Mainz, Rhineland-Palatinate, Germany
Senior Medical director with broad clinical and research background in Hematology, Oncology, Hematopoietic Stem Cell Transplantation, and Cell and Gene Therapy. Investigator in multiple translational and pharmaceutical clinical trials in Hematology-Oncology and Rare Diseases. Medical Lead at Parexel for Cell and Gene Therapy clinical development projects, supporting scientific, clinical, operational, regulatory and business teams. Global Medical monitoring in international clinical trials for hematological diseases, and cancer, from early to late stages. Board Certified Medical Affairs and Regulatory Affairs in Pharmaceuticals. Currently, Director of Clinical Development in BioNTech SE, focused on early and pivotal trials with immunotherapies for patients with solid tumors. Always focused on looking for best options for each patient. Passionate about the immune system and genetic technology as life-transforming therapies. Grateful for living in these exciting times. Always learning….Thank you to all people who wake up daily to improve others' lives.
• Clinical Development strategies for Immunotherapies against solid tumors, focusing on protocol development and regulatory submissions. • Execution of clinical trials with personalized inmmunotherapy, ensuring patient safety through rigorous medical monitoring and data quality thanks to solid experience in medical data review. AI enhanced skills and data-driven decisions based on data analysis and business intelligence training. • Collaboration with multidisciplinary teams to operationalize complex clinical trials involving autologous tissue samples and individualized therapies. • Medical Affairs activities building partnerships with stakeholders to strengthen project outcomes.
Medical and scientific strategic leader in Cell and Gene Therapy across all the indications. Early clinical development for C&G therapies including translational, operational, set up and regulatory activities, in malignant, non-malignant ( neurodegenerative, autoimmune) and rare diseases. Global and regional EU Clinical trial monitor in Hematology (Leukemia, Lymphoma, Multiple Myeloma) and solid tumors with target therapy, bispecific and drug conjugate antibodies, and CAR-T, from early to late phases. Post-authorization safety long term follow up study of CAR-T in Multiple Myeloma (PASS). Clinical trial data review and support overall program safety reporting.
Customized design of allo-transplant platform. Reduced intensity and low toxic conditioning regimens in non-malignant diseases. Allo-transplant after CAR-T CD19 therapy in ALL. Biological and pharmacological prophylaxis and treatment of GvHD. Transplant coordinator and responsible for the HSCT/CT program and JACIE accreditation. Responsible for Good Clinical Practice and pharmacovigilance
Ex-vivo expanded cord blood for HSCT in acute childhood leukemia CART19 in relapsed/refractory ALL, pediatric patients JAK inhibitor for pediatric patients with severe GvHD Virus-specific T lymphocytes from a healthy donor registry against CMV, VEB, and adenovirus in HSCT Photoapheresis and Mesenchymal Stromal Cells in refractory GvHD
Dr. Teresa Olive was my mentor in the HSCT Unit. I learned everything about being a physician, pediatric hematology, and transplantation from her and from our patients and their families. Activity: 50 allogeneic/ 10 autologous trasplants per year for all indications ( 50 % non-oncology) with all stem cell sources and individualized platform design for conditioning, graft design and GvHD prophylaxis. Diagnosis and Optimization prior to trasplant Indications: Hematology malignancies ( acute leukemia, lymphoma, etc.), and solid tumors (CNS, neuroblastoma), Genetic disorders: -Inherited bone marrow failure syndromes: Fanconi Disease, Congenital dyskeratosis -Hemoglobinopathies: thalassemia and sickle cell disease - Immunodeficiency and immune dysregulation disorders. - Metabolic disorders: leukodystrophy diseases and mucopolysaccharidosis Expertise on: Myeloablative and reduced-intensity conditioning regimens (pharmacokinetics) Graft versus host disease prophylaxis and treatment, including mesenchymal cells and extracorporeal Photoapheresis. Post-transplant complications diagnosis/treatment: sinusoidal occlusion syndrome, thrombotic microangiopathy, infections (sepsis/shock, ARDS, viral reactivation/disease) Long-term follow up (10-15 years), delayed adverse events and vaccinations Peripheral blood stem mobilization and bone marrow harvesting in children/infants. Handling of cell therapy and infusion. High-dose tandem autologous transplant for refractory solid tumors and refractory autoimmune diseases. Cellular Agents: donor lymphocyte infusions, ex-vivo expanded cord blood, Mesenchymal Stromal Stem Cells, and specific T lymphocytes for viral reactivation (CMV, adenovirus, VEB). Therapeutic agents and procedures: Blinatumomab for relapsed/refractory ALL, treosulfan, alemtuzumab, plerixafor, defibrotide, infliximab, immunosuppressants (ruxolitinib), antivirals, eculizumab, and thrombopoietin receptor agonists after transplant
Hematology: Clinical experience on diagnosis and treatment of hematological diseases in children in inpatient and outpatient setting. - General: anemia, neutropenia and thrombocytopenia ( genetic or adquired), pancytopenia/aplasia/bone marrow failure syndroms, hemoglobinopathies, coagulopathies ( thrombotic/bleeding). - Neonatal specific hematological disorders - Malignant: acute leukemia, myelodisplasia and lymphoma. Laboratory ( full blood count, blood film and BM aspirate/biopsy, coagulation, disease-specific tests, as cytogenetics, MFC and molecular studies). Therapy prescription: chemotherapy ( including intrathecal/Omaya), immunotherapy. Blood trasfusion and growth factor support. Technical skills: Bone marrow aspirate/biopsy, preparation/staining and evaluation Oncology: Diagnosis and treatment of solid tumors in children ( neuroblastoma, central nervous system, sarcoma, Wilms). Biopsy and imaging assessment. Hematopoietic stem cell transplant Auto and allo trasplant for all indications with all sources and individualized conditioning, graft manipulation and GvHD prophylaxis platform. Bone marrow harvest, mobilization schedule of peripheral blood for apheresis Handling, and infusion of cell therapy Patient care in Intensive and Emergency department, palliative and follow-up.
Training in Paediatric Hemato-oncology for 1 year