Understanding Bayesian Optimal Interval (BOIN) Design for Clinical Trials

🌟 Big news for Epion Therapeutics! 🌟 We’re excited to share that the 𝗨.𝗦. 𝗙𝗼𝗼𝗱 𝗮𝗻𝗱 𝗗𝗿𝘂𝗴 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 (𝗙𝗗𝗔) 𝗵𝗮𝘀 𝗴𝗿𝗮𝗻𝘁𝗲𝗱 𝗙𝗮𝘀𝘁 𝗧𝗿𝗮𝗰𝗸 𝗱𝗲𝘀𝗶𝗴𝗻𝗮𝘁𝗶𝗼𝗻 for 𝗘𝗽𝗶𝗦𝗺𝗮𝗿𝘁 𝗘𝗽𝗶𝘁𝗵𝗲𝗹𝗶𝘂𝗺-𝗢𝗻 𝗖𝗿𝗼𝘀𝘀-𝗟𝗶𝗻𝗸𝗶𝗻𝗴 𝗦𝘆𝘀𝘁𝗲𝗺, our novel drug-device combination designed to treat keratoconus. Fast Track designation is intended to expedite development and review of drugs that 𝘁𝗿𝗲𝗮𝘁 𝘀𝗲𝗿𝗶𝗼𝘂𝘀 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀 and 𝗳𝗶𝗹𝗹 𝗮𝗻 𝘂𝗻𝗺𝗲𝘁 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗻𝗲𝗲𝗱. This designation marks an important step forward in our effort to bring a safe, accessible, and minimally-invasive treatment to millions of keratoconus patients worldwide. 🔗 Read the full announcement: https://lnkd.in/e-aNquj5 #Keratoconus #Ophthalmology #CrossLinking #CornealCrossLinking #FDA #FastTrack

Interest in radioligand therapy (RLT) continues to accelerate. An analysis of PubMed data from 2000–2024 shows a clear upward trend in publications on clinical therapeutic radionuclides—evidence of both increasing innovation and growing clinical focus on systematic radioligand therapy (SRT). What does this momentum mean for the future of radiotheranostics? We explore the implications in a recent blog, drawing on data from Radiotheranostic landscape: A review of clinical and preclinical development (Tran et al., 2025). Read more here: https://lnkd.in/eraa8PNd #RadioligandTherapy #SRT #Radiopharmaceuticals #LifeSci #Bracken

Radiopharmaceuticals continues to accelerate both in investment and as this paper shows, publications. This provides a fascinating visual insight into the publications by radionuclide, as a trailing indicator of the changes we are seeing in the landscape.

Series B rounds abound with Kardigan raising $254M and Kailera Therapeutics pulling in $600M. Kardigan is advancing three cardiovascular assets into late-stage clinical trials, while Kailera is focused on its obesity pipeline and global phase III efforts. The financings represent the top two series B rounds of biopharma companies in 2025.   Read Karen Carey’s report in BioWorld News: https://lnkd.in/ecnnpWCm (Access this exclusive content with a Premium BioWorld subscription: https://lnkd.in/ex_sZAtE) #biopharma #cardiovascular #obesity Clarivate for Life Sciences & Healthcare

The escalating cost and prolonged timelines associated with drug development have prompted global regulatory authorities to focus on ways to accelerate the availability of innovative therapies in the market. Nowhere is this more critical than in the fields of oncology and rare diseases where patients often face limited treatment options and urgent clinical need. To learn more about the expedited pathways and regulatory collaborations, read our latest whitepaper from ICON regulatory experts Karen Benson, Tamie Malaska and Robin Loconte. https://ow.ly/2cIf50WPm5v #pharma #biotech #oncology #regulatoryaffairs #regulatorycompliance #clinicaltrials #FutureOfPharma

In today’s biopharma landscape, the rising cost and extended timelines of drug development are driving a critical need for smarter, faster regulatory strategies. Global health authorities are responding with expedited pathways and collaborative frameworks designed to bring breakthrough therapies to patients sooner. This is especially vital in oncology and rare diseases, where unmet medical needs and limited treatment options demand urgency and innovation. Our latest whitepaper—authored by ICON regulatory experts Karen Benson, Tamie Malaska, and Robin Loconte—explores how biopharma companies can leverage these evolving regulatory mechanisms to optimize development timelines and navigate complexity with confidence. Read the full whitepaper to learn how your team can stay ahead in a rapidly shifting regulatory environment.

The FDA recently issued a draft Guidance for Industry: “Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development.” In this short video, Dr. Amandine Manon highlights the key takeaways from the guidance and what they mean for sponsors developing these innovative therapies. 🎥 Watch the full video: https://ow.ly/SEEz50X96at #Certara #Radiopharmaceuticals #DosageOptimization #FDAGuidance #DrugDevelopment

Biopharma companies developing early-stage therapeutics often find moving from preclinical through translational medicine to clinical development is an arduous journey on the path to first-in-human clinical trials, says Melissa Allensworth at Tunnell Consulting, Inc.. In her article with Drug Discovery Online, she says that one of the most effective ways to de-risk a therapeutic program is to enter preclinical development with a regulatory mindset and a strategic, data-driven approach. Take a look at her key takeaways for executives: https://lnkd.in/ehjvQT8B #drugdiscovery #drugdevelopment #FDA

Q3 2025 FDA Decision Dates: Key Approvals to Watch As we approach the third quarter of 2025, several significant FDA decisions are on the horizon that could shape the future of biotech and pharma. From innovative oncology treatments to advancements in rare disease therapies, these upcoming approvals may open new avenues for patient care and industry growth. Stay informed about these pivotal dates and their potential impact on the healthcare landscape. View the full list of Q3 2025 FDA decision dates: https://loom.ly/KtKLnak #Biotech #Pharma #FDAApprovals #PDUFA #Q32025 #DrugDevelopment

Regulatory speed is a game-changer for biotech companies advancing oncology therapies, helping to achieve critical milestones and bring life-saving treatments to patients faster. In this insightful expert interview, Joshua Taylor, PhD, RAC, Senior Director, Regulatory Affairs at Allucent, shares how biotech companies can strategically leverage the FDA’s expedited programs, Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review, to streamline communication, shorten review timelines, and accelerate patient access. Dr. Taylor highlights how these programs enable tools such as rolling submissions under Fast Track, earlier FDA collaboration under Breakthrough Therapy, and approval based on surrogate endpoints under Accelerated Approval, all while maintaining rigorous regulatory standards. He emphasizes the importance of early planning, frequent FDA engagement, and the strategic use of biomarkers and companion diagnostics to strengthen eligibility for these programs. Beyond speeding development, these pathways can also enhance funding opportunities and competitive positioning for emerging biopharma companies. Learn how to align your oncology program with a proactive regulatory strategy to drive success in drug development. Watch the video interview here: https://lnkd.in/e8Z2XucD #Allucent #BringingNewTherapiesToLight #AcceleratedApprovals #RegulatoryAffairs #FDA #OncologyClinicalTrials