Mike Auerbach
While there are many drugs to make the end of life easier and less painful, the fundamental problem of deciding when to end life is a topic and a decision few want to address.
Lesley Barton
Continuity of care is generally defined in terms of a patient’s ongoing contact with a clinical team and how smoothly their care progresses between providers. Often overlooked is the pharma supply chain and its role in ensuring this continuity.
Huei-Mei Chen
The regulatory landscape for CGTs is moving towards more explicit, risk-based assessment of intended editing outcomes, off-target activity, and genomic integrity. This evolution reflects both the promise of new editing technologies and the need to understand their potential consequences in clinically relevant biological settings.
Kevin Denny, MBA, DABT
For decades, in vivo models have been the standard in preclinical testing before a drug moves to first-in-human (FIH) trials. But a recent evolution in regulatory expectations has accelerated a steady shift away from in vivo testing, in favor of New Approach Methodologies (NAMs).
Irina Pototskaia
Environmental monitoring activities should not be assumed to be interchangeable because contamination control questions are not interchangeable. Different contamination control questions require different information. Environmental monitoring exists to generate that information.