Citeline Podcasts

Join Sarah Anderson, Therapeutic Strategy Director, Oncology at Novotech, and Izabela Chmielewska from Citeline as they explore how next-generation immuno-oncology strategies are reshaping cancer research. From emerging modalities to smarter trial design and evolving regulatory expectations, discover what’s driving the next wave of innovation in oncology.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月31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。 本次要闻: 本期要闻——第三季度并购交易回暖； 诺华收购Avidity后并购火力依旧；韩美制药肥胖症候选药物展现三期试验潜力；英伟达合作推动礼来人工智能计划；礼来收购Adverum强化基因疗法布局。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MQMX2YHSAVHBTJFR4RAEAYNFNQ/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 31, 2025. In this episode: third quarter dealmaking picks up; Novartis still has M&A firepower even after Avidity acquisition; Hanmi’s obesity contender shows Phase III promise; NVIDIA partnership progresses Lilly’s AI plans; and Lilly builds gene therapy push with Adverum buy. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MQMX2YHSAVHBTJFR4RAEAYNFNQ/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration announcement that a comparative efficacy study is no longer a prerequisite for biosimilar approval (:35), as well as the upcoming guidance stating the interchangeability switching study requirement will be dropped (11:25). They also discuss agency efforts to clarify the intent of the upcoming inspection force “Simple Reform” (15:13). More On These Topics From The Pink Sheet US FDA’s Makary Wants Lower Biosimilar Launch Prices As Clinical Study Mandate Changed: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/us-fdas-makary-wants-lower-biosimilar-launch-prices-as-clinical-study-mandate-changed-5ARJRC6QYBBMTLTQ5S46F5YGXQ/ Biosimilar Interchangeability Guidance Eliminating Switching Studies Coming Soon: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biosimilar-interchangeability-guidance-eliminating-switching-studies-coming-soon-ILNP4IGYJZGZLAJVDZ77URZDNQ/ ‘Simple Reform’ Not A Step Back From Program Alignment, US FDA’s Elizabeth Miller Argues: https://insights.citeline.com/pink-sheet/compliance/manufacturing/simple-reform-not-a-step-back-from-program-alignment-us-fdas-elizabeth-miller-argues-TCTFWMGBARD6VLRDT7YWUZBJQE/

What if we could train AI to understand how stem cells become any cell type in the human body? In this episode of the In Vivo Podcast, host David Wild sits down with Micha Breakstone (CEO & Co-founder) and Samantha Dale Strasser (VP of Strategy) from Somite.AI to explore how their company is using foundation models to revolutionize cell therapy development. Somite has pioneered a breakthrough approach that generates cell differentiation data at 1000x the efficiency of traditional methods using proprietary hydrogel capsule technology. By capturing millions of trajectories showing how cells respond to signals over time, they're building DeltaStem—a foundation model that could do for developmental biology what AlphaFold did for protein structure prediction. Topics covered: - How bringing cells to signals (rather than signals to cells) unlocks exponential scale - Why wet lab innovation is just as critical as AI models - Manufacturing optimization: improving purity, reducing variability, and cutting costs - From beta cells for diabetes to brown fat for metabolic disease—the therapeutic pipeline - Why even AI experts underestimate what's coming in the next decade - Lessons from building biotech companies from academic concepts to commercial ventures Whether you're in pharma, biotech, AI or just fascinated by the intersection of technology and human biology, this conversation offers a grounded look at how foundation models are moving from hype to real therapeutic impact.

Joseph Haas, senior writer, Scrip, speaks to guest panelists Robert Darwin, partner, Sidley law firm, and Arda Ural, Americas Life Sciences Leader, EY.

스톤브릿지벤쳐스의 김현기 상무는 Scrip과의 인터뷰에서 벤처캐피탈의 국내 바이오 투심 회복을 제약하는 요인과 투자 고려사항, 전략 등을 이야기했습니다. https://insights.citeline.com/scrip/leadership/interviews/a-vc-perspective-on-korean-bioventures-new-catalysts-needed-to-jumpstart-activity-Z7IXGZWZVVGKFDPNOWNJJPMWLQ/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月24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。 本期聚焦柏林欧洲医学肿瘤学会会议的新成果：Enhertu在早期乳腺癌中的应用；Padcev/Keytruda在膀胱癌领域的突破；Pluvicto的III期试验成功；Trodelvy与Datroway在乳腺癌治疗领域的较量；默克公司为乳腺癌治疗带来新希望。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 24, 2025. In this episode we focus on the most significant results presented at the European Society for Medical Oncology meeting in Berlin: Enhertu in early-stage breast cancer; Padcev/Keytruda in bladder cancer; Phase III wins for Pluvicto; Trodelvy and Datroway in breast cancer tussle; and Merck & Co. raises hopes in breast cancer. . Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs explain the reasons for the US Food and Drug Administration’s planned “Simple Reform” of its inspection group, including the move away from specialized teams (:44). They also consider industry’s current thinking on best practices for navigating the agency’s new position on direct-to-consumer ad regulation (18:45). More On These Topics From The Pink Sheet US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/ Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/industry-rethinking-visual-elements-and-quality-of-life-claims-after-us-fda-drug-ad-crackdown-WMXPANFVC5B55GZZQ6IWJG4FRE/ US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-adpromo-crackdown-letters-came-from-opdp-staff-not-artificial-intelligence-RKTSXQ5ZV5BPJD4DXGAOS5SS5Q/

Biotech funding is tougher than ever, but some companies still win big. Join Claire Riches, VP, Clinical Solutions, Citeline and Alistair McDonald, CEO of Worldwide Clinical Trials as they reveal insider strategies for securing investors, navigating partnerships, and turning innovative science into real-world success. View the video series and find out more information here: https://www.citeline.com/biotech

As the potential of in vivo CAR-T therapy moves closer to clinical reality, biotech innovators are reimagining what’s possible in autoimmune disease. With groundbreaking scientific advances and evolving regulatory perspectives, this next generation of cell therapy could redefine how immune-mediated conditions are treated. In this episode, Pete Robinson, Therapeutic Strategy Director, Novotech, joins Meredith Landry, Managing Editor, Custom Content, Citeline, to discuss how in vivo CAR-T is opening new possibilities for autoimmune therapies—and what it will take to translate early promise into patient impact. They explore: • The breakthrough potential of in vivo CAR-T—and what could make it a true game-changer for autoimmune disorders • Early lessons from the clinic that are shaping the next phase of development • How innovators are rethinking trial design and regulatory strategy for this emerging modality • The partnerships and operational moves that could separate first-movers from fast followers

Hear experts Matthieu Culié and Alessandro Agosti as they discuss how Olon stands out in a competitive landscape through its fully integrated end-to-end ADC manufacturing expertise, global operations, impurity control and strategic facilities.

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月17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。 本次要闻: 大型药企仍看好细胞与基因疗法前景；ESMO会议关注焦点；科伦制药TROP2抗体药物偶联物创全球首例；强生预期与白宫政策保持一致；BioFuture会议揭示行业不确定性。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ADAR4VZIGRFIFCOMXI7UTZS76U/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 17, 2025. In this episode: big pharma still sees value in cell and gene therapy; what to look out for at ESMO; world first for Kelun’s TROP2 ADC; J&J expects alignment with White House policies; industry uncertainties aired at BioFuture meeting. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ADAR4VZIGRFIFCOMXI7UTZS76U/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the reasons US Food and Drug Administration Commissioner Martin Makary could have helped negotiate the Most Favored Nation drug pricing deal with Astra Zeneca (:30) and the deal’s potential impact on the 340B program (16:35). They also consider the Justice Department’s alternative interpretation of off-label promotion regulations and the effect on the scientific exchange of information about drugs (19:16). More On These Topics From The Pink Sheet US FDA Commissioner’s Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-fda-commissioners-involvement-in-astrazeneca-pricing-deal-raises-ethical-legal-questions-IJV4LMTDA5E65KCOFQUQM76GCA/ EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/emd-serono-ivf-candidate-among-first-us-fda-priority-voucher-recipients-as-part-of-mfn-deal-LKHA6VRTKRE6DJERGNCWCGMBF4/ Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/manufacturer-most-favored-nation-deals-how-they-could-be-protected-from-340b-FALSG7GHM5GQBFN3I5SPERJIYU/ Off-Label Promotion: DOJ May Take New Look At Scientific Information Exchange: https://insights.citeline.com/pink-sheet/legalandip/litigation/off-label-promotion-doj-may-take-new-look-at-scientific-information-exchange-R62PQJFQTRBCVGCZE57GWM3Q3Q/

Adalvo: Exploring European B2B Pharma’s Next Steps by Citeline

Join host David Wild as he speaks with Stacie Bell, chief clinical research officer at Lupus Therapeutics, about the dramatic transformation happening in lupus drug development. From a field once avoided by pharma companies to one generating unprecedented excitement, Bell discusses how her organization's 62-center network is revolutionizing clinical trials through patient engagement and scientific innovation. Learn about promising oral therapies, Genentech's cancer drug Gazyva under FDA review for lupus nephritis, cell therapy approaches offering potential long-term remission and how combination treatments may become the new standard. Bell shares insights on overcoming clinical trial barriers, advancing biomarker research and ensuring representative participation from lupus communities. A must-listen for anyone interested in autoimmune disease research, clinical development innovation, and patient-centered drug development.

Listen now: Adalvo – advancing pharma with private equity and an asset-light model

In Vivo spoke with Emma Johnson, CEO of Essential Pharma, to discuss the company's strategic priorities and plans for growth as it expands its portfolio in rare diseases.