Citeline Podcasts

4.2 (30)
Business
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.

6h ago

Drug Fix: How Will US FDA Navigate Midterm Blue Wave’s Aftermath?

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential changes that the midterm election rout by Democrats could create for the US Food and Drug Administration in the short-term as agency officials await confirmation of a new commissioner and a new funding bill (1:02), as well as longer-term when the user fee package (14:12) and other issues like vaccines and drug pricing could emerge (25:36). More On These Topics From The Pink Sheet Democratic Wins In Congress Will Fuel MFN, FDA Oversight, May Advance Bipartisan Legislation: https://insights.citeline.com/pink-sheet/legislation/elections/democratic-wins-in-congress-will-fuel-mfn-fda-oversight-may-advance-bipartisan-legislation-KGXTFNXCYBE3XGLKI6XX47WNHI/ US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats’ Capitol Hill Takeover: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-acting-chief-of-staff-sees-stable-user-fee-path-despite-democrats-capitol-hill-takeover-FOLLZZTLH5CNDK2NEI5V4Z3VKI/ Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/another-midterm-wave-coming-us-fda-chief-counsel-announces-departure-INESSWGPL5A6NE7VGWCD6JQ3AE/
15h ago

Proof of Concept: The Money Is Back In RNA, But What Stands Between Headlines And Routine Medicine?

"The money is back in RNA. In recent weeks, Merck KGaA agreed to pay about $1.1 billion for Silence Therapeutics, Novartis signed a deal worth up to $7.8 billion with Abogen Biosciences, and Roche paid more than $1 billion for an RNAi obesity drug from Rona Therapeutics. Meanwhile, Merck and Moderna’s personalized melanoma vaccine cut the risk of recurrence or death by 42% in a Phase 3 trial. So, is RNA now a durable drug modality, and what still separates today’s headlines from routine medicine? In this episode of Proof of Concept, In Vivo's David Wild speaks with Dr. John Cooke, cardiologist, founder and president of the Society for RNA Therapeutics, and founding director of the Center for RNA Therapeutics at Houston Methodist. Cooke discusses his team’s first-in-human personalized mRNA vaccine for osteosarcoma relapse, the vision of 'RNA in a box' deployable manufacturing units at hospitals, the misconceptions that still dog RNA therapeutics, and why delivery remains the field’s biggest hurdle. He also compares mRNA, circular RNA, self-amplifying RNA, and RNAi, and looks at in vivo CAR-T and extrahepatic targets." Proof of Concept is the monthly innovation-focused podcast from the teams at In Vivo, Scrip, and MedTech Insight.
23h ago

【3分で解説 #世界のファーマ】第32回　民主党逆転の米国中間選挙　製薬業界への影響は？(Japanese-language podcast)

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 Democratic Wins In Congress Will Fuel MFN, FDA Oversight, May Advance Bipartisan Legislation https://insights.citeline.com/pink-sheet/legislation/elections/democratic-wins-in-congress-will-fuel-mfn-fda-oversight-may-advance-bipartisan-legislation-KGXTFNXCYBE3XGLKI6XX47WNHI/ Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/another-midterm-wave-coming-us-fda-chief-counsel-announces-departure-INESSWGPL5A6NE7VGWCD6JQ3AE/ US FDA Acting Chief Of Staff Sees Stable User Fee Path Despite Democrats’ Capitol Hill Takeover https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-acting-chief-of-staff-sees-stable-user-fee-path-despite-democrats-capitol-hill-takeover-FOLLZZTLH5CNDK2NEI5V4Z3VKI/ This and all our other podcasts are available on the Scrip channel on Apple Podcasts, and Spotify Podcasts and on TuneIn. Scrip YouTube Podcasts: https://www.youtube.com/@scrip-commercial/podcasts Pink Sheet YouTube Podcasts: https://www.youtube.com/@pinkSheet-regulatory-n/podcasts Any comments? podcasts@norstella.com
4d ago

Rethinking Risk: Why Early Evidence Strategy Matters for Emerging Biotechs

For emerging biotech companies, development success is often measured by clinical milestones, safety, and efficacy. However, demonstrating an asset’s value extends beyond regulatory approval. Understanding patient needs and treatment experiences, as well as evolving stakeholder expectations, early in development plays an important role in shaping a more informed evidence strategy. In this podcast, Ashwin Rai, Director of Data Science and Advanced Analytics, and Gale Harding, Senior Research Leader, from the PPD clinical research business of Thermo Fisher Scientific, discuss how integrating real-world data and patient-centered insights earlier in development can help developers address evidence gaps, inform critical decisions, and build a stronger foundation for demonstrating treatment value. What the Podcast Explores • Why evidence planning should begin early in asset development, rather than closer to commercialization • How real-world data can help identify unmet needs, understand patient journeys, and inform development decisions, and why more data doesn’t necessarily mean better data • The importance of capturing patient experiences and outcomes beyond traditional clinical endpoints • How patient-centered research can help address evidence gaps and strengthen an asset’s value story • Why evidence strategies must evolve alongside changing stakeholder expectations and development priorities
Oct 30

Drug Fix: Could Other Products Use Peptide Order For Access, Industry Opposes CRL Release

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the impact of the Health and Human Services Department’s temporary order allowing compounding of unapproved peptides on the drug industry (1:58), including whether stakeholder could use the precedent to gain access to other products (4:05). They also analyze HHS’ dismissal of US Food and Drug Administration safety concerns (11:28). In addition, the group discusses the Pharmaceutical Research and Manufacturers of America’s opposition to releasing complete response letters and the future of legislative efforts to codify the practice (19:52). More On These Topics From The Pink Sheet HHS Peptide Policy Brushes Off US FDA Safety Concerns As Hypothetical: https://insights.citeline.com/pink-sheet/compliance/manufacturing/hhs-allows-compounding-of-six-unapproved-peptides-UEKWZWETHFG4XJXTVA4VUNE3PU/ Peptides Compounding Would ‘Undermine’ US FDA Drug Approval Process, Ex-Agency Official Argues: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/peptides-compounding-would-undermine-us-fda-drug-approval-process-ex-agency-official-argues-7RZQLE3HJ5B4FMB3AUREB5LUZU/ US FDA’s Complete Response Letter Postings A Gift To Chinese Competitors, PhRMA Says: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fdas-complete-response-letter-postings-a-gift-to-chinese-competitors-phrma-says-IJ2VETAAGND5NH6CXWADH3R6TU/
Oct 27

Strategic Intent: Understanding Crossover Strategies in Biotech With Sofinnova Partners’ David Evans

In this episode of Strategic Intent, Partner at Sofinnova Partners, David Evans discusses his transition from Roche Venture Fund, different investments strategies, general market analysis across Europe and US, as well as growing therapeutics area trends within biotech.
Oct 22

Scrip Awards Podcast – Parabilis CEO Mathai Mammen Interview

Ahead of the awards presentation on Dec 2, the Scrip Awards podcast speaks to Mathai Mammen, CEO of Parabilis, one of the shortlisted companies for Biotech of The Year.
Oct 20

Strategic Intent: Can Blood Tests Break the Alzheimer’s Diagnosis Bottleneck?

Disease-modifying Alzheimer’s treatments have arrived, but diagnosing the right patients at scale is still a major bottleneck. In this episode of Strategic Intent, Marion Webb (MedTech Insight) speaks with Dr. Soeren Mattke, research professor of economics at USC, director of the Brain Health Observatory, and member of the scientific advisory board of ALZpath, about how FDA-cleared blood tests are changing the picture. They cover why amyloid PET scans and spinal taps struggle to scale, how p-tau217 blood tests work and who makes them, and how primary care doctors can use them to prioritize patients and better prepare referrals to overstretched neurologists. They also discuss test limitations, including false positives and the potential of misdiagnosis when patients have other diseases like kidney disease and obesity, why screening people without symptoms isn’t recommended yet, and the economics: roughly $5,000 for a PET scan versus about $125 for a Medicare-reimbursed blood test. Follow the In Vivo podcast on Apple Podcasts and Spotify to stay ahead of what’s shaping life sciences next.

See All (643)

4.2

out of 5

30 Ratings

Solid podcast

12/04/2024

987362847

The guy needs to stop saying "um" and "uh" so much between his thoughts.
Ahh and Humm

05/24/2024

oololaya

Can you please send your reporters to Toastmasters so they can focus on removing all the filler words Ahs and Hums form there speech! I can hardly listen to the episodes as one of your reporting says more filler words than real content.
Too many “uh” during the conversation

02/08/2024

Jiayi.C

Too many “uh” and broken sentences. I find it so painful to follow
Good information, bad delivery

02/26/2023

Odie8387

Often times a podcast with very good information, but quite poorly delivered. As someone who regularly conducts market research interviews via telephone and web, I’m very familiar with reading through far too many colloquialisms, filler words, and trite expressions. Words and phrases such as “right “and you know” “um” “and” “uh” make it painful to listen to in any regular basis.

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.