BioCentury
ARTICLE | Politics, Policy & Law

Stepping Through

How regulatory innovation lays the foundation for new business models

September 1, 2018 2:58 AM UTC

Once considered obstacles to biomedical product development, regulators around the world have become enablers of the kinds of scientific and economic innovations that will underpin new business models. They are building gateways that could help make medical product development more efficient and enable new types of products. Industry’s challenge is to determine which of these gateways are feasible, and to step through them into uncharted territory.

Lower prices and reduced revenues will be characteristics of whatever models supplant or supplement the specialty pharma model. This means that to maintain the margins needed to attract investment in biomedical innovation, companies will need to come up with ways to develop new drugs at lower cost, and faster. ...