Friday, September 7, 2012

TIBBS Summer Series Session 4: Getting Things Done: How to do Science in an Industry Setting

Author: Dana Walsh

Getting Things Done: How to do Science in an Industry Setting

Part I: Transitioning from a University Setting to Industry in a GLP Environment

Keynote Speaker: Patricia O’Brien Pomerleau, M.S., RQAP-GLP

Biography: Patricia O’Brien Pomerleau is a Registered Quality Assurance Professional in GLPs (RQAP-GLP) by the SQA. She has been in Quality Assurance (QA) for 30 years. Recently, she became a consultant. Before that, she was Director of Quality Assurance and managed the Archives at The Hamner Institutes for the Health Sciences in Research Triangle Park, NC for over 21 years. She has experience in QA and Good Laboratory Practice (GLP) regulations and has managed and directed a QA group for inspecting preclinical studies, performed in-house and at contract laboratories, under the GLP regulations in an FDA and EPA regulated setting. Her previous experience in QA includes Manager of QA for GLPs and GCPs at Rhone-Poulenc Rorer Pharmaceuticals. Patricia has given over 90 professional presentations, including invited lectures at the FDA National Training Course on the Non-Clinical (GLP) Biomedical Monitoring program. She is a member of the NCSOT, the NCCSQA and the SQA University and GLP Specialty Sections. Patricia earned her B.S. degree in Biology from Marymount College and her M.S. in Cellular Biology from Fairleigh Dickinson University.

Summary: Patricia gave some background information on why Good Laboratory Practices (GLPs) were established for industry, what regulations are in place to enforce them, and the agencies that enforce them. She also discussed her experiences as a Registered Quality Assurance Professional.


The History Behind Good Laboratory Practices (GLPs)
GLPs exist to ensure that the end product of a safety study that a company produces is valid and that the data behind it is not fraudulent. The establishment of the regulations was a result of a 1976 investigation by the Food and Drug Administration (FDA) into Industrial Bio-Test Laboratories (IBT). It was estimated that, at this time, IBT was performing 35 – 40% of all toxicology tests in the United States. The FDA’s investigation turned up many instances of incorrect documentation, data falsification, inadequately run studies, and no sponsor reviews, among other questionable practices. The original 1983 article on IBT’s poor conduct can be read here, courtesy of Planet Waves. 

The investigation led to a senate hearing, in which it was deemed that IBT’s staff was unqualified, adequate documentation was not maintained, study plans either did not exist or were changed mid-way through, and they had major issues with animal care and protocols. There were inconsistencies in final reports and issues with archives, as well as data falsification. For example, a pathologist examining tissues for IBT found lesions but was forced to change this in his documentation by the company. The major issues that were identified were documentation and conduct.

Overall, the FDA and senate discovered that not all science was quality science. Based on the hearing, the senate concluded that non-clinical federal regulations for safety studies in industry were needed in order to protect the public. Good Manufacturing Practices (GMPs), which were put into place to ensure high-quality work in manufacturing, were taken and adapted for laboratory work, resulting in GLPs. The FDA first came up with these regulations in 1979, while the Environmental Protection Agency (EPA) developed two more sets.

Doing Science in a GLP-Regulated Environment
The GLP regulations are intended to support the pre-clinical safety of compounds. Although they are meant to assure the quality and integrity of the work, they do not assure or regulate science. The regulations establish standards for documentation and traceability of the work and focus on getting high-quality data into an archive where it can speak for itself in the future. This puts controls on pre-clinical studies. Both the FDA and EPA have inspection agents that visit companies to ensure they are meeting GLP requirements.

Where to find GLP regulations:
Scientific Safety Study References
The links above will help guide you through the GLP regulations and ensure that the study you design meets the required safety standards. Following is another set of useful resources to orient you to GLP requirements and prepare you for a GLP inspection:

  • FDA Warning Letter
    • This is a list of warning letters the FDA has written to non-compliant investigators and/or companies
    • Investigators and/or companies are given 15 days to correct their mistake; if not, they can be barred from conducting future studies

EPA Office Chemical Safety and Pollution Prevention (OCSPP) Harmonized Test Guidelines Series

Series 870Health Effects Test Guidelines  These guidelines will help you decide what techniques to use when investigating the health effects of your compound

OECD Series on Principles of GLP and Compliance Monitoring A list of downloadable papers on the OECD’s GLP principles

FDA, EPA, OECD Comparison Chart – GLPs A useful chart comparing the differences between FDA and EPA GLP regulations

North Carolina Chapter of the Society of Quality Assurance  This local society usually has 4 meetings in the Research Triangle Park area per year and will keep you up to date on ethics, the GLP standards and many other topics

Differences Between Academic and Industry Settings in Light of GLPs
The chart below outlines the things we are used to working with in academia and how they are defined in industry under GLP regulations:

Part II: Intellectual Property Awareness Discussion

Speaker: David J. Levy, Ph.D., J.D., Of Counsel, Womble Carlyle Sandridge & Rice

Biography: Dr. David Levy is a patent attorney with a solo practice. He brings nearly 40 years of high-level pharmaceutical and life sciences patent experience to his practice. David created the U.S. Patent Group for pharmaceutical giant GlaxoSmithKline, and served as the company’s Vice President and Patent Counsel. Because of his background, David is in a unique position to advise general counsel on organizing and structuring patent teams and patent portfolios, particularly those related to the pharmaceutical industry. He provides strategic advice on patent portfolio approaches and other patent-oriented organizational issues, taking into account the organization’s structure and the legal and regulatory environment the company operates in. Prior to joining GlaxoSmithKline, David worked as patent counsel with Johnson & Johnson and with ICI Americas, Inc. David has extensive experience writing and prosecuting U.S. and foreign patent applications for corporate clients, managing patent litigation, including interferences, and in licensing pharmaceuticals as both the negotiator and author of licenses. He has significant experience in all phases of patent practice, particularly in pharmaceuticals and specialty chemicals.

Summary: David’s presentation focused on intellectual property and the process of patenting your idea.


Intellectual Property
Intellectual property is not tangible, although it can be perceived in something tangible. The chart below summarizes types of intellectual property and how the law protects them.

Richard C. Hsu, 2011

Timeline for Obtaining a Patent
The following graphic summarizes the steps involved in patenting your idea:

David Levy, 2012

After coming up with a patentable idea, a provisional application must be filed with the U.S. Patent and Trademark Office. Twelve months later, a non-provisional application is filed and the patent becomes pending. It takes three to five years for the patent to be issued, but the resulting patent is active for twenty years. Maintenance fees are required during this time period at the time points indicated in the graphic above. In 1984, the Hatch-Waxman Act was passed, which extends the protection of a patent for up to five years beyond the initial twenty. Further, it made it easier for generic drugs to enter the market by requiring that they prove bioequivalence of their product to the patented product. This way, generic drug makers do not have to spend the money on clinical safety studies already done by the patented product, making it easier and cheaper for generic drugs to get to the market. The wording of the patent can also cover more compounds than were actually made. More information on the patenting process can be found here.

Patents in Academia
In 1980, the Bayh-Dole Act was passed. It created a uniform patent policy among the federal agencies that fund research, allowing universities to retain rights to inventions made with federal funding. More information on this act can be found here. It also encourages universities to collaborate with companies in order to develop inventions made with federal funding. Under the act, universities are expected to file patents on inventions they want to own and to give licensing preference to small businesses.

About the author: Dana Walsh is a second year graduate student in the Curriculum of Toxicology at the University of North Carolina at Chapel Hill. She works with Dr. Ilona Jaspers at UNC and Dr. David Diaz-Sanchez at the Environmental Protection Agency Environmental Public Health Division. Her research focuses on how air pollution affects the microorganisms inhabiting the airways and their relation to disease.


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