Grace Gable

👋 * If you are a hiring manager or job seeker in the #Pharma & #LifeSciences industry, this post is for you!* Our most recent – and interactive💡– blog titled, "Navigating The Evolving Tides: Top Trends In Pharma & Life Sciences Recruitment," explores key trends shaping recruitment, like the rise of tech-savvy scientists and the growing focus on diversity & inclusion. Take a peek and discover how you can make sure to thrive in this evolving market. 💪 #pharma #lifesciences #recruiting #careerdevelopment #nextlevelimpacts #dei #diversity #equity #inclusion Keith Roher • Cameron Massie • Jamie Maceroni • Jen Rasmussen

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🔬 Big News Alert! 🔬 🌟 FDA, EPA, and USDA join forces to streamline regulation for biotech products! 🌟 Interesting times ahead for the biotech industry as these agencies collaborate to simplify pathways to market while maintaining rigorous safety standards. How do you think this will shape the future of biotech? 💥 #Biotech #Regulation #Innovation #FDA #EPA #USDA

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Discover the Importance of Diversity in Clinical Research Dive into our latest blog post to explore why diversity in the clinical research workforce matters. Learn about the current state of diversity, its impact on research outcomes, and strategies to enhance inclusivity. Read More: https://lnkd.in/gGc49Nxu #clinicalresearch #diversity #inclusion #patientcare #clinicalresearchcoordinator #nlcresearch #clinicalresearchtraining

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Industry leaders, the FDA has released a guidance draft document on data integrity for in-vivo bioavailability and bioequivalence studies. This document is now open for comments. Data integrity is a critical component to ensure the accuracy of data submitted for INDA and NDA's, and the FDA guidelines on this are very welcoming. Certain data handling practices in CROs have always been questioned by authorities, making this guidance document a crucial step in ensuring the integrity of data in the industry. Share your thoughts and comments on this important topic. QvalFocus #IndustryLeaders #DataIntegrity #Bioavailability #Bioequivalence #FDA #CROs Follow us at #QvalFocus for current trends and jobs in the industry.

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📣 FREE Webinar for #Biostatisticians this Friday! 📣 Join us for “Elevating Careers Through Recognition and Visibility”. Learn how Biostatisticians can enhance their VISIBILITY & IMPACT, both within their organizations and in the broader industry. 🚀   This FREE webinar is one of many in the series on "Career Development in the Pharmaceutical Industry". The series aims to bridge the gap between academic training and the practical knowledge required in the pharmaceutical industry.  In this webinar sponsored by the International Chinese Statistical Association (ICSA) & The Lotus Group LLC, industry experts will share invaluable insights and actionable strategies on navigating recognition & amplifying influence.   Our teammate, Helena Fan, will facilitate a robust discussion with panelists Dr. Yaohua Zhang & Dr. Wencong Chen. Dr. Yaohua Zhang is currently Associate Director at Vertex Pharmaceuticals. With nearly 7 years in Vertex, Yaohua has increasing responsibilities from lead study statistician for pivotal Phase 3 studies, key member of submission team, to project lead statistician, leading biostatistics team supporting neurology pipeline development projects. His research interests include rare disease clinical trail designs, basket trials, adaptive designs, dose finding, real world evidence and recently the application of AI in clinical trials. Since 2023, he became an adjunct faculty in Boston University. Yaohua received his Ph.D. in Statistics from University of Connecticut. Dr. Wencong Chen Ph.D. is currently Associate Director in Biostatistics at Bristol Myers Squibb. He has more than 8 years’ work experience as a biostatistician since he obtained his PhD in Statistics from Baylor University, USA. During his career, he has been in charge of clinical trials across multiple therapeutic areas, e.g., genetic disorder, hematology, critical care, and oncology. He is actively in statistical methodology research and collaboration, e.g., dose optimization, missing data, and Bayesian hierarchical model. There are more than 20 peer-reviewed journal papers under his name since he started his career in biopharmaceutical industry. Helena Fan is a co-founder of The Lotus Group. She has an MBA from the University of Southern California and a Master in Public Health from West China University of Medical Science. Helena has a wealth of knowledge and expertise accumulated over her 20-year career in the staffing industry. Throughout her journey, she has assisted countless individuals in realizing their career aspirations and securing their dream opportunities.   We hope you will join us. Please feel free to invite your friends/fellow students/connections too! 🔥 Link to Register is in comments. #statistics #statistician #biostatistics #biostatistician #pharmajobs #pharma #phdstudents

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🚀 Exciting News from Illumina! 🚀 Illumina is set to spin off its multi-cancer early detection firm, GRAIL, by issuing shares to existing stockholders later this month. 📅 Effective June 24, Illumina will issue one share of Grail for every six shares of Illumina stock, retaining a 14.5% stake in Grail. 🧬💹 Grail will become an independent, publicly traded company, listing on Nasdaq under the ticker symbol "GRAL." With around 31.1 million shares of common stock and an estimated capitalization of $3.99 billion, Grail is poised for a remarkable journey in advancing genomics and improving human health. 🌍🔬 CEO Jacob Thaysen emphasises this milestone as a pivotal step for Illumina: "As we prepare to lead the next era of genomics innovation, we believe Grail will play an important role in advancing the industry and improving human health." This move follows the divestiture orders from the US FTC and European Commission and is aligned with activist investor Carl Icahn's campaign, which led to significant leadership changes within Illumina. 🚀📊 Transaction costs are estimated at $20M for Grail and $60-75M for Illumina, with Grail's cash position post-spinoff bolstered by Illumina’s funding. 💰💼 In after-hours trading, Illumina's shares saw a 2% increase, reflecting positive investor sentiment. 📈💹 #Genomics #HealthcareInnovation #BiotechNews #Investing #NASDAQ #Grail #Illumina #GenomicsRevolution #HealthTech 🚀🔬💼

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🎧 Check out the Mendelspod podcast episode, "Two Industry Leaders on Dealing with the Growing Complexity of Genomic Cancer Data," featuring JAX's Cara Statz & Illumina's Erica Schnettler discussing the landscape of oncology research, oncology testing and variant interpretation:

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The antibody drug conjugate (ADC) market has skyrocketed from $1 billion to $10 billion in yearly sales from 2015 to 2023 and is projected to hit $28 billion by 2028! Despite their efficacy in targeting tumors, ADCs aren't curing patients yet, though they offer significant benefits like prolonged life and progression-free survival. 🚀 Enter immunostimulatory ADCs (iADCs)! By combining the precision of ADCs with immunotherapy, iADCs aim to enhance the immune response against cancer. This approach shows promise, with companies like Mersana Therapeutics and Sutro Biopharma, Inc. leading the charge with innovative therapies in clinical trials. 💡 “Engineering very targeted therapies to dial up potency will advance cancer care significantly,” says Jane Chung of Sutro Biopharma, Inc. Biopharma. 📈 Despite challenges and past clinical failures, the potential of iADCs is driving investment and research, paving the way for breakthroughs in cancer treatment. #Pharma #Biotech #CancerResearch #Innovation #ADCs #iADCs #HealthcareInnovation https://lnkd.in/eypUJJFf

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Innovation starts here. For sponsors looking to make a real impact, #GeneTherapies are promising. Pharmacokinetic analysis can shape dosing strategies and provide input into drug safety & efficacy – learn more: https://bit.ly/3zDqPRs #CGT #GeneTherapy #PKassessments

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The 2024 Drug Testing Index™ is here! Learn more about the increasing drug use trends in the American workforce from the analysis of millions of drug tests. https://lnkd.in/dy8sTtw #DrugTestingIndex #WorkforceHealthSolutions #DrugUseTrends

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Reminder: Our complimentary webinar "Innovating H.R. Hiring Practices: Virtual Drug Testing Strategies for a Modern Workforce" is tomorrow. Last chance to register: https://bit.ly/4ancclH #BackgroundScreening #DrugTesting #OralFluidTesting #Proctoring #HumanResources #RemoteWorkforce

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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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As pharmaceutical companies welcome recent graduates into early-career rotational programs, there is an often-untapped opportunity to increase the return on investment for participants and employers by incorporating strategic learning and development initiatives. 💡 Kotter Managing Director Gaurav Gupta explains how the pharma industry can optimize rotational programs for success through intentional training in his recent Pharmaceutical Executive article: https://hubs.li/Q02ySJT50. #Pharma #Training #StrategicLearning

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If you are considering participation or want to know about the latest active clinical research, click here: https://ow.ly/oB8r50SEz59. PLEASE NOTE: Narcolepsy Network does not endorse, advise, recruit, or promote participation in any specific clinical trial or study. #NarcolepsyNetwork #narcolepsy #idiopathichypersomnia #hypersomnia #sleepdisorder #clinicalresearch

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Are you currently #hiring CRAs? Check out our recent recruiter's guide to hiring a CRA, where we explore: 📄 The key responsibilities of the role 🙋 What the ideal candidate looks like 💼 The questions you should ask in your interviews, and more! https://phrmwb.com/3L8TaFe Want to see a guide on a particular job role? Let us know in the comments 👇 #guide #recruiterguide #recruitment #clinicalresearch

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Looking for help in evaluating new drug efficacy, conducting toxicity tests, or validating biomarkers? 🔬 Our specialists will optimize your animal disease model to fit the unique needs of your development program and have experience with a variety of drug administration options. Elevate your research here: https://ow.ly/CfAC50RZ9RG #infectiousdisease #drugdelivery #invivo #animalmodels #biomarkers #animalresearch #therapeutics

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🧬 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐦𝐞𝐧𝐭 Regeneron teams up with Mammoth Biosciences for in vivo CRISPR-based gene editing therapies, marking a significant collaboration in the field of genetic medicine. Key takeaways 🔽 💰 𝐃𝐞𝐚𝐥 𝐃𝐞𝐭𝐚𝐢𝐥𝐬: The collaboration entails a substantial investment of $100 million upfront, with potential milestone payments totalling $370 million per target, highlighting the commitment to advancing gene editing technologies. 🔬 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥 𝐒𝐲𝐧𝐞𝐫𝐠𝐲: Regeneron's adeno-associated viral vectors (AAVs) for targeted delivery will synergize with Mammoth's ultracompact nucleases and gene editing systems, promising optimized payload delivery for diverse disease types. 🤝 𝐌𝐮𝐭𝐮𝐚𝐥𝐥𝐲 𝐁𝐞𝐧𝐞𝐟𝐢𝐜𝐢𝐚𝐥 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩: Both companies stand to benefit, with Regeneron gaining access to Mammoth's cutting-edge editing technology, while Mammoth receives upfront equity, and opportunities for co-funding and profit sharing. 🌟𝐅𝐮𝐭𝐮𝐫𝐞 𝐏𝐫𝐨𝐬𝐩𝐞𝐜𝐭𝐬: This collaboration underscores Regeneron's strategic focus on gene editing therapies, complementing its existing partnership with Intellia Therapeutics and paving the way for innovative treatments in genetic disorders like transthyretin amyloidosis. ℹ️ 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐈𝐦𝐩𝐚𝐜𝐭: With Regeneron's track record of successful collaborations and Mammoth's pioneering gene editing platforms, this partnership has the potential to drive significant advancements in genetic medicine and reshape the landscape of biotechnology. 𝐅𝐮𝐥𝐥 𝐚𝐫𝐭𝐢𝐜𝐥𝐞 𝐛𝐞𝐥𝐨𝐰 🔽 #genetherapy #mammothbiosciences #regeneron https://lnkd.in/eXQsZDNU

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Major Milestones in the Cell Therapy Revolution The cell therapy field is witnessing significant strides, with leading biotechs at the forefront of innovation. Let's dive into some of the latest developments: 1) Bristol Myers Squibb and bluebird bio continue to make waves with their CAR-T cell therapy Abecma, recently approved by the FDA for treating relapsed or refractory multiple myeloma patients. A pivotal advancement in the fight against this blood cancer. 2) Roche's Genentech is taking its stem cell therapy for age-related macular degeneration, a leading cause of vision loss, into Phase 3 clinical trials. The potential to restore vision through stem cell therapy is truly remarkable. 3) Tissue Tech Autologous Corp (TTIC) has demonstrated promising results with its regenerative cell therapy for chronic diabetic foot ulcers. According to FiercePharma, the therapy significantly improved healing rates in clinical trials, offering hope for reduced amputation risk. As major players like Bristol Myers Squibb, Roche, and innovative biotechs such as TTIC lead the charge, the cell therapy landscape is rapidly evolving. We could be witnessing the advent of transformative treatments that improve lives and offer new therapeutic avenues. I'm excited to see what groundbreaking advancements lie ahead in this dynamic field. Share your thoughts on these developments in the comments below and get in touch if you are interested in working on cell therapy Programs. +1 332-219-0879 or ncrowley@i-pharmconsulting.com

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