Evnia’s Post

⚠️ WEBINAR ALERT⚠️ 🧬 GlobalData Plc Presents: Cell & Gene Therapy Intended Audience: VPs Commercial Strategy  Market Access Pricing  Competitive Intelligence Brand Managers  Manufacturing Supply chain Sectors Covered: Service providers (CMOs, CDMOs, CROs) Biotechs  Drug manufacturers and developers Clinical trial operators  Analytics providers MoHs  Market access consultancies Financial capital markets  Delivery suppliers WHEN: UK - Thursday 9th Nov 4pm Korea - Friday 10th Nov 1am India - Thursday 9th Nov 9:30pm *If these times are not suitable for you, please still register as you can watch the playback at any time post the event finishing. This virtual conference will provide an all-encompassing view of regenerative medicine from leaders in GlobalData’s pharmaceutical team, alongside an exclusive Q&A session. Key industry challenges across the pharmaceutical value chain will be addressed, from drug development and clinical trials, to manufacturing and supply chain management. Split into three insight sections on therapeutic areas, contract service providers, and pricing and market access, and followed by a Q&A, this event is not to be missed. Register Here: https://lnkd.in/gEGmE5u8 Looking forward to hearing the insightful speakers: Jasminemay Barcelon Barbora Salcman Amanda Murphy Fiona Barry Milena Izmirlieva #pharmanews, #drugdevelopment #pharmaceuticals #celltherapy #cellandgenetherapy #cellandgene #cellandgenetherapies

The week in pharma: action, reaction and insight – week to December 15, 2023 - The Pharma Letter >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharma #healthcare #competitivemarketing #pharmaceutical

How can we avoid clinical stage failures and get drugs to patients faster? We share our thoughts on navigating R&D with evidence from large human populations in this latest Cell Press Trends in Biotechnology piece https://lnkd.in/e7q52qWP Reducing clinical failures is the biggest opportunity in drug development: 90% of drugs fail in clinical trials, with 50% failing for efficacy reasons. Stakeholders lack critical evidence on whether their drug target will work in humans before trialing for it, and they lack tools to use insights on target biology to optimize clinical positioning. Human evidence from large populations offers critical insights to navigate and de-risk R&D: ensure target safety and efficacy at the earliest stages and align target biology with the right clinical phenotypes benefitting from target modulation. Interested in learning more about how PheironGPS can benefit your program? We’d love to know https://lnkd.in/ey_B2gHj #clinicalsuccess #drugdevelopment #targetidentification #targetvalidation #humanevidence #geneticevidence #targets #biomarkers #populations

Fellow professionals and leaders in #pharmaceuticals and #biopharma: We have a responsibility to pay attention to – and be part of – rapid whole genome sequencing (#rWGS) advancement.    If you haven’t yet, make sure to give our FiercePharma article a read. We explore the great potential of rWGS in drug development and commercialization, spotlighting the cross-industry initiatives leading the charge.     When we share expertise and resources, our impact on the lives of all newborns can be that much greater.    Share this with someone you know to support the advancement of #RareDisease diagnosis and treatment.    https://lnkd.in/g7xgMmb4     #SentynlSeeks #NewbornSequencing 

The U.S. Food and Drug Center for Drug Evaluation and Research (CDER) 𝐚𝐩𝐩𝐫𝐨𝐯𝐞𝐝 𝟓𝟓 𝐧𝐨𝐯𝐞𝐥 𝐝𝐫𝐮𝐠𝐬 𝐢𝐧 𝟐𝟎𝟐𝟑, according to their annual New Drug Therapy Approvals report, 𝑛𝑜𝑡 𝑖𝑛𝑐𝑙𝑢𝑑𝑖𝑛𝑔 vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2023. This was ✅ 50% more than in 2022, ✅ the highest since 2018 and ✅ the second highest number of approvals in 30 years. So far, in the first 10 days of 2024, one therapy has been approved and there are several other novel therapies in the FDA’s pipeline for approval this year. Based on this information, ➕ the excitement coming out of #jpm2024 ➕ the Fed's cautious optimism about inflation and the likelihood of not having to raise rates again ➕ record high levels of employment ...I'd say that 2024 promises to be a good year for executive-level employment in life sciences and healthcare. The competition for top talent will be tough, but companies with solid talent strategies and strong corporate partners (hint, wink) will win. 🏆 There you go. You asked, I answered. Sincerely, Your Biotech Bestie Your Healthcare Homegirl Your Board Boo #biotech #healthcare #hospitals #executivesearch https://lnkd.in/eq-wTBM3 g͟r͟a͟p͟h͟i͟c͟s͟: NME = New Molecular Entities BLA = Biologics License Applications https://lnkd.in/eFeeCNmK.

The week in pharma: action, reaction and insight – week to December 15, 2023 - The Pharma Letter >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #biotech #healthcare #competitivemarketing

"Healx pitches itself as a “drug discovery pipeline” that identifies hidden connections between existing chemical compounds (e.g., drugs and pharmaceuticals at various stages of the development cycle) and rare diseases. It does this by collating a myriad of public and proprietary data sources, like biomedical literature, disease and biochemical datasets, clinical trials and patents to create a “biomedical knowledge graph” of rare diseases." - https://lnkd.in/gxwgRNXC - #raredisease

50% of clinical failures are attributed to a lack of efficacy. Reasons for this often go back to the earliest phases of R&D: decisions on the target and the clinical positioning do not only set the foundations for development but also largely determine success rates. Today, stakeholders lack tools to systematically assess target efficacy and safety with human evidence. Our mission at Pheiron is to change that. We use #AI and #populationgenetics to find routes through early R&D that have a higher likelihood of clinical success: de-risked targets, linked biomarkers and aligned clinical phenotypes. Read more about what we’re building here: https://lnkd.in/e6kubYvv #phenotyping #geneticevidence #AI #populationgenetics #predictiveutility

Excited to share insights from the online presentation attended: "Planning for a Successful Initial IND and Moving Beyond: Regulatory CMC Considerations for Biotherapeutics and Cell and Gene Therapies," hosted by Regulatory Affairs Professionals Society (RAPS) and Veristat.   Interested in delving into comparability studies and assessments within therapeutic development or clinical research, this online presentation provided a comprehensive picture of comparability studies in a nutshell.   One key takeaway was the importance of comparability studies in pharmaceutical manufacturing. These studies assess whether changes to the manufacturing process or product impact quality, safety, or efficacy. Evaluating Critical Quality Attributes (CQAs) is central to this process, ensuring consistency and performance of the investigational product.   I learned about the analytical techniques and strategies for comparability studies, emphasizing their vital role in product development. From physicochemical properties to potency and stability, every aspect is meticulously evaluated to maintain product integrity.   Looking forward to getting insights from all of you and applying these in my regulatory affairs work!   #RegulatoryAffairs #Pharmaceuticals #CMC #Biotherapeutics #ClinicalResearch #TherapeuticDevelopment #ComparabilityStudies #ContinuousLearning #RAPS #Veristat #OnlinePresentation #northeasternuniversity #raps #certification

Unlike traditional drugs, advanced therapeutic modalities (ATMs) are designed rather than discovered. They’re also about to become a standard modality. Writing for Harvard Business Review, L.E.K.’s Alex Vadas, Jeff Holder, Ph.D. and Adam Siebert explain how ATMs are different and what that means for life sciences companies as they confront profound changes in strategy, investment and risk management. https://bit.ly/48EK5NW #lifesciences #pharma #pharmaceuticals #pharmaceuticalindustry