Incredibly excited to share a very informative #FDA guidance on #externalcontrols hot off the presses! So proud to have led the #statistics effort on this one, in conjunction with colleagues across including
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Paul Kluetz
@pkluetz
med onc, interested in trial design, endpoints and scientifically rigorous measurement of the patient experience- tweets and opinions are my own
Joined December 2008
Paul Kluetz’s Tweets
We enjoyed meeting with Heme/Onc Fellowship Program Directors from to discuss ways to collaborate and advance #drugdevelopment education in clinical training!
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Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology ja.ma/3QxttQH via .
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presenting the In4M study during the digital technology scientific workshop. Solutions to study challenges include modified eligibility criteria and patient outreach to help with wearable devices issues. #ASH22
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#ASH22: Dr. Kelly Norsworthy presents an FDA Perspective on Challenges Posed by Inconsistent Classifications, Sat. Dec. 10 at 10:30 am CT
ash.confex.com/ash/2022/webpr
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Save the Date! National Black Family Cancer Awareness Week is June 15-21, 2023. Note our new web page: fda.gov/about-fda/proj. Check out the new social media toolkit and images and join us for #BlackFamCan!
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#FDAOncology's Dr. Nicole Gormley will deliver the keynote address for #ASH22 session "What is a Decentralization of Clinical Trials?" on Dec. 9 at 2:03 pm CT. hematology.org/meetings/annua
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Martha Donoghue, MD, was appointed OCE's Associate Director of Pediatric Oncology & Rare Cancers and Acting Associate Director for Pediatric Oncology, Office of Oncologic Diseases. She succeeds Greg Reaman, MD, now Scientific Director, Childhood Cancer Data Initiative
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Learn about FDA's role in drug development and oncology trial design considerations in the first four episodes of the OCE Regulatory Science Online Lecture Series.
fda.gov/about-fda/onco
#OCEProjectSocrates
#cancerclinicaltrials
#biostats
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We are cohosting with the first ASH-FDA Collaboration: A Workshop on Regulatory Science in Hematology. We are enjoying this two-day meeting and information exchange with ASH. Thank you to co-chairs .
hematology.org/advocacy/get-i
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It was a wonderful experience to share my pt perspectives & learn at the Project FrontRunner Mini Symposium yesterday
👆explored moving #clinicaltrials with novel agents to earlier lines in St IV #CRC
Lots of insightful discussions
👀forward to more new drugs for more pts
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October is American #PharmacistsMonth! We're celebrating pharmacists working at #FDAOncology to improve lives of patients with cancer. Meet Meena Murugappan, PharmD, MPH, visiting scientist in the Oncology Center of Excellence.
#FDAPhamily #CelebrateFDAPharmacists #OCECareers
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Congratulations and welcome to Dr. Monica M. Bertagnolli, the 16th director of the . She is the first woman to hold the position of NCI director. bit.ly/3SPNCBp
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OCE welcomes Dr. Meena Murugappan to the Patient-Focused Drug Development Program & the Regulatory Affairs & Policy Team. She received her PharmD and MPH in Epidemiology at University of Minnesota and is a PhD candidate at UMN in Health Economics and Outcomes Research
#OCECareers
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OCE's received the 2022 Association of Community Cancer Centers Annual Achievement Award, recognizing her efforts leading scientific and policy initiatives to address disparities in oncology drug development. #OCEProjectEquity
accc-cancer.org/home/about/awa
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We welcomed Dr. Gabriel Hortobagyi of MD Anderson Cancer Center on Sept. 26 for a fantastic talk on breast cancer as part of OCE’s Icons in Oncology Distinguished Lecture Series! #OCEProjectSocrates
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OCE leadership & #ProjectOrbis met today at FDA HQ with Prof John Skerritt, PhD, Deputy Secretary for Health Products Regulation in Australia's and head of , a #ProjectOrbis partner. Photo: OCE's #MarcTheoret #AngeloDeClaro & Prof. Skerritt.
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OCE welcomes Dr William Maguire as a clinical reviewer on the GU Team led by . After & , he earned an MD-PhD @ Tri-Institutional Program , did research and residency/fellowship .
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OCE welcomes Dr James Buturla to the Division of Oncology 1 as a clinical reviewer on the Breast/GYN cancer team led by Dr Christy Osgood. He received his MD , completed residency and Hematology-Oncology fellowship .
#OCECareers
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FDA's spoke Sept. 21 PHEN Annual African American Prostate Cancer Disparity Summit on increasing participation of African American patients in prostate cancer clinical trials.
#ProstateCancerAwarenessMonth
#OCEProjectEquity
phensummit.org/2022-2/session
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OCE welcomes pediatric oncologist Michael Barbato, MD, to the Div. of Oncology 2 NPR team (CNS/pediatric/rare tumors) led by Dr. Diana Bradford. He earned his MD , completed residency & peds heme/onc fellowship
#OCECareers
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Great Opportunity to join a fantastic team.
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The Genitourinary Malignancies Branch of the NCI is recruiting a medical oncologist to join the prostate cancer clinical team. The candidate must be licenses in the US and Board Certified in Medical Oncology. Please contact Dr Ravi Madan or Dr. W. Douglas Figg if interested. #NCI
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FDA pooled analysis #ASCO22 abstract #9029: Association of PFS and ORR with OS in 1st-Line RCTs of ICI-Based Regimens for Metastatic - presented by #FDAOncology's on Monday, June 6 Hall A Poster #5; 8 am CDT
bit.ly/3Ngi45x
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Patient reported outcomes in pediatric cancer registration trials -- a US Food and Drug Administration perspective #pedonc #pedcsm #FDAOncology's #GregoryReaman #NajatBouchkouj - via
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Oncology careers beyond academia? Learn more from #FDAOncology's on June 3, 3pm Central time in E350 or online. #ASCO22.
meetings.asco.org/2022-asco-annu
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We're looking forward to joining colleagues in clinical oncology for scientific and regulatory discussions Annual Meeting #ASCO22 soon. Check out the lineup of #FDAOncology speakers here 👇
fda.gov/about-fda/onco
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#FDAOncology #OladimejiAkinboro will present an abstract, Outcomes of anti-PD-(L)1 therapy with/without chemotherapy for 1st-line treatment of advanced non-small cell lung cancer with PD-L1 score ≥50%: FDA pooled analysis. #ASCO22
6/3, Hall D1, 1pm CDT
bit.ly/3t04ivC
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Thankful to be faculty for the 1st time at #ASCO22 with these incredible panelists ➡️ discussing methods to enhance patient centric clinical evidence generation across the continuum. #RCT #RWD Please join the discussion on June 5th! twitter.com/ASCO/status/15
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Today, oncology reviewers and staff who joined the FDA in the past 3 years met on the White Oak campus to have pizza with OCE Director , OCE leadership and staff, and Divisional leadership. Bonus visit from !
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Published in this month’s issue. A discussion on unique challenges of time-to-deterioration of symptoms or function using #PROs in cancer trials. Great multi-disciplinary team effort with J Roydhouse TY Chen S Tang
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Interested in dose optimization? Join us for the OCE and workshop Getting the Dose Right: Optimizing Dose Selection Strategies in Oncology, May 3 & 5, 2022. 1-4:45 pm ET. #OCEProjectOptimus #AACR22
fda.gov/news-events/fd
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🐊Really honored to be a #40GatorsUnder40! 🧡💙Abundant gratitude to my family, friends, & colleagues for your guidance and collaboration! 🧡💙 Thanks . Dream Big, Build Resilience, & Be Kind! Go out there and change the 🌎 #GoGators #GoGreater twitter.com/ufalumni/statu
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Thanks to participants for the OCE #ACR22 patient engagement roundtable and Shonte’ Drakeford for this dynamic discussion. #OCEProjectCommunity #EndCancerAsWeKnowIt #CancerMoonshot #BlackFamCan
abstractsonline.com/pp8/#!/10517/s
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Now that I’m 7 weeks into the job, I’m up to speed on the status 5 years after leaving my first term. The time is right to advance regulatory science and collaborative efforts across FDA, HHS and communities served by FDA’s centers to improve evidence generation.
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Impactful use of #PRO and other patient generated data-> treatment side effects and impacts -> tolerability -> optimizing dose. #projectoptimus #OCEPFDD #AACR22 #fdaoncology
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Today's schedule for #FDAOncology @ #AACR22 Friday, April 8:
DC04. Using Patient-Generated Data to Optimize the Dose for Oncology Drugs, 3-4:30pm Rm 265-268 Conv Center. With FDA's Mirat Shat @pkluetz @vishalbmd Jeanne Fourie Zirkelbach @MallorieFiero
abstractsonline.com/pp8/#!/10517/s
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#BLOODPACSummit I have seen the impact of #BLOODPAC from a clinical standpoint, it has allowed for trial initiation and clinical data getting generated.
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Postdoctoral Fellows - Find the right #JobOpportunity for you and launch your career with us! Begin your search here: ccr.cancer.gov/careers/traini #CCRTraining
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Clinical Evidence Generation During a Pandemic: Lessons Learned for Sustaining Progress - workshop report via The Cancer Journal @califf001
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The goal of #AcceleratedApproval is to provide earlier access to drugs and biologics based on initial evidence of safety and effectiveness. Learn how we work to accomplish this with #OCEProjectConfirm: fda.gov/about-fda/onco
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