Next Generation Therapies: Access, Pricing and Ethical Issues in Perspective
This white paper explores NGTs, the market access and commercial challenges facing these innovations, solutions to those challenges, as well as patient and clinical ethical considerations.
What Qualifies as a Next Generation Therapy (NGT)?
NGT is a term for a range of new, leading-edge therapies that:
- Expand science – NGTs employ an expanding number of scientific approaches to diagnose and treat disease, including gene therapy, cell therapy, RNA therapy, immunotherapy, and hybrids of these therapeutic models
- Meet the significant unmet need – NGTs have secured approval by the EMA and/or FDA to meet significant unmet medical needs or promise significant improvement in patient health over current standards of care
- Gain expedited market access – NGTs are often approved through the FDA’s Breakthrough Therapy, EMA Prime Review, Rare Disease, and other priority review pathways—often after expedited reviews and clinical trials based on surrogate endpoints
Download this white paper to learn more about:
- Classification of Next Generation Therapies
- Challenges in access and commercialization of Next Generation Therapies, from clinical to access and commercialization challenges
- Innovative solutions for Next Generation Therapies access
- Patients’ view and ethical concerns