Eric Axelrod

Let’s talk about the advancements in diagnostic technology…

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I hope this blog article doesn't offend any of my fellow consultants or eQMS partners, but I've always been critical of over-stuffed Quality Manuals, and with the upcoming FDA QMSR alignment with ISO 13485 it will become a requirement for all FDA-regulated device companies. I keep seeing postings offering to solve the problem with templatized, one-size fits all Quality Manuals, and every one of them is guilty of overthinking the 13485 requirements and intent. You don't actually think any of your employees actually read your 20, 30, 40+ page Quality Manual, do you? #QRxPartners #QRxInforms #QualityManual #QMS #MLV #QMSR #FDA #ISO13485

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Are you prepared for the FDA's new LDT regulations? Join us for ECI Live on Tuesday, August 27th as we dive into these changes with Sr. IVD Consultant Sonia Lecce. Learn how these new rules could impact your strategies, operations, and even the approval process for LDTs. This is your chance to get real-time insights and ask questions LIVE. Link to the LinkedIn Live: https://lnkd.in/g5CkuXkn Don't miss out and I hope to see you there! #LDT #FDA #strategy #live #consulting

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Mental Health Awareness, prevention and education is so important in today’s world.

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👨‍🔬💬 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐍𝐞𝐰𝐬: 𝟐𝐧𝐝 𝐉𝐮𝐥𝐲 𝟐𝟎𝟐𝟒 👩‍🔬💬 🧬 Genezen is acquiring uniQure's commercial gene therapy operations in Lexington, MA for total consideration of $25 million, comprised of $12.5 million of newly issued Series C Preferred Stock and a $12.5 million convertible note. Genezen will be responsible for manufacturing global commercial supply of HEMGENIX® for CSL and providing development and manufacturing services to support uniQure’s investigational gene therapies. uniQure and CSL will be entitled to preferred customer status. 🧬 Hemgenix is to be made available for NHS patients after approval from the UK's NICE - National Institute for Health and Care Excellence. The gene therapy for haemophilia B, will immediately be available at eight specialist centres across England. Hemgenix is used to treat adults with moderately severe and severe haemophilia B, a genetic condition caused by the partial or complete loss of factor IX, a protein essential to produce blood clots. 🦠 SCG Cell Therapy announced FDA clearance for their IND application to start Phase 1/2 trials of SCG142, a next-gen HPV-specific TCR T cell therapy for HPV-associated solid tumors. SCG142, developed from SCG's GianTCR™ platform, targets HPV-16 and HPV-52 genotypes and shows promise in preclinical studies. This therapy uses a chimeric switch receptor to enhance T cell functionality and tumor inhibition. SCG plans multi-center trials to assess SCG142’s efficacy and safety. 🧬Vertex Pharmaceuticals announced FDA acceptance for its New Drug Application (NDA) for investigational once-daily vanzacaftor/tezacaftor/deutivacaftor triple combination therapy (vanza triple) for people living with cystic fibrosis ages 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene responsive to the vanza triple. 🧬 Rejuvenate Bio received a $4M grant from the California Institute for Regenerative Medicine (CIRM) to advance RJB-0402, a gene therapy for desmoplakin gene variant arrhythmogenic cardiomyopathy (DSP ACM). RJB-0402 uses AAV8 to deliver FGF21 protein, targeting multiple disease drivers. Preclinical studies showed improved cardiac function and reduced arrhythmias. This funding will enable IND-enabling activities and clinical trials, addressing a significant unmet medical need for DSP ACM patients. 🦠 Codexis, Inc. announced an asset purchase agreement with Crosswalk Therapeutics for its investigational gene therapy assets including Fabry and Pompe disease compounds. Under the terms of the agreement, Codexis is eligible to receive future development and commercial milestone payments in addition to a low-to-mid single-digit percentage net sales-based royalty. 🛎 My aim is to be the messenger when it comes to your CGT news. Follow #mCGT to stay updated! #celltherapy #genetherapy #ATMP

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