Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned From the FDA Webinar October 24, 2025 Earlier this week, I had the privilege of presenting a webinar, “Applying Patient-Level Data & AI in Rare Diseases & Oncology,”. We closed the session by demonstrating how AI can reduce up to 40% workloads for key functions […]
Inder Jaggi’s Highlights From Our Webinar Read More »
NIH Strategic Data Plan October 24, 2025 🧬The National Institutes of Health (NIH) unveiled its ambitious 2025-2030 Strategic Plan for Data Science, highlighting a transformative vision to enhance biomedical research through innovative data science. 📌 Key priorities include making data Findable, Accessible, Interoperable, and Reusable (FAIR) — embracing global standards to maximize the impact
NIH Strategic Data Plan Read More »
Prostate Cancer Awareness Month – Duplicate – [#3107] October 24, 2025 More than 10,000 rare diseases affect over 30 million Americans, with nearly 70% appearing in childhood. Families often face long, challenging diagnostic journeys—navigating multiple specialists and fragmented medical records. Yet, only 5% of roughly 7,000 rare diseases have FDA-approved treatments. A recent study projects
Pediatric Rare Disease Therapy Gap Read More »
Prostate Cancer Awareness Month September 18, 2025 John White, a biotechnology engineer, was no stranger to data or innovation. But when diagnosed with prostate cancer, he faced a reality that numbers can’t always predict. Standard treatments failed. So he turned to a clinical trial—where immunotherapy didn’t just extend his life. It gave it back. 📖
Prostate Cancer Awareness Month Read More »
Patient Registry makes History September 18, 2025 Once seen as supplemental—patient registries are now becoming central tools in shaping regulatory decisions specifically for rare disease drug development. For many rare conditions and hard-to-study cancers, traditional clinical trials are simply not feasible—as there are just not enough patients. Leveraging high-quality real-world data 📊 from patient
Patient Registry makes History Read More »
Ovarian Cancer Awareness Month September 11, 2025 🦋 Ovarian Cancer Awareness Month: Heleena’s Courageous Story 🦋 September is more than a page on the calendar—it’s a bold call for awareness and action. At Clinakos, we’re spotlighting real patient stories, and this year, Heleena’s journey brings the message home. Just 27, Heleena noticed she
Ovarian Cancer Awareness Month Read More »
Real World Data to Real World Evidence September 9, 2025 Real-world data (#RWD) is no longer an afterthought—it’s being integrated earlier in the development lifecycle to: ✅ Map disease progression ✅ Inform trial design ✅ Recruit patients ✅ Benchmark therapies ✅ Identify gaps in access and representation This shift is particularly impactful in rare
Real World Data to Real World Evidence Read More »
Webinar: Applying Patient-Level Data & AI in Rare Diseases & Oncology September 5, 2025 📢 We’re excited to announce our upcoming webinar on October 7, 2025! Clinakos Inc. invites you to an exclusive webinar on Applying Patient-Level Data & AI in Rare Diseases & Oncology. 🧬 Rare diseases and oncology represent some of the most
Webinar: Applying Patient-Level Data & AI in Rare Diseases & Oncology Read More »
Leukemia and Lymphoma Awareness Month September 4, 2025 🌟 September is Leukemia and Lymphoma Awareness Month! 🌟 Every story starts with one step—and sometimes, that step is noticing something just isn’t right. At Clinakos, we’re proud to spotlight Marc Lees’ journey—an unforgettable reminder of how courage and community fuel hope when facing blood cancer. Marc,
Leukemia and Lymphoma Awareness Month Read More »
FDA Orphan Drug Approvals in 2025 September 2, 2025 In the first half of 2025, the FDA approved 16 novel therapies, with 10 of these being orphan drugs for rare diseases—demonstrating a clear focus on this area. 🌟 To put this into perspective, orphan drugs made up 47% of novel therapies in 2024 and 49%
FDA Orphan Drug Approvals in 2025 Read More »
