National Research Project to Improve Drug Safety in Children Receives $500,000 Grant From Pfizer

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pfizerVANCOUVER, BRITISH COLUMBIA--(CCNMatthews - Nov. 28, 2006) - A major national research project, co-led by Drs. Bruce Carleton and Michael Hayden, to improve drug safety for children, today received a major contribution of $500,000 from Pfizer Canada Inc. The project, named Genotype-Specific Approaches to Therapy in Childhood (GATC), receives major funding from a Genome Canada/Genome BC-sponsored research program and is led from two research centres within the Child & Family Research Institute (CFRI) at BC Children's Hospital.

A failure of modern medicine is the debilitating and lethal consequences of adverse drug reactions (ADRs) which rank as one of the leading causes of death and illness in North America. Children are at a greater risk for severe ADRs, yet there remains a lack of understanding of their causes due in part to an inability to conduct pediatric patient studies of similar rigour and scope as in adult populations. The goal of GATC is to promote the health and well-being of Canadian children and of the global pediatric community by developing cost-effective interventions to reduce life-long disabilities and deaths caused by severe ADRs. The project will identify pediatric patients experiencing ADRs, collect DNA samples, apply genomics-based technologies to identify ADR-associated genetic markers and help predict and prevent drug toxicity.

The GATC project is also working collaboratively with the Canadian Association of Pediatric Health Centres (CAPHC) and Health Canada to develop this active surveillance program for adverse drug effects in children.

Dr. Bruce Carleton, Director of the Pharmaceutical Outcomes Research at the Children's & Women's Health Centre of BC and UBC's Faculty of Pharmaceutical Sciences, is an international leader in drug safety research. Dr. Michael Hayden, the Director of the Centre for Molecular Medicine & Therapeutics, is an internationally recognized expert in genetics.

The GATC project budget is set at $8.4 million over three years and half of this funding is provided by Genome Canada through Genome British Columbia.

Project partners include nine universities and fifteen other companies and institutions.

"This project will bring a more personalized approach to therapy in children by tailoring therapy for a particular patient based on their genetic make-up and thereby reduce adverse events of different treatments," says Dr. Hayden.

"Our ultimate goal is to be able to translate the genetic knowledge that our team will generate into safer and more effective drug therapy for children, and for patients of all ages," adds Dr. Carleton.

"We are pleased to welcome Pfizer Canada Inc. as a partner in this important national initiative. This program will help to save lives by identifying adverse drug reaction markers that may be used to prevent and predict drug toxicity in children," said Alan Winter, President and CEO of Genome BC. "It also demonstrates the value of collaboration between government, academia and industry for the benefit of all Canadians."

The CFRI and UBC's Faculty of Pharmaceutical Sciences, as advocates for drug safety research, especially welcome the participation of a company that is a major force for innovation in the development of medicines.

"We welcome the participation of Pfizer Canada Inc. as a clear demonstration of the company's commitment to drug safety generally, and children specifically," says Dr. Stuart MacLeod, Executive Director of CFRI.

"The international caliber of Drs. Hayden and Carleton sets the stage for this unique project to discover the specific genetic markers that will predispose a child to have an adverse drug reaction," says Mr. Jean-Michel Halfon, President of Pfizer Canada Inc. "Participating in this research project is another example of Pfizer Canada's leadership and commitment to independent science-based research on the safety of medicines," he added.

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's leading research-based pharmaceutical company. Pfizer discovers and develops leading prescription medicines for both humans and animals, as well as many of the world's best-known over-the-counter healthcare products. Pfizer Canada employs more than 2,000 people across Canada.

BACKGROUNDER

Genotype Specific Approaches to Therapy in Childhood

Adverse drug reactions (ADRs) are one of the top ten causes of death in North America. Half of these reactions are caused by inherited genetic differences and are currently considered 'unavoidable'. The Genotype-specific Approaches to Therapy in Childhood (GATC) project, led by Drs. Michael Hayden and Bruce Carleton, seeks to understand why certain drugs are safe for use in some children but not in others and then to create an-easy-to-administer diagnostic test that will predict and therefore prevent ADRs in children. The goal of the GATC program is to prevent ADRs in children by identifying predictive genomic markers for these reactions. This project aims to create personalized dosing recommendations for common drugs based on a child's genetic profile.

The GATC project will identify ADR predictive markers by comparing DNA and plasma samples from patients who suffered ADRs with patients of the same age who had no reaction after the same medication. The project will obtain its clinical material from two unique Canada-wide surveillance networks: 1) the Canada Paediatric Surveillance Program, a network of 2,300 paediatricians and 2) the GATC hospital-based active surveillance network across 10 major Canadian hospitals. "Two networks of health professionals are needed to capture ADRs," explains Dr. Carleton, "because they occur in both community and hospital settings."

These networks stretch from the Pacific to the Atlantic oceans and include the following institutions:

Children's and Women's Health Centre of BC - Vancouver

Alberta Children's Hospital - Calgary

Winnipeg Children's Hospital - Winnipeg

Children's Hospital of Western Ontario - London

The Hospital for Sick Children - Toronto

Children's Hospital of Eastern Ontario - Ottawa

Montreal Children's Hospital - Montreal

IWK Grace Health Centre - Halifax

Using these valuable clinical resources and harnessing existing strengths and expertise in clinical genomics and genetics, the GATC project will apply innovative large-scale genomic and proteomic strategies to define the genes that cause, or are predictive of childhood ADRs.

The post-genomic era represents an unprecedented opportunity to prevent 'unavoidable ADRs' by translating genomic and proteomic knowledge into tools that can impact the care and treatment of children. Armed with new predictive knowledge of a child's genomic ADR risk profile, GATC will provide a cost-effective prevention strategy to reduce the incidence of childhood ADRs. The outcomes of the project have the power to influence paediatric medical practices around the world.

source -  CCN Mathews