Premier Perspectives The blog for insider insights in clinical development Recent Posts Learn more about the latest events and updates. By expertise area All expertise areas AnalgesiaDermatologyMedical DeviceNeuroscienceOncology & HematologyPediatricsRare DiseaseOtherCOVID-19Data Management & BiostatisticsCell & Gene Therapy By functional area All functional areas Clinical Research: Phase 1 - Phase 4ConsultingData Management & BiostatisticsFunctional Service Provider (FSP)Global ComplianceMedical and Regulatory AffairsPatient and Stakeholder EngagementProject ManagementQualitySafety/PharmacovigilanceStudy DesignStudy Start-UpOtherCOVID-19 Medical and Regulatory Affairs How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher – And How We Handled It By Naomi Kautz January 14, 2021 Medical and Regulatory Affairs Site Selection, Manufacturing & Long-Term Follow-Up: Looming Challenges for a Rescue Phase 1/2 Gene Therapy Trial By Naomi Kautz January 12, 2021 Consulting How to Navigate Global Regulatory Frameworks & Expedited Programs for Gene Therapy Development in the U.S., EU, & Japan By Naomi Kautz December 21, 2020 Clinical Research: Phase 1 - Phase 4 Choose the Right FDA Program to Expedite Your Rare Oncology Trial By Rupa Doshi December 2, 2020 Consulting Beware of Underestimating the Value of a Pre-NDA Meeting By Lisa Crose November 18, 2020 Clinical Research: Phase 1 - Phase 4 Adaptive Design Methods Offer Rapid, Seamless Transition Between Studies By Rupa Doshi November 17, 2020 Previous 1 2 3 4 … 40 Next × ALSO OF INTERESTNostalgia or Shell Shock? Assessing PTSD Is a...5 Stages of Medical Device DevelopmentKey Considerations When Designing a Phase 1...