Lexitas Pharma Services’ Post

Presbyopia clinical trial news from Market Scope: LENZ Therapeutics reported April 3 positive topline results from its Phase III CLARITY trials of LNZ100 and LNZ101 for presbyopia. LNZ100 (1.75% aceclidine) achieved the primary endpoint and key secondary endpoints in CLARITY 1 and CLARITY 2, with statistically significant three lines or greater improvement in near vision, without losing one line or more in distance visual acuity. #presbyopia #clinicaltrial #drugdevelopment #refractiveerror Read more: https://lnkd.in/ggWrcCgY

@Veristat's comprehensive planning is the key to success for a biotech company's first Phase I trial. From lab to clinic, Veristat's roadmap to success is a testament to the importance of careful planning in clinical development. Take a closer look at this success story and learn the key takeaway: Planning is the foundation of success. Download the case study today > https://lnkd.in/gnz5K_7f Interested in learning more? Reach out! #CancerAntibody #Veristat

RegenMed Circles will be attending this year's Interventional Orthobiologics Foundation MAX Experience! The expansive orthobiologics agenda now includes a section dedicated to real-world data, where numerous IOF members will present updates on their real-world results, and connect with one another to launch, and/or join, other real-world studies of interest. For example, don't miss: Peter A. Everts, PhD, FRSM. presenting up to 1 year patient outcomes data from the Gulf Coast Biologics Knee Circle, and; Imran Siddiqui, presenting on "Real-World Evidence: The Future of Orthobiologics Research", and; Ariana De Mers, presenting "MFAT Data on the Shoulder" from an ongoing investigator-initiated study. Join us in Scottsdale, and learn more about how the IOF is advancing the field of orthobiologics through #realworlddata and #realworldevidence. Learn More about IOF Max: https://lnkd.in/dDrX5KQM Learn More About IOF Research: https://lnkd.in/dxrPv-Dq

Spherix's Patient Chart Dynamix™ reveals AstraZeneca’s Saphnelo as having the highest use among CLE patients, surpassing its use in SLE or SLE/LN. Approved for SLE and in Phase 3 for CLE, Saphnelo is on track to potentially become the first therapy approved specifically for CLE. 🌟Other promising CLE treatments in the pipeline include Biogen’s litifilimab, Bristol Myers Squibb’ Sotyktu, Amgen’s daxdilimab, Merck’s enpatoran, and Gilead Sciences’s GS-5718. 𝗪𝗵𝗮𝘁 𝘄𝗼𝘂𝗹𝗱 𝘆𝗼𝘂 𝗱𝗼 𝘄𝗶𝘁𝗵 𝘂𝗻𝗽𝗮𝗿𝗮𝗹𝗹𝗲𝗹𝗲𝗱 𝗺𝗮𝗿𝗸𝗲𝘁 𝗲𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲 𝗮𝗻𝗱 𝟰𝟬𝟬 𝗖𝗟𝗘 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗰𝗵𝗮𝗿𝘁𝘀 𝗮𝘁 𝘆𝗼𝘂𝗿 𝗱𝗶𝘀𝗽𝗼𝘀𝗮𝗹❓ #marketresearch #rheumatology #CLE #SLE

A big day at Juvena Therapeutics, as their lead candidate, JUV-161, has received positive FDA feedback and Orphan Disease Designation (ODD) for the treatment of Myotonic Dystrophy Type 1 (DM1). This is a major win for the broader ecosystem as an example of how founder-led biotech can truly change how we think of addressing unmet medical needs. As an early investor, I take immense pride in the team's dedicated efforts over the course of five and a half years, involving hard work and determination, to establish a world-class, fully integrated platform for the discovery and development of biologics. Their unique approach to repairing and restoring muscle health with a biologic that enhances muscle regeneration, metabolism, and function, countering the effects of aging and degenerative disease. Congrats Hanadie Yousef, Jeremy O'Connell, Neil Berkley, Mo Tabrizi, all the scientists, biologists, engineers, rest of the team, other investors, and the many partners who have believed in this group. Big things ahead!!! 🚀 Link to the announcement: https://lnkd.in/gvRTC2NS #biotech #venturecapital #founderled #healthcare #MyotonicDystrophy #RareDisease #unmetmedicalneed #healthspan #sarcopenia

Are you attending the Sept. 25th San Francisco #AdvancedTherapiesXchange? Drawing on his 30+ years of experience leading immune cell operations, Kevin King, Senior Director of #CellandGeneTherapy Strategy and Growth at BioIVT, will be leading the 11:25am session “From Donor to Development: Minimizing Risks in the Cell Starting Materials Supply Chain” discussing strategies to de-risk the utilization of cellular starting and raw materials in the manufacture of #AdvancedTherapies: https://hubs.ly/Q02Qbz6B0 In the absence of industry-wide standardization of human cells, tissues, and cellular and tissue-based products (HCT/Ps), production and manufacturing processes are not equivalent among suppliers. This can create significant efficiency, quality and regulatory obstacles as therapeutic platforms transition from preclinical to clinical application. Kevin will also be joined by Lisa Kretzschmar, Senior Scientific Advisor for CGT at BioIVT, and Adam Ross, Technical Sales Specialist for CGT at BioIVT, for 1:1 meeting requests to discuss: - Why you need a partner that can take you from RUO to GMP - The value of having a geographically expansive, secure supply chain - The importance of donor diversity and its impact on your success - How BioIVT can support your CGT development, from discovery to clinical development Make sure to connect with our expert team if you’d like to schedule a meeting! Learn more about our CGT solutions: https://hubs.ly/Q02QbVwK0 #CellTherapy #GeneTherapy #ATMPs #hubXchange

Improving patient outcomes with the right test and the right therapy!

Yesterday, I attended a webinar delivered by Kim Watanabe, Michele Duggan, and Mindy Sadik from Thermo Fisher Scientific, which focused on positioning early cell therapy programs for clinical success. The session provided insights into mitigating risks and ensuring GMP readiness in this rapidly evolving field. Key takeaways from the webinar included: 1. Strategic Planning: It is essential to 'begin with the end in mind', strategically planning every step to mitigate risks and ensure GMP readiness. 2. Technological Integration: Streamlining workflows through the integration of advanced technologies can significantly enhance efficiency. 3. Operational Optimisation: Efficiency can be optimized through various means, such as automation, digitisation, and scalable platforms. 4. Analytical Rigor: Analytical assays play a critical role and should be qualifiable, transferable, and adhere to appropriate standards and controls. 5. Collaborative Partnerships: Collaborating with CRO/CDMO partners simplifies the cell therapy value chain and enhances patient-centricity. Reflecting on the insights shared, it's evident that many of these principles resonate with our approach at adthera bio. We've embraced a digital-first mindset and integrated a diverse range of automated platforms, including closed systems. Our goal at adthera bio is to bring novel C&GTs to the market with a highly personalised approach, ensuring a seamless journey from the client to the patient. #cellandgenetherapy #atmps #digitalfirst #cell&genetherapyinsights #biotechnology

We couldn't be prouder of Lexitas senior leaders Andrew D. Pucker, OD, PhD, and Lanita Scott, M.D. for their contributions to this publication of the most comprehensive summary of ophthalmic clinical trial metrics in the US to date! These findings and insights will be invaluable to stakeholders across the industry, helping to drive more precise enrollment planning and ensure successful execution as we collectively work toward better outcomes. Follow the link to read the full report which includes: -Most studied indications -List of most prolific ophthalmic trial Sponsors -List of most studied drugs -Enrollment rates by indication and trial phase Read more here: https://lnkd.in/gTZ7f4Xb #clinicalresearch #ophthalmology #Lexitas #metrics #enrollment #thoughtleadership

Short Interest Update for Editas Medicine, Inc. (NASDAQ: EDIT) https://lnkd.in/gYiG5DNw Short Interest Update for Editas Medicine, Inc. (NASDAQ: EDIT). This update provides information on the number of shares sold short. The short interest is useful for investors interested in Editas' stock. #editasmedicine #nasdaq #shortinterest CEO Outlook Magazine