Mark Dale

This month, #EMA launched new advice pilots aimed at improving the quality of clinical trial applications: https://lnkd.in/eCAshghs ➡ The first pilot (𝗦𝗔𝗪𝗣-𝗖𝗧𝗖𝗚) offers developers of medicinal products scientific advice on #clinicaltrials and on requirements for marketing authorisation applications (MAA). For this pilot, joint scientific advice on clinical trials will be provided for the first time by the Scientific Advice Working Party (SAWP) and Clinical Trials Coordination Group (CTCG) to minimize divergencies between the two groups. ➡ The second pilot (𝗽𝗿𝗲-𝗖𝗧𝗔 𝗮𝗱𝘃𝗶𝗰𝗲) is coordinated by the CTCG and provides technical and regulatory support on the dossier of a #CTA prior to its submission. Previously, applicants could only receive technical and regulatory support at a national level from the Member State evaluating the application. The pre-CTA pilot will provide consolidated views of the Member States on pre-submission topics. A webinar is scheduled on 𝟭𝟳 𝗝𝘂𝗹𝘆 𝟮𝟬𝟮𝟰 to provide information and background on these newly launched advice pilots. Attendees are expected to gain an understanding of the scope and benefits of the pilots along with a Q&A session with agency representatives. Questions may be submitted until 10 July 2024! https://lnkd.in/gKuBa8dF

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⏳ Last chance to submit an abstract for our upcoming meeting on the use of irreversible modulation in drug discovery: https://lnkd.in/eW4dwG6B Don't miss this chance to share your research at AstraZeneca's new R&D hub The Discovery Centre in Cambridge! 🔬💊💉 #DrugDiscovery #ScientificConference #CallForAbstracts #Pharmacology #Pharmaceuticals #Pharma #ResearchAndDevelopment #IrreversibleModulation

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🦠 From our latest issue 🦠 An antibody against the #HIV-1 MPER epitope binds through a two-step process. This knowledge may aid the development of MPER-targeting #vaccines Read it here: https://lnkd.in/eQS_E-DV #MPERvaccine

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In a new white paper, Avalere experts in #vacccinepolicy consider key questions related to strain selection, ACIP recommendation, and coverage and reimbursement of adult combination vaccines in development. Read here: https://lnkd.in/eeyAWaGp #vaccines #healthpolicy #preventivecare #respiratorydisease #respiratoryvaccine #influenza #influenzavaccine #covidvaccine #covid19vaccine #RSV #RSVvaccine

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Featured highlights from today's Efortless Update: [Clinical Trials] 「uniQure reports 80% slowing of disease progression in phase I/II trial of AMT-130 for Huntington's disease at 24 months」 「DiscGenics reports phase I/II trial results of IDCT with significant improvements in lumbar disc disease patients up to 2 years」 「S.BIOMEDICS reports phase I/IIa trial one-year follow-up for TED-A9 in Parkinson's disease showing motor function improvement and increased dopamine transporters」 「HilleVax. reports that HIL-214 vaccine candidate fails to meet primary and secondary efficacy endpoints in NEST-IN1 infant trial」 「OXOLIFE reports phase 2 trial results of OXO-001 with increased ongoing pregnancy and live birth rates in IVF, ICSI」 [Deals] 「Prelude Therapeutics partners with Merck to evaluate PRT3789 and KEYTRUDA in phase 2 trial for SMARCA4-mutated cancers」 「Moderna and Mitsubishi Tanabe Pharma Corporation join forces to co-promote mRNA vaccine portfolio in Japan until 2029」 「Taiho Pharmaceutical Co., Ltd., exercises option for Arcus Biosciences' quemliclustat in Japan and Asia, bolstering global phase 3 pancreatic cancer study」 View the full newsletter contents for free via the link in the comments.

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EULAR 2024: New drugs for RA? Abiprubart is an Abatacept distant relative, targeting T cell activation through a different target/molecular interaction (CD40/CD154). https://buff.ly/3Xq72Ct

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In a new pooled analysis of trials assessing daridorexant (Quviviq; Idorsia Pharmaceuticals Ltd), results revealed a favorable benefit-risk profile for both the 25 mg and 50 mg doses, with greater efficacy and safety observed in the 50 mg group. https://lnkd.in/eng3dMt7

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In the second part of our #GenomicsJourneys series, our group of #NHS professionals take us through the next steps: how they built their #genomics knowledge and use it in their clinical practice. https://buff.ly/3VWkvkv #GenomicsConversation

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Watch our latest webinar to hear about 5 real-world case studies, including insight into our 98% collection deliverability rate for CGT!

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Aging-US #published this #trendingwithimpact research #paper in Volume 16, Issue 3, entitled, “Prognostic model development and molecular subtypes identification in bladder urothelial cancer by oxidative stress signatures." https://lnkd.in/eZdGQGsi #aging #bladdercancer #immunotherapy #tumor #microenvironment #research #researchpaper #openaccess #openscience #peerreview #journal #publication #publishing #trending #meded #agingshort #video

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Aging-US #published this #trendingwithimpact research #paper in Volume 16, Issue 3, entitled, “Prognostic model development and molecular subtypes identification in bladder urothelial cancer by oxidative stress signatures." https://lnkd.in/eZdGQGsi #aging #bladdercancer #immunotherapy #tumor #microenvironment #research #researchpaper #openaccess #openscience #peerreview #journal #publication #publishing #trending #meded #agingshort #video

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📣 The latest podcast episode of Conversations in Drug Development is now available! In "Exploring Genome Editing Technologies in Drug Development," host Katherine Bowen and expert Harriet Edwards, Associate Director in Regulatory Affairs, delve into the fascinating world of genome editing technologies. This episode offers an introduction to genome editing technologies, with a special focus on their regulatory landscapes in the UK, EU, and US. Join us as we explore the complexity of genome editing methods, the irreversible nature of genetic changes, and the associated challenges and risks. Visit to find out how to listen on your favourite podcast platform or search 'Conversations in Drug Development' on Spotify, Apple Podcasts or Amazon Music. #genomeediting #genomeeditingtechnologies #regulatoryaffairs

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🎉ANTIBODY THERAPEUTICS XCHANGE - SAN FRANCISCO 2024 🎉REGISTRATION NOW LIVE! 🎫 Have you secured your COMPLIMENTARY pass? 🧪🔬 1 full day, 5 tracks, 10+ topics, 10 industry experts! 🧫 🧬 📢 Register Now https://bit.ly/3Vtwg1n 📅 Monday, 23rd September 2024 📍 DoubleTree by Hilton, San Francisco Airport. 📖Tracks ‣ Bi/Multispecifics ‣ Emerging Technologies ‣ Formats & Scaffolds ‣ Lead Identification & Optimization ‣ Target Selection Meet our industry thought leaders & presenters🤝🏼 🗣️ Lu Shan, Senior Director, Antibody Discovery and Protein Engineering, Alector 🗣️ Remi-Martin Laberge, Co-founder, SVP & Head of Research, Arda Therapeutics 🗣️ Narayan Sastri Palla, Ph.D., Principal Scientist, TrueBinding 🗣️ Steven A. Everett, MBA., Ph.D., Founder & CEO, MaveriX Oncology, Inc. ... many more! 🗨️  Our Partners   ‣ Bio-Rad Laboratories ‣ WuXi Biologics ‣ Rapid Novor ‣ Specifica, a Q² Solutions Company ‣ MABPLEX USA, INC ‣ Scorpius BioManufacturing, Inc. ‣ IPA (ImmunoPrecise Antibodies) ‣ Ailux Biologics XtalPi Inc. ‣ Nicoya ‣ ImmunXperts, a Q² Solutions Company ‣ Neochromosome, Inc. ‣ AVANTGEN ‣ Single Cell Technology Inc. 💊 Only available for Senior Scientists and above, from Bio and Pharma companies with a drug pipeline. 💊 #Registration #OpeningAddress #KeynotePresentation #BiMultispecifics #CellEngagerToxicity #AntibodyDiscovery #ProteinEngineering #EmergingTechnologies #HumanCDRH3Repertoire #AntibodyLeadIdentification #TargetSelection #TherapeuticWindows #SponsorRoundtable #NetworkingLunch #SpotlightPresentation #PosterPresentation #CurrentChallenges #SolidTumours #AntibodyTherapeutics #CancerResearch #IndustryExperts #PharmaInnovation #BiotechRoundtable #ScientificDiscussion #hubXchange #Xchanges #Roundtable #FreePass #RegisterNow #ComplimenatryPass

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