INSIGHTS ON CELL & GENE CLINICAL TRIALS
-
![Lecture, business meeting, staff training-GettyImages-1166624555]( "Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation")
Field Notes: APEC RHSC's Workshop On ATMP Development And EvaluationScientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
-
![CAR T cells-GettyImages-2243155532]( "Target Selection Drives The Future Of CAR T Therapy In Solid Tumors")
Target Selection Drives The Future Of CAR T Therapy In Solid TumorsTarget selection is the defining challenge in CAR T therapy for solid tumors, shaping safety, efficacy, and the field’s path forward.
-
![clinical-trials-cros-GettyImages-1346675527]( "How Australia's Leading CRO Is Driving Biotech's Acceleration From First-In-Human To Global Markets")
How Australia's Leading CRO Is Driving Biotech's Acceleration From First-In-Human To Global MarketsThe next era of clinical trials will be defined by global expansion across the Asia-Pacific region, rapid and cost-effective pathways to regulatory approval, and reliable, patient-centric leadership.
-
![Medical team, tablet, meeting-GettyImages-2177971058]( "Real-World Evidence Revisited")
Real-World Evidence RevisitedExplore how the latest regulatory updates transform real-world data into a credible evidentiary pathway. Learn the new standards for data reliability and hybrid study design.
-
![GettyImages-2200850893-US-FDA-Food-Drug-Administration]( "General Wellness Isn't A Vibe Anymore: What The 2026 FDA Update Means")
General Wellness Isn't A Vibe Anymore: What The 2026 FDA Update MeansThe FDA’s 2026 guidance has put an end to "wellness by disclaimer." Learn how new standards for wearables and apps impact study design, participant safety, and the evolving ethical role of the IRB.
-
![GettyImages-1245953899 IRB compliance]( "What Does The FDA's 2025 Safety Reporting Guidance Mean For You?")
What Does The FDA's 2025 Safety Reporting Guidance Mean For You?New FDA guidance aligns IND safety reports with unanticipated problems, shifting the focus from administrative definitions to proactive participant protection and trial integrity.
-
![Car-T cell attacking cancer cell-GettyImages-2252478724]( "Mitigating Challenges In Solid Tumor Delivery")
Mitigating Challenges In Solid Tumor DeliveryCAR T-cell therapy is advancing in solid tumors by improving target selection, trafficking, tumor-microenvironment resistance, and long-term function, but major biological barriers still require combined solutions.
-
![GettyImages-1729701910 research]( "Galvanizing Large And Small For Clinical Success")
Galvanizing Large And Small For Clinical SuccessSee how two academic investigators accelerated corneal regeneration and lung fibrosis therapies from preclinical research to clinical trials by leveraging scalable GMP solutions and regulatory-ready materials.
-
![clinical-compliance-GettyImages-2259718661]( "10 Clinical Research Practices That Feel Like Compliance (But Aren't)")
10 Clinical Research Practices That Feel Like Compliance (But Aren't)Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
-
![anticancer drug, ADC-GettyImages-2148345960]( "Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials")
Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC TrialsZymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.
