What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A translational perspective

  • Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements;...

Value Proposition

The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where new value can be created and how the company can best capture that value.

We will review challenges in translation required to develop the ATMPs pharmaceutical product (cell and gene therapy products) from nonclinical to the clinical stage, as well as the challenges related to the determination of proof-of-concept, how to choose clinical...