Andy Fenny

BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM

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Demonstrating the technical leadership of SK pharmteco! 🧬 Catch up with our team at ASGCT to discuss how SKPT can support your #cellandgene development!

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Get ready for Episode 7 of the GxPodcast! 🎙️ This week, we're joined by Chris Lewis, the Vice President of GMP Quality for Umoja Biopharma. Tune in to hear us discuss quality culture and excellence in life sciences. We look at cell and gene manufacturing, the connection between innovation and purpose, and the importance of data management in our industry. Tune in to the full episode here: 🔗 https://lnkd.in/exW4jkBB #GXPodcast #iPharmGxP

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🚀 Exciting collaboration announcement! Kincell Bio and Imugene Limited have unveiled a strategic manufacturing and process development partnership, featuring the sale of Imugene's North Carolina CGMP manufacturing facility and the transfer of process and analytical development activities to Kincell. 💼 The strategic alliance includes a manufacturing supply agreement wherein Kincell will manufacture Imugene's Azer-cel to support ongoing clinical trials. Additionally, Kincell will take over the process and analytical development of Azer-cel to optimize its readiness for commercial production. 🏭 The acquisition of Imugene's 32,800-square-foot CGMP-compliant facility marks a significant milestone for Kincell, enabling them to evolve site capabilities and manufacture a broad portfolio of autologous and allogeneic products. The facility's location in Research Triangle Park (RTP) will facilitate access to talent in the fast-growing biotech hub. 🌍 This partnership underscores the commitment of both Imugene and Kincell to advancing immunocellular therapies and addressing significant unmet medical needs for patients worldwide. 🌐 #PharmaceuticalIndustry #Partnership #TherapeuticInnovation #ImmunocellularTherapies #Biotech #CDMO #Collaboration

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Are you experiencing Upstream Process Development screening capacity constraints? Leverage Culture Biosciences’ cloud-connected bioreactors to accelerate your project. #processdevelopment #processoptimization #cloudconnectivity #bioreactor #bioprocess

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There are so many advantages of the co-located lab and clinic that we offer in Lincoln. From the scientific advantage such as PBMC prep, Flow Cytometry and rapid sample analysis to the cost and risk savings of eliminating sample shipment to the improved ease of business by having a one stop shop for your Phase 1 and other Clin Pharm studies with one contract, one site to visit and a single point of contact who can get EVERYONE running a study in the same room. This just can’t happen anywhere else. The analysis is literally one staircase away from the clinic processing lab. Not only that, for your bioanalytical needs we will conduct all of your assays in the same building: safety labs, PK LCMS/LBS, Flow cytometry, biomarkers or qPCR. Give us a call for your next study! #celerion #celerionbioanalysis

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Are you navigating the complex landscape of sourcing #leukopaks and cellular starting materials for your advanced therapies?     Join us for an on-demand webinar where Matt Chorley, Parijat Jain PhD, and Wini Luty dive into crucial considerations including GMP/GTP compliance and GMP material sourcing efficiency. Gain insights into how to select the right suppliers and streamline your journey through the #CellAndGeneTherapy development pipeline: https://lnkd.in/gZtjSASx     #FDARegulation #CellTherapy #GeneTherapy

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Our next webinar, with Dr. Samantha Atkinson from NSF, looks at how a quality culture can positively impact GMP compliance which, in turn, can impact supply chains and GMP compliance. - https://bit.ly/3KWIKbX

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Curious about how the FDA's guidance on Benefit-Risk Assessment for New Drug and Biologic Products impacts your development program? Read our blog here: https://lnkd.in/enfY73V9

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Check out this report from Drug Development & Delivery #Pharma #Biotech #CDMO #Formulation #DrugDevelopment #DrugManufacturing

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Thoughts on this? >> Cellular Origins Partners with CGT Catapult on Automated CGT Manufacturing - BioPharm International >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #biotech #competitivemarketing #pharma #healthcare

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Our next webinar, with Dr. Samantha Atkinson from NSF, looks at how a quality culture can positively impact GMP compliance which, in turn, can impact supply chains and GMP compliance. - https://bit.ly/3XbiLVq

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Kyowa Kirin, Inc.- U.S. 𝐡𝐚𝐬 𝐫𝐞𝐜𝐞𝐢𝐯𝐞𝐝 𝐛𝐨𝐚𝐫𝐝 𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐭𝐨 𝐩𝐫𝐨𝐜𝐞𝐞𝐝 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐞𝐬𝐭𝐚𝐛𝐥𝐢𝐬𝐡𝐦𝐞𝐧𝐭 𝐨𝐟 𝐚 $𝟓𝟑𝟎 𝐦𝐢𝐥𝐥𝐢𝐨𝐧 𝐛𝐢𝐨𝐥𝐨𝐠𝐢𝐜𝐬 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐟𝐚𝐜𝐢𝐥𝐢𝐭𝐲 𝐢𝐧 𝐒𝐚𝐧𝐟𝐨𝐫𝐝, 𝐍𝐨𝐫𝐭𝐡 𝐂𝐚𝐫𝐨𝐥𝐢𝐧𝐚. Construction of the 𝟏𝟕𝟏,𝟕𝟎𝟎-𝐬𝐪𝐮𝐚𝐫𝐞-𝐟𝐨𝐨𝐭 𝐬𝐢𝐭𝐞 is set to begin in the latter half of this year, with the facility expected to be operational by 2027. This state-of-the-art plant will produce innovative biologic therapies, including next-generation antibodies, for clinical trials and eventual commercial use. It will be Kyowa Kirin's first manufacturing site in North America and will complement its existing facility in Takasaki, Japan, streamlining the tech transfer process. According to Toshiyuki Kurata, the company's chief supply chain officer and global manufacturing head, the new site will significantly accelerate drug development and production. https://lnkd.in/eSHwMgGq #Biotech #PharmaNews #Biologics #Manufacturing #Innovation

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Alvotech and Teva Pharmaceuticals Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab) SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara SELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion process, which are the same type of cells and process used for the production of Stelara REYKJAVIK, Iceland & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States. The FDA approval of SELARSDI, referred to as AVT04 during development, was based on a totality of evidence, including analytical and clinical data. The clinical development program included data from: 1) Study AVT04-GL-301, a randomized, double blind, multicenter, 52-week study to demonstrate equivalent efficacy and to compare safety and immunogenicity between SELARSDI and the reference product Stelara in patients with moderate to severe chronic plaque-type psoriasis. The study was conducted in four countries in Europe and enrolled 581 patients. The primary efficacy endpoint was Psoriasis Area and Severity Index (PASI) percent improvement from Baseline to Week 12; 2) Study AVT04-GL-101, a Phase I, randomized, double-blind, single-dose, parallel-group, 3-arm study to compare the pharmacokinetic, safety, tolerability, and immunogenicity profiles of SELARSDI, administered as a single 45mg/0.5mL subcutaneous injection with that of the US-licensed Stelara as well as EU-approved Stelara. The study was conducted in Australia and New Zealand and enrolled 294 healthy adult volunteers. https://lnkd.in/ea3Z4qTx

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Last week was thrilling as we participated in two key industry events 🚀 —the North Carolina Regulatory Affairs Forum (NCRAF) and the Biomanufacturing and Process Development (BPD) Cell and Gene Therapy Symposium. These events highlight our dedication to leading innovation and regulatory standards in the Life Sciences industry. We are aware of the marked differences between Cell & Gene Therapy (CGT) and Biopharmaceutical BLA submissions and our services are tailored to help both startups and global companies get their products to market faster with guaranteed potency and lifesaving results. #LifeSciences #RegulatoryAffairs #Biomanufacturing #GeneTherapy #NCRAF #BPDSymposium

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GMP-manufactured CRISPR/Cas9 technology as an advantageous tool to support cancer immunotherapy The latest advancements in GMP procedures are allowing an efficient improviement of personalized medicine. In particular immunotherapy is strongly taking advantage of clinical manufacturing platforms to cure patients who are refractory to previous therapy or who relapse upon a first period of remission. CRISPR/Cas9 technology has become the most widely used gene-editing tool in cancer immunotherapy favoring differentiation and persistence of genetically modified T-cells. The discovery of cancer-selected markers remains one of the principle obstacles while the use of allogenic CRISPR/Cas9-modified CAR T-cells is overcoming the difficulties to treat relapsing cancer cells showing an antigen different from that expressed at the onset of the disease. CAR T-cells generated against multiple tumor targets are preventing relapsing events. The manufacturing processes still comprised procedures performed manually even if supported by semi-automated manner, which result in product variability and very high cost. The development of a more controlled and cost-effective manufacturing process remains the pivotal aim to ensure CAR T-cells therapy for all patients. https://lnkd.in/eWkEGiNq

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Curious about the future of pharmaceuticals? Join Christopher Conway, President of R&D at Curia, as he discusses the latest trends and challenges in the industry – from funding hurdles to the promise of continuous flow technology and the potential of mRNA and AI. Read the full article at Chemical Industry Review’s website: https://ow.ly/ZWhU50Reemy Contact our experts to learn more: https://ow.ly/Batu50Rf7Z5 #CuriaInsights #PharmaTrends #ResearchAndDevelopment #ContinuousFlowTechnology #mRNA #AIinPharma #FundingChallenges #ChemicalIndustryReview #PharmaInnovation

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