Professional Documents
Culture Documents
Critical Succes
Critical Succes
Critical Succes
Biopharmaceutical Business
A Comparison Between Finnish and Californian Businesses
Tanja Rautiainen
ISSN 1239-758X
ISBN 952-457-042-4
Cover: LM&CO
Page layout: DTPage Oy
Printers: Paino-Center Oy, 2001
Foreword
This paper is based on the authors Masters thesis Critical Success Factors in Biopharmaceutical
Business: Finland vs. California published in 2000. Since the thesis is written in an academic form
and comprises of a total of over hundred pages, this second version was written for a lighter, more
enjoyable reading experience.
I would like to thank Tekes, especially Solveig Nylund and Jari Kauppila for extending this great
opportunity to me to study the biopharmaceutical business in Finland and California. Special
thanks go to all the 25 interviewees who remain anonymous throughout the study.
I have been impressed by the high quality of biotechnology research and the effectiveness of the
business environment in Finland. I hope that this study brings new valuable information to all its
readers, and I also hope to contribute to the strengthening of the industry in the coming years.
Helsinki, May 2001
Tanja Rautiainen
Contents
Foreword
1
Introduction 1
Conclusions 19
References 21
Technology Reviews from Tekes 23
1 Introduction
Most biopharmaceutical companies today are in their development stage by all measures. Hardly any of them are
making a profit, but are nevertheless in a capital spending
race to build superior technology platforms, capture firstmover advantage, and accumulate intellectual property
(IP) rights. They are all facing long product development
cycles and years of business development before, if at all,
becoming sustainable operating companies. However,
some of the biopharmaceutical companies of today will become the Amgens or Genentechs of tomorrow.
The business angels, venture capitalists, equity analysts,
and business managers are all asking the same questions:
Which companies will succeed? What are the signs of success? Many biopharmaceutical success stories have originated from California, where biotechnological research has
been actively turned into business since the early 1980s.
Generally, Europe has lagged behind the USA, and now
European newcomers are facing a tough challenge; the international market for biotech products is already very consolidated, and the entry barrier is much higher today than
when the American biopharmaceutical business was in its
infancy. The newcomers must conquer their niches strategically.
Critical success factors (CSFs) for a product development
company have been a popular research topic among economists for the past two decades. Most of the research is fo-
cused on information technology (IT) companies or product development processes in general, and biopharmaceutical companies have very seldom been studied as a homogenous group.
The aim of the present study was to determine those CSFs
that are specific for biopharmaceutical companies. First, an
extensive literature review was conducted to find the major
CSFs and to form a hypothesis. Seven CSF groups were
identified, and the hypothesis was then tested for biopharmaceutical companies by interviewing 25 industry experts with a technique referred to as theme interview.
While 15 of the total 25 interviewees were Finnish, 10 of
the interviewees were Californians. This led to an interesting setting Finland as the worlds mobile IT forerunner
and a biotechnology challenger vs. California, the birthplace of modern hi-tech business and the indisputable number-one biobusiness hotbed in the world.
The CSFs were thus also used to compare the Finnish and
Californian biopharmaceutical businesses (see Figure 1):
what seemed to be critical in California was not necessarily
considered critical in Finland and vice versa. Most CSF
differences found could easily be explained by differences
in the infrastructure and business culture of these two geographically distant areas. And the differences are very important to remember when planning overseas business operations.
Differences
between Finnish
and Californian
biopharmaceutical
businesses
IN FINLAND?
IN CALIFORNIA?
Pharmaceuticals are a USD300 billion business. The manufacturing and marketing of drugs are well covered by
large pharmaceutical companies, the big pharmas. Most
big pharmas today were restructured during the late 1980s
as the result of a strong consolidation trend in the industry.
The consolidation generated ever fewer and larger companies, which eventually became too large to fill their own
product pipelines. This in turn led to the emergence of a
new, fast-growing industry sector in the 1990s: the pharmaceutical R&D industry.
BIG PHARMA
PRODUCT DEVELOPMENT PROJECTS
Financing:
Angels
Vcs
Government
agencies
IPO
etc.
Biopharmaceutical
companies
INNOVATIONS
ACADEMIA
Figure 2. Structure of the pharmaceutical R&D industry.
Service
providers
Test labs
CROs
Manufacturers
Lawyers
Human resources
Products
Networking
Then again, collaborating with a partner can be both a measure of performance and a CSF. It measures performance in
the sense that the partner has considered the company to be a
valuable ally and the coproject to be worth the risk. Or, it can
be a CSF in the sense of gaining resources and experience
essential to making the project under collaboration succeed
and at the same time making the company succeed. There is
only a thin line between the cause and the effect.
A successful IPO indicates a good company in the sense of
public evaluation. At the same time it creates cash inflow
important for the company. Is money a success factor? It
surely is critical for the companys existence, but this is
where the line is drawn here. Capital from VCs or IPOs and
cash inflow from product sales are considered to be consequences of having the right success factors in the company,
not merely success factors per se.
The outcome of a CSF analysis often includes results such
as organizational structure and process that support the
Company climate
External Success
Factors
Clusters
Infrastructure
National policies
2.1
Human Resources
Weisbach and Moos (1995) listed the general characteristics of desirable biotech employees as follows:
Flexible
Resourceful (whatever it takes to get things done)
Entrepreneurial (finding and making something out
of things that others miss)
Open-minded
5
Table 2. Result of the analysis of human resources as a critical success factor. Finnish biopharmaceutical companies
compared with Californian companies.
Success Factor
FIN
CA
Key factors
FIN
CA
Commitment
Entrepreneurism
Human resources
Quick study
Focused
Mentor-derived success traits
Broad grounding in physical and life sciences
Ownership (taking special pride in having an impact)
2.1.1 Commitment
For any company to be successful it is critical to have committed key personnel. Lester (1998) and Cooper and Kleinschmidt (1996) studied product development processes in
general and ranked senior management commitment as the
first and sixth CSF. In biopharmaceutical companies commitment of the key personnel is usually maintained through
company stock option programs.
According to the interviews, commitment was considered
easier to maintain in a small biopharmaceutical company
than a large one. Commitment as a CSF was supported by
only a couple of experts. This was a surprising result, but
after a brief look into the interviews, an explanation could
be found.
The key managements commitment is usually ensured
with shares of the company, and according to Finnish experts it is easy to find committed personnel in Finland: first
of all, it is a question of national character and second,
there are not that many alternative companies in Finland. In
+
Teamworking skills
Management skills
2.1.2 Entrepreneurism
Entrepreneurism is a characteristic difficult to define. In a
sense, commitment, teamworking, and management skills
could be understood to be characteristics of entrepreneurism. Steinmetz (1998) described entrepreneurial personnel as individuals who can succeed in different environments, show tenacity, have a sense of urgency, and who are
pragmatic and can identify the nonobvious. Steinmetz also
emphasized that every scientist who joins a biotech company should realize that it is not all about the excitement of
science and technology, but about sustaining a profitable
business.
The entrepreneurial characteristic of the people was supported among Californian experts more than in Finland.
Expert C2 described the desired quality of a biopharmaceutical company recruit as people who are generalists,
who are able to do many things whatever it takes, drivers. Expert F6 called for people who have the ability to
maintain enthusiasm and speed in business development.
The essence of a fat product pipeline in an IPO is inevitable. A biotechnology company going public must have
substance, not just future promise. The candidate for a successful offering must demonstrate the ability to generate
contract and royalty revenue, have products close to market introduction, and have a full research and regulatory
pipeline. The products should also be validated by partners
or VCs. A successful company has validations for more
than one of its products.
2.2
Products
Table 3. Result of the analysis of products as a critical success factor. Finnish biopharmaceutical companies compared
with Californian companies.
Success Factor
FIN
CA
Key factors
FIN
CA
+
Unmet needs
Marketing
2.3
Networking
Generating good ideas for new technologies requires expertise, skills, motivation, appropriate boundaries, and
time. Often it also requires leveraging of expertise outside
the company. Typically, a biopharmaceutical firm focuses
on one or two core competencies and outsources the other
parts of the product development to its allies. Partnerships
are formed to access resources, expertise, and new product
ideas, or to some extent to share the risks of drug development. Another main strategy behind partnering is to find a
way across national borders. Alliances are most useful
when the allies are not rivals but are at different points on
the same value chain. A biopharmaceutical seeks its allies
from academia, big pharmas, or companies in foreign
markets.
Networking was proven to be a success factor by both
Finnish and Californian interviewees, but an interesting
observation was made: the two expert groups saw networking in a different light. Finnish experts often mentioned
networking when the quality of human resources was under discussion; the employees ability to network was described as a success factor. Networking was seen as a tool
to access knowledge spillovers, and creation of the network was seen to be critical. In California, networking was
never mentioned as a desired capability of an employee,
but was instead seen more as a structural matter; todays
virtual companies operate in a network, point-blank. Networking was usually seen as a series of on- and off-going
partnerships.
Table 4. Result of the analysis of networking as a critical success factor. Finnish biopharmaceutical companies compared
with Californian companies.
Success Factor
Networking
FIN
CA
Key factors
FIN
CA
Academia
Big pharma
Foreign partners
2.3.1 Academia
Public science, i.e. universities, research institutes, and
government laboratories play an important part in all industries, but a recent study by McMillan et al. (2000) revealed that the linkage between the biotechnology industry
and public science is much more critical than in any other
industry. Biotechs rely on public science for very basic scientific research, and they rely on academia to a much
greater extent than big pharmas do. Proximity of research
institutions is definitely a CSF.
In California, networking toward academia was seen to be
more important than in Finland. Expert C3 explained the
need to be close to academia as access to smart people as
consultants and expert C2 stated that you have to know
what the scientific predators are up to. Even access to libraries(C3) was mentioned as one of the reasons why a
company should network with academia. The reason why
networking toward academia was emphasized more in California than in Finland probably involves the fact that Californian companies are generally relatively older and larger
not so attached to the original academic research, whereas
the Finnish biopharmaceutical companies are younger and
close to academia anyway. Networking with academia was
seen to be more obvious and natural in Finland.
2.4
Company Climate
be most effective when they were offered favorable ownership and entrepreneurial characteristics of speed, agility,
and adaptability, i.e. the teams were allowed to operate as
though they were in business for themselves.
The small corporate environment brings yet another advantage to the start-ups. According to Weisbach and Moos
(1995), the young, bright scientists prefer working in a
small company with an entrepreneurial setting where they
can proceed to key positions quickly, rather than work at a
big corporation where the fear is to get stuck at a
lower-level supporting role for years. This is another factor
making it harder for a big pharma to access new, academic
innovations.
The company climate was supported as a CSF by only four
Finnish and two Californian experts. Expert C1 saw creating a climate of success in the company as a CSF. Expert
C7 linked human resource commitment with the small corporate environment: After 50 to 100 employees it is hard
to keep up the start-up like feeling and it is harder to keep
the people committed. The Finnish experts who supported
the small corporate environment as a key factor for a successful company climate saw the small corporate environment not only as a breeding ground for a certain climate,
but as a success factor in itself: virtually operating light organization is a success strategy.
2.5
Clustering
Table 5. Result of the analysis of clustering as a critical success factor. Finnish biopharmaceutical companies compared
with Californian companies.
Success Factor
Clustering
FIN
CA
Key factors
CA
Labor pooling
Knowledge spillovers
Specialized services
10
FIN
ject was approached by looking for the advantages of belonging to a cluster. Californians saw the advantages of being situated in a cluster area as labor pooling and knowledge spillovers, but not so much as having ready access to
nearby specialized services.
2.6
General Infrastructure
In the same way as clustering, general infrastructure interacts with the geographic location of a company. Endersby
(1999) listed some critical factors in the infrastructure:
transportation, telecommunications, energy, and education
thereby maintaining prosperity and high quality of life.
To attract people into a company, a reputation for quality of
life in a certain area is critical. For example, there has been
an extraordinary amount of criticism about the extreme increase in cost of living in San Francisco affecting businesses ability to attract new professionals to move to the
area.
Finnish experts considered the Finnish infrastructure to be
highly efficient and pointed to it generally as a success factor. Quality of life was mentioned as a key factor only by
expert F11 who emphasized the good level of education as
the basis for an overall good quality of life. The reason why
Finnish experts did not emphasize quality of life more is
probably due to the fact that the Finnish nation is used to
having a good infrastructure and a high quality of life automatically schools are free, medical aid is free, and a
shortage of clean water or electricity would never even occur to a Finn.
Californian experts supported quality of life as a key external factor in a biopharmaceutical companys success.
There were two subjects that the Californian experts especially brought up. The first was the sunny, warm Californian climate it is not too difficult to attract professionals
to move to California. The second common subject was the
cost of living and how it affects the quality of life. Northern
11
Table 6. Result of the analysis of national policies as a critical success factor. Finnish biopharmaceutical companies compared with Californian companies.
Success Factor
National policies
FIN
CA
Key factors
FIN
CA
Tax reductions
the research groups to find partners from industry even before the innovation has been born. In California, the National Institutes of Health (NIH) grants were appreciated
highly, and the fact that research conducted by federal
funding could be commercialized was also rated as highly
important.
2.7
National Policies
Gilmartin (1998) brought up national policies as an external success factor in a biopharmaceutical company. Some
enabling activities that nations often provide include national, or federal, support of basic biomedical research,
support for start-up companies, and tax reductions.
12
Giesecke (2000) studied the roles of government in development of the biotechnology industry and concluded that
direct government intervention aimed at science-based
high-tech industries is more likely to failing its goals than
indirect enhancement of the already existing economic
structure connecting academic innovations with market
opportunities. According to Giesecke, successful indirect
approaches include the enhancing of incubator environments that the academic institutions can provide, availability of venture capital and professional business advice, exit
opportunities for early investors, possibilities for diffusion
of knowledge, and competence of political bodies to distribute research money where innovations are most probable.
In Frsts (1999) opinion there is a limit to which a government must stop funding and let the free market environment pick the strongest companies. For example, there has
been discussion about the State interfering too much in
Germany, that German biomanagers do not have to strive
hard enough to keep their companies alive, and that less
funding from the State would create more aggressive management teams similar to their American counterparts.
In Finland governments financial support for new companies was found to be essential, whereas Californians spoke
mainly of legislative enhancements: The Bayh-Dole act
and the several bills supporting small research-based companies have had a tremendous positive impact on biopharmaceutical business (C6).
Endersby (1999) introduced the provincial strategy to reinvigorate the biotechnology business in Ontario, Canada.
First, there is the tax incentive: every dollar spent on R&D
earns tax credits. Large, public, or foreign-owned compa-
13
The table below summarizes the outcome of the CSF analysis. The reasons for the differences between Finnish and
Californian biopharmaceutical companies were discussed
shortly in the previous chapters. In this chapter we will go
some further steps into the background: how do these two
markets differ from each other? What are the similarities?
Generally, the differing can be explained by the cultural
differences and the different sizes and ages of the business
clusters.
3.1
Table 7. Outcome of success factor analysis. A (+) was given to a factor that was supported by 50% or more of the interviewees.
Success Factors
Internal Success Factors
FIN
CA
Key factors
FIN
CA
Commitment
Entrepreneurism
Human resources
+
Teamworking skills
Management skills
Networking
Unmet needs
Marketing
Academia
Big pharma
Foreign partners
Company climate
External Success Factors
Clustering
CA
Key factors
FIN
CA
Labor pooling
Knowledge spillovers
Specialized services
Infrastructure
National policies
Quality of life
Tax reductions
15
3.2
16
3.3
3.4
17
directly employed by organizations developing therapeutics and diagnostics, manufacturing medical devices, preparing laboratory instruments and equipment, supplying
laboratory services, and distributing medical products. An
additional 41 000 Californians are involved in biomedical
and clinical research in Californias 75 public and private
research institutions.
In conclusion, the above data suggest that there are 750
biotechs involved in the medicine throughout the USA
(Dibner, 2000) and 2500 biomedical companies in California (Gollaher, 2000). Here, the terminology is slightly confusing, but it can be presumed that in Gollaher has counted
the entire life science sector in the Californian figures.
From screening through tens of articles and directories, it
can however be estimated that the number of companies
and organizations involved in the American pharmaceutical R&D sector may well approach several thousand. Furthermore, the number of true pharmaceutical development
SMEs, i.e. biopharmaceutical companies as they are called
in this study, is somewhere between 500 and 600. There is
no doubt that the great majority are located in California.
18
4 Conclusions
19
References
Lester, D.H., Critical Success Factors for New Product Development, Research Technology Management 41
(1998) No 1, 36-43.
Flynn, J.V., Rhodes, J.D, and Glazier, F., Reasons for Rivalry, Pharmaceutical Executive 18 (1998) No 6, 88106.
Rule, E., Ross, N., and Donougher, M., Beating the odds:
Making a strategic alliance succeed, Pharmaceutical
Executive 19 (1999) No 1, 78-83.
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