Citeline Podcasts

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee (:30), whether industry would improve clinical trial diversity with tougher enforcement of the regulation (22:26), as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program (33:07). More On These Topics From The Pink Sheet As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs: https://pink.citeline.com/PS154707/As-Biosecure-Bill-Mores-Forward-Clock-Ticking-For-Industry-To-Move-Away-From-Chinese-CDMOs BIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern’: https://pink.citeline.com/PS154692/BIOSECURE-Act-Update-Offers-Biotech-Companies-Eight-Years-to-Divest-Contracts-With-Firms-Of-Concern Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity: https://pink.citeline.com/PS154688/Senate-Work-On-Biosecurity-Issues-Continues-Even-As-House-Is-Current-Focus-Of-Legislative-Activity US FDA Asked To Tighten China Risk Control By Legislators As Markup Looms: https://pink.citeline.com/PS154675/US-FDA-Asked-To-Tighten-China-Risk-Control-By-Legislators-As-Markup-Looms ‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks: https://pink.citeline.com/PS154696/Do-It-Or-Were-Not-Going-To-Approve-Your-Drug-Industry-Reps-Ask-FDA-For-Trial-Diversity-Sticks US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals: https://pink.citeline.com/PS154702/US-FDA-Using-Platform-Ideas-Outside-Of-Formal-Designations-To-Speed-Cell-and-Gene-Approvals

Flora gives an overview of the budding landscape of neoadjuvant therapy in melanoma and provides insight on the nuances of this market. 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

In this bilingual Chinese- and English-language edition, China-based editors Brian Yang and Dexter Yan, along with guest speaker Derrick Gingery from the Pink Sheet in the US, discuss the planned US BIOSECURE Act and markup vote. Brian and Dexter also look at recent R&D updates from Chinese biopharma firms on their antibody-drug conjugate pipelines. https://scrip.citeline.com/SC150255/China-Biotech-Podcast-BIOSECURE-Markup-Biotech-Pipeline-Updates Other podcasts in the series: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma

Audio roundup of selected biopharma industry content from Scrip over the business week ended 10 May 2024. In this episode: AstraZeneca’s Vaxzevria farewell; the next wave of cardiometabolics; Pfizer recruits prominent analyst: foundation pleas for China rare disease therapies; and Gossamer partners up for respiratory therapy. https://scrip.citeline.com/SC150240/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

In this episode, HBW Insight chats with sustainable packaging expert Tony Perrotta about why it’s so difficult to replace plastic pill packs in medicines packaging. Perrotta works for PA Consulting, which set up the Blister Pack Collective alongside consumer healthcare partners Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the collective hopes will be ready to commercialize in the next 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which also hopes to use the same dry molded fiber technology to replace plastic bottles in food, personal care and consumer health industries, will soon be launching its first market trial.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 3 May 2024. In this episode: Japan’s Ono buys US oncology firm; strong growth but supply issues for Lilly; Novo and Lilly make their money work; BMS cuts jobs, costs; and Big Pharma’s support for bioventures. https://scrip.citeline.com/SC150211/Quick-Listen-Scrips-Five-MustKnow-Things More podcasts in this series: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things?si=17107bcf40ad4c54b5148e7f58f28b69&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing

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 More podcasts from the Pink Sheet: https://soundcloud.com/citelinesounds/sets/podcasts-from-the-pink-sheet?si=a64a3c5c834a470ca9e71dc19777df04&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing

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?

Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation (:34), upcoming guidance on accelerated approval for gene therapies (14:15), and partisan attacks on the agency from Capitol Hill (27:13). More On These Topics From The Pink Sheet Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says: https://pink.citeline.com/PS150143/Rx-Advertising-Interchangeability-Doesnt-Mean-Clinical-Superiority-To-Other-Biosimilars-FDA-Says US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios: https://pink.citeline.com/PS150140/US-FDA-Gene-Therapy-Accelerated-Approval-Guidance-Will-Describe-Buckets-Of-Use-Scenarios Partisan Politics Returns To US FDA Congressional Oversight: https://pink.citeline.com/PS150114/Partisan-Politics-Returns-To-US-FDA-Congressional-Oversight

Pulmonologist Bing Xue, MD, reviews the latest GOLD guidelines and discusses relevant topics regarding COPD treatment.

Join Scrip's China-based editors Brian Yang and Dexter Yan in this Chinese/English podcast as they look at data presented to AACR by Chinese pharma firms and recent acquisitions of China-based companies. UK-based writer Andrew McConaghie also joins to provide his perspectives, including on the proposed US BIOSECURE Act. https://scrip.citeline.com/SC150164/China-Biotech-Podcast-AACR-BIOSECURE-European-Perspectives

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Citeline - Cerba Research Podcast V2 by Citeline

Scrip's Joseph Haas, Kevin Grogan and Edwin Elmhirst talk about the biopharma M&A environment and which companies might look particularly appealing to potential acquirers.

In this episode of the In Vivo podcast, Eric Finzi, CEO of Healis Therapeutics, discusses how his company is targeting major depression, post-traumatic stress disorder and other mental illnesses using facial botox injections.