Pharmaceutical Development
Dr. Faber has held positions in pharmaceutical development, working in the German-based cell therapy research institute, Fraunhofer, and for companies including, IQVIA, Covance, and Sanofi-Aventis. As a part of her work, she has assessed novel ideas and supported scientists in making these products commercially viable while contributing to original grants and research papers and patents.
She has deep understanding of the mechanism of action and signal transduction for pharmaceuticals in indications including neurology, oncology and rare diseases. She worked extensively in clinical trials for CBD for the treatment of epilepsy. Currently, she is active in developing and bringing to the market new treatments for epilepsy with the Italian company Angelini Therapeutics. Her interests lie in creating innovative solutions for projects which could benefit both patients and the scientific community, in part by initiating projects with top scientists, industry and regulatory agencies. Learn more about her work on clinical trials.
Employment History
Professional Experience
Adjunct Professor - Epidemiology and Public Health, Faculty of Medicine
2022 - Present
UNIVERSITY OF OTTAWA, Ottawa, Canada
- Mentoring graduate students in psychology and neuroscience
- Presentation of research of scientific events seminars and symposia
- Lecture and training in culturally-informed research and clinical care
Medical Science Liaison - Neurology
2020 - Present
ANGELINI PHARMA, Berlin, Germany
- Development and maintenance of long-term partnerships with investigators, KOLs, and key stakeholders for East German sites
- Organization of scientific events seminars and symposia
- Provision of expertise in epilepsy research to clinicians
Medical Science Liaison - Neurology
2018 - 2020
SYNEOS HEALTH, Berlin, Germany
- Initiation and submission of IITs, including an Epilepsy Register in Germany’s largest hospital and a retrospective clinical trial for early access epileptic patients
- Initiation of a study to carry out whole exome sequencing for the diagnosis of mentally disabled adult epilepsy patients
- Creation organization and planning seminar series for the training and mentoring of young epilepsy researchers and physicians interested in epilepsy research
- Organization of scientific events, seminars, symposia, journal clubs, Advisory Boards, and presentation at scientific and medical conferences of scientific findings related to epilepsy clinical trials
Site Intelligence and Medical Science Liaison
2016 - 2018
IQVIA, Berlin, Germany
- Development of new investigators for clinical trials in oncology, hematology, pediatrics, and rare diseases
- Establishment of research Neurology group circle for hospital department heads
- Mentoring of CRAs on critical site visits, optimization of processes in contracts, billing, recruitment and logistics for 60 active clinical trials (200 total)
- Analysis of company internal raw-data metrics for all Berlin trials in start-up to assess, control, report and improve overall site metrics and operations
- Created innovative analyses to prioritize trials, localize potential patient cohorts, maximize recruiting windows and decrease time to trial start-up
Clinical Trial Lead in Neurology, Oncology, and Rare-Disease Trials
2014 - 2016
COVANCE Clinical & Periapproval Services, Berlin, Germany
- Lead role in Neurology investigator-initiated phase II trial testing cabazitaxel in patients with temozolomide refractory glioblastoma. Lead in oncology & rare-disease (Niemann-Pick) clinical trials; Project coordination according to ICH/GCP
- Strategic analysis and advancement of project goals through thorough assessment of project progress and appropriate measures for each trial which included development of trial protocols, and patient informed consent, as well as analysis of competitive recruiting environment to implement measures to shorten trial duration
Clinical and Business Development in Oncology Trials
2013 - 2014
GESELLSCHAFT FÜR MED. INNOVATION HÄMATOLOGIE & ONKOLOGIE mbH, Germany
- Lead in the analysis and review of 14 active hematology/oncology investigator-initiated clinical trials, two completed trials, and two registries enrolling in total approx. 800 patients
- Set and met scientific goals and direction for the team
- Created protocol design, organization, promotions, and presented publicly for a co-created competence center (EMSCO - European MDS Studies Coordination Office) in Myelodysplastic Syndrome together with physicians
Founding Partner / Senior Clinical Project Manager in Neurology & Cell Therapy
2011 - 2012
BIOVILLE GmbH, Leipzig Germany
- Management and hiring of 5 direct reports to carry out Neurology-focused clinical projects following the successful acquisition of Saxony Bank Grants
- Identification and attendance at Germany-based neuro-oncology meetings to recruit top-tier German KOLs and clinical sites
- Set-up and management of dendritic-cell-therapy trials to treat Glioblastoma for US and UK based clients.
- Ethics and regulatory submissions according to GCP/ICH and FDA/EMA requirements for US client with cell therapy products being manufactured by the Fraunhofer IZI
- Site visits, vendor identification (lab, courier, etc.) key-opinion leader/communications and public relations as well as staff internal training in GCP
- Protocol design, and data analysis of multiple individual case studies (compassionate use) carried out at hospitals with clients’ novel viral dendritic cell "combination therapy" to collect data points for a statistical analysis of population size
- Carried out endpoint consideration (i.e. progression free survival vs. overall survival) and calculated number of patients based on effect size and randomization factors with Identification of stratification factors (MGMT promoter methylation and IDH1 status)
Clinical Project Manager in Neurology
2010 - 2011
AC IMMUNE, SA, Lausanne, Switzerland
- Headed site operations as CRO manager for Alzheimer’s clinical trial, including administering trial and manufacturing budget, recruiting and enrolling patients, coordinating internal staff, pre-clinical activities and regulatory affairs
- Brokered vendor contracts, supervised audits and ensured compliance with GCP/ICH and FDA/EMA requirements
- Managed phase II Alzheimer’s disease trial including conceptualizing clinical/pre-clinical plans, schedule, budget, and internal milestones
- Designed and taught management level course in GCP for Sponsors
Business Development and Clinical Project Manager
2005 - 2010
FRAUNHOFER INSTIUTE FOR CELL THERAPY & IMMUNOLOGY, Leipzig Germany
- Set-up and management of dendritic-cell-therapy trials to treat Glioblastoma for US and UK based clients
- Management and market analysis for cell therapies, therapeutic antibodies, advanced therapy medical products (ATMPs), clinical trials, and diagnostics
- Protocol design and medical writing for cell-therapy, multiple sclerosis and transplant projects Development of projects in cell therapy for stroke and spinal cord injuries
- Acquisitioned new projects, served as internal contact to EU regulatory body on ATMPs, and led scientific management of IIT anti-CD4 liver tolerance clinical trial. Orchestrated secure, technology transfer for diagnostics and cell-therapy products
- Consulted on budgeting and drafting for German government (EU, BMBF, and BWMA) grant projects and 20M Translational Medical Center
Clinical Research Associate
2003 - 2004
UNIVERSITÄTSKLINIKUM BONN, Klinik und Poliklinik für Epileptologie, Germany
- Pre-Assessment of inclusion and exclusion criteria for epilepsy clinical trials
- Organization of visits and clinical trial finances
- Collection of patient data, and coordination of medical appointments
- Translation of medical documents from German to English