Pediatric Rare Disease Therapy Gap
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 about 45 new pediatric rare disease therapies by 2033, but 95% […]
Prostate Cancer Awareness Month
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. Read his journey—https://www.cancerresearch.org/stories/patients/john-white At Clinakos Inc., we see […]
Patient Registry makes History
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 registries and natural history studies is becoming increasingly useful […]
Ovarian Cancer Awareness Month
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 wasn’t feeling herself—nothing alarming at first, just what seemed like minor […]
Real World Data to Real World Evidence
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 and heterogeneous cancers, where traditional trials often struggle with participant diversity […]
Webinar: Applying Patient-Level Data & AI in Rare Diseases & Oncology
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 complex therapeutic areas with the highest unmet medical needs. ⚕️Drug development and commercialization in these fields […]
Leukemia and Lymphoma Awareness Month
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, an energetic retail manager and devoted family man, was caught […]
FDA Orphan Drug Approvals in 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% in 2023. This year, if the current trend continues, 2025 […]
From Margins to Mainstream: Including Underrepresented Patients in RWE
Underserved. Underdiagnosed. Underrepresented. That’s the reality for millions of patients missing from real-world evidence. They don’t show up in the claims. They’re undercoded in EHRs. They’re overlooked in traditional cohort designs. And when they’re invisible to your data, they’re invisible to your strategy. At Clinakos, we bring these patients into focus—with purpose. ✅ Integrated Patient […]
Auto-inflammatory awareness month
August is Autoinflammatory Disease Awareness Month! Did you know that autoinflammatory diseases are rare, often misunderstood conditions where the immune system causes inflammation by attacking the body itself? These diseases can be difficult to diagnose and manage, impacting patients and families in profound ways. A major survey analyzed data from 1,043 patients across 52 countries […]
