Sahana Suresh Babu

Assessing Technical Expertise: Choosing the Right CDMO for Advanced Therapy Medicinal Products (ATMPs) Recently, reflecting on a panel discussion I participated in with industry experts Louis Garguilo, Praveen Prasanna, and Vibhav Patel, I've developed a comprehensive framework for evaluating a Contract Development and Manufacturing Organization's (CDMO) technical capabilities. https://lnkd.in/dFWSrtcg Selecting the Right CDMO: 10 Critical Evaluation Criteria 1.    On-Site Due Diligence Conduct comprehensive on-site visits to assess capabilities. Immerse yourself in process development, QC labs, and GMP manufacturing suites to gain direct insights into the team's expertise and culture. 2.    Talent Assessment Evaluate the organization's talent approach: ·      Retention of top-tier professionals ·      Team interaction and communication dynamics ·      Leadership's commitment to technical excellence ·      Evidence of continuous learning 3.    Project-Specific Expertise Verify the CDMO's ability to demonstrate: ·      Specific ATMP methodologies ·      GxP compliance ·      Successful technology transfer ·      Regulatory understanding 4.    Analytical Capabilities Scrutinize analytical expertise: ·      Safety and purity testing ·      Identity verification ·      Quantitative analysis ·      ATMP-specific potency testing 5.    Industry Reputation ·      Leverage professional network insights ·      Seek candid colleague feedback ·      Treat CDMO selection like a critical review 6.    Problem-Solving Skills Assess their approach to challenges: ·      Deviation handling ·      Root cause analysis ·      Innovative problem-solving 7.    Talent Pool Considerations ·      Local talent availability ·      Recruitment strategies ·      Ability to attract top talent 8.    Subject Matter Expert Access Ensure direct communication with: ·      Project-specific SMEs ·      Technical experts ·      Professionals with nuanced insights 9.    Regulatory Track Record Verify: ·      Post-approval inspection performance ·      Patient-ready product history ·      Comprehensive Drug Master File 10. Technological Infrastructure Evaluate: ·      State-of-the-art facilities ·      Cutting-edge equipment ·      Novel ATMP technology expertise Final Insight Selecting the right CDMO requires systematic assessment of these critical aspects to align with your ATMP development goals. #ATMP #Biotechnology #CDMOSelection #RegulatoryCompliance #IndustryInsights

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Excited to share the latest feature in our "Partnering Spotlight" series, where we share some of the connections we are building to foster scientific innovation in healthcare. In this edition, our very own Neha Kaushal sits down with Daniel Anderson, Professor of Chemical Engineering at MIT, to discuss the potential of innovative #mRNA applications in vaccines and novel treatments for genetic diseases. Check out the video to learn more about our collaboration! https://lnkd.in/eHwpyjeY #vaccines #immunoscience

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🔬 Biopharma Layoffs: Navigating Challenges in a Shifting Landscape Recent trends in biopharma layoffs have left many scientists reeling. Here are key takeaways from a recent STAT article: 67% of life science layoffs in H1 2024 were at large biopharma companies (>$1B annual sales), up from 47% in 2021-2023. Job postings in biotech dropped from 21,366 to 12,300 between early 2021 and 2024. Scientists face unique challenges in job searches, including maintaining confidentiality about previous work. Visa constraints add pressure for international workers, limiting job search time. Networking remains crucial: Some successful companies are hiring primarily through personal connections. The industry sees this as part of a cyclical pattern, influenced by patent expirations and acquisitions. Despite these challenges, opportunities still exist. Adaptability, networking, and a broader job search approach are key for scientists navigating this evolving landscape. What strategies have you found effective in weathering industry changes? Share your thoughts below! #BiopharmaJobs #CareerTransition #LifeSciences #Networking

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For anyone building diagnostics: Very cool approach to gain valuable insights into FDA decision summaries. Brendan O'Leary scraped the FDA’s decision summaries and provided some simple R code for anyone to get up and running in no time to prod and probe those summaries. Very nice work!

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How do you quantify and analyze in a rare matrix? I am proud to share that Dr. Prajita Pandey, Assistant Director of Chemistry at Emery Pharma, has developed an LC-MS/MS method for quantitating a small molecule in vitreous humor using human plasma as a surrogate matrix. This approach, aligned with ICH M10 guidelines, addresses bioanalytical challenges such as matrix interference and analyte instability. The method’s robust validation includes specificity, recovery, carryover, stability studies, and parallelism to ensure accurate and precise results. By employing a surrogate matrix, this strategy enhances detection limits and method reliability, offering a cost-effective solution for bioanalysis in challenging matrices.. #LCMS #bioanalysis Moji Bonakdar Ryan Cheu, Ph.D. Hui Zhao Emmett Cunningham Bill Galush Adrienne Graves Eric Donnenfeld https://lnkd.in/grHCyTz4

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The Biopharma Job Market in 2024: A Reality Check I feel compelled to address some misconceptions about the current job market. While some recruiters may be expressing optimism about hiring picking up or the market turning around, the data tells a different story. Let's look at the facts: Layoff Trends: Q2 2024 saw a significant increase in biopharma layoffs, with at least 7,616 workers impacted. This is more than triple the 2,398 layoffs reported in Q1 2024. Major Players Affected: Industry giants like Novartis, Indivior, CureVac, and Takeda have all announced substantial job cuts in recent months. Ongoing Restructuring: Many companies are still in the midst of restructuring efforts, with some planning layoffs that will continue into late 2024 and beyond. Biotech Volatility: While there are pockets of growth, particularly in well-funded startups, the overall biotech sector remains volatile. What This Means for Job Seekers: Be Cautious: Exercise caution when hearing overly optimistic projections from recruiters. Always verify claims with industry data. Stay Informed: Keep abreast of industry trends, company financials, and pipeline news to make informed decisions. Diversify Your Search: Consider roles in emerging biotech startups or adjacent industries that value pharma experience. Enhance Your Skills: Focus on developing skills that are in high demand, such as data analytics, digital health, or regulatory affairs. Network Strategically: Build relationships within the industry, not just for immediate opportunities but for long-term career growth. As recruiters, our role is to provide accurate, data-driven insights to both clients and candidates. While we all hope for market improvement, it's crucial to approach the current landscape with realism and strategic thinking. What strategies are you employing in this challenging market? Let's discuss in the comments. #PharmaceuticalIndustry #BiotechJobs #CareerAdvice #RecruitmentTrends

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🚨 Biopharma Trivia Time! 🚨 Alright, science buffs and pharma fans, it's time to put your knowledge to the test! 🧪💡 Question: Which of these biopharmaceuticals is NOT made using recombinant DNA technology? (Don't worry, no PhD required 😉) A) Insulin 🍬 B) Erythropoietin (EPO) 🏃‍♂️ C) Monoclonal Antibodies (mAbs) 🧫 D) Heparin 💉 Bonus Round! First person to comment the name of the first FDA-approved biologic drug made with recombinant DNA wins bragging rights (and maybe a virtual high five! 🙌) Drop your answers below and let's see who's the biopharma whiz! 🏆 #PharmaTrivia #ScienceIsFun #Trivia

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Bristol Myers Squibb and Biotechs Push Boundaries in Autoimmune Disease Treatment with CAR-T Cell Therapy Exciting advancements are unfolding in the treatment of autoimmune diseases! At the recent American College of Rheumatology annual meeting, Bristol Myers Squibb (BMS), Cabaletta Bio, and Kyverna Therapeutics shared promising clinical data on their innovative cell therapies. 🔬 Bristol Myers Squibb presented the first data from their clinical trial using an experimental CAR-T cell therapy, adapted from their approved blood cancer treatment Breyanzi but with a streamlined five-day manufacturing process. Remarkably, all seven lupus patients treated showed clinical responses after just one month of follow-up. In a noteworthy case, one patient became pregnant shortly after treatment, suggesting the therapy doesn't impair fertility—a significant consideration for many patients. 💡 Rheumatologist Georg Schett highlighted the rapid growth in this field: "Two years ago at the ACR, nobody spoke about cell therapy. And now this is really something everybody knows about." 🤝 Cabaletta Bio reported that eight patients, including four with lupus, were able to discontinue immunosuppressants after receiving their cell therapy. 🌐 Kyverna Therapeutics announced they've treated over 50 patients across more than 15 autoimmune conditions with their experimental CAR-T cell therapy. Focusing on diseases like lupus nephritis, systemic sclerosis, and multiple sclerosis, they've seen positive responses, with patients no longer requiring immunosuppressants post-treatment. Importantly, Kyverna reported no severe cases of cytokine release syndrome or neurotoxicity (ICANS) across their patient group. 🚀 With industry veterans like Warner Biddle joining Kyverna as CEO, there's a clear momentum towards advancing these therapies through clinical trials and regulatory approvals. Biddle emphasized the shift towards focusing on trials that "can get us to the first BLAs and getting access to a broader set of patients." The Bottom Line: These developments represent a significant leap forward in treating autoimmune diseases. Using CAR-T cell therapy—a method previously successful in oncology—could revolutionize patient outcomes and quality of life. Let's keep an eye on these groundbreaking efforts that bring hope to millions affected by autoimmune conditions.

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𝗕𝗿𝗲𝗮𝗸𝗶𝗻𝗴: 𝗔 𝟯𝟬-𝗬𝗲𝗮𝗿 𝗕𝗿𝗲𝗮𝗸𝘁𝗵𝗿𝗼𝘂𝗴𝗵.... The FDA just approved 𝗖𝗼𝗯𝗲𝗻𝗳𝘆! The first new 𝘀𝗰𝗵𝗶𝘇𝗼𝗽𝗵𝗿𝗲𝗻𝗶𝗮 𝗱𝗿𝘂𝗴 in decades. Developed by Bristol Myers Squibb, it targets 𝗮𝗰𝗲𝘁𝘆𝗹𝗰𝗵𝗼𝗹𝗶𝗻𝗲, offering 𝗳𝗲𝘄𝗲𝗿 𝘀𝗶𝗱𝗲 𝗲𝗳𝗳𝗲𝗰𝘁𝘀 and better outcomes. This isn’t just a treatment..  ...it’s a 𝗹𝗶𝗳𝗲𝗹𝗶𝗻𝗲 for millions. ***************** And it’s just the start. Want to know more? Watch the video for the full story. #Schizophrenia #FDA #Innovation #MentalHealth

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Eli Lilly and Company CEO Dave Ricks Announces Major Expansion of India Research Hub, Poised to Transform Global Drug Innovation Eli Lilly announced plans to expand its R&D!center in India. The decision, spearheaded by CEO David Ricks, is aimed at bolstering the company’s global research efforts and accelerating innovation in critical therapeutic areas such as diabetes, oncology, and immunology. During a recent briefing, David Ricks highlighted India’s growing significance in the global pharmaceutical landscape, noting the country’s talent pool, infrastructure, and commitment to healthcare innovation. "India plays a pivotal role in our global R&D strategy," said Ricks. "Our expansion here reflects our commitment to tapping into India’s diverse expertise, fostering collaboration, and advancing our mission to discover and develop life-changing medicines." The research center, located in #Bengaluru, has been a crucial hub for Eli Lilly’s work in biopharmaceutical research, data science, and clinical trials. With this expansion, the company aims to double its investment in India over the next few years, creating hundreds of new jobs and enhancing its research capabilities in cutting-edge areas such as AI-driven drug discovery and personalized medicine. Eli Lilly’s expansion plan also aligns with the Indian government's initiatives to position the country as a global R&D destination. By leveraging local talent and infrastructure, Eli Lilly aims to deepen its footprint in India while contributing to the development of high-quality treatments that will benefit patients worldwide. https://lnkd.in/gcZTumai

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Keytruda Goes Injectable💉: A Game-Changer for Cancer Care in India🇮🇳 When I heard about Merck Group’s breakthrough with Keytruda, I immediately thought about the impact it could have on #cancer patients in India. The injectable version of Keytruda, proven to be as effective as its intravenous (IV) counterpart, could revolutionize how cancer care is delivered across the country. Take the example of Ravi, a school #teacher from a small town, traveling hours to the nearest oncology center for his IV infusions. For many like him, the logistical and financial burden of cancer treatment can be overwhelming. An injectable version of Keytruda could make treatment far more accessible, reducing the need for specialized infusion setups and saving valuable time🕰 and resources. In a country where #healthcare infrastructure is stretched thin, simplifying administration is a massive leap forward. Injectable Keytruda could empower smaller #clinics and community health centers to offer cutting-edge cancer therapies, bringing care closer to patients in rural and underserved areas. While Merck & Co., Inc.'s shares saw a 1.8% rise globally after this announcement, the real win lies in how this development could transform cancer care in India. It’s a step toward making life-saving treatments more patient-centric, accessible, and inclusive. #Keytruda #Oncology #CancerCareInIndia #HealthcareInnovation #PatientFirst Merck Healthcare

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Will we see more opportunity for Validation Professionals in 2025? The validation market is heating up as big players and industry shifts create new opportunities for CQV and Validation professionals. Here’s what’s driving the change: 📈 Biotech Expansion — With huge investments from Amgen ($1.5B), J&J ($2B), and Fujifilm Diosynth ($1.2B), demand for CQV engineers is set to rise. With many opportunities across Aseptic Processing, Equipment Validation and Automation. ⚙️ Tech-Enabled Validation — The shift to digital validation systems and paperless CQV is here. Companies are turning to cloud-based tools to streamline data capture and boost audit-readiness. 🌿 Sustainable Validation — As biopharma adopts green manufacturing, validation engineers must ensure compliance for eco-friendly production and energy-efficient systems. 💥 What’s Next? With 2025 a few weeks away I am looking to connect with CQV and Validation Consultants to discuss projects upcoming in Q1 next year. 👉 Do you think 2025 will have more opportunity that 2024? Let me know! #Validation #CQV #PharmaTrends #Biopharma #Innovation #AsepticProcessing #CellAndGeneTherapy #Sustainability

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FDA establishes CDER Center for Clinical Trial Innovation (C3TI) [4/15/2024] Today, FDA's Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally. “CDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need,” said Patrizia Cavazzoni, M.D., director of CDER. “We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across industry and within CDER.” For years, CDER has championed innovation, and our activities to foster and support innovation span drug development programs, therapeutic areas, and disciplines. These CDER efforts have led to improvements in the design and conduct of clinical trials that are intended to efficiently generate evidence on the safety and effectiveness of new therapies in ways that meet the growing demands of drug development. Recently, we sought to understand the impact of these efforts by holding interviews, listening sessions, and a public workshop with both internal and external parties, and soliciting comments to a public docket. Based on these engagements, we recognize an opportunity to enhance the implementation of our innovative efforts and maximize the impact on drug development. C3TI will be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the efficiency of drug development. C3TI will facilitate the sharing of lessons learned across CDER’s existing clinical trial innovation initiatives and will communicate and collaborate with external parties. C3TI will also manage a demonstration program that will expand opportunities for sponsors of innovative clinical trials to interact with CDER staff and for these trials to serve as case examples to spur further implementation. The three initial project areas under the C3TI Demonstration Program are 1) point-of-care or pragmatic trials; 2) Bayesian analyses; and 3) trials using selective safety data collection. https://lnkd.in/eDxpeGyy

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Please join us in the webinar next Monday to learn the latest update for our AAV manufacturing platforms, using transient transfection and stable producer cell lines, and advanced analytics in genome integrity that can support your path to IND and beyond. "Current AAV manufacturing often suffers from low productivity and scalability, high cost of raw materials, supply chain complexity, and high batch-to-batch variation. To overcome these limitations and industrialize AAV manufacturing, Lonza has developed two high-performing Xcite® AAV manufacturing platforms, using transient transfection and stable producer cell lines (PCL) technologies. Lonza’s AAV transient transfection platform consistently delivers industry leading AAV titers (E11 to E12 vg/mL), high full/empty capsid ratio and overall yield (20-40% recovery). Lonza’s proprietary suspension HEK293 cell line and plasmids, optimized manufacturing processes and innovative AAV analytics have been integrated to generate a robust and scalable platform (3L to 250L) with proven performance using multiple serotypes (AAV2, 5, 6, 8, 9 and novel capsids) and transgenes. The streamlined transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development. Building upon the proprietary HEK293 cells, Lonza further developed a high-producing, helper virus-free AAV stable PCL technology. AAV production is tightly regulated and is chemically induced using doxycycline. Selected PCL clones have been identified with higher AAV titer (> 1E12 vg/mL) than transient transfection process with comparable full/empty capsid ratio (> 30% full capsids at harvest). These stable clonal cells maintain long-term stability (> 30 passages) for AAV productivity and packaging efficiency. Helper-virus free AAV PCL eliminates the need for costly plasmids, reduces supply chain and manufacturing complexities and can be easily scaled to 2000L+. Taken together, our Xcite® AAV platforms can enable high quantity and quality of commercial AAV manufacturing at a scale you need for your valuable therapies."

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Eli Lilly and Company Soars to New Heights on Stellar Drug Performance 🚀 💰 📈 Eli Lilly delivered a financial masterclass with its phenomenal Q2 sales topping $11.3 billion! This surge is largely thanks to the diabetes and obesity blockbusters Mounjaro and Zepbound, sending Lilly's stock skyrocketing 7% 📈. The company even hiked its 2024 guidance, projecting a whopping $45.4-46.6 billion revenue range! 🏆 What's driving this success? - Mounjaro and Zepbound: These GLP-1 receptor agonists are changing the game in diabetes and obesity treatment, offering efficient blood sugar control and significant weight loss 📉. Mounjaro alone generated a staggering $3.1 billion in Q2 sales! - Streamlined Manufacturing: Lilly has cleverly overcome Zepbound's initial supply chain hurdles, making all vial sizes available and ensuring patients have access to this crucial medication. 📈 Investors Applaud Wall Street is clearly impressed, with analysts revising their outlook on Lilly's potential. This positive sentiment is a clear vote of confidence for the company's future. 💡 What's Next for Lilly? The company is pushing R&D boundaries with an oral GLP-1 and dual GLP-1/GIP therapy in the pipeline. Their dedication to innovation paves the way for further breakthroughs in diabetes, obesity, and Alzheimer's treatment. 🤔 Is Eli Lilly the Next Pharma Powerhouse? With financials booming and revolutionary drugs in their arsenal, Lilly is undoubtedly a force to be reckoned with. Their commitment to growth and improving patient outcomes points to a bright future. What are your thoughts on Lilly's trajectory? Share your insights in the comments! #EliLilly #Mounjaro #Zepbound #FinancialResults #PharmaInnovation #Diabetes #Obesity #RD #Growth

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digiM's recent FDA IDIQ contract award marks a big step in advancing the role of microstructure analysis in regulatory assessment for complex generics. This partnership is set to deepen industry knowledge around product quality attributes and release mechanisms in key drug products, from injectables to implants. This recognition highlights the growing impact of microstructure tools like 3D microscopy and AI-based modeling, demonstrating how essential microstructure science is becoming within the pharmaceutical industry. https://lnkd.in/d5sj5Eds

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