Transcript What is the market for your drug?

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
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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)
Target
Lead
Drug
ValidaDiscovery
Dev
tion
Pharma.
Basic Research Scientist,
Process
Chemists, Patent status,
R&D
Pharmacologists,
Formulation and Process
Chemistry
Target
ID
PreClinical
Safety
Assessment
Clinical
NDA
Phase I, II, III
Research to
Identify New Drug Candidates
What is the market for your drug?
• Selectivity
• Potency
• Pharmacokinetics
• In vivo efficacy
• Toxicity
• Metabolism
• Promiscuity screen
•
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
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
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
Mfg
Backup
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