Intellus Worldwide 2026 Summit Announcement Post
🌎 Clinakos is heading to the Intellus’ Worldwide 2026 Summit, the leading forum for healthcare insights, analytics, and evidence generation. From uncovering deep rare disease and oncology insights with Clarion™, to empowering advanced analytics teams with Acceleron™, to strengthening diagnosis verification through Confirmis™, we’re excited to share how our Medically Smart AI™ agents and Integrated […]
FDA’s focus on rare disease approvals
Half of FDA’s 2025 approvals targeted rare diseases. Real-world data made the difference.🧬 In 2025, rare diseases dominated the FDA approval portfolio: 26 of 46 novel drugs approved addressed rare or orphan disease indications. That’s consistent with a five-year trend—but this year was different. 📈 Why? The FDA’s Rare Disease Evidence Principles (RDEP) framework—introduced in […]
FDA’s 2026 PDUFA Calendar
📅 2026 FDA PDUFA Calendar Highlights a Pivotal Year for Rare Disease Innovation Beyond headline approvals, the FDA’s 2026 calendar underscores how far the rare disease pipeline has come—especially in cell and gene therapy. A number of key orphan drug decisions will shape the year ahead, reflecting the culmination of over a decade of translational […]
Understanding Rare Disease Patients
🔍 Understanding rare disease patients starts with seeing the full story behind every symptom, delay, and misdiagnosis—not just the ICD code. Why understanding rare disease patients matters 👥 Rare diseases collectively impact over 300 million people worldwide, yet each condition often affects only a small group of patients who are frequently overlooked. ⏳ Many patients […]
Importance of Data Privacy and Data Security
Patients, providers, and life sciences partners are all betting on the same thing: that the data connecting them is protected as carefully as any clinical intervention. 🧩 When that trust breaks—through a breach, outage, or misuse of data—the impact ripples across care delivery, research, and ultimately patient outcomes. 🔒 Security as a shared foundation For […]
AI Agents and Patient-Level Data – From Confirmation of Diagnosis to Insights
Join us on February 4, 2026, for an engaging discussion on how AI agents are transforming the way patient-level data is collected, validated, and turned into powerful insights. “AI Agents and Patient-Level Data – From Confirmation of Diagnosis to Insights” Presented by Wes Michael, President of Rare Patient Voice, and Inder Jaggi, CEO of Clinakos […]
Clinakos at JPM Healthcare Conference 2026
Join Clinakos Inc. at the J.P. Morgan Healthcare Conference 2026, where the future of medicine is shaped by insight, innovation, and collaboration. 👥 While many in our ecosystem are still evaluating how AI Agents can transform Life Sciences Drug development and Commercialization, our team will be at the conference to share how our clients are […]
FDA’s announcement – agentic AI solutions for reviewing new drug applications
In December 2025, the U.S. Food and Drug Administration (FDA) officially deployed Agentic AI capabilities across all agency teams — marking a major milestone in the modernization of regulatory science. These advanced systems can reason, plan, and execute multi-step workflows, supporting complex functions like review validation, post-market surveillance, compliance, and administrative automation. Agentic AI represents […]
Piper Sandler Conference Learnings
Piper Sandler this year was a powerful reminder of how quickly the ground is shifting under our feet for life sciences & healthcare companies. As CEO of Clinakos Inc., I walked away with a few clear learnings that will shape my thinking for 2025 and beyond. 👇 Here are my biggest takeaways from four days […]
Recent Breakthrough: CRISPR Gene Editing Therapy
One patient. One mutation. One groundbreaking approach to gene editing. 🔬 🚀 Recently, researchers at the Children’s Hospital of Philadelphia (CHOP) made history when they treated the first patient using a personalized CRISPR-based therapy—carefully designed to correct a unique genetic mutation. This important milestone in rare disease treatment will have a lasting impact to shape […]
