Biological Materials Applications
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The definition of biological materials for this purpose is expansive and includes cells and biological entities as well as those substances described as biologics, biological factors, and biological products.
- Cells and Biological Entities
- Cells are defined by the National Library of Medicine as the fundamental, structural, and functional units or subunits of living organisms. Included in this group are transformed, hybrid, and tumor cell lines, as well as stem cells, among others. The term “biological entity” is a broad term. Biological entities for this purpose include biological materials typically described as an “organism” as well as non-living entities such as viruses. An organism may be defined as an individual that is capable of carrying out all of life’s functions, such as growth, homeostasis, and reproduction. Included in this group are animal disease models.
- Biologics
- Biologics are biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology according to the Center for Biologics Evaluation and Research (CBER), a Center within the Food and Drug Administration.
- Biological Factors
- The National Library of Medicine defines biological factors as endogenously-synthesized compounds that may influence biological phenomena or represent quantifiable biomarkers. Biological factors are a variety of extracellular substances that are not otherwise classified under enzymes, hormones, or hormone antagonists. Included in this definition are antigens, biological markers, blood coagulation factor inhibitors, blood coagulation factors, chemotactic factors, inflammation mediators, intercellular signaling peptides and proteins, pheromones, pigments, and biological toxins.
- Biological Products
- The National Library of Medicine defines biological products as complex pharmaceutical substances, preparations, or agents of organic origin, usually obtained by biological methods or assay. They are used especially in diagnosis and treatment of disease (as vaccines or pollen extracts). Biological products are differentiated from biological factors in that the latter are compounds with biological or physiological activity made by living organisms. Included in this definition are antitoxins, immune sera, menotropins, Picibanil, plant exudates and preparations, and vaccines.
Biological materials identified, developed or created by a research study may have innovative applications in future research studies (bench or clinical) and are a critical type of knowledge transfer. There are nearly 1,350 clinical trials, worldwide, involving biological materials and applications as of 2008 (Source: Gene Therapy Clinical Trials Worldwide). Many of these clinical trials are also testing delivery mechanisms of biological materials.
Assessment
Documentation of use of particular biological material or application of the material in a bench study or clinical trial study is recommended for tracking of knowledge transfer.
Comprehensive review is required to locate biological materials and applications that are being tested in clinical studies or involved in bench studies.
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Search using the keywords of the biological material or application, title or the name of the author/research study that developed or created the initial material or application. |
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Some resources that may be helpful include the following:
Center for Biologics Evaluation and Research (CBER)
The Center for Biologics Evaluation and Research (CBER), operated by the FDA, is responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics. CBER’s regulation of biological products has expanded in recent years to include a wide variety of new products such as biotechnology products, somatic cell therapy and gene therapy, and human cells, tissue and cellular and tissue-based products. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology. These products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.
Clinical Trials.gov
Clinical Trials.gov includes clinical trials from all sources of funding from over 157 countries. Clinical Trials.gov allows for searching by a number of criteria including interventions which allows for a search for a specific drug, device, procedure or vaccine.
Cochrane Library – Clinical Trials
The Cochrane Library consists of a regularly updated collection of evidence-based medicine databases to inform healthcare decision-making. Cochrane provides additional resources such as other systematic reviews, abstracts, technology assessments, economic evaluations, and individual clinical trials.
The Cochrane Library offers a Clinical Trials database that allows for searching of clinical trials as noted in MEDLINE and EMBASE and from other published and unpublished sources. From the main page of the Cochrane Library, select the Clinical Trials resource. Search tips are noted on the main page of the Clinical Trials database.
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Cochrane Library home page |
Gene Therapy Clinical Trials Worldwide
Gene Therapy Clinical Trials Worldwide allows for searching by criteria such as: Trial country, Principal investigator, Disease category, Indication, Vector used, Gene transferred, Gene type, Clinical phase, Trial status, and the Year trial approved/initiated.
Genetic Modification Clinical Research Information System (GeMCRIS)
Genetic Modification Clinical Research Information System (GeMCRIS) is a comprehensive information resource and analytical tool for scientists, research participants, institutional oversight committees, sponsors, federal officials, and others with an interest in human gene transfer research. GeMCRIS allows for access to information about human gene transfer trials registered with the NIH, including medical conditions under study, institutions where trials are being conducted, investigators carrying out these trials, gene products being used, route of gene product delivery, and summaries of study protocols.
National Center for Biotechnology Information (NCBI)
The National Center for Biotechnology Information (NCBI) is a national resource for molecular biology information and is especially useful for research studies that generate biological materials. NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information – all for the better understanding of molecular processes affecting human health and disease. There are cross-searchable databases on a variety of topics such as nucleotide, protein, structure, taxonomy, genome, expression, and chemical databases. A cross-search allows for searching of multiple databases simultaneously and the results in NCBI are displayed to allow for presentation of search results by individual resource.
RePORT Expenditures and Results (RePORTER)
RePORTER is a new database that replaces the Computer Retrieval of Information on Scientific Projects (CRISP) database. RePORTER retains all of the search capabilities of the CRISP database which provided information on federally funded biomedical research projects conducted at universities, hospitals, and other research institutions supported by the Department of Health and Human Services (DHHS).
RePORTER provides additional query fields, hit lists that can be sorted and downloaded to Excel, NIH funding for each project (expenditures), and the publications and patents that have acknowledged support from each project (results). RePORTER also provides links to PubMed Central, PubMed, and the U.S. Patent & Trademark Office Patent Full Text and Image Database for more information on research results.
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Last updated: July 30, 2009