The University Hospital Frankfurt (UHF) at the Goethe University Frankfurt (GUF), Germany

Laboratory expertise

• Establishment of cell culture systems supporting full viral life cycle and allowing high through-put testing of drug banks leading to identification of compounds with antiviral effects.
• Implemented cell culture system for SARS-CoV-2 to screen for antiviral compounds.
• Performance of proteomics with SARS-CoV-2 infected host cells and identification of several potential therapeutic targets.
• SARS-CoV-2 isolates from different strains (Germany, Italy, Iran, Israel, China).
• Ability to perform diagnostic assays under GCLP conditions.
• Fast and robust cell culture system for human cells (Caco-2).
• Primary cell culture systems (lung, kidney cells).

Clinical trial expertise

• Extensive experience in the design and conduct of clinical trials (phase I-IV) in the area of infectious diseases.
• Complete service spectrum of an academic clinical research organization on site.
• Integrated phase I unit with PK/PD capacities and long in-patient stay options.
• High Level Isolation Unit for the treatment of patients with highly pathogenic organisms.
• Outpatient clinical trial center with access to over 2,000 immunocompromised patients
• Access to a broad range of patients from specific high-risk populations (e.g. stem cell transplantation and organ transplant recipients, patients with acute leukemia and other hematological/oncological diseases, patients with rheumatological diseases, intensive care unit patients, children).

Laboratory expertise

• Innovative cutting-edge technologies within the MIC (Mondor Immunomonitoring Center) to perform key analyses: T cell phenotype, multiplex cytokine measurement, in vitro functional assays, cell sorting, epimax technology (Luminex/Simoa), New Generation Sequencing of transcriptome, single cell, B and T -cells repertoire analyses.
• Established BSL-2 and BSL-3 facilities.

Clinical trial expertise

• Extensive experience in conducting clinical trials in the field of HIV immunotherapy (IL-7, immunomodulators), vaccines and in immune monitoring of these trials thanks to set-up of tools to analyze biological responses to immunotherapies and vaccines.
• Vast knowledge with several phase I/II therapeutic and prophylactic trials on HIV and Ebola vaccines.
• Multiple trial experience in the field of antiretroviral therapy, immune-based therapeutic strategies and vaccines (HIV and infectious diseases).

Clinical trial expertise

• ISO9001:2015 certification for clinical research, design and conduct of clinical trials in infectious diseases and vaccine research.
• Extensive experience in the full range of clinical trial management activities from study design to reporting to competent authorities and dissemination which are conducted at the highest standard of quality.
• Methodological innovative and tailored solutions for trial design.
• Routine services include data management, highly secured data storage, statistical analysis reports and end-of-study reports, risk-based monitoring approaches, timely data quality control and performance reports, such as real-time event validation, real-time trial management and trial performance indicators.

Laboratory expertise

• Fully equipped medical microbiology lab for molecular virological, biochemical and antiviral studies.
• Several BSL-2 labs and a state-of-the-art BSL-3 facility with the possibility to use radioactive isotopes (for Mechanism-of-Action studies) and automation for medium-throughput screens.
• Recently acquired facility for mouse experiments at BSL-3 level and for drug screening activities.
• State-of-the art genomics, proteomics, next-generation sequencing and imaging (light and electron microscopy).
• Knowledge in characterization of the coronavirus replicative enzymes, RNA synthesis, replication organelles, and innate immune evasion strategies.
• Major experience with the reverse genetics of +RNA virus genomes, including the ~30-kilobase genomes of the SARS- and MERS-coronaviruses.
• Expertise in the mechanism-of-action of a wide variety of compounds with antiviral activity.
• Involvation in molecular diagnostics and NGS-based pipelines for virus identification in patient materials.

Clinical trial expertise

• Extensive experience in the design and conduct of clinical trials (phase I-IV) in the area of infectious diseases.
• All services of an academic research organization on-site.
• Phase I Unit with 40 beds and over 35 years of experience.
• > 50.000 active volunteers database.

Laboratory expertise

• Established mass cytometry and single cell gene expression profiling capabilities for highly multiplexed analysis of cells.
• Laboratory of AIDS Immunopathogenesis: facilities for molecular biology and protein chemistry, cell culture, flow cytometry and cell sorting, ELISpot, ELISA, HIV-1 neutralization and Luminex bead assays and a P3 facility.
• Vaccine and Immunotherapy Center (VIC): ISO17025 certified with extensive experience in vaccinology, clinical research immune monitoring and basic immunology.
• The P3 laboratory: state of the art facility for handling and treating infectious samples from patients, includes a cell sorter for the selective isolation specific cell populations.
• Strong platform on the delineation of B cell maturation and generation of broadly neutralizing antibodies.
• Novel multiplexed Luminex assays for evaluating of antibody binding to different protein antigens.
• High throughput optimization of neutralizing antibodies through site directed mutagenesis of the antibody CDR regions.
• Antigen specific stimulations to monitor functional profiles and proliferation to characterize individual pathogen specific responses.
• B-cell phenotypic evaluations including differentiation state, memory subsets, activation and transcription factor profiles with the ability to follow several pathogen specific B-cell populations simultaneously through antigen-tetramer staining.

Clinical trial expertise

• Research activities focused on in depth phenotypic analysis of T-cell memory subsets, helper cell populations, activation and regulatory receptor profiles as well as expression of transcription factors that control cell fate.
• Multiple phase I and II trials on HIV, TB and Malaria vaccines, bNabs and new drugs with a track record of rapid recruitment and high retention.

Clinical trial expertise

• Extensive experience in the development of HIV vaccines in collaboration with academic and industrial partners.
• Vast knowledge in managing large international research consortia: Regulatory affairs, product management, liaison in GMP manufacturing, product delivery to clinical trial sites.
• Activity as sponsor or co-sponsor of several phase I/II prophylactic clinical trials in Europe and Africa.

Clinical trial expertise

• Extensive experience in conducting clinical trials: regulation, design, development and coordination, procedures, pharmacovigilance, pharmacokinetic and PK-PD analysis.
• Relevant knowledge in the design, start-up, development and analysis of both independent and industry-sponsored Phase I to Phase IV clinical trials.
• ISO accredited Clinical Trials Unit for early phases (First-Time-In-Human, Phases I and II).
• Vast expertise in drug-drug interaction studies.
• Clinical Trials Unit with capability to carry out methodological, regulatory, GCP monitoring tasks and statistical analysis through all the development phases.
• Best disposition for development of dose range, development of PK-PD models and preliminary safety assessment in patients (e.g. hepatotoxicity, QTc).
• Wide Experience in European projects.
• Coordinators of the Spanish Cinical Research Network (SCReN), the Spanish ECRIN (European Clinical Research Infrastructure Network) partner.