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CASE STUDIES

Case Study 1 • Case Study 2 • Case Study 3

Case Study 1

Organizational and Biotechnological Experience

  1. On the basis of a lead generated by the web site, Dr. Glasel was hired by a small R&D company as a consultant.

    1. The company had designed and built sensors to detect chemical warfare agents and other hazardous gases
    2. Global's task was to facilitate the company's entry into design of sensors for bacteriological warfare (BW) agents

  2. Dr. Glasel wrote proposals for the use of cutting-edge scientific research and technology to design sensor for BW agents and for early detection of infection of military and civilian personnel by these agents.

    1. One proposal was submitted to TSWG (Technical Services Working Group) to be reviewed by personnel representing the FDA (Federal Drug Administration) and USDA (U.S. Department of Agriculture)

      1. The proposal was one of the 12 successful proposals among several hundred submitted in the aftermath of the September 11, 2001 attacks

    2. Another proposal was submitted to the ONR (Office of Naval Research) after being earmarked in the DoD budget

      1. Dr. Glasel wrote the Congressional language that resulted in the earmark

    3. The total amount of funding provided to the company via these proposals was over $5,000,000

  3. The company then appointed Dr. Glasel Acting Director of their new Division of Biotechnology

    1. Global was requested to write advertisements for, vet, and hire PhD- and technician-level staff to perform the research required by the funding agencies
    2. Global was also requested to arrange rental laboratory space and direct renovation of the space to meet the requirements of the proposed research
    3. In addition, Dr. Glasel directed the purchase of all necessary laboratory equipment for the Division—which ultimately comprised 5 PhD-level researchers along with supporting personnel

  4. Dr. Glasel was responsible for the direction of the research performed by the group

    1. He wrote the required detailed monthly reports on progress
    2. He wrote new proposals for further earmarked research in an additional scientific direction

      1. This proposal was also funded, netting the company over $6,000,000

    3. Global personally represented the company at business and scientific meetings in the U.S. and overseas

      1. Global arranged a congressional visit to the Division's facilities
      2. Global prepared promotional literature for the Division's activities
      3. Dr. Glasel presented verbal progress presentations to FDA, USDA and ONR representatives

  5. Dr. Glasel continued the activities described above until leaving the company to pursue other consulting jobs.

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Case Study 2

Teaching in a Business Setting

  1. One of Global's clients asked Dr. Glasel to develop courses in cleanroom microbiology, sterilization techniques, and aseptic processing for professionals drawn from the Pharma and Medical Device Industries.

    1. The courses were not to assume any prior knowledge of microbiology
    2. The courses were to be given to audiences with a wide range of industrial experiences from working technicians to administrative personnel

  2. On the basis of an academic teaching career where Dr. Glasel participated in didactic and problem-solving courses given to students of many levels — undergraduate, graduate, medical/dental, and post-doctoral — he created PowerPoint-based courses designed to provide accurate and useful information for professionals.

    1. "Cleanroom Microbiology for Non-microbiologists"
    2. "Sterilization Techniques for Non-microbiologists"
    3. "Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products"

  3. These courses, which have continued for 4 years, consist of 2 days of intensive instruction presented via 350-400 PowerPoint slides with additional printed notes, glossaries and references.

  4. Results (some student comments):

    1. "This course provided information that DIRECTLY impacted & related to my current job position. The Course Director was very knowledgeable and was able to relate the material to day-to-day "real world' issues." Sr. Aseptic Technician

    2. "This class was exactly what I was looking for. I really enjoyed the format with free interaction and Q&A. I received the information I wanted and the class had a good balance of technical knowledge and practical applications." Manufacturing Manager

    3. "The Course Director was clearly very knowledgeable in the broad spectrum of topics covered within this course. I was anxious to learn and was not disappointed. I found the concepts are applicable throughout our facility, not only in aseptic filling but also in other controlled assembly areas." QA Manager

    4. "Very informative seminar. Excellent facility used." Associate Quality Engineer

    5. "Overall a good fundamental exposure to aseptic principles and cleanroom 'health'." Senior Manager, Supplier Audits

    6. "This course was very informative for me. It helped me to understand basic microbiology without having to take a microbiology course." Manager, Quality Assurance

    7. "Good training course! The instructor was very knowledgeable." Manager, Quality Assurance

    8. "This is a very good source of information for medical device professionals to better understand and increase job performance." QA Supervisor

    9. "Great information and very helpful for those just starting out in the business." Quality Engineer

    10. "Good training course!" Sr. Sterility Assurance Technician

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Case Study 3

Scientific/Technical Writing

  1. Global was hired by a client to write an in-depth review of pharmacogenomics

  2. Using a valuable resource Global has available — on-line access to electronic editions of all major physical sciences and biomedical journals and their archives — Dr. Glasel was able to quickly gain an understanding of the rapidly evolving ideas and debates in this area of "personalized medicine."

  3. The resulting publication that appeared in a volume of a widely respected series was a 50-page chapter titled "Drugs, the Human Genome, and Individual-based Medicine" that covered a wide range of topics relating to pharmacogenomics.

    1. The chapter was reviewed in several biomedical journals

      1. Example, from SAR and QSAR in Environmental Research, vol. 14 (4), August 2003, pp. 317-318, Jucker, E., Progress in Drug Research Vol 58. Birkhauser Verlag AG, Switzerland, 2002, Hardcover, p. 321, ISBN 3-7643-6624-9, 214.95e
        "This 58th volume of the series Progress in Drug Research includes six reviews highlighting some of the latest developments in drug research. In the first chapter, Jay A. Glasel provides a critical analysis of the practical impact that increasing knowledge of human molecular genetics will have on drug development in the next 5-10 years. Ethical considerations are also discussed. Asthma is used as example for illustrating the problems dealing with the application of pharmacogenomics to clinical medicine."

  4. Before and since this publication, Global has written many scientific and technical articles and reports that enabled us to exercise our wide knowledge of physical and biological sciences. We have available powerful assets to assist in performing a wide range of writing activities. These include:

    1. Wide-band in-office access to all major scientific and biomedical e-journals and their archives

    2. In addition to Microsoft Office, other major desktop computer software programs including Adobe Acrobat Standard, PhotoShop, PageMaker, and Illustrator, GraphPad Prism statistical analysis, OmniPage15 optical character recognition, SciFinder Scholar (Chemical Abstracts,) Chem4dd molecular drawing and modeling, EndNote reference editor

    3. In-office access to electronic editions of many major medical monographs and textbooks

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