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Dive into a decade of health breakthroughs! 🚀 The approval of cell and gene therapies has paved the way for transformative outcomes for patients. Discover the FDA's expert guidance as they navigate companies through the CMC requirements process, ensuring the approval of products that mend and rejuvenate human cells to combat diseases. 🧬 Explore the journey here: https://lnkd.in/en8_UwJc #HealthInnovation #FDAInsights #CMCRequirements

Different rules for cell and gene therapies across countries pose challenges for manufacturers, delaying market access and hindering patient treatment. By proposing practical solutions and advocating for regulatory adjustments, T2Evolve's recommendations aim to simplify processes and expedite approvals at EU level, facilitating timely access to innovative therapies. Learn more with this Innovative Health Initiative (IHI)'s article: https://lnkd.in/dKWcw2TD

Cell and gene therapies (CGTs) have the potential to revolutionize healthcare by treating and curing previously incurable diseases. With a projected compound annual growth rate of 46%, the global market for CGTs is set to reach $37B over the next five years. However, challenges in reimbursement and operating margins hinder commercial viability. To bridge the gap, leaders must focus on pricing strategies and reducing manufacturing costs. How to make cell and gene therapies financially sustainable > https://owy.mn/45NOFcS #OWHealth #CellandGeneTherapy #healthcare

Gene therapy offers hope in the fight against #geneticdisorders, representing a paradigm shift in the way we approach treating these devastating diseases. Despite significant strides, the field continues to grapple with challenges like delivery complexities, safety concerns, and #patientaccessibility. These challenges signify the need for ongoing vigilance and refinement in safety protocols. However, with continued innovation and collaboration, the industry can overcome these challenges and realize the promise of #genetherapy in revolutionizing patient care. Industry leaders must prioritize safety, bolster R&D investments, and foster interdisciplinary partnerships to navigate these challenges effectively. As gene therapies continue to evolve we have an incredible opportunity to bring these life saving therapies to patients who previously had few treatment options.  https://lnkd.in/eEWmXhjs

The complexity of the infrastructure required to support cell and gene therapies necessitates early consideration of supply chain issues, even before entering human studies. In this interview, Tobias Handschuh sits down with Vice President of Scientific Affairs at TrakCel, Matthew Lakelin, to discuss the requirements for ensuring the safe, efficient, and timely delivery of cell and gene therapies to patients. Watch the full interview here > https://owy.mn/4dfy0SY #OWHealth #healthcare #SupplyChain

The emergence of new gene therapies is changing the face of healthcare. Anthem is committed to keeping pace with this rapid advancement, both through managing costs and making these innovative therapies accessible. Learn more about how it’s possible for self-insured employers to connect their employees to the latest innovative gene therapies while mitigating risk to your bottom line. #stoploss #costofcare #healthcareinnovation https://ow.ly/gIAp30sFRCu

The commercialization of cell and gene therapies (CGTs) is no easy task. With the FDA approving 7 new CGTs in 2023 alone, the total has risen to 34. But from high costs to healthcare infrastructure challenges, there’s a lot to navigate. Read more in this blog from Kyle Felmet, VP of Specialty Commercialization, and Paul Archer, Chief Commercial Strategy Officer, about how AI and innovative strategies are shaping the CGT landscape.

Embark on a Decade of Breakthroughs with DS InPharmatics! 🚀 Over the past ten years, the approval of cell and gene therapies has paved the way for extraordinary health outcomes for patients. 🌐💊 Curious about the FDA's role in guiding companies through the CMC requirements process for these groundbreaking therapies? 🧬🛠️ Dive into the details and elevate your understanding: https://bit.ly/3Hk9elP Stay informed, stay inspired! Let DS InPharmatics be your guide to the future of healthcare. 💙 #DSIGeneTherapies #HealthcareInnovation #FDAApprovals

The commercialization of cell and gene therapies (CGTs) is no easy task. With the FDA approving 7 new CGTs in 2023 alone, the total has risen to 34. But from high costs to healthcare infrastructure challenges, there’s a lot to navigate. Read more in this blog from Kyle Felmet, VP of Specialty Commercialization, and Paul Archer, Chief Commercial Strategy Officer, about how AI and innovative strategies are shaping the CGT landscape.

The commercialization of cell and gene therapies (CGTs) is no easy task. With the FDA approving 7 new CGTs in 2023 alone, the total has risen to 34. But from high costs to healthcare infrastructure challenges, there’s a lot to navigate. Read more in this blog from Kyle Felmet, VP of Specialty Commercialization, and Paul Archer, Chief Commercial Strategy Officer, about how AI and innovative strategies are shaping the CGT landscape.