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

Drug Fix: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation

Guest speaker Guangzuo Luo, chief scientific officer of Bioncetech, joins China-based editors Brian Yang and Dexter Yan in this episode, which looks at Chinese biotechs going global, and the opportunities and challenges in the latest industry latest trends.
https://scrip.citeline.com/SC150370/China-Biotech-Podcast-Going-Global-Trends-Rare-Disease-Drug-Development

Playlist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma?si=80b1209c44874afa9c44bf7d30538320&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing

China Biotech Podcast - 5 June 2024 (Chinese language)

Generics Bulletin's editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA's Orange Book.

The Generics Bulletin Podcast: Teva, Sandoz, Sawai and US Orange Book patents

Audio roundup of selected biopharma industry content from Scrip over the business week ended 7 June 2024. In this episode: BIO Notebook; ASCO roundup; data on Carvykti in community at ASCO; strong new results for tirzepatide in MASH; and orphan slowdown signals new path ahead.
https://scrip.citeline.com/SC150401/Quick-Listen-Scrips-Five-MustKnow-Things
Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 10 June 2024

글로벌 제약업계는 암 연구의 미래를 어떻게 보고 있을까? Scrip의 ASCO 현장 취재 기사를 요약한 내용입니다.

https://scrip.citeline.com/SC150378/ASCO-Roundup-Looking-For-The-Future-Of-Cancer-Research

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

ASCO 결산: 암 연구의 미래는? (Korean-language podcast)

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

China Biotech Podcast - 14 June 2024 (Bilingual Chinese/English)

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​

June 2024 Datamonitor Healthcare Podcast: ASCO 2024

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!

Building And Scaling Your Workforce: The Importance Of A Flexible Delivery Model In 2024 & Beyond

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

Scrip's Five Must-Know Things - 17 June 2024

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.

The Power Of Herbs For Women’s Wellness, With The SABI’s Hilary Metcalfe and Anna Cave-Bigley

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.

Lung Life AI's CEO Shares Regulatory And Reimbursement Journey For Lung Cancer  Diagnostic, Lung LB

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

Drug Fix: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation

Citeline

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