Carey Cunningham

The latest FDA guidance for orally inhaled and nasal drug products (OINDPs), released on 15th February 2024, highlights new strategies for demonstrating bioequivalence (BE) that do not require clinical endpoint trials. Clair Brooks, our Applications Specialist, shared her insights with #OINDPnews to discuss these evolving test methods, focusing on realistic aerodynamic particle size distribution (APSD) measurement and the drive for better in vitro-in vivo correlation (IVIVC). Download the full Q&A now ➡️ bit.ly/3zJTzMF #Innovation #Article #Compliance #Pharma #InhalerTesting #DrivingResults #Pharmaceuticals #Formulations

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In the most recent edition of CCLM: Understanding the limitations of your assay using EQA data with serum creatinine as an example By Rachel Marrington and Finlay MacKenzie This is an Open Access Article: https://lnkd.in/eGbDcmeX

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Wondering how to accelerate #NGS data analysis in a GMP-compliant environment? Join our webinar where Head of Scientific Consulting Devon Ryan will showcase how Genedata solutions enable next-generation automation and tracking of NGS workflows: https://buff.ly/3OBLHQQ #DigitalizingBiopharma #Playbooks #Automation #GenedataSelector

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Learn about the 5 key stages of our UpperNose™ Development Platform. In our latest webinar, Richard Johnson discusses the importance of target product selection in formulation and clinical development. Watch now ➡ https://lnkd.in/ees4VxRB #CDMO #DrugDevelopment #Webinar

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In our latest #PharmorphixFix post, Veranova’s Senior Scientist, Ruth Lunt, explains how our Pharmorphix team helped a customer resolve batch-to-batch API manufacturing inconsistency through solid form and particle size control. Find out below how the team undertook a range of studies, employing multiple techniques and analyses, to develop a solution that resulted in high product yields and facilitated particle size optimization. You can also visit our website to find out more about our solid form and particle engineering capabilities and discover how we can help you overcome API complexity: https://lnkd.in/ehMqRZHK

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Source LDPath (a part of Source BioScience) has published a new white paper offering a comprehensive analysis of the challenges and opportunities in NHS digital pathology. Drawing on insights from leading stakeholders across the UK, the publication delves into the practical aspects of histopathology service delivery and outlines a strategic approach to accelerating digital transformation. Designed to complement existing NHS initiatives, it provides actionable guidance to address key barriers and support seamless integration into current systems. The paper offers a roadmap for advancing digital pathology, featuring proven strategies for department-wide implementation and practical recommendations to drive large-scale success. By addressing both the obstacles and opportunities, it aims to transform the delivery of histopathology services within the NHS, enabling more efficient and effective care. Find out more on Pathology News: https://lnkd.in/gPNH-iEF #digitalpathology #pathologynews

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Another day, another headline story for MAXWELLIA. This week the Chemist+Druggist report how MAXWELLIA is positioned as a 'switching machine,' as we continue to focus on the reclassification of medicines to improve self care. Read the featured story for insights from our CEO Anna Maxwell, including the future role of over-the-counter medicines. You'll find the link in the comments. #OTC #overthecounter #selfcare #NHS #switching #femalefounder #buywomenbuilt

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Interested in learning how we can support you on your #ATMP development journey? ➡️ https://ow.ly/tcYp50U2VI7 Head over to our website where you can read industry case studies on how we have helped accelerate the development of #cell and #gene therapies in the UK and across the world 👆 #CellTherapy #GeneTherapy #AdvancedTherapies #Collaboration #Innovation

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Did you know that 9% of all global ongoing #ATMP clinical trials have representation in the UK? ➡️https://ow.ly/GsRC50TTluX Learn more about the current state of the UK's #AdvancedTherapies sector in the Cell and Gene Therapy Catapult Annual Review 2024 Learn more ☝ #️GeneTherapy #CellTherapy #Innovation #Collaboration #CGTCatapult

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Struggling with clinical trial compliance? Benefit from an immediate understanding of the regulatory requirements for unapproved in vitro diagnostic tests, dose adjustments and other patient sample testing in pharma and biopharma trials around the globe with ARC360. Learn more from Darren Ross during an interview state-side. #IVD #ClinicalStudies #RegulatoryCompliance #IVDR #ARCRegulatory https://lnkd.in/eqwxaiVU

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Join Matthew Hewitt's presentation, “Fast technology coupled with deliberate regulatory: How can the field adapt new guidance to meet therapeutic demand?” CAR-TCR Summit Series As the number of CGT market approvals accelerates, Matt will discuss challenges in manufacturing and address how working collaboratively with partners and regulators aids in tackling the pain points of therapeutic development and clinical trial design. Don't miss this insightful session on regulatory guidance. https://okt.to/KTZMwk #cartcr #cgtdevelopment #celltherapy

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In light of #WearYellowDay for Cystic Fibrosis, we are proud to highlight the great work being done in partnership with Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium (GTC, consisting of researchers from Imperial College London, University of Oxford and The University of Edinburgh) and Oxford Biomedica on the development of BI 3720931, a novel, self-inactivating, replication deficient, 3rd generation lentiviral vector, in an inhaled formulation as a potential long-lasting therapeutic option.   There is currently no cure for Cystic Fibrosis – a genetic condition affecting around 11,000 people in the UK that slowly destroys the lungs and digestive system – however the research being done by Boehringer Ingelheim and GTC is a step in the right direction and doing great work in alleviating the symptoms of patients.   To read more about this research, please click here: https://bwnews.pr/4bcVl5t   #CysticFibrosis #DiseaseAwareness #CFWeek #CellandGeneTherapy

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Listen to feedback from our customer 😍 We are having launching promo for this test! Refer to previous posts for further information ✨ NIPT is safe and effective. Non-invavise, and tested by the experienced experts with clinical experience ❤️ #mgrc #prenatal #pregnancy #genetics #genes #genetictesting #health

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🌟 Does your technology decision make sense for sites? 🌟 Earlier today at the Society for Clinical Research Sites (SCRS) West Coast Summit, Lilith Mist from Merck highlighted the importance of being "systematic" when engaging sites. This approach ensures that your technology decisions are well-aligned and effective for sites. ✅ Before choosing a technology, it's helpful for sponsors to consider: Does the technology actually alleviate site burden or just add another layer of complexity? #IgniteThePossibilites #SCRS2024 #ClinicalDevelopment #ClinicalTrial #ClinicalTrialTechnology #SCRSWest #SiteEnablement

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In Drug Development & Delivery's recent special feature report on outsourcing #formulation development and #manufacturing, Abzena's Head of Formulation, Dr Gary Watts, discusses our customer-centric approach that supports complex biologics and ADCs throughout their entire lifecycle. From #preformulation and generation of formulations for toxicology and first-in-human (FIH) trials through to clinical in-use studies, formulation optimization, robust­ness, and device interaction studies, we streamline and de-risk the development path for our customers. Gary shares, "Broadly speaking, Abzena applies two approaches to formulation studies: First-in-Clinic approach, which is a streamlined methodology focused on enabling the cus­tomer to obtain FIH results in the shortest time possible; and a Best-in-Clinic ap­proach, focused on providing a superior product format to the competitors, often applied after Phase 1." Click here to access the full report and learn more about our unique two-pronged approach: https://lnkd.in/gp88BJQF #CDMO #CRO #drugdevelopment #biologics #ADCs

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Final day at #BIO2024! 🎉 What an incredible event it's been! We’ve enjoyed sharing how our expertise in quantitative pharmacology and PKPD modelling can streamline your R&D process. From understanding drug behaviour to optimising dosing regimens and predicting clinical outcomes, we’re here to help you make informed decisions throughout the drug development lifecycle. 🤝 There’s still time to connect! Reach out via the partnering system or contact Hayley Close directly. Biotechnology Innovation Organization #biotech #pharma #drugdevelopment #pkpdmodelling #quantitativepharmacology #mathematicalmodelling

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With more emphasis on patient-focussed drug development, clinical trials need a new approach to trial design. Outcomes measures benefit patients and drug developers, increasing patient adherence and engagement. ICON’s Sonia Bothorel explains to PHARMAPHORUM MEDIA LIMITED why it’s time clinical trials moved beyond endpoints. Read the article. https://ow.ly/9rr650UoSs7 #ClinicalOutcomeAssessments #PatientCentricity #ClinicalTrials

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