Dr. Esther Schwich entwickelt Zulassungsstrategien für Rx- und OTC-Arzneimittel und steuert europäische Verfahren (CP/DCP/MRP) inklusive Lifecycle-Management. Sie koordiniert eCTD-Einreichungen, Variations und Renewals und fungiert als Ansprechpartnerin für europäische Behörden, Subkontraktoren und interne Fachabteilungen.
Expertise und beruflicher Hintergrund
- Arzneimittelzulassung (DCP/MRP, RUP)
- Dossier-Erstellung und Publishing (eCTD)
- Environmental Risk Assessment (ERA)
- Produktabgrenzung (MP, MD, Kosmetik)
- KI im regulierten Umfeld
- Produktentwicklung im Phytobereich
- Lifecycle Management AM
Mitgliedschaften
- Ausschuss Selbstmedikation, BPI
- Ausschuss Phytopharmaka, Pharma Deutschland
- Arbeitsgruppe Arzneimittel-Medizinprodukte Kombinationen, Pharma Deutschland
- Ausschuss Internationale medizinisch-pharmazeutische Themen, Pharma Deutschland (ergänzendes Mitglied)
- Arbeitsgruppe Erfahrungsaustausch ERA, Pharma Deutschland
- Arbeitsgruppe Arzneimittel, IGEPHA
Elevated sHLA-G plasma levels post chemotherapy combined with ILT-2 rs10416697C allele status of the sHLA-G-related receptor predict poorest disease outcome in early triple-negative breast cancer patients
Hoffmann O, Wormland S, Bittner AK, Hölzenbein J, Schwich E, Schramm S, Rohn H, Horn PA, Kimmig R, Kasimir-Bauer S, Rebmann V, Frontiers in Immunology, 2023 May 22:14:1188030.
Systematic Evaluation of HLA-G 3'Untranslated Region Variants in Locally Advanced, Non-Metastatic Breast Cancer Patients: UTR-1, 2 or UTR-4 are Predictors for Therapy and Disease Outcome
Rebmann V, Schwich E, Michita RT, Grüntkemeier L, Bittner AK, Rohn H, Horn PA, Hoffmann O, Kimmig R, Kasimir-Bauer S, Frontiers in Immunology, 2022 Jan 12:12:817132.
Soluble HLA-G and HLA-G Bearing Extracellular Vesicles Affect ILT-2 Positive and ILT-2 Negative CD8 T Cells Complementary
Schwich E, Hò G-G T, LeMaoult J, Bade-Döding C, Carosella E, Horn PA, Rebmann V, Frontiers in Immunology, 2020 Aug21;11:2046. Doi: 10.3389/fimmu.2020.02046. PMID: 32973812
Tumor-Derived Extracellular Vesicles Impair CD171-Specific CD4+ CAR T Cell Efficacy
Ali S, Toews K, Schwiebert S, Klaus A, Winkler A, Grunewald L, Oevermann L, Deubzer HE, Tüns A, Jensen MC, Henssen AG, Eggert A, Schulte JH, Schwich E, Rebmann V, Schramm A, Künkele A, Frontiers in Immunology, 2020 Mar;11:531.
Decreased Soluble Human Leukocyte Antigen E Levels in Patients After Allogeneic Hematopoietic Stem Cell Transplantation Are Associated With Severe Acute and Extended Chronic Graft-versus-Host Disease and Inferior Overall Survival
Kordelas L, Schwich E, Lindemann M, Heinemann F, Buttkereit U, Horn PA, Beelen DW, Rebmann V, Frontiers in Immunology, 2020 Jan 10;10:3027.
Soluble Programmed Death Receptor Ligands sPD-L1 and sPD-L2 as Liquid Biopsy Markers for Prognosis and Platinum Response in Epithelial Ovarian Cancer
Buderath P, Schwich E, Jensen C, Horn A, Kimmig R, Kasimir-Bauer S, Rebmann V, Frontiers in Oncology, 2019 October 15;9:1015.
HLA G 3‘ untranslated region gene variants are promising prognostic factors for BK polyomavirus replication and acute rejection after living-donor kidney transplantation
Rohn H, Schwich E, Michita RT, Schramm S, Dolff S, Gäckler A, Korth J, Heinemann F, Wilde B, Trilling M, Horn PA, Kribben A, Witzke O, Rebmann V, Human Immunology, 2019 October 31.
Vesicular-bound HLA-G as a Predictive Marker for Disease Progression in Epithelial Ovarian Cancer
Schwich E, Rebmann V, Horn PA, Celik A, Bade-Döding C, Kimmig R, Kasimir-Bauer S, Buderath P, Cancers, 2019 Aug 2;11(8).
Individual Immune-Modulatory Capabilities of MSC-Derived Extracellular Vesicle (EV) Preparations and Recipient-Dependent Responsiveness
Kordelas L*, Schwich E*, Horn PA, Beelen DW, Börger V, Giebel B, Rebmann V, Int J Mol Sci. 2019 Apr 2;20(7).
HLA-G 3‘ untranslated region variants +3187G/G, +3196G/G and +3035T define diametrical clinical status and disease outcome in epithelial ovarian cancer
Schwich E, Rebmann V, Michita RT, Rohn H, Voncken JW, Horn PA, Kimmig R, Kasimir-Bauer S, Buderath P, Sci Rep. 2019 April 1; 5407.
The Donor Major Histocompatibility Complex Class I Chain-Related Molecule A Allele rs2596538 G Predicts Cytomegalovirus Viremia in Kidney Transplant Recipients
Rohn H, Michita RT, Schwich E, Dolff S, Gäckler A, Trilling M, Le-Trilling VTK, Wilde B, Korth J, Heinemann FM, Horn PA, Kribben A, Witzke O, Rebmann V, Front Immunol. 2018 May 8;9:917.