Special Article ReprintCW

Profile: Contract Research Organization

From Volume 13, Issue 17. April 27, 2009. Copyright © 2009 by CenterWatch. All rights reserved.

How and why was PFC Pharma Focusfounded?

PFC Pharma Focus is a Swiss-based CRO foundedin 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 establishtheir own company in Switzerland. At first, theirclients were the pharma companies based inSwitzerland, a large enough client base to supportPFC Pharma Focus, but for many years now ourclients come from all over Europe as well as fromthe U.S. PFC Pharma Focus is proud to deliverhigh quality clinical research. Once we have aproject, we are entirely dedicated to that project.If we take a project, we can deliver a successfulclinical trial. This is why we have 85% repeatbusiness.We have experience in about 300 clini-cal trials, and we work in almost all indications,with greater emphasis on market demands asoncology, infectious diseases, cardiovascular andgastroenterology.

What differentiates PFC Pharma Focus fromother CROs?

Our clients can immediately identify that we havebeen in the business for many years because ofour experienced people. Upfront, we ask the rele-vant questions so that we can prevent clientsfrom making critical mistakes. All our employeestake 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 goesinto internal comprehensive training, high-caliberproject teams and academic activities.We are aCertified Training Center for PharmaceuticalMedicine accredited by the Swiss PharmaceuticalAssociation and the Swiss Medical Association.Our office in Israel also differentiates us.We

have locations in three countries: headquarters inSwitzerland; an office in Germany, which gives usaccess to European countries that are a part ofthe EU; and then a third office, which often puz-zles people, in Israel. Israel has a strong biotechand medical device history, it is well-established inclinical research and has a good reputation. InIsrael, the majority of our clients are U.S. compa-nies. It’s a user-friendly environment for Americancompanies because we can submit all the docu-mentation in English, apart from the informed

consent form, which has to be in Hebrew. Thespoken language in clinical research is English.The prices in Israel are 30% to 40% lower thanthose 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 forwhich the investigator serves as both the sponsorof the study and the clinician-investigator, andthey are governed by the same regulations thatapply to clinical studies sponsored by a pharma-ceutical company. The aspects that require specialconsideration by the CRO in IIT are quite differentthan in studies that are sponsored by a pharma-ceutical company.PFC Pharma Focus manages several investiga-

tor-initiated studies in Europe and Israel. Some ofthese can be considered as pivotal from the num-

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PFC Pharma Focus, Zurich, Switzerland

An interview with Ran Frenkel, CEO, Pharma Focus Israel, and vice president ofbusiness development, PFC Pharma Focus

Interview conducted at the DIA EuroMeeting in Berlin

Year founded: 1992Offices: Zurich, Switzerland; Munich,

Germany; and Tel Aviv, IsraelEmployees: 50Therapeutic areas: Oncology,

ophthalmology, psychiatry, neurology,gastroenterology, autoimmune dis-eases, respiratory, cardiovascular andinfectious diseases

Tel: +972(3)5360623Email: ran.frenkel@pfc-cro.comWeb site: www.pfc-cro.com

CWWeekly, April 27, 2009 2 of 2

PFC Pharma Focus (continued from page 1)

ber of sites and patients; however, an IIT is notmeant for registration purposes. The largest IIT weare managing is a 450-patient study in Israel andSouth Africa—the biggest ever done in the indica-tion of post-traumatic stress disorder. These arethe 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 CROsbecause these studies are usually modest andrequire a very high level of efficiency as well asprofessionalism to manage. You need a very expe-rienced person who can deal with and mediatebetween the investigators and pharmaceuticalcompanies.We are proud of our unique strength in concept

development and drug development consultancy.There are not many companies with continuousexposure. That allows us to always be at the frontand to come up with innovative solutions. This wecan do through many years of experience in lead-ing positions of globally active pharmaceuticalcompanies and CROs.We feel that, for us, clinicalresearch is not just a profession, it is a mission.

What challenges do you face?

Although our clientele includes some of the largestpharma companies, we are also attracting busi-ness from smaller pharma companies and biotechnow because they need a true partner. They pro-vide projects that are challenging for us not onlyscientifically but also financially, because they usu-ally have lower budgets.We have to convincethem of intelligent ways to save without endan-gering the quality of their program. Often, the

principals at small biotech companies are hiredfrom Big Pharma and naturally implement BigPharma processes in the new entrepreneurial envi-ronment. This can add unnecessary cost. This sur-prised us, because the small biotechs thrive ontheir innovation.Today, even at Big Pharma, especially because

of the worldwide financial crisis, we see budgetsfor clinical research getting cut and requirementsincreasing. The processes in Big Pharma are lessflexible and they often look on CROs more as acommodity, concentrating on hourly costs.We’veencountered some companies that try to imposefreelance hourly costs, ignoring the fact that ouremphasis on continuous quality and training ofeach employee is an added value for the customer.Or, that payments based on ‘unit pricing,’ such asnumber of visits and fixed time on site onlyencourages inefficient monitoring if it is clear thatsome sites need more time. Inefficient monitoringdemotivates our staff as well as the site staff,making it more difficult to run the study.We seethat sponsors’ thinking is evolving, based on theirprevious experience as well as the practice in theindustry.We suffer when other CROs take advan-tage of the system, but we can show our clientsthat they need to revise their preconceivednotions.With regard to pricing, we have to tailor a

unique pricing model that will fit the company andits financial status or stability. Thus, we work close-ly with venture capitalists and other investmentgroups, filling the gap between regulatory andclinical requirements and the company budgetthrough fair market value pricing. This is a chal-lenging activity in itself and positions PFC in differ-ent segments than other CROs.

What are your plans for growth?

We have recently finished a five-year plan. Itencompasses further development and strengthen-ing of our international project management andour QA/QC groups with a moderate expansion.Our primary expansion is where our core officesare.We have evaluated what the margin is in eachof the offices to grow and to what level.We arecurrently a company of 50 employees. Our expan-sion plan goes to 120 employees within the nextfour years.We have identified three additionallocations in Europe where we would like toexpand into.We have just recently opened a newoffice in New Delhi, India, because this market isbecoming increasingly attractive to find the num-ber of patients, which is increasingly difficult inEurope, and we have excellent ties to local clinicalresearch facilities through Excel Life Sciences [apharmaceutical research organization]. This collab-oration makes a startup very efficient and effec-tive. We would also like to better penetrate theU.S. market.We don’t think the way is to open ourown office in the U.S. but to liaise with a local U.S.CRO that shares the same values.We are notlooking for a huge CRO but a CRO of comparablesize that would like to penetrate the Europeanmarket. PFC always builds a project team tailoredto the needs of the project and allies with nationaland regional CROs to extend its geographicalreach. The project teams are carefully managedand supervised by our project management andquality assurance groups.

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