Biopharmaceuticals (includes Biologics)
Advanced therapies, including gene and cell therapies plus tissue engineered products, have entered the stage as real game changers to treat life-threatening diseases. Often these therapies offer a curative effect with one treatment application. The exponential growth of research by innovative companies has catapulted the field to the forefront and it is expected to be the largest growth sector next year.
Although advanced therapies, including gene editing, provide major opportunities to offer and/or improve treatment of serious disease, the innovative nature increases the residual risk which needs to be addressed by sufficient regulatory oversight.
The session brings together industry experts with firsthand experience conducting multinational clinical studies involving various types of gene therapy technologies to share their lessons learned and best practices. What are the regulatory requirements and standards currently available and how were they applied? What opportunities for interactions with the regulators were taken? How far was it possible to negotiated requirements specifically suitable to a certain product and/or influence regulator to explore new ground?
Four industry experts will share their experience in developing various gene therapy based technologies (e.g. gene therapy, gene editing product, regenerative medicinal advanced therapy) addressing pitfalls, hurdles, successes and lessons learned. The audience will have ample time to ask questions and support the session by providing responses to polls throughout the session, discussing their experience during the final panel discussion.