Shows
BioSpaceBioSpace x DIA: Robust Integrated Regulatory StrategiesHow do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology?
Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement.
Additionally, we are joined by Tamei Elliott of DIA who shares insights on key discussions and themes of the upcoming meeting in San Diego.
This is the third and final episode in our preparation for the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products taking place at the DIA 2024 Global Annual Meeting.
2024-06-0621 min
BioSpaceBioSpace x DIA: Advanced Therapy Product Regulatory ConfusionRegulators suggest developers engage in discussions early, however those conversations cannot take place unless developers are sure of the asset's category.
Existing confusion surrounding advanced therapy products may become more challenging as both science and technology evolve.
With both developers and regulators, two risk adverse entities, addressing this evolution and continually updated regulations, advanced therapy product development continues to be a collaborative process.
This is the second episode in our preparation for the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products taking place at the DIA 20...2024-05-3018 min
BioSpaceBioSpace x DIA: Navigating the Emergence of CGT Combination ProductsWith every new advancement in either science or technology there is increased excitement as we see the potential. Cell and gene therapies (CGT) as combination products are emerging as the stage in the evolution of technology and science merging together. While the potential benefits for patients are great, there are risks and challenges that must be carefully considered.
This discussion is part of one of a precursor of the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products taking place at the DIA 2024 Global Annual Meeting.
James Wabby...2024-05-2320 min
Herpetological Highlights156 Comfort Eating LizardsStress can come from many places, loud noises are one example. So how do lizards react when their home is constantly bombarded by loud noises? We also have a new gecko for Species of the Bi-week.
Become a Patreon: https://www.patreon.com/herphighlights
Merch: https://www.redbubble.com/people/herphighlights/shop
Full reference list available here: http://www.herphighlights.podbean.com
Main Paper References:
Kepas ME, Sermersheim LO, Hudson SB, Lehmicke AJJ, French SS, Aubry LM. 2023. Behavior, stress and metabolism of a parthenogenic lizard in...2023-05-0431 min
Invent: Life SciencesCell Therapy Manufacture: How to scale the manufacture of living drugs
Following our first episode of two focusing on cell and gene therapies, outlining the promise and practicalities of delivering curative therapies for chronic diseases, we now focus on cell therapies - so called ‘living drugs’ that are both as powerful as they are complex. Despite the impressive trials and life-changing impacts at the individual level, it’s still not possible to manufacture cell therapies at scales that could benefit a wider range of patients. So what are the differences between cell therapies and conventional medicines that make them so difficult to manufacture? Can we redeploy hardware and learnings from other...2022-07-0546 min
The BioInsights PodcastWhere will tomorrow’s workforce come from? PART 3: Innovation in staff sourcing, training and retention - what works and what doesn’t?PART 3: Innovation in staff sourcing, training and retention - what works and what doesn’t? Welcome to a 4-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?”The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade now, fuelled by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in activity from both investors and big pharma. But with this relentless pace of growth and innovati...2022-06-2026 min
The BioInsights PodcastWhere will tomorrow’s workforce come from? PART 2: How is the educational system responding, and how can the cell and gene therapy community at large help?Part 2: How is the educational system responding, and how can the cell and gene therapy community at large help?Welcome to a four-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?” The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade, fuelled by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in activity from both investors and big pharma. But with this relentless pace of growth and innova...2022-06-0732 min
The BioInsights PodcastWhere will tomorrow’s workforce come from? PART1: Framing the issueWelcome to a 4-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?”The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade, fuelled by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in activity from both investors and big pharma. But with this relentless pace of growth and innovation comes the fundamental challenge of developing a sufficiently large and skilled workforce to support and maintain the se...2022-06-0728 min