FOCUS Clinical Drug Development Exploratory Drug Development of NCEs / NBEs
FOCUS Clinical Drug Development is an independent full-service CRO specialised in early clinical development and integrated proof of concept (PoC) packages. FOCUS has conducted more than 600 high-quality early-phase clinical studies in healthy volunteers and many patient populations.
Core indications are CNS, cardiovascular and metabolism, and immunology / oncology. We provide our clients with clinical research expertise and global drug development knowledge, as well as strategic advice and scientific consultancy.
Clinical pharmacology and exploratory drug development
FOCUS offers the unique combination of drug development and clinical pharmacology / exploratory drug development know-how, plus an infrastructure to manage complicated clinical studies with chemical drugs, biologicals and vaccines in expedited time lines with a high standard of quality. FOCUS has been audited five times by the US FDA.
FOCUS has 120 experienced and dedicated employees. We support many different exploratory development study designs and activities, including:
- First in human studies
- Translational medicine / exploratory CTA
- Biomarker / imaging studies / fMRI / PET in animal and man
- PoC packages
- Efficacy / dose finding studies
- Drug – drug interaction studies
- Vaccine development
- Ethnobridging studies (Caucasian / Japanese / Asian / African)
- Bioequivalence / bioavailability / PK
- QTc studies, EEG studies, special safety studies
- Protocol writing and CRF
- Regulatory support
- Scientific advice
- Pharmacy / CTS management
- Study conduct
- Biomarker and immunology lab
- Bioanalytics and PK, assay development
- Central clinical laboratory, phamacogenomics testing
- Data management / biostatistics
- Quality assurance
State-of-the-art drug development clinics
The FOCUS Neuss Unit in Germany is located within the FOCUS headquarters. It has 120 beds, a special S2-ward for biologicals / cell-based products, and an on-site GMP pharmacy with dedicated QP. It has performed >600 Ph I-III studies, more than 80 first-in-man studies (NCE / NBE) and 38 Ph I studies in Japanese subjects since 1997.
The FOCUS Hospital-Based Unit is located within Düsseldorf University Hospital. It has 12 dedicated beds and is close to the ICU. The unit performs first-in-human studies (NCE / NBE) in healthy volunteers or patients, and other exploratory patient studies.
The FOCUS Clinical Research Unit in Moscow, Russia, has been performing studies in patients for six years. Our own hospital-based ward is located in Hospital 81. It offers competitive recruitment rates in many patient populations and indications.
The FOCUS Clinical Research Centre in Belgrade, Serbia, has a clinical network of professors at the Belgrade University School of Medicine and offers competitive patient recruitment rates in many patient populations.
Ethnobridging studies (global phase I approach)
FOCUS is one of the pioneers of performing ethnobridging studies in Japanese volunteers in Europe. We have successfully conducted over 38 ethnobridging studies over the past 12 years. Designing ethnobridging studies is one of our strengths. We offer subjects of different ethnicities such as Japanese, Chinese, black African and Caucasian.
PoC product development management (PDM)
Based on our extensive development know-how FOCUS offers a comprehensive, tailor-made, one-stop shopping service package to progress your development candidate from preclinical / discovery stage to clinical PoC in the most timely and economical fashion, in the form of an integrated project management.
We provide a complete early development package in the form of the regulatory documentation file, the common technical document (EMEA CTD), to be used for decision making for late development continuation or outlicensing.
Development of biologicals
With its own molecular biology / biomarker lab FOCUS is especially experienced to explore new biologicals in phases 0, 1 and 2. Please ask for our special expertise regarding your molecule or therapy approach.
Immunology services for exploratory drug development
FOCUS Immunology provides:
- MoA-defined testing packages: providing solutions by addressing pertinent immunological aspects for your development compound, like the immune screening package, cytokine modulation package, antibody package, immunosuppression package, immunostimulation package and the biologicals (of higher risk) package
- Immunogenicity testing: preclinical immunogenicity testing for novel biologicals and biosimilars according to EMEA-guideline No. EMEA / CHMP / BMWP / 14327 / 2006
- Functional testing of immune cells for mode-of-action analyses: separation and functional testing of immune cell populations from patient and / or volunteer samples
- Immune-monitoring of clinical trials: worldwide collection, quality-controlled processing and analysis of samples for the monitoring of immune system parameters in single and multi-centre clinical trials
For the analysis of cells of the specific and innate immune system FOCUS Immunology has established cellular assays including agonistic ligands for Toll-like and NOD-like receptors.
Cellular assays either use bulk culture-analysis or flow cytometry-based single cell analysis. Readout parameters include cell proliferation, analysis of activation markers by flow cytometry, EliSpot or ELISA, chemotaxis, NK cell activity, NO production, histamine release, oxidative burst reaction, apoptosis induction, PCR-analysis and others.
Products and Services
Rubraca (rucaparib) for the Treatment of Advanced Ovarian Cancer
Alofisel (darvadstrocel) for the Treatment of Complex Perianal Fistulas in Crohn’s Disease
TAVALISSE (fostamatinib disodium hexahydrate) for the Treatment of Chronic Immune Thrombocytopenia
Trogarzo (ibalizumab-uiyk) for the Treatment of Multidrug-Resistant HIV-1 Infection
Herzuma (trastuzumab biosimilar) for the Treatment of Breast and Gastric Cancers
Darzalex (daratumumab) for the Treatment of Multiple Myeloma
Kanuma (sebelipase alfa) for the Treatment of Lysosomal Acid Lipase Deficiency (LAL-D)
Portrazza (necitumumab) for the Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
Ninlaro (ixazomib) for the Treatment of Multiple Myeloma
Abilify (aripiprazole) Digital Medicine for Treatment of Schizophrenia
Onivyde (irinotecan liposome injection) for the Treatment of Metastatic Pancreatic Cancer
Iluvien for the Treatment of Diabetic Macular Oedema
FOCUS Clinical Drug Development Expands Phase II-IV Activities and Launches Volunteer Community Website
FOCUS Clinical Drug Development's new volunteer community website FOCUS4you has gone live today. This is the first German volunteer community platform established to facilitate the exchange of information among our volunteers (healthy subjects and patients) – and with FOCUS. By using thRead more
We would like to inform our sponsors about our new capabilities and latest accomplishments: The recent FDA pre-approval inspection audit of our Phase II clinical study site and office facilities in Moscow, Russia, was flawless and resulted in no FDA 483 remarks for the sponsorRead more