FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. fda.gov/drugs/resource…

#OCENewsBurst

So great seeing friends!! Ishwaria Subbiah, MD MS FASCO Jasmine Kamboj Harpreet Singh, MD Paul Kluetz Timil Patel, MD

In NSCLC IO trials, the moderate link between ORR & PFS and OS necessitates thorough OS analyses, even if initial PFS results are not promising. This critical measure ensures potential survival benefits are not overlooked. Bernardo Haddock Lobo Goulart Harpreet Singh, MD FDA Oncology

Just released: Report to President Biden from President's Cancer Panel highlights recommendations in 5 priority areas to accelerate progress towards the #NationalCancerPlan goals. Read the full report here: bit.ly/42T4vBE

An OCE reunion at Biopharma Congress! A fun & interesting discussion led by Rick Pazdur on misconceptions of the FDA and industry from individuals who know both arenas very well! FDA Oncology Friends of Cancer Research Prevision Policy

Even our most complex trials can be made more patient-centric by moving some assessments closer to where pts live. Shaalan Beg MD MBA FASCO & Vivek Subbiah, MD offer an insightful perspective on modernizing precision medicine protocols w/ DCT elements. This will be the future!

🚨Hot off the press JAMA Oncology JAMA 👉🏼Delighted to share 👉🏼
Modernize Precision Oncology With Decentralized Trial Tools Shaalan Beg MD MBA FASCO OncoAlert OncoDaily Oncology Brothers jamanetwork.com/journals/jamao…

More #GI24 photos!
Great company, conversations, and even more collaborations!

Malaria kills almost 1/2 million kids every year in #Africa . Today rollout of a #malaria vaccine begins. This is a turning point in #HistoryofMedicine . Congrats to all who made it happen. Science will win. Believe it. 💪🙏🏆

#GetVaccinated #VaccinesWork

statnews.com/2024/01/22/gsk…

Friends of Cancer Research is excited to announce the addition of Roy Herbst to our board of directors.

“I am honored to have the opportunity to work more closely together with the leadership of Friends.'

Read Friends statement here: bit.ly/48LlZl3

Yale Cancer Center Smilow Cancer Hospital

The Cancer Moonshot Task Forces met yesterday The White House to discuss the incredible progress that has been made to expand cancer screening, accelerate drug development & finding ways to support patients and caregivers! #BidenCancerMoonshot

It’s an honor to speak at the President’s Cancer Panel! Thank you President's Cancer Panel!

FDA is investigating reports of T-cell malignancies, including chimeric antigen receptor (CAR) positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies. fda.gov/vaccines-blood…

Applications for the February 2024 FDA Oncology-ASCO Fellows Day Workshop are now being accepted until Nov 27! Apply online here asco.smapply.org/prog/FebruaryF…, and look forward to meeting the next group of fellows in a few months! #OCEProjectSocrates

At the Friends of Cancer Research Annual Meeting - Dr. Monica M. Bertagnolli and Dr. Robert M. Califf emphasize that where appropriate cancer clinical trials need to be simplified to generate better evidence. #FriendsAM23

OCE Deputy Director Dr. Paul Kluetz sat for a Keynote Fireside Chat with @dtraorg co-co-founder Craig Lipset at the Nov. 6 DTRA annual meeting. The topic of conversation was 'Mythbusting and the Future of Decentrialized Cancer Trials.'
#PatientFocusedDrugDevelopment

Thank you DTRA for the opportunity to speak on the regulatory perspective on DCTs! What an incredible event!

#Covid_19 emphasized the necessity for proactive planning in clinical study disruptions. In a panel led by Paul Kluetz, featuring the U.S. FDA & CTTI, they explored building future emergency preparedness & the potential of decentralized trial elements to ⬆️ trial resilience.

⭐️Fantastic keynote lecture on “The FDA perspective on early phase pre-market dose optimization” by the amazing Dr. Paul Kluetz Paul Kluetz U.S. FDA FDA Oncology !
✅ OCE’s Project Optimus
✅Dose optimization in early phase drug development
✅Patient reported outcomes & patient