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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


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)


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


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


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


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


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


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)


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


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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