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Pharmaceutical Research glossary & taxonomy
Evolving terminology for emerging technologies
Suggestions? Comments? Questions?  Mary Chitty mchitty@healthtech.com
Last revised June 15, 2012

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 Informatics term index: Finding guide to terms in these glossaries   Site Map  Related glossaries include Business  Biopharmaceutical Alliances  Business of biopharmaceuticals  Biopharmaceutical Finance  Clinical Molecular Diagnostics  Molecular Medicine  Drugs  Biologics   Drug discovery & development  
Informatics  Algorithms  Bioinformatics  Cheminformatics  Drug discovery informatics  Clinical & medical informatics 
Technologies Technologies overview  
Advances in technologies often accompany research breakthroughs.

Complex biological problems often require integrative and multidisciplinary approaches for their solution. However, individual laboratories may lack the necessary breadth of expertise and resources to achieve this goal. The collaboration of investigators with different intellectual and technical approaches may promote the novel insights required to achieve significant research advances. NIGMS Support for Collaborative Science 2009  http://grants1.nih.gov/grants/guide/notice-files/NOT-GM-08-130.html 

applied research: Aimed at gaining knowledge or understanding to determine the means by which a specific, recognized need may be met. In industry, applied research includes investigations oriented to discovering new scientific knowledge that has specific commercial objectives with respect to products, processes, or services. National Science Foundation, Definitions of Research & Development  http://www.nsf.gov/statistics/randdef/fedgov.cfm 

Right now, NSF is more open to application-oriented research. They need to show Congress that the money spent on research benefits the US economy. Some years ago, the word "applied" was a bad word at NSF. Now it's a good word. The pendulum between focussing on basic or applied research has about a 20 year periodicity. You always need to check to find out where it is at the moment. Check with the program director and knowledgeable colleagues. Susan Finger, Advice on writing proposals to the NSF http://www.cs.cmu.edu/~sfinger/advice/advice.html 

basic research: The objective of basic research is to gain more comprehensive knowledge or understanding of the subject under study, without specific applications in mind. In industry, basic research is defined as research that advances scientific knowledge but does not have specific immediate commercial objectives, although it may be in fields of present or potential commercial interest. National Science Foundation, Definitions of Research & Development http://www.nsf.gov/statistics/randdef/fedgov.cfm 

bleeding edge: (General industry usage) Synonym for "cutting edge," with an added implication of the pioneer's vulnerability. Ex: "We're really on the bleeding edge with this product. Hope it sells through." Being "edgy" is still, however, a desirable Microsoft quality. Ken Barnes et. al., Microsoft Lexicon, 1995-1998 http://www.cinepad.com/mslex.htm

bottom-up: The classical reductionist approach to biology which aims to examine the smallest units to gain insight into the larger ones. Mendelian genetics, which looks at single genes, is a bottom- up approach. Compare top- down. Narrower term: Nanoscience & miniaturization glossary nanofabrication- bottom- up

CORDIS Community Research and Development Information Service: Business of biopharmaceuticals glossary  

CRADA Cooperative Research and Development Act:  Biopharmaceutical law & Intellectual property glossary

clinical research: Molecular medicine glossary

collaborative science: The Administrative Supplements for Collaborative Science (SCS) program is designed to provide a rapid and flexible mechanism to enable NIGMS grantees to form new collaborations that bring novel approaches and ideas to the aims of the funded grant. ...  Collaborations must be newly formed, i.e., there cannot be a substantial history of collaboration in the past 3 years. All collaborators must contribute significant intellectual input to the project, in addition to any technical and/or resource contributions. National Institute of General Medical Sciences, NIH http://www.nigms.nih.gov/Initiatives/Collaborative/SCS.htm 

cutting- edge: See under bleeding edge

data sharing:  NIH Data Sharing Policy, 2003 http://grants.nih.gov/grants/policy/data_sharing/
Sharing Research Data
, National Academies Press, 1985 http://books.nap.edu/catalog/2033.html

Delphi technique:  A cerebral process -- the Delphi Technique -- to identify and then forecast the outlook for these technologies. The Delphi process, developed shortly after World War II to get a better fix on the future, taps the brainpower of a jury of experts.  Dave Beal, St. Paul Pioneer Press, Scenarios, Minnesota FutureWork  

determinism: Molecular Medicine glossary

development: Systematic application of knowledge or understanding, directed toward the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.  National Science Foundation, Definitions of Research & Development http://www.nsf.gov/statistics/randdef/fedgov.cfm Related terms: applied research, basic research 

Early Stage Investigator Policies: This policy represents a change in NIH New Investigator policies designed to encourage early transition to independence.  Under this policy, New Investigators within ten years of completing their terminal research degree or within ten years of completing their medical residency will be designated Early Stage Investigators (ESIs).  Traditional NIH research grant (R01s) applications from ESIs will be identified and the career stage of the applicant will be considered at the time of review and award.  Definition of Early Stage Investigator: A Program Director/Principal Investigator who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if he/she is  within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).  http://grants.nih.gov/grants/new_investigators/index.htm#earlystage

experimental design: The use of mathematical and statistical methods to select the minimum number of experiments or compounds for optimal coverage of descriptor or variable space.  IUPAC Computational

Framework Programme, European Union: Business of biopharmaceuticals glossary

glue grants: NIGMS [National Institute of General Medical Sciences, NIH, US] has two initiatives that seek to promote the integrative and collaborative approaches that are increasingly needed to solve complex problems in biomedical science. Because these programs are meant to provide resources to bring people together, they have been nicknamed "glue grants." http://www.nigms.nih.gov/funding/gluegrants.html

Good Publication Practice: Guidelines for pharmaceutical companies  Good Publications Practice Working Group, 2003 http://www.gpp-guidelines.org/ 

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: The first comprehensive Federal protection for the privacy of personal health information. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule.  NIH http://privacyruleandresearch.nih.gov/   

See also Molecular medicine clinical research and HIPAA      

high risk high reward research: The past two decades have brought tremendous scientific advances that can greatly benefit medical research. While this unprecedented period of progress in the biological, behavioral, clinical, social, physical, chemical, engineering, and mathematical sciences will continue into the foreseeable future, human health and well-being would benefit from accelerating the current pace of discovery. One way to achieve this goal is to support scientists of exceptional creativity who propose highly innovative approaches to major contemporary challenges in biomedical research. By bringing their unique perspectives and abilities to bear on key research questions, these visionary scientists may develop seminal theories or technologies that will propel fields forward and speed the translation of research into improved health.  NIH has traditionally supported research projects, not individual investigators. However, complementary means might be necessary to identify scientists with ideas that have the potential for high impact, but that may be too novel, span too diverse a range of disciplines, or be at a stage too early to fare well in the traditional peer review process. To address this, the NIH Common Fund created three companion awards, the NIH Director's Pioneer, New Innovator, and Transformative R01 Awards, to encourage creative, outside-the-box thinkers to pursue exciting and innovative ideas about biomedical research. A fourth award in the High-Risk Research Program, the NIH Director's Early Independence Award (EIA), was created in fiscal year 2011 to support exceptional early career scientists who possess the intellect, scientific creativity, drive, and maturity to flourish independently immediately following their graduate training, eliminating the need for traditional post-doctoral training.  High Risk Research, NIH Common Fund http://commonfund.nih.gov/highrisk/overview.aspx 

holism: The idea that ``the whole is greater than the sum of the parts.'' Holism is credible on the basis of emergence alone, since reductionism and bottom-up descriptions of nature often fail to predict complex higher- level patterns.   Gary William Flake, Computational Beauty of Nature: Computer Explorations of Fractals, Chaos, Complex Systems, and Adaptation, MIT Press, 1998 http://mitpress.mit.edu/books/FLAOH/cbnhtml/glossary-intro.html

Coined by General J. C. Smuts (1870-1950) to indicate the tendency of nature to produce wholes. First recorded 1926 in Holism & Evolution.  Oxford English Dictionary Related term: top- down.

hypothesis driven research:  The traditional approach of moving from a hypothesis to a specific understanding through research. The era of high- throughput and systematic functional analysis of genes has not rendered hypothesis- or problem driven biological research obsolete or outmoded. Instead, it has created a vast set of new problems to be solved by the traditional biological research approach, centered on human researchers rather than automated systems. However, biologists carrying out hypothesis- or problem driven research often do so utilizing new tools made possible by genomics and other cutting edge systemic technologies (e.g., bioinformatics databases, model organisms for which there are extensive genomics information, and array technology).   
Related terms: discovery driven research, problem driven research; Functional genomics glossary forward genetics 

information silos: The cultural aspects impeding communication between different groups can be immense, are often not recognized or articulated, and greatly impede interdisciplinary research.   Wikipedia http://en.wikipedia.org/wiki/Information_silo  Google = about 2,220 July 7, 2003; about 38,400 Feb. 20, 2006;a bout 74,000 Nov 10, 2006

innovators awards: The NIH Director's New Innovator Award addresses two important goals: stimulating highly innovative research and supporting promising new investigators. Many new investigators have exceptionally innovative research ideas, but not the preliminary data required to fare well in the traditional NIH peer review system. NIH Director's New Innovator Awards http://nihroadmap.nih.gov/newinnovator/index.aspx    See also high risk high reward research

Institutional Review Board: Regulatory Affairs

interdisciplinary research:  Health research traditionally has been organized much like a series of cottage industries, lumping researchers into specialty areas, where their efforts remain disconnected from the greater whole by artificial barriers constructed by technical and language differences between different disciplines and departmentally-based specialties. But, as science has advanced over the past decade, two fundamental themes are apparent: the study of human biology and behavior is a wonderfully dynamic process, and the traditional divisions within health research may in some instances impede the pace of scientific discovery.  The broad goal for the IR program therefore, is to change academic research culture, both in the extramural research community and in the extramural program at the NIH, such that interdisciplinary approaches are facilitated.  Interdisciplinary Research NIH Common Fund  http://commonfund.nih.gov/interdisciplinary/overview.aspx 

There is room for both big and small science, stated George Kenyon [Univ. of Michigan] No one group, company or government entity is going to solve these [proteomics] problems, there is a great need for interdisciplinary collaboration, locally, nationally and globally. Defining the Mandate of Proteomics in the Post- Genomics Era, Board on International Scientific Organizations, National Academy of Sciences, 2002 http://www.nap.edu/books/NI000479/html/R1.html

Terminology and ideas relevant to genomics comes from a wide variety of disciplines: analytical chemistry, biochemistry, bioinformaticsbiomechanics, biophysics, biotechnology, cell biology, clinical and research medicine, computer sciences, developmental and structural biology, electrochemistry, electronics, engineering, enzymology, epidemiology, imaging, immunology, mathematics, microbiology, molecular biology, optics, pharmacology, public health, statistics, toxicology, virology and aspects of business, chaos theory, ethics and law are all relevant. 

Few people (if any) can be truly interdisciplinary and expert in all of these subjects. Universities are struggling with the challenge of (and need to) building bridges between departments. Companies are as well.  We all need to learn more to participate in informed public debate. 

kilogram: Redefinition of the kilogram: An idea whose time has come, Ian Mills et. al, Metrelogia 42: 71-80, 2005  http://www.iop.org/EJ/abstract/0026-1394/42/2/001  

longitudinal research: Studies done over time, with data collected from the same population.

market research: Business of biopharmaceuticals glossary

meta-analysis Clinical informatics

new investigators: New investigators are the innovators of the future - they bring fresh ideas and technologies to existing biomedical research problems, and they pioneer new areas of investigation. Entry of new investigators into the ranks of independent, NIH-funded researchers is essential to the health of this country’s biomedical research enterprise. NIH’s interest in the training and research funding of new investigators is understandably deep and longstanding.  http://grants.nih.gov/grants/new_investigators/index.htm 

new paradigms: An investigation by Science revealed that use of the term "new paradigm" in MEDLINE and the ISI database of leading journals increased steadily during the 1990’s, as did its use in NIH and NSF databases of new grants. J Cohen "The March of Paradigms" Science 283 : 1998-1999 Mar 26, 1999 

While many advances are unlikely to be truly new paradigms, a few developments show signs of being more than incremental improvements. Roger Brent compares microarrays to the microscope and telescope because they "enable observation of the previous unobservable" [transcripts expressed under different conditions in cells, tissues, and organisms]  R. Brent, "Functional genomics: learning to think about gene expression data" Current Biology 9: R338-R341, May 1999 This is no overstatement. Related terms: paradigm, paradigm shifts

NIH Common Fund: The NIH Common Fund was enacted into law by Congress through the 2006 NIH Reform Act to support cross-cutting, trans-NIH programs that require participation by at least two NIH Institutes or Centers (ICs) or would otherwise benefit from strategic planning and coordination. The requirements for the Common Fund encourage collaboration across the ICs while providing the NIH with flexibility to determine priorities for Common Fund support. http://nihroadmap.nih.gov/about.aspx 

NIH roadmap:   Now called the NIH Common Fund

nominal group technique: Research in group dynamics indicates that more ideas are expressed by individuals working alone but in a group environment than by individuals engaged in a formal group discussion. The Nominal Group Technique is a good way of getting many ideas from a group. It has advantages over the usual committee approach to identifying ideas. Group consensus can be reached faster and everyone has equal opportunity to present their ideas. ... The nominal group is a structured group that meets to gather information about a specific concern; that is, to identify problems and priorities. Individuals work alone but in a group setting. GUIDELINES FOR USING THE NOMINAL GROUP TECHNIQUE, Center for Rural Studies, Univ. of Vermont, 1997 http://crs.uvm.edu/gopher/nerl/group/a/meet/Exercise7/b.html

paradigm: An archetypal solution to a problem. [News about the passing away of Thomas Kuhn, NY Times obituary, 19 June 1996] http://www.brint.com/kuhnnews.htm
Paradigm
, Keith Cunningham, 1994. http://capita.wustl.edu/ME567_Informatics/concepts/paradigm.html   Narrower terms: new paradigm, paradigm shifts

paradigm shifts: The opposite of incremental changes.  Related terms: new paradigms, paradigm

peer review: The evaluation by experts of the quality and pertinence of research or research proposals of other experts in the same field. Peer review is used by editors in deciding which submissions warrant publication, by granting agencies to determine which proposals should be funded, and by academic institutions in tenure decisions. MeSH, 1994

problem driven research: Applied research, contrast with basic research and discovery- driven, hypothesis- driven.  Are there other nuances?  

R&D research & development: Narrower terms: applied research, basic research, development; Alliances glossary  pre- competitive R&D 

reductionism: The development of molecular genetics on the heels of Mendelian genetics has raised the inevitable philosophical question of whether the discovery of DNA represents the ultimate reduction of biological to physicochemical processes. Numerous philosophers of science have approached the issue, especially the basic question of what exactly is meant by "reductionism." A useful exploration of this issue, specifically in relation to genetics, is by Kenneth Schaffner in "Approaches to Reduction," Philosophy of Science, 1967, 34:137-147. In another paper Schaffner argues that molecular biology was not built on a conscious attempt to reduce Mendelian to molecular genetics: ... Garland E. Alen "Life Sciences in the Twentieth Century" History of Science Society Newsletter, 17 (5) Supplement 1988 http://depts.washington.edu/hssexec/newsletter/1997/allen.html    

"Often used as a term of abuse for those theories which simplify too much" Oxford English Dictionary

research- how to: See Biopharmaceutical Algorithms artificial intelligence How to do research in the MIT AI Lab  Practical and useful, not just for artificial intelligence. Other good references?

Research Joint Venture RJV: Any group of activities, including attempting to make, making, or performing a contract, by two or more persons for the purpose of (a) theoretical analysis, experimentation, or systematic study of phenomena or observable facts, (b) the development or testing of basic engineering techniques, (c) the extension of  investigative findings or theory of a scientific or technical nature into practical application for experimental and demonstration purposes … (d) the collection, exchange, and analysis of research information, or (e) any combination of the [above].” RJV members can be from different sectors as well as from different countries. NCRA quoted in National Science Foundation's Science & Engineering Indicators 1998  
Broader term: Biopharmaceutical Alliances glossary  joint venture

SBIR Small Business Innovation Research: Biopharmaceutical Alliances glossary  

team science: The Science of Team Science is a rapidly emerging field concerned with understanding and managing circumstances that facilitate or hinder the effectiveness of large-scale research, training, and translational initiatives. National Cancer Institute, Cancer Control and Population Sciences  2008 http://cancercontrol.cancer.gov/brp/scienceteam/index.html 

top-down: A systems approach, which looks at the big picture and complexity. Genomics is essentially a top- down approach, the opposite of a bottom- up approach. Our ways of thinking have been so profoundly influenced by bottom- up, reductionist approaches that we are having to learn to think in very different ways to begin to fully exploit genomic data. Narrower term: Nanoscience & miniaturization glossary nanofabrication- top- down

TRA Technology Research Associations; technology transfer: Biopharmaceutical Alliances glossary

truth: Making new technology work may be easier than using it to discover truth. Roger Brent, "Functional genomics: learning to think about gene expression data" Current Biology 9: R338- R341, 1999

Question from Nature column Lifelines put to Michel Brunet, palaeontologist "What is the one thing about science you wish the public understood better?" Answer "That the 'truth' is always an asymptotic ideal." Dreams of the past, Nature 423 (6939): 121, 8 May 2003

uncertainty: Molecular Medicine glossary

Bibliography
FDA, Innovation or stagnation: Challenge and opportunity on the critical path to new medical products, 2004 http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
Good Publication Practice: Guidelines for pharmaceutical companies  Good Publications Practice Working Group, 2003  http://www.gpp-guidelines.org/ 
Institutional Review Board Glossary, Office Human Research Protection, HHS, US, 150+ terms http://www.hhs.gov/ohrp/irb/irb_glossary.htm  
IUPAC  International Union of Pure and Applied Chemistry, Glossary of Terms used in Computational Drug Design, H. van de Waterbeemd, R.E. Carter, G. Grassy, H. Kubinyi, Y. C.. Martin, M.S. Tute, P. Willett, 1997. 125+ definitions. http://www.iupac.org/reports/1997/6905vandewaterbeemd/glossary.html
NIAID Glossary of Funding and Policy Terms and Acronyms, 2007 http://www.niaid.nih.gov/ncn/glossary/default.htm
Office of Extramural Research, NIH Glossary & Acronyms 2009  http://grants.nih.gov/grants/glossary.htm   Acronym list, 2008  http://grants.nih.gov/grants/acronym_list.htm 
RePORT Expenditures and Results (RePORTER)  replaces CRISP Thesaurus, NIH, US Guide to Federally Funded Research. 

Alpha biopharmaceutical glossary index

How to look for other unfamiliar biopharmaceutical  terms

IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry.


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