Interviews

In a Pink Sheet interview Chief Scientist Bumpus discusses need to move diversity conversation up further in the pipeline. Better ‘organs on a chip’ should help.

As drug companies get “really organized” about incorporating patient-centric elements in their clinical trials, a senior executive at a global courier company says the time is ripe for the EU to produce harmonized guidance on easing a clinical trial participant’s access to the study drug.

As Japan widens its window for the use of real-world data to support drug development though revision of the Next Generation Medical Infrastructure Act, the pharma industry is hoping for more regular inclusion in regulatory filings. A dedicated group within the PMDA shares its views on how the area is developing and practical measures being taken to drive RWD adoption.

In an interview with the Pink Sheet, Stealth’s CEO says she is not confident the company could design a clinical trial in the rare disease that would meet the FDA’s expectations.

From rapidly identifying antigenic targets to automating clinical trials, AI has an important role to play in cutting vaccine development time down to 100 days, says Melanie Saville, executive director of R&D at CEPI.

Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.

Significant financial reward awaits drugmakers that invest more in companion diagnostics during the development and marketing of precision cancer drugs, says Peter Keeling, CEO of Diaceutics – but Novartis warns that relying on pharma firms to fund these tests is unsustainable.

Rhythm is working with country-level authorities and centers of excellence in Europe to gain reimbursement and access for its obesity treatment Imcivree.

Robet Steinbrook, the third director of the 50-year-old health group, plans to stay true to the organization’s long-held mission of holding FDA drug approvals to high standards, pushing for stronger evidence of benefit, more attention to safety, and advisory committee votes.

The former US FDA commissioner turned venture CEO believes the biopharmaceutical industry can cure many of society’s ills, but firms need to talk to the agency more.

This second segment of a two-part article on a regional comparison of EU and US approaches to decentralized clinical trials highlights the differences between the two regions relating to the more practical aspects of setting up and running such studies.

In this regional comparison, regulatory experts at a US-based decentralized clinical trials (DCT) firm discuss their views on how the FDA’s draft DCT guideline compares with the pan-EU recommendation paper on this topic. This first segment of a two-part article dwells on the thinking behind why US and EU regulators tend to go down different paths. 

CEO Shawn Singh discusses path forward for fasedienol (PH94B) using the classic LSAS primary endpoint in next clinical trial. Pherine nasal spray candidate failed to meet the primary endpoint (the patient-reported SUDS) in its first pivotal Phase III study, whose design was constrained by the Covid pandemic.

In a Pink Sheet interview, BIO Chief Advocacy Officer Nick Shipley raised concerns that Medicare’s Alzheimer’s coverage decision is indicative of a broader agency view on accelerated approval that could limit drug reimbursement in both the public and private sector. 

COVID vaccine makers already licensed in the US will have a leg up on in the combination respiratory vaccine space since aspiring new entrants like GSK will have to do efficacy work to get FDA approval. CEO Walmsley offers insight into the company’s vaccine strategy.

From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.