Andelyn Biosciences’ Post

Thank you Alliance for Regenerative Medicine for coordinating a very informative workshop with the FDA and NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals. I believe the Platform Technologies Designation Program has the potential to significantly increase patients' access to novel medicines as well as transform how the industry approaches drug development and CMC. This regulation promises to incentivize more complete product and process characterization and subsequently leveraging that information to accelerate drug approvals. Peter Marks and CBER continue to demonstrate that their focus is on facilitating the development of therapies that provide major benefits to clients. Here are my top 3 takeaways: 1) Developers must do more to demonstrate knowledge and control over their technologies. 2) We need to define strong guardrails to ensure safety and continued innovation. 3) The scope for platform technologies needs to be inclusive of CDMOs and device developers who drive manufacturing innovation. #PlatformTechnologies #FDA #PlatformTechnologiesDesignationProgram #AllianceforRegenerativeMedicine #ARM #NIIMBL #CellandGeneTherapy #CGT #manufacturing #CDMO

The biotech industry is evolving at rapid speed, and staying ahead demands a proactive approach. In this on-demand webinar, our CTO, Hanna P. Lesch, along with industry experts share their practical insights to help you navigate the challenges and seize opportunities in cell and gene therapy. By watching, you'll learn: 🔍 Key strategies to secure vital funding in a competitive market 🏆 How to refine your operations while maintaining top-notch quality and regulatory compliance 🌐 How to overcome hurdles to get your therapies approved and into the market 💰 Tips for mastering the complexities of pricing to ensure your therapies reach patients and remain profitable Watch on-demand below. https://lnkd.in/e7a-zrZx #GeneTherapy #CGT

Biocom California recently invited Sapient to contribute an article for its Lifelines Magazine edition focused on innovations in #genetherapy and #celltherapy. https://bit.ly/3V6gqd4 While cell- and gene-based treatments are advancing rapidly, spurred by a landmark year of FDA approvals, their development is not without challenges. We discuss how #multiomics for gene and cell therapy can deliver the novel insights needed to realize the incredible therapeutic potential represented in these pipelines today: https://bit.ly/3V6gqd4

The November issue of Life Science Leader is out! Krish Krishnan and Suma Krishnan of (Pittsburgh-based) Krystal Biotech, Inc. are on the cover, sharing details of their journey to bring the first topical, redosable gene therapy to market. Sath Shukla talks about Spero Therapeutics' business model for novel antibiotics, Wayne Koberstein covers Freya Biosciences in 'Companies To Watch,' and more: https://lnkd.in/gggauDAb.

Register for a free webinar on "Navigating the New Era of Asset Maintenance Management: A Gene Therapy Company's Transformation". https://lnkd.in/gHFh-dG8 . Attendees will learn how 4D Molecular Therapeutics overhauled their manual maintenance-related processes throughout their facility, unveiling a plethora of improvement opportunities. Dave Porrill from Blue Mountain and Wes Champion from PCI will discuss 4DMT’s journey of implementing a validated Computerized Maintenance Management System (CMMS) and the tangible benefits they reaped. It not only brought about better alignment and structure to their processes, but it also revolutionized their maintenance workflow. Register here to attend: https://lnkd.in/gHFh-dG8 . #BlueMountainRAM #GMPDigitalMaturtityModel #RegulatoryAssetManager #AdvanceGMPcompliance

Rich insights from Industry Giants - Rob Schulz and James Wabby. Take a moment to listen, truly worthwhile. Regulatory intelligence must consider cultural norms and political climate to drive a successful regulatory submission strategy. Find out how.

Exciting webinar alert! Discover how 4D Molecular Therapeutics upgraded their maintenance processes with a validated CMMS. Hope to see you there for insightful discussions with industry leaders Dave Porrill and Wes Champion!

Hope you can make this webinar as AI continually speeds the process of innovation and it is more crucial then ever to be compliant and audit ready!!!!

Last chance to register | Expert Roundtable: Streamlining Cell and Gene Therapy Scalability With 2024 CGT approvals by the FDA anticipated to reach double figures, now more than ever it is critical to consider the end product from the earliest stages of development. We’re uniting an esteemed panel from AAVantgarde Bio, Axovia Therapeutics, Gamma Biosciences, and Nanoscope Therapeutics Inc. to uncover: - Key differences between material requirements for research vs. GMP vectors - The importance of standardizing materials and manufacturing processes - Real-world examples of how the pathway to the clinic can be streamlined Join us on May 13: https://okt.to/C19sHp James Cody Phil Vanek Samarendra Mohanty Victor Hernandez #viralvectors #genetherapy #roundtablewebinar #humangenetherapy