Jeffrey M. Gimble

The Circular Continuum: Papers to Grants to Patents

This chapter discusses the importance of papers, peer-reviewed publications, grants, and patents in both academia and biotechnology, and focuses on efficient ways to integrate their design and completion. A manuscript in a peer-reviewed journal is the fundamental monetary unit in science. Publications make up ones permanent, public record of accomplishment. Researchers in universities and not-for-profit institutions routinely submit grant applications to the federal government and private research foundations for funding. The private sector is also eligible for grant support. Annually, 2.5% of the federal research budget is specifically set aside for Small Business Innovative Research (SBIR) grants. Many experienced scientists believe that the best grants are those for which 90% of the work has already been completed. Successful grant applications to the National Institutes of Health (NIH) and other federal agencies generally share features in common. Although a manuscript may be the basic monetary unit of science, it is the equivalent of a charitable donation from a business perspective if ones intellectual property does not have patent protection. While the US Patent Office allows investigators to obtain patents on ideas for up to 12 months after a public disclosure, the majority of the worlds legal systems do not.Publisher Summary This chapter discusses the importance of papers, peer-reviewed publications, grants, and patents in both academia and biotechnology, and focuses on efficient ways to integrate their design and completion. A manuscript in a peer-reviewed journal is the fundamental monetary unit in science. Publications make up ones permanent, public record of accomplishment. Researchers in universities and not-for-profit institutions routinely submit grant applications to the federal government and private research foundations for funding. The private sector is also eligible for grant support. Annually, 2.5% of the federal research budget is specifically set aside for Small Business Innovative Research (SBIR) grants. Many experienced scientists believe that the best grants are those for which 90% of the work has already been completed. Successful grant applications to the National Institutes of Health (NIH) and other federal agencies generally share features in common. Although a manuscript may be the basic monetary unit of science, it is the equivalent of a charitable donation from a business perspective if ones intellectual property does not have patent protection. While the US Patent Office allows investigators to obtain patents on ideas for up to 12 months after a public disclosure, the majority of the worlds legal systems do not.

The Circular Continuum

This chapter discusses the importance of papers, peer-reviewed publications, grants, and patents in both academia and biotechnology, and focuses on efficient ways to integrate their design and completion. A manuscript in a peer-reviewed journal is the fundamental monetary unit in science. Publications make up ones permanent, public record of accomplishment. Researchers in universities and not-for-profit institutions routinely submit grant applications to the federal government and private research foundations for funding. The private sector is also eligible for grant support. Annually, 2.5% of the federal research budget is specifically set aside for Small Business Innovative Research (SBIR) grants. Many experienced scientists believe that the best grants are those for which 90% of the work has already been completed. Successful grant applications to the National Institutes of Health (NIH) and other federal agencies generally share features in common. Although a manuscript may be the basic monetary unit of science, it is the equivalent of a charitable donation from a business perspective if ones intellectual property does not have patent protection. While the US Patent Office allows investigators to obtain patents on ideas for up to 12 months after a public disclosure, the majority of the worlds legal systems do not.Publisher Summary This chapter discusses the importance of papers, peer-reviewed publications, grants, and patents in both academia and biotechnology, and focuses on efficient ways to integrate their design and completion. A manuscript in a peer-reviewed journal is the fundamental monetary unit in science. Publications make up ones permanent, public record of accomplishment. Researchers in universities and not-for-profit institutions routinely submit grant applications to the federal government and private research foundations for funding. The private sector is also eligible for grant support. Annually, 2.5% of the federal research budget is specifically set aside for Small Business Innovative Research (SBIR) grants. Many experienced scientists believe that the best grants are those for which 90% of the work has already been completed. Successful grant applications to the National Institutes of Health (NIH) and other federal agencies generally share features in common. Although a manuscript may be the basic monetary unit of science, it is the equivalent of a charitable donation from a business perspective if ones intellectual property does not have patent protection. While the US Patent Office allows investigators to obtain patents on ideas for up to 12 months after a public disclosure, the majority of the worlds legal systems do not.

How to Close a Laboratory

This chapter outlines the specific areas that one needs to address as one packs up ones laboratory. Many circumstances can lead to the closure of a laboratory. One may have initiated the event by accepting a position at another institution. Alternatively, the event may be prompted by an institutional decision to release ones services at the completion of a contract. A company closure event may need to be announced by the board of directors rather than by one or other staff members. One needs to coordinate the announcement of ones laboratorys closure after taking such factors into consideration. A laboratory contains many toxic substances. Institutional, state, and federal regulations require a detailed inventory of these materials and documentation of their safe storage and disposal. One needs to prepare inventories of chemicals, biohazards, and radioisotopes in ones laboratory. Over the course of operation, ones equipment has been exposed to chemical and radioactive hazards. Therefore, one needs to clean and sanitize the equipment and prepare documentation asserting that it is not contaminated in any way.

How to Choose a Postdoctoral Position

This chapter outlines some of the elements that can help scientists decide from where to complete a postdoctoral fellowship. Many young investigators will complete two postdoctoral positions before finding a full-time position in academia or industry. Whether one is a PhD student about to complete ones thesis or a current postdoctoral fellow, the selection process is the same and can be summarized in one phrase: define ones goals. One way in which the scientists can accomplish this is to discuss their career plans with their mentor, colleagues, friends, and family. These are the people who know them and who can serve as a sounding board for their ideas. When deciding on a postdoctoral position, one area to consider is the kind of environment one wants to work in. Institutional choices are abundant, and each type has unique features. Compared to the relatively protected time of ones career in the postdoctoral period, institutional policies will most likely have a strong impact on one. Private universities have unique missions, depending on their charter. Federal research laboratories serve the needs of the public at large and have congressionally mandated research agendas. The scientists need to narrow their search process by determining the type of research they wish to pursue.

The Federal Biologics/Drug/Device Approval Process

This chapter introduces the general process of meeting regulatory standards in the development of a clinical product. It is likely that the US Food and Drug Administration (FDA) or its equivalent agency in other countries will regulate the final product, regardless of its form. Without the FDAs approval, one will not be able to license, market, or sell ones product for use in the US. The FDA will convene and assign a review panel to ones companys product. This will include FDA reviewers with expertise in basic science, clinical issues related to ones field, and Chemistry, Manufacturing, and Controls (CMC). The FDA can accept or reject the Biologics License Application (BLA) for its review. If accepted for review, the FDA can take up to 1 year or more to reach its judgment. To meet the FDAs approval, ones product must be examined and determined to meet the standards established in ones BLA.

Designing and Writing a Patent

This chapter introduces some of the key concepts of preparing patents. The concept of timing differs throughout the world. One is by the records established in bound laboratory notebooks that have been routinely signed, witnessed, and dated on a regular basis. Another is by a Record of Invention filed by the investigator or inventor within his or her own institution. The right to patent an idea or invention is established in the US Constitution. The USPTO determines the merits of a patent application based on three criteria: novelty, utility, and non-obviousness. There are strategic considerations in writing a patent. The precise legal language that is used can make the difference between a line on ones curriculum vitae and a revenue-generating document. One of the most complex parts of the patent is the writing of the Claims, for which the exact choice of words has long-lasting consequences for the intellectual property. The filing process requires one to list all of the inventors on the application.

Chapter 5 – Designing and Writing a Grant

This chapter discusses the strategies that one should employ while designing and writing ones grants. One needs to target ones grant application to a specific agency or foundation. The formats that one will use to write grants for the National Institutes of Health (NIH), the US Department of Defense, or the National Institutes for Standards and Technology (NIST) are completely different. The grant application is only as good as the people involved. One needs to provide documentation that one, ones colleagues, and ones collaborators have the expertise, training, and record of productivity required to successfully complete the project. Granting agencies such as the NIH favor grants that include extensive preliminary data sections. Other agencies, such as the Defense Advanced Research Projects Administration (DARPA), are more receptive to projects at early stages of development. Research studies proposing to use animal subjects must be reviewed by an Institutional Animal Care and Use Committee (IACUC) composed of a veterinarian, scientist, ethicist, and a community representative.

How to Choose a Biotechnology Company

This chapter discusses the importance of institutional and cultural considerations in choosing a biotechnology company. There is a need to focus on the scientific, intellectual, and financial advantages and disadvantages of each environment in relation to ones current position. Scientifically, there are major differences between academia and biotech. It is important to appreciate the infrastructure that academia offers. In biotech, one must be prepared to drop a project that has excellent scientific merit for nonscientific reasons that one may not fully understand. The scientific staff in biotech is not always privy to confidential information used to reach decisions behind closed doors in company boardrooms. It is important to find answers to several questions concerning the biotech companys area of research. Once one begins interviewing, one needs to determine how much control one will have over ones own destiny. Each company has its own distinct culture. In some companies, the management team has specific ideas about the company culture and has taken active steps to foster and encourage certain corporate behaviors at the institutional level.

Designing a Manuscript

This chapter discusses some of the basic themes that one needs to consider as one designs and writes manuscripts for peer-reviewed journals. The process of writing a manuscript serves multiple purposes. First, it is a mechanism to report ones findings and progress to ones scientific peers. Second, it teaches others in the field how to reproduce ones findings. Third, it provides a public record of ones professional accomplishments. A proactive approach using the scientific method to outline ones entire manuscript in advance of the study, is recommended. This approach does not require one to know the outcome of ones experiments in advance, but it instead has one simply consider what possible outcomes one may encounter. Whenever possible, a manuscript should serve the needs of the existing grants of ones laboratory by documenting ones completion of a specific aim or of future grant applications by generating supportive preliminary data. While there is significant debate in the scientific and academic community concerning the relevance of impact factors, one is advised to use this information in making ones publishing decisions.

How to Administer a Laboratory

This chapter discusses how to administer ones laboratory by using scientific knowledge and training, and by developing personnel management. The local talent pool is less expensive to bring on board and may have local connections of value to the laboratory, such as direct knowledge of the operating systems of ones institution. To identify the right people, one will need sophisticated interviewing skills. Before beginning, one needs to talk to ones human resources (HR) officer or personnel director for suggestions and guidance. One needs to determine the personnel one needs in ones laboratory, while taking into consideration ones budget. Always ask for and check references from individual candidates. Word of mouth is often the best way to find and check qualified applicants. The best references, from ones viewpoint, will come from the individuals one already knows. In some instances, employers reduce the responsibility level of or fire employees who have pursued other job opportunities. Therefore, one should not insist on references from a current employer.