FibroGen, Inc.'s new CMO, Deyaa Adib, MD isn't fazed by the competition in prostate cancer. Their FG-3246 boasts an impressive 8.7 months PFS in Phase 1, and they're calling out others to show their data! Here's the challenge: PSA isn't the only measure that matters, PFS is key. They believe FG-3246 stacks up well against competitors, even Novartis' Pluvicto. Intrigued? Different companies report data differently, making comparisons tricky. Stay tuned as more info emerges, but FibroGen seems confident they're in the fight! #ProstateCancer #ClinicalTrials #ADC #FibroGen FibroGen throws down the prostate cancer gauntlet | ApexOnco - Clinical Trials news and analysis (oncologypipeline.com)
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Building a quality management system (QMS) tailored to your development phase is crucial for small biotech companies - and the right leader is critical to champion these priorities. A few points for thought: Ensure Regulatory Compliance: Early implementation of a QMS helps you navigate regulations like Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) as your product progresses. Reduce Risks and Costs: A well-designed QMS identifies and mitigates potential quality risks throughout development, saving time and resources in the long run. Strengthen Investor Confidence: A robust QMS demonstrates your commitment to quality and de-risks your development journey, making you more attractive to investors. However, implementing a QMS effectively requires strong leadership. Here's how the right leader can make a difference: Strategic Champion: A visionary leader understands the long-term benefits of a QMS and can effectively communicate its value to all stakeholders. Cultural Shift: Building a strong quality culture requires leadership that fosters ownership and accountability for quality throughout the organization. Pragmatic Solutions: Leaders who champion a QMS understand the need for a system that is scalable and adaptable as the company grows. By prioritizing a phase-appropriate QMS and having a leader who champions its strategic implementation, small biotechs can navigate the development journey with greater efficiency, mitigate risks, and ultimately bring high-quality products to patients.
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I couldn’t put this book down, “The Battle for Your Brain: Defending the Right to Think Freely in the Age of Neurotechnology” Nita A. Farahany explores the intricate interplay between neuroscience and ethics. In simply skimming the progress in neuro research across the industry, it is clear we’re at the forefront of a revolution where brain science meets technology. But what are the implications for us as individuals and communities? And who should be asking these questions? Farahany delves into the legal and ethical complexities arising from brain tracking, cognitive enhancement, and mind control. She challenges us to safeguard fundamental human rights—privacy, cognitive autonomy, and mental sovereignty—as we navigate this brave new world. Whether you’re a neuroscientist, bioengineer, bioethicist, or just a fan of your Apple Watch, this book compels us to grapple with the profound implications of neurotechnology on our very essence. #neuroscience #neurotechnology #bioethics
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Congratulations to Applied StemCell for two excellent hires! Much success to the entire team! https://lnkd.in/g8bBCnXB
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A shout-out to my HR network! Looking for Head-of experience within public and commercial biotech. Please DM me.
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Paul Anderson reposted this
🌟Congratulations to our CEO, Michael Stomberg, and all the Entrepreneur Of The Year® 2023 Midwest winners! 🌟 We are incredibly proud of Mike's visionary leadership and innovative spirit that has driven ProPharma to new heights. This well-deserved recognition is a testament to his dedication, hard work, and unwavering commitment to success. Read more here: https://lnkd.in/gYYAZi2U EY #EntrepreneurOfTheYear #MidwestWinners #EOYUS #EOYMW
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Paul Anderson reposted this
🌟 Seeking a Heavy-Hitting Global Head of Clin Ops for a CRO with Major Growth Plans! 🌍💥 My team and I are looking for a true trailblazer who can lead our clients Clinical Operations team to new heights. 🔍 Role Highlights: ✓ Global leadership position with significant influence and impact. ✓ Drive strategic initiatives and optimize clinical trial operations. ✓ Work with top-tier pharmaceutical and biotech clients on ground-breaking projects. ✓ Collaborate closely with cross-functional teams, including Medical, Regulatory, Data Management, Business Development & Operations. ✓ Shape the future of clinical research in a dynamic, fast-paced environment. 🎯 Qualifications: ✓ Extensive experience in Clinical Operations leadership within the CRO industry. ✓ Proven track record of successfully managing global clinical trials. ✓ Deep understanding of regulatory guidelines and industry best practices. ✓ Exceptional leadership and communication skills. ✓ Strategic mindset with a focus on driving operational excellence.
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Paul Anderson reposted this
New therapeutics exploring novel targets as guided by the biology of aging continue to make progress in the Alzheimer's pipeline, providing new hope that we will one day have a #CombinationTherapy and #PrecisionMedicine approach to treat Alzheimer's. Last week, ADDF-funded Therini Bio, Inc. recently reached a milestone for the Phase 1 trial of their therapeutic targeting #neuroinflammation with the initiation of the first dose in humans. The biotech is a pioneer in the space, researching potential #Alzheimers treatments that address inflammation, one of the many different aging pathways that has been shown to contribute to the onset of Alzheimer's. Learn more about the study here: https://bit.ly/3BHRZYM via Liza Laws at Outsourcing-Pharma. Katerina Akassoglou Leslie Schulze
Therini Bio's first in-human dosing for Alzheimer's therapeutic and new chair of board
outsourcing-pharma.com
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