Mireille Vossen, Phd, Pmp® Email & Phone Number

Amsterdam, 1105Bp, Nl

Responsible for global Program Management of various AAV gene therapies in development for CNS and liver indications, including AMT-260 (refractory Temporal Lobe Epilepsy).

Amsterdam, 1105Bp, Nl

Responsible for global oversight of various AAV gene therapies in development for CNS and liver indications, including AMT-260 (Refractory Temporal Lobe Epilepsy).

Amsterdam, 1105Bp, Nl

Responsible for global Program Management of various AAV-based gene therapies in development, in varying phases of development.

Leiden, Nl

Project lead of various operational project teams: * responsible for transfer of R&D projects into Operations* responsible for production, label and packaging and shipment of Clinical Trial Material (IMP) Project lead of team for a high impact Type II variation

Tasks and responsibilities:• Accountable for nonclinical and clinical development of complex generic injectable drug products (e.g. nanoparticles, microparticles, liposomes)• Preparing project plans• Defining, balancing and controlling timelines, quality, budget and KPI’s of studies • Identifying risks and countermeasures; defining multiple scenarios for implementation• Addressing, resolving and communicating project challenges• Managing internal and external stakeholders, such as Global R&D, Regulatory Affairs, Legal, Pharmacovigilance, Purchasing, and CRO’s• Acting as (non-)clinical representative in multidisciplinary global project teams• Preparing project documents (e.g. project plans, reports, and for approval: Scientific Advice/pre-ANDA, and IB, IMPD and eCTD for EMA and FDA)• Designing, outsourcing and monitoring of nonclinical and clinical studies - GCP or GLP • Translating study data to product development strategies and convincing internal and external stakeholdersMain achievements:• Effectively managed internal and external stake-holders to accelerate timelines and reduce costs• Performed all studies successfully and timely; mitigated risks through continuous improvement with lower costs and/or reduced lead times• Clearly presented project progress to multidisciplinary teams. Proactively contributed ideas to other disciplines; acted as sparring partner for (Sr.) scientists.• Defined follow-up research on the basis of data- and trend analyses of a long-acting microparticle; major impact on design of studies and data interpretation• Proactively edited and contributed to a document to convince CHMP that clinical studies are not required for approval of a complex generic nanoparticle, on the basis of its in vivo characteristics and in vitro studies; authorization of a complex generic without clinical studies

Tasks and responsibilities:• Preparing project plans and outsourced pre-clinical safety and efficacy studies for development of cell-based and/or egg-based seasonal and pandemic influenza vaccines – GLP and non-GLP• Acting as pre-clinical representative in project teams for development of novel products and process optimization; responsible for the pre-clinical development plans and pre-clinical scientific advice• Leading a multidisciplinary cell-mediated immunity team for development of T-cell parameters to assess vaccination efficacy in clinical studies• Contributing to internal global pre-clinical toxicological team, designed to harmonise pre-clinical safety studies for (bio)pharmaceutical research and development• Preparing pre-clinical regulatory documents for internal and external purposes

Title of thesis: Immune responses to herpesvirus infections in immunocompromised children. The scope of the project was to reveal factors that contributed to impaired immunity to herpes viruses in immune compromised children, focussing mainly on T-cell and Natural Killer cell immunity towards varicella-zoster virus, Epstein-Barr virus and cytomegalovirus. The data provide better insight into the recognition of children with an increased risk of developing severe complications due to herpes virus infections. Key parts of the immune system involved in protection against these viruses were identified.

Msc, Medical Biology

Advanced Vaccinology Course (Advac7)

Gymnasium-B

Post-Doctoral Education In Toxicology