The Universidad de Navarra (UNAV) is a private university, offering excellent education and prestigious research in the field of Biomedicine, through the faculties of Medicine, Pharmacy and Science.
The R&D carried out at the Universidad de Navarra is tightly linked to the activities assumed by the University Clinic of Navarra (CUN) and the Center for Applied Medical Research (CIMA).
As main goal, the R&D activities, undertaken by the researchers, are carried out with a clear practical and applied focus.
Such an environment constructs the UNAV as a reference University in the field of Biomedicine, offering and applying our high experience to develop a drug from idea to patient.
As a result of the experience in Drug Development, the UNAV owns the Drug Development Unit Universidad de Navarra (DDUNAV). This Unit supports the Preclinical and Clinical Development (Phase I to Phase IV Studies) of Biotechnology and Pharma companies.
This Unit offers a full range of services that include: Drug formulation, development and validation of analytical methods, Toxicology studies, Efficacy studies and PK/PD Modelling . All competences are covered by quality standards.
The UNAV has consolidated its biomedical R&D activities through the following foundations:
1. Drug Development: participating in a wide range of drug development projects from bench to clinical phases.
2. Team: high experience in preclinical development under contract and a flexible structure to adapt according to companies’ needs.
Our team is highly experienced in Drug Development and a flexible structure to adapt to customer needs.
A Project manager is assigned to each Project who is the one coordinating all communications between the client and our scientific team.
MAIN SECTOR: Biotechnology / R&D Services
- Drug Delivery (Preclinical studies)
- Analytical Services
Summary Products / Services / Technologies:
A.Preclinical studies focused on pharmaceutical and biotechnology drug development:
- Formulation Development:
The Drug Formulation Area offers the following capabilities, both for small molecules and biologics products:
• Design and formulation studies
• Characterization of physical properties
• Chemical reactivity and forced degradation studies
• Process development optimization
• Excipient compatibility studies
• Preliminary process identification
• Commercial formulation development
We offer a wide know-how in nanotechnology and drug delivery systems (mainly applied in cancer, infectious diseases, cardiovascular and neurodegenerative diseases). The above mentioned expertise is protected under patent and transferred to society across licensing agreements to Companies and/or collaborative projects.
- Analytical and Bionalytical Services.
The Analytical Area can offer a full method development and validation, technology transfer, and tailoring of methods for specific requirements.
The Bioanalitycal Area develops and validates bioanalytical methods, analysing as well many types of samples from animal studies to clinical trials samples.
Unit covered by GLP certification:
• Development and validation methods
• Sample analysis for clinical and non-clinical studies
• Methodology transfer
• Chromatographic Analysis: HPLC-UV, HPLC-FLD, HPLC-MS/MS (TOF-Ionic Tramp-QqQ); GC-MS; Capillary electrophoresis (CE) – DAD; Differential Scanning Calorimetry (DSC).
• ICH Stability Studies (controlled temperature and humidity) in the climatic areas I to IV conditions.
• Custom reporting.
- Toxicology studies
This Area owns high expertise in biosafety studies under GLP standards using different dose regimens, model species (from rodents to non-human primates) and routes of administration (parenteral, enteral, topical, subcutaneous, oral, ocular,…).
• General Toxicology: single dose toxicity studies, repeated dose toxicity studies, Maximum Tolerated dose studies and Immunogenocity studies.
• Specific Toxicology: Local Tolerance (topical, intramuscular, subcutaneous), Skin and eye irritation/corrosion, Mutagenicity and Genotoxicity (Ames Test, Mouse micronucleus Test, Chromosome aberration Test and Comet Assay) .
• Pharmacokinetics and Toxicokinetics Studies
• Expertise in Animal Development Model.
• Efficacy Studies: in vitro and in vivo models.
- Pharmacometrics-PK/PD Modeling:
PK-PD Modeling Area develops the activity related to the building of mechanistic models describing and predicting the time course of disease progression, and the “in vivo” drug action at every step during the development of new drugs.
• In vitro – in vivo correlation: Predicting in vivo pharmacokinetic based on in vitro dissolution profiles.
• Physiological based pharmacokinetic models: Early prediction of human pharmacokinetics.
• Pharmacokinetic/pharmacodynamics models: Establishing the link between drug concentration and bio- and/or surrogate makers.
• Population pharmacokinetics and pharmacodynamics: Developing models to describe the clinical outcome (i.e., survival) using phase I-III information from clinical trials.
• Optimal design: Provide based on statistical considerations and computer simulations the best in vitro or in vivo scenario for future experiments/studies.
• Personalized medicine: Choose the right drug (or combination of drugs) at the right dose(s) for each patient.
Universidad de Navarra - University Clinic of Navarra has participated in 250 clinical trials in the last 5 years in collaboration with a large number of Biotechnology and Pharmaceuticals companies, offering the following facilities:
• Phase I Unit: The facilities feature 6 beds and a Bio-analytic service for the development of drug in early phase clinical research.
• Phase II-IV clinical trials: All the departments of the University Clinic of Navarra (already of 27 different areas) participate in clinical trials.
The majority to these clinical trials are carried out in the fields of Medical Oncology, Hematology, Dermatology, Cardiology, Neurology, among others.
DDUNAV is a Unit which offers, just in one location, the possibility to support the Preclinical Development studies (for small molecules and biologics products) and Clinical Trials, through the Clinical Trials Unit which helps to develop the products to commercialization. All these capabilities permit us to cover all the drug development process from Preclinical stages (Toxicology, Analytical Unit, Formulation,…) to clinical stages.
DDUNAV is opened to collaborate with Biotechnology and Pharma Companies which are looking for a strategic partner to develop its early stage product to clinical stage.
As it is reflected in our portfolio services, we offer a One-Stop-Shop for the drug development process, benefiting the companies which choose us as a strategic partner, a single point of contact and a multidiscipline expertise for the development.
We can support you in all the process until clinical phases or in a specific point of your development.
Our University collaborates with national/international Biotech and Pharma Companies, these collaborations are felt as an added value and a strategic partner for the drug development and future commercialization.
Moreover, to be a partner in contract research studies, the University is opened to participate in any type of competitive national and international projects.
Furthermore of the excellence of our research, the DDUNAV contributes to the process with a high experienced team in the following areas:
• Project Management: we conduct your project across all the preclinical and clinical stages, enhancing the development of the products.
• Competitive Projects: wide experience in leadership and participation in international and national Projects.