Helbling @Laura_HπŸ”Amgen, Bristol and Merck SVPs agree 100% user fee funding is a "bad idea. "I don't think we would be able to do anyth twitter.com ing right at that point," Merck's Sandra Milligan.
Cancer Research @CancerResrchπŸ”High priority for administration is bringing forward safe and effective treatments to patients - @US_FDA's Abram #BPC3
Zach Brennan @ZacharyBrennanπŸ”On Q of whether FDA should only rely on user fees (as Trump wanted)? Unanimous no. $MRK SVP says: it’s not the money, it’s the balance #BPC3
Cancer Research @CancerResrchπŸ”We have a real opportunity to show this integrated approach is forward-leaning; Congress created the Oncology Center twitter.com of Excellence, now they need to fund it - Jeff Allen
Elad Sharon @EladSharonMDπŸ”Talking about using drug reviews as a model for other diseases ’s Biopharma Congress twitter.com
Cancer Research @CancerResrchπŸ”The opportunity is NOW - Jeff Allen #BPC3 #oncologycenterofexcellence #OCE
Elad Sharon @EladSharonMDπŸ”Talking about using drug reviews as a model for other diseases ’s Biopharma Congress twitter.com
Cancer Research @CancerResrchπŸ” Oncology Center of Excellence @US_FDA can be a model for future integration. Disruption is a good thing for patients. #BPC3
Wendy Selig @wendyseligπŸ”Oncology Center of Excellence @US_FDA can be a model for future integration. Disruption is a good thing for patients. #BPC3
REVON Systems @RevonSystemsπŸ” We need to take a structure approach to collecting #realworldevidence - @bmsnews' Hukkelhoven #BPC3
Wendy Selig @wendyseligπŸ”Harmonize processes between divisions and offices @US_FDA to minimized differences among people who lead them. #BPC3
Wendy Selig @wendyseligπŸ”Predictability and consistency are important buzzwords for @US_FDA #BPC3
Cancer Research @CancerResrchπŸ”With a changing landscape, we're looking at how to be the most efficient organization moving forward - 's Stein twitter.com
Berrett Stradford @BerrettDCπŸ”Unable to join us for BioPharma Congress III? Follow along on our Facebook Live feed or #BPC3 @CancerResrch
Berrett Stradford @BerrettDCπŸ” "Need to benchmark where we are, which will help show where we need to go" - Jeff Allen on #realworldevidence #BPC3
Wendy Selig @wendyseligπŸ”Need to define quality of RWE data and Clinical study methods. @US_FDA looking for ways to incorporate data. Totality of evidence. #BPC3
Donna Young @DonnaYoungDCπŸ” $AMGN SVP says companies shouldn’t wait for FDA guidance on piloting uses of real world data #BPC3
Ramsey Baghdadi @Ramsey_BaghdadiπŸ”First theme at is aggressive piloting of RWE. FDA put a lot of resources behind it. Companies should come in with a twitter.com ll kinds of proposals.
Wendy Selig @wendyseligπŸ”Pre-competitve efforts could help benchmark RWE endpoints to move us forward. @CancerResrch Jeff Allen #BPC3
Cancer Research @CancerResrchπŸ”"Need to benchmark where we are, which will help show where we need to go" - Jeff Allen on #realworldevidence #BPC3
Wendy Selig @wendyseligπŸ”Some companies need more convincing to use real world evidence. Why?? Patients in trials don't match patients who use drugs. #BPC3
Zach Brennan @ZacharyBrennanπŸ”$AMGN SVP says companies shouldn’t wait for FDA guidance on piloting uses of real world data #BPC3
Cancer Research @CancerResrchπŸ”We need to take a structure approach to collecting #realworldevidence - @bmsnews' Hukkelhoven #BPC3
Michael McCaughan @RPMReportMikeπŸ”Panel 1 at BioPharma Congress III is now underway! Weren’t able to attend? Follow our hashtag for updates throughout the day
Diana M Merino @d2merinoπŸ”Amazing panelists on stage to discuss PDUFA VI twitter.com
Cancer Research @CancerResrchπŸ”Panel 1 at BioPharma Congress III is now underway! Weren’t able to attend? Follow our hashtag for updates throughout twitter.com the day
Diana M Merino @d2merinoπŸ”@PrevisionPolicy @CancerResrch Oops! Here’s the right hashtag #bpc3

05

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive