Citeline Podcasts

在本期中国生物技术播客中，Dexter Yan回顾了他在4月的美国癌症研究协会年会（AACR）举办前和再鼎医药总裁及全球肿瘤研发负责人Rafael Amado的采访。Amado在采访中详细阐述再鼎在AACR展示的两个临床前项目，分别是PD-1/IL-12 双抗和靶向LRRC15的抗体偶联药物（ADC）。Dexter还采访到Arbele的创始人和CEO John Luk，请他介绍Arbele在钙粘蛋白17（CDH17）靶点研发上的最新进展和心得体会。最后Dexter回顾了4月维升药业和映恩生物在香港交易所首次上市的情况。

此外，Xu Hu分享了她最近撰写的有关中国企业研发肠促胰岛素类体重管理药物的综述。除此之外，Xu点评了中国药监局最近公布的有关药品试验数据保护的征求意见稿。

Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 May 2025. In this episode: industry makes its case to Trump; Sarepta slammed by double blow; Chinese firms build obesity pipeline; Swiss biopharma staying strong; and Merck & Co looks to immunology and ophthalmology.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HVFSXCWENFCU7FLRVPHK3P4WFU/

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 early excitement and concern about Vinay Prasad’s potential impact on product development as director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (:20). They also consider the consequences of the FDA missing product-specific guidance publication deadlines (14:59) and its potential impact on the upcoming user fee reauthorization negotiations (20:00).

More On These Topics From The Pink Sheet

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tougher-approval-standards-may-follow-vinay-prasads-appointment-to-lead-us-fdas-cber-WEULXI5EJRE43BWU752PGDGE44/

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-guidance-roadblock-writing-continues-but-publication-has-slowed-or-stopped-TZF4DMPEMVHT3JJPRUX7LJJIHU/

Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 May 2025. In this episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LV7ZA2GKQVHEZDZYYNZFKYQZ74/

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

The potential for real world evidence (RWE) is huge, according to enthusiasts, but to the uninitiated it can seem like a complicated and forbidding subject. In this Over the Counter double episode, IQVIA Consumer Health’s vice president of global research and development and real-world evidence services, Volker Spitzer, makes understanding real world evidence easy. We start with the basics, with what it is and what companies need to know about it, and what the key difference is with randomised control trials. Many companies are already using real world evidence, Volker notes, and he extracts some key lessons for companies interested in trying it out based on his extensive experience working with industry on such projects.

Timestamps

2:00 – Introductions

4:00 – What is real world evidence?

5:00 – Can RWE and clinical trials complement each other?

10:00 – Why RWE is particularly attractive today

14:00 – Don’t reinvent the wheel

18:00 – Why is this important for consumer health companies?

25:00 – Why RWE is often a good value option, especially for SMEs

33:00 – Applications of RWE in consumer health

Guest Bio

Volker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer.

Since October 2017, Volker has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.

Anil Matai, director general, Organization of Pharmaceutical Producers of India, discusses the evolving intellectual property landscape in India post the 2024 amendments and long-standing sticking points including Section 3(d) of India’s patent regulations and regulatory data protection. Big pharma’s experience when it comes to the Bolar provision and the impact of geopolitical shifts on innovation were some of the other topics he touched on.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider the impact of FDA Commissioner Martin Makary directing one of his assistants to take over the review of Novavax’s COVID-19 vaccine (:40), as well as how states or courts could respond (19:19). They also discuss several announcements of missed user fee deadlines and whether FDA layoffs could have contributed (28:33).

More On These Topics From The Pink Sheet

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review: https://insights.citeline.com/pink-sheet/vaccines/political-official-pushing-novavax-to-conduct-covid-19-vaccine-postmarket-rct-BZTIWKSTK5G77BUQGGD3G2IOFY/

How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch: https://insights.citeline.com/pink-sheet/vaccines/how-states-and-courts-could-insulate-america-from-an-anti-vaccine-executive-branch-DARDVWDMLVFCHM6DE75AJQHSBQ/

US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioners-office-plans-involvement-in-many-approvals-in-potential-major-change-JFPWOQ2VF5D2JAFKXKGK54REZU/

US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts: https://insights.citeline.com/pink-sheet/product-reviews/us-fda-miss-on-stealths-elamipretide-boosts-signal-of-broader-delays-due-to-staff-cuts-5ITZREGXX5H75ID6IL4Q2MHKBE/

Scrip senior writer Joseph Haas discusses the potential impact of the recent FDA staff cuts with attorneys Andrew Goodman of Paul Hastings LLP and Alan Minsk of Arnall Golden Gregory, as well as Naya Therapeutics CEO Daniel Teper

In this episode, we recap the key takeaways from BIO-Europe 2025, held in Milan, Italy, in March 2025, with Trajko Spasenovski, Vice President of Strategic Account Management at Evaluate, and Carolyn Hall, Senior Director of Content and Thought Leadership Marketing at Evaluate.

After the conference, Citeline’s Managing Editor, Meredith Landry, spoke with them about their experience there and what they learned about trends in early-stage deal-making, emerging areas like cardiovascular and rare disease therapies, and the expanding role of AI in R&D. Trajko and Carolyn also shared how conferences like BIO-Europe help Norstella and its clients forge meaningful partnerships, uncover market needs, and accelerate the path to life-saving therapies through data-driven insights and strategic collaboration.

Emma Wille and Summer Colling discuss the 2025 American Academy of Neurology (AAN) conference with CNS and I&I analysts Wen-Yu Huang, Joseph Jacob and Istafa Armughan.