In the second part of HBW Insight’s chat with Bristows digital health regulatory expert Jamie Hatzel, we talk about artificial intelligence. Specifically, we discuss what happens to Software as a Medical Device within incoming EU artificial intelligence legislation, which has now entered trilogue negotiations. Issues such as the meaning of “high risk” within the proposed AI Act, in contrast to its meaning in the existing Medical Device Regulations, highlight the importance for manufacturers in this space or thinking about entering it of getting good advice, Hatzel points out.

What Happens To Software As A Medical Device Under The EU AI Act? With Bristows’ Jamie Hatzel

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

Scrip's Five Must-Know Things - 13 May 2024

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

China Biotech Podcast - 15 May 2024 (Chinese- and English-Language)

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

May 2024 Datamonitor Healthcare Podcast: Neoadjuvant Therapy in Melanoma

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

Audio roundup of selected biopharma industry content from Scrip over the business week ended 17 May 2024. In this episode: the life of a blockbuster; blockbusters by indication; gene therapy struggles; sun shines on AstraZeneca and GSK; and Korean ventures look to Japan.
https://scrip.citeline.com/SC150281/Quick-Listen-Scrips-Five-MustKnow-Things
Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 20 May 2024

In this episode, HBW Insight catches up with Albert Swane, founder and CEO of Dutch consumer healthcare firm, TheOTCLab, to talk about business strategy. Having grown the company with widely successful European OTC medical devices like Dr. Yglo, FungeX and Kidsner, Swane is perfectly placed to explain how to create and grow OTC brands. Swane also offers some sage advice on partnering, reflects on the fantastic opportunity of TheOTCLabs expanding into the US, and shares his experiences of using social media to raise the profile of the OTC industry.

How To Grow A Consumer Health Brand, With TheOTCLab’s Albert Swane

빅파마 기업들의 블록버스터 신약 확보 전략에 대한 Scrip 기사를 요약한 내용입니다.
https://scrip.citeline.com/SC150256/Development-Versus-Dealmaking-How-To-Obtain-A-Blockbuster
Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

개발 VS 딜메이킹: 블록버스터 신약을 확보하는 방법 (Korean-language podcast)

In this episode, HBW chats with John Hite of the leading producer responsibility organization administering three Extended Producer Responsibility laws launching next year. With a 1 July deadline to register for his PRO, Circular Action Alliance, Hite discusses steps companies should take now, how his organization will assist producers and expectations on fee collection.

Voice Recorder

Leading PRO Discusses Plans For Administering State EPR Programs

In this episode of the In Vivo podcast, Hakim Yadi, CEO and co-founder of UK techbio company Closed Loop Medicine, discusses how his company is pairing software and predictive analytics with medications old and new to tailor drug dosing to each patient.

Closed Loop Medicine: Pairing Software With Drugs To Optimize Dosing

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。

今回取り上げた記事はこちら
「Hibernating Squirrels And Exercise In A Pill: The Next Wave of Cardiometabolic Therapies（ 邦題意訳：GLP-1を超える心代謝系治療薬のヒントは、冬眠するリスか、地道な運動か）」

（日本語版）
https://www.citeline.com/ja-jp/resources/hibernating-squirrels-and-exercise-in-a-pill
※全文の閲覧には情報の登録（無料）が必要です。

（英語版）
https://scrip.citeline.com/SC150222/Hibernating-Squirrels-And-Exercise-In-A-Pill-The-Next-Wave-of-Cardiometabolic-Therapies

世界の製薬ビジネスメディアScrip（スクリップ）とは？
https://www.citeline.com/ja-jp/products-services/commercialization/scrip

【3分で解説  世界のファーマ】第18回 GLP-1を超える肥満治療薬のカギとは？(Japanese-language podcast)

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.

What Happens To Software As A Medical Device Under The EU AI Act? With Bristows’ Jamie Hatzel

Citeline

Related tracks