|
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.what.php
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. It is 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, 64
industries and 139 sub-industries. Morgan Stanley Capital International Inc.,
GICS http://www.msci.com/equity/gics.html
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.cid.harvard.edu/cidbiotech/events/henderson.htm
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 Management November 6-7, 2012 • Philadelphia, PA 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
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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
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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
psychographics:
Determination of psychological factors influencing consumer decisions. Marketing
and advertising term.
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: Evidence
required for post-marketing pricing and reimbursement decisions differs
significantly from evidence needed for regulatory approval. Therefore, it is
important to formulate goals for generating, collecting, and analyzing such
reimbursement evidence early in product development in order to ensure
commercial success of a therapeutic, diagnostic, or device. We are witnessing
the emergence of a new integrated strategy as the biopharmaceutical industry
is partnering up with payers to develop evidence around a product’s validity
and utility, and comparative clinical and cost effectiveness. Pricing,
Reimbursement and Market Access for Targeted Cancer Therapies
November 6-7, 2012 • Philadelphia, PA Program
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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
resource management:
Strategic Resource
Management November 5-6, 2012 • Philadelphia, PAProgram | 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/Reports/All.aspx?s=PSS
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 Glossar, 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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