Boyds’ Post

Oncology Drug Development - Navigating The Timeframe Dynamics Oncology trials can be fast, just 5 months longer than others. Smart tactics like targeted therapies and FDA pathways can speed things up. Non-oncology trials are measured due to crowded markets and regulations. Here's a Strategy: explore rare diseases, innovate trial designs. Read more on the Pharma Leaders Blog. #OncologyTrials #TimeTravel #FluxCapacitor

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

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Ph.D., M.Sc., Senior Vice President, Head, Regulatory Strategy Europe share their perspectives on the just-released FDA draft guidance on generating clinical evidence from oncology multiregional clinical trials (MRCTs).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

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

The FDA's oncology chief, Dr. Richard Pazdur, adopting a familiar "regulatory flexibility" language when it comes to confirmatory trial requirement at the time of an accelerated approval, said: “If we really believe that there are no other therapeutic alternatives, then there will be obviously some degree of flexibility. When we do see, however, that there may be accelerated approval with the same class of drugs with the same diseases and with sponsors previously having most of the confirmatory study accrual already completed at the time of accelerated approval, we have to have a level playing field for all of the pharmaceutical companies.” #acceleratedapproval #FDA #cancerdrugs #oncology #oncologydrugs

I believe that international effort and collaboration are necessary to improve clinical trial diversity. Having this diversity is in the best interests of everyone. For patients, it widens the amount of people who can benefit from new treatments. For researchers, it gives them a better understanding of how different people respond to a particular treatment. Finally, for pharmaceutical companies, it gives their drugs a wider patient base. We have the tools to achieve greater diversity. We just have to act with intention. #ClinicalTrials #Oncology #PatientDiversity #Collaboration

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

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

"Ambitious" may not be strong enough of a word here if they intend to launch 20 new drugs within the next six years. For some context, AZ manufactures, markets, and/or distributes ~37 drugs in the US, so this would be a major leap forward. I suppose that "launch" can be interpreted in many ways 😁 . It remains unclear how they intend to get there by "maintaining" their current R&D trajectory and instead focusing on operational and productivity improvements. An aggressive M&A strategy could provide one strategic path, but isn't forecasted. Nonetheless, it still feels like a small win for the industry to see such an aggressive plan come out at such a struggling time for the life sciences. Fingers crossed for patients that AZ will be able to hit even 10% of this goal.

Oncology drug spending is expected to continue increasing substantially in the U.S. With new FDA medication approvals, the industry is still facing shortages of oncology drugs. Learn about advancements in oncology therapy including CAR-T and new drug approvals as well as the challenges related to current drug shortages of generic injectable cancer drugs.