Opinion

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.

The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.

Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.

The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.

Scientists who focus only on generating data risk missing their role in shaping strategy and driving innovation.

Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics and Intellia Therapeutics.

We must treat drug resistance as a central scientific priority rather than an unavoidable complication.

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.

Finding the right people for critical open roles can be difficult even for biopharma leaders. In this column, Kaye/Bassman’s Michael Pietrack discusses four pitfalls executives face during the hiring process, starting with confusing scientific brilliance with leadership ability.

While prominent physicians can provide companies with valuable guidance during development, their perspective is limited when it comes to projecting how well or how readily a new product will be adopted. Here’s how to perform rigorous commercial diligence.