Ran Zheng

The CDMO business model is changing. As it moves away from contracts and towards strategic partnerships, it's clear that leaders will need to change with it. A recent report from WittKieffer has highlighted some key skills. Digital transformation, AI, and ESG skills will all help leadership teams better navigate the changing landscape and adapt to new technology. However, soft skills will be just as valuable. The shift to partnerships will require leaders to hone their interpersonal and collaboration skills if they want to see success. #LeadershipSkills #Leadership #CDMOs #Partnerships

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Among #cell and #genetherapy companies, the pressure for manufacturing innovation and optimization can incentivize them to seek third-party partners who possess technical, manufacturing, and regulatory expertise. In addition to industry giants that include Lonza, Catalent​, WuXi Advanced Therapies, Minaris Regenerative Medicine, and others, there are specialty CDMOs serving the CGT marketplace. For example, FUJIFILM Cellular Dynamics opened a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products. Helixmith, a biotech company with an extensive gene therapy pipeline and a CAR-T program targeting solid tumors, expanded into CDMO services for early-stage CAR-T developers. ThermoGenesis launched CDMO services with expertise in CAR-T cells, T cell receptor (TCR), tumor-infiltrating leukocytes (TILs), natural killer cells (NKs), iPSCs, and MSCs. Anemocyte announced itself as the first BMO (Biotech Manufacturing Organization) in the field of cell and gene therapies. In addition to building 2000 sq. meters of GMP and GMP-compliant facilities for the production of ATMPs, its FLYn’ICE project is using drones equipped with cryogenic pods to achieve temperature controlled transit of cell and gene therapies. Excellos opened its doors with $15M in funding and access to one of the largest cellular material procurement portfolios yet to support cell and gene therapy manufacturing. RoslinCT, a cell and gene therapy CDMO based in the UK, and Lykan Bioscience, a CDMO focused on cellular therapeutics in Hopkinton, MA, merged to form an international CDMO specializing in advanced therapeutics—with a specialty in gene editing and iPSC capabilities. Of course, there have been hefty M&A deals inked within the cell and gene therapy CDMO sector as well. Thermo Fisher Scientific snagged Brammer Bio for an astonishing $1.7B, while Catalent acquired Paragon Bioservices for an impressive $1.2B and MaSTherCell for $315M. Also, HCATS, apceth, and Hitachi Chemical Co., Ltd. Regenerative Medicine now operate under Minaris Regenerative Medicine, while Charles River Laboratories (CRL) acquired Cognate BioServices for $875M. Ascend Gene & Cell Therapies raised an impressive $132.5M to launch itself as a CDMO specializing in AVV-based gene therapies. In late 2023, Bayer opened a $250M cell therapy manufacturing facility to advance regenerative medicines on a global scale. Around the same time, Ajinomoto Co. acquired CDMO Forge Biologics for an astounding $620M to enhance its Bio-Pharma Services business. In January 2024, EXO Biologics launched its subsidiary, ExoXpertTM, as a CDMO specializing in exosomes. Similarly, Esco Aster is a global CDMO that is supporting the rapidly emerging field of EVs. Finally, Novo Holdings announced it was acquiring the global CDMO Catalent for a staggering $16.5 billion in enterprise value. Learn more here: https://lnkd.in/edtzMzx

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November marks Alzheimer Disease Awareness Month, a time to reflect on the urgent need for innovative solutions to this devastating disease. Today, over 6.9 million Americans live with Alzheimer disease and this number is projected to double by 2060. The past year has seen significant progress with several #cellandgenetherapies emerging as a viable treatment to address this complex disease and rising prevalence. Advancements in several novel #genetherapies targeting genetic risk factors and promising #celltherapies have the potential to address key mechanisms or slow progression of the disease. The work is far from over, but with these advanced therapies moving through the clinical pipeline, there is a new hope for patients and families battling this devastating disease. 

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As CPHI's recent research suggests, 49% of CDMOs are "highly positive" about contract services growth over the next 18 months, primarily driven by investments in late-stage drug candidates and proving the industry's resilience and adaptability following the fluctuations of the COVID-19 era. However, it's no secret that funding for early-stage assets has been more elusive, which poses a challenge for CDMOs that rely on a steady flow of projects moving through the development pipeline. More importantly, CDMOs can position themselves through their advisory services and become strategic partners by adding value throughout the development cycle. Still, with every challenge, there's an opportunity: leveraging robust data and demonstrating these early-stage candidates' potential effectiveness and market viability, CDMOs can turn this challenge into a strength. Collecting comprehensive data isn't just about proving the science—it's about telling a compelling story that resonates with stakeholders, payers, and regulators alike.  https://lnkd.in/e7SpUrf5

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Our upcoming "office hours" session on August 20th is a great, informal way to have your questions on DILIsym and RENAsym (liver and kidney safety prediction platforms) addressed! Please join us by registering and submitting insightful questions! #SimulationsPlus #DILIsym #QSP

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🎉 Get Ready to Dive into Target Selection with Nikolai Suslov🌟 Join us in welcoming Nikolai Suslov, Senior Director of Protein Engineering at Phenomic, as our distinguished facilitator for the roundtable discussion on Target Selection at Antibody Therapeutics Xchange in Boston 2024! 🗓️ Date: June 17th, 2024 📍 Location: Woburn Hilton Hotel, 2 Forbes Road, Woburn, US 📌 Secure your Complimentary Pass and reserve your seat alongside industry leaders: https://bit.ly/3vjUhhb With over a decade of experience in biotherapeutic discovery and optimization, Nikolai brings unparalleled expertise to guide you through the strategies for target selection. Here's what you can expect: 🔍 Insights into what a protein engineer brings when selecting therapeutic targets. 💡 Discover new bioinformatic databases for target ranking. 🎯 Valuable tips on Tabs/Lens.org mining for generating tool mabs for target validation. * Agenda subject to change 💊 Only available for Senior Scientists and above, from Bio and Pharma companies with a drug pipeline. 💊 #AntibodyTherapeutics #TargetSelection #BioTech #Pharma #Innovation #BostonEvent #ProteinEngineering #MolecularBiology #ScienceAndTechnology #ResearchAndDevelopment #MedicalAdvancements #HealthcareInnovation #Biopharmaceuticals #LifeSciences #DrugDevelopment #PrecisionMedicine #Biologics #DrugDiscovery #ScientificCommunity #IndustryLeadership #NetworkingEvent #BostonTech #HealthcareIndustry #MedicalResearch #InnovativeScience #ScientificAdvancements #hubXchange #Roundtable #FreePass #RegisterNow #ComplimentaryPass

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As we approach a potential vote in the United States Senate, now is the time for #biotech leaders to stand up for reputable #CDMOs in China like WuXi AppTec. The #biosecure act is misguided and politically motivated in an election year. Trying to discredit companies that have become trusted members of the US #biopharma ecosystem and key contributors to our R&D programs based on unsubstantiated and unvalidated allegations is disgraceful. What is a “biotechnology company of concern?” Biotechnology Innovation Organization John F. Crowley

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I am pleased to share the second article from my recent interview with Louis Garguilo, Chief Editor at Outsourced Pharma. The U.S.-China geopolitical landscape is undeniably complex and ever-evolving. With the passage of the BIOSECURE ACT by the House of Representatives this week, we are seeing further shifts in this dynamic. The Pharma and Biotech industries have already begun reconsidering major strategies. For U.S. and EU-based CDMOs, staying competitive requires ongoing investment and continuous improvement, regardless of external circumstances.   You can read the article here: "Warning To U.S.-Based CDMOs: Don't Get Complacent." https://lnkd.in/g9nk34ej   A big thank you to Louis Garguilo and the team at Outsourced Pharma for this opportunity!   #DrugDevelopment #Regulatory #CDMO #Biotech #PharmaceuticalIndustry #Manufacturing #CMCDevelopment Oliyai Consulting

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Samsung Biologics launches new high-concentration drug formulation platform Samsung Biologics said it officially launched its high-concentration drug formulation platform S-HiCon on Monday. With the launch of the platform, the company has introduced four new CDO platforms this year, bringing its total portfolio to nine. The company unveiled the platform during the BIO Japan 2024 event held from last Wednesday to Friday in Yokohama, Japan. During the event, the company showcased S-HiCon to potential clients and attendees. The launch of S-HiCon comes in response to the rising demand for high-concentration drug formulations, particularly for subcutaneous and ophthalmic injections. High-concentration formulations require smaller doses compared to low-concentration drugs, which leads to lower storage and transportation costs—factors that have driven their growing market demand. However, challenges such as increased viscosity and changes in pH levels often arise during the development of high-concentration formulations. https://lnkd.in/gDCv-qMJ

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SCG Cell Therapy And A*STAR Launch Joint Labs To Advance iPSC Technology For Scalable GMP Manufacturing Of Cellular Immunotherapies - https://lnkd.in/g8RhX7Xc SCG Cell Therapy (SCG) and the A*STAR - Agency for Science, Technology and Research announced the launch joint laboratories for cellular immunotherapies. This collaboration, at a combined funding of close to S$30 million supported under Singapore’s Research, Innovation and Enterprise 2025 Plan (RIE2025), aims to advance the development of induced pluripotent stem cell (iPSC) technology to produce novel cell therapies that meet Good Manufacturing Practice (GMP) standards. The collaboration will also establish a talent development programme to train the next generation of experts in this field, in accordance with current GMP and regulatory requirements. “Cellular immunotherapies herald a new era of regenerative medicine, offering hope for patients with cancers and other serious illnesses. As a key player in T cell receptor (TCR) T cell therapeutics, SCG has developed in-house cGMP manufacturing capabilities to supply high-quality cell therapy products to patients. Through this first-of-its-kind joint collaboration with A*STAR, we bring together A*STAR’s advanced iPSC technology and bioprocessing capabilities with our expertise in GMP cell therapy manufacturing and clinical development, furthering our mission to provide affordable off-the-shelf cell therapy treatment options to patients”, said Christy Ma, Chief Strategy Officer of SCG Cell Therapy. “The discovery of iPSCs has revolutionised regenerative medicine, offering the potential for standardised, off-the-shelf cell therapies. Through this collaboration with SCG Cell Therapy, we aim to accelerate the translation of iPSC research into clinically viable therapies and strengthen Singapore’s position as a global leader in cell therapy innovation. By leveraging our complementary expertise and resources, the joint labs will not only advance iPSC technology for scalable, GMP-compliant cell therapy production but also serve as a platform for nurturing the next generation of talent in this transformative field,” said Prof Boon Tong Koh, Executive Director, A*STAR’s BTI. Read more at: https://lnkd.in/g8RhX7Xc #ipsc #celltherapy #stemcell

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Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) to Discuss Second Quarter 2024 Financial Results on August 9, 2024 Conference Call and Provide Business Update   Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP), a clinical stage #biopharmaceutical company focused on developing new #antibiotics for difficult-to-treat #bacterial infections, has announced a conference call to discuss its second quarter 2024 financial results. The call is scheduled for August 9, 2024, at 8:00 am ET, before the U.S. financial markets open.   The company's President and CEO, David Luci, along with CFO Robert Shawah, will host the call to present the #financial results and provide a business update. #Investors and interested parties can join the call using the provided toll-free number for U.S. participants or international access numbers.   https://lnkd.in/esMuCywW #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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Another fantastic ISPE Delaware Valley Chapter (ISPE DVC) meeting in the books! Albert Dyrness gave an illuminating talk on Computational Fluid Dynamics and its applications in #pharma and #biopharma manufacturing. Our motto is "Know it Before You Build it." Learn how you can leverage this technology to save time and scaleup costs by downloading our free ebook, "Applications of Computational Fluid Dynamics in Pharmaceutical Manufacturing" - https://lnkd.in/ee_W_RQh. #CFD #processengineering #lifesciences #CQV #knowitbeforeyoubuildit

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Our lead asset, AU-007, is leveraging IL-2 differently. Hear what makes our #AI -backed approach different on #BusinessofBiotech with Matthew Pillar. https://bit.ly/3YxaZpp #BioTech #Oncology Bioprocess Online

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🌟 Discover the Future of Antibody Therapeutics at Xchange 2024! 🌟 We’re thrilled to feature Dr. Sundee Dees, Ph.D. , Senior Manager of Business Development at WuXi Biologics, as she takes the stage for an exclusive spotlight presentation at the upcoming Antibody Therapeutics Xchange in Maryland! 🎤💡 📅 Date: October 28, 2024 📍 Location: Marriott College Park, MD 🕑 Spotlight Presentation: 1:20 PM – 1:50 PM Dr. Dees, will be sharing groundbreaking insights in her talk, "Innovative Production and Engineering Strategies for Fab, ScFv & VHH". 🧬✨Whether you're addressing the challenges of antibody fragment development or fine-tuning production processes, this session is one you won’t want to miss! 💥 Key Highlights 🔑 🚀 Cutting-edge strategies for Fab, ScFv, & VHH production 🔍 Solving challenges in yield, purity, and stability 🏆 Tips to accelerate development with innovative molecular design 🤝 Plus, enjoy unparalleled networking with leaders in pharma and biotech! Secure your place now and connect with industry trailblazers like Dr. Dees,! 🎯 👉 Register Here: https://lnkd.in/gesVbeMS 💊 Only available for Senior Scientists and above, from Bio and Pharma companies, with a drug pipeline. 💊 #AntibodyTherapeutics #Biopharma #Innovation #PharmaLeaders #Biotech #DrugDevelopment #AntibodyFragments #FabEngineering #ScFv #VHH #Therapeutics #Biologics #Immunotherapy #PharmaNetworking #AntibodyDiscovery #PharmaInnovation #hubXchange #Xchanges #Roundtable #FreePass #RegisterNow #ComplimentaryPass

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So Exciting! Johnson & Johnson 's Harsha Gunawardena is teaming up with Protein Metrics, LLC to do a webinar on Novilytic's #Proteometer fueled by #MASC. See https://bit.ly/4eCpPQh to learn how Harsha and his Team utilize this great software and AI to accelerate Biopharmaceutical Characterization and Quantification using MASC !!!

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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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DEC 19 - Do We Have Adequate Tools to Solve Solubility and Bioavailability Challenges of Drugs in Contemporary Pipelines: KinetiSol ™ Technology

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