Advanced therapies are medicines for human use that are based on genes, tissues or cells. They offer cutting-edge opportunities for the treatment of disease and injury. They include a complex and innovative class of biopharmaceuticals that are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. Moreover, these therapies often developed SMEs university and academia with limited regulatory experience.
ATMPS include Medicinal products based on cells or genes which are very different from medicines based on chemical entities or biological / biotechnological origin but are still subject to the same requirements of safety and efficacy. Attrition rates in the regulatory process are disappointingly high.
In this session we will count with:
- Asphalion, a leading Spanish scientific and regulatory consultancy services firm with extensive experience in the regulatory process of ATMP and member of ARDAT consortium.
- AEMPS representative who will explain how the Committee for Advanced Therapies supports academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs.
- Hospital Clinic researcher with experience in the development of ATMPs and access to the clinics.
- Splice Bio, who has a proprietary Protein Splicing platform that is applying to develop the next generation of gene therapies.
- Spark therapeutics, an international biotech company leader in the development of gene therapy.
- Sol Ruiz, Head of division for Biological Products. Advanced Therapies and Biotechnology AEMPS/EMA (Spain)
- Manel Juan Otero, Head of inmunology Department at Hospital Clinic (Spain)
- Miquel Vila-Perelló, PhD, CEO, Splice Bio
- Yemisi Corinaldi, Regulatory Affairs Leader at Spark Therapeutics (UK)
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