CW Special Article Reprint

A CenterWatch Publication

Profile: Contract Research Organization

PFC Pharma Focus, Zurich, Switzerland
An interview with Ran Frenkel, CEO, Pharma Focus Israel, and vice president of
business development, PFC Pharma Focus
Interview conducted at the DIA EuroMeeting in Berlin
How and why was PFC Pharma Focus
founded?
PFC Pharma Focus is a Swiss-based CRO founded
in 1992. The founders, Dr. Kurt Pfister and Dr.
Kathryn Voegeli, previously worked for J&J, and,
after several years in the industry working in regu-
latory and clinical affairs, they decided to establish
their own company in Switzerland. At first, their
clients were the pharma companies based in
Switzerland, a large enough client base to support
PFC Pharma Focus, but for many years now our
clients come from all over Europe as well as from
the U.S. PFC Pharma Focus is proud to deliver
high quality clinical research. Once we have a
project, we are entirely dedicated to that project.
If we take a project, we can deliver a successful
clinical trial. This is why we have 85% repeat
business. We have experience in about 300 clini-
cal trials, and we work in almost all indications,
with greater emphasis on market demands as
oncology, infectious diseases, cardiovascular and
gastroenterology.
What differentiates PFC Pharma Focus from
other CROs?
Our clients can immediately identify that we have
been in the business for many years because of
our experienced people. Upfront, we ask the rele-
vant questions so that we can prevent clients
from making critical mistakes. All our employees
take ownership of the projects. Since we’ve identi-
fied that our strength is in our people, we contin-
uously invest in them, and this investment goes
into internal comprehensive training, high-caliber
project teams and academic activities. We are a
Certified Training Center for Pharmaceutical
Medicine accredited by the Swiss Pharmaceutical
Association and the Swiss Medical Association.
Our office in Israel also differentiates us. We
have locations in three countries: headquarters in
Switzerland; an office in Germany, which gives us
access to European countries that are a part of
the EU; and then a third office, which often puz-
zles people, in Israel. Israel has a strong biotech
and medical device history, it is well-established in
clinical research and has a good reputation. In
Israel, the majority of our clients are U.S. compa-
nies. It’s a user-friendly environment for American
companies because we can submit all the docu-
mentation in English, apart from the informed
Year founded: 1992
Offices: Zurich, Switzerland; Munich,
Germany; and Tel Aviv, Israel
Employees: 50
Therapeutic areas: Oncology,
ophthalmology, psychiatry, neurology,
gastroenterology, autoimmune dis-
eases, respiratory, cardiovascular and
infectious diseases
Tel: +972(3)5360623
Email: ran.frenkel@pfc-cro.com
Web site: www.pfc-cro.com
consent form, which has to be in Hebrew. The
spoken language in clinical research is English.
The prices in Israel are 30% to 40% lower than
those in the U.S. From the Israeli office, we man-
age also places outside Israel for our U.S. clients.
Another area of differentiation is that PFC
Pharma Focus is very experienced with investiga-
tor-initiated trials (IITs). These are studies for
which the investigator serves as both the sponsor
of the study and the clinician-investigator, and
they are governed by the same regulations that
apply to clinical studies sponsored by a pharma-
ceutical company. The aspects that require special
consideration by the CRO in IIT are quite different
than in studies that are sponsored by a pharma-
ceutical company.
PFC Pharma Focus manages several investiga-
tor-initiated studies in Europe and Israel. Some of
these can be considered as pivotal from the num-

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From Volume 13, Issue 17. April 27, 2009. Copyright © 2009 by CenterWatch. All rights reserved.
CWWeekly, April 27, 2009
PFC Pharma Focus (continued from page 1)
ber of sites and patients; however, an IIT is not
meant for registration purposes. The largest IIT we
are managing is a 450-patient study in Israel and
South Africa—the biggest ever done in the indica-
tion of post-traumatic stress disorder. These are
the most challenging studies. We work hand-in-
hand with the investigator, who is a great clini-
cian, to help him learn what implication his spon-
sorship has on his responsibilities.
Many CROs don’t want to enter into the IIT
services area. It’s not an attractive area for CROs
because these studies are usually modest and
require a very high level of efficiency as well as
professionalism to manage. You need a very expe-
rienced person who can deal with and mediate
between the investigators and pharmaceutical
companies.
We are proud of our unique strength in concept
development and drug development consultancy.
There are not many companies with continuous
exposure. That allows us to always be at the front
and to come up with innovative solutions. This we
can do through many years of experience in lead-
ing positions of globally active pharmaceutical
companies and CROs. We feel that, for us, clinical
research is not just a profession, it is a mission.
What challenges do you face?
Although our clientele includes some of the largest
pharma companies, we are also attracting busi-
ness from smaller pharma companies and biotech
now because they need a true partner. They pro-
vide projects that are challenging for us not only
scientifically but also financially, because they usu-
ally have lower budgets. We have to convince
them of intelligent ways to save without endan-
gering the quality of their program. Often, the
Copyright © 2009 CenterWatch. Duplication of this publication is prohibited.
principals at small biotech companies are hired
from Big Pharma and naturally implement Big
Pharma processes in the new entrepreneurial envi-
ronment. This can add unnecessary cost. This sur-
prised us, because the small biotechs thrive on
their innovation.
Today, even at Big Pharma, especially because
of the worldwide financial crisis, we see budgets
for clinical research getting cut and requirements
increasing. The processes in Big Pharma are less
flexible and they often look on CROs more as a
commodity, concentrating on hourly costs. We’ve
encountered some companies that try to impose
freelance hourly costs, ignoring the fact that our
emphasis on continuous quality and training of
each employee is an added value for the customer.
Or, that payments based on ‘unit pricing,’ such as
number of visits and fixed time on site only
encourages inefficient monitoring if it is clear that
some sites need more time. Inefficient monitoring
demotivates our staff as well as the site staff,
making it more difficult to run the study. We see
that sponsors’ thinking is evolving, based on their
previous experience as well as the practice in the
industry. We suffer when other CROs take advan-
tage of the system, but we can show our clients
that they need to revise their preconceived
notions.
With regard to pricing, we have to tailor a
unique pricing model that will fit the company and
its financial status or stability. Thus, we work close-
ly with venture capitalists and other investment
groups, filling the gap between regulatory and
clinical requirements and the company budget
through fair market value pricing. This is a chal-
lenging activity in itself and positions PFC in differ-
ent segments than other CROs.
2 of 2
What are your plans for growth?
We have recently finished a five-year plan. It
encompasses further development and strengthen-
ing of our international project management and
our QA/QC groups with a moderate expansion.
Our primary expansion is where our core offices
are. We have evaluated what the margin is in each
of the offices to grow and to what level. We are
currently a company of 50 employees. Our expan-
sion plan goes to 120 employees within the next
four years. We have identified three additional
locations in Europe where we would like to
expand into. We have just recently opened a new
office in New Delhi, India, because this market is
becoming increasingly attractive to find the num-
ber of patients, which is increasingly difficult in
Europe, and we have excellent ties to local clinical
research facilities through Excel Life Sciences [a
pharmaceutical research organization]. This collab-
oration makes a startup very efficient and effec-
tive. We would also like to better penetrate the
U.S. market. We don’t think the way is to open our
own office in the U.S. but to liaise with a local U.S.
CRO that shares the same values. We are not
looking for a huge CRO but a CRO of comparable
size that would like to penetrate the European
market. PFC always builds a project team tailored
to the needs of the project and allies with national
and regional CROs to extend its geographical
reach. The project teams are carefully managed
and supervised by our project management and
quality assurance groups.
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