Christian Schneider – VJRegenMed

Impact of COVID-19 on the advanced therapies sector

Simon Ng — Tue, 23 Nov 2021 15:26:01 +0000

Christian Schneider, MD, Biopharma Excellence, Munich, Germany, discusses the effects of the COVID-19 pandemic on the advanced therapies sector. Development of cell and gene therapies were accelerated due to the pandemic, as there was an increased focus on solving unmet needs. Regulatory pathways were additionally optimized during COVID-19, enabling expedited authorization of various advanced therapies. This interview took place at Meeting on the Mesa 2021.

Remaining issues in developing advanced therapies

Simon Ng — Mon, 15 Nov 2021 18:13:01 +0000

Christian Schneider, MD, Biopharma Excellence, Munich, Germany, describes key challenges that need to be overcome in the development and commercialization of advanced therapies. Developers may face issues relying on previous research and safety data on vectors in gene therapy, due to the rapid evolution of research within the field. Dr Schneider additionally highlights the need for using animal models and potency assays predicative for humans, as well as cooperation within the industry to facilitate authorization and reimbursement. This interview took place at Meeting on the Mesa 2021.

Addressing the regulatory barriers advanced therapies face

Simon Ng — Mon, 15 Nov 2021 18:13:00 +0000

Christian Schneider, MD, Biopharma Excellence, Munich, Germany, addresses the regulatory challenges advanced therapy manufacturers face. Existing regulatory guidelines may not be sufficiently detailed for developers from a scientific perspective and Dr Schneider emphasizes the need for a personalized approach by working with regulators early on to adapt current guidelines for the specific needs of new products. This interview took place at Meeting on the Mesa 2021.