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Pharmaceutical Research glossary & taxonomy

Evolving terminology for emerging technologies
Suggestions? Comments? Questions? 
Mary Chitty MSLS mchitty@healthtech.com
Last revised January 10, 2020

Informatics term index:  Related glossaries include Business  Biopharmaceutical Alliances  Business of biopharmaceuticals  Biopharmaceutical Finance  Clinical Molecular Diagnostics  Molecular Medicine   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: Applied research means the effort that (a) normally follows basic research, but may not be severable from the related basic research; (b) attempts to determine and exploit the potential of scientific discoveries or improvements in technology, materials, processes, methods, devices, or techniques; and (c) attempts to advance the state of the art. When being used by contractors in cost principle applications, this term does not include efforts whose principal aim is the design, development, or testing of specific items or services to be considered for sale; these efforts are within the definition of "development," given below. https://wayback.archive-it.org/5902/20160210164701/http://www.nsf.gov/statistics/randdef/fedgov.cfm

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  https://wayback.archive-it.org/5902/20160210164701/http://www.nsf.gov/statistics/randdef/fedgov.cfm

biomedical research:  (In this document, the term “biomedical” will be used in the broadest sense to include biological, biomedical, behavioral, social, environmental, and clinical studies that relate to understanding health and disease.)  Centers of Excellence for Big Data Computing in the Biomedical Sciences (U54), July 2013  http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-13-009.html

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  [no longer on web]

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 nanofabrication- bottom- up

contract research organization (CRO):  a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant.[citation needed] CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.).[1] Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[2][3]  … The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as:[6]:10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions." Wikipedia 2018 Nov 10 https://en.wikipedia.org/wiki/Contract_research_organization   See also drug discovery & development, Contrast Clinical Trials Clinical Research Organization CRO

cutting- edge: See under bleeding edge

data sharing:  NIH Data Sharing Policy, 2007 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    

development: Development, as used in this part, means the systematic use of scientific and technical knowledge in the design, development, testing, or evaluation of a potential new product or service (or of an improvement in an existing product or service) to meet specific performance requirements or objectives. It includes the functions of design engineering, prototyping, and engineering testing; it excludes subcontracted technical effort that is for the sole purpose of developing an additional source for an existing product. https://wayback.archive-it.org/5902/20160210164701/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

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 NIH: Four unique NIH Director's awards are available for exceptionally creative scientists who propose highly innovative approaches with high-impact potential to major challenges in biomedical research:  https://commonfund.nih.gov/highrisk

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.

Horizon 2020: the financial instrument implementing the Innovation Union, a Europe 2020 flagship initiative aimed at securing Europe's global competitiveness. http://ec.europa.eu/programmes/horizon2020/en/what-horizon-2020

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 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  

Institutional Review Board: Regulatory

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, bioinformatics,  biomechanics, 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 https://www.nist.gov/publications/redefinition-kilogram-decision-whose-time-has-come-0

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

meta-analysis Clinical informatics

Next generation researchers initiative On August 31, 2017, NIH announced policy details in the NIH Guide Notice: “Policy Supporting the Next Generation Researchers Initiative (NOT-OD-17-101)”. The policy amends the definitions of, and policies supporting, early stage investigators (ESIs). In addition, it creates a new policy for early established investigators (EEIs), previously referred to as mid-career investigators, and describes how NIH will monitor the implementation of the policy to determine the impact on ESI and EEI diversity in the NIH portfolio https://grants.nih.gov/ngri.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 

  Increase has certainly continued

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

nominal group technique: The nominal group technique (NGT) is a group process involving problem identification, solution generation, and decision making.^[1] It can be used in groups of many sizes, who want to make their decision quickly, as by a vote, but want everyone's opinions taken into account (as opposed to traditional voting, where only the largest group is considered).^[2] The method of tallying is the difference.  Wikipedia accessed 2018 Feb 6 https://en.wikipedia.org/wiki/Nominal_group_technique

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
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  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