Clinal Trial Management
Dr. Faber's work in protocol design, medical writing, and project management has included pre-clinical and clinical activities for Phase II and III trials across multiple indications.
Regional Clinical Project Lead (CPL)
| A Dose Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study, of SAR650984 (isatuximab) Administered Intravenously in Combination with Bortezomib, Cyclophosphamide and Dexamethasone in Adult Patients with Newly Diagnosed Multiple Myeloma Non Eligible for Transplantation | ||||||
|---|---|---|---|---|---|---|
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Multiple Myeloma | Ib | 18 | 3 | 1 | Clinical | Ethics, Site Qualification, Budget |
| Multinational, Prospective, Observational Study to Assess the Unmet Medical Needs associated with Basal Insulin Use in Patients with Type 2 Diabetes Newly or Recently Initiated with Basal Insulin Treatment | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Diabetes | Observational | 4000 | 400 | 2 | Clinical | Ethics |
| A phase 2/3, multicenter, randomized, double-blinded, placebo-controlled, repeat dose, dose-comparison study to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of olipudase alfa in patients with acid sphingomyelinase deficiency | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Niemann-Pick | II/III | 23 | 15 | 1 | Clinical | Ethics, Budget, Management |
| A phase 1/2, multi-center, open-label, ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of olipudase alfa in pediatric patients aged <18 years with acid sphingomyelinase deficiency | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Niemann-Pick pediatric | I/II | 12 | 6 | 1 | Clinical | Ethics, Budget |
Clinical Project Manager (CPM)
| Prospective validation of a predictive model of response to Romiplostim in Patients with IPSS low or intermediate-1 risk Myelodysplastic Syndrome (MDS) and Thrombocytopenia | ||||||
|---|---|---|---|---|---|---|
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| MDS | II/III | 90 | 35 | 2 | Clinical | Ethics, CA Submission, Site Qualification, Budget |
| A Randomized Phase III study of Decitabine with or without Hydroxyurea versus Hydroxyurea in patients with advanced proliferative Chronic Myelomonocytic Leukemia | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| CMML | III | 168 | 40 | 2 | Clinical | Ethics, CA submission, Site Qualification, ISF, Budget |
| A Phase II Clinical Trial Evaluating the Newcastle Disease Virus & Autologous dendritic cells activated with autologous oncolysate for the treatment of Glioma (Delta Vir) | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Glioblastoma | II/III | 130 | 20 | 1 | Clinical | Site Design |
| A Phase II Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme (NWBT) | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Glioblastoma | II/III | 266 | 25 | 1 | Clinical | Ethics, PEI Submission, Site Qualification |
| A double-blind placebo-controlled study of the Safety tolerability and efficacy of 12 months treatment with ACI-91 in patients with mild to moderate Alzheimer’s Disease (ACImmune) | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Alzheimer’s | II | 64 | 15 | 2 | Clinical | Recruitment, Vendors, SAP Management |
Clinal Research Assistant and Coordinator
| CE-Ultra: Multi-centric clinical trial, for the diagnosis of early liver metastasis after colon and rectum cancer comparing the specificity and sensitivity of contrast-enhanced-ultrasound (CEUS) versus MRI | ||||||
|---|---|---|---|---|---|---|
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Liver Cancer | II | 250 | 4 | 1 | Clinical | IIT, Conception, Writing |
| Impact of daclizumab, low-dose cyclosporine, mycophenolate mofetil and steroids on renal function after kidney transplantation (Hoffman-La Roche) | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Adult Renal Transplant | II | 156 | 14 | 3 | Writing | Post-Trial Paper |
| Non-Randomized, Open Label, Uncontrolled, Diagnostic Study on the Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis (Biotectid) | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Arthritis | II | 30 | 1 | 1 | Writing | Medical Writing |
| hEPO: Double-blind, randomized, placebo-controlled, mono-centre clinical trial, monitoring regeneration rates in patients undergoing liver resection, treated post-operatively with erythropoietin | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Liver resection cirrhotic / non | II | 112 | 1 | 1 | Clinical | IIT, Conception, Protocol, Planning, Submission |
| Induction of immunological Tolerance in Liver transplant patients using a monoclonal anti-CD4 antibody MAX.16H5 in combination with immunosuppressive standard therapy | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Liver Transplant | I/II | 20 | 1 | 1 | Clinical | IIT, Conception, Protocol, IB, Submission |
| MInT: Phase III clinical trial: 823 DLBCL patients (18–60 years) were randomized to receive either RITUXAN plus a standard anthracycline-containing chemotherapy regimen (CHEMO) or CHEMO alone as induction therapy (Roche) | ||||||
| Indication | Phase | Patients | Sites | Countries | Services | Study Stage |
| Leukemia | III | 800 | <30 | 18 | Clinical | Data Collection and Entry |