Paul Talierco

BMS is poised to enter the Eosinophilic Esophagitis (EoE) market. Buried in the BMS Q2 2024 earnings call was news that company's eosinophilic esophagitis (EoE) treatment, cendakimab, successfully met Phase 3 clinical endpoints. Similar to already-approved, Dupixent, cendakimab is a biologic with subcutaneous injections every other week. Specifics on the data have yet to be released, this new agent could pose some competitive pressure for Dupixent in EoE. #gastroenterology #clinicaldata https://lnkd.in/g_2a2MWv

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🌾 𝗪𝗵𝗲𝗮𝘁'𝘀 𝗪𝗲𝗲𝗸𝗹𝘆!! 🌾   #WheatsWeekly - August always feels quiet on LinkedIn, but we do have some exciting CDMO updates to share!   𝗕𝗿𝗲𝗮𝗸𝗶𝗻𝗴 𝗡𝗲𝘄𝘀   ✅ Eli Lilly and Company open their new 12-story innovation center in the Boston Seaport, occupying 346,000 square feet!   🔐 Ajinomoto Bio-Pharma Services lay off 71 staff members at California site after the Forge Biologics acquisition.   𝗠&𝗔 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗲𝗲𝗸   🤝 Evotec and Bristol Myers Squibb further progress their strategic partnership, triggering a $75 million performance and program based milestone payment to Evotec.   🇫🇮 Nanoform and Takeda collaborate on on plasma-derived therapy development.   𝗘𝘅𝗽𝗮𝗻𝘀𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗲𝗲𝗸   🏭 CiVentiChem has completed a new facility in Hyderabad, significantly expanding its manufacturing capacity by 300%.   🧬 Evonik expands formulation capabilities for lipid nanoparticles using KNAUER's scientific instruments. 𝗜𝗻𝘃𝗲𝘀𝘁𝗺𝗲𝗻𝘁 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗲𝗲𝗸   💰Phosphorex receive new investment from NOF AMERICA CORPORATION to accelerate the establishment of their cGMP capabilities for enhanced collaboration and innovation in nanoparticle-based drug delivery.   𝗡𝗲𝘄 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽   🌟 Britton Jimenez is names the new SVP of Commercial Ops at Codexis, Inc.   👨‍🔬 Tanguy Le Talaer is named Head of CDMO Sales & Marketing at Sentiss Pharma Pvt. Ltd. 💫 Amit Thakkar, PhD, PMP is named VP of BD at Suven Pharmaceuticals.   Did I miss anything, let me know in the comments! 👇   #CDMO #pharma #biotech

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FDA Awards Fast Track Designation to CB-012 in Relapsed/Refractory AML Sep 3, 2024 The FDA has granted fast track designation to the allogeneic CAR T-cell therapy CB-012 for relapsed/refractory acute myeloid leukemia. The FDA has granted fast track designation to the allogeneic anti–CLL-1 CAR T-cell therapy CB-012 for patients with relapsed/refractory acute myeloid leukemia (AML).1 CB-012 is under investigation in this patient population in the ongoing phase 1 AMpLify trial (NCT06128044). We are pleased to receive fast track [designation] from the FDA. This is a testament to the significant unmet need and the potential of…CB-012 as [a] readily available, off-the-shelf CAR-T-cell [therapy],” Tina Albertson, MD, PhD, chief medical officer of Caribou Biosciences, stated in a news release. “Most patients with AML are refractory or relapse quickly after currently available therapeutic options, and allogeneic hematopoietic stem cell transplant is the only potentially curative option after salvage chemotherapy regimens. As we advance CB-012 and enroll patients at dose level 2, we are focused on our goal to deliver an effective, off-the-shelf treatment option for patients living with this disease.” CB-012 is engineered with 5 genome edits that are enabled by the next-generation CRISPR technology platform, which uses chRDNA and Cas12a genome editing to improve genome edit specificity. CRISPR hybrid RNA-DNA guides—called chRDNAs—direct more precise genome editing compared with all-RNA guides and can be used to carry out multiple edits with high efficiency. CB-012 uniquely employs checkpoint disruption through PD-1 knockout, as well as immune cloaking through B2M knockout and B2M–HLA-E fusion protein insertion. These armoring strategies are designed to bolster antitumor activity. https://lnkd.in/eUMrNTs3

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📢 Check out our report on the explosive growth of the Cell and Gene Therapy (CGT) industry in Greater Philadelphia! 🌟 #LeadingLifeSciences! The region is now the nation’s #2 CGT hub, serving as home to 60 of the estimated 500 CGT companies worldwide. Dive into the report here: https://lnkd.in/edNneij9

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FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development The U.S. Food and Drug Administration (FDA) released a new draft guidance on September 16th titled "Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs”.1 Recognizing that most drug development is global, the guidance explains how drug developers should address requirements for ensuring that oncology MRCTs include populations that enable interpretability and relevance of the results to U.S. patients. The guidance also clarifies the FDA’s position on the use of foreign data to support marketing applications for cancer therapies in the U.S. The FDA will no longer accept data from clinical trials conducted in only one country or single geographical region as sufficient to support a marketing application, since these data will not enable understanding of any differences in treatment effect for the diverse U.S. population. While FDA regulations allow for the use of foreign data to support a marketing application2,3, the regulations, along with the guidances4,5,6 focused on ensuring diversity in clinical trials, state that foreign data are acceptable only if the patient population is representative in terms of criteria such as demographics and disease characteristics. Consequently, companies developing therapies for oncology indications who have already conducted their clinical trials in a single country or geographical region may have to conduct additional trials to ensure their clinical program is representative of the target U.S. patient population. The guidance also means that companies must begin their Diversity Action Plan as early as Phase 1 and well before their Phase 3 pivotal studies. In many instances, companies rely upon their Phase 2 oncology study(ies) to support their marketing application, with the Phase 3 trial(s) serving as confirmatory and completed post-approval. The guidance's overall goal is to ensure that data from oncology MRCTs are applicable to the U.S. population and medical practice while maintaining the efficiencies of global trials. https://lnkd.in/ea86t7YQ

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📢 FDA Announces Final Guidance on M12 Drug Interaction Studies The FDA has released the final guidance for "M12 Drug Interaction Studies" and a supplemental Q&A document. Prepared by the ICH, this guidance offers recommendations on evaluating enzyme and transporter-mediated pharmacokinetic drug-drug interactions for investigational drugs. The aim is to harmonize regional guidelines for designing, conducting, and interpreting in vitro and clinical evaluations of drug interactions. This guidance replaces the draft issued on August 29, 2022. Know more - https://lnkd.in/eq4RMH97 #DrugDevelopment #Pharmacokinetics #FDA #ICH #DrugInteractions #clinicalstudy #pharmacovigilance

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Standard operating procedures are often a focal point in our support engagements with RA/QA teams across the FDA-regulated industries. We recently spoke with Klaus Goodwin, EQSM, LSS BB, a biopharma senior executive turned independent consultant, to gain some frontline insight into common SOP issues he frequently encounters in the field and explore his playbook of best practices. Here are a few of Klaus's main takeaways at a glance: 𝐃𝐫𝐚𝐟𝐭𝐢𝐧𝐠 𝐒𝐎𝐏𝐬: ——— • Define the scope of the SOP clearly, detailing which functions or departments are affected. Use process maps to help visualize the entire process flow and identify potential bottlenecks and inefficiencies, which can be addressed early in the SOP development phase. • Avoid over-specification. Excessive detail that ties SOPs to specific job titles or systems can make procedures too susceptible to small business changes. Instead, focus on broader functional roles and use generic descriptions for tools and systems to keep SOPs flexible and applicable even with changes. • Directly incorporate applicable regulations and guidelines within your procedures. While specific sections often shouldn't be cited due to potential changes in guidelines, a general reference helps maintain alignment with regulatory standards and facilitates easier updates. 𝐌𝐚𝐢𝐧𝐭𝐚𝐢𝐧𝐢𝐧𝐠 𝐑𝐞𝐥𝐞𝐯𝐚𝐧𝐜𝐞: ——— • SOPs should regularly be updated to reflect current practices, technologies, or regulatory changes. Establish a predefined review schedule and involve a cross-functional committee that includes feedback from all stakeholders. • Engage stakeholders from various departments during the development and review phases. Prototype and temporarily implement drafts to collect iterative feedback and make sure the procedure is practical and aligns with real workplace conditions. 𝐀𝐝𝐚𝐩𝐭𝐢𝐧𝐠 𝐭𝐨 𝐂𝐡𝐚𝐧𝐠𝐞: ——— • Use planned process deviations to manage minor adjustments without needing full revisions. For significant changes (like technology shifts or reorganizations), a thorough overhaul may be necessary. • Develop quality agreements with vendors and regularly assess and adapt SOPs to regulatory, business, or technological changes to ensure they remain relevant. ——— 𝐍𝐞𝐞𝐝 𝐞𝐱𝐩𝐞𝐫𝐭 𝐒𝐎𝐏 𝐬𝐮𝐩𝐩𝐨𝐫𝐭?  We provide extensive support for organizations aiming to enhance compliance and operational efficiency. Our SOP services encompass developing and writing clear, compliant SOPs and rigorous reviews to ensure these procedures meet the latest regulatory standards and industry practices. We also specialize in training on and implementing SOPs, providing comprehensive training sessions and materials to ensure staff can effectively implement and adhere to these procedures. This extends to compliance audits, identifying potential risks and non-conformance that could impact regulatory inspections. Talk to us when you need to ensure that SOPs remain effective and relevant. #SOPs

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Are you interested in learning more about #QPS #bioanalysis capabilities? Get an inside look at the QPS laboratories in this short video. To learn more, visit https://shorturl.at/asPrS or email [email protected]. 

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Encountering roadblocks with SOP reviews in your pharma, biopharma, or other industries? Brian's latest post shares practical tips to simplify the process.

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Key Clinical Compound Updates from November 2024 | https://lnkd.in/gKiaSfUa This summary of major clinical updates from November covers FDA approvals, the initiation of new clinical trials, notable trial outcomes for key drug candidates, and news on paused and discontinued trials and programs. The highlights feature exciting data on GLP-1-based therapeutics for weight loss and metabolic disorders, promising results for a potential first-in-class oral lipoprotein(a) inhibitor, and disappointing performance of a schizophrenia drug with a promising mechanism. Read more here: https://lnkd.in/gKiaSfUa

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🚨 BREAKING NEWS 🚨 The FDA has approved Biofrontera Inc.'s Supplemental New Drug Application (sNDA) to increase the maximally approved dosage from one to three tubes of aminolevulinic acid HCI (Ameluz®) for actinic keratosis treatment. The sNDA was supported by two clinical Phase I safety studies, showing blood concentrations of the active ingredient and the metabolite were below those at which side effects are known to occur. Find out more: https://lnkd.in/eGnHuvdu #FDANews #Dermatology #MedicalNews

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Get the most effective characterization and quantification of your #genomeediting with our award-winning rhAmpSeq™ #CRISPRAnalysis System. Go from sample to publication-quality analysis in less than a week. Learn more here: https://idtb.io/65y3n4

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Last week, we surveyed over 400 biopharma/biotech #Regulatory Affairs professionals, #HR leaders, and senior executives within the #pharmaceutical, #biotech, and diagnostic sectors. Are Regulatory Affairs professionals happy? Will the upcoming #election affect #hiring for the rest of the year in Regulatory Affairs? Find out what the Regulatory community told us about whether they will change jobs this year, and what the hiring outlook is for the remainder of 2024. #weknowregulatory #regulatoryaffairs

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with so much disruption in prescription drug policy and markets, it is important to understand how biosimlars are developed, priced, covered and recent policy changes in Part D that will impact patients and providers. if you have questions or thoughts, please reach out!

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