Pharmaceutical Executive

Fred Blais, RBQM Lead at CluePoints, has spent the last 13 years of his 19-year clinical trial career inside Central Statistical Monitoring and Risk-Based Quality Management. His experience has led him to a conclusion – RBQM implementation failure is caused by a lack of understanding of human behavior – not faults in the software. He discusses how design decisions based on behavioral science mirror ICH E6(R3) and what is needed to produce extraordinary outcomes.

Novartis instituted program-wide clinical holds across eight Rap‑cel autoimmune trials after three IEC‑HS events with fatal outcomes, prompting regulator engagement and comprehensive cross-program safety review.

Novartis and Bristol Myers Squibb pause autoimmune CAR-T trials over safety concerns, a dealmaking roundup covers Alteogen's licensing deal with Novartis, NewBiologix's gene therapy partnership with Synastra, and RedHill's acquisition of Rebyota and Clenpiq from Ferring, and Lexi Cogswell and Tom Rotolo make the case for real-world insights in obesity medical strategy.

Christian Tinel on why IBD's unmet need comes down to one thing: an oral therapy with biologic-like efficacy and better safety.

Melanie Whittington, managing director and head of the Leerink Center for Pharmacoeconomics, joins Ron Lanton to argue that biopharmaceutical policy only makes sense when traced back to its purpose.

Carelon Research's Mark Cziraky on why trusted research environments don't change how analysis is done — just how fast and richly it can begin.

Nate Hill, co-founder & CEO, Strive, notes the key milestone to watch for during the remaining step in FDA's formal Category one announcement for peptides.

Tom brings 18 years of medical strategy and communication experience developing and executing solutions for a wide array of pharmaceutical clients with specific aim at positive behavior change from target audiences. He has applied his deep knowledge of therapeutic areas and competitive landscapes to help align diverse client teams across product lifecycles and therapy classes.

Ultragenyx shares plunge more than 40% after apazunersen fails to meet both endpoints in a Phase III trial for Angelman syndrome.

Ultragenyx shares plunge after apazunersen fails its Phase III trial in Angelman syndrome, Mark Cziraky of Carelon Research talks through the mechanics of analyzing linked real-world data sets, and Melanie Whittington joins The Ron Lanton Report to argue biopharma policy needs to stay tethered to patients, not abstractions.