BioSpace

The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.

In this episode of Denatured, sponsored by SK Pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we discuss how CDMOs are revamping supply‑chain strategy for a new generation of intricate modalities. Topics addressed include moving from smarter raw‑material sourcing and precision cold‑chain logistics to navigating geopolitical and regulatory uncertainty and deploying AI to building sustainable, scalable capabilities from clinical through commercial.

This episode is presented in partnership with SK Pharmteco.

Host
Jennifer Smith-Parker, Director of Insights, BioSpace

Guest
Arvind Singh, VP & Global Head of Supply Chain

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way.

In this episode of Denatured, you’ll listen to Christina Takke, managing partner at V-Bio Ventures and Mariette van der Velden-Roesink, founding partner at Curie Capital. We examine why Benelux delivers world‑class science yet remains an investment patchwork, and what it will take to knit the region into a truly unified biotech investment corridor.

Host

⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace

Guests

Christina Takke, Managing Partner, V-Bio Ventures

Mariette van der Velden-Roesink, Founding Partner, Curie Capital

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme.