Opinion

Innovation drives CROs to win new business, but unchecked customization creates complexity that undermines reproducibility, weakens renewals and leads to turnover—making standardization a strategic necessity, not a constraint.

The 2022 search approach is no longer working. Companies need to think critically about how they are acquiring top regulatory, clinical and commercial executives or risk their programs in this new regulatory and market reality.

When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.

Controlling CEOs, manipulative middle managers and high-performing jerks can damage employees’ trust in employers and motivate them to hit the job market. Kaye/Bassman’s Michael Pietrack discusses the problematic behaviors executives must watch for in the workplace.

While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.

While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.

As the industry faces policy changes and significant cuts to federal funding, local ecosystems can bolster companies through innovative resources to sustain growth and keep the U.S. at the center of biomedical innovation.

The FDA must provide consistent and predictable regulatory frameworks if the U.S. is to maintain its leadership in gene therapy, one of the most consequential therapeutic fields of our generation.

Rather than getting hung up on what to call DEI in the workplace, leaders should take three specific actions to help their employees embrace and engage with it. Companies and the patients they serve will benefit.

PD-(L)1×VEGF bispecifics have emerged as a closely watched new class in immuno-oncology, with multiple candidates advancing through trials in lung cancer. But the potential of these drugs may be highest in cancers where angiogenesis and immune escape are tightly intertwined.