Citeline Podcasts

Pink Sheet editors discuss the US FDA’s consideration of regulatory changes to promote innovative clinical trial designs (:32), an NIH proposal to require patent licensees create plans to ensure access to the commercialized product (7:29), and lawmakers longing for the days when Janet Woodcock ran the FDA’s Center for Drug Evaluation and Research (15:35). More On These Topics From The Pink Sheet ‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research: https://pink.citeline.com/PS154721/US-FDA-Looking-To-Modernize-Clinical-Trial-Regulations-To-Spur-Evolution-In-Research NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional: https://pink.citeline.com/PS154744/NIH-Drug-Patent-Licensees-Would-Develop-Access-Plan-Under-Proposal-Pricing-Commitments-Optional Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach: https://pink.citeline.com/PS154745/Woodcock-Nostalgia-GOP-Rep-Bilirakis-Wants-CDER-To-Recapture-Her-Flexible-Approach

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

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.

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.

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

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.

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

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?