![Page 1: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/1.jpg)
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])
![Page 2: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/2.jpg)
Background
• Why pharmaceutical or biotech rather than academic career?
![Page 3: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/3.jpg)
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
![Page 4: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/4.jpg)
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
![Page 5: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/5.jpg)
Research toIdentify New Drug Candidates• What is the market for your drug?• Selectivity• Potency• Pharmacokinetics• In vivo efficacy• Toxicity• Metabolism• Promiscuity screen
![Page 6: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/6.jpg)
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
![Page 7: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/7.jpg)
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
![Page 8: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/8.jpg)
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
![Page 9: Obtaining and Negotiatiing a Position in Industry/Biotech](https://reader035.vdocument.in/reader035/viewer/2022072013/56812c2e550346895d90b08a/html5/thumbnails/9.jpg)
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