Drug Discovery and Preclinical Development

Drug Discovery and Preclinical Development

Neal G. Simon, Ph.D. Professor

Department of Biological Sciences

Disclaimer

"Those who have knowledge, don't predict. Those who predict, don't have knowledge."

Lao Tzu, 6th Century BC Chinese Poet

Discovery and Preclinical Development

I. Background II. The R&D Landscape III. Innovation and Transformation IV. The Preclinical Development Process V. Case Study: Stress-related Affective Disorders

Serendipity or Good Science: Building Opportunity

Hoffman

Osterhof

I. Background

Drug Development Process

Biopharmaceutical Drug Development: Attrition

Drug Discovery

Pre-Clinical

Clinical Trials

FDA Review

Large Scale Manufacturing / Phase IV

10,000 Compound

s

250 Compounds

5 years

1.5 years

IND Submitted NDA Submitted

Phase I 20-100 Volunteers

Phase III 1000-5000 Volunteers

5 Compounds

Phase II 100-500 Volunteers

6 years

1 FDA Approved

Drug

2 years 2 years

Quelle: Burrell Report Biotechnology Industry 2006

Capitalized Cost Estimates per New Molecule

*All R&D costs (basic research and preclinical development) prior to initiation of clinical testing ** Based on a 5-year shift and prior growth rates for the preclinical and clinical periods.

DiMasi and Grabowski (2007)

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