I oversee technical regulatory compliance and authority interaction to ensure timely product development and process transfers to CMOs to support our clinical development programs

I am teaching basics of preclinical and clinical development in the Master Class Biotechnology

I am supporting small and mid-sized companies regarding CMC outsourcing strategies and CMO selection, regulatory strategies and IND/IMPD writing. I contribute to manufacturing process development or scale up projects as well as tech transfers. I also provide GMP and regulatory training, risk analysis workshops and individual coaching. Projects cover (GT)ATMPs, vaccines, antibodies and therapeutic proteins. All products are NBEs, most are first-in-class substances.

Tasks Responsibilities:Cross functional team lead overseeing process development, supply chain management and life cycle management of the legacy SuppreMol productsHighlights: Successful integration of SuppreMols CMC/Manufacturing strategies into the Baxter/Baxalta/Shire organisationsBuilding of international teams to drive development of the legacy SuppreMol products

Tasks Responsibilities:Supply chain managementCMO selection, contraction and management including budget oversightTechnical regulatory affairs and definition of development pathways, including Quality DocumentationRepresentation of CMC at partnering negotiations / due diligenceHighlights:Two successful Phase II studies with SuppreMols lead compoundEstablishment of relevant management systems to oversee CMO management (e.g. Change Control, Deviations Management… Show more Tasks Responsibilities:Supply chain managementCMO selection, contraction and management including budget oversightTechnical regulatory affairs and definition of development pathways, including Quality DocumentationRepresentation of CMC at partnering negotiations / due diligenceHighlights:Two successful Phase II studies with SuppreMols lead compoundEstablishment of relevant management systems to oversee CMO management (e.g. Change Control, Deviations Management, Supplier Qualification and Oversight)Aquisition of SuppreMol through Baxter in March 2015 Show less

Tasks Responsibilities:Team leader Technical Regulatory AffairsCompilation of Quality documentation for all TRION products for clinical studies and MAAs Lead coordination of Q&A procedures during CTA and MAA procedures, including Authority MeetingsIntegration of regulatory Compliance Systems and Life Cycle Management tools into Quality Management Highlights:MAA for Catumaoxomab in the EU and IsraelSeveral CTAs in EU and US for other monoclonal antibodies (Phases… Show more Tasks Responsibilities:Team leader Technical Regulatory AffairsCompilation of Quality documentation for all TRION products for clinical studies and MAAs Lead coordination of Q&A procedures during CTA and MAA procedures, including Authority MeetingsIntegration of regulatory Compliance Systems and Life Cycle Management tools into Quality Management Highlights:MAA for Catumaoxomab in the EU and IsraelSeveral CTAs in EU and US for other monoclonal antibodies (Phases I through III)Successful end-of-phase 2 meeting with the FDA to proceed to phase 3 clinical development with catumaxomab in the US Show less