In this white paper we provide a fleeting look at some of the CMC ‘building blocks’ that can be assembled for moving a microbiome product from R&D into first into human studies.

...

Early access programmes (sometimes also called compassionate use or temporary use authorisation) were set up because of the rapid advances in science and the legitimate expectations of physicians or patients for early access to unauthorised medicinal products prior...

The widespread adoption of mobile and wireless technologies, including smartphones and tablets, has given rise to the growing field of mobile health (m-Health) which is poised to revolutionize sectors of healthcare. The rapid pace of growth in m-...