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Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort (:32), the agency’s efforts to help the clinical trial modeling and simulation industry (16:22), and the UK’s MHRA plan to use artificial intelligence to assist in drug application reviews (21:05).

More On These Topics From The Pink Sheet

US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes?: https://pink.citeline.com/PS150167/US-FDA-Adcomm-Reform-Does-Listening-Session-Suggest-No-Major-Near-Term-Changes

US FDA Wants Advice About Advisory Committees: Try Having Some?: https://pink.citeline.com/PS154644/US-FDA-Wants-Advice-About-Advisory-Committees-Try-Having-Some

US FDA Developing Model Master File System To Grow Modeling, Simulation Field: https://pink.citeline.com/PS154647/US-FDA-Developing-Model-Master-File-System-To-Grow-Modeling-Simulation-Field

UK’s MHRA To Use AI In Regulatory Review Process & RWD Analysis: https://pink.citeline.com/PS154643/UKs-MHRA-To-Use-AI-In-Regulatory-Review-Process--RWD-Analysis

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s draft framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and Apple Watch’s new feature to help people with Parkinson’s disease.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

BD’s CTO Beth McCombs Discusses Key Initiatives – AI/Gen AI; DE&I Strategy; Succession Planning

HSS Spine Surgeon Sees Potential For AI Chatbots, But Not To ‘Practice Medicine’

Philips Portfolio Includes ‘No Single Product That Does Not Use A Type of AI,’ Says CEO and AI Thought Leader Roy Jakobs

Discreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple Watch

CDHR’s AR/VR Home Space Will Serve As An ‘Idea Lab’ For Device Stakeholders

Flora and Emma are joined by Datamonitor’s CNS analysts Summer, Joseph, and Wen-Yu to discuss coverage from AAN.

Other platforms (in addition to SoundCloud):​

Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836​

Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz​

TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/​

Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 April 2024. In this episode: 2023’s top selling drugs and the COVID cliff; falling sales force Roche to reassess priorities; Phase III immunology win for Sanofi; BMS’s strong pipeline: and which companies could be acquired next.
https://scrip.citeline.com/SC150182/Quick-Listen-Scrips-Five-MustKnow-Things

2024 Global Generics & Biosimilars Awards by Citeline

Learn how molecular technology is enhancing patient safety for CAR-T clinical trials.

US FDA recently initiated class safety labeling changes after evaluating the safety of CAR-T cancer treatment therapies. What does this mean for developers in the CAR-T landscape? Listen to your free podcast to find out.

Listen in on the conversation as experts from Cerba discuss facilitating patient safety measures in CAR-T therapies by accurately identifying the integration of viral vectors, utilizing flow cytometry, and more.

Listen now as experts discuss answers to:
· What patient monitoring is required by the FDA?
· What molecular technology does Cerba use and how does it meet FDA requirements?
· What is the importance of cytometry assays in monitoring CAR-T cells?
· What are the opportunities for combining flow cytometry with genomic solutions?
· What key innovations are poised to improve patient monitoring in clinical trials?