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:

Study designs:

• 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

FOCUS activities:

• 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.