Ines Mende

Sad to see the #PacBio news! They have laid off 195 employees as part of cost-cutting measures, this comes after disappointing preliminary financial results for the first quarter. "𝘝𝘪𝘳𝘵𝘶𝘢𝘭𝘭𝘺 𝘢𝘭𝘭 𝘧𝘶𝘯𝘤𝘵𝘪𝘰𝘯𝘴 𝘪𝘯 𝘢𝘭𝘭 𝘳𝘦𝘨𝘪𝘰𝘯𝘴 𝘰𝘧 𝘵𝘩𝘦 𝘸𝘰𝘳𝘭𝘥" 𝘸𝘦𝘳𝘦 𝘢𝘧𝘧𝘦𝘤𝘵𝘦𝘥 𝘣𝘺 𝘵𝘩𝘦 𝘭𝘢𝘺𝘰𝘧𝘧𝘴, 𝘴𝘢𝘪𝘥 𝘊𝘌𝘖 𝘊𝘩𝘳𝘪𝘴𝘵𝘪𝘢𝘯 𝘏𝘦𝘯𝘳𝘺 In addition to the layoffs, the firm will be closing its San Diego location. If you have been affected by the recent restructuring or any others in the biotech market please reach out. We can help with 𝗖𝗩 𝘄𝗿𝗶𝘁𝗶𝗻𝗴, 𝘂𝗽𝗱𝗮𝘁𝗶𝗻𝗴 𝗟𝗶𝗻𝗸𝗲𝗱𝗜𝗻 𝗽𝗿𝗼𝗳𝗶𝗹𝗲𝘀, 𝗶𝗻𝘁𝗲𝗿𝘃𝗶𝗲𝘄 𝗮𝗱𝘃𝗶𝗰𝗲 𝗲𝘁𝗰. 𝐖𝐞 𝐡𝐚𝐯𝐞 𝐪𝐮𝐢𝐭𝐞 𝐚 𝐟𝐞𝐰 𝐯𝐚𝐜𝐚𝐧𝐜𝐢𝐞𝐬 𝐚𝐜𝐫𝐨𝐬𝐬 𝐄𝐮𝐫𝐨𝐩𝐞 𝐚𝐧𝐝 𝐔𝐒: 𝗨𝗦𝗔 🚚𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿 𝗼𝗳 𝗟𝗼𝗴𝗶𝘀𝘁𝗶𝗰𝘀 – Washington DC – Life Sciences 🔬𝗔𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿 𝗼𝗳 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗦𝗮𝗹𝗲𝘀 – Boston – Bioanalytical Services 🔬𝗔𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿 𝗼𝗳 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗦𝗮𝗹𝗲𝘀 – San Francisco – Bioanalytical Services 🥼𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿 𝗼𝗳 𝗦𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 – West Coast – Bioanalytical Drug Development 📈𝗦𝗲𝗻𝗶𝗼𝗿 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗿 – East Coast (Remote) – Proteomics Equipment 📈𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗿 – East Coast (Remote) – Proteomics consumables ⚖️𝗦𝗲𝗻𝗶𝗼𝗿 𝗣𝗮𝘁𝗲𝗻𝘁 𝗔𝗴𝗲𝗻𝘁 – San Jose – Life Science 🛠️𝗗𝗲𝗽𝗼𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗿 – Maryland – Life Sciences 🥼𝗔𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲 𝗦𝗰𝗶𝗲𝗻𝘁𝗶𝘀𝘁 – San Jose – NGS Library Prep 𝗘𝘂𝗿𝗼𝗽𝗲 🧬𝗖𝗘𝗢 – Bioinformatics - UK 🔬𝗦𝗮𝗹𝗲 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁 – North UK – Proteomics Equipment 🖥️𝗦𝗮𝗹𝗲 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁 – Germany – Bioinformatics 🔬𝗙𝗶𝗲𝗹𝗱 𝗦𝗲𝗿𝘃𝗶𝗰𝗲 𝗘𝗻𝗴𝗶𝗻𝗲𝗲𝗿 – Nordics – Lab Equipment 🛠️𝗙𝗶𝗲𝗹𝗱 𝗦𝗲𝗿𝘃𝗶𝗰𝗲 𝗘𝗻𝗴𝗶𝗻𝗲𝗲𝗿 – France – Analytical Sciences 🥼𝗙𝗶𝗲𝗹𝗱 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁 – France – Analytical Sciences 🩸𝗙𝗶𝗲𝗹𝗱 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁 – Germany – Biomedical Sciences 𝐈𝐟 𝐲𝐨𝐮’𝐝 𝐥𝐢𝐤𝐞 𝐭𝐨 𝐤𝐧𝐨𝐰 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐭𝐡𝐞 𝐫𝐨𝐥𝐞𝐬 𝐨𝐫 𝐰𝐨𝐮𝐥𝐝 𝐥𝐢𝐤𝐞 𝐚𝐧𝐲 𝐚𝐝𝐯𝐢𝐜𝐞 𝐫𝐞𝐚𝐜𝐡 𝐨𝐮𝐭 𝐯𝐢𝐚 𝐋𝐢𝐧𝐤𝐞𝐝𝐈𝐧 𝐨𝐫 𝐜𝐨𝐧𝐭𝐚𝐜𝐭 𝐤𝐝𝐚𝐯𝐢𝐬@𝐢𝐧𝐯𝐞𝐧𝐢𝐚𝐠𝐫𝐨𝐮𝐩.𝐜𝐨𝐦!

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Umoja Biopharma Announces Publication in Blood Highlighting Successful Generation of In Vivo CAR T-cells in Non-Human Primate Modeling First landmark, peer-reviewed publication of successful in vivo CAR T-cell data in an immune competent NHP model Data validate the VivoVec™ platform in a translationally relevant model and support its transition into human clinical testing, offering a potential paradigm shift in the field of CAR T-cell therapies Key Study Findings VivoVec particles (VVPs) incorporating CD80 and CD58 costimulation proteins exhibit enhanced capacity for in vivo CAR T-cell generation and produce CAR T-cells with increased antitumor functionality compared to those produced from VVPs displaying anti-CD3 scFvs alone. Combining the anti-CD3 scFv together with the ligand binding domains of CD80 and CD58 into a single multi-domain fusion (MDF) protein markedly augments the particles’ ability to bind, activate, and transduce T-cells. VVPs incorporating MDF compatible with NHP T-cell activation and costimulation potently generate anti-CD20 CAR T-cells in vivo, comprising up to 65% https://lnkd.in/eqsSTKjf

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The more we understand how #CellTherapies help patients, the better we will be able to develop safer, durable, and efficacious treatments! #TheMoreWeKnow "The immune system overreaction known as cytokine release syndrome (CRS), and neurologic toxicities are two well-known side effects of CAR-T treatment. Last week, regulators removed a requirement for clinicians to report serious cases of the side effects as part of its Risk Evaluation and Mitigation Strategies for Gilead’s treatments Yescarta and Tecartus." https://lnkd.in/efmXtYZ5

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The FY2024 House National Defense Authorization Act (NDAA) is a bill of significant importance, and its implications for WuXi and the US biotech landscape are worth noting. According to CEO Rick Connell, "We're reading the context of the bill, and it's all about human genome sequencing data. We genuinely did not understand why we were inserted into the bill." It appears that Congress knows more about WuXi than their CEO! Let's delve into this together and read this article to learn more about the bill's impact on WuXi and the implications for the US biotechnology landscape. #FY2024 #NationalDefenseAuthorizationAct #WuXi #biotech #genomesequencing

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What cancer clinical treatment cut the risk of death by more than half? A two months increase in life span is usually heralded. The combination of Kytruda (Merck) that enhances the immune response generally, and Padcev (Seattle Genetics), an antibody to nectin-4 that is over expressed in cancer cells, conjugated to a cell division disrupter, did just that for bladder cancer (Nature 623,p.231, 2023). The latter drug is a biotechnology Antibody Drug Conjugate (ADC). See also the blog https://lnkd.in/gaN_WB8F

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Genentech Wins FDA Approval for First Adjuvant Therapy for ALK-Positive, Early NSCLC The FDA on Thursday greenlit the use of Genentech’s Alecensa (alectinib) for the adjuvant treatment of patients with early-stage, anaplastic lymphoma kinase-positive non-small cell lung cancer who have undergone tumor resection. With the approval, Alecensa is now the “first and only” ALK inhibitor approved for this indication and patient population, according to Genentech. Thursday’s regulatory win is backed by data from the Phase III ALINA trial, a randomized, active-controlled and open-label study comparing adjuvant Alecensa with platinum-based chemotherapy. The study enrolled 257 patients with Stage IB to IIIA tumors who had undergone resection and tested positive for anaplastic lymphoma kinase (ALK) using an FDA-approved test. Results from ALINA, which the company released in October 2023, showed that Alecensa could cut the risk of disease recurrence or death by 76% versus platinum-based chemotherapy. This treatment effect was highly significant and yielded a p-value of less than 0.0001. The ALK blocker also led to a significant improvement in central nervous system-disease-free survival, according to an exploratory analysis of ALINA. Genentech CMO Levi Garraway in a statement on Thursday called ALINA’s disease-free survival data “unprecedented,” adding that “Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer.”

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All-optical phase conjugation using diffractive wavefront processing https://lnkd.in/gcC8KQF2 UCLA Henry Samueli School of Engineering and Applied Science California NanoSystems Institute at UCLA ECE Department UCLA Bioengineering #diffractiveprocessors

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I'll be participating in the Multiple attribute Method (MAM) workshop panel discussion this evening, June 3rd So, if you’re interested in real life application of mass spectrometry or just interested in an emerging and developing technologies in the biopharma world this is an event worth attending. 🛎Overview: This Biotherapeutic Interest Group workshop seeks active discussion to continuously define MAM and common aspects when MAM is applied at different molecular levels (e.g., intact, subunit) and process stages (e.g., characterization, QC). The workshop will offer a forum for members to share and discuss those new aspects in the development and implementation of MAM. The advances of therapeutic modalities in the pharmaceutical industry drives the development of new analytical methods to assess, characterize and quantify various attributes of complex biotherapeutic. Furthermore, as we enter a new decade of technology and method development, MAM's utility is expanding. Recent advances in mass spectrometry instrumentation have provided novel opportunities in reforming the original MAM. The industry-wide MAM Consortium inspires method development and diversity for new MAM approaches that fit into different application in biopharma R&D schemes. New approaches to MAM are emerging (e.g. fully automatic sample preparation, MAM for cell and gene therapies, compact MS for MAM in QC, and new data acquiring approaches). #ASMS2024 #massspectrometry #biopharmaceutical #biotech #biopharma #chemistry #research ##qualitycontrol #MAM #therapeutics American Society For Mass Spectrometry (ASMS)

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RNAi-based drug design: considerations and future directions More than 25 years after its discovery, the post-transcriptional gene regulation mechanism termed RNAi is now transforming pharmaceutical development, proved by the recent FDA approval of multiple small interfering RNA (siRNA) drugs that target the liver. Synthetic siRNAs that trigger RNAi have the potential to specifically silence virtually any therapeutic target with unprecedented potency and durability. Bringing this innovative class of medicines to patients, however, has been riddled with substantial challenges, with delivery issues at the forefront. Several classes of siRNA drug are under clinical evaluation, but their utility in treating extrahepatic diseases remains limited, demanding continued innovation. In this Review, we discuss principal considerations and future directions in the design of therapeutic siRNAs, with a particular emphasis on chemistry, the application of informatics, delivery strategies and the importance of careful target selection, which together influence therapeutic success. https://lnkd.in/ecB46Cfr

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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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UC Irvine study reveals circadian clock can be leveraged to enhance cancer immunotherapy Optimizing individual time-of-day delivery offers new avenues for prevention and treatment Irvine, Calif., May 28, 2024 — A multidisciplinary research team at the University of California, Irvine has revealed that the circadian clock – the biological pacemaker that governs daily rhythms in physiological processes, including immune functions – can be leveraged to enhance the efficacy of checkpoint inhibitor cancer therapy. Checkpoint inhibitors block different proteins from binding to tumor cells, allowing the immune system’s T cells to kill the tumor. The study, published online today in the journal Nature Immunology, provides deeper insights into the intricate relationship among the circadian clock, immune regulation and tumor development and found that a therapeutic approach optimizing time-of-day delivery based on an individual’s unique circadian patterns offers new avenues for prevention and treatment. “Disruption of the internal biological pacemaker is an inherent aspect of modern society that may contribute to the rising incidence of many cancer types. We found that proper regulation of circadian rhythms is necessary to suppress inflammation and support peak immune function,” said corresponding author Selma Masri, UC Irvine associate professor of biological chemistry. “Understanding precisely how circadian disruption promotes disease progression could lead to behavior modification to reduce cancer risk.” Team members used an advanced single-cell RNA sequencing technique in a genetic model of colorectal cancer and identified clock-dependent changes controlling the number of myeloid-derived cells that suppress T cell activation. They discovered that disruption of the internal clock in the epithelial cells lining the intestine alters secretion of cytokine proteins, leading to heightened inflammation, increased numbers of immunosuppressive myeloid cells and cancer progression. These findings were leveraged to demonstrate that providing immunotherapy at the time of day when these immunosuppressive myeloid cells are most abundant significantly enhanced the efficacy of immune checkpoint blockades in solid tumors. https://lnkd.in/eJFkhSVi https://lnkd.in/ena2V39T

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Over the past 6+ months I met with 50 board members of early stage biotechs (seed stage and early series stage) to discuss their experiences on boards in an effort to better understand cash compensation/equity, time commitment, board composition, meeting mechanics/best practices, motivation, etc. In addition, we also reviewed fifty S-1 filings 📃 from recent IPOs to gather pre-IPO data on board composition and compensation. Here are some common suggestions and observations gleaned from our conversations👇 ✔ No surprises at the board meeting. ✔Many board chairs have 1:1 conversations with each board member prior to meetings. ✔Send materials out to board members at least 1 week in advance. ✔If delivering science/technical presentations, you need to save time to discuss and make decisions. ✔May be beneficial to have these presentations in a separate session prior instead of trying to cram it into a board meeting. ✔Create opportunities for the board to meet and get to know key leaders on your team. ✔Board agreements were often (not always) used and generally include confidentiality agreements, and compensation/equity details. Some reported agreements included term limits, potential conflict of interest disclosures, an board roles and expectations. ✔There are many board candidates who don’t expect cash compensation for seed stage/early series stage biotech boards. They all expect equity, but motivation isn’t typically financially driven. ✔Board motivation includes desire to give back, opportunity to stay active in life sciences after retirement, and an opportunity to see the business from a different angle. **If you are interested in a copy of our report, please shoot me a message. #boards #benchmarks #biotech

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https://lnkd.in/eD72nFaM It is truly an exciting time for #AAV gene therapy in the #brain, with numerous capsid advancements announced at #ASGCT. This article from Alzforum nicely summarizes the Deverman lab's new #BBB crossing #capsid, which allows novel approaches in #Alzheimers, #Parkinsons, and more. Also see the insightful perspective from our Chief Science Officer, Olivier Danos in the Comments.

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The latest U.S. Biotechnology Instruments Market report unveils remarkable growth and new opportunities. Here are 10 essential takeaways for every biotech professional: 1️⃣ Market Growth Projections: The market is set to surge from USD 36.16 billion in 2024 to an impressive USD 49.11 billion by 2033, with a CAGR of 3.46%. 2️⃣ Dominance of Analytical Instruments: Analytical instruments, holding a 65.9% market share in 2023, play a vital role in biotechnological applications, from research to quality control. 3️⃣ Rapid Growth in Cell Culture Instruments: The cell culture instruments segment is poised for the fastest growth through 2033, driven by advancements in biopharmaceuticals, regenerative medicine, and personalized healthcare. 4️⃣ Pharmaceutical & Biotech Companies Lead in End-Use: Dominating the end-use segment with a 40.11% market share in 2023, these companies showcase the industry's dedication to drug discovery and genetic engineering. 5️⃣ Rising Investment in Precision Medicine: With expanding applications, precision medicine presents substantial opportunities, boosting demand for biotechnology instruments crucial for genomic sequencing and biomarker analysis. 6️⃣ Regional Innovation Hubs: California and Massachusetts remain strongholds of biotech innovation, with emerging clusters in Texas and North Carolina contributing significantly to industry growth. 7️⃣ Addressing Regulatory Challenges: Navigating regulatory complexities, especially around gene editing and stem cell research, is crucial for sustaining innovation and market growth. 8️⃣ Global Market Size Estimates: The global biotech instruments market is projected to grow from USD 89.85 billion in 2023 to USD 132.36 billion by 2033, at a CAGR of 3.95%. 9️⃣ Recent Product Innovations: 2024 saw notable advancements, including LICORbio's Odyssey® F biomolecular imaging systems and Waters Corporation’s Alliance iS Bio HPLC System, enhancing productivity and research capabilities. 🔟 Impact of Biopharmaceutical R&D: The expansion of biopharmaceutical R&D, focusing on biologic drugs like monoclonal antibodies and cell therapies, is driving increased demand for sophisticated biotechnology instruments. For those looking to stay ahead, these insights provide a roadmap to understanding market dynamics and seizing growth opportunities. Dive into the full report for an in-depth analysis. Procure Complete Report (220+ Pages PDF with Insights, Charts, Tables, and Figures) @ https://lnkd.in/dGry4wGJ #Biotech #MarketInsights #Innovation #PrecisionMedicine #Genomics #Biopharmaceuticals #BiotechInvestments #RegulatoryAffairs #BiotechResearch #MarketGrowth Let's continue to elevate the biotech industry together! 🚀

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Cutting edge opportunity here.

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Century Therapeutics Raises $60 Million, Acquires Clade Therapeutics, and Expands Pipeline of Allogeneic, iPSC-Derived Cellular Therapies - https://lnkd.in/ehDg3gC9 Century Therapeutics, Inc (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory diseases, announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications. CNTY-101 is currently being evaluated in a clinical trial in B-cell malignancies (ELiPSE-1) as well as a planned clinical trial in systemic lupus erythematosus (SLE) (CALiPSO-1), which is on track to be initiated in the first half of 2024. Century plans to pursue additional autoimmune disease indication regulatory filings in 2024. Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors. Concurrently, Century announced pipeline and platform enhancements through the acquisition of Clade Therapeutics, Inc. (“Clade”), a privately-held biotech company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, with a focus on iPSC-derived αβ T cells. The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases. “Today’s news signifies a transformative milestone for Century, as we accelerate and broaden our research and development initiatives in autoimmune diseases and iPSC-derived cell therapy on a larger scale. With support from a distinguished group of investors, coupled with the acquisition of Clade, we are poised for continued success,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century. “Under the leadership of a pioneering team of scientists and senior leaders with decades of experience in stem cell biology and iPSC differentiation enabled by significant capital investment from their investors, Clade has established a discovery engine with industry-changing potential,” said Hy Levitsky, M.D., President of R&D of Century. Read more at: https://lnkd.in/ehDg3gC9 #ipsc #cancer #autoimmunediseases

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Congratulations and good luck to Sanket Shah for launching Otsuka Precision Health, Inc. (OPH). With FDA's new PDURS framework, we are confident a playbook will evolve for molecules and digital medicine to co-exist. It's hard to dismantle molecules from digital medicine. Keeping that in mind, we always conducted our clinical trials to show how JOGO Health + pills provide better outcomes. In one of the clinical trials, we demonstrated that adding JOGO to migraine medications improved MIDAS(Migraine Disability Assessment) score significantly. Another trial demonstrated JOGO's foundational science reduced side effects of cancer medications and medication discontinuation. pill + bytes is where digital medicine is heading.

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With portable, low-cost, and scalable platforms, #nanoporesequencing has revolutionized genomics, transcriptomics, and epigenomics. But did you know that nanopores are not just for DNA and RNA? A new field of protein sensing and sequencing through nanopores is emerging, and some of our close collaborators, including Hagan Bayley, Yujia Qing, and Jeff Nivala, are at the forefront. Check out this article to learn more about the groundbreaking work being done in this area. Protein Sequencing is coming. #science #proteinsensing #proteinsequencing Link to the article: https://lnkd.in/eEZG7a82

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Autophagy-mediated degraders offer great versatility as autophagy can be induced by fasting or Rapamycin.

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