Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman, and Editor-in-Chief Nielsen Hobbs discuss Heidi Overton’s financial and educational background as she begins navigating the path to US Food and Drug Administration commissioner confirmation (1:01), as well as an FDA incentive program that she would not be able to use to recruit additional staff should she get the job (23:05). They also consider the reasons for recent changes to the COVID-19 vaccine postmarketing trials (26:59).

 More On These Topics From The Pink Sheet

US FDA Nominee Overton Left Hopkins Residency, Pushed ‘Conservative’ Science, Has Few Pharma Ties: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-nominee-overton-left-hopkins-residency-pushed-conservative-science-has-few-pharma-ties-KTW56Z3D7RGCBMR5FDLEPK7Y6U/

US FDA Spikes COVID-19 Vaccine Postmarketing Trials Due To ‘Feasibility Challenges’: https://insights.citeline.com/pink-sheet/vaccines/us-fda-spikes-covid-19-vaccine-postmarketing-trials-due-to-feasibility-challenges-PS54RXHTEBAZDEEMDQY6264BLA/

Cancer Research UK is best known for funding science. But its commercial arm, Cancer Research Horizons, does something less obvious: it builds companies. This episode features Phil Masterson and Neil Jones, who run its ventures and drug discovery arms, unpacking why charities are increasingly bridging the gap between a promising result in the lab and a medicine in the clinic.

Drug discovery, oncology, cancer research, R&D, venture capital, early-stage investment

In the second episode of Off-Patent, On Record, Generics Bulletin’s senior reporter Urtė Fultinavičiūtė hears how patients with cystic fibrosis travelled to Bangladesh to collect generic version of Vertex’s highly inaccessible Trikafta. Urtė is joined by Wilna Lottering and her son Josh from South Africa, as well as Gayle Pledger, a cystic fibrosis campaigner.

A medical device can work beautifully and still go nowhere. In this episode of Strategic Intent, Krishna Eluri sits down with Mark Saxton, U.S. CEO of Baird Medical, who has spent more than 25 years bringing first-of-their-kind procedural technologies to market. Their conversation digs into medtech's hardest problem — not inventing a technology, but getting physicians to switch and payers to cover it.

Using Baird's effort to introduce microwave ablation for thyroid nodules, a minimally invasive alternative to surgery, into the U.S., Mark unpacks how to build a payer strategy early, earn the backing of medical societies, train physicians for genuine adoption, and sidestep the market traps that have sunk countless promising devices.

His parting advice for founders who are winning abroad but stuck at the U.S. starting line: do your homework on the market before you spend on the science.

Products like ibuprofen and loratadine are now grabbed off a pharmacy shelf without a second thought, but both started out as prescription-only medicines.

A landmark three-country survey by the ZS consulting and technology firm , which shows the rapid trend towards patients' uptake of AI tools that empower them on their healthcare journeys. ZS’ Jon Roffman and Bhargav Mantha set the scene.

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential differences between Most Favored Nation drug pricing agreements for small and mid-size companies and the largest pharmas (1:03), as well as the impact of potential vaccine policy changes on the US public health apparatus (15:10). 

More On These Topics From The Pink Sheet

MFN Deal Impact Unclear As White House Ready To Announce Agreements With Mid-Size Pharmas: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/mfn-deal-impact-unclear-as-white-house-ready-to-announce-agreements-with-mid-size-pharmas-ECRFYU4TOVBSPG63U26CWI5FIM/

HHS Builds A Legal Firewall Around Its Next Vaccine Moves With RFI On Federal Categories: https://insights.citeline.com/pink-sheet/vaccines/hhs-builds-a-legal-firewall-around-its-next-vaccine-moves-with-rfi-on-federal-categories-5HILL2G52BE3PI5BJTJ4UZ76RI/

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.

As US Threatens A Tariff Bomb On Generic Drugs, Will Exemptions Be Negotiated? https://insights.citeline.com/pink-sheet/policy-regulation/as-us-threatens-a-tariff-bomb-on-generic-drugs-will-exemptions-be-negotiated-6NUJIGIPNFCT5HRSSIEIXJSJZY/ 

Trump Tariff Action On Generics Highlights Temporary Nature Of Exemptions https://insights.citeline.com/scrip/business/strategy/trump-tariff-action-on-generics-highlights-temporary-nature-of-exemptions-GJOW5MWMOJBKLEWSDMM222DTYI/ 

Trump’s Generic Tariff Clock Demands Compression Of US FDA Review Timelines https://insights.citeline.com/pink-sheet/biosimilars-and-generics/trumps-generic-tariff-clock-demands-compression-of-us-fda-review-timelines-5C4DXMVVCRGRRGXG2QRUH62GTQ/ 

BMS Likely Main APAC Beneficiary Of Any AstraZeneca Mergerhttps://insights.citeline.com/scrip/business/deals/bms-likely-main-apac-beneficiary-of-any-astrazeneca-merger-NVNVSZTPHFBAXHZR6H6IPI35JU/  

※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？https://www.citeline.com/ja-jp/products-services/commercialization/scrip

A videocast for the In Vivo podcast section, with Goodwin's Sophie McGrath - talking about healthtech and pharma trends.

Innovation, investment, legal, Goodwin, Sophie McGrath, EU, Europe