Join us on Tuesday, January 28 at 11am EST for an HCW@Home virtual fireside chat, featuring a panel of experts from Gyre Therapeutics. Chief Executive Officer Han Ying, Regulatory Affairs Consultant Suzana Corritori, and Clinical Development Consultant Que (Roger) Liu will be joined by HCW Research Analyst Ed Arce for an in-depth discussion on Gyre’s lead drug, F351. They will cover the latest advancements, the drug's key indications, and the company’s strategic outlook. Please visit https://lnkd.in/e2QiCud8 to register.
H.C. Wainwright & Co., LLC’s Post
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> John Maraganore turns to ex-Alnylam colleague to lead his latest RNAi bet; Amylyx names commercial chief >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #productmarketing #biotech #pharmaceutical
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Thoughts on this? >> John Maraganore turns to ex-Alnylam colleague to lead his latest RNAi bet; Amylyx names commercial chief >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #biotech #healthcare #productmarketing #pharma
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Get ready for SCOPE Europe Summit 2024! We’re excited to be attending the SCOPE 2024 in Barcelona and learn about the new updates in the clinical trial space. Catch up with our Chief Strategy Officer, Kristin Yakimow, on October 29 to discuss how real-world imaging datasets (RWiD) can help optimize clinical trials by improving patient selection, trial efficiency, and data-driven decision-making. Segmed’s fit-for-purpose Real world imaging datasets (RWiD) and multimodal longitudinal datasets are key to unlocking new possibilities for pharmaceutical and Biotech companies in accelerating drug development, improving clinical trial design, and driving innovation. To schedule a meeting and to understand more about Segmed - https://hubs.li/Q02VxgRm0 #SCOPE2024 #ClinicalTrials #RWiD #Innovation #Pharma #Biotech #CRO #DrugDevelopment #Segmed #RWD #imagingdata #realworldimagingdata
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Finding the right research sites, principal investigators, and patient populations is a challenge in any therapeutic area, and the search only becomes more complex when you’re studying treatments for rare diseases. We spoke with Pamela Fearon, VP of Global Study Operations at BioMarin Pharmaceutical Inc. to hear about the challenges she faces in these areas and how they’re implementing H1's clinical intelligence to overcome them. See the conversation about how H1 supports BioMarin’s clinical research here: https://lnkd.in/ehwZ7gCv #biomarin #siteselection #sitefeasibility #principalinvestigators #rarediseases #clinicalintelligence #clinicalresearch
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Director at SJLife Sciences | Passionate about making a difference within the High Unmet Medical Need space 💊
Wow! Leveraging patient-level data to identify effective therapies is a game-changer for the industry and, more importantly, for patients 👏🏻 #RWE #raredisease #drugdevelopment
Physician-Scientist @ UPenn | National Bestselling Author, Chasing My Cure | Co-Founder @ Every Cure & CDCN
The FDA approved a drug for a new disease without requiring a clinical trial! Tacrolimus, initially used off-label for lung transplant rejection, proved so effective that once the data was analyzed, the FDA approved it for this new indication. This highlights the power of real-world evidence analysis, a strategy we embrace at Every Cure. By leveraging patient-level data., we can uncover which drugs are actually working and identify opportunities to expand their use to even more patients. This approach is not only faster and less expensive than traditional clinical trials but also a game-changer in getting lifesaving treatments to people worldwide. #raredisease #pharma #drugdevelopment
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PRP provides Quality & Regulatory Compliance Consultants/Contractors to Life Science Companies
This is an incredible example of the impact real-world evidence can have on expanding treatment options. Leveraging patient-level data to identify effective therapies is a game-changer for the industry and, more importantly, for patients. It’s exciting to see innovation like this paving the way for faster, more accessible solutions to unmet medical needs!
Physician-Scientist @ UPenn | National Bestselling Author, Chasing My Cure | Co-Founder @ Every Cure & CDCN
The FDA approved a drug for a new disease without requiring a clinical trial! Tacrolimus, initially used off-label for lung transplant rejection, proved so effective that once the data was analyzed, the FDA approved it for this new indication. This highlights the power of real-world evidence analysis, a strategy we embrace at Every Cure. By leveraging patient-level data., we can uncover which drugs are actually working and identify opportunities to expand their use to even more patients. This approach is not only faster and less expensive than traditional clinical trials but also a game-changer in getting lifesaving treatments to people worldwide. #raredisease #pharma #drugdevelopment
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Physician-Scientist @ UPenn | National Bestselling Author, Chasing My Cure | Co-Founder @ Every Cure & CDCN
The FDA approved a drug for a new disease without requiring a clinical trial! Tacrolimus, initially used off-label for lung transplant rejection, proved so effective that once the data was analyzed, the FDA approved it for this new indication. This highlights the power of real-world evidence analysis, a strategy we embrace at Every Cure. By leveraging patient-level data., we can uncover which drugs are actually working and identify opportunities to expand their use to even more patients. This approach is not only faster and less expensive than traditional clinical trials but also a game-changer in getting lifesaving treatments to people worldwide. #raredisease #pharma #drugdevelopment
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Chief Technology Officer | Gene Therapy Innovation, Process Development, Global Leadership | I help biotech reach patients faster by optimizing CMC strategies and managing multiple global vendor relationships.
From 'off-label' to FDA-approved: How real-world patient data just revolutionized drug approval... This is a fantastic example of evidence-based medicine evolving! The FDA's approval of tacrolimus for lung transplant rejection based on real-world evidence is truly groundbreaking. The data from the U.S. Scientific Registry of Transplant Recipients showed dramatic improvements in patient outcomes compared to historical controls - demonstrating how systematically analyzing existing treatment data can validate what clinicians observe in practice. This approach to drug approval not only saves time and resources but, most importantly, helps get proven treatments to patients faster. What impresses me most is how the FDA combined this real-world evidence with supporting data from other solid organ transplant studies to make a robust case for approval. It's a perfect blueprint for how we can responsibly expand drug indications when strong observational data exists. Looking forward to seeing more innovative approaches like this in drug development! #Healthcare #Innovation #ClinicalResearch #raredisease #everycure
Physician-Scientist @ UPenn | National Bestselling Author, Chasing My Cure | Co-Founder @ Every Cure & CDCN
The FDA approved a drug for a new disease without requiring a clinical trial! Tacrolimus, initially used off-label for lung transplant rejection, proved so effective that once the data was analyzed, the FDA approved it for this new indication. This highlights the power of real-world evidence analysis, a strategy we embrace at Every Cure. By leveraging patient-level data., we can uncover which drugs are actually working and identify opportunities to expand their use to even more patients. This approach is not only faster and less expensive than traditional clinical trials but also a game-changer in getting lifesaving treatments to people worldwide. #raredisease #pharma #drugdevelopment
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Thoughts on this? >> Sionna licenses clinical-stage cystic fibrosis assets from AbbVie shortly after large Series C >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #productmarketing #biotech #healthcare
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In this latest K-Cast series, “Advancing Healthcare With Prescription Drug Therapeutics,” Masha Salsabili, PharmD, PhD offers insights on the future of prescription digital therapeutics (PDTs) and how the landscape might evolve for PDTs over the next 5 years. Watch the series here: https://bit.ly/4dR4oLW #ManagedCare #HealthTech
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