1. Obtaining and Negotiatiing a Position in Industry/Biotech Roy G. Smith Ph.D. Director, Huffington Center on Aging Professor, Department of Molecular and Cellular Biology (N704, rsmith@bcm.edu)

2. Background Why pharmaceutical or biotech rather than academic career?

3. Requirements for Successful Career in Pharma/Biotech Passion to develop a new drug Anticipate a tougher work ethic than academia Interpersonal skills Communication skills Team building skills Attention to detail – greater rigor necessary than in academia Fearless approach to disproving your hypothesis Flexibility Strong desire to learn the process from drug discovery to FDA approval

4. Discovery to New Drug Application (NDA) Target ID Target Valida- tion Lead Discovery Drug Dev Pre- Clinical NDA Safety Assessment Phase I, II, IIIPharma. Process R&D Basic Research Scientist, Chemists, Patent status, Pharmacologists, Formulation and Process Chemistry

5. Research to Identify New Drug Candidates What is the market for your drug? Selectivity Potency Pharmacokinetics In vivo efficacy Toxicity Metabolism Promiscuity screen

6. GLP Safety Assessment Toxicity in rats and dogs 3, 6, 12 month P450 profile activator/inhibitor Metabolite profile: comparison rat, dog, human (radiolabeled drug) Organ distribution of drug Cardiovascular toxicity CNS toxicity Reproductive toxicology Preclinical Development

7. Clinical Development Initiate and complete Preclinical Safety File IND and Initiate Phase I (healthy volunteers) Initiate Phase II (patients – dose selection) Phase III, Manufacturing and Marketing File NDA await FDA approval

8. Estimated Drug Development Timelines Q2 ‘02 Q1 ‘02 Q4 ‘03 Q3 ‘02 Q1 ‘03 Q2 ‘03 Q3 ‘03 Mfg Q4 ‘02 Tox Studies Phase I Phase II Additional Tox Studies Lead Backup Mfg Tox Studies

9. Tips for Negotiating Make it clear you have always wanted to develop a drug and that you know the process Indicate you are aware, what is important before beginning a new project is the potential market should you be successful If you express an idea for a drug/target show you are aware of competitive products – what is your advantage? Pick a target for a drug that meets and unmet medical need