IDRx’s Post

Did you miss the opportunity to ask your questions during @Veristat's recent webinar on 'Aligning New Oncology Drug Development with FDA's Project FrontRunner'? Don't worry! Veristat has compiled all the questions and answers from the experts. Dive into the insights now ⬇️ https://lnkd.in/eipZv3vw #Veristat #FDA #ProjectFrontRunner

Did you miss out on the Q&A during our webinar with Clinical Leader on 'Align New Oncology Drug Development with FDA's Project FrontRunner'? Don't worry, we gathered all the questions and expert responses. 💻Take a read of our latest blog to find out what they were ⬇️ https://bit.ly/3Kp9fXh #FDA #ProjectFrontRunner #OncologyDrugDevelopment

The patient’s voice is not just important—it’s essential. With the FDA's new benefit-risk guidelines for drug development, patient-centricity has become more critical than ever, particularly in the arena of cancer treatments. Want to learn more? Martin Collyer, MSc., FCCA, Bracken's in-house patient engagement expert, explores the unique challenges of oncology drug development, the FDA's emphasis on patient perspectives, and the opportunities and challenges ahead in this uncharted territory. Read the blog now: https://lnkd.in/gKm2g6m3 #BenefitRiskAssessment #Oncology #PatientCentricity #CancerCare #FDA #LifeSci

CAR-Ts face FDA scrutiny on March 15th jeopordizing indications in earlier lines of treatment for MM. The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for BMS and 2seventy bio’s Abecma and J&J and Legend Biotech’s Carvykti in earlier treatment of multiple myeloma, a government filing (PDF) shows. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the FDA’s pulse around the benefit-risk profile of CAR-T cell therapies amid an investigation into a new safety signal of secondary T-cell cancers. #oncology #cartcelltherapy #fdaapproval #drugsafety https://lnkd.in/eb3XSVvk

In the oncology space, drug developers are keen to develop cutting-edge solutions—and lay claim to a piece of a market estimated to hit $359.1 billion by 2028. However, most Phase III trials fail to present significant clinical improvements on the standard of care. Attached is a brief article from BioSpace that highlights five trials with game-changing potential for oncology and the potential to influence the current market. 

“𝑊ℎ𝑎𝑡 𝑤𝑎𝑠 𝑐𝑙𝑒𝑎𝑟 𝑓𝑟𝑜𝑚 𝐴𝑆𝐶𝑂24, 𝑡ℎ𝑒 𝑐𝑜𝑚𝑏𝑖𝑛𝑎𝑡𝑖𝑜𝑛 𝑜𝑓 𝐴𝐷𝐶𝑠 𝑎𝑛𝑑 𝐼𝑂 𝑤𝑖𝑙𝑙 𝑐ℎ𝑎𝑛𝑔𝑒 𝑡ℎ𝑒 𝑓𝑖𝑟𝑠𝑡 𝑙𝑖𝑛𝑒 𝑜𝑓 𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡 𝑏𝑦 𝑐𝑜𝑚𝑏𝑖𝑛𝑖𝑛𝑔 𝑡ℎ𝑎𝑡 𝑖𝑚𝑚𝑢𝑛𝑒 𝑠𝑦𝑠𝑡𝑒𝑚 𝑒𝑛ℎ𝑎𝑛𝑐𝑒𝑚𝑒𝑛𝑡 𝑎𝑛𝑑 𝑑𝑖𝑟𝑒𝑐𝑡𝑒𝑑 𝑡ℎ𝑒𝑟𝑎𝑝𝑦 𝑡𝑜𝑔𝑒𝑡ℎ𝑒𝑟.”  [Carlos Doti; AstraZeneca VP & head of medical affairs, US oncology division.] “𝑇ℎ𝑒 𝑟𝑒𝑎𝑠𝑜𝑛𝑖𝑛𝑔 𝑖𝑠 𝑤𝑒 ℎ𝑎𝑣𝑒 𝑡ℎ𝑒 𝑎𝑏𝑖𝑙𝑖𝑡𝑦 𝑡𝑜 𝑟𝑒𝑝𝑙𝑎𝑐𝑒 𝑐ℎ𝑒𝑚𝑜𝑡ℎ𝑒𝑟𝑎𝑝𝑦 𝑡ℎ𝑎𝑡 ℎ𝑎𝑠 𝑏𝑒𝑒𝑛 𝑢𝑠𝑒𝑑 𝑓𝑜𝑟 𝑑𝑒𝑐𝑎𝑑𝑒𝑠... 𝐼𝑓 𝑦𝑜𝑢 𝑐𝑜𝑚𝑏𝑖𝑛𝑒 𝐴𝐷𝐶𝑠 𝑎𝑛𝑑 𝑖𝑚𝑚𝑢𝑛𝑜𝑡ℎ𝑒𝑟𝑎𝑝𝑖𝑒𝑠, 𝑓𝑜𝑟 𝑒𝑥𝑎𝑚𝑝𝑙𝑒, 𝐼 𝑠𝑒𝑒 𝑡ℎ𝑎𝑡 𝑎𝑠 𝑡ℎ𝑒 𝑛𝑒𝑥𝑡 𝑏𝑖𝑔 𝑤𝑎𝑣𝑒 𝑡𝑜 𝑢𝑛𝑙𝑜𝑐𝑘 𝑝𝑎𝑡𝑖𝑒𝑛𝑡𝑠 𝑤ℎ𝑜 ℎ𝑎𝑣𝑒𝑛’𝑡 𝑏𝑒𝑒𝑛 𝑢𝑛𝑙𝑜𝑐𝑘𝑒𝑑 𝑏𝑒𝑓𝑜𝑟𝑒.” [Pedro Valencia, PhD; AbbVie VP solid tumor pipeline strategy] Following-on from all the eye-catching data unveiled at ASCO24, it's great to hear the vision of major players like AstraZeneca and AbbVie for ADC therapies to start replacing conventional chemotherapy as first-line treatments. Thanks to Michael Gibney and the folks at BioPharma Dive for the interesting article. https://lnkd.in/eqdyMUgT

In an article with Drug Target Review, Rebecca Goldstein, PhD, CMPP, Senior Principal, Strategic Consulting, explores how anchoring drug development programs to patient experiences can help navigate the evolving oncology landscape. Discover how patient-centered approaches are reshaping the landscape and the role of regulatory bodies like the FDA and EMA in integrating patient input through patient-reported outcomes and real-world evidence initiatives. Read the full article here. 👉🔗 https://lnkd.in/gUkjJrkR. #Oncology #DrugDevelopment #HealthcareInnovation

Radiopharmaceutical Therapies (RPTs) have tremendous potential to improve patient care. It's exciting to see BMS investing in the space so soon after Lilly did and joining Bayer and Novartis in the space. What often gets missed in these exciting headlines are all of the contributing elements required to make RPTs work. For example, recently European Association of Nuclear Medicine (EANM) published the European Association of Nuclear Medicine Focus5: Consensus on Molecular Imaging and Theranostics in Prostate Cancer. One of the questions that the experts reached consensus on was: "Administered activity in [177Lu]Lu-PSMA therapy should be based on dosimetry." Mirada Medical has been working on dosimetry solutions since 2015 with fantastic results in clinical trials. We are excited to see our affiliate TeleDaaS delivering these to the market. #dosematters

Are you trying to navigate the evolving regulatory landscape for emerging cancer treatments like 𝗧𝗮𝗿𝗴𝗲𝘁𝗲𝗱 𝗥𝗮𝗱𝗶𝗮𝘁𝗶𝗼𝗻 𝗧𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀 (𝗧𝗥𝗧)? The FDA and EMA are issuing new guidelines so staying informed on regulations is crucial. Our latest blog explains both Project Optimus and the recent EMA radiopharmaceutical updates and their impact on TRT development. Read more here: https://ow.ly/5C4p50QZ5OB #CancerResearch #TargetedRadiationTherapy #CancerTreatment #Oncology #ClinicalTrials #FDAguidelines #EMAguidelines #ProjectOptimus #ModelingSimulation #PKdata #DoseSelection #ClinicalPharmacology

Did you know WEbRX USA Inc. is leading the way in oncology advisory services with the Oncology Global Medical Advisory System (OGMAS)? This platform is designed to support pharmaceutical and life sciences companies with new global launches or in-licensing opportunities. OGMAS unites the world’s top 10% of medical experts from the WEbRx global panel, medical affairs professionals of Pharma, and local country oncology experts in lung, breast, GI cancers, and hematologic malignancies. OGMAS insights offer crucial recommendations and best practices in oncology. These expert insights aid in the development of NCEs, biologics, and biosimilars, while also optimizing the standard of care in oncology and transforming the patient journey. We have helped companies significantly reduce time to market and create early KOL advocacy. I am delighted to share our experience of bringing Dr. Martine Piccart, a top authority in breast cancer, along with a few selected national KOLs of India, to formulate new India-specific guidelines on HER2 breast cancer. This initiative is especially timely as India is launching a biosimilar version of Pertuzumab. It is important to understand how to choose dual therapy and adapt patient-based treatment strategies.