Opinion

The choices that change a career often look like extra work at the time. Executive coach Angela Justice examines why the projects, questions, relationships and conversations people almost dismiss can become the ones they later recognize as turning points.

FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.

Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.

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.

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.

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.