Regulatory approval is, as ever, a crucial factor to bear in mind during the later phases of clinical trials. Regardless of the cell line approach chosen, keeping a consistent process and product output is key for establishing a successful project without it being hamstrung at the final hurdle.

Some additional measures announced include the launch of the Cell and Gene Therapy Access Model, as well as the interpolation of RWE into trials and a potential move away from animal models in validating treatment efficacy.

Immuno-oncology company Sensei Bio gave a presentation which outlined convincing preclinical data for their novel antibody therapeutic.

The announcement comes with the news that the cell and gene therapy manufacturing market is now worth US$ 19.3 billion, with a compound annual growth rate (CAGR) of 29% between 2022 and 2023.

Opinion leaders from Merck and AbbVie discuss how antibody-based molecular engineering is developing with new AI/ML technologies.

What are the regulatory considerations for CAR T cell therapy, and what's next for the approach?

Biocon suffer another FDA rejection due to data and manufacturing concerns, this time for their bevacizumab biosimilar.

Following FDA approval for the use of Jemperli in the context of patients with dMMR recurrent or advanced scenarios, the therapeutic's applications are being investigated in registrational enabling studies as monotherapy and as part of combination regimens.

On-Demand Webinar featuring Dr Darragh Duffy, LabEx Coordinator at Institut Pasteur

The Vaccines Working Party was established last year by the EMA, but what are its main tasks, and how are they looking to achieve them?

An interview with Russell LaMontagne, Co-Founder and Chief Executive Officer, Boston Immune Technologies and Therapeutics

The Oncologic Drugs Advisory Committee are preparing to weigh in on whether the FDA should grant another indication for Roche’s POLIVY.