Obtaining and Negotiatiing a Position in Industry/Biotech Roy G. Smith Ph.D. Director, Huffington...
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Transcript of Obtaining and Negotiatiing a Position in Industry/Biotech Roy G. Smith Ph.D. Director, Huffington...
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, [email protected])
Background
• Why pharmaceutical or biotech rather than academic career?
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
Discovery to New Drug Application (NDA)
TargetID
Target Valida-
tion
Lead Discovery
Drug Dev
Pre-Clinical
Clinical NDA
Safety Assessment
Phase I, II, IIIPharma. Process R&D
Basic Research Scientist, Chemists, Patent status, Pharmacologists, Formulation and Process Chemistry
Research toIdentify New Drug Candidates• What is the market for your drug?• Selectivity• Potency• Pharmacokinetics• In vivo efficacy• Toxicity• Metabolism• Promiscuity screen
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
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
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 StudiesLead
Backup
Mfg
Tox Studies
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