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?

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