We had a wonderful time meeting with key stakeholders from around the world at this year’s American Diabetes Association (ADA) 84th Scientific Sessions. To read about the data we presented for our preclinical product candidate REJUVA® which was selected as the number one abstract out of 8,000 submissions by the Scientific Sessions Meeting Planning Committee, click here: https://lnkd.in/eTVrZWEf To hear a recap of our KOL event with Dr. David D’Alessio, visit the IR page on Fractyl.com. We look forward to seeing you again next year. *Rejuva is in preclinical development and has yet to be assessed by regulatory agencies #ADA2024 #ADAScientificSessions #Fractyl #obesity #type2diabetes #T2D #biotech
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In 2019, the FDA set its target to approve between 10 to 20 CGTs annually by 2025. With eight therapies approved in 2023, they are currently on track. 📈 Over the last few years, their strategic actions have shown commitment to shaping a streamlined pathway for CGT approvals. The establishment of both the Accelerated Access Pathway and the Office of Therapeutic Products are key to expediting this regulatory process. To keep momentum towards this target, it is imperative that regulators such as the FDA work closely with the wider CGT industry. Only with regulatory agility –combined with insights into research, development and manufacturing – can we work towards ensuring that therapies are approvable, accessible and affordable. Read more about the FDA's role in the future of CGTs: https://lnkd.in/gSj4up4S #celltherapy #genetherapy #biotechnology #manufacturingbrighterfutures #advancedtherapies
The FDA is at a crossroads on cell and gene therapies
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🔔 Half-day #workshop on the important topic of #phospholipids at Controlled Release Society (CRS) Annual Meeting in Bologna/Italy. 🗓 July 08, 2024, at 8 am to 12 pm. 📌 Our speakers: Session 1️⃣ on Phospholipids as #excipients Simon Drescher (Phospholipid Research Center Heidelberg): The Phospholipid Research Center Heidelberg: An introduction and ongoing research projects Peter van Hoogevest (Phospholipid Research Center Heidelberg): An Introduction on the use and properties of phospholipid excipients Paulina Skupin-Mrugalska (Poznan University of Medical Sciences): Phospholipids as excipients in (amorphous) solid dispersions Paola Luciani (Universität Bern): Phospholipids in parenteral depot formulations: recent advances, current challenges, and future opportunities Session 2️⃣ on #liposomes and lipid nanoparticles (#LNPs) Mans Broekgaarden, PhD (Université Grenoble Alpes): Radiocontrolled drug delivery with high-Z element-functionalized liposomes Davide Brambilla (Université de Montréal): Phospholipid nanoparticles for lipase deficiency gene replacement therapy Maria Manuela Gaspar (Universidade de Lisboa): Advancing the treatment of infectious diseases – the key role of liposomes as delivery systems Félix Sauvage (Universiteit Gent): Photo-induced destruction of vitreous opacities using nanobubbles generating liposomes Hope to see you! #education #pharma #drugdelivery #genetherapy
CRS 2024 Annual Meeting and Exposition - Phospholipid Research Center
https://www.phospholipid-research-center.com
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🔊 United States Pharmacopeia (#USP) has released a draft chapter for public comments: USP <1040> "𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗼𝗳 𝗣𝗹𝗮𝘀𝗺𝗶𝗱 𝗗𝗡𝗔 𝗨𝘀𝗲𝗱 𝗮𝘀 𝗮 𝗦𝘁𝗮𝗿𝘁𝗶𝗻𝗴 𝗠𝗮𝘁𝗲𝗿𝗶𝗮𝗹 𝗶𝗻 𝗖𝗲𝗹𝗹 𝗮𝗻𝗱 𝗚𝗲𝗻𝗲 𝗧𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀". https://lnkd.in/dBfidDAu This chapter aims to describe considerations for the manufacture and release of plasmids that are used as starting materials in the manufacture of #cellandgenetherapy drug products. It is important to note that plasmids used as DS or DP or plasmids used in protein production are out of scope of this chapter. The chapter provides an overview of: 🔹 Manufacturing considerations such as facility design 🔹 Establishment of critical materials such as bacterial master cell banks 🔹 Phase appropriate quality systems, facilities, and risk management 🔹 Quality attributes, analytical procedures, and example acceptance criteria for the MCB and final vialed plasmid With the rise in approval of #CGT based therapies, guidances such as USP<1040> that aim to bring standardization in production of starting materials are much needed! Kudos!
〈1040〉 Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies
doi.usp.org
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Drug interaction research is essential for reducing exposure of harmful drug combinations in patients and avoiding morbidity, mortality, and even premature death. In this article, "Exploring the impact of CYP2D6 and UGT2B7 gene-drug interactions, and CYP-mediated DDI on oxycodone and oxymorphone pharmacokinetics using physiologically-based pharmacokinetic modeling and simulation." Congratulations to the authors for their novel research methods. Klose et al, were able to "predict oxymorphone exposure to be highest in CYP2D6 UMs/UGT2B7 PMs in the presence of ketoconazole (strong CYP3A4 index inhibitor) and lowest in CYP2D6 PMs/ UGT2B7 NMs in the presence of rifampicin (strong CYP3A4 index inducer) covering a 55-fold exposure range." Take a read here https://lnkd.in/e6V5Pygi.
Exploring the impact of CYP2D6 and UGT2B7 gene-drug interactions, and CYP-mediated DDI on oxycodone and oxymorphone pharmacokinetics using physiologically-based pharmacokinetic modeling and simulation - PubMed
pubmed.ncbi.nlm.nih.gov
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Structural cardiotoxicity (SCT) presents a high-impact risk that is poorly tolerated in early drug discovery unless significant benefit is anticipated. Our recently published paper explores calcium transient assays and identifies a shortlist of genes which could be used to mitigate SCT risk and make drugs safer for patients in the longer term. I'm both privileged and grateful to have been part of this collaborative and interdisciplinary study! #AstraZeneca #UniversityOfBirmingham #drugdiscovery #structuralcardiotoxicity #transcriptomics #bioinformatics #machinelearning https://rdcu.be/dMeMt
Computational approaches identify a transcriptomic fingerprint of drug-induced structural cardiotoxicity - Cell Biology and Toxicology
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Revolutionizing Medicine: Cyclimids Unveil Precise Pathways for Targeting Disease Proteins, Pioneering Future Drug Discovery and Transformative Patient Care. This groundbreaking study introduces cyclimids embedding L-aspartimide, setting a new standard in targeting disease at the molecular level for significantly improved drug development and patient treatment strategies. At Innoventyx, we closely follow advancements in protein degraders such as cyclimids and their groundbreaking impact on targeted protein degradation. Our expertise in fundraising, IP protection, and strategic commercialization positions us uniquely to propel pharmaceutical and biotech firms leveraging these novel molecules. Let us guide your venture through the complexities of drug development and due diligence to unlock transformative patient care solutions. https://lnkd.in/g7rraeRK #biotechnology #fundraising #pharmaceuticals #pharma #healthcare #medicine #innovation #strategy #leadership #business #success #duediligence #innoventyx
The cyclimids: Degron-inspired cereblon binders for targeted protein degradation
cell.com
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CEO (Innoventyx) | Consultant | Pharmaceutical/Biotech/Life Science | R&D/Clinical Trials/Commercialization | Fundraising | Due Diligence
Cyclimids, a new class of binding molecules with L-aspartimide as a new E3 ligase-recognition moiety, unlocks the potential to precisely target and degrade disease-causing proteins, opening transformative pathways in drug discovery and molecular degraders for better patient outcomes. https://lnkd.in/g9xdY7tZ Leveraging the latest breakthrough in cyclimids, I offer comprehensive consulting services to navigate the emerging landscape of targeted protein degradation. With deep expertise in R&D, due diligence, commercialization, and fundraising, I am uniquely positioned to accelerate the translation of these novel molecules into transformative therapies, driving forward innovation and improved patient outcomes in the pharmaceutical and biotech industries. Let's partner to harness the full potential of this cutting-edge technology. #biotechnology #fundraising #pharmaceuticals #pharma #healthcare #medicine #innovation #strategy #leadership #business #success #duediligence #innoventyx
Revolutionizing Medicine: Cyclimids Unveil Precise Pathways for Targeting Disease Proteins, Pioneering Future Drug Discovery and Transformative Patient Care. This groundbreaking study introduces cyclimids embedding L-aspartimide, setting a new standard in targeting disease at the molecular level for significantly improved drug development and patient treatment strategies. At Innoventyx, we closely follow advancements in protein degraders such as cyclimids and their groundbreaking impact on targeted protein degradation. Our expertise in fundraising, IP protection, and strategic commercialization positions us uniquely to propel pharmaceutical and biotech firms leveraging these novel molecules. Let us guide your venture through the complexities of drug development and due diligence to unlock transformative patient care solutions. https://lnkd.in/g7rraeRK #biotechnology #fundraising #pharmaceuticals #pharma #healthcare #medicine #innovation #strategy #leadership #business #success #duediligence #innoventyx
The cyclimids: Degron-inspired cereblon binders for targeted protein degradation
cell.com
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💊𝗕𝗹𝗼𝗴𝗴𝗲𝗿 #ConnectingInforming #DrugDiscoverytoDrugDelivery 💻𝗩𝗶𝗱𝗲𝗼 𝗖𝗼𝗻𝘁𝗲𝗻𝘁 𝗖𝗿𝗲𝗮𝘁𝗼𝗿 YouTube: RSK Life Science Media 📈𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝗻𝘁-LinkedIn/Marketing/Media/Events, Brand Champion
#News: The FDA has finalised its industry guidance for #chimericantigenreceptor (CAR)-T #cell products and #genetherapies, while also acknowledging a lack of precedent in the space. The new guidance, Considerations for the Development of CAR-T Cell Products: Guidance for Industry, follows a March 2022 draft release that received feedback from industry players, including the @Biotech Innovation Organization (#BIO) They urged the agency to take a closer look at the role of manufacturing processes, refine early-stage trial guidelines and define how guidelines apply to other therapies beyond #CART. The new guidance not only focuses on CAR-T cell products, but can also be applied to other #geneticallymodified #lymphocyte products, including #CARnaturalkiller (NK) cells or #Tcellreceptor (TCR) modified T cells. Additionally, the #FDA also indicates differing specifications for #allogenic versus #autologous therapies, underscoring the importance of characterisation data during early studies. The agency considered the challenging nature of developing, manufacturing and testing CAR-T cells by acknowledging that the process involves “complex multi-step procedures, which are potential sources of variability among product lots”. “Appropriate in-process testing at relevant time points is vital to achieve and maintain control of the manufacturing process,” wrote the FDA. Read more from #PMLiVE 👇🏼 https://lnkd.in/eWpPnSxk
FDA publishes final industry guidance for CAR-T and gene therapies
pmlive.com
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Gwen Eak and Kelli Phillips, experts in bioanalysis, outline the evolution of biosimilar drug development regulations in the last two decades, giving background on key milestones and harmonization efforts in the U.S. and EU. They also delve into key areas specific to bioanalysis in biosimilar programs, including: • Method development and validation • Immunogenicity assays • PK considerations • Comparability assessment 📥 Download the white paper » https://bit.ly/46IyU6V
Reducing Regulatory Risks in PCR Assays for Bioanalytical Validation
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PFIZER INC. Inc (NYSE:PFE, ETR:PFE)'s experimental #genetherapy for #haemophiliaA has succeeded in a Phase 3 study, overcoming safety concerns that had halted the trial for almost a year. The therapy, #giroctocogenefitelparvovec, is a one-time infusion designed to enable patients to produce Factor VIII, a protein essential for normal blood clotting. Currently, haemophilia A patients rely on regular Factor VIII #infusions to prevent bleeding episodes. In the AFFINE study, researchers monitored 75 patients for at least 15 months post-infusion. Pfizer reported that participants experienced fewer bleeding episodes and had higher Factor VIII levels compared to the standard prophylactic treatment prior to the infusion. Only one patient resumed prophylactic infusions. The study results bring hope for patients looking to avoid the frequent burden of Factor VIII injections,... More at #Proactive #ProactiveInvestors http://ow.ly/OwYY105Caqy
Pfizer's experimental gene therapy for haemophilia A shows promise in Phase 3 study
proactiveinvestors.com.au
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3moCongratulations Lin Quek