An upcoming themed section in Value in Health will feature papers dedicated to a number of issues pertaining to therapies aimed at returning individuals to normal states of health, which may include regenerative, biologics, gene therapies, as well as novel medical devices or procedures. Authors of these papers will present on topics that include regulatory and market access challenges, methodological issues in assessing the value of such interventions, as well as potential financing mechanisms to manage risks. Presenters will represent various stakeholder perspectives, reporting on case studies, proposing novel approaches, and expanding the depth and scope of dialogue among developers, regulators and payers in an effort to bring these new therapies to improve patients’ health and well being.