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  http://blogs.nature.com/tradesecrets/2011/05/31/ripco-fipco-nrdo-fipnet-vipco

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. https://www.census.gov/eos/www/napcs/index.html

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/   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 http://www.executivedecisionmaking.com/immuno-oncology-ops 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

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 https://languagetips.wordpress.com/category/payorpayer/

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) https://data.oecd.org/healthres/pharmaceutical-spending.htm#indicator-chart

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.

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

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/?articles.view/articleNo/14772/title/Pipeline-Anxiety--Scientists-Pumped-into-New-Roles/    Related terms: business model - pharmaceutical, business models -chemical genomics, R&D productivity

Project Portfolio Management master class 2019 Oct 14-15  Philadelphia PA http://www.executivedecisionmaking.com/MasterClass   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 http://www.investorwords.com/3899/proof_of_concept.html 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 http://en.wikipedia.org/wiki/Proof_of_concept 

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, Epilepsy Res. 2006 Jan;68(1):48-52.  https://www.ncbi.nlm.nih.gov/pubmed/16377153  

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 https://en.wikipedia.org/wiki/Pharmaceutical_policy#Reimbursement  
Five keys to drug reimbursement, Clinical Informatics News, 2013 http://www.clinicalinformaticsnews.com/2013/6/20/five-keys-drug-reimbursement.html    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?" Informationweek.com: 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 https://www.fastcodesign.com/1672672/5-ways-to-make-any-piece-of-tech-sexy

SIC Standard Industrial Classification codes: https://en.wikipedia.org/wiki/Standard_Industrial_Classification  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 https://en.wikipedia.org/wiki/Small_and_medium-sized_enterprises

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 http://www.drugchannels.net/2013/02/defining-specialty-pharmacy.html  

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  https://www.healthaffairs.org/do/10.1377/hpb20131125.510855/full/ 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 https://www.baybridgebio.com/startup_database.html

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   https://www.forbes.com/sites/natalierobehmed/2013/12/16/what-is-a-startup/

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.  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

https://www.forbes.com/sites/natalierobehmed/2013/12/16/a-new-nonprofit-model-meet-the-charitable-startups/

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:  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.  

Business Resources
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
Ernst & Young Life Sciences http://www.ey.com/US/en/Industries/Life-Sciences 
McKinsey, Pharmaceuticals and Medical Products https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights
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
Investor words Investor Guide.com Inc., 2017 http://www.investorwords.com/terms-by-letter.php
Investopedia http://www.investopedia.com/dictionary/ 
PriceWaterhouseCoopers MoneyTree^Tm Definitions, https://www.pwc.com/us/en/technology/moneytree/moneytree-definitions.html  Definitions of industry sectors, stages of financing, type of financing and methodology.

How to look for other unfamiliar  terms