NewBiologix’s Post

I was excited to welcome Rajiv Gangurde, Ph.D., the Vice President of Technical Operations, Cell & Gene Therapy at Parexel to the Shurig Solutions, Inc. SSI Executive Conversations Podcast. In Part 1 of our conversation Rajiv and I discuss some important topics relevant to the C&GT industry. With over 1500 clinical trials in progress last February and the recent announcement of the first CRISPR FDA approval, we discuss the current state of C&GT FDA approvals, the challenges around CMC, and the specifics of AAV-based gene therapy. https://lnkd.in/ePmHsRk8 #cellandgenetherapy #innovation #clinicaltrials #cmc #regulatorypathway #biotechnology #pharmaceutical

Confirming a drug’s mechanism of action and potency are essential for any drug submission, including vaccines, gene therapies, and oncolytic viruses. 💉 Developing, validating, and performing these assays is complex work - so let our science team do the heavy lifting for you! We pair different assay platforms with rigorous statistical analysis to measure the different functional activities of drug candidates. These include: ✔️Enzymatic/reporter-based assays ✔️Complement dependent cytotoxicity (CDC) ✔️Antibody dependent cellular cytotoxicity (ADCC) ✔️Potency ✔️Proliferation ✔️Migration ✔️Inhibition ✔️Apoptosis ✔️Cytokine release ✔️Immunofluorescence 👉Curious how #cellbasedbioassays can help you reach your pharmaceutical development goals? Explore our capabilities: https://buff.ly/3sANQFn #bioassays #bioanalysis #CBA #potency #potencyassays #drugdevelopment

Thoughts on this? >> Beacon raises $170M to see eye disease gene therapy through pivotal study - FirstWord Pharma >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #competitivemarketing #pharmaceutical #healthcare

Thoughts on this? >> Edgewood's $20M Series A; Nanoscope to pursue FDA approval for eye gene therapy later this year >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #pharmaceutical #biotech #productmarketing

Announcing a new publication! 🧬📄 The development of cell and gene therapies has resulted in many bespoke and proprietary solutions, each requiring its own development program and regulatory review. Our latest whitepaper highlights the key discussion points of our November 2023 FDA Scientific Exchange, co-sponsored by NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals, which focused on identifying reusable elements of CGT technologies that could be leveraged to improve the time and resource efficiency of development and review. The paper outlines the viability of specific building block proposals in LNP, iPSC, and AAV and explores potential regulatory paths toward establishing reusable technologies. https://lnkd.in/efbJdv3H

Top 5 #CDMOs driving advanced therapies to market amid rising demand and challenges Contract development and manufacturing organizations (CDMOs) perform vital services for the #biopharmaceutical industry – a role that is growing as cell and gene therapies gain momentum. Here are five of the top CDMOs bringing advanced therapies toward the market. https://lnkd.in/gTdeKsdd

Thoughts on this? >> Voyager's journey to identify a new shuttle mechanism to bring gene therapies into the brain - BioCentury >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #pharmaceutical #biotech #competitivemarketing

Thoughts on this? >> Voyager's journey to identify a new shuttle mechanism to bring gene therapies into the brain - BioCentury >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #competitivemarketing #pharmaceutical #pharma #healthcare #biotech

Thoughts on this? >> Voyager's journey to identify a new shuttle for bringing gene therapies into the brain - BioCentury >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #competitivemarketing #pharmaceutical #healthcare #pharma #biotech

Thoughts on this? >> Voyager's journey to identify a new shuttle for bringing gene therapies into the brain - BioCentury >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #pharmaceutical #biotech #competitivemarketing