Clinigen’s Post

"🔬 Delighted to share my achievement of mastering the art of Good Clinical Practices through an intensive NIDA Clinical Trials course! 🚀💼 Equipped with the power to drive groundbreaking discoveries in the pharmaceutical realm, I'm primed to make a difference in the world of clinical research. 🌐 Let's connect and collaborate to revolutionize the future of medicine together! 💪 #ClinicalTrials #GoodClinicalPractices #NIDACourse #PharmaceuticalInnovations"

🌟 Join Circuit Clinical for an enlightening webinar series on enhancing participant representation in research through community-based clinical trials! 💡 The first webinar in the series explores Circuit Clinical’s Community Research Network and the impact of community #healthcare on accelerating drug development and medical innovation. 🎤 Featured speakers will delve into: ➔ The significance of community-based research in the pharmaceutical landscape ➔ How community-based research sites differ from traditional models ➔ Challenges and considerations for pharmaceutical sponsors and CROs ➔ Factors to weigh when selecting a community research site 🔗 REGISTER HERE: https://buff.ly/3uP4XEq ⭐ Featured speakers: Alaina Anderson, MBA Elizabeth Seyfert Laura Warwick #DrugDevelopment #ClinicalResearch #PatientRecruitment #ClinicalSites #PatientParticipation

EuropaBio - the European Association for Bioindustries was on the opening panel of day 2 of the World Orphan Drug Congress Europe, where Adrien Samson ran through the disproportionate impact of the proposed revision of the general pharmaceutical legislation proposed by the European Commission on small and mid-size biotechs bringing innovation to patients: We need to get this piece of legislation right. We need to deliver for European patients.” We will continue this crucial conversation tomorrow on a panel on how to enable wider access to innovation from small biotech companies, so please join us to talk about orphan drugs, innovation, and the biotech ecosystem! #healthcare #europeanunion #patients #wodc

Real-world Evidence (RWE) can help provide valuable insights into the safety and effectiveness of medical interventions. The FDA recently finalized its industry guidance on the use of RWE, including support for regulatory decisions. The FDA’s decision to expand the use of JNJ’s device for paroxysmal AFib https://lnkd.in/eVt4MZva, demonstrates their commitment to consider RWE for practical patient application. A collaboration between Star Biopharma Consulting, LLC. and Clinical Research Strategies used data from a U.S. claims-based study as a substitute for a second randomized clinical study to drive the successful approval of Eladynos® (abaloparatide) by the European Medicines Agency in 2022. This example also demonstrates how real-world study, when properly designed and executed with prior review by or feedback from regulators, can also be used across various regions to accelerate access to medications for those in need. #RWD #starbiopharmaconsulting #clinicalresearchstrategies #patientoutcomes  

[📆 #Event - #DigitalTwins] “Le jumeau numérique en santé” Webinar has just ended. We would like to express our gratitude to POC Media and Florent Detroy for their trust, as well as to the other speakers for participating in this roundtable. For those who were unable to attend, we'll be sure to relay the replay of the show when it becomes available. Stay tuned ! As a reminder, Alexandre Templier (President) spoke about how “pragmatic” digital twins are revolutionizing decision-making in the pharmaceutical industry to drive drug development (from clinical development to market access and portfolio management). #artificialintelligence #DigitalHealth #ClinicalTrials

We are thrilled to announce that Chief Scientific Officer, ARMELLE PINDON, PhD, and Board Member, Alexis Elder, will both be panelists at the 2024 World Orphan Drug Congress USA in Boston, MA on April 24-25. "The World Orphan Drug Congress brings together leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers. The conference is a place to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapies." -WODC Website We look forward to sharing more about all the wonderful discussions! #WorldOrphanDrugCongress #WODC #VCPdisease #raredisease #CureVCPDisease