Top Institute Pharma Has Started 42 Research Projects Totaling 260 Million Euros

Main Category: Pharma Industry / Biotech Industry
Also Included In: Biology / Biochemistry
Article Date: 20 Mar 2008 - 1:00 PDT

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Eight new and highly innovative research projects are starting in the Top Institute Pharma's Strategic Research Program. Top Institute Pharma is a Dutch public-private partnership founded in 2006. Within TI Pharma, consortia of industrial and academic research teams conduct groundbreaking, cross-disciplinary research projects that fit into the Priority Medicines program of the WHO. Each year, the Dutch government funds the top institute 30 million Euros. The pharmaceutical industry and academia each contribute an additional 15 million Euros per year. TI Pharma is becoming an international leader in pharmaceutical research, training and education. TI Pharma's fellows are trained in understanding the intricacies of the entire drug R&D process.

Exploitation of toll-like receptors in drug discovery (project D1-101)

This TI Pharma research project is being conducted by a consortium consisting of Organon (part of Schering-Plough), Numico Research, ISA Pharmaceuticals, Radboud University Nijmegen, Radboud University Nijmegen Medical Centre, TNO Quality of Life, Leiden University, Leiden University Medical Center, Maastricht University, University Medical Center Utrecht and Utrecht University.

Toll-like receptors are the sentinels of the innate immune system and play a crucial role in host defense against infection. It has become clear that the innate and adaptive immune systems are closely linked. Research has also shown that toll-like receptors are not just important in infectious diseases but in all diseases where the immune system is deregulated. For some toll-like receptors, agonists and their mode of action are fairly well understood. These can, for example, be used to develop tumor and infection vaccination strategies. For other toll-like receptors, the link to disease is less well understood and the validity of targeting these to realize new therapeutic strategies still needs to be verified.

Mechanism-based PK-PD modeling platform (project D2-104)

This TI Pharma research project is being conducted by a consortium consisting of Organon (part of Schering-Plough), Johnson & Johnson PRD, GlaxoSmithKline, Eli Lilly, Nycomed, Pfizer, Leiden University, Erasmus MC (University Medical Center Rotterdam), University of Groningen, and University Medical Center Utrecht.

Significant progress has been made in the field of pharmacokinetic/pharmacodynamic (PK-PD) modeling. In particular, mechanism-based PK-PD models have been developed, with considerably improved properties for extrapolation and prediction. The models are valid for drug effects in stationary biological systems. However, biological systems are often non-stationary. This is observed in progressive diseases (e.g., osteoporosis, COPD) and infants and children. The main goal of this project is to develop PK-PD modeling concepts for non-stationary biological systems. The ultimate result will be a mechanism-based PK-PD model library and a database of biological system specific information for use in drug discovery and development.

Towards novel translational safety biomarkers for adverse drug toxicity (project D3-201)

This TI Pharma research project is being conducted by a consortium consisting of Organon (part of Schering-Plough), Solvay Pharmaceuticals, Pepscan, NOTOX B.V., BioDetection Systems, PamGene, BioFocus DPI, Utrecht University, University of Groningen, Radboud University Nijmegen Medical Centre, Leiden University, VU University Amsterdam, and Leiden / Amsterdam Center for Drug Research.

Approximately 25% of all human adverse drug reactions (ADRs) are not predicted by preclinical safety testing nor clinical trials. This results in delay or cancellation of potentially effective treatment and economic loss. It has a major social impact (hospital admissions, patient discomfort) and additional treatment to solve ADRs may be necessary. For hepatotoxicity, blood dyscrasias and drug hypersensitivity in particular, no adequate translational predictive safety strategies are available. Yet these ADRs are the top three reasons for market withdrawals of drug candidates in development. The ultimate goal of this project is to use Dutch molecular pharmaco-epidemiologic data to develop novel in vitro predictive screening tools, in vivo translational models and biomarkers improving ADR hazard identification.

Vaccine delivery: alternatives for conventional multiple injection vaccines (project D5-106)

This TI Pharma research project is being conducted by a consortium consisting of OctoPlus N.V., Netherlands Vaccine Institute, Leiden University, Utrecht University and VU University Medical Center Amsterdam.

Poor patient compliance, inadequate delivery and adjuvant properties of existing vaccines are limiting factors in vaccination programs for the prevention or treatment of infectious diseases. The aim of this project is to rationally design novel improved vaccine delivery strategies based on nano- and microparticles for different administration routes. The results may lead to new and improved vaccination strategies that can be used for prevention or treatment of infectious diseases, cancer, and autoimmune diseases.

Osteoarthritis: models, mechanisms and markers for patient stratification (project T1-213)

This TI Pharma research project is being conducted by a consortium consisting of Centocor, Erasmus MC (University Medical Center Rotterdam), Leiden University Medical Center and TNO Quality of Life.

Osteoarthritis is the most common joint disorder, especially in the elderly. Little is known about its etiology and pathophysiology, and no treatments are available. In its Priority Medicines Report, the WHO calls for additional research. Yet it is not known which patients will develop rapidly progressing osteoarthritis and why this happens. The current project will investigate the role of synovium and fat tissue in osteoarthritis development and progression. The ultimate goal of this research project is to optimize the efficiency of clinical trials for osteoarthritis by improving patient stratification, understanding disease mechanisms and predicting disease outcome.

Immune modulation and tolerance induction (project T1-214)

This TI Pharma research project is being conducted by a consortium consisting of Numico Research, IQ Therapeutics, Vaxinostics, the University Medical Center Utrecht, Utrecht University, and VU University Medical Center.

Inflammatory diseases like allergies and autoimmune diseases are increasingly occurring in the Western world. These diseases are often associated with a disturbed immune balance and a lack of immunological tolerance. Consequently, there is a wide interest in the discovery and development of safe treatments that can modulate immune disorders and compensate for the lack of tolerance. Understanding the immune system and selecting appropriate immune modulators is crucial for generating safe and effective therapeutic and/or preventive treatment strategies, which is the main objective of the underlying project. In addition, the identified components might be of high interest as adjuvants for vaccines.

The Mondriaan project: The Dutch health care landscape as a population laboratory (project T6-101)

This TI Pharma research project is being conducted by a consortium consisting of GlaxoSmithKline, University Medical Center Utrecht, and Utrecht University.

The Netherlands has an outstanding international reputation in the use of routine medical data for pharmaco-epidemiologic and health economic research. The Dutch healthcare landscape with its highly-structured general practitioner information systems, national hospital morbidity and pharmacy registrations, and the health statistics database, currently allows for ongoing access to longitudinal data about clinical and laboratory tests, medical drug prescriptions, primary and secondary care diagnosis and disease outcomes for Dutch citizens. The Mondriaan Project aims to provide a grid to integrate and enrich existing and new health data platforms in order to fuel pharmaceutical research in the Netherlands and to enable the Netherlands to play an internationally competitive role in drug innovation.

The Escher project: Science-driven drug regulation and innovative research throughout phased drug development (project T6-202)

This TI Pharma research project is being conducted by a consortium consisting of Organon (part of Schering-Plough), MSD, GlaxoSmithKline, Amgen, WINAp, Utrecht University, University Medical Center Utrecht, Erasmus MC (University Medical Center Rotterdam), University of Groningen, and University Medical Center Groningen.

This project encompasses a series of synergistic research activities that address three questions. What kind of regulatory barriers preventing the launch of medicinal products on the market can be identified, are there scientifically sound alternatives, and how can these contribute to science-based regulatory reform? What are the foundations of current research designs for testing the efficacy and safety of new drugs, are there scientifically sound alternative models (in terms of design, statistical analyses and outcomes definition) and how can these contribute to efficiency in drug development? What can we learn from the accumulated regulatory and drug development data, is scientifically valid information management feasible, and how can these data contribute to an improved understanding of the interface between drug development, regulatory affairs and clinical use of medicines?

About Top Institute Pharma (TI Pharma)

Top Institute Pharma (TI Pharma) aims to achieve leadership in research and education in areas that are critical for the international competitive position of the pharmaceutical industry.

The Institute conducts groundbreaking, cross-disciplinary research and offers advanced training programs focused on improving the efficiency of the entire process of drug discovery and development. This will eventually reduce the 'time- & cost-to-patient' of new medicines and contribute to the well-being of society. TI Pharma devotes special attention to the Priority Medicines project of the World Health Organization.

www.tipharma.com