Nooma’s Post

Through Project Optimus, the FDA is taking aim at revising dose-ranging studies for oncology drug development. The future of oncology is here! While our team published this article in 2022 when the project was introduced, we've made recent revisions, offering new recommendations and insights. If you are developing an oncology drug, we recommend you collaborate with the FDA and to review the January 2023 guidance shared in this content – it is full of insights and a strong step in a positive direction for patients and industry. https://hubs.la/Q02lYyPQ0 Questions about your oncology development plan and your regulatory strategy? Connect with Halloran. We’re ready when you are. #Oncology #OncologyResearch #DrugDevelopment #ProjectOptimus #FDA #ClinicalTrials

The cancer drug shortage has been a critical issue, with significant impacts on patient care and clinical trials. Crystal Denlinger, MD, FACP, CEO of the National Comprehensive Cancer Network® (NCCN®), highlights the primary causes, including manufacturing issues, supply chain disruptions, and regulatory delays. Watch here! #CancerCare #DrugShortage #Oncology #ClinicalTrials #NCCN #Pharmaceuticals

In our recent blog, Dr Katherine Bowen, Senior Director of Regulatory Affairs, and Dr Julie Warner, Vice President of Regulatory Affairs, explore the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU. Read more: https://lnkd.in/eb2-NtXB #oncology #regulatoryaffairs #US #Europe #oncologydrugdevelopment

My esteemed colleagues Mwango Kashoki, M.D., MPH, SVP, Global Head of Regulatory Strategy and Sinan Sarac, M.D., Ph.D., M.Sc., Senior Vice President, Head, Regulatory Strategy Europe share their perspectives on the just-released FDA draft guidance on generating clinical evidence from oncology multiregional clinical trials (MRCTs). The guidance emphasizes the importance of ensuring MRCT populations that are representative of the target U.S. patients, and therefore the guidance has significant implications for developers of oncology drug products. #ClinicalTrials #Oncology #FDA #WithHeart https://lnkd.in/eAkJAgqT

EU access to oncology medicines lags behind in the Netherlands In the study, funded by the European Fair Pricing Network (EFPN), time-to-patient access was assessed at the hospital level, including those products that entered markets initially under early access programmes. - https://lnkd.in/dSbVUtrQ #pharma #oncology #medicineaccess #marketaccess

Lampgen Clinical Research: Partnering in the Evolution of Oncology Drug Development Kathy Giusti’s remarkable journey from pharmaceutical executive to patient advocate and founder of the Multiple Myeloma Research Foundation (MMRF) is a powerful reminder of what can be achieved when passion, knowledge, and advocacy converge. Diagnosed with multiple myeloma in 1996, Kathy has not only defied the odds but also fundamentally changed the landscape of #drugdevelopment for this rare #cancer. Through her leadership, MMRF has raised over $600 million, launched nearly 100 clinical trials, and played a pivotal role in bringing more than 15 new #drugs to market. The five-year survival rate for multiple myeloma has nearly doubled, a testament to the advancements driven by #patientadvocacy and #innovativeresearch. At Lampgen Clinical Research, we understand the importance of having dedicated and experienced #oncology #CRAs to ensure that the clinical trials we support are monitored with the highest standards of ICH/GCP expertise. We are inspired by leaders like Kathy Giusti, who demonstrate the critical role that effective collaboration between researchers, companies, and regulators plays in developing new #therapies. The progress seen in #multiplemyeloma treatment highlights the significance of patient-focused research and the need for continued investment in oncology trials. Lampgen is committed to supporting these efforts by providing the best oncology CRAs who are not only skilled but also passionate about making a difference in the lives of patients. As we continue to partner with pharmaceutical companies and CROs, Kathy Giusti's story reminds us of the impact that can be made when the right people come together with a shared mission. Together, we can drive the next generation of breakthroughs in oncology, ensuring that more patients have access to the life-saving treatments they need. #Oncology #ClinicalResearch #OncologyCRAs #CancerResearch #MultipleMyeloma #ClinicalTrials #PatientAdvocacy #ICHGCP #DrugDevelopment #LampgenClinicalResearch #MMRF #CancerSurvivorship https://lnkd.in/e9dBWAvb

🧬 Celltrion has received approval from the US FDA for IND application for a phase 3 clinical trial of CT-P51, its biosimilar to Keytruda (pembrolizumab). 💉 With this IND approval, Celltrion plans to initiate a global phase 3 clinical trial involving 606 patients with metastatic non-small cell lung cancer (NSCLC). 🌍 The trial aims to demonstrate that CT-P51 is as effective as Keytruda, the original drug.

Our session on “Optimizing the Use of Expedited Pathways and Oncology Center of Excellence Programs to Optimize Drug Development in Oncology” is happening next week, and we want to ensure you can attend! Register now to: ✔️ Gain knowledge on the constellation of programs available to sponsors of oncology products to accelerate drug development ✔️ Consider key decision points and potential outcomes that drive expedited programs in oncology ✔️ Understand how these programs address the balance between rapid approval and robust demonstration of efficacy/safety Share this post with your network and register here: https://hubs.li/Q02NXnML0 #OneMMS #DrugDevelopment #Oncology #NDA #BLA #MAA #Pharmaceuticals

Congratulations to Kairos Pharma Ltd. (NYSE: KAPA) on their recent New York Stock Exchange (NYSE) Initial Public Offering. This is a significant milestone for any company. With IPO behind them, the Kairos team is now focused on advancing in clinical trials its innovative therapeutic program that aims to reverse cancer resistance against standard of care therapeutics.    Kairos has chosen Prevail InfoWorks as its Clincial Research Organization (CRO) to manage its phase II randomized multi-institutional center trial of ENV 105 for patients with castrate-resistant prostate cancer and a phase I trial of ENV 105 in patients with EGFR-driven lung cancer who have developed partial or complete resistance to Osimertinib. Prevail was recently awarded the title of "Most Advanced Tech-Enabled CRO 2024" and these studies will benefit from Prevail’s integrations and advanced analytics data-driven approach for accelerated analysis in clinical trials. "We're honored to partner with Kairos Pharma in advancing these critical trials, leveraging our clinical services and technologies to support their mission of delivering life-saving therapies to patients in need." - Jack Houriet, CEO of Prevail InfoWorks What advancements in oncology are you most excited about, and how do you see them shaping the future of cancer treatment? Learn more via the press release: https://lnkd.in/eKsAWZvF #KairosPharma #ClinicalTrials #CRO #OncologyResearch #PharmaInnovation #CancerTreatment #ProstateCancer #LungCancer #ClinicalPartnership #IntegratedAnalytics #DataDrivenHealthcare #PatientCare #Pharmacovigilance #HealthcareTechnology #TrialManagement #EGFRLungCancer #Osimertinib #CancerResearch #BiotechCollaboration #PrevailInfoWorks

📢 Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5- Year Retrospective Analysis 📍The study shows how the business pipeline meeting platform represents a valuable tool for the developers of medicinal products and provide insight on key challenges in the development of oncology medicines. #ema #medicinalproducts #oncology #businesspipelinemeetingplatform