Cohesive Evidence Generation for Both Regulators and HTA Bodies

There is an increasing desire from regulators and health technology assessment (HTA) bodies to provide insight to pharmaceutical and biotechnology companies earlier in the drug development process to allow better alignment of evidence needs for both regulatory approval and market access. While early engagement from regulatory agencies is standard practice, scientific advice from HTA bodies is a relatively recent addition and quickly growing in interest. Providing this consultation in parallel can provide invaluable insight to manufacturers in optimizing evidence generation.