Serge Ahmed’s Post

Every „bright“ idea in science needs the right model to test it. We at Fraunhofer ITEM think that drug development for personalized medicine also needs personalized preclinical development utilizing models faithfully reflecting the clinical situation to prevent clinical trial fail and the loss of promising drug candidates and life of patients. Therefore, we have developed a platform for ex-vivo drug response assays (PEDRA) utilizing fresh clinical samples from indication specific cohorts for immediate drug testing. Thereby, PEDRA can deliver in a fast, flexible and cost effective manner early proof for the clinical fitness of your drug candidates. So, if your 💡 is shining bright, see me and let’s find the right model for your drug together. Looking forward to meet you! #personalizedtumortherapy #tumortherapy #cancerresearch #clinicalresearch #ESMO24

#ClinicalTrial #DrugDevelopment #Biotech Clinical trial complexity continues to grow, especially when it comes to biomarker studies and the early phases of research. Overcoming challenges like coordinating study setup, sample logistics, and timely result delivery are key to reaching study milestones and progressing to the next phase. Discover how LabConnect’s FSP team accelerates clinical trials with flow cytometry expertise and insights into the biological activity of investigational therapies. 👉 https://lnkd.in/gzjAUJKB

PROTACs and molecular glues are becoming a part of the therapeutic pipelines for most pharmaceutical and biotech companies. Join William Farnaby , Amy Bartlett , Robert Plumb and me next week as we discuss some of the work we have been doing with these molecules in our labs. #PROTACs #bioanalysis #LCMS #TPD

Explore the critical aspects of lipid-based formulations, from preclinical studies to clinical applications and delve into the various mechanisms through which these formulations exert their effects. Watch this webinar now. https://ow.ly/2HL250U9iAF

🌱 🌱 Check out this #HighlyCitedPaper# by Peter Hamar et al: "Recent Preclinical and Clinical Progress in Liposomal Doxorubicin" You can find it at: https://lnkd.in/gnRUNmWp

📣Another great educational offering from #FDA 📣 September 4th, FDA CDER Small Business and Industry Assistance (SBIA) will be hosting a webinar to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics. Topics will center on: ✅Regulatory resources and early engagement programs available at CBER, CDER, and CDRH ✅Chemistry, Manufacturing, and Controls (CMC), non-clinical, and clinical guidance documents for early product development ✅Early-stage small molecule drug and biologic anticancer-drug development, cell and gene therapy anticancer-drug development, and anticancer-device and diagnostic development. This webinar has also been pre-approved by Regulatory Affairs Professionals Society (RAPS), Society of Clinical Research Associates (SOCRA), Society of Quality Assurance, and ACRP - Association of Clinical Research Professionals for those of you looking to collect CE credits. Registration 👇

Having the right technical and scientific support can make a critical difference on your study's success. You need project managers that are not only knowledgeable in study setup, assay development, and validation but are also skilled at troubleshooting and maintaining assays once they're deployed for sample analysis. LabConnect's SMEs fit that bill! Read our latest blog to learn more

‼️💻📣 FREE September 4! SBIA Webinar: FDA - NIH – Regulatory Do’s and Don’ts 📣💻‼️ #When September 4, 2024 | 11:00 AM - 3:00 PM ET #Cost This a #NO #COST #FREE Webinar. #AboutTheEvent The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. This activity is intended to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics. The target audience is entrepreneurs new to the FDA regulatory world that could benefit from support in better understanding when to contact the Agency during preclinical development. Additionally, there will be a Q&A session at the end of each session for the audience to ask questions. #IntendedAudience - #Academic spin-off and early-stage companies (small businesses) developing therapies, devices, diagnostics, and digital health technologies. - #Researchers developing new anti-cancer drugs. - #Healthcare professionals developing new anti-cancer drugs. #EventTopics - #Regulatory resources and early engagement programs available at FDA Center (CBER, CDER, and CDRH) - #Chemistry, Manufacturing, and Controls (CMC), non-clinical, and clinical guidance documents for early product development. - #EarlyStage —> small molecule drug and biologic anticancer-drug development. —> cell and gene therapy anticancer-drug development. —> anticancer-device and diagnostic development. - #QandA session with FDA regulators #ContinuingEducation (CE) Real-time participation is required for the certificate of attendance, which can be used in support of CEs for the following professional organizations: RAPS, SOCRA, SQA, and ACRP. Certificates are only available during the two weeks post-event. To learn more about the event and access the event’s website and register, follow the link below.

#Skyreg #Egypt Update #Clinical #preclinical #medicaldevices Draft **Now avaliable** GL for Preclinical test. and clinical invest. for MD