Pharmaceutical Biotechnology

Precision medicine is expected to lead to a paradigm shift in treatment approach. Scientific and technological advances lead to another type of medicinal product: precision medicine is targeted (‘personalized’) medicine, as opposed to small molecule one-size-fits all blockbusters. ATMPs entail gene therapy, somatic cell therapy and tissue engineered products. This presentation explores in view of the applicable legislation about how ATMPs are regulated. The role of the committee for advanced therapies (CAT) will be explored in the marketing authorization process and what are the opportunities and pitfalls? In this presentation, the hurdles and issues to consider beforehand will be discussed i.e., How will ATMPs and precision medicine change the pharmaceutical market; what could be the legal implications; How about GMP; How about product liability; and What does the hospital exemption entail in the light of ATMPs. If the ATMP aims to treat patients with an unmet medical need, timely access opportunities may apply. Furthermore, precision medicine may need genetic data before treatment can be personalized - this concerns personal data. What issues should be considered in view of the general data protection regulation (GDPR)? In short, this presentation provides a snapshot of what should be considered in the light of ATMPs used in precision medicine. This presentation may yield a lively discussion afterwards.