Stepping Through

How regulatory innovation lays the foundation for new business models

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.

FDA and other regulatory agencies that once shied away from addressing the economic implications of their actions are explicitly attempting to drive down the cost of medical product development, experimenting with new policies that aim to lower development costs and usher in new market opportunities.

In many areas, such as novel clinical trial designs, the integration of digital technologies with drugs and diagnostics, and the development of new regulatory models for regenerative medicines, FDA, EMA and Japan’s PMDA have gone beyond merely making innovation possible. They are driving change.

Nations such as China that are building regulatory systems from the ground up, and that

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