Pharmaceutical Toxicology Workshop: Designing Studies to Reduce Animal Use, While Maximizing Human Translation

Drug toxicologists today are caught between a rock and a hard place. The economic climate requires us to achieve more with less - 

more predictive safety, with less time, staff and resources. This Workshop will address this issue directly through dialog and debate in a highly interactive setting. Expert lectures will be followed by break-outs, where speakers and attendees will head for the blackboard to solve the “more with less” challenge. Prototype study designs will be used to start discussion and solicit new approaches. Traditional and new ideas will be tested against the potential to reduce animal use, “false economy” and real workplace constraints. The discussion and outcomes of the Workshop will be recorded through publication in a white paper; this is a key opportunity to contribute experience to an ongoing initiative as follow-on projects are expected.

Topics include: 

• New study  designs/approaches that provide  more translatable data for human risk assessment

- Applicable to small molecule drugs or biologics such as recombinant proteins 

• How studies and endpoints can be efficiently combined to minimize  cost and animal use

- Safety pharmacology; rodent and non-human primate reproductive toxicology

- Efficient design of toxicology/TK/immunotox studies performed in rodents 

• International  industry  and consortium perspectives on 3Rs.

- Europe, UK, and US views from chemical and pharmaceutical industry 

• In vitro studies which  complement toxicology programs or reduce animal use - today 

Who Should Attend

Scientists and managers directly involved in toxicology programs (study directors, scientists, and regulators) in the pharmaceutical, biotech, agrochem industries, or government regulation.

Confirmed  Speakers

Marilyn Brown

Executive Director, Animal Welfare and Training, Charles River

Kathryn Chapman Programme Manager, NC3Rs Gary Chellman

Principal Director, Developmental Toxicology Program Director, Charles River

Christine Copeman

Scientific Director, Infusion, Pharmacology and Neurotoxicology, Charles River

Ian Cotgreave

Director of Toxicology and Safety Assessment, AstraZeneca

Sean Gehen

Senior Toxicologist, Dow AgroSciences 

Alan Hoberman

Executive Director, Developmental (DART) Program Director, Charles River

Henry Holzgrefe

Senior Global Director Safety Pharmacology, Charles River

Steve Madden

Manager, Pharmaceutical Metabolism, Charles River

Stephen Wilson

Research Scientist, Charles River

Program Committee

Lauren Black and Marilyn Brown, Charles River; Kathryn Chapman and Stuart Creton, NC3Rs