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Business of biopharmaceuticals glossary & taxonomy
Evolving Terminologies for Emerging Technologies
Suggestions? Comments? Questions? 
Mary Chitty MSLS
Last revised September 10, 2019.

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SCOPE NOTE: big pharma, biotechnology firms, blockbusters, competitive advantage, FIPCO Fully Integrated Pharmaceutical Company, franchises, hype, incubators, KOL Key Opinion Leaders, megabrands, stage gate criteria

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   

Related glossaries include  Alliances    Financial    Intellectual Property & legal    Molecular Medicine, Drug discovery & development   Research  Informatics overview    Technologies overview   Ethics

Adaptive Design AD: a clinically intelligent, self-sustaining system for rapidly developing, doing and improving patient-centered care within and across disciplines.  . Dr. John Kenagy What is adaptive design?

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:  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 Fall Unlocking the value in big pharma" McKinsey Quarterly No. 2, 2001  Related terms: brand name sector, pharmaceutical industry

Bio Medical Entreprenur resources: NIH funded collaboration

biomedical companies:  Limited relationships to SIC/ NAICs codes?

biotechnology examples: has applications in four major industrial areas, including health care (medical), crop production and agriculture, non-food (industrial) uses of crops and other products (e.g. biodegradable plastics, vegetable oil, biofuels), and environmental uses. Wikipedia accessed 2018 Sept 18

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 

biotechnology industry:  375 biotech products have received U.S. marketing approval since the 1980s, from 18 during 1980-89 to 179 in 2010-18; biotech products now account for more than 30% of all U.S. Food and Drug Administration (FDA) new drug and biologic approvals. Total biotech sales as a share of all company sales almost doubled between 2007 and 2017, from 23% to 41% among the top 20 pharma companies. ...Biotech products account for 31% of all U.S. approved products with an orphan drug designation.  Tufts Center for the Study of Drug Development, IMPACT Report, 2018 Nov/Dec 

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, 2012

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.

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,

blockbuster drugs:  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 

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, megabrands, 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  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

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

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: Wikipedia: competitive intelligence Definition and external resources.

compound annual growth rate CAGR:  mean annual growth rate of an investment over a specified period of time longer than one year.  Investopedia

concentration ratios: 

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"

corporate DNA: is business jargon for organizational culture.  Wikipedia accessed 2018 Feb 7

Diagnostics Advanced Coverage and Reimbursement for Advanced Diagnostics  August 20-21, 2019 Washington, DC Program  More and more payers are implementing processes that make it progressively more difficult for molecular diagnostics companies and labs to secure payment for their tests. Prior authorization and product registration require laboratories to deliver additional information from clinical trials, physicians, tumor boards, medical societies, etc. 

Diagnostics Molecular in Pharma, Healthcare and the Clinic Commercializing  August 21-22, 2019 Washington, DC Program |   Commercializing molecular diagnostic tests requires comprehending the changing landscape of diagnostic testing, taking stock of reimbursement and regulatory conditions, gaining traction with key opinion leaders and building a successful product launch.

Diagnostics Dx Reimbursement Outlook March 14-15, 2019 San Francisco, CA Program | Getting Paid for Advanced Diagnostics Achieving commercial success for an IVD product or an LDT assay is becoming progressively more difficult in the current healthcare environment. The combination of tightening budgets and the launch of a large number of expensive molecular tests creates complications for payers to respond in traditional ways

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 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, 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: new chapters highlight many of the trends examined in earlier chapters revealing their trajectories as we move into the latter twenty-teens: the cost of drug development rising to over $2.5 billion; the dominance of oncology among FDA approvals and biotechnology in terms of pipeline growth. Updates also present a number of metrics analyses of therapeutic areas with ongoing significance – diabetes and cardiovascular disease – as well as those of emerging importance – immune-oncology and regenerative medicine. Tufts Center for the Study of Drug Development, FDA Approval Trends March 2018

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. "About ebXML" 2001 Broader term: Computers & computing XML

elevator pitch: Sound bite version of your business plan.   

emerging growth companies: A "startup" is a term that generally applies to younger companies that lack a proven or mature business model.  Early-stage startups are searching for business model traction, and fortunate later-stage startups that have traction are searching for business model maturity.  An emerging growth company is a defined term in the JOBS Act - you can read more about the definition here: 

In general, most businesses meet the criteria of an "emerging growth company" if they have less than $1 billion in annual revenue.
Tony Bako, QUORA 2012

emerging technologies: technologies that are perceived as capable of changing the status quo. These technologies are generally new but include older technologies that are still controversial and relatively undeveloped in potential, such as preimplantation genetic diagnosis and gene therapy which date to 1989 and 1990 respectively. Emerging technologies are characterized by radical novelty, relatively fast growth, coherence, prominent impact, and uncertainty and ambiguity. In other words, an emerging technology can be defined as "a radically novel and relatively fast growing technology characterised by a certain degree of coherence persisting over time and with the potential to exert a considerable impact on the socio-economic domain(s) which is observed in terms of the composition of actors, institutions and patterns of interactions among those, along with the associated knowledge production processes. Its most prominent impact, however, lies in the future and so in the emergence phase is still somewhat uncertain and ambiguous.".[1]  Emerging technologies include a variety of technologies such as educational technologyinformation technologynanotechnologybiotechnologycognitive science, psychotechnology, robotics, and artificial intelligence.[2] New technological fields may result from the technological convergence of different systems evolving towards similar goals. Convergence brings previously separate technologies such as voice (and telephony features), data (and productivity applications) and video together so that they share resources and interact with each other, creating new efficiencies. Emerging technologies are those technical innovations which represent progressive developments within a field for competitive advantage;[3]converging technologies represent previously distinct fields which are in some way moving towards stronger inter-connection and similar goals. However, the opinion on the degree of the impact, status and economic viability of several emerging and converging technologies.  Wikipedia accessed 2018 Nov 19

EphMrA: European Pharmaceutical Marketing Research Association 

Executive Decision Making Oct 14-18, 2019 Philadelphia PA  Portfolio management, Strategic Resource Management, Project Portfolio Management, Immuno-Oncology Development Challenges.  In an environment of declining revenues and uncertain commercial success, biopharma, device and R&D companies must continuously optimize their strategy, evaluate their portfolios, improve decision making, reduce risk and effectively deploy resources. 

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

FIPCO Fully Integrated Pharmaceutical Company: With the FIPCO/FIBCO (Fully Integrated Pharmaceutical/Biopharmaceutical Company) model, the strategy is to build and fully integrate most parts of the drug discovery and development chain. Given the large amount of capital required, few biotech firms attain this model, although many dream of it. Janette Dixon  RIPCO, FIPCO, NRDO, FIPNET, VIPCO, , Nature blogs, May 2011

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

franchises - pharmaceutical:  Commercial managers who are responsible for a number of brands face a constant dilemma in choosing where across the franchise or portfolio to invest limited human and financial resources. How can these choices be optimised? The franchise can take a number of forms: the traditional therapy area portfolio with a number of constituent products; a brand with a number of indications each requiring resource; or, at a global level, a single brand with a number of local markets each one competing for investment and support. Pharmafile, Managing the Franchise 2010

Global Industry Classification Standard GICS:  an industry taxonomy developed in 1999 by MSCI and Standard & Poor's (S&P) for use by the global financial community. The GICS structure consists of 11 sectors, 24 industry groups, 68 industries and 157 sub-industries [1] into which S&P has categorized all major public companies.  Wikipedia accessed 2018 Feb. 20

health spending:  measures the final consumption of health care goods and services (i.e. current health expenditure) including personal health care (curative care, rehabilitative care, long-term care, ancillary services and medical goods) and collective services (prevention and public health services as well as health administration), but excluding spending on investments. Health care is financed through a mix of financing arrangements including government spending and compulsory health insurance (“Government/compulsory”) as well as voluntary health insurance and private funds such as households’ out-of-pocket payments, NGOs and private corporations (“Voluntary”). This indicator is presented as a total and by type of financing (“Government/compulsory”, “Voluntary”, “Out-of-pocket”) and is measured as a share of GDP, as a share of total health spending and in USD per capita (using economy-wide PPPs). OECD (2018), Health spending (indicator). doi: 10.1787/8643de7e-en (Accessed on 05 November 2018)

Healthcare: Baker Library Guide, Harvard Business School

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 

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

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
Creating Breakthrough Innovations at 3M
, Eric von Hippel, Stefan Thomke and Mary Sonnack  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. 

life sciences: The life sciences or biological sciences comprise the branches of science that involve the scientific study of life and organisms – such as microorganismsplants, and animals including human beings. Life science is one of the two major branches of natural science, the other being physical science, which is concerned with non-living matter. By definition, biology is the natural science that studies life and living organisms, with the other life sciences being its sub-disciplines. Some life sciences focus on a specific type of organism. For example, zoology is the study of animals, while botany is the study of plants. Other life sciences focus on aspects common to all or many life forms, such as anatomy and genetics. Some focus on the micro scale (e.g. molecular biologybiochemistry) other on larger scales (e.g. cytologyimmunologyethologyecology). Another major, branch of life sciences involves understanding the mind – neuroscience.  Wikipedia accessed 2018 Dec 1

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

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

marketing life sciences: Every marketer knows the difficulty of providing the right content through the right channel to the right audience at the right time. Not to burst anyone’s bubble, but it won’t be getting easier any time soon. Social media’s rapid adoption in the workplace has opened countless avenues to reach potential customers. … In our survey we have polled over 500 active professionals (60% of which identified as researchers or scientists) across the Biotech, Pharma, Academic, Healthcare, Hospital, Government and CRO industries. The survey explores consumer preferences related to both outbound promotions and inbound content marketing tactics…. key categories, including: Technology and Mobile, Outbound Marketing, Email Marketing, Telemarketing, Direct Mail Marketing, Social Media, Content Marketing, Advertising Mediums, Tradeshows and Other Media. Marketing to Life Scientists: A Best Practice Guide for Marketers, 2015  

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  Related term: blockbusters, brand name sector, multibusters

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).

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.

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.   An industry taxonomy. Related term SIC codes

NAPCS North American Product Classification System: The North American Product Classification System (NAPCS) is a comprehensive, market- or demand-based, hierarchical classification system for products (goods and services) that (a) is not industry-of-origin based but can be linked to the NAICS industry structure, (b) is consistent across the three North American countries, and (c) promotes improvements in the identification and classification of service products across international classification systems, such as the Central Product Classification System of the United Nations.

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   This trend continues.

Oncology & Immuno-Oncology Opportunities Strategic and Operational Challenges of Oncology and Immuno-Oncology Drug Development Responding to the New Reality and Pace of Immuno-Oncology and Immunotherapy Projects and Trials OCTOBER 14-15 , 2019, Philadelphia PA Each new cancer diagnosis underscores the importance of delivering new therapies to patients. The biopharmaceutical industry is investing resources in developing new treatments, but the timelines are long and the costs are very high. In addition, the pathway for development is unclear and the rapidity of new approvals is highly impactful to programs in process…and benchmarks are constantly changing! To optimize development of new oncology and immuno-oncology treatments for cancer, we must shorten the time of development, while reducing the overall costs and the number of failed attempts. We need to be smarter and more innovative about how we execute oncology studies. For program managers and TA heads, is there an efficient way to get to decisions faster? With no clear pathway for development, the program managers, project managers and clinical trial leaders in the biopharma industry who must ferry these long, complicated programs through all phases and, ideally, to market, play a critical role at the intersection of science, business and operations

open source intelligence: Wikipedia   Not related to open source software.

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? 

payers or payors:  A reader writes: Is payor an acceptable word?  I know it is commonly used in discussions about insurers and insurance payments for health care, and I know that the word “payer” is correct, but is the spelling “payor” also correct?

The current view is that ‘payer’ is the preferred term in all contexts. However, that doesn’t mean that ‘payor’ is wrong. It is not. Some people differentiate between an institution (e.g., payor—the insurance company) and an individual (e.g., payer—Joe is the payer of his family’s bills). Some people say that ‘payor’ is the GB version, and ‘payer’ is the US version. These people would be wrong; ‘payer’ is seen more often in both GB and the US. In law, ‘payor’ is the preferred word for legal writing. When I was learning this word in school as a child, the word was ‘payor.’ Ask any of the other dinosaurs—they’ll tell you. AMA Manual of Style likes ‘payer’ in every context. The Chicago Manual of Style accepts either word, but has a slight preference for ‘payer.’ Language Usage Weblog 2013

payor healthcare: means: (a) Any insurance company authorized to provide health insurance in this state;  (b) A health maintenance organization;  (c) A health care service contractor; (d) Any legal entity that is self-insured and provides benefits for health care services to its employees; (e) Any legal entity responsible for handling claims for health care services under a state or federal medical assistance program; (f) The State of Oregon or any local government within this state that makes payments for health care services; (g) Any insurer authorized under ORS chapter 731 to transact workers' compensation or casualty insurance this state; or (h) Any employer authorized under ORS chapter 656 to self-insure its workers' compensation risk.  Legal Glossary, Oregon Laws

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.

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 
Related terms: biotechnology industry, blockbuster drugs, market fragmentation. 
Pharmaceuticals Library Guide
Baker Library, Harvard Business School, 2011   Annotated bibliography

pharmaceutical marketing: Wikipedia 

pharmaceutical spending: covers expenditure on prescription medicines and self-medication, often referred to as over-the-counter products. In some countries, other medical non-durable goods are also included. Pharmaceuticals consumed in hospitals and other health care settings are excluded. Final expenditure on pharmaceuticals includes wholesale and retail margins and value-added tax. Total pharmaceutical spending refers in most countries to “net” spending, i.e. adjusted for possible rebates payable by manufacturers, wholesalers or pharmacies. This indicator is measured as a share of total health spending, in USD per capita (using economy-wide PPPs) and as a share of GDP.  OECD (2018), Pharmaceutical spending (indicator). doi: 10.1787/998febf6-en (Accessed on 05 November 2018)

Portfolio Management  2019 Oct 17-18  Philadelphia PA Program  In an environment of declining revenues and uncertain commercial success, biopharma, device and R&D companies need to continuously evaluate their portfolios. Manufacturers must make tough decisions about which products and projects to pursue to optimize long-term revenue and reduce overall risk.
Portfolio Management

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

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    Related terms: business model - pharmaceutical, business models -chemical genomics, R&D productivity

Project Portfolio Management master class 2019 Oct 14-15  Philadelphia PA   begins with well-founded economic and portfolio theory, and quickly moves to practical training in portfolio value maximization using Excel add-in optimization software. Economic principles learned in the master class can be used during preparations and analysis for portfolio reviews and executive decision-making

proof of concept: Evidence that demonstrates that a business model or idea is feasible. Investorwords a realization of a certain method or idea in order to demonstrate its feasibility,[1] or a demonstration in principle with the aim of verifying that some concept or theory has practical potential.[citation needed] A proof of concept is usually small and may or may not be complete. Wikipedia accessed 2018 Feb 27 

Compare proof of principle. Proof of concept is certainly more prevalent as a term..  These two terms are sometimes used interchangeably, though proof of concept seems generally earlier than proof of principle.  While many of the examples have a financial context these terms are also used in drug discovery informatics   

proof of principle: Proof of Principle studies are an early stage of clinical drug development when a compound has shown potential in animal models and early safety testing. This step of proof-of-principle (PoP) or proof-of-concept (PoC) often links between Phase-I and dose ranging Phase-II studies. These small-scale studies are designed to detect a signal that the drug is active on a pathophysiologically relevant mechanism, as well as preliminary evidence of efficacy in a clinically relevant endpoint. Sponsors use these studies to estimate whether their compound might have clinically significant efficacy in other diseases states as well as epilepsy (e.g., migraine, neuropathic pain, anxiety, depression). Endpoints other than seizure frequency often reveal special characteristics of the drug. A structured dose escalation design can reveal dose-dependent effects and adverse effects, crossover studies can demonstrate change, presurgical studies can define efficacy, interictal discharges and photosensitivity models can explain changes in seizure features, transcranial magnetic stimulation evaluates hyperexcitability. PoP studies allow exploration of a wide range of potential therapeutic areas beyond epilepsy as part of an integrated CNS development plan. Proof of Principle studies, B. Schmidt,  2006 Jan;68(1):48-52.  

reimbursement: Once a regulatory agency has determined the clinical benefit and safety of a product and pricing has been confirmed (if necessary), a drug manufacturer will typically submit it for evaluation by a payer of some sort. Payers may be private insurance plans, governments (through the provision of benefits plans to insured  populations or specialized entities like Cancer Care Ontario, which funds in-hospital oncology drugs) or health care organizations such as hospitals. At this point the critical issue is cost-effectiveness. This is where the discipline of pharmaco-economics is often applied. This is a specialized field of health economics that looks at the cost/benefit of a product in terms of quality of life, alternative treatments (drug and non-drug) and cost reduction or avoidance in other parts of the health care system (for example, a drug may reduce the need for a surgical intervention, thereby saving money).  Wikipedia accessed 2018 Feb 27  
Five keys to drug reimbursement
, Clinical Informatics News, 2013
   See also payers/payors. 

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?" 116-124, Nov. 6, 2000  Narrower terms: licensing risk, product risk; target risks.  Related term: Molecular medicine glossary uncertainty

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"? 

Five ways to make any piece of tech sexy, 2013

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. See also NAICS.

Small and medium-sized enterprises (SMEs, also small and medium enterprises) or small and medium-sized businesses (SMBs) are businesses whose personnel numbers fall below certain limits. The abbreviation "SME" is used in the European Union and by international organizations such as the World Bank, the United Nations and the World Trade Organization (WTO). … Industry Canada defines a small business as one with fewer than 100 paid employees and a medium-sized business as one with at least 100 and fewer than 500 employees. … In the United States, the Small Business Administration sets small business criteria based on industry, ownership structure, revenue and number of employees (which in some circumstances may be as high as 1500, although the cap is typically 500).[29] Both the US and the EU generally use the same threshold of fewer than 10 employees for small offices (SOHO).[citation needed]  Also in the United States small and medium-sized manufacturers are referred to as SMM's [30] which the U.S. Department of Energy classifies as having gross annual sales below $100 million, Fewer than 500 employees at the plant site, and annual energy bills more than $100,000 but less than $2.5 million.[31]   Wikipedia accessed 2018 Sept 3

specialty pharmaceuticals:  Although there is no accepted definition of specialty pharmaceuticals, they generally are drugs and biologics (medicines derived from living cells cultured in a laboratory) that are complex to manufacture, can be difficult to administer, may require special patient monitoring, and sometimes have Food and Drug Administration (FDA)-mandated strategies to control and monitor their use. Increasingly, specialty pharmaceuticals have come to be defined by exceeding a certain threshold cost, such as $600 per month, that may place such drugs on higher cost-sharing tiers. Within the current version of the Format, a product can be classified as a specialty pharmaceutical if:  It requires a difficult or unusual process of delivery to the patient (preparation, handling, storage, inventory, distribution, Risk Evaluation and Mitigation Strategy (REMS) programs, data collection, or administration) or, Patient management prior to or following administration (monitoring, disease or therapeutic support systems).  ... From a distribution perspective, specialty pharmaceuticals may require specialized shipping and temperature-controlled storing and handling. Therefore, a class of providers, known as specialty pharmacies, exists to distribute and dispense these products.;..  The AMCP Format is intended as a guide for “…manufacturers of pharmaceuticals, biologics and vaccines who are responding to an unsolicited request from a healthcare system to support reimbursement and/or formulary placement consideration of a new product, new indication, or new formulation of an existing product.”  Academy of Managed Care Pharmacy, 2013  

Specialty pharmaceuticals are a rapidly growing share of total drug expenditures by public and private health plans. These drugs, typically used to treat chronic, serious, or life-threatening conditions, such as cancer, rheumatoid arthritis, growth hormone deficiency, and multiple sclerosis, are often priced much higher than traditional drugs. Total costs can be in the thousands of dollars a month and can exceed $100,000 a year for some products. There are usually few if any low-cost generic equivalents. Specialty Pharmaceuticals, " Health Affairs Health Policy Brief, November 25, 2013.DOI: 10.1377/hpb20131125.510855 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.

startup database, Bay Bridge Bio

start-ups: The American Heritage Dictionary suggests it is “a business or undertaking that has recently begun operation.” … “A company five years old can still be a startup,” writes Y Combinator accelerator head Paul Graham via email. “Ten [years old] would start to be a stretch.” I’ll go out on a limb and say categorically that after about three years in business, most startups cease being startups. This often coincides with other factors that indicate a graduation from startup-dom: acquisition by a larger company, more than one office, revenues greater than $20 million, more than 80 employees, over five people on the board, and founders who have personally sold shares….  the key attribute of a startup is its ability to grow. As Graham explains, a startup is a company designed to scale very quickly. It is this focus on growth unconstrained by geography which differentiates startups from small businesses. A restaurant in one town is not a startup, nor is a franchise a startup. ... In recent years, popular lexicon has begun equating startups with tech companies, as though the two are inherently intertwined … a company contemplating an IPO or one that has already gone public is far from being a startup. ...a company contemplating an IPO or one that has already gone public is far from being a startup. And if you’re flying first class and wearing a suit to work, you’re likely no longer a startup, either. ... If you are generating revenues below $20 million, have less than 80 employees, and remain resolutely in control of the company you started, you're likely running a startup.  What is a startup? Natalie Robehmed, Forbes 2013 Dec 16

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 

New businesses, often one looking for funding.  Merriam-Webster dates the use of "start-up" to 1845.   See also emerging companies

startups, philanthropic: in recent years philanthropic ventures have begun adopting the technological know-how and scrappy mentality of startups to develop a new breed of lean nonprofits. … “All we focus on [is] growth and impact – at the end of the day, we just need to make the numbers go up and to the right,” said Chase Adam, founder of Watsi, a medical crowdfunding charity that was the first nonprofit to be included in a Y Combinator accelerator class….  “Startups test new innovations and are always evolving – I think that that’s really, really important for any organization.” A New Nonprofit Model , Natalie Robehmed, Forbes 2013 Dec 16

strategic resource management:  Strategic Resource Management  Oct 16-17 2019 • Philadelphia PA Program | Although investment in pharma R&D continues to increase, approval of new drugs remains relatively low. This productivity crisis presents new challenges to biopharma R&D in terms of resource management, forecasting, and capacity planning. To counteract the decline in new therapeutics and high risk of product failure, biopharma must adapt with improved performance planning, intelligent outsourcing, and new big data analytics aimed at developing strategic and flexible resource management systems.

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.  

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

uncertainty: Molecular Medicine

unicorn company or unicorn startup: a private company with a valuation over $1 billion. As of August 2018, there are more than 260 unicorns around the world. Variants include a decacorn, valued at over $10 billion, and a hectocorn, valued at over $100 billion. CB insights, Global Unicorn Club, 2018

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.

Business Resources
Business Conferences
Business CDs, DVDs
Business Short courses

Ernst & Young Life Sciences 
McKinsey, Pharmaceuticals and Medical Products
Pharma Marketing Glossary, Pharma Marketing News 

Among the most useful business glossaries I’ve found are
American Institute of Certified Public Accountants Glossary of Terms, Acronyms and Abbreviations
Investor words Investor Inc., 2017
PriceWaterhouseCoopers MoneyTreeTm Definitions,  Definitions of industry sectors, stages of financing, type of financing and methodology.

How to look for other unfamiliar  terms

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