Evaluation of drugs without animals.

REMA (The Spanish Network of Alternative Methods).

Chairs:

Domingo Gargallo (Ferrer International. Toxicology and Safety  Pharmacology Barcelona)

Joan Albert Vericat (Noscira. Madrid. Spain)

Objective:

Review the different possibilities today available to reduce the attrition rate during regulatory non-clinical and clinical development. Is there enough information available in early screening to conduct a limited safety assessment? Until which degree animals can be removed from non-clinical development?

Lecture 1:

Introduction I: The Regulatory Frame in Non-Clinical Drug:

Genetic Toxicology Early Screening

Esperanza Herreros and Santiago Ferrer (In vitro Toxicity and Toxicity, GSK, Madrid)

Lecture 2:

Introduction II: The concept of the 3Rs+R2 (= Replacement, Refinement, Reduction + Responsibility in Research); attrition rates and overview of existing non-animal approaches

Joan Albert Vericat (Noscira. Madrid. Spain)

Lecture 3:

Genetic Toxicology Early Screening (30+10 minutes)

Domingo Gargallo (Ferrer International, Barcelona)

Lecture 4:

Metabolism & ADE; (1) Metabolism. (2) ADE & Modeling.

Lourdes Gombau (Avancell, Barcelona)

José Vicente Castell (Centro Investigación, Hospital LaFe, Valencia)

Lecture 5:

Need for complexity: Integration in vitro and in vivo activities

Joan Albert Vericat (Noscira. Madrid. Spain)

Lecture 6:

Points of view of Regulatory Authorities

Federico Goodsaid (US-FDA)

Final Discussion:

Open discussion and take home messages.