INDUSTRY ISSUES

What Is a
Biopharmaceutical?
Part 2: Company and Industry Definitions
By Ronald A. Rader

T
his is the conclusion and (mis)use of biopharmaceutical
of a two-part article (and biotechnology), particularly as
about basic terminology applied to companies and the indus-
problems concern- try. This includes terminology used
ing biopharmaceutical by the financial community, popular
K EVIN R STEFFY PRIER

(and biotechnology) products, press, industry analytical studies, trade

technologies, companies, and the associations (BIO and PhRMA), and
industry. Part 1 reviewed basic defi- various companies and industry sec-
nitions, concentrating on products tors claiming to be biopharmaceutical.
1. Four different views and patterns

of use of biopharmaceutical were BIO IN BIOPHARMA

described—each with its own defini- The broad biotechnology paradigm
tions of products and companies. (See defines biopharmaceutical as involv-
“Paradigms of Biopharmaceutical ing biotechnology and recognizes
Both major US trade Terminology.”) With diverse defini-
tions in use, exercise caution and
that most relevant companies are
R&D-intensive and have no marketed
associations dilute skepticism whenever encountering
biopharmaceutical (and biotechnology)
products. Based on this, a good work-
ing definition of a biopharmaceutical
the use of the word or related terms. The speaker/author
may be referring to biopharmaceutical
company is:
A company primarily (determined
biopharmaceutical, in the context of
• biotechnology-derived
as majority of revenue, activity, and
so on) involved in the research,
especially as it refers pharmaceuticals
• just new biotechnologies (genetic
development, manufacturing and/or
marketing of biotechnology-based
to companies, such engineering and later)
• biotech-like companies, including
pharmaceutical products or surrogates,
including gene and protein sequences.
that the industry small-molecule and drug R&D service
companies
This definition may be broad-
ened to include companies primarily
no longer exists. • the entire pharmaceutical industry.
This article examines definitions
involved with related supplies and
services—culture media, bioreac-

The opinions expressed in this article are those of the author. We

invite readers to contribute their own ideas on this important
subject. Despite the obvious lack of consensus, we believe the
effort to define biotechnology accurately is necessary and
worthwhile. For more food for thought, see the BEI Company
Study on page 22.
—The Editors
42 BioExecutive International MAY 2005
 Paradigms of Biopharmaceutical Terminology
BIOPHARMACEUTICAL BIOTECHNOLOGY PHARMACEUTICAL DRUGS USERS
BROAD All biotechnology-based Involves living All medicinal Chemical/non- Core biopharma
BIOTECHNOLOGY pharmaceuticals organism sources/ products (all biological source industry (especially
bioprocessing pharmaceuticals) pharmaceuticals in United States);
many tech-savvy
sources
NEW Only new biotech (genetic Only new All medicinal Chemical/non- Some in biopharma
BIOTECHNOLOGY engineered) pharmaceutcals biotech (genetic products (all biological source industry (especially
(primarily rDNA protein and engineered) pharmaceuticals) pharmaceuticals in Europe); some
monoclonal antibody-based) products tech-savvy sources;
EMEA/EU
BIOTECHNOLOGY All pharmaceuticals All products All medicinal Chemical/non- Business/financial
BUSINESS from biotech-like (small, from biotech-like products (all biological source communites;
R&D intensive) life companies (plus pharmaceuticals) pharmaceuticals popular press; BIO
science companies (plus biotech products
biopharmaceuticals from Big from large
Pharma) companies)
PHARMA All medicinal products All products from Biopharmaceutical Term often Some Big Pharma
BUSINESS (all pharmaceuticals are pharmaceutical and used as synonym for dropped from supporters
biopharmaceuticals) biotech companies pharmaceutical usage
At least four conflicting paradigms of biopharmaceutical terminology are in common use: broad biotechnology,
new biotechnology, biotechnology business, and pharma business. Part 1 of this article considered the first two paradigms.
Part 2 discusses the second two.

tors, assays and analytical services, in biopharmaceuticals. Thus, when drug discovery and related service
and facilities design. Thus is would considering parameters such as total companies that have no involve-
include companies primarily involved industry sales, it is better to total the ment in or use of biotechnologies are
in bioinformatics, genomics, pro- sales of individual products rather called biopharmaceutical. Similarly,
teomics, and so on, including drug than classify a company with diverse large international drug companies
(non-biological molecule) design products as either biopharmaceutical (Big Pharma) are often included.
companies that are substantially using or drug. Also, few biopharmaceuticals For example, the BioSpace Glossary
recombinant proteins, phages, nucleo- can be attributed to a single company. defines a biopharmaceutical company
tide sequences, or other biological Different companies often deserve as “involved in research of new drugs
molecules or technologies. credit for research, development, as well as the manufacturing, market-
It excludes companies primarily manufacturing, and marketing. ing, and distribution of pharmaceutical
involved with non-biological chemical/ products” 2. If “drugs” is presumed to
drug technologies, including novel HYPE ABOVE ALL mean pharmaceuticals, that definition
chemistries for screening or develop- But few outside the core encompasses the entire pharmaceuti-
ment of small-molecule drugs. Here biopharmaceutical industry use such cal industry. Similarly, the NASDAQ
is a simple test: If a pharmaceutically a definition of biopharmaceutical (or Biotechnology Index includes small
oriented company’s end products— biotechnology). That is particularly true biotechnology and small pharmaceutical
the agents being screened, designed, among the financial community and companies 3.
delivered, or developed, and/or its associated media, downstream popular Articles in the major business/
core technologies—are biotechnology- media, and many drug companies, financial periodicals, newspapers, and
based (involve the use of organisms, pharmaceutical industry sectors, other popular press often apply bio-
cells, or derived biological molecules and trade associations. Among those pharmaceutical (and biotechnology) to
or surrogates), it is a biopharmaceutical people, the biotechnology-busi- products and companies without any
company. Otherwise, it is almost cer- ness and, to a growing extent, the real biotechnology involvement. The
tainly a drug company working with pharmaceutical-business paradigms terms appear where it would be more
chemical materials and technologies. predominate. Although authors and appropriate to use emerging, R&D-
Classification of organizations/ analysts commonly base their stories intensive, biotech-like, startup, new, or
companies as biopharmaceutical (or and analyses on technologies, few small molecule. Misuse is so common
not) can be more complex than clas- seem to make relevant distinctions that even writers working from sources
sifying products and technologies. based on them. that have taken care with their termi-
Some biopharmaceutical companies— In the biotechnology business nology often generalize and arbitrarily
Biogen, Amgen, and Genzyme—also view, anything that appears high- use other terms, resulting in serious
develop, manufacture, and market tech and involves pharmaceuticals errors and problems for those trying to
synthetic drugs. The reverse is also (or life sciences), particularly if it is interpret what is reported.
true: Many large international drug about small companies, is described In terms of sheer volume, the press
companies—Hoffmann-La Roche, as biopharmaceutical (and/or bio- is dominated by public relations,
Merck, and others—are also involved technology). Thus, hundreds of small dumbed-down communications, spin,

MAY 2005 BioExecutive International 43

 Products Before Companies
as “a biopharmaceutical company
Many industry analysts consider biopharmaceutical to encompass essentially all phar- developing novel chemistries for the
maceutical (drug and biopharmaceutical) companies and service suppliers except development of small molecule drugs.”
Big Pharma. They sometimes switch to more restrictive definitions when referring to Many of these companies and their
products.
technologies are solely chemical based.
For example, Ernst & Young in its 18th annual study of the US healthcare-related Terminology abusers include com-
biotechnology industry includes “companies that use modern biological techniques to pany executives who should spot such
develop products or services” 4. But it excludes large pharmaceutical companies and mislabeling as errors or incompetence
includes many companies with no significant use of biotechnology. Six of 14 (43%) when reviewing market research, com-
of the “biotech products” listed as approved in 2003 are actually fully synthetic petitor analysis, or other information
drugs (Cialis, Entriva, Rebetol, Lexiva, Gliadel, and Fuzeon), while a list of industry block-
for their own decision-making.
busters is confined to “biologics,” a term not defined or used elsewhere but apparently
restricted to recombinant proteins, including some regulated as drugs.
Many executives and companies
persist in misusing biopharmaceutical
Companies such as Gilead Sciences, Vertex, BioCryst, and many others with little or and biotechnology in presentations,
no use of biotechnology or its products are repeatedly discussed as “biotech” compa- publications, and press releases.
nies. Other drug companies—Theravance, Idenix, and Triangle Pharmaceuticals—are Why? Perhaps they rationalize that
included among the top biotech acquisitions and mergers in 2003.
they are just following the pack. Or
maybe they believe (or want to) that
and hype. The main concerns of the pharmaceutical industry studies use biopharmaceutical and biotechnology
great majority of biotechnology com- biopharmaceutical (or its synonyms) need not involve actual biotechnol-
panies are financing, stock sales, and to refer to all small pharmaceutical or ogy. Or maybe they hope to avoid the
prices. Proper use of terminology is life sciences companies or to all phar- image and other problems facing Big
a low priority at best. Much of the mis- maceutical companies. Few of these Pharma by redefining themselves as
use in the popular press reflects reports and sources bother to define biopharmaceutical.
the inconsistent and incorrect use of their terms or their criteria for includ-
the words in the hundreds of press ing some companies and products and UNINTENDED CONSEQUENCES
releases issued daily, particularly by excluding others. Incomplete, ill-defined, and mis-
small companies. To make matters worse, many leading BIO and PhRMA product
Much, if not most, of what is reports use terminology inconsistently lists have persisted for years. (See
reported by companies, analysts, and even within the same report and, “(Dis)Associations.”) This has resulted
the popular press involves spinning particularly, between years (with in the widespread promulgation of
interesting or compelling stories for small-molecule drug companies incorrect and misleading information
technologically illiterate audiences. more commonly included in recent about biopharmaceutical products
Biopharmaceutical and biotechnology reports than in older ones). Many and the industry. Despite their caveats
are buzzwords that attract audience leading industry reports—such as and problems, most users look at the
attention and evoke warmer, more those from Ernst & Young, Burrill titles, take those lists to be authorita-
positive images than alternatives such & Co., Recombinant Capital and tive, and use them to report progress
as drugs. Both companies and journal- major stock analysts—obviously use and provide statistics concerning
ists often seem to care more about fluid definitions and criteria because biopharmaceutical products and
attracting attention and exploiting bio- they discuss different products and the industry. For example, a recent
tech’s positive image than about precise companies. Even in the same report front-page article in the Washington
use of particular terms. For many users or section, authors may use various Post about the debate over generic
and uses, lumping all smaller high- terms—biopharmaceuticals, biologics, biopharmaceuticals included a bar
tech life sciences and pharmaceutical drugs, biotech drugs, and so on. (See chart showing by year the number of
companies together is appropriate, “Products Before Companies.”) These “biotech drugs” approved in the past
but this does not warrant labeling and other terminology-based problems decade, based on BIO’s data with its
them all as biopharmaceutical are further compounded as down- many small-molecule drugs from com-
(or biotechnology) companies. stream writers and analysts reinterpret panies with no significant use of or
results, often using their own haphaz- involvement with biotechnology 9.
WORTHLESS ANALYSES ard terminology. How did these lists become so
Misuse of terminology has rendered Biopharma Company Wannabes: inconsistent and misleading? BIO has
much biopharmaceutical industry Analysts are not the only source of vested interests in redefining biotech-
data, market and other analytical the problem. Many pharmaceuti- nology and biopharmaceutical to be
reports, and press coverage worth- cal and life science companies that more inclusive of its diverse member-
less, misleading, and/or impossible lack any significant use or involve- ship and to bulk up the number of
to compare with other data. Nearly ment with biotechnology claim to relevant new products. PhRMA and
all of the widely recognized and pre- be biopharmaceutical. These com- its members have interests in associat-
sumed authoritative biotechnology and panies often describe themselves ing themselves with the hard-earned

44 BioExecutive International MAY 2005

 (Dis)Associations
Those seeking clarity and authoritative information—lists of Not only does BIO include products in its list that do not use
marketed or recently approved biopharmaceuticals, for exam- biotechnology in their production, it fails to include a large
ple—will find little help and much inconsistency and contrived number of biologics, particularly vaccines and plasma-derived
propaganda from the major US biotechnology and pharmaceuti- proteins (perhaps because they are from non-member Big
cal trade associations: Biotechnology Industry Organization (BIO) Pharma companies). Essentially all relevant nonrecombinant
and Pharmaceutical Manufacturers and Research Association vaccines are omitted, including acellular pertussis (DTaP),
(PhRMA). Those organizations use varying terminology inconsis- hepatitis A, rabies, varicella, pneumococcal conjugate, and
tently to refer to biopharmaceuticals. Even their lists of approved haemophilis B vaccines. Similarly, only a few plasma-derived
products are substantially misleading. proteins are listed, and several monoclonal antibody-based
radiodiagnostics are excluded.
BIO: For biopharmaceuticals, BIO primarily uses the terms
biotech(nology) drugs, biotechnology therapeutics and biologics PhRMA’s 2004 survey, Medicines in Development: Biotechnology
without differentiating among the terms. BIO has a simple defini- lists products in development and those approved in the United
tion of biotechnology, citing use of biological processes to solve States 8. Hidden in the footnotes is a disclaimer that the lists
problems and make useful products 5. However, in many of its of products are not comprehensive. In fact, they exclude many
communications, the organization ignores its own definition. relevant products. The lists tend to include products from large
(more likely to be member) companies.
BIO’s list of “Approved Biotechnology Drugs, 1982–2003,” includes
“biologics developed by biotechnology companies and pharma- The glossary defines biotechnology as involving industrial bio-
ceutical companies, as well as small-molecule products devel- processing and biotechnology medicines in line with EU usage
oped by biotechnology companies, and other selected small- (the new biotechnology paradigm). Buried within the glossary’s
molecule or tissue-engineered products.” Biologics is defined definition of biotechnology is a note that for this publication,
much the same as biopharmaceutical is in the broad biotech- “only those products that involve recombinant DNA, monoclonal
nology paradigm. This list does not claim to be—nor should antibody/hybridoma, continuous cell lines, cellular therapy, and
it be considered—complete or authoritative, but most gene therapy are included.”
reporters and writers using it presume that all products
Thus only users who examine the appended glossary and
included are biopharmaceuticals (and/or from actual bio-
footnotes in detail would ever realize that only recombi-
technology companies). Labeling the list biotechnology drugs
nant, monoclonal antibody, and a few other products are
(itself a self-conflicting euphemism) is thus misleading.
included, and nonrecombinant cultured proteins, vaccines,
BIO’s arbitrary inclusion of many small-molecule drugs inflates the blood-derived, and other biopharmaceuticals are excluded.
number of new biotechnology drugs. A total of 69 of 184 (38%) Continuous cells lines are within the report’s own criteria, but
products listed are clearly drugs (nearly all synthetic). BIO reports many relevant products are omitted—poliovirus, hepatitis A,
37 FDA product approvals in 2003, more than all new molecular rabies, and varicella vaccines. PhRMA’s biotechnology listings also
entities (both drugs and biologics) reported by the FDA that year include some small-molecule drug products.
6. A source that uses the broad biotechnology paradigm to
define biopharmaceuticals reports at most half that many 7.

and well-deserved good will and maceuticals, particularly in terms of mined by the quality and strength of
public image of biotechnology and companies. That may no longer be their communications” 10. With both
biopharmaceuticals and with new, true. BIO now takes in and represents BIO and PhRMA under new leadership,
thoroughly innovative technologies. any life-sciences–based or small- it will be interesting to see whether
Neither BIO nor PhRMA has incen- pharmaceutical companies, including and how they fix their terminology
tive to use clearly defined terms and a relatively recent influx of small-mol- problems. Perhaps it is time for the core
criteria nor to provide comprehensive ecule drug, drug-design, and other biopharmaceutical industry to start its
lists of approved biopharmaceuticals. R&D service companies. Many of own trade association, and/or for BIO
For BIO, it would mean significantly those do not actually use biotechnol- to be renamed something else—perhaps
paring down its list and including ogy, and most of them primarily serve the Biological Industries Organization.
many products from Big Pharma (non- Big Pharma.
members). For PhRMA, it would mean As recently noted by BioCentury, PHARMA–BIOPHARMA FICTION
including products not genetically “BIO can best be viewed as a powerful The idea—associated with the pharma-
engineered, particularly vaccines and megaphone that collects and amplifies ceutical industry paradigm—that the
blood products, which many perceive the voices of groups of relatively small pharmaceutical industry is converg-
as old or low-tech and/or which evoke and highly disparate entrepreneurial ing, morphing, or being reborn as the
negative images (such as vaccines with companies united more by attitude than biopharmaceutical industry has been
their unending safety controversies technology. PhRMA’s task is to put a repeated in many studies, articles,
and plasma protein products with their human face on companies that, because and meetings. The pharmaceutical
historical contamination with HIV and of their size, success, and the essential industry’s adoption of biotechnolo-
hepatitis C virus). nature of their products, are easy to gies for drug screening, discovery, and
BIO and the biotechnology industry dislike. In both cases, the ability to other preclinical R&D—largely based
were long dominated by biophar- influence public policy is directly deter- on outsourcing and in-licensing from

46 BioExecutive International MAY 2005

  References  combination of biotechnology and
1 Rader RA, “Biopharmaceutical Terminology, Part I: What is a (Boolean OR) pharmaceuticals—add
Biopharmaceutical Product? Is the Industry Losing Its Identity?,” BioExecutive a little biotechnology into the mix and
International, March 2005, p. 60–65.
the industry is now biopharmaceutical.
2 The BioSpace Glossary. BioSpace. www.biospace.com/gls_index.cfm (Accessed
March 3, 2005).
As defined in the report and the
accompanying Burrill & Co. press
3 NASDAQ Biotechnology Index. NASDAQ. http://dynamic.nasdaq.com/
dynamic/nasdaqbiotech_activity.stm (Accessed March 3, 2005). release 14, a biopharmaceutical
4 Resurgence: The Americas Perspective–Global Biotechnology Report 2004.
company need only be involved in
Ernst & Young: New York, NY. 2004. R&D of medicines for healthcare.
5 Biotechnology Industry Organization. Editors and Reporters Guide 2004-2005.
Biotechnology companies are
BIO: Washington, DC, p. 45–63; www.bio.org/speeches/pubs/er/BiotechGuide.pdf . defined as not members of PhRMA
6 FDA Fast Facts: FDA Approvals: More Drugs in Less Time. US Pharmacist; (Big Pharma). That usage follows
www.uspharmacist.com/index.asp?show=article&page=8_1232.htm the pharmaceutical industry para-
7 Rader RA. BIOPHARMA: Biopharmaceutical Products in the U.S. Market. digm or view of biopharmaceutical.
Biotechnology Information Institute: Rockville, MD, September 2004; www.biopharma. Throughout PhRMA’s Pharmaceutical
com/approvals.html. Industry Profile 2005, which switched
8 Pharmaceutical Research and Manufacturers Association. 2004 Survey: its terminology just this year,
Medicines in Development: Biotechnology. PhRMA, October 2004; www.phrma.org/ biopharmaceutical is used where it
newmedicines/resources/2004-10-25.145.pdf.
would be better to use pharmaceuti-
9 Kaufman M. Biotech Drugs’ Generic Future Debated. Washington Post February
cal. What’s next? Will PhRMA rename
10, 2005: 1, 6.
itself BiophRMA?
10 Commentary: Rethinking Everything. BioCentury 13(6) 2005: A1–7.
What is particularly trouble-
11 Convergence: Ernst & Young’s Biotechnology Industry Report, Millennium Edition.
some about this paradigm for the
Ernst & Young: New York, NY, 2000.
actual biopharmaceutical industry
12 DeVol R, et al. Biopharmaceutical Industry Contributions to State and U.S.
Economics. Milken Institute: Santa Monica, CA, October 2004; pp 17–18; www.
is that biopharmaceutical products
milkeninstitute.org/pdf/biopharma_report.pdf. and companies are not mentioned
13 Pharmaceutical Research and Manufacturers Association. Pharmaceutical
and seemingly do not exist. Instead,
Industry Profile 2005. PhRMA, March 2005; www.phrma.org/publications/ everything formerly pharmaceuti-
publications//2005-03-17.1143.pdf. cal is suddenly biopharmaceutical.
14 Burrill & Co. Press Release: Biopharmaceutical Industry Research & Biotechnology and pharmaceu-
Development Tops $49 Billion In 2004. March 17, 2005; www.burrillandco.com/burrill/ tical are defined as subsets of
pr_1111088393. biopharmaceutical, with biotechnol-
15 Dibner MA. Biopharmaceuticals in 2005 and Beyond. BioExecutive International ogy companies generally subservient
January 2005: 46–53. to Big Pharma. That is unlike the
traditional, generally accepted para-
small companies—is the basis for this rebrand the pharmaceutical industry, digm in which biopharmaceutical is a
supposed transformation. particularly its members (Big Pharma), distinct subset of pharmaceutical, with
The Ernst & Young 2000 bio- as the biopharmaceutical industry biopharmaceutical being the intersec-
technology industry report used 13. PhRMA’s industry profile report tion, not the union, of biotechnology
convergence as its theme and follows that of the Milken Institute in and pharmaceutical.
claimed that “the lines between bio- laying the groundwork (public rela- A Google or other broad Internet
tech and pharma [are] inextricably tions-wise) for the idea of industry search now results in a number of
intertwined” 11. A more recent convergence. Both reports were hyped recent reports, articles, and meetings
report, Biopharmaceutical Industry in widely disseminated press releases. about the convergence of informa-
Contributions to State and US As crudely explained without tion-, bio- and nanotechnologies.
Economics, published by the Milken support or documentation, the phar- So the fad of pharmaceutical and
Institute with partial sponsorship from maceutical industry has undergone a biopharmaceutical convergence may
PhRMA, further illustrates that idea transformation and morphed into the already be passé.
12. That report uses Bureau of Labor biopharmaceutical industry, becom- In any case, the pharmaceuti-
employment statistics covering the ing more research-driven through cal industry has not morphed into
entire pharmaceutical and parts of the adoption of biotechnologies for the biopharmaceutical industry.
biotechnology industry and renames research (particularly, lead identifi- Biopharmaceutical and drug prod-
the whole thing biopharmaceutical cation) and ties to high-tech R&D ucts, technologies, R&D, companies,
(with more than 400,000 employees). service and biotechnology companies. and industries can be readily distin-
PhRMA’s Pharmaceutical Industry Also, computational chemistry and guished. As discussed in part 1 of
Profile 2005 appears to be part of other breakthroughs have altered this article, research methods do
a concerted disinformation or pro- the basic nature of the industry. not define industries. Products and
paganda campaign to redefine and Biopharmaceutical is defined as the their methods of production—

48 BioExecutive International MAY 2005

biological or chemical—define Some people argue that biotechnol- Research methods
industries. Nothing has altered these ogy is now involved in the discovery
two industries’ basic business models and early R&D of just about every do not define
or the big picture. pharmaceutical product. But one could
The underlying source of the also argue that chemistry and chemical industries. Products
pharmaceutical industry’s products, technologies are comparably essen-
R&D, technologies, and revenues tial to the R&D and manufacture of and their methods of
remains primarily chemical, with every biopharmaceutical. Computers
the industry dominated by drugs at and information technology have production—biological
all levels. Depending on the criteria fundamentally altered pharmaceutical
used, at most 15–20% of pharmaceuti- R&D and the industry as much as or or chemical—define
cal products, sales, and R&D involve more than biotechnology, but no one
biopharmaceuticals 15. Only a small proposes changing the name of the industries.
portion of Big Pharma is substantially industry based on that.
involved in biopharmaceuticals—has
one or more internally developed and/ STRATEGIC CONSIDERATIONS detriment of companies actually using
or manufactured product(s). A few Big Removing the link between biotechnology to create human thera-
Pharma companies are the source for biopharmaceutical (and its synonyms) peutic products.
nearly all older biopharmaceuticals— and biotechnology devalues and
primarily vaccines and plasma eliminates its utility for those truly USE IT OR LOSE IT
proteins. More large drug companies involved with biopharmaceutical This article recommends adoption of
will be manufacturing and/or market- products, technologies, companies, the broad biotechnology paradigm of
ing biopharmaceuticals in the coming and industry. Biopharmaceutical biopharmaceutical as involving bio-
years, particularly recombinant mono- and biotechnology evoke positive technology-derived pharmaceuticals.
clonal antibodies. However, other than images in comparison with drug Biopharmaceutical has significant
in terms of the number of companies, and pharmaceutical. Redefining advantages over other terminology:
drugs have and will continue to clearly the pharmaceutical industry to be It has a long history of use; appears to
dominate the pharmaceutical industry. biopharmaceutical is simply wrong be the predominant term (particularly
Outsourcing = Biopharma? Big and purposely misleading. Everyone in the United States); allows use of the
Pharma has become more depen- wants to gain advantage, get in on, abbreviations biopharma or biopharm,
dent on outsourcing services—most and be associated with a good thing. which fits well with other common
recently drug screening, design, Because of their hard-earned, well- terminology (pharma); uses bio-,
and other R&D—and in-licensing deserved reputation for advanced which provides a well-understood link
technology. That has resulted in the technology, innovation, and high to biotechnology; sounds better than
creation of hundreds of new support value to society, biopharmaceutical terms such as biotechnology medicine;
and services companies. However, terms are already being abused and and is not self-conflicting, (biotech
that does not constitute a revolution co-opted. Terminology obfuscation drugs). Regulatory-based terms, such
nor warrant renaming the indus- is also a common way to influence as biologics and drugs have their own
try biopharmaceutical. It is simply a regulations. For example, how bet- specific and convoluted definitions and
continuation of trends evident in the ter to complicate the public debate are best avoided for general use.
1990s with industry consolidation and and delay generic biopharmaceutical To prevent the loss of its unique
outsourcing of clinical trials, IT, and regulations than to take over, muck identity, the biopharmaceutical indus-
other activities. up, or obfuscate the underlying try and its supporters must be mindful
PhRMA members spend more terminology? of terminology. They should adopt and
than $38.8 billion annually on US- Terminology used incorrectly or consistently use biopharmaceutical (or
based R&D 13. Outsourcing of just without definition becomes useless a synonymous term) and define the
a small percentage of R&D can easily among a jumble of other terms and terms they use, or at least make their
account for hundreds of new small meanings. Then others can adopt, meaning clear in context. 
companies. Also, most of the drug co-opt, or redefine it. If these terms
screening/discovery technologies continue to be (mis)used to refer to Ronald A. Rader is president of the
heralded as biopharmaceutical and anything biotech-like or pharmaceuti- Biotechnology Information Institute,
revolutionary are not fundamentally cal, they could well be used to rebrand 1700 Rockville Pike, Suite 400, Rockville,
new. The industry adopted similar (in name only) the entire pharmaceuti- MD 20852, 1-301-424-0255, fax
chemical modeling, structure–activ- cal industry—Big Pharma becoming 1-301-424-0257, biotech@biopharma.
ity relationships, and automated drug Biopharma. Those who stand to gain com. Biopharmaceutical terminol-
screening/discovery technologies as from rebranding themselves may find ogy and information issues are further
early as the 1970s. these terms irresistible for market- discussed at www.biopharma.com.
ing and image reengineering, to the

MAY 2005 BioExecutive International 49