Citeline Podcasts

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials.

Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out (:35), as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making (27:30).

More On These Topics From The Pink Sheet

Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says: https://pink.citeline.com/PS154894/Diversity-Action-Plans-Should-Be-Brief-And-Waiver-Requests-Filed-Early-US-FDA-Says

Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups: https://pink.citeline.com/PS154895/Diversity-Enrichment-US-FDA-Guidance-Suggests-Sponsors-May-Need-To-Overenroll-Key-Groups

US FDA Guidance On Artificial Intelligence For Regulatory Decision-Making Expected This Year: https://pink.citeline.com/PS154868/US-FDA-Guidance-On-Artificial-Intelligence-For-Regulatory-Decision-Making-Expected-This-Year

Guest speaker “Angus” Shipo Xie of Hankun Law joins Brian Yang to discuss new overseas data transfer rules, while Dexter Yan explains China biotechs' Hutchmed, Jiangsu Hengrui and Innovbent Bio’s clinical data readouts at the recent EHA and ADA annual meetings.

https://scrip.citeline.com/SC150487/China-Biotech-Podcast-EHAADA

Playlist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma

Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 June 2024. In this episode: the outlook for 2025 launches; Merck confident in new pneumococcal vaccine; multiple US setbacks for Japanese firms; Stock Watch on Moderna missteps; and Sun’s North America head talks plans and strategy.

https://scrip.citeline.com/SC150476/Quick-Listen-Scrips-Five-MustKnow-Things

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul

Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed

a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through

the highlights of Lung Life AI’s journey to date and its future ambition for a strategic partnership.

He also provides advice to similar diagnostic companies seeking reimbursement and

compliance with the US FDA Lab Developed Test ruling.

In this episode, HBW Insight chats with women’s health start-up The SABI about the power of herbal medicine for hormonal wellness. “Inspired by a series of painfully honest conversations they had about their hormonal and emotional challenges,” The SABI markets a range of herbal infusions aimed at alleviating some of the impacts of painful periods and hormonal imbalances, such as digestive discomfort, sleep disruption and anxiety. The SABI founders Hilary Metcalfe and Anna Cave-Bigley also reveal the difficulties of being a woman-led, women’s health startup in a male dominated world, especially when it comes to funding and research. We also discuss the importance of getting the message right, both in terms of connecting women to their hormonal health but also distinguishing The SABI from less credible women’s wellness brands.

Timestamps:

2:00 Introductions

5:00 The power of herbs

11:45 The challenges of being a women’s health startup

17:30 The demand for natural women’s health products

24:50 Controversies surrounding natural women’s health alternatives

32:45 What’s next for The SABI

Biographies

Anna Cave-Bigley is CEO at The SABI, leading sales and strategy “with her signature drive and keen insight on everything from motherhood, hormone balance and mental health to strategy, sales and global operations.” From being a founding member of the international practice for a leading London communication consultancy to spearheading international investment initiatives for the British Government, Anna has honed her operational business expertise over 13 years. She is mother to Lorenzo and Alfie, who “inspired her to co-found The SABI after her devastating experience with clinical postpartum depression.”

Co-founder Hilary Metcalfe is a Harvard graduate and accomplished business strategist, who dedicated 12 years to impact investment, sustainability, and management consulting before her health intervened. “Conventional medicine offered only a lifetime of medication for chronic migraines and my then-undiagnosed endometriosis. Determined to find a more natural approach, I became a certified holistic nutritionist, product developer and chef, building and selling a successful plant-based food startup in Amsterdam.” During this time Hilary began formulating the remedies and products that would become The SABI’s core collection.

Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 June 2024. In this episode: Boehringer best in MASH?; biopharma funding on an upswing?; Moderna’s combo jab; clinical trial recover from pandemic; and Astellas’s US commercial head speaks.

https://scrip.citeline.com/SC150442/Quick-Listen-Scrips-Five-MustKnow-Things

Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

In this podcast, Janelle Hart, Managing Editor, Citeline, joins industry experts Jessica Wall, Director of Talent Acquisition, and Morgan Seaman, Associate Director of FSS Operations, both from Advanced Clinical, to discuss the latest trends and challenges in building, scaling and differentiating workforces in the life sciences sector.

Talent acquisition is central to fostering creativity and innovation within any organization. In today’s highly competitive and fast-moving life sciences sector, it’s more important than ever. Tune into this free podcast to gain valuable insights on maintaining a competitive edge through innovative recruitment and retention strategies. Listen now to explore more!

The oncology team from Datamonitor Healthcare and healthcare journalist, Alaric, provide broad analytical coverage of key highlights from the ASCO 2024 conference.

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​

Guest speaker, US-based Pink Sheet senior writer Sarah Karlin-Smith, joins Brian Yang and Dexter Yan in China to discuss the recent BIO Conference, updates to the planned US BIOSECURE Act and industry preparations for its impact. Dexter also discusses China biotech's data highlights from ASCO 2024.

https://scrip.citeline.com/SC150438/China-Biotech-Podcast-BIOSECURE-Act-Updates--ASCO-Highlights

Playlist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma