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