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MBC 3100
Practices in Pharmaceutical Research
January 15, 2015
Course director: Zahoor Shah
Speaking Today: James Slama
Academic, industrial and government research
Organization of research
The Pharmaceutical work force
January 15, 2016
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Scientific Research
- Basic research
- Objective is to advance knowledge
- University
- Results are made public: books & journal publications
- Government, foundation supported
- Applied research & Development
- Object is to create a new product
- Industry—formulation, manufacturing, sales
- Produces patents and trade secrets
- Investor, private capital supported
But, now the old division is changing…government and universities are very interested commercialization, and government and foundation money goes to companies
- Universities are eager to see the “intellectual property” developed on campus patented and licensed as a revenue source.
- Universities are eager to collaborate with companies
- University faculty are encouraged to form small companies
- Companies can accept research grants from the government to address national needs.
- Grants are earmarked to support small business innovation and technology transfer.
- Government research and clinical testing are licensed to firms for commercialization
Research is not the only thing going on… technical training is also necessary for
Education & government
- Teaching
- Administration
- Laboratory support
- Regulatory agencies
- Health and safety
- Technical support in hospitals—instruments and clinical testing
Industry and biotech
- Finance & management
- Regulatory affairs
- Manufacturing
- Quality control
- Technical sales
- Customer technical support
- Industrial hygiene
Research in the Pharmaceutical Sciences
- Industry
- Big Pharmaceutical Companies–Merck
- Contract Research (manufacturing) Companies–Battelle
- Generic Drug Manufacturers–Dr. Reddy’s Laboratories Charlotte, NC
- Biotechnology Companies—Cleveland Biolabs
- Medical device manufactures–NAMSA
- Instrument manufacturers and fine chemicals—Aldrich/Sigma
- Cosmetic companies (Avon, Niadyne)
- Manufacturing (Amylin Ohio)
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Research in the Pharmaceutical Sciences
- Government
- Intramural (government’s own research labs)
- Department of energy: Argon, Fermi, Oak Ridge
- National Institutes of Health
- Department of Defense
- Department of Agriculture
- Extramural: these agencies fund research grants, where the research is conducted by universities and even by companies
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Research in the Pharmaceutical Sciences
- Academia—research and the extension of knowledge is considered an essential part of a university
- Universities with undergraduate and graduate programs
- Academic medical centers
- Any institutions granting a Ph.D.
- Academic technology transfer and academic start-up companies
- Research is funded by government grants, and industrial contracts
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How important are Grants and contracts to Universities?
- National Institutes of Health–fy 2013
- Ohio State University: 360 grants; $128,659,310
- University of Cincinnatti: 154 grants $63,434,296
- University of Toledo Hlth Sci Campus: 34 grants, $11,955,060
- Johns Hopkins University: 1,271 grants, $558,187,054
Research in the Pharmaceutical Sciences
- Research Institutes
- Not companies, exactly, but not really universities although they may give graduate degrees
- Rockefeller University (NY)
- Scripps Institute (La Jolla, CA)
- Sauk Institute (CA) (Society for Infantile Paralysis—Polio vaccine)
- Money comes from private donations, industry or from government
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Ohio Bioscience
Taken from BioOhio Website
Ohio Bioscience Organizations
Distribution across the state of Ohio
NIH Supports Research
Academic Institutions
- Produces trained graduates, who must be gainfully employed, many in companies.
- Academic institutions are now very interested in commercializing the results of their research—licensing patents, startup companies by faculty
- Academic Institutions are dependent on the federal government for research funds but also contract with companies
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Workforce in Pharmaceutical Sciences
- Scientific training—B.S., M.S., Ph.D.
- Associates degree, bachelors, masters, and doctoral in technical specialties
- Doctoral training is often required for leadership in research
- Ph.D. degree is designed to be research training
- Masters level training indicates a high technical expertise and some independence
- Bachelors level represents the entry level for most research jobs, although manufacturing offers opportunity for 2 year college or high school grads
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Workforce in Pharmaceutical Sciences (continued)
- Medical Specialties
- MD and PharmD holders provide patient care and design and review clinical trials
- Business management
- MBA or specialized financial training
- Many technical specialists “cross over” into management after a number of years
- Information Transfer (IT)
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Graduate Programs
- Emphasize research: the thesis (M.S.) and the dissertation (Ph.D.) is the heart of the program.
- The thesis/dissertation requires that the candidate make an original contribution to the knowledge of the field.
- The doctoral programs requires a more significant and substantive contribution to the knowledge
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Masters Degrees
- 2-5 semesters past the B.S. degree;1-2 yrs.
- Graduate credit ≥ 30 semester hours, minimum.
- Can be course work only, or require a thesis or a project.
- A thesis is based on the results of original research
- An MS thesis is a shorter project that that which is expected of a doctoral student
- Objective is advanced training in the field beyond that which is expected of an undergraduate—technical expertise
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