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Obtaining and Negotiatiing a Position in Industry/Biotech

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

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Obtaining and Negotiatiing a Position in Industry/Biotech

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  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 Clinical NDA Basic Research Scientist, Chemists, Patent status, Pharmacologists, Formulation and Process Chemistry Pharma. Process R&D Safety Assessment Phase I, II, III

  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. Preclinical Development • 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

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

  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

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