In the fourth edition of our neurosciences blog series, Parexel expert and former regulator, Simona Stankeviciute, M.D., shares valuable insights on several best practices and creative approaches to assist biotech companies in developing effective trial design strategies and planning for successful regulatory submissions. Read the full article here: https://lnkd.in/eQzRjeci #Alzheimers #RWD #RWE #ParexelBiotech
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💡 Join Dr. Vince Clinical Research for an upcoming webinar on managing renal and hepatic impairment trials. These trials are essential for assessing the impact of organ impairment on #pharmacokinetics (PK), but recruitment challenges make them more complex than standard clinical studies. Learn how tools like population PK (#PopPK) and physiologically based PK (#PBPK) modeling, combined with adaptive trial designs, can reduce patient burden and improve trial outcomes. ➡️ Learn more + register here: https://buff.ly/4gASg2T 🌟 Featured speakers: Korey Nevitt Harry Alcorn PharmD George Atiee Toni Grant #ADME #DrugDevelopment #ClinicalResearch #PatientRecruitment #NASH #NAFLD #TherapeuticAreas #TranslationalResearch #NonalcoholicSteatohepatitis
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💡 Join Dr. Vince Clinical Research for an upcoming webinar on managing renal and hepatic impairment trials. These trials are essential for assessing the impact of organ impairment on #pharmacokinetics (PK), but recruitment challenges make them more complex than standard clinical studies. Learn how tools like population PK (#PopPK) and physiologically based PK (#PBPK) modeling, combined with adaptive trial designs, can reduce patient burden and improve trial outcomes. ➡️ Learn more + register here: https://buff.ly/4gASg2T 🌟 Featured speakers: Korey Nevitt Harry Alcorn PharmD George Atiee Toni Grant #ADME #DrugDevelopment #ClinicalResearch #PatientRecruitment #NASH #NAFLD #TherapeuticAreas #TranslationalResearch #NonalcoholicSteatohepatitis
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Parent Project Muscular Dystrophy’s mission has always been clear: to fight Duchenne by putting patients at the heart of every research effort. By leveraging CTTI’s Patient Group Engagement recommendations, particularly their “Chevron Diagram,” they’ve been able to amplify the patient voice throughout the entire drug development process. From discovery to post-approval, patient preference studies now play a crucial role in shaping research priorities and clinical trial designs. The results? Seven patient preference studies completed to date, providing critical insights that are guiding decisions at every stage. Learn more about how together we’re building a research ecosystem that values patient insights and fosters meaningful collaboration. https://bit.ly/PPMDcs
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🌍 Ask the Experts: Why Diversity Matters in Clinical Trials 🌍 Dr. A. Craig Lockhart addresses “Why does diversity matter in clinical trials?" in our latest #clinicaltrial video clip. Inclusive representation is key to advancing medical treatments. Special thanks to Arcus Biosciences for supporting this series! Watch the full interview: https://lnkd.in/eV8j4xy2 The views and opinions in this video are those of the speaker and do not necessarily reflect the views or positions of Arcus. #DebbiesDreamFoundation #ClinicalTrials #HealthEquity #RepresentationMatters #stomachcancer #gastriccancer #CancerResearch
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Can Encorafenib plus binimetinib be used as a new treatment option for #BRAF V600-mutated #thyroidcancer? Scientists perform a multicenter clinical trial to answer this. Check the new study out in #ThyroidJournal. https://ow.ly/e75y50QNPcM
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Video 1 | When we say virtually invisible, we mean it. We are excited to start sharing some learnings from our Lumbar Injectrode Feasibility Evaluation (LIFE) first-in-human clinical trial. This video shows the Injectrode placement site immediately after placement on day 0, and then again on day 25. As you’ll see, the Injectrode is virtually invisible from the outside! Stay tuned for more highlights from the LIFE study and a full press release next week. #Injectrode #PainManagement #MedicalDevice #Neuromodulation
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Our February Research Summary is available to view Please visit our Research and Clinical page on our website: https://lnkd.in/eJaUdBRy If you have any questions, please get in touch with info@alextlc.org #alextlc #helptocope #helptohope #leukodystrophy
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A Phase I clinical trial for a BAFF CAR T for relapsed and refractory multiple myeloma is underway. Developed by Reshmi Parameswaran, MD, PhD, and led by Leland Metheny, MD, read how this trial makes significant step in bringing treatment to patients: https://lnkd.in/ej8rmsxm
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I mentioned at the beginning of 2024 outlining as to how much of a foundational year the psychedelic industry is shaping up to be. As we learn more and more we start to get a better understanding of each companies story, and the pathway to revenue, along with a glimpse as to how commercialization will look. 2024 highlights so far have included: ✅ Lykos Therapeutics (formerly MAPS PBC) receiving NDA submission approval, and priority review from the FDA regarding their Phase 3 trial results, plus raising $100m ✅ MindMed announced ground breaking Phase 2b data that was some of the best data ever reported. 48% of participants achieving remission. ✅ Numinus announcing as the lead clinical site for Mindmed’s Phase 2 trial. ✅ Compass Pathways marking 1 year of their Phase 3 trial for treatment resistance of depression and finally .. ✅ I caught up this week with Cybin Inc CEO Doug Drysdale to talk further about their positive end of Phase 2 meeting with the FDA, which later resulted in successfully securing $150m from a group of long term biotech investors. Big week to say the least. One last note, did you know that almost 40% of all FDA research trials that are being conducted right now are from the psychedelic industry? The world is waking up. Interview posted in comment section. Lars Christian Wilde Christian Angermayer Michael Oakes Florian Brand Payton Nyquvest Robert Barrow Dan O'Brien Paul Glavine Rick Doblin Dane Stevens Amy Emerson E. Blair Clark-Schoeb Graham Farrell Damon Michaels Rob Crocker Cody Shandraw Joe Caltabiano Daniel Carcillo E. Matthew ("Whiz") Buckley Michael Boughner Melissa Lavasani Matt Solomon Preston Robitaille Brad White Darren Raycroft Hamza Ali Rebecca Kacaba Monica Kretschmer Shobana Thaya Williams, MBA Michael B. Galloro, CPA #biotech #biotechnology #pharma #pharmaceuticalindustry #mentalhealth #depression #anxiety #psychedelics #psychedelic #psychedelicstocks
We just had an insightful conversation with Doug Drysdale, CEO of Cybin Inc, about the significant strides Cybin is making in psychedelic medicine. Here's what we uncovered about Cybin's journey and the road ahead for 2024: - Highlighting Cybin Inc's financial achievement with an oversubscribed private placement of $150 million, orchestrated by leading investors such as Deep Track Capital and RA Capital Management. - Celebrating the FDA’s Breakthrough Therapy Designation for CYB003, which underscores its potential in revolutionizing the treatment of Major Depressive Disorder, backed by compelling four-month durability data. - Outlining the strategic approach for the upcoming Phase 3 trial in mid-2024. Don’t miss this deep dive into the promising future of psychedelic medicine with Cybin! #psychedelictherapy #psychedelicresearch #psychedelicscience
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We just had an insightful conversation with Doug Drysdale, CEO of Cybin Inc, about the significant strides Cybin is making in psychedelic medicine. Here's what we uncovered about Cybin's journey and the road ahead for 2024: - Highlighting Cybin Inc's financial achievement with an oversubscribed private placement of $150 million, orchestrated by leading investors such as Deep Track Capital and RA Capital Management. - Celebrating the FDA’s Breakthrough Therapy Designation for CYB003, which underscores its potential in revolutionizing the treatment of Major Depressive Disorder, backed by compelling four-month durability data. - Outlining the strategic approach for the upcoming Phase 3 trial in mid-2024. Don’t miss this deep dive into the promising future of psychedelic medicine with Cybin! #psychedelictherapy #psychedelicresearch #psychedelicscience
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