Citeline Podcasts

Citeline
  • 4.2 (29)
  • BUSINESS
  • UPDATED DAILY

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.

  1. Drug Fix: US FDA’s Prasad Leaves, Harry Potter, And Is CNPV Effective Because Of RTOR?

    47M AGO

    Drug Fix: US FDA’s Prasad Leaves, Harry Potter, And Is CNPV Effective Because Of RTOR?

    Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs discuss potential directions for the US Food and Drug Administration’s Center for Biologics Evaluation and Research after the departure of Director Vinay Prasad (:32), including similarities between the center’s leadership issues and the staffing problems in the Harry Potter saga’s Hogwarts School of Witchcraft and Wizardry (7:48), as well as the potential policy implications (10:11). They also discuss the contributions of the agency’s Real-Time Oncology Review (RTOR) pilot program to the quick reviews of two Commissioner’s National Priority Voucher (CNPV) awardees (17:19). More On These Topics From The Pink Sheet US FDA’s Vinay Prasad, Controversial CBER Director, Leaving In April: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-vinay-prasad-controversial-cber-director-leaving-in-april-DJO7ACE73RCNTLZKQWCN2S26LM/ US FDA’s CNPV Approvals Ride RTOR Pilot’s Coattails: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fdas-cnpv-approvals-ride-rtor-pilots-coattails-3HEGU5MDWJEG7OYHSZQR6TE5NM/

    34 min
  2. Killing Cancer Loudly: Onchilles Pharma's Neutrophil-Derived Path to Pan-Cancer Therapy

    1D AGO

    Killing Cancer Loudly: Onchilles Pharma's Neutrophil-Derived Path to Pan-Cancer Therapy

    What if a drug could kill cancer cells broadly, spare the immune system and then train it to keep fighting, without triggering resistance? That's the promise behind the ELANE pathway, a mechanism discovered not from a hypothesis but from studying fundamental biology in patients. In this episode of the In Vivo Podcast, Court Turner, CEO and co-founder of Onchilles Pharma, and Lev Becker, CSO and scientific founder, discuss how a neutrophil elastase-based mechanism is being translated into N17350, a first-in-class intratumoral agent targeting solid tumours including head and neck, skin and breast cancers. With $40m raised, GMP manufacturing of thousands of clinical doses completed, a US IND approved, and a first-in-human study underway in Australia, Onchilles is moving from "stubborn optimism" to clinical execution. Court and Lev discuss the dual mechanism that sets N17350 apart from both traditional chemotherapy and immunotherapy, why histone H1 functions as a universal tumour vulnerability rather than a conventional biomarker, and how they're thinking about combinations, partnering and the eventual value story for payers.

    28 min
  3. Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.9, 2026

    4D AGO

    Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.9, 2026

    本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月6日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻: 中小型企业考虑在最惠国待遇下拓展欧洲市场；辉瑞CEO谈FDA疫苗审批决策；人工智能时代大型药企对CRDMOs有何期待；神经科学研究资金蓄势复苏；优时比与中国达成重大合作。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-N3WEPHD34BHGBGRM5BNJPTS2NY/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

    16 min
  4. Scrip's Five Must-Know Things - Mar.9, 2026

    4D AGO

    Scrip's Five Must-Know Things - Mar.9, 2026

    Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.6, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – smaller companies consider European expansion under MFN; Pfizer CEO on FDA vaccine decisions; what does big pharma want from CRDMOs in AI age; neuroscience funding poised for comeback; and UCB’s big China deal. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-N3WEPHD34BHGBGRM5BNJPTS2NY/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

    16 min
  5. Drug Fix: The State Of Facility Inspections With Two Former Senior US FDA Execs

    MAR 6

    Drug Fix: The State Of Facility Inspections With Two Former Senior US FDA Execs

    Pink Sheet Executive Editor Derrick Gingery and Senior Editor Sue Sutter are joined by special guests Michael Rogers, former US Food and Drug Administration associate commissioner for inspections and investigations, and Douglas Stearn, former principal deputy associate commissioner in the FDA Office of Inspections and Investigations, both now at Canal Row Advisors. They talk about the current state of the agency inspection cadre and resource challenges (1:04) and offer thoughts on the FDA’s efforts to increase foreign inspections (25:24), as well as discuss the growing threat that receiving an Official Action Indicated (OAI) classification presents (35:20) and consider whether user fee goals eventually could be impacted (45:02). More On These Topics From The Pink Sheet US FDA Use of ‘Potential Official Action Indicated’ Flag Raises Concerns About Facility-Based CRLs: https://insights.citeline.com/pink-sheet/compliance/us-fda-use-of-potential-official-action-indicated-flag-raises-concerns-about-facility-based-crls-3JLUE3CW6BEIFOKQRZ5C4FKFOM/ US FDA’s Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-failure-to-implement-key-workforce-reforms-puts-oversight-at-risk-gao-says-B64V7RAIQNBNBI57ID5ZU3DYAE/ US FDA Remote Assessments Need Clearer Closeout Process, More Transparency, Experts Argue: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-remote-assessments-need-clearer-closeout-process-more-transparency-experts-argue-4P5UQEPW7NDLNDDQERUQY5Y56M/

    49 min
  6. Unpacking Europe’s Probiotic Rules with David Pineda Ereño

    MAR 2

    Unpacking Europe’s Probiotic Rules with David Pineda Ereño

    The European market for probiotic dietary supplements is one of the most dynamic, but also one of the most complicated, areas of self‑care right now. Probiotics are hugely popular with consumers, widely used across Europe, and backed by an expanding body of science. But for companies trying to bring these products to market, one major obstacle remains: the European Union’s fragmented and highly restrictive regulatory environment. To help us unpack this, I’m joined on this episode of HBW Insight’s Over the Counter podcast by one of the leading experts on probiotics and the wider “biotics” category: David Pineda Ereño, managing director of DP International Consulting. In this first part of our conversation, we explore why the current international definition of “probiotic,” which currently includes the assertion that these microorganisms confer a health benefit on the host. It is this inbuilt health claim that has become such a regulatory sticking point in Europe. We discuss whether this definition could be revisited at the Codex Alimentarius level, and what that might mean for future harmonization. We also look at the growing divergence within the EU, as countries like Italy, Spain, Denmark and others move away from the European Commission’s restrictive position and allow the use of the term “probiotic” under certain conditions. Timestamps 2:00 – Introductions 4:30 – What are probiotics? 6:00 – Probiotic regulation in Europe 12:30 – Changing the definition 16:30 – The EFSA view 19:30 – EU member state divergence 22:15 – The Commission view 24:00 – What’s next? Guest Bio David Pineda Ereño is managing director of DPE International Consulting, an international consultancy firm that provides strategic and regulatory advice on the policy, regulation and trade of foods and food supplements. David has over 20 years of experience providing strategic solutions to companies, trade associations, and government bodies at national, regional, and international level, in Europe, Latin America, Asia, Middle East and Africa, and the United States.

    26 min
  7. Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar. 2, 2026

    MAR 2

    Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar. 2, 2026

    本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月2日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。 本期要闻: Zealand首席执行官呼吁终结减肥竞赛；默沙东谈人工智能辅助研发管线；布鲁斯·莱文的CAR-T疗法故事；生物制药并购活动回暖；2025年美国IPO市场艰难。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LTCVEH6JLFGRXBOQCFW6V72NVI/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

    16 min
  8. Scrip's Five Must-Know Things - Mar.2, 2026

    MAR 2

    Scrip's Five Must-Know Things - Mar.2, 2026

    Audio roundup of selected biopharma industry content from Scrip over the business week ended Feb.27, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Zealand CEO calls for end to weight loss Olympics; MSD on AI-assisted pipelines; Bruce Levine’s CAR-T stories; biopharma dealmaking bounces back; and 2025 was a tough year for US IPOs. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LTCVEH6JLFGRXBOQCFW6V72NVI/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

    16 min
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4.2
out of 5
29 Ratings

About

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.

Information

  • Creator
    Citeline
  • Years Active
    2014 - 2026
  • Episodes
    526
  • Rating
    Clean
  • Copyright
    © All rights reserved
  • Show Website
    Citeline Podcasts

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