The meeting was focused on two main topics:
1) updating the status of the phase I clinical trial, and
The project brings together the expertise of a number of European groups (Spain, Belgium, and Netherlands) in a number of fields required for an adequate development of the therapeutic vaccine (dendritic cell targeting, rational design of immunogens, mRNA manufacturing and immuno-virological monitoring, among others).
Asphalion supports research consortia as SME Regulatory Expert Partner with experience in proposal preparation and application process. Asphalion can support with the following activities: Orphan Drug Designation application, Paediatric Investigation Plan, Regulatory Roadmaps, IMPD / IB for Clinical Trials, Clinical Trial Applications, Scientific Advice / Protocol Assistance, Clinical / Nonclinical/CMC development plans, SME application to EMA. Asphalion has worked with wide variety of product types: Biosimilar, Biotech, Cell Therapy products, Gene therapy products, Herbal products, Medical Devices, Plasma derived products, Small molecule.