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

Winning Biotech Investors Through Strategic Partnerships and Trial Innovation

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

Scrip's Five Must-Know Things - Oct. 20, 2025

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

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

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/ 

Drug Fix: Another FDA Inspection Reorg, Industry Navigating New DTC Landscape

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

Scrip's Five Must-Know Things - Oct. 27, 2025

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



Medium: https://medium.com/@jsmith0475/how-ai-learned-to-write-perfect-pharmaceutical-protocols-4487ba139f72
"How AI Learned to Write Perfect Pharmaceutical Protocols," by Dr. Jerry A. Smith, presents a research paper detailing a novel Artificial Intelligence (AI) architecture designed to generate analytical protocols for pharmaceutical testing that comply with Good Manufacturing Practice (GMP) regulations. This system addresses the slow, expensive process of human-led method development by using a multi-agent generation approach, creating five protocol variants at varying levels of creativity, which are then evaluated and selected through a triadic judge system and a four-round tournament elimination. Critical to its success is a cognitive anchoring framework that constrains the Large Language Model (LLM) to regulatory-compliant outputs, preventing the common problem of AI "hallucinations." The authors demonstrate that the AI-generated protocols achieved a +2.1% quality improvement over deterministic methods and maintained 93.54% similarity to GMP compliance while drastically cutting time and cost.

How AI Learned to Write Perfect Pharmaceutical Protocols

Micah returns to the conference world after twenty years, diving into the CDISC/TMF Interchange in Nashville. From acronyms to alignment debates, Suus and Micah unpack how the industry’s drive for standards collides with the messy, very human side of collaboration. Along the way: networking hacks, risk logs, Dutch “poldering,” and yes—chicken and waffles.

Conferencing Standards: From CDISC to Chicken & Waffles -  Inside the push to standardize TMFs—and rediscovering the human side of biotech.

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

국내 바이오텍 펀딩 활성화를 위해 새로운 촉매제 필요 (Korean-language podcast)

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

Scrip M&A Podcast: What's Next For Dealmaking In The Obesity Space?

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.

In-Depth Explorations of Neuroscience-Inspired Architectures Revolutionizing AI.

New tracks tagged #PHARMA