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Business of biopharmaceuticals glossary & taxonomy
Evolving Terminologies for Emerging Technologies
Suggestions? Comments? Questions?  Mary Chitty mchitty@healthtech.com
Last revised December 23, 2013.

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Applications  Map: Finding guide to terms in these glossaries  Site Map Related glossaries include sub-categories Alliances, Financial, Intellectual Property & legal
Applications Molecular Medicine, Drug discovery & development  Informatics Research  Informatics overview  Technologies overview   Ethics

Beyond discovery-oriented biology lies the actual development of marketable diagnostics and therapeutics. In the commercial realm, most of the value ascribed to genomic and proteomic technology and data is tied directly to the pharmaceutical industry’s ability to translate that information into such products. Cambridge Healthtech Drug Discovery Map http://www.healthtech.com/drugdiscoverymap.asp 

adaptive design: Modeling innovative methods of forward-looking companies, Adaptive Design empowers management to create solutions to problems as they happen on the front line. These small changes lead to progressively better care at lower cost. When a patient doesn’t get what he or she needs, the system calls for improvement right there, on the spot, in real time. Dr. John Kenagy What is adaptive design?  http://kenagyassociates.com/adaptive-design/what-is-adaptive-design/overview/

applied research: Research pharmaceutical

benchmarking: The first step in process optimization is benchmarking. By measuring performance at various stages of drug discovery and development, from individual tasks to programs, benchmarking can help identify processes that are not functioning as intended. It enables companies to pinpoint unwanted delays between processes and evaluate the effectiveness of newly implemented technologies and strategies. Narrower term: productivity benchmarking

best practices:  This digest was created to assist biosciences industry partners and their economic development practitioners in identifying key state legislative and administrative efforts needed to create, nurture and retain the bioscience industry. The policies and legislation cited in this document are key examples of state efforts to grow and sustain bioscience industry development. Biotechnology Industry Organization, http://www.bio.org/local/industryDev/ 

Important to remember that the biopharmaceutical industry is cutting - and bleeding- edge.  Agreement on best practices is preliminary at best.  Consider also "lessons learned" and "ongoing challenges".  

big pharma: It is possible to find various lists of  "big pharma" companies.  An article cites Pfizer and GlaxoSmithKline (with ethical drug revenue of more than $20 billion, Merck, AstraZeneca, Bristol Myers Squibb, Novartis, Aventis and Johnson & Johnson ($10- 20 billion) and American Home Products [now Wyeth], Pharmacia [now part of Pfizer], Roche, Eli Lilly, Abbott Laboratories, Schering- Plough and Bayer ($7- 10 billion). MedAdNews publishes an annual list of the top 50 pharmaceutical companies each September. Unlocking the value in big pharma" McKinsey Quarterly No. 2, 2001  Related terms: brand name sector, pharmaceutical industry

bioentrepreneur:  Nature Publishing Group's portal dedicated to scientists interested in commercializing their research. . http://www.nature.com/bioent/index.html 

biomedical companies:  Relation[s] to SIC/ NAICs codes?

biosciences   The biosciences are a diverse group of industries and activities with a common link-they apply knowledge of the way in which plants, animals, and humans function. The sector spans different markets and includes manufacturing, services, and research activities. By definition, the biosciences are a unique industry cluster and are constantly changing to incorporate the latest research.  The Four Major Sectors of Biotechnology The biosciences industry sector is defined as including the following four subsectors: Agricultural Feedstock and Chemicals; Drugs and Pharmaceuticals; Medical Devices and Equipment; and Research, Testing, and Medical Laboratories     Biotechnology Industry Organization, http://www.bio.org/local/industryDev/ 

biotechnology: Biologics

biotechnology firms: The congressional Office of Technology concluded in its pathbreaking 1984 report, and emphasized even more strongly in another 1991 report, that "biotechnology" is not an industrial sector, but rather a set of methods useful in many industrial sectors (usually established ones such as drugs and biologics, devices, or agriculture), but also for some entirely new applications (e.g., DNA forensics). Many firms, almost 1500 listed by the various online services, are called "biotechnology" firms because they are largely built around technologies developed since 1980. These firms are generally competing in established markets, however, even when they compete by using novel products, services, and technical approaches. Robert Cooke- Deegan et. al., World Survey of Funding for Genomics Research: Final Report to the Global Forum for Health Research and the World Health Organization,  September 2000 http://www.stanford.edu/class/siw198q/websites/genomics/finalrpt.htm 

biotechnology industry:  Developers of technology promoting drug development, disease treatment, and a deeper understanding of living organisms. Includes human, animal, and industrial biotechnology products and services. Also included are biosensors, biotechnology equipment, and pharmaceuticals. PriceWaterhouseCoopers MoneyTree Survey definitions, 2003 http://www.pwcmoneytree.com/moneytree/nav.jsp?page=definitions

The biotechnological innovations of the 1970’s took until the 1990’s to integrate. "The Pharmaceutical Industry and the Revolution in Molecular Biology: Exploring the Interactions between Scientific, Institutional and Organizational Change, Iain M. Cockburn, Rebecca Henderson, Scott Stern, 1999. http://www.cid.harvard.edu/cidbiotech/events/henderson.htm

Biotechnology started as a means for producing biopharmaceuticals.  It is only now really starting to be used in the drug discovery and development process.    
Biotechnology Library Research  Guide
, Baker Library, Harvard Business School,  Annotated bibliography, 2005 http://www.library.hbs.edu/guides/biotech/ 

blockbuster drugs:  At CHI’s recent Translational Medicine meeting*, panelists debated the future of the blockbuster. The discussion showed just how much controversy and uncertainty remains surrounding this question.  Malorye Allison, Biomarkers vs. Blockbusters, BioIT World April 2007 http://www.bio-itworld.com/issues/2007/april/biomarker-report/ 

The pharmaceutical business model is currently built on the blockbuster, and many are reluctant for anything to disrupt that. But now that the sequencing project is winding down, the National Institutes of Health (NIH) is investing those dollars into research to identify pharmacogenetic markers.  In some situations, pharma companies will have invested a lot in a compound, and an adverse event will occur, or a certain percentage of patients just won’t respond. To save that drug, they will look to develop a PGx predictive test, which could improve the compound’s value proposition. Pharmacogenetics Offers New Opportunities in Disease Treatment and How Medicines Are Marketed: Interview with Craig Fitzgerald of HealthCarta, CHI's GenomeLink 25.2 http://www.chidb.com/newsarticles/issue25_2.asp 

Mega blockbusters (or drugs that have sold more than $10 billion in sales per year) and super blockbusters (or drugs that have sold more than $2 billion each annually). Though pharma growth slides blockbusters reach new record, WTN News 2005 http://wistechnology.com/articles/1885/ 

Blockbuster drugs have sales of $1 billion plus. 

90% of drugs marketed by big pharma bring in less than $180 million per year. Compare that number to the total cost of $350- 600 million for approving a single drug (including all the failures that lead up to it). Of course, one might think that the money can be made back in four years, but drugs have a huge maintenance cost in terms of regulatory compliance, marketing and sales. The margin on a drug- to- drug basis is very slim. This places the onus on the other 10% of drugs to be blockbusters – to more than make up for most of the other drugs that are earning far too little revenue. This is how the industry has structured itself around a blockbuster mentality – a reliance on drugs that bring in at least $500 million per year in revenue. Considering the odds of achieving blockbuster status, this is a very high- risk strategy. Pharmaceutical companies will have to change their ways if they are going to enter the new era of individualized medicine. Related terms: FIPCO, franchises- pharmaceutical, market fragmentation, multibusters,  niche busters, pharmaceutical industry, targeted therapeutics

brand name sector: Pharmaceutical companies which specialize in developing new drugs, as opposed to generic or "me-too" drugs.  Tend to be highly R&D oriented. Related term: mega-brand

business intelligence: Wikipedia http://en.wikipedia.org/wiki/Business_intelligence  See also competitive intelligence

business models - R&D:  When considering the R&D productivity crisis it is imperative that current thinking, processes and models be challenged. For example, does the current strategy to align R&D by therapeutic area need to be further enhanced or do we chart a different course? The focus will not be on tools or technology for the promises of technology have arrived. The next wave of strategic thinking needs to be around business models and structures. Additionally, the impact of globalization on these evolving models must be understood and leveraged in order to successfully take the next step forward. 

business rules:  Any statement that can be put in the form of "if then". Business rules cam be implemented in a computer program by programming if- then statements in- line. This is very efficient performance- wise, but you have to know exactly what rules need to be placed where. Isabelle Rouvellou, el. al., Combining different business rules technologies: A rationalization, 2000  http://ebusiness.mit.edu/bgrosof/paps/oopsla00-br-wksh.pdf

Centers for Medicare and Medicaid Services: Was HCFA Health Care Financing Administration, name changed in June 2001. http://cms.hhs.gov/

competitive advantage: The business environment in the pharmaceutical industry is changing so fast that the Darwinian concept of "adapt or die" is on the mind of every senior executive. Genomics, microarray analysis, high- throughput screening, and other technologies have increased the complexity of pharmaceutical research; regulatory policy shifts and an ever- shrinking period of product exclusivity threaten profitability; and pharmacogenomics and personalized medicine may turn the old market structure on its head. 

competitive intelligence CI: the process of monitoring the competitive environment and analyzing the findings in the context of internal issues, for the purpose of decision support. CI enables senior managers in companies of all sizes to make more-informed decisions about everything from marketing, R&D, and investing tactics to long-term business strategies. Effective CI is a continuous process involving the legal and ethical collection of information, analysis that does not avoid unwelcome conclusions, and controlled dissemination of actionable intelligence to decision makers.  Strategic and Competitive Intelligence Professionals http://www.scip.org/content.cfm?itemnumber=2214&navItemNumber=492 
Wikipedia: competitive intelligence 
http://en.wikipedia.org/wiki/Competitive_intelligence Definition and external resources.
Competitive Intelligence Glossary
, SCIP http://scip.cms-plus.com/files/Prior%20Intelligence%20Glossary%2009Jan.pdf 

compound annual growth rate: Forecasting.

concentration ratios: http://www.agbioforum.org/v6n3/v6n3a07-oehmke.htm 

convergence strategies: Finding new combinations of formerly distinct market segments for a company’s pharmaceuticals, therapeutic devices, and diagnostic processes or equipment. CHA, Cambridge Healthtech Advisors,  Strategic Considerations for the US Pharmaceutical Industry report, 2005

core competencies: A harmonious blend of capabilities which are difficult for competitors to imitate. Traditionally, core competencies have been directly linked to the competitive attributes of price and performance of products and services. But as techniques and standards for achieving low cost and high quality are increasingly simple to imitate, core competencies must be continuously refined as the source of differential advantage. This implies that today and in the future, the real source of competitive advantage lies within the ability to optimize the blend of technology, procedures, and human skills, all with attributes of flexibility and the ability to optimize the changing opportunities in environment and marketplace. American Institute of Certified Public Accountants "CPA Vision Process Glossary"  http://www.cpavision.org/poll/glossary.cfm

corporate DNA: A company's core values, culture, personality, etc., that supposedly gets passed along to all new employees. Corporate DNA, however, is actually altered slightly every time a new person is hired. And a wholesale shift can occur by simply replacing the CEO. Nominated by Laurel Sutton.  Buzzwords, Buzzwhack, 2002  http://www.buzzwhack.com/buzzcomp/indac.htm

disintermediation: An Internet term referring to the removal of intermediaries in a commercial transaction. The trend toward disintermediation in healthcare will actually arise from the application of the Internet to healthcare.  In one example, Orchid Bioscience announced GeneShield.com an Internet- based genetic testing service to identify people with mutations that could trigger side effects or reduce the efficacy of certain widely- prescribed drugs. Use of this service can potentially place more knowledge and decision power in the hands of the consumer.  There are at least a half dozen of these websites with business models similar to GeneShield.com, all directed to the consumer. CHI Summit Report Transforming the Pharmaceutical Industry  2001

disruptive technologies: Some technology improvements are linear or incremental. Others truly change the paradigm. Harvard Business School faculty member Clayton Christensen's Innovator's Dilemma (1997) analysis (of data from the disk drive industry) found disruptive technologies are much cheaper than existing ones. Big mainstream companies were quite capable of developing these technologies (and had). What they couldn't do was figure out how to market them (and justify devoting sufficient resources to them). The pharmaceutical industry is mentioned only in passing, but the success of larger established companies either partnering with smaller less established ones (clearly happening in the pharmaceutical and biotechnology sectors) or spin- off of promising developments as separate companies (Johnson & Johnson said to be particularly good at this) makes a lot of sense.  Related term: nonlinear

drug development - costs: The fully capitalized cost to develop a new drug, including studies conducted after receiving regulatory approval, averages $897 million, according to an analysis by the Tufts Center for the Study of Drug Development.  The announcement expands on the $802 million estimate released by the Tufts Center in November 2001, by including post-approval R&D costs. The $802 million figure includes total average preclinical and clinical costs up to the time of receiving FDA marketing approval. Estimates are in year 2000 dollars. Joseph DiMasi et. al, Tufts CSDD,  May 13, 2003  http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=29

drug repositioning: Drug discovery & development 

ebXML: Sponsored by UN/CEFACT and OASIS, is a modular suite of specifications that enables enterprises of any size and in any geographical location to conduct business over the Internet. Using ebXML, companies now have a standard method to exchange business messages, conduct trading relationships, communicate data in common terms and define and register business processes. ebXML.org "About ebXML" 2001 http://ebxml.org/ Broader term: Computers & computing XML

elevator pitch: Sound bite version of your business plan.   Advice on from the MIT Enterprise Forum http://www.mitforumcambridge.org/archive/r_apr00.html#editor

emerging companies: While innovation can, and does regularly, occur in any type of business, there are identifiable types of business activities that have combined innovation with extraordinary growth in revenues and employment, at least when compared to other entrepreneurial firms.  These businesses are often referred to as "emerging companies" and typically have a technology-based focus in their products, services and processes.  Emerging companies were once found primarily in the United States; however, it is now abundantly clear that these types of firms can emerge and disrupt markets from almost anywhere in the world and that the strategies deployed by such firms are influenced by a wide range of cultural and environmental factors. Center for Management of Emerging Companies http://www.emergingcompaniesblog.com/ 

EphMrA: European Pharmaceutical Marketing Research Association http://www.ephmra.org/ 

FIPCO Fully Integrated Pharmaceutical Company: In the 1991 – 1992 cycle, people were obviously drawn to the FIPCO model, which is the fully integrated pharmaceutical model. This is based on the idea that it is reasonable for a life sciences startup company to pursue a strategy that involves development of all the downstream capabilities - basic R&D through clinical development, manufacturing, and, ultimately, marketing - under one roof. That philosophy was debunked as a viable business strategy for many of the companies from the 1991– 1992 class that tried to expend substantial resources to build those kinds of capabilities over a product portfolio that was quite narrow and limited in its maturity. In the last cycle of the mid-1990s, the business model that people came full circle to accept was more of an outsourcing model. In this we see companies focusing on what they do best and partnering with bigger companies for clinical trials, marketing and manufacturing. Russell Ray (Credit Suisse First Boston Health Care Group) Roundtable Discussion, Trends in Capital Markets From Convergence: Ernst & Young's Biotechnology Industry Report, Millennium Edition, 2001

For most of Lilly’s history, we applied the model of the “Fully Integrated Pharmaceutical Company” … or “FIPCO.” Under the FIPCO model, which all of Big Pharma adhered to, we believed that individual companies needed to own nearly every part of development, manufacturing, and marketing … in order to bring innovative products to patients efficiently … and at a high level of quality At Lilly, we created a new term describe the structural model for the future that is now taking shape. We call it a Fully Integrated Pharmaceutical Network, or FIPNet. Our goal is still to be “fully integrated,” but not within one company. Instead, we seek to create a fully integrated global network that includes Lilly … but also other companies, organizations, and even individuals in some cases. These collaborators will not be owned or employed by Lilly but nevertheless assembled, led, and managed by us. Borderless Innovation: Evidence and Implications of a Global R&D Network Sidney Taurel Chairman — Eli Lilly and Company November 19 , 2008 Phoenix Committee on Foreign Relations, Phoenix, Arizona http://www.lilly.com/news/speeches/081119/default.html 

Not a term heard as frequently now as in the 1990's.  Related terms: biotechnology industry, pharmaceutical industry

fail fast: A term that makes people in drug discovery and development wince, but considering the costs of later failures, it looks more and more like an important option.

failure http://www.cs.indiana.edu/mit.research.how.to/section3.13.html

franchises - pharmaceutical: In the pharmaceutical industry, we tend to think of franchises as a suite of relevant drugs marketed to a specific cluster of physicians. While this definition served our needs for sales efficiency and scientific credibility, it has left too much value on the table. We encourage the industry to re-think the idea of franchise in terms of brand identity, of the images, values and ideas consumers and other stakeholders, such as pharmacists, associate with a given brand. Vimal Bahuguna and Bob Lieberman, "From Patents to Franchises, Bogart Delafield Ferrier, US 2001 http://www.bdf.com/patentstofranchises.htm 

free market: vs. price controls.  CHA, Cambridge Healthtech Advisors,  Strategic Considerations for the US Pharmaceutical Industry report, 2005 

Global Industry Classification Standard GICS:  GICS classifications aim to enhance the investment research and asset management process for financial professionals worldwide. They are the result of numerous discussions with asset owners, portfolio managers and investment analysts around the world and is designed to respond to the global financial community’s need for an accurate, complete and standard industry definition. The GICS structure consists of 10 sectors, 24 industry groups, 59 industries and 122 sub-industries. Morgan Stanley Capital International Inc., GICS  http://www.msci.com/resources/pdfs/MK-GICS-DIR-3-02.pdf  

Healthcare: Baker Library Guide, 2005 http://www.library.hbs.edu/guides/healthcare/ 

high tech industry: The traditional perception of high tech - still reflected in our indicators - has been research- intensive manufacturing industries, like computers and aircraft. The penetration of technologies like information technology, biotechnology, and advanced materials throughout the economy has, however, changed the basic meaning of high tech. Rather than referring to the output of R&D intensive industries, high tech now refers to a style of work applicable to just about every business ... This change is said to have revolutionized the features of a successful technology policy. Distributed knowledge, skill, entrepreneurship, together with new forms of collaboration between firms, universities and the government, can now result in more effective products and services.  Importantly for both firm and worker income, they can result in significantly differentiated products and services. In other words, technology policy must be more user- centered and demand- based than ever before. Nicholas S. Vonortas "US Policy towards Research Joint Ventures" Nov. 1999 http://elliott.gwu.edu/assets/docs/research/vonortasuspolicy04.pdf 

hype: In the long run, not a useful contribution to awareness of and debate about 21st century science. Related terms marketing; Molecular diagnostics & Genetic testing "good genes, bad genes"

hypercompetitive:  In Richard A. D'Aveni's Hypercompetitive Rivalries: Competing in Highly Dynamic Environments, (1995) he describes situations in which competitive advantages are not sustainable. Companies must be willing to cannibalize their own customers and positions, making all products obsolete including their own. The pharmaceutical industry is sometimes described as hypercompetitive.

incubators: The United States is home to the world’s first research park, launched in 1951 at Stanford University. In the sixty years since, another 170 university-related research parks have sprung up across the country, promoting innovation, incubating technology, and stimulating economic growth. Today, however, the United States has lost its lead. China, India, and Korea are home to the world’s largest research parks, developed by their national governments, attracting global research and development companies from afar to their shores.  In 1981, Congress passed the Bayh-Dole Act, giving universities the lead role in transferring technology into the private sector from federally supported research. Such research contributes anywhere from $47 billion to $187 billion annually to our nation’s gross domestic product (GDP). Association of University Research Parks Power of Place 2.0 Power of Innovation, 2010 http://data.memberclicks.com/site/aurp/AURPPowerofPlace2.pdf

innovators: Research pharmaceutical

KOL Key Opinion Leader: Thought leaders, an important part of many pharmas marketing strategies. May be global, national, regional or local. 

lead users: Contrary to conventional wisdom, successful innovations are often first developed and tested by product or service users themselves - "lead users" rather than by the firms that are first to bring those innovations to market.  Eric von Hippel, Sloan School, MIT, US  http://web.mit.edu/evhippel/www/
Creating Breakthrough Innovations at 3M
, Eric von Hippel, Stefan Thomke and Mary Sonnack  http://www.leaduser.com/documents/3M_Breakthrough_Article.html Related term: innovation

life cycle management: Successful drugs follow a typical pattern of heavy up- front investment in development, followed by market penetration and peaking sales, followed by a decline in the face of follow- on drugs or generics. A number of approaches can be used to alter the shape of this revenue curve, including second- generation follow- on compounds, extended life through formulation and drug delivery enhancements, outcome studies and management of the generification process. Some steps can be taken early to maximize the benefits of drug life cycle management. 

MDDL Market Data Definition Language: An XML- based interchange format and common data dictionary on the fields needed to describe 1) financial instruments, 2) corporate events affecting value and tradability and 3) market-related, economic and industrial indicators.  http://www.mddl.org/default.asp

METI Ministry of Economy, Trade and Industry: In January [2001] the Ministry of International Trade and Industry was transformed into the Ministry of Economy, Trade and Industry (METI).   http://www.meti.go.jp/english/

Previously known at MITI, Japan. Described as "an ambitious effort to restructure the research arm of Japan's industry ministry", made up of 45 institutes and centres with a structure "designed to combine application- orientated goals with considerable operational autonomy for the institutes". D Cyranoski "Goal- directed revamp for Japanese research" Nature 401:7, 1 Mar. 2001 Related term Alliances TRAs Technology Research Associations.

MITI Ministry of International Trade and Industry (Japan): Now MET

market forecasting- pharmaceutical:   Accurately forecasting the market potential for new compounds is becoming an essential tool in long- term strategic planning, as it aids in various decisions that are pivotal to the survival and success of a biotech or pharmaceutical company. Forecasting is used in many situations: to evaluate a licensing opportunity, to assess a particular lead compound and even in pipeline and R&D portfolio analyses. Forecasting is also essential in understanding how the dynamics of a market are changing, and in raising awareness of a company's current and future competitors. .. Top- down forecasting extrapolates from available sales data, using algorithms of how a particular drug class or market has previously performed. Bottom- up forecasting involves reconstructing the market from its components, which allows the analyst to model how particular changes over the forecast period will affect the base- year assumptions.  John Earl "What makes a good forecaster?" Nature Reviews Drug Discovery 2(1): 83, Jan. 2003 http://www.nature.com/drugdisc/nj/articles/nrd1005.html

market fragmentation - pharmaceutical industry: Likely to occur as drugs are developed for specific population subsets with optimized safety and efficacy. Of the perils listed, this is perhaps the least founded. Currently, the percentage of patients that react favorably to a drug ranges from 20-80%. The market segments itself as patients and doctors switch between medications in order to find the one that works. In fact, market share may erode further even in the absence of significant competition as physicians avoid prescribing a drug if a subset of patients suffer toxic side effects. By defining the population that responds well to a drug, pharmacogenomics can help secure market share. Blockbusters are still possible if the defined population is large.

market research: Can be difficult to impossible to find data in emerging sectors and for disruptive technology. Related term: competitive intelligence

megabrands: According to AstraZeneca, a megabrand is a product that has the following characteristics: Reaches $1 billion in annual sales by year two of launch and is clearly destined to achieve peak sales of several billion dollars Requires a rapid global roll- out to around 60 countries within that two- year period Needs a huge marketing investment.  IMS Health, Market Insight, Mar. 2, 2000 http://www.ims-global.com/insight/news_story/news_story_000201e.htm  Related term: brand name sector

milestones: Specific business accomplishments, often tied to funding sources.

multibusters:  Multiple drugs for a single indication, efficacious in identifiable sub- populations.  Related term: blockbuster drugs

NAICS North American Industry Classification System: Replaces US SIC codes. Developed jointly by the U.S., Canada, and Mexico to provide new comparability in statistics about business activity across North America. http://www.census.gov/epcd/www/naics.html   An industry taxonomy. Related term SIC codes

NAPCS North American Product Classification System: On February 2, 1999, in partnership with its counterparts in Mexico and Canada, the Economic Classification Policy Committee (ECPC) of the [US] Office of  Management and the Budget launched a three country initiative to create a product classification system for NAICS industries. We will use this classification system to coordinate the collection, tabulation, and analysis of output and price data for the products. http://www.census.gov/epcd/products/

neuroeconomics: A  highly synthetic and interdisciplinary effort to understand how both humans and animals make decisions. ,,It now seems clear that every day, at every action, our brains unconsciously compute and store the values of every event that befalls us. ,,  What we are trying to do is to combine economics, psychology, and neuroscience into a single descriptive model that explains how we make choices.  Paul Glimcher, Decision making and the brain http://www.amnh.org/news/2011/01/decision-making-and-the-brain/#more-2760 

niche busters: with increased competition from generic drugs, sky-rocketing costs of marketing blockbusters and declining support from regulators, pharmaceutical companies are starting to shift their growth strategies away from blockbuster drugs and on to niche-centric drugs. Niche-busters, as they are being labeled, face less competition and lower marketing costs. The value of theses niche-buster drugs grows significantly when an increased focus on research and development yields faster development times. Champions 2.0, Issy Goldwasser, Symyx Technologies,  BioIT World 2007 http://www.bio-itworld.com/issues/2007/march/champions/symyx/ 

open source intelligence: Wikipedia  http://en.wikipedia.org/wiki/Open_source_intelligence   Not related to open source software.

optimization: A discipline that uses mathematics and computer science techniques to solve complex business problems whose results depend on hundreds, thousands, or even millions of interconnected variables.  Open Channel Foundation "Optimization" http://www.openchannelfoundation.org/discipline/Optimization/  Narrower terms: process optimization; Assays & screening lead optimization

organization of pharmaceutical R&D: By far the most common organizational structure within pharmaceutical R&D is based on therapeutic indications. As target pathways and target families become better recognized as opportunities for synergistic development that cut across disease indications, what are the implications for how best to capture this synergy? As molecular tools are increasingly applied beyond target biology to more of the entire development process, how can expertise in specific tools best be leveraged across different departments? As chemistry and biology become more intertwined, how can researchers trained in one discipline or the other learn to better communicate with each other? As researchers trained in reductionist techniques and used to working on small projects become involved in much larger systems biology and high throughput chemistry projects, how does this change the nature of the work they do? What organizational structures and policies may facilitate optimal performance under these changing conditions? 

outsourcing:  Within the past several years, a number of government labs as well as private and joint venture CRO’s have or will soon offer preclinical GLP study services to Western clients. This report, built on discussions and facility visits to the most advanced labs, provides a detailed view of the current and evolving preclinical study capabilities in China, their structures and services, as well as an analysis of the comparative costs between US and China-based CRO’s. Outsourcing Preclinical Studies to China July 2009 Table of Contents | Tables and Figures | Executive Summary

In the battle against declining productivity, pharma companies have generally responded by restructuring the R&D organization, investing in technology tools and platforms, and entering into mergers and deals. However, an alternative and highly effective approach to the innovation deficit has been quietly gaining momentum. This report examines the reasons, the models, and the benefits of outsourcing in five key areas of R&D: discovery research, ADMET, formulation manufacturing, full-scale manufacturing, and clinical development.  CHA Cambridge Healthtech Advisors, Successful Outsourcing of Pharmaceutical R&D: Trends and Strategies report, 2004

partnering: See Financials partnering

pharmaceutical industry: The pharmaceutical industry thrives on innovative products and clinically differentiated medicines that can create real value. Innovation has the greatest impact on a pharmaceutical company’s long- term success, yet pressure to reduce drug prices from both government and consumers may force drug companies to seek alternative revenue streams. ...  a thorough analysis of current trends and issues that are challenging high- level decision making, including the following: The main issues that companies face as a result of globalization. The need to align products and markets, and differentiate products. Key issues in forming development partnerships. Convergence strategies  — finding new combinations of formerly distinct market segments for a company’s pharmaceuticals, therapeutic devices, and diagnostic processes or equipment. Outstanding needs in new product development & commercialization. Managing the regulatory environment and drug approval process. Insight Pharma Reports, 2015: Strategic Considerations for the U.S. Pharmaceutical Industry report, 2005

I have said for a number of years that I hoped drug companies which encouraged open sharing of scientific information would prosper in the long run, but without finding much evidence (even anecdotal) to validate this.  I was delighted to find the following report which quantified the positive correlation between companies encouraging peer reviewed scientific publication and productivity (correlating patents issued to company scientists with articles published in peer- reviewed journals by company scientists). Diffusion of Science Driven Drug Discovery Organizational Change in Pharmaceutical Research,  Iain M. Cockburn, Rebecca Henderson and Scott Stern, NBER, Sept. 1999 http://www.nber.org/papers/w7359 
Related terms: biotechnology industry, blockbuster drugs, market fragmentation. 
Pharmaceuticals Library Guide
Baker Library, Harvard Business School, 2011  http://www.library.hbs.edu/guides/pharma.html   Annotated bibliography

pharmaceutical marketing: Wikipedia http://en.wikipedia.org/wiki/Pharmaceutical_marketing 

pharmagraphics: The emerging discipline of understanding how different segments of the population relate to their health information needs. How do factors such as age, income, education or disease indication affect consumer behavior and preferences? How can a better understanding of these segments be used effectively to improve the impact of promotional and educational spending allocations between different channels and campaigns  Related term: psychographics

portfolio management:  Portfolio ManagementPortfolio Management  October 22-23, 2013 • Bethesda, MD Program | Register | Download Brochure

price trends - prescription drugs: The purpose of this report is to examine pricing dynamics for prescription drugs for recent years. The prices of new drugs will be analyzed over time and by factors that may be associated with launch prices. Price trends for 1995 to 1999 will also be examined by therapeutic category for a number of major categories (in terms of expenditure levels or growth) with well- defined subclasses that can be analyzed individually and compared on the basis of the age of the category. The pricing of generic substitutes in these therapeutic categories will also be provided for comparative purposes. Finally, launch prices during the study period for new entrants to existing subclasses within the therapeutic categories will be examined and compared to the prices of the incumbents in the subclass. The results show that new drugs can vary substantially in their impact on drug expenditures. Some drugs are introduced at significant discounts to existing drugs that are highly substitutable with the new drug. In addition, while entirely new classes of compounds to treat a disease or condition are often priced at a premium relative to older classes, this is not always the case. The data also suggest that new drug prices tend to reflect the degree of price sensitivity in the market and the perceived value of the product to patients. Finally, average price increases over time for the pharmacologic and chemical classes examined varied in all directions in relation to general price inflation. However, most class price increases were similar to economy- wide inflation rates. Joseph A. DiMasi, PRICE TRENDS FOR PRESCRIPTION: PHARMACEUTICALS: 1995- 1999, Aug. 8- 9, 2000 http://aspe.hhs.gov/health/reports/Drug-papers/dimassi/dimasi-final.htm

pricing: Comparative case studies of market launch, market access, and product pricing strategies for a variety of cancer drugs and companion  diagnostics. Effective and sustainable commercialization strategies will be discussed. Pricing, Reimbursement and Market Access for Targeted Cancer Therapies November 6-7, 2012 • Philadelphia, PA Program | Register | Download Brochure 

process optimization: Rather than focusing on technology alone, companies must closely examine workflow, capacity and communication to optimize discovery much as one might optimize a manufacturing process. Benchmarking performance at multiple points within drug discovery and development is an essential pre- requisite to process optimization. 

productivity:  Iain Cockburn, a professor at the Boston University School of Management who has extensively studied pharmaceutical research productivity, believes the current dearth of new drugs is merely an inevitable pause in the industry's development cycle. Today's drug deficit is often compared with a golden age of applications in the early 1990s that were spawned by advances in small- molecule chemistry 15 to 20 years earlier, he says. Now the industry is adjusting to a new era of molecular biology that will take time to produce results. The adjustment, Cockburn suggests, was side- tracked somewhat by the 1990's biotechnology boom, which confused the process of drug development as large pharmaceutical firms and biotech companies sorted out their roles as potential rivals and collaborators. Further, he says, it is simply harder to invent new drugs now, because the low- hanging fruit -- such as the once- revolutionary ace inhibitors -- has already been plucked. "Now the industry is focusing on cancer, Alzheimer, and exotic viruses. They're working on tougher problems," he says. "The way you come up with these drugs is through a lot of heavy- duty science rather than industrial chemistry, and it's just a lot more expensive."  Susan Warner, Pipeline Anxiety: Scientists Pumped into New Roles, Scientist, 17 (10) May 19, 2003  http://www.the-scientist.com/yr2003/may/prof1_030519.html   Related terms: business model - pharmaceutical, business models -chemical genomics, R&D productivity

proof of concept: Evidence that demonstrates that a business model or idea is feasible. Investorwords http://www.investorwords.com/p5.htm#proofofconcept 
Wikipedia http://en.wikipedia.org/wiki/Proof_of_concept 

Industry and academic experts will be discussing the latest in patient stratification theories and strategies, comparative effectiveness in the PoC stages, and the role of precision medicine in accelerating PoC. The trend of in-licensing molecules to keep the development pipeline fed will be examined, as PoC strategies may differ for “optioned entities.” Presentations will focus on strategic and scientific advances and methods to accelerate PoC.  Accelerating Proof of Concept  November 5-7, 2012 • Philadelphia, PA Program | Register | Download Brochure Accelerating Proof of Concept

Compare proof of principle. Proof of concept is certainly more prevalent as a term. (166,000 hits on Google May 15, 2002 vs. proof of principle 13,600.  These two terms are sometimes used interchangeably, though proof of concept seems generally earlier than proof of principle.  While many of the above examples have a financial context these terms are also used in drug discovery informatics    Google updated Nov 10, 2006 proof of concept 3,170,000 vs. proof of principle 750,000

proof of principle: Proof of principle research aims to provide evidence for the impact of new, alternative disease control tools and approaches. On the basis of such evidence, current disease control strategies may be improved. Research and Training in Tropical Disease, WHO http://www.who.int/tdrold/topics/pop/default.htm 

The lowest cost program aimed at developing an integrated and broad understanding of the basic scientific and engineering aspects of the concept which can be scaled with confidence to provide a basis for evaluating the potential of the concept for fusion energy applications. The basic prerequisite for embarking on an engineering PoP [proof of principle] stage is that (1) its scientific and engineering basis looks promising and that (2) it will lead to an attractive energy utilization embodiment. As with the concept exploration stage, the PoP stage is a combined effort involving experiments, modeling and theory. Snowmass US Fusion energy sciences program, 1999 http://www.fusion.ucla.edu/snowmass/questions/common3/common3prospectus.html

Provider-Payer-Pharma Cross-Industry Data Collaboration  April 28-29, 2014 • Medical Informatics World Boston, MA Program | Register | Download Brochure

R&D productivity: This report examines the convergence of scientific, regulatory, social, political, and economic factors that are inhibiting the development of new molecular entities (NMEs), resulting in the current discovery deficit that threatens the pharmaceutical industry and the delivery of healthcare as we know it. ...offers potential solutions toward securing the future of innovative drug discovery and development. Insight Pharma Reports, Pharmaceutical R&D Productivity: The Path to Innovation, 2005  http://www.insightpharmareports.com/reports/2005/55_RDProductivity/overview.asp 

reimbursement: Generating Evidence for Reimbursement Decisions: Therapeutics  October 21-22, 2013 • Bethesda, MD Program | Register | Download Brochure

Generating Evidence for Reimbursement Decisions: Diagnostics  October 22-23, 2013 • Bethesda, MD Program | Register | Download Brochure

risk management: Can be loosely defined as a systematic process for the identification, analysis, control, and communication of risks ...  Risk management should be integrated into the life cycle of any process or project that's important to a business. The use of a risk- management methodology lets a company make informed decisions about the allocation of scarce resources to areas that are most at risk. B. Paul "How much risk is too much?" Informationweek.com: 116-124, Nov. 6, 2000  Narrower terms: licensing risk, product risk; target risks
Related term: Molecular medicine glossary uncertainty

SIC Standard Industrial Classification codes: The 1997 Economic Census demonstrates the relationship between NAICS and SIC by showing data for the lowest common denominators between the two systems. 1997 census records were assigned both SIC and NAICS codes.   http://www.census.gov/epcd/ec97brdg/   Related term NAICS (replacing SIC codes).

SME Small and Medium Sized Enterprise: Currently defined as a company: which has fewer than 250 full-time equivalent employees; whose annual turnover is no more than €40 million, or whose total assets do not exceed €27 million; which is no more than 25% controlled by a company that is not itself an SME. Science & Society Glossary, Cordis, European Union  http://www.cordis.lu/science-society/glossary.htm#glo_s20 

Semantic Web Business Special Interest Group: http://Business.SemanticWeb.org/ Broader term: Computers, computing & information management glossary: semantic web

sexy technologies: What makes technologies sexy? It seems to be a combination of being new, innovative and challenging, affording clever people a chance to learn new skills (and demonstrate how competitive and bright they are) and expensive (or otherwise not available to just anyone). A quick search of the web identifies artificial intelligence, fuel cells, high- speed computers, robotics, nanotechnology, Java, smart cards, wireless communications and biomaterials as "sexy" by some criteria. I'd be interested to hear other interpretations and nuances of this class of technologies. Are there significant differences in what biologists, businesspeople, chemists, computer scientists and others consider "sexy technologies"? 

SOPs standard operating procedures: This report focus on standard operating procedures SOPs relevant to backup compound strategies and tactics.  Here SOPs do not mean  rigid protocols. Rather they are more like templates into which factors specific to the market opportunity in question are inserted to help decide the ideal approach to backups and to provide higher management with information needed for decisions on resource allocations in and among therapeutic areas.  Insight Pharma Reports, Backup Compound Strategies: Best Practices for Reducing Phase II Risk, 2007 

specialty pharmaceuticals:   Targets a small- medium population disease with high unmet medial need. Often a large molecule injectable. Insight Pharma Reports  Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade  2006

Companies that employ novel corporate strategies with respect to the segments they operate in, technology platforms they work on, and/or the products they market, can be classified under specialty pharma. The first wave of such companies focused on niche therapeutic areas such as ophthalmology and various orphan diseases. Gradually, they have come to include a whole gamut of companies- from therapeutic area concentrators (such as Lundbeck, Actelion), to drug delivery experts (such as Elan), to generics players (such as Teva and Barr) and focused marketers (such as Akorn and SuperGen). In certain cases, other players that have unconventional business models are also classified under specialty pharma. Thus, coming up with a holistic definition of the term "specialty pharma" is a rather tricky proposition. Frost & Sullivan, Evolving Paradigms in the Specialty Pharma industry 2007 http://www.frost.com/prod/servlet/market-insight-top.pag?docid=103268702 

An evolving definition, moving from the "one drug (or one formulation)" model.  Contrast: blockbusters

spin-offs: Large(r) companies may find spinning off smaller divisions (or newly acquired ones outside their core competencies) makes more sense than trying to integrate different companies and cultures. Some spin- offs eventually become larger than the parent.  Johnson & Johnson is noted by Clayton Christensen in his Innovator's Dilemma as being particularly good as spinning off a number of successful enterprises.   Related term: disruptive technologies

stage gate criteria: Process for making periodic go/no go decisions in R&D standards: A challenge to develop for disruptive technologies. See standards: 

start-ups: Startups, the authors [Joshua S. Gans, David H.  Hsu and Scott Stern] observe, have two options when it comes to commercializing innovations. They can compete with incumbents through the product market, or they can cooperate with established businesses by selling their technologies through the market for ideas. In the second case, a startup can, for example, license its technology to a larger company, form a strategic alliance or agree to be acquired outright. If entrepreneurs typically choose one of these cooperative strategies, the balance of market power is likely to be preserved. But if they decide to compete with industry leaders, Joseph Schumpeter's "gale of creative destruction" may well be unleashed. ...when intellectual property protection is strong and complementary assets are critical for success, startups can earn the highest returns by becoming ideas factories and auctioning their innovations to established corporations. The pharmaceutical industry is one sector in which that pattern has prevailed. What's the best Commercialization Strategy for Startups? Sloan Management Review, 43 (3): 10, Spring 2002 http://www-management.wharton.upenn.edu/hsu/inc/doc/media-mentions/david-hsu-mit-spring-2002.pdf 

New businesses, often one looking for funding. Examples of start- ups that eventually achieved capitalization and revenue greater than its parent include: Affymetrix, Abgenix and Guilford Pharmaceuticals.

Merriam-Webster dates the use of "start-up" to 1845.   See also emerging companies

Strategic Alliance Management Congress  May 5-7, 2014 • Philadelphia, PA Program | Register | Download Brochure

strategic resource management:  Strategic Resource ManagementStrategic Resource Management  October 21-22, 2013 • Bethesda, MD Program | Register | Download Brochure

strategies: The pharmaceutical industry thrives on innovative products and clinically differentiated medicines that can create real value. Innovation has the greatest impact on a pharmaceutical company’s long-term success, yet pressure to reduce drug prices from both government and consumers may force drug companies to seek alternative revenue streams. The pharmaceutical industry is in a constant state of flux, and it has never been more important for industry insiders to identify trends and anticipate outcomes. Insight Pharma Reports. Strategic Considerations for the US Pharmaceutical Industry, report, 2005

strategy - pharmaceutical series PSS: PSS programs have been designed to help the R&D leaders and corporate executives assess business opportunities, enhance corporate value and forecast the economic and regulatory landscape within the rapidly changing pharmaceutical & biotechnology industries. Pharmaceutical Strategy Series PSS, Cambridge Healthtech Institute

technology assessment:  http://en.wikipedia.org/wiki/Technology_assessment 

technology audit: Assessment of  a company's technology, present and future needs (including user training), capabilities, and impact upon the core competencies.

technology integration: Easier said than done.  

technology sensing:  
technology transfer: Legal and Intellectual property

time to market: A major consideration for strategic planning in the pharmaceutical industry.

UDDI Universal Description, Discovery and Integration project: The project creates a platform- independent, open framework for describing services, discovering businesses, and integrating business services using the Internet, as well as an operational registry.  http://www.uddi.org/about.html

uncertainty: Molecular Medicine
white space: Financial  Related term: market research

XBRL eXtensible Business Reporting Language: Provides a common platform for critical business reporting processes and improves the reliability and ease of communicating financial data among users internal and external to the reporting enterprise. XBRL.org http://www.xbrl.org/

Bibliography
Business Conferences http://www.healthtech.com/Conferences/Search.aspx?k=&r=&s=PSS
Business CDs, DVDs http://www.healthtech.com/Conferences/CompactDiscSearch.aspx?k=&r=&s=PSS
Business Short courses http://www.healthtech.com/Conferences_Upcoming_ShortCourses.aspx?s=PSS
Business Insight Pharma Market Research Reports http://www.insightpharmareports.com/BioPharma-Strategy-Reports/
    Outsourcing report http://www.insightpharmareports.com/Reports_All_Reports.aspx?t=470355
Business Barnett books http://www.barnettinternational.com/EducationalServices/Publications.aspx?j=Marketing

Booz Allen Hamilton Health Industry http://www.boozallen.com/capabilities/Industries/healthcare 
Ernst & Young Life Sciences http://www.ey.com/US/en/Industries/Life-Sciences 
McKinsey, Pharmaceuticals and Medical Products http://www.mckinsey.com/Client_Service/Pharmaceuticals_and_Medical_Products.aspx 
Pharma Marketing Glossary, Pharma Marketing News http://www.glossary.pharma-mkting.com/ 

Among the most useful business glossaries I’ve found are
American Institute of Certified Public Accountants Glossary of Terms, Acronyms and Abbreviations http://www.aicpa.org/Press/DownloadableDocuments/Acronyms_and_Abbreviations.pdf
Blue Cross Blue Shield Association, Personal Health Records Glossary,  http://www.bcbs.com/healthcare-partners/personal-health-records/phr-glossary.html
Investor words Investor Guide.com Inc., 1997 - 2003, 5000 + terms http://www.investorwords.com/directory.htm
Investopedia http://www.investopedia.com/dictionary/  2007, 5,3000 + terms
PriceWaterhouseCoopers MoneyTreeTm Survey Definitions and Methodology, 2003  http://www.pwcmoneytree.com/moneytree/nav.jsp?page=definitions About 20 definitions of industry classifications and stages of financing.
Private Equity Glossary, Amos Tuck School of Business at Dartmouth, http://mba.tuck.dartmouth.edu/pecenter/resources/glossary.html
Science, Biotech Business http://www.sciencemag.org/feature/plus/sfg/biotech/index.shtml 

Alpha glossary index

How to look for other unfamiliar  terms

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