Belgium - pharmaboardroom.com · Belgium. In addition, ... Ad_GxP_203x267_final.indd 1 21.01.2013 15:56:12 Uhr ... GSK Biolog-ics, UCB and Solvay Pharmaceuticals

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BelgiumPharma reportApril 2013

Acknowledgements

Focus Reports would like to warmly thank

Mr. Leo Neels for being exceptionally welcoming and introducing us to

Belgium. In addition, Wim Eynatten, Donald Niesten and Omer Saka of

Deloitte were not only insightful, but also very supportive of the report.

3

CONTENTS

This report was prepared by Focus ReportsProject Director: Mary Carmen Luna Matuk Project Coordinator: Aleksandra Klassen. Publisher: Ines Nandin Editor: Fred Gebhart

CopyrightAll rights reserved. No part of this publication maybe reproduced in any form or by any means, whether electronic, mechanical or otherwise including photocopying, recording or any information storage or retrieval system without prior written consent of Focus Reports.While every attempt is made to ensure the accuracy of the information contained in this report, neither Focus Reports nor the authors accept any liabilities for errors and omissions. Opinions expressed in this report are not necessarily those of the authors.

CONTENTS

INTERVIEWS

2 Acknowledgements5 Belgium: Europe’s Pharma Brewhouse6 The Good, The Bad, and The Unanticipated: The Good10 EuroGenTec – A Spin-off Success Story11 Innovation through Cross-Pollination13 Sanofi – Health is Wealth14 The Good, The Bad, and The Unanticipated: The Bad15 World Courier: Specialization, Specialization, Specialization19 The Good, The Bad, and The Unanticipated: ...and The Unanticipated

22 INTERVIEW WITH: Minister Laurette Onkelinx – Minister of Social Affairs and Public Health

24 INTERVIEW WITH: Tom Heyman – Managing Director & Chairman of the Board, JANSSEN’ & Sonja Willems - Managing Director, JANSSEN Benelux

28 INTERVIEW WITH: Philippe Vandeput – VP & Managing Director, Northern Europe of UCB

30 INTERVIEW WITH: Janneke van der Kamp - Country President of Novartis

32 INTERVIEW WITH: Patricia Lanssiers – Managing Director, Lilly Belgium and The Netherlands

34 INTERVIEW WITH: Jan Hendrickx – General Manager, Benelux of Sanofi

36 INTERVIEW WITH: Chris Juliam – Managing Director of TAKEDA, Belgium

38 INTERVIEW WITH: Eduardo Bravo – CEO of TiGenix

40 INTERVIEW WITH: Dr. Patrik De Haes - CEO, ThromboGenics

GxP Compliance

in the World Courier Network

About GxP

“GxP” is a collective term for the Good Practice quality guide-

lines and regulations used in many fields, encompassing such

internationally-recognized standards as GMP (Good Manufacturing

Practice), GCP (Good Clinical Practice), GSP (Good Storage Prac-

tice) and GDP (Good Distribution Practice). These guidelines are

designed to ensure that products are safe, meet their intended use

and, in regulated industries such as drugs, food, medical devices

and cosmetics, adhere to quality processes during manufacturing,

control, storage and distribution.

Our Position

World Courier acknowledges the critical

role that Good Practice plays in servi-

cing its biopharmaceutical customers. It

remains dedicated to ensuring company

GxP compliance at a worldwide organi-

zational level as it relates to the transport

and storage of investigational drugs, bio-

logical samples and additional supplies

used in global clinical trials.

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5Special SponSoRed Section

apRil 2013 FOCUS REPORTS S2

Belgium Report

This sponsored supplement was produced by Focus Reports.

Project Director: Béatrice ColletProject Coordinator: Aleksandra KlassenEditorial Coordinator: Roslan KhasawnehProject Publisher: Mary Carmen Luna Matuk & Ines Nandin

For exclusive interviews and more info, please log onto or write to [email protected]

despite its small size and lack of natural resources, Belgium is among the most prosperous and

competit ive countries in the world. The country holds many assets required for the development of a strong knowl-edge-based economy including an open economy dominated by international functions, the presence of decisive mul-tinational enterprises, the availability of a highly productive and skilled work-force as well as an enviable geostrategic location in Europe.

Among Belgium’s hallmarks is its

indulgent frothy beverage, beer, which appears to be limitless in variety and taste ranging from pale lager to Lam-bic or Flemish red. Simultaneously, Belgium has achieved remarkable suc-cess in a loosely related industry that also requires a seemingly magical mix-ture of ingredients under highly con-trolled and complex environments to produce a product many also view as indispensable: pharmaceuticals.

With an economy defi ned by in-ternational trade, Belgium exports roughly 60% of both its barley pop

by Ben Heine © 2013 — www.benheine.comBELGIUM: Europe’s Pharma Brew House

6 Belgium pharma report April 2013Belgium Report

Special SponSoRed Section

S3 FOCUS REPORTS apRil 2013

and pharmaceutical drugs production. However, the phar-maceutical industry directly employs in excess of 30,000 people and represented 10.4% of Belgium’s total exports in 2011. Belgium is in fact still the world’s second largest exporter of pharmaceuticals. As such, the pharmaceutical industry is a significant positive contributor to the coun-try’s trade balance.

Today, the Belgian pharmaceutical market is valued at approximately €4.5 billion (USD 6.1 billion) and is sup-ported by “a highly commendable healthcare system which provides a high standard of services to patients,” declares Laurette Onkelinx, minister of Social Affairs and Public Health. Belgium’s life sciences industry has evolved into a world-class contender. The country is regarded as a hub for clinical trials, a leader in the biopharmaceutical indus-try and a hub for pharmaceutical production and distribu-tion. Belgium has been the driving force behind a number of global giants such as Janssen Pharmaceutica, GSK Biolog-ics, UCB and Solvay Pharmaceuticals.

In part, Belgium’s excellence in pharmaceutical R&D is supported by the government’s attractive R&D patent and tax incentives that have served to nurture and attract in-numerable life science companies. Yet in terms of market access and reimbursement, Belgium is found to be lacking due to sub-optimal market authorization and reimburse-ment processes and pressure to balance healthcare budgets.

Nonetheless, Belgium remains an attractive destination for investment by the pharmaceutical industry. This is illus-trated by numerous investments made over the recent past, including UCB’s new biotech pilot plant, Janssen Pharma-ceutica’s new distribution center and Pfizer’s new produc-tion unit, to name a few.

The Good, The Bad and The UnanTicipaTed:The Good: a Mecca for BiotechsBelgium’s biopharmaceutical sector enjoys a leading

position on a global level. The biotech-nology industry is an increasingly important player in Europe and has been playing a central role in sup-porting Belgium’s economy.

H i s t o r i c a l l y , Belgium boasts an impressive track re-

cord in biopharmaceutical innovations. Some of the break-throughs made in the country include the first unraveling of the DNA sequence of a gene, the discovery of tPA (for dis-solving coronary clots) and the discovery of the HIV drug Tenofivir.

Today, there are over 140 biotechnology companies op-erating in Belgium (7% of all such companies in Europe) that accounted for 16% of Europe’s turnover and almost 10% of European R&D expenditures. Patrik De Haes, CEO of ThromboGenics, a successful biotech spin-off from the Katholiek Universiteit Van Leuven (KUL), stated that although Belgium is a small country, “in terms of biotech-nology we are right on top.”

Eduardo Bravo, CEO of TiGenix, the first and only com-pany with an approved cell-based product in Europe and also a spin-off of KUL and Universiteit Gent (UG), agrees that Belgium offers unique opportunities in biotech. “Bel-gium finds itself in a privileged position for cell therapy due to the concentration of cell therapy companies located in the Benelux region, particularly in Belgium.”

Yet Omer Saka, director at Deloitte submits that there is still room for improvement. “With the right policies and incentives in place, Belgium could very easily become the European leader in the biopharmaceutical sector. I consider the biotech sector to be the jewel in the economic and finan-cial crown of the country.” More specifically, Saka notes that “Belgium would benefit significantly by setting this as a major objective for her industrial policy. The government therefore has to put the vision out there to be the leading country, not just in R&D, but also in manufacturing bio-pharmaceuticals.”

In part, Belgium’s success in biotechnology can be traced to its excellent academic network, abundance of expertise and the trend towards cooperation and clusterization in the industry. Belgium boasts an academic network of 16 universities within a 60 mile radius and a high concentra-tion of university hospitals. A 2008 study by The Scientist found that four out of the top 10 universities in life science research, as measured by citations, are located in Belgium.

Janssen Beerse I Site Aerial Photo

From left: Laurette Onkelinx, Minister of Social Affairs and Public Health; Leo Neels, CEO of pharma.be (The General Association of the Pharmaceutical Industry)



Belgium Report

This is the greatest academic concentra-tion of any country outside of the US.

De Haes notes that “in Belgium, the number of drugs in development per million inhabitants is the highest in the world, ahead of the UK or the United States.” Likewise, Bravo goes on to say that Belgium maintains a “favorable position that obviously derives from the quality of its universities, especially with regard to the quality of the spin-offs they produce. With the highest con-centration of life science employees in the world, the country has become the birthplace of several world R&D centers for the biopharma industry.”

clinical Research In addition to its positioning as a center for research excel-lence, Belgium’s academic distinction has also contributed towards classifying the country as a hub for clinical trials. Michele Garot, vice president of BeCRO, Belgium’s Asso-ciation of Clinical Research Organizations, explains that one driver for the country’s strong competitive position in clinical research is “the time required to gain approvals for clinical research is much shorter compared to elsewhere in Europe and the world (less than 2 weeks for phase I).”

These rapid approval processes have made Belgium a particularly attractive destination for clinical trials. This is stressed by Patricia Lanssiers, manag-ing director of Eli Lilly Belgium and The Netherlands. “Considering that Belgium boasts one of Europe’s most favorable and rapid approval processes for clinical trials, it comes as no surprise that it hosts Europe’s highest number of clinical trials per capita. Needless to say, we are taking full advantage of this

situation, shaping the Belgian affiliate as one of the most attractive destinations for clinical studies across Europe.”

“One of the key drivers of our strong presence in the clinical research sector is the high-quality standard of the universities and research institutions,” she says. “Further-more, Belgium is home to several well-known key opinion leaders in the therapeutic areas that we are focused on. This combination of Belgium’s outstanding academics and our dedication to innovation makes the country a highly attrac-tive landscape for investment in clinical trials.”

Similarly, Mark Connolly, managing director at Boeh-ringer Ingelheim, highlights that “the main attraction is the number of high quality research centers to work with

and the expertise of the investigators. When we work in partnership with these centers we consistently see high stan-dards of management of the studies as well as superior data management. Overall, I would say that it is a mixture of reputation and consistent delivery of results that make the environment so appealing.”

“For Belgium, building such a reputation and level of

Source: pharma.be estimate based on figures published by or obtained from the three companies (GlaxoSmithKline, Janssen and UCB Pharma)

Patrik De Haes, CEO of Thrombogenics

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expertise certainly takes a great deal of hard work and dedication. For that reason, we have continued to invest in Belgium for over 50 years now and we have consistently expanded our clinical devel-opment activities in the coun-try.”

Numerous other leading multinationals have made signifi cant investments to es-tablish a strong local base for drug development including Novartis, Merck Sharp & Dohme (MSD), Jans-sen and UCB. “We certainly make the most of the country’s widely rec-ognized clinical research capabilities, from initial phase studies – which are very important for us – up until phase III studies. We have a range of clinical centers across the country recruiting as many as 1000 patients last year in more than 300 sites and developing ap-proximately 40 new compounds,” says Jean-Christophe Bencteux, general manager of Amgen.

Nevertheless, the European Com-mission has been making progress towards adopting a new proposal from the European Parliament and the Council on clinical trials that will replace the existing Clinical Trials Di-rective (2001/20/EC). On a European level, the proposal is expected to arrest the general decline in European clini-cal activities by offering centralized application procedures and harmonize approval times across member states, thereby increasing cost competitive-ness. However, in relation to Belgium’s rapid clinical approval processes, Ga-rot warns that “the new regulation will unfortunately make Belgium’s fast track differentiating factor obsolete.”

Despite the directive’s potential im-pact, many believe Belgium’s clinical trials industry is still in a favorable po-sition owing to its expertise and long track record of rapid approvals. Jan De Backer, founder and CEO of Flu-idDA, a cutting edge clinical research

organization (CRO), accentuates this point. “Generally speaking, I think that Belgium has somewhat of a head start in this respect owing to its famil-iarity with rapid approval procedures for clinical trials. On the other hand, if certain countries are currently accus-tomed to a three month time frame for instance, then it will be very diffi cult for them to quickly adapt to the new time frames. Illustratively, we carry out a number of multi-center clinical trials in Europe as a whole and the differences between Belgium and the Netherlands for instance is huge where these procedures require extended time periods. That is, there is an un-derlying dissimilarity in mentalities towards these activities. Therefore, even with the introduction of the new policies, I do not believe that the re-spective people’s attitudes will change as easily.”

Although Mark Connolly, manag-ing director of Boehringer Ingelheim, believes that the new regulation will infl uence their clinical operations to a certain degree, he maintains an equal level of confi dence in Belgium’s clinical expertise. “The new European regula-tion could very well have an impact on our clinical research activities. None-theless, whatever the regulations, what really matters is the ability to deliver good quality data, good quality man-agement of studies according to the plan as well as recruitment rates. Of course, together these elements are critical to maintaining a healthy clini-cal trials environment and I believe

that Belgium’s reputation in doing that will undoubtedly last.”

a push towards openness and collaborationConsidering the increasing costs and complexities associ-ated with drug discovery and development and the urgency to address unmet medical needs, the need for collabora-tion has never been greater.

AstraZeneca has recognized the fact, asserts Tarja Stenvall, country presi-dent of AstraZenaca Belux. She empha-sizes that, “innovation is very much at the heart of what AstraZeneca is and does. Despite the associated increased risks and long-term investments, we realize that science and a commitment to discovering new treatments can help to drive innovation. As such, we aim to profi le the Belgian affi liate as a key contributor to AstraZeneca’s global innovativeness. One way in which we do this is through various partner-ships with academic and commercial research institutions that provide us with a solid platform on which we can nurture future innovations.”

Stenvall is certainly not the only one to identify the importance and po-tential for collaborations. Jean-Pierre Delwart, CEO of EuroGenTec, a Bel-gian biotech that has grown to become a leading international biotechnology supplier, notes that “as a spin-off of the Liège University, EuroGenTec has an inherent propensity for academic collaborations. Since academics are of-ten our customers or regular contacts, we maintain a large base of contacts in Europe as well as the United States with them. For instance, when a re-searcher is willing to develop a certain type of product, we lend our support to them in whatever way possible, so long as there is the potential for a mutually benefi cial outcome, of course. Simulta-neously, we also try to develop various partnerships with other academics or

From left: Patricia Lanssiers, Managing Director of Lilly Belgium & The Netherlands; Mark Connolly, Managing Director of Boehringer Ingelheim; Tarja Stenvall, Country President of AstraZeneca, Belux

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10Belgium Report



researchers to explore new scientific or technological avenues. This is an ideal approach to staying at the forefront of technological breakthroughs and scien-tific advancements.”

Philippe Baudier, managing director of SMB Laboratories, an independent group of Belgian companies specialized in pharmaceutical R&D and manufac-turing, suggests that such a degree of collaboration between academia and

industry is a relatively new phenomenon in Belgium. “Over the past ten years, the academic community and industry have been intensifying their collaborative efforts. This runs in sharp contrast to the situation as it was over 30 years ago when I first started in this business. At that time, SMB had partnered with a certain professor from the University of Liège. However, this professor was stigmatized by his academic counterparts for choosing to work with the indus-try – which at that time was considered to be a dishonest act in Belgium. This was highly divergent from the trends prevalent in the US for instance where academics actively seek partnering activities with the industry.” Fortunately,

times have changed maintains Baudier “and such industry-academic collaborations are now widely accepted in Bel-gium and Europe as a whole.”

The pharmaceutical industry has made great efforts to streamline their operations over recent years to achieve greater efficiency and focus on their core competencies. Besides enhanced industry openness and appetite for part-nerships, pharma service providers have also observed

Founded in 1985 as a spin-off of the University of Liège, Eurogentec is a prime example of Belgium’s academic institutions turning research projects into highly innovative commercial enterprises. EuroGenTec has grown to become a leading provider of reliable and innovative products and services to the Life-Science, Diagnostic and Pharmaceutical community across 40 markets.

How would you describe EuroGenTec’s strategic focus today?EuroGenTec offers a broad range of custom and cat-alogue products for basic research in Genomics and Proteomics. We offer a wide range of GMP oligonucle-otide-based components and GMP Taq DNA polymer-ases for Molecular Diagnostic applications, such as molecular diagnostic kits, lab developed tests (ASRs) and companion diagnostics. Moreover, we are also a well-established full-service biopharmaceutical con-tract manufacturing organization, providing technology transfer, process development, and cGMP manufactur-ing of recombinant proteins and plasmid DNA obtained by microbial fermentation for preclinical, clinical and commercial use.

How would you describe the complementarity of your three business units?Simply put, EuroGenTec offers the life sciences com-munity a complete and comprehensive range of solu-tions, starting at the research level, extending through to the GMP manufacturing services at the clinical tri-als stage. Illustratively, starting at the research level, we offer genomic solutions in the target identification stage, followed by the proteomics in the target valida-tion phase. Moving further along in to the assay devel-opment, we offer in vitro (molecular) diagnostic prod-ucts and services. Finally, this brings us to the clinical trials stage which includes the GMP manufacturing so-lutions that we offer. With this in mind, it is easy to see how EuroGenTec has ideally positioned itself to becom-ing a true partner of choice, able to support its clients through each and every developmental stage in the life sciences, diagnostic and pharmaceutical industries.

EuroGenTec – Spin-off Success Story

Jean-Pierre Delwart, CEO of EuroGenTec

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Belgium pharma report April 2013



Belgium Report

increased activity in recent years. Philippe Vandiest, founder and CEO of PromoMed, a provider of broad spectrum outsourced services to the pharmaceutical and healthcare indus-try, says that “an interesting attribute of outsourcing companies in Belgium today is that they are among the very few companies in the pharmaceuticals industry that are experiencing real growth.” Not only is this development good for business but Vandiest claims this also makes services providers more appealing to potential employ-ees, increasing the pool of candidates service providers have access to.

At least in terms of sales representa-tives, the outsourcing industry in Bel-gium shares a past similar to that of academic collaborations in that they both made a late entry in Belgium. Vandiest explains that “Belgium is perhaps among the last markets in the European Union to develop a pharma-ceutical outsourcing industry, which was practically non-existent about 20 years ago. Since Belgium is a fairly dy-namic market boasting very accessible people with many competencies in a small geographical area, outsourcing was never a necessity at the time. If you compare this to the French mar-ket for example, outsourcing was es-sential because 40 years ago if you wanted to launch a product in the market, the communication rules were not the same as they are today prompt-ing the need to have some correspon-dence across all departments in France in order to provide information about the product. This marked the start of pharmaceutical outsourcing in France, and the rest of the EU for that matter with the exception of smaller countries like Belgium.”

Outsourced pharmaceutical repre-sentatives in Belgium now represent 17% of of all representatives in the country. A PriceWaterhouseCooper’s report forecasts that this figure will climb to 40% by 2015.”

Generally however, the industry has

traditionally been resistant to change. Vandiest recalls the difficulty associat-ed with establishing their operations. “As you may know, changing habits is one of the most difficult things in life.” The reluctance to change likely stems from the unwillingness to relinquish control over offerings and processes. In order to curtail their anxiety, ser-vice providers are putting their cus-tomers in the driver’s seat.

Patrick Leyseele, founder and CEO of pi, a Belgian based global regula-tory and technical service provider, proclaims, “our ultimate goal is to become a truly global strategic part-ner for our customers. We envision the most potential where customers have specialized partners who think with them and not for them. That is

why I always remind our customers that they should remain in the driver’s seat, while we are just the navigators. The advantage of this is that they are reminded that they are still in control and have a good feel for what is hap-pening while we take care of the rest for them. In other words, we do not intend to have our clients rely on us, nor do we want to create monopolies. Instead, we simply aspire to be their partners.”

This strategy has proven to be widely successful for pi since they have already managed to form “a special relation-ship with one of the top five Fortune 500 pharma companies,” Leyseele con-tinues. “pi has been selected as their preferred partner for outsourcing all of their work related to a platform for

Belgium’s pioneering life science organizations are ex-ploiting the opportunities presented by industry cross pollination. Jan De Backer, founder and CEO of FluidDa provided an example of how cross pollination can be a source of innovation.

FluidDA: With a background in aerospace engineer-ing, De Backer and his father, Wilfried De Backer – di-rector of the Department of Respiratory Medicine at the university hospital in Antwerp, quickly identified the potential of applying the principles of computational fluid dynamics used in airfoil design in the respiratory system. This was particularly interesting to them as they recognized that it was becoming increasingly difficult to mea-sure the efficiency of new interventions in the respiratory system using the classical outcome parameters.

They began evaluating the possibility of combining flow simulations with the CT scans or other conventional imaging modalities to develop personal-ized medicine. The underlying idea was to phenotype a given patient and determine whether these new output parameters can be used to detect the efficiency of new medications with high sensitivity.

After countless clinical trials and the publication of validation studies in prominent scientific journals, FluidDA has evolved into a leading company in the R&D of imaging biomarkers to enhance drug development and patient care. One key advantage their technology offers is reduced costs of drug development through reduced clinical trial sample sizes. FluidDA can also accelerate the introduction of the given drug to the market due to a more efficient clinical trial process. Jan De Backer believes that “FluidDA has the real opportunity to be among the first to make personalized medicine a reality.”

Innovation through cross pollination

Jan De Backer, CEO of FluidDa

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Belgium Report

Europe and the US and have ongoing discussions to expand the service globally.”

Geographical GemIn the same way that Belgium is the leading European des-tination for clinical trials, the country is also a European leader for logistics and distribution. Its geostrategic loca-tion has played a central role in enticing multinational gi-ants such as Janssen, MSD and GSK Biologics to establish international distribution centers in Belgium.

Although Belgium is a small market with 11 million in-habitants, companies situated in Belgium have access to a much broader market. Fully 60% of EU spending power lies within a 300-mile radius of Belgium. The strong presence of the pharma industry in Belgium highlights the strategic importance of the region, says Daniel Gagnon, EU region healthcare marketing director at United Parcel Services (UPS). “The motivation behind establishing our healthcare supply chain solutions facility in the region relates to the fact that it provides us with great capacity when it comes

down to ocean, air and road transpor-tation.”

These attributes have also attracted logistics providers specialized in the life sciences industry. “As a country with a deep history in the pharmaceu-tical industry, boasting some of the industry’s biggest players and a strong positioning in clinical trials, Belgium is undoubtedly an important compo-nent of World Couriers business,” says Alain Moureau, general manager of World Courier. The company is a lead-

ing provider of premium full-service, value-added, GxP-compliant logistics services for global clinical trials, operat-ing in close partnership with over 500 biopharmaceutical companies – including each of the top 50 global players – as well as with all major international CROs, clinical trial sup-pliers and central labs. Moureau explains that “since most of these companies have a presence in Belgium, the country plays an integral role in our business operations and is a strong contributor to our revenue stream.”

Given today’s challenging economic environment, ageing populations and shrinking healthcare budgets, Jan Hendrickx, general manager of Sanofi for the Benelux region, offers a fresh perspective on the vision for healthcare.

“Let us change the present vi-sion on healthcare. Today the words that are frequently recited are costs, quotas, spending, it’s too expensive, we cannot do this, etc…

When asked what the most important thing in our lives is, we all anxiously respond saying it is our health. Let us then recognize this.

I would like to propose to change the present, rather defensive, vision to a more positive and hopeful one: namely, ‘Health is Wealth,’ in the broadest sense of the word. After all, healthy people are happy people and healthy, happy people are a major asset for any econo-my, now and in the future. So let us all work together to achieve this.

Although we have made significant contributions on our part, this demonstrates our openness to holding dis-cussions with a wide range of stakeholders. Embracing such a philosophy will stimulate investments in innova-tive new drugs and make them accessible in the market at reasonable prices.”

Sanofi – Health is Wealth

Jan Hendrickx, General Manager of Sanofi, Benelux

Dan Gagnon, Healthcare Logistics Marketing Director of UPS, EMEA

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Not only is the pharmaceutical logistics market in Bel-gium well established and highly attractive, it presents transportation service providers with ample growth op-portunities. In response to client requests, World Courier recently expanded their services to address the need for specialized temperature controlled ground transportation services.

The Bad… pricing & Market access Market access and price reimbursements have grown in im-portance over the last decade due to increasingly expensive drugs entering the market, coupled with enormous pressures on governments to cut their healthcare costs. Belgium is no exception since these elements have led to the emergence of an uncertain market environment. In this context, Mark Con-nolly, managing director of Boehringer Ingelheim said that despite their understanding of the challenges faced by the Belgian government “the first word that came to mind when reflecting on the current market environment in Belgium was unpredictability. This makes planning a challenging task.”

These views are shared by Patricia Lanssiers, managing director of Eli Lilly and vice president of the board at pharma.

be, the general as-sociation of the pharmaceutical in-dustry. “As innova-tors in the pharma-ceutical industry, we would like to see a system that is more predictable and sustainable. We would like to serve the patients

and help to increase the quality of public health through the innovative drugs we develop. Clearly, doing so requires signifi-cant and long term investments. However, given the current environment’s unpredictability, and the fact that drug devel-opment takes on average ten years of research and develop-ment, we are facing some risks and uncertainties.

“In my capacity as the vice chairman of pharma.be, we are working on a long-term agreement with the health au-thorities to agree on certain principles that are essential for the sustainability of the Belgian system. Likewise, we are jointly working with the government authorities on find-ing the solutions to keep the healthcare budget in control. After all, innovative pharmaceutical companies help to sup-port the economy by providing high employment levels and investments while allowing patients to gain access to the latest drugs.”

Investment in research is vital for the success of any pharmaceutical sector. As a hub for R&D activities, Belgian pharma companies re-invested a remarkable 52% of their turnover into R&D activities in 2011 according to pharma.be. This is in sharp contrast to the global average reinvest-ment rate of 17%. However, pricing reimbursements in Belgium, or the lack thereof, represent one of the key ob-stacles that diminishes the industry’s capacity to reinvest in R&D. Reimbursement is a collective concern in Belgium’s industry.

A key factor behind these low prices can be traced to the reference pricing system in Belgium which was first in-troduced in 2001. Vlad Hogenhuis, managing director at Merck Sharp & Dohme (MSD) explains that “fundamen-tally, a reference pricing system makes a lot of sense for a consuming country that imports more medicines than it ex-ports. However, for a country that is a net exporter of medi-cines, the exporting countries often form the base price of the country that receives the medicine. Therefore, if our prices are lowered significantly, that can be considered to be a good thing from the perspective of the healthcare budget. However, from the perspective of pharmaceutical compa-nies located in an exporting country, this is abysmal. Il-lustratively, as Belgium adopts the reference pricing system,

From left: Alain Moureau, General Manager of World Courier; Noël Foucart, Global Marketing Director of World Courier

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Belgium Report

World Courier is the leader in specialty logistics for glob-al clinical trials, delivering fully-integrated GxP-compli-ant temperature-controlled transportation, storage and distribution solutions worldwide in over 10,000 clinical studies. In light of the increasingly complex and strin-gent regulatory environment in the clinical trials global supply chain, Noël Foucart, global marketing director of World Courier sheds light on the company’s dedication to providing complete solutions for global clinical trials.

To what degree has World Courier been able to introduce innovative solutions to provide investigators with com-prehensive solutions? World Courier is the only specialized courier company that is accredited with GxP standards. In order to main-tain this level of compliance, we have also employed many professionals from the pharmaceutical industry, among them quality advisors. In fact, we do so in a pro-

active manner, implementing the various GxP require-ments well before they are enforced. This is very im-portant for us since the pharma industry is increasingly undergoing regulatory changes and we must ensure we are able to comply with these strict requirements at all times. This represents one aspect of our value added services. Our clients can surely confide in our services since we are absolutely dedicated to maintaining the industry’s highest standards and are frequently audited across our entire network.

Another unique characteristic of World Courier is that we are the only company to have invested in as many as 13 depots for clinical trial supply chain services (CTSCS) since 2005. These depots are client driven GMP-compliant investigational drug facilities with loca-tions in Latin America, Asia-Pacific, Africa and Europe continuously experiencing ongoing expansions as a re-sult of high demand.

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Belgium Report

World Courier is the leader in specialty logistics for glob-al clinical trials, delivering fully-integrated GxP-compli-ant temperature-controlled transportation, storage and distribution solutions worldwide in over 10,000 clinical studies. In light of the increasingly complex and strin-gent regulatory environment in the clinical trials global supply chain, Noël Foucart, global marketing director of World Courier sheds light on the company’s dedication to providing complete solutions for global clinical trials.

To what degree has World Courier been able to introduce innovative solutions to provide investigators with com-prehensive solutions? World Courier is the only specialized courier company that is accredited with GxP standards. In order to main-tain this level of compliance, we have also employed many professionals from the pharmaceutical industry, among them quality advisors. In fact, we do so in a pro-

active manner, implementing the various GxP require-ments well before they are enforced. This is very im-portant for us since the pharma industry is increasingly undergoing regulatory changes and we must ensure we are able to comply with these strict requirements at all times. This represents one aspect of our value added services. Our clients can surely confide in our services since we are absolutely dedicated to maintaining the industry’s highest standards and are frequently audited across our entire network.

Another unique characteristic of World Courier is that we are the only company to have invested in as many as 13 depots for clinical trial supply chain services (CTSCS) since 2005. These depots are client driven GMP-compliant investigational drug facilities with loca-tions in Latin America, Asia-Pacific, Africa and Europe continuously experiencing ongoing expansions as a re-sult of high demand.

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the healthcare budget can save €1 (USD 1.34) per product, for instance, while at the same time there could very well be a loss of €20 (USD 26.8) or more, for example, on phar-maceutical companies’ balance sheets. This magnifi ed loss will be a result of losses arising from the erosion of R&D

budgets and investments in new drugs for instance.”

Leo Neels enthusiastically shares these thoughts. “Such a system is the most unintelligent, unproductive and shortsighted measure that Belgium can adopt. Effectively, this pricing sys-tem serves to drive the prices of drugs to lower levels, limiting the resources available for further investments in growth, R&D and in new innovative products,” he explains.

In anticipation of the far-reaching ripple effects of such measures, Hogenhuis clarifi es that “access to innovation is critical to sustain the investments stemming from the phar-maceutical industry in any given country. With the increas-ing trends of globalization, there are a number of competing countries, such as India and China, which are becoming increasingly attractive destinations of investment. Once these investments are channeled there, I believe that it will be near impossible for Belgium or other EU countries to reverse the trend and bring them back.”

In proposing a solution, Jean-Christophe Bencteux, general manager of Amgen, maintains that “it is critical that Belgium become aligned with other European countries with respect to the international refer-ence pricing system. Considering most countries within Europe calculate their prices with reference to each other, one can easily see how this can create a downward spiral, pushing prices to increasingly lower levels which is by no means a sustainable measure.”

Looking further into the future, Bencteux refers to having to man-age the current price levels and diffi cult cost containment measures. “These measures are sometimes highly dispro-portional and simply unfair,” he says. “At one end of the spectrum, the pharmaceutical industry faces higher taxes and, at the other, gradually eroding patent protections. All these measures together can pose a serious threat to the sus-tainability of the industry. The authorities must understand that the development of new products is a long-term invest-ment and that return on investment is a principle driver of our business. We have the innovative products, we know where we intend to go but we have to manage this unpre-dictability. A constructive dialogue with the authorities is therefore a prerequisite for success.”

In terms of market access, “Belgium has always been a challenging destination for market access, and this is a trend we are seeing across many European countries,” says

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Chris Juliam, managing director of Takeda.

Jan Hendrickx, general manager of Sanofi Benelux, agrees that “unfortu-nately, it is no secret that Belgium is among the slowest countries in the EU to provide innovative drugs with market access. Although we recog-nize that the budget must be kept in balance and that everyone must con-tribute in one way or another, we are convinced that this should not be done on behalf of new innovative drugs or solutions. They must realize that such innovations will ultimately contribute towards mending the economy and im-proving people’s well-being. There is much room for improvement with re-gards to overregulating procedures to improve market access for new innova-tive drugs in Belgium.”

In addition to irregular mar-ket access processes, Omer Saka of

Deloitte explains how this is a two-sided issue. “The biggest challenge at this point is the lack of standardized approaches both by the payers and the life sciences companies.” To help over-come this issue, Saka proposes that “pharmaceutical companies in Europe must focus on conveying the value of their products clearly to payer agen-cies. In addition to this, they must also think and act like a partner to the au-thorities – not as an industrial partner that creates jobs – but rather a partner that actually provides healthcare solu-tions.”

This view is echoed by Tom Hey-man, managing director and chairman of the management board at Janssen Pharmaceutica. “Whether of not at we like it or not, it is not just about the patients anymore. We have to be able to demonstrate through studies, as well as through solid relationships

with authorities, that we can help au-thorities manage their budgets togeth-er with providing better solutions for patients.”

Despite these challenges, Patri-cia Lanssiers asserts that “there is a healthy level of dialogue and under-standing with the authorities and we are making progress on reaching solu-tions that are mutually beneficial for both parties.”

The collective efforts of the phar-maceutical association and its mem-bers seem to have paid off. In October 2012 the industry was given a breath of fresh air when pharma.be announced that it had finally reached a long-term framework, or ”stability pact” with the Ministry of Health and Social Affairs. that “this agreement recognizes the role of the innovative industry in Bel-gium and clearly outlines that during any future budgetary discussions, the

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Belgium Report

industry will act as the preferred part-ner in the discussion process, allow-ing us to contribute in evaluating any proposed policies.” “What we have on paper today is translated into reality in the near future,” he adds.

Tarja Stenvall maintains that the agreement “demonstrates the govern-ment’s appetite to support and safe-guard the industry as well as to boost its capacity to innovate. I believe the pact also exhibits the authorities’ ac-knowledgment of the fact that they cannot tackle the industry’s challenges on their own and are therefore becom-ing increasingly open to new sugges-tions and ideas. Although overcoming these challenges will be no easy feat, it is certainly an encouraging sign from the authorities. Nonetheless, only time will tell what influence the pact will have on the healthcare and pharma in-dustry as a whole.”

“It is evident that the pharma in-dustry does have a voice in the decision making process today.” However, she maintains that the industry’s capac-ity to innovate “will help to determine exactly how strong this voice is and whether we could do more.”

Fragmentation Belgium is characterized by cultural and political fragmentation. Each of its regional areas (Brussels, Flanders and Wallonia) has its own executive and legislative powers. Although this can encourage local specialization and better allocation of state resources, it generally leads to regional inefficien-cies and inconsistencies and increases the cost and complexity of doing busi-ness in Belgium.

“In a country of about 11 million in-habitants, Belgium has more ministers than Germany or France,” jests Albert Maudens, general manager of Bioco-dex. “This highly fragmented structure makes it difficult to speak of opportu-nities as it inflates our business expens-es, among others. Every important de-cision that needs to be made, requires

that all the various governments and authorities come together to discuss the matter at hand which makes for a very time-consuming and counterproductive process. For instance, drug costs and hospital expenses are decided on a fed-eral level while costs related to elderly care centers are decided at a regional level. All this makes new developments in Belgium lengthy and difficult.”

Despite these challenges, Maudens

suggests that implementing a flexible and adaptive business model can help to overcome this issue and still remain profitable. “We were able to grow our revenues from €2 to €10 million (USD 2.7 to 13.4 million) over the last de-cade and we continue to see strong results.”

…and The UnanTicipaTed GenericsConsidering the Belgian government’s determination to balance its health-care budgets and the capacity of ge-nerics to create savings for healthcare systems, one might assume that gener-ics enjoy a strong position in the mar-ket. Belgium, however, has among the smallest generic drug market shares in Europe by both volume and value.

Joris Van Assche, managing direc-tor at FeBelGen, Belgium’s generic drug association, puts the situation

From left: Tom Heyman, Managing Director & Chairman of the Board of Janssen; Sonja Willems, Managing Director of Janssen, Benelux

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into perspective. “In 2011 we launched 20 new generic molecules on the Bel-gian market, representing savings of €66 million (USD 88.3 million) per year for the Belgian State, but only ob-tained an average of 5% market share for these generic molecules in 2012 (FeBelGen estimate as of June 2012). Cheap prescriptions have stagnated 50% in Belgium since 2010. In the meantime, no less than 40 new generic molecules have been launched!”

In terms of savings, Pascale Enge-len, managing director of Mylan which boasts a 20% generic drug market share in Belgium, elaborates on the potential savings that generics can pro-vide. “Since 2001, generic drugs have been able to create savings of €3.2 bil-lion (USD 4.3 billion) for the healthcare budget.” Along with these gigantic sav-ings, Van Assche highlights that generic companies also offer valuable contribu-

tions to the economy in that about 50% of generics sold in Belgium are pro-duced locally.

Van Assche explains that the root cause for the low penetration of gener-ics relates to the fact that there is no real policy or long-term vision to in-centivize the use of generics.

According to Carlo Ciapparelli, general manager of IMS Health, one way the government can realize fur-ther cost savings is to allow generics to realize their fullest potential in or-der to ease the burden on healthcare budgets. “This has to be compensated via an efficient reimbursement system that recognizes innovation and assigns the right prices to drugs,” he says. “In this respect, Belgium has been stand-ing still, not addressing one issue or the other. The real solution here can-not be found in placing further pres-sure on the R&D-based industry or

in delaying reimbursement decisions. These are all very shortsighted ‘solu-tions’ to a very real problem. The fo-cus should be in stimulating the right generic business.”

Belgium’s authorities seem to be re-sponding to these concerns according to Annabelle Bruyndonckx, counsel at Baker & McKenzie. “The authorities have recently introduced a number of new measures designed to promote the increased use of generics throughout the healthcare system.” Earlier in 2012, she explains, “the authorities intro-duced a new law that further encour-ages the prescription of generic drugs. With this new measure physicians are still endowed with the freedom to pre-scribe what they feel is most appropri-ate but at the same time pharmacists have the right to substitute prescribed antibiotics and antimycotics with other cheaper medicinal products.”

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22 Interview with: Minister Laurette Onkelinx – Minister of Social Affairs and Public Health

INTERVIEW WITH:

Minister Laurette Onkelinx – Minister of Social Affairs and Public Health

Focus Reports: With an expenditure of more than 10% of GDP on health, Belgium main-tains one of the world’s leading healthcare systems. That said, could you please com-ment on the current state of the healthcare system and the governments’ key priorities with respect to health? MINISTER LAURETTE ONKELINX: Indeed, Bel-gium does boast a highly commendable healthcare system which provides a high standard of services to patients. Nonethe-less, our primary objective and key chal-lenge today is ensuring the sustainability of the system by preparing ourselves for the future and bolstering the ballooning expense levels. Viewed in the broader con-text of the government’s budget, it was not uncommon to have budgetary cuts imposed on our expenditure. However, since the eco-nomic crisis we have experienced dramatic increases in the size of these mark-downs, culminating with an unprecedented mas-sive decrease in the government budget in excess of €12 billion in 2012. Without a doubt, this introduced a new era in the gov-ernments tightening budget. Fortunately, I managed to maintain a sufficient, though smaller, growth in the healthcare budget.

More specifically, although our chal-lenges are not widely dissimilar to those experienced throughout Europe, Belgium is faced with a rapidly aging population as well as a declining availability of healthcare professionals. That is, owing to innovations in healthcare and medical treatments, we

are fortunately able to improve the wellbe-ing and life expectancy of the population. At the same time however, this is leading to a situation where we have an increas-ingly larger aging population that out num-bers the younger population. Obviously, this gives way to two key issues. First being the increased burden on the healthcare budget and therefore its sustainability since the elderly require medical care. Sec-ond is the system’s increasing difficulty in coping with these demands due to the declining availability of healthcare profes-sionals (namely nurses and general practi-tioners) as a result of the professions dwin-dling attractiveness.

On a more personal level, I am also par-ticularly concerned with the inequality of people’s access to healthcare. Several local as well as European studies have indicated that there is to some degree a level of inequality in terms of access to healthcare for those from lower educational back-grounds, lower incomes or even different gender groups. Hence, in line with my socialist views, I would like to ensure that all patients are guaranteed equal access opportunities regardless of their back-grounds.

Broadly speaking, these represent the key issues which we have prioritised and have been working towards addressing. Nonetheless, there remains much room for improvement and we are dedicated to addressing these throughout the future.

Minister Laurette Onkelinx – Minister of Social Affairs and Public Health

23

FR: How does the Ministry of Health balance its cost containment objectives with its ambition to improve healthcare by ensuring access to the latest innovative medication? MINISTER LAURETTE ONKELINX: Simply put, our predominant objective is not cost reduction; rather it is ensuring access to the best available medicines. More specifi-cally, we first allocate a budgetary target applicable to drugs and then within these parameters, our goal is to provide full access to innovative drugs. Hence, we have placed access to novel medicines as an abso-lute priority for the public healthcare sys-tem while the means employed in realizing this remain provisional and dependant on the expenditure levels at the time. In other words, the cost containment measures will never be directed at denying access to new and innovative drugs.

FR: Would you say that the industry, or other stakeholders, can contribute in one way or another towards guaranteeing the health-care systems sustainability? MINISTER LAURETTE ONKELINX: As a public institution, we must first ascertain that our financial resources are employed effectively and efficiently. Therefore, although the incidences of non-value added, so called ‘me-too’, drugs is generally on the decline, we must ensure that our resources are expended on more urgent and necessary activities; namely, unaddressed medical needs. Fortunately, pharmaceutical com-panies today are increasingly directing their research efforts towards addressing the myriad of therapeutic areas with unmet needs including oncology, orphan diseases and even basic pathologies that still have research gaps, among many others. Having said that, such efforts by the pharmaceuti-cal industry will certainly contribute

towards minimizing inefficient healthcare spending and we are delighted that this is the general trend we are observing in the industry today.

Similarly, despite the fact that we as a public institution have widely dissimilar objectives from the market driven profit-orientated pharmaceutical companies, we do share a level of understanding of our respective situations and constraints. As a result, we have been able to find a common ground and are increasingly engaging in partnerships where we attempt to share the costs in some occasions. For example, in instances when we are presented with certain highly innovative but prohibitively expensive drugs, we manage to strike a deal which gives us access to these drugs at affordable price levels. These are negotiated contracts between INAMI - the local reim-bursement authority - and the respective companies where either the costs or risks associated with the drug are shared.

Broadly speaking, such sharing schemes are a relatively new practice in the industry but I believe this is a reflection of the changing environment which necessitates a more unified approach. It comes as no surprise therefore that we have been able to form close and constructive collabora-tive initiatives with the industry which cer-tainly has positive outcomes. After all, it is much easier to be constructive now that we have common goals which primarily include ensuring full access to critical drugs. n

I differentiate only between innovative products and generics, regardless of the source, and if it benefits people, everything will be accelerated.

24 Interview with: Tom Heyman - Managing Director & Chairman of the Management board, JANSSEN & Sonja Willems - Managing Director, JANSSEN Benelux

INTERVIEW WITH:

Tom Heyman - Managing Director & Chairman of the Management board & Sonja Willems - Managing Director, JANSSEN Benelux

Focus Reports: Mr. Heyman, you inherited the chair and management of Janssen Phar-maceutica. What core values and spirit of Janssen Pharmaceutica founder, Dr. Paul Janssen, were you asked by the family to perpetuate throughout the years? TOM HEYMAN: Janssen Pharmaceutica is all about innovation-developing, producing and providing innovative healthcare solu-tions for patients.

When I started here in 1982, Dr. Paul, as we all called him, was still around. And every time I met him dashing around some-where, he always asked the same question: “what is new?” We could run into each other several times a day and every time he would ask that same question and you had better provide him with a good and dif-ferent answer each time!

Dr. Paul has always been interested in an innovative approach, continuously ask-ing himself “what can we do to help patients?” and always reminding us that “the patients are waiting.”

In short, this is what we are trying to do at this campus today-saving or improving patients’ lives worldwide with our innova-tive products. This is the core value of Jans-sen.

FR: Janssen has grown to have a presence

on five continents. What are your key world-wide markets today and what are the most challenging markets for Janssen in the future?TOM HEYMAN: Janssen Pharmaceutica became a member of the family of Johnson & Johnson companies in 1961, which has given this company the opportunity to glo-balize itself.

The markets in which we have a strong presence include the traditional markets such as Europe, the United States and Japan as well as China. In fact, we started our operations in China in the late seven-ties, which made us one of the first foreign- owned companies to have a presence in that market. This was only possible through a joint venture with the government, which has been critically important for the growth of our business in China.

Brazil is another market in which we are very successful and have had a long stand-ing presence there. More recently, Russia has become an important market for us as well as it is a rapidly developing market.

Today, our focus is on all emerging mar-kets. This extends beyond the BRICS coun-tries to also include other countries that are becoming increasingly important as well. Fifteen years, ago people talked about the tigers of Asia - South Korea and Taiwan

Tom Heyman - Managing Director & Chairman of the Management board, JANSSEN

25

- subsequently however we witnessed the BRICS countries attract the attention of the world. In the same way, we believe that the next wave of rapidly developing econo-mies will include countries such as Viet-nam, Philippines, Nigeria, Indonesia and potentially Egypt. Hence, for the time being we are keeping a watchful eye on these countries.

On the other hand, the markets that are becoming increasingly complex are in fact the developed ones. Actually, these coun-tries have already been complex. More spe-cifically, highly developed markets have governments that play a major role in how healthcare is provided and paid for. Of course, this does not mean that a pharma-ceutical company cannot be successful in a mature market. Growing by 1% in a G5 country means generally higher revenue than growing 10% in Russia, for instance, due to the variances in base measures.

FR: Janssen has been one of the few compa-nies that really managed to break into the global arena to become known as one of the most innovative companies in the world. What factors would you attribute to this success? TOM HEYMAN: Again, it is all about innova-tive compounds. However, the definition of innovation has changed over time. At this moment, it is not sufficient to merely bring improvement to an existing product. Rather, today it is about innovative prod-ucts that not only make a difference to patients’ lives but also make a difference to the payers as well. We have to be able to show that we are able to deliver health-eco-nomic benefits on top of clinical benefits.

This is something that we have been able to deliver on over the last three years for the medicines that we developed and pro-

duced in Belgium. Our advantage is that we also have a strong commercial organiza-tion, which is able to demonstrate to the authorities that there is an economic ben-efit on top of the clinical one. Whether we like it or not, it is not just about the patients anymore. We have to be able to demon-strate through studies, as well as through solid relationships with authorities, that we can help authorities manage their bud-gets together with providing better solu-tions for patients.

FR: Janssen’s Incivo(r) drug has achieved widespread success which was made possi-ble partly due to the use of an innovative spray-dry technology in your production methods. What are the implications of these new production methods for future medi-cines?TOM HEYMAN: The spray-dry technology was first applied in one of our HIV products. This HIV product would not have come to the market without this technology, which was interestingly derived from the foods industry. For patients suffering from HIV,

Tom Heyman - Managing Director and Chairman of the Management Board& Sonja Willems - Managing Director Benelux Janssen Pharmaceutica

26

they were previously required to consume up to 40 pills a day. However, since we implemented this new technology, we were able to bring the dosage down to as little as 3 pills a day - a significant leap forward. Subsequently, we used this argument in our discussion with Vertex, the originator of Incivo(r) and were able to convince them to partner with us.

This undoubtedly demonstrates yet another example of Janssen’s ability to innovate. This technology was sourced ini-tially from the milk industry in Denmark where we sent our people to learn about it. Moreover, we brought people here and built collaboration between our pharmaceutical industry development, chemical develop-ment and production facilities. This resulted in the development of a system which we implemented first in our HIV products and now for Incivo(r). Needless to say, the spray-dry technology is an inter-esting and effective technology that we will certainly apply in the future to other prod-ucts.

One of our objectives is to learn from each other on our campus. The challenge of having so many different functions on our campus is to have them talk to each other in order to nurture new opportuni-ties and ideas. Coming back to Dr. Paul’s spirit and philosophy, we are constantly trying to foster an environment of collab-oration and communication which results in synergies and innovation. Moreover, I want people here to understand that their contributions at Janssen have an impact on patients’ lives because everyone who works here touches people’s lives.

FR: Janssen is engaging in open innovation through both internal and external part-nerships. What are the motivations driving

this relatively underexplored initiative? TOM HEYMAN: It is rather simple in the sense that the amount of money spend world-wide across universities, governments, companies and other institutes in R&D is a drop in the ocean compared to the amount of money that we as a pharma group spend, which is highly significant. Likewise, the fact that we have come to the realization that innovation does not stop here at the boarders of our Beerse site. We are well aware that there is a lot of innova-tion going on outside this campus. For us to get access to that innovation we need to understand the medical needs, the new approaches to medicines and start looking at medical solutions which are of utmost importance. We do not possess the capac-ity to develop all of this on our own. Thus, we are creating collaborations with other parties and have been doing this for a long time now.

More specifically, we have relationships with every university in Belgium and con-duct research with other academic institu-tions across the world as far as China. We also have partnerships with all sorts of bio-tech companies on a global basis. This is a way of living for us at Janssen.

Furthermore, we also have for example a German company, Biocartis, which we are also working closely with on our campus. Likewise, we have a university center spe-cialized in Alzheimer disease with a labo-ratory here. For us, it is not just partner-ship in the sense that you strike a deal; rather it is about increased interaction by bringing scientists together to create an environment where ideas are exchanged.

FR: Mr. Heyman, you were previously quoted saying that the changing pharmaceutical environment demands a proactive shift in

Interview with: Tom Heyman - Managing Director & Chairman of the Management board, JANSSEN & Sonja Willems - Managing Director, JANSSEN Benelux

Sonja Willems - Managing Director Benelux, JANSSEN

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the research model to cope with this trend. What did you mean by this and what is the future of Janssen’s research model?TOM HEYMAN: You have to shift your focus in R&D to those products that bring health-economic benefit. Very early on in development plans you have to think that through. Today, it is no longer sufficient to show that your product works and that is has a reasonable toxicological profile, but you also have to demonstrate that it is bet-ter than the current standard of care. This needs to be built in your clinical studies at an early stage otherwise you are going to miss the boat.

Furthermore, we have to open ourselves to the external environment and realize that there is more innovation going on out-side our walls. Solving diseases such as Alzheimer is a very complicated process. In Schizophrenia, for instance, we have been investing in R&D for sixty years now and although we know how to treat its symptoms, we do not yet know how to treat the disease. Similarly, we do not have solu-tions for an array of oncological diseases as well.

On the other hand, I would say that the disease we have achieved the most prog-ress in the over the last 30 years is HIV. In the early eighties this was a deadly disease but now, at least in the developed world, it is a chronic disease. Life expectancy of an HIV patient is more or less the same as yours and mine.

FR: Looking ahead, where would you like to take the Belgian operations of Janssen in the next couple of years and what goals would you like to achieve?SONJA WILLEMS: We need to intensify the dialogue with our partners in the market such as government, sick funds and uni-

versities to see how we can all better pre-pare ourselves for the future. With respect to Belgium, the main challenges we are looking at include the aging populations and tightening healthcare budgets. The industry is not able to solve this alone so has to sit with partners in order to find the right solutions.

From our point of view we have to con-tinue looking for innovating solutions not only in medication but also in services and support to patients while also becoming more efficient and effective in everything we do, like everybody else at the moment. TOM HEYMAN: Considering that we launched eight new products over the last two years, we should be safe for the medium term. However, the challenge for us is to recreate a new pipeline of highly innova-tive products that meets patients’ needs while offering well balanced health-eco-nomic benefits to secure our long term ambitions.

For the campus particularly, we need to ensure that investments continue to follow here. We have a dedicated and pro-fessional workforce here and the Belgium government has created a good environ-ment especially from a fiscal point of view to conduct R&D. However, we would hope that they will also create a better environ-ment for our local commercial companies here with respect to access and pricing.

Nonetheless, for us it is important to continue to invest in the country as it rep-resents the very roots of Janssen. More-over, Belgium boasts a good infrastruc-ture, high standard of education and academic institutions and is an attractive destination for clinical trials and we need to ensure that we maintain this competi-tive edge and continue to attract invest-ments. n

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INTERVIEW WITH:

Philippe Vandeput – VP & Managing Director, Northern Europe of UCB

Focus Reports: UCB is among the handful of originally Belgian pharmaceutical compa-nies that truly achieved worldwide recogni-tion, with the key distinction of doing so entirely on its own without being absorbed by global giants. How has your independent status contributed to the success of UCB? PHILIPPE VANDEPUT: I believe that UCB’s independent structure and its compara-tively smaller size can certainly be consid-ered as one of its assets. These qualities allow us to be quite agile as a company; able to rapidly respond to the changing environment which is a big advantage in today’s turbulent marketplace.

Likewise, we have recognized that we do not have the capacity to do everything on our own given our size. This encourages us to seek the best external partners to complement our expertise. I believe this represents a great opportunity to explore new ideas and engage in open collabora-tions. Moreover, since financial resources are limited, UCB is an extremely cautious investor that is mindful of the invest-ments and partnerships it seeks, develop-ing only the most value added projects. Furthermore, it does so with an eye towards engaging in active collaborations designed to build upon and complement our expertise.

Hence, I think that UCB’s flexibility and its ability to partner with the leaders in the industry - including universities such as Harvard, Oxford as well as locals such

as K.U. Leuven or the University of Liège- that endows us with a unique strength and positioning as a company. This certainly helps us to forge ahead and maintain our independent corporate structure with a rich early- and late-stage pipeline.

FR: In 2011 UCB was the largest Belgian investor in R&D across all industries. What motivates these decisions to continue investing in the country in light of increas-ing competition from emerging nations? PHILIPPE VANDEPUT: Belgium as a whole offers a range of unique benefits. For instance, the educational system here sat-isfies the highest standards and produces highly qualified professionals in various fields. In addition to this, in terms of attracting foreign talent (particularly for researchers since Belgium is a hub for R&D), I think that Belgium is also an appealing destination for expatriates to reside in. Altogether, this provides us with access to a great pool of talent to fuel our R&D, manufacturing and even commercial activities.

Another important element to consider is the openness of government authorities to partnering with the industry. This is partly a result of the government’s aim of creating an attractive investment climate and setting up the foundations for the healthy development of the biopharma industry.

Philippe Vandeput – VP & Managing Director, NORTHERN EUROPE AT UCB

Interview with: Philippe Vandeput – VP & Managing Director, Northern Europe at UCB

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FR: UCB recently launched its €65 million USD 85 million) biotech plant in Braine-L’Alleud. What does this tell us about the importance of biologics for the future head-ing of the company? PHILIPPE VANDEPUT: This is a testimony to our commitment to Belgium as it is an inte-gral part of our success. Moreover, as UCB is primarily focused on the immunology and central nervous system (CNS), this investment further strengthens our stra-tegic focus on the immunology and biolog-ical aspects of the company.

FR: Can you tell us more about your CNS research hub in Braine-L’Alleud?PHILIPPE VANDEPUT: As mentioned earlier, UCB is focused on two core therapeutic areas: in immunology, with a site in Slough (UK) which houses the immunology research hub, and in CNS which is based in our strategic Braine-L’Alleud site (Bel-gium).

FR: How does UCB foster an environment that is truly conducive to creativity and innovation?PHILIPPE VANDEPUT: There are three compo-nents to this. First is the revamping of our internal research team which was realized by Mr Ismail Kola (joined in 2009 as Exec-utive Vice President and President UCB New Medicines). Developing on the exper-tise UCB had developed over the years, Ismail Kola gave the early research organ-isation somewhat of a fresh start that allowed our team to look at things from a different perspective.

Second is UCB’s open innovation model which recognizes that development of innovative therapies is not always achieved alone but as a result of partnerships. This allows our researchers to tap into a wider range of collective brain power than before while also challenging them to excel.

The third component of fostering inno-

vativeness involves making sure that we position ourselves close to where the action is. That is, we think it is important to pay attention to the interactions between phy-sicians and patients to evaluate what is going well, what requires our attention and what aspects of unmet needs can be under-stood better. As mentioned earlier, we are applying this philosophy of patient centric-ity and customer insight throughout the entire value chain of our company includ-ing the commercial, research and develop-ment sides.

FR: Looking ahead, what are your goals for the Belgian operations of UCB over the fore-seeable future?PHILIPPE VANDEPUT: My primary goal is par-allel to that of the overall company; to ensure that our new products, Cimzia(r), Neupro(r) and Vimpat(r), continue to gain momentum and achieve the success we think they deserve. These products repre-sent UCB’s growth drivers for Belgium and Northern Europe and I think this is the best way in which I can support the com-pany’s operational objectives. Similarly, we have an excellent pipeline of products with a number of new indications, some of which are demonstrating great potential and are expected to be commercialized within the next few of years.

In a broader sense, we are also deter-mined to maximize the effectiveness and synergies of the partnerships we maintain with academic institutions. Moreover, we intend to ensure that we continue to develop our strategic research and produc-tion sites in Belgium including our newly inaugurated biotech plant.

In conclusion, I would say that, as a company, we have many things working in our favour in Belgium and are therefore strongly committed to enhancing our pres-ence here. n

30 Interview with:Janneke van der Kamp - Country President of Novartis

INTERVIEW WITH:

Janneke van der Kamp - Country President of Novartis

Focus Reports: Mrs van der Kamp, you launched your career as a strategy consul-tant however, since then you have moved into the pharmaceutical industry by joining Novartis where you quickly worked your way up the ladder. What attracted you to this industry and Novartis specifically?

Prior to beginning my career as a con-sultant, I earned my degree in chemistry which explains why I joined the pharma-ceutical industry. Following my studies, I enjoyed transitioning from a scientific field into the strategy consulting profession because I felt like focusing on science would be too narrow for me. Moreover, I believe that launching a career in strategy consult-ing was a great first step as it was an ideal learning experience being exposed to so many different companies and industries while having the opportunity to be brought out to an executive level at a young age which is uncommon for people at the begin-ning of their career.

Following three and a half enjoyable years in strategy consulting, I went on to pursue an MBA at INSEAD from which I wanted to achieve two things. Firstly, since I am strongly result oriented, I wanted to position myself in an environment which was closer to execution and results. Sec-ondly, having been distanced from the field of chemistry, I wanted to return to the sci-entific and medical disciplines. After all, the reason I had pursued chemistry was because I had always been fascinated by the inner functions of the human body and I think it is the most beautiful machine there

is. Therefore, following my MBA, I began seeking placement within the biotech or pharma field so that I could, once again, be involved in and contribute to that beautiful machine.

Given that I was still new to the indus-try, I opted to target pharma companies instead of biotech since I figured I would learn more in a large pharmaceutical com-pany. Among the sea of pharma companies, I was drawn to Novartis because its CSR activities appealed to me as did its strong performance and solid product pipeline. Perhaps most importantly, however, I was invited to enrol in Novartis’ renowned tal-ent management program that enabled me to gain extensive experience into the com-pany’s various operations. In summary, these are the features, which drew me to become part of the Novartis team where I continue to enjoy experiences and expo-sure to a great deal of opportunities.

Janneke van der Kamp - Country President of Novartis

Janneke van der Kamp of Novartis meets the Focus Reports team

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Focus Reports: Novartis Pharma is the larg-est division of the group in Belgium and has posted impressive growth figures in the recent past. What have been your main growth drivers in the Belgian market?

Clearly, Novartis has for the past few years been undergoing a transformation with the rejuvenation of its portfolio, suc-cessful launches and a strong pipeline, which will allow our company to offset the loss of one of our blockbusters, Diovan. Furthermore, the diversity of Novartis’ products and addressed therapeutic areas is undoubtedly an advantage for the com-pany as it helps to balance its potential risks. On the other hand however, this diversity can also be viewed as a challenge since we have to compete with specialized drug companies that are only focused on specific therapeutic areas. For instance, as we are active in multiple sclerosis (MS) and diabetes, we have to be able to com-pete directly with companies that are ded-icated exclusively to those fields.

In terms of products that have contrib-uted the most to our sales over the last few years, Lucentis has been a great per-former. Another product that we have recently launched is Gilenya. Besides being highly effective, this drug is also very convenient since patients no longer need to inject themselves to treat their ill-ness. Despite its recent release, this prod-uct has taken off quite rapidly and we expect it to perform very well in the future. In addition to this, our Chronic Obstructive Pulmonary Disease (COPD) portfolio is also very strong as is our oncology portfolio. It is therefore clear that our success is not rooted in a small number of specific products but rather in a broad range of many products, demon-strating the strength of having a diversi-fied portfolio and a strong product pipe-line with at least one launch every year.

Focus Reports: In your opinion, what attri-butes does Belgium have in terms of being an attractive investment destination for the pharmaceutical and healthcare indus-try and what can be done to increase its attractiveness?

As mentioned, some of Belgium’s advantages include its strength in R&D as well as the fact that pharmaceuticals is viewed as a partner by the government because of the large numbers of highly skilled people it employs. The pharma and biotech industry is indeed a key pillar in the Belgian economy and its reputation for innovation. On the other hand, the price levels in Belgium, which are at the low end of the European range, constitute some of the drawbacks in the market. In addition to this, reimbursement timelines are also rather lengthy in Belgium, taking at least nine months from Competent Health Authorities approval to reimburse-ment on the Belgian market. Needless to say, this is detrimental to the patients’ well-being and the overall business envi-ronment. Of course, we can understand the government’s decisions for cost con-tainment measures, however at a certain point this could drive investments and products away from the Belgian market.

In summary, I would say that structur-ally, from an R&D perspective, Belgium is very attractive, however, operationally it is challenging. n

the diversity of Novartis’ products and addressed therapeutic areas is undoubtedly an advantage for the company as it helps to balance its potential risks

32 Interview with: Patricia Lanssiers – Managing Director, Lilly Belgium and The Netherlands

INTERVIEW WITH:

Patricia Lanssiers – Managing Director, Lilly Belgium and The Netherlands

Focus Reports: Since 1969, Eli Lilly & Com-pany has been investing in Belgium. Can you describe the company’s Belgian history and highlight some of your most notable achieve-ments?PATRICIA LANSSIERS: Eli Lilly & Company is a global leading American pharmaceutical company headquartered in Indianapolis, Indiana, US. From the very beginning, Lilly has always been focusing on quality and innovation. This has always been done in line with our core values which are excel-lence, integrity and respect for people. These were my main reasons to join Lilly in December 2000 as Corporate Affairs Direc-tor for the Belgian affiliate. Looking back at my last four years as Managing Director I would like to highlight our sustainable performance which has allowed us to con-sistently improve patients’ outcomes. Hav-ing that said, I am convinced that having the right molecule for the right patient will lead to additional sustainable results over time. On the other hand, I believe my role as Managing Director acts as the link between the internal and external environ-ment ensuring that our organization is pre-pared for challenges and opportunities derived from the external environment. For that reason, my management team and I are continuously examining future pros-pects and trends while evaluating the adap-tations that must be made to seize tomor-row’s opportunities and overcome its challenges. This is coupled with having the

right people and the need to build on diver-sity. We have invested significantly into the development of our people who are com-mitted, alert and have the right attitude to ascertain that we have the capabilities required to forge ahead.

In that respect, I believe my main con-tribution to the development of the Belgian affiliate stems from my external focus. After all, it is not inside our office walls where the real differences are made. Instead, they occur beyond these spaces, in the external environment where we gain feedback from our stakeholders and patients with regards to our existing prod-ucts and those under development.

In addition to my responsibilities at Lilly, I aim to make a positive impact on the industry through my role as Vice Chairman of Pharma.

be – the Belgian association of the phar-maceutical industry - by encouraging a favourable and sustainable development of the regulatory environment. Similarly, prior to pharma.

be, I have been Chairman of the LAWG – the Local American Working Group. Within this organization, we organized an event last year with the American Ambas-sador and key stakeholders aiming to increase awareness of the importance of the life sciences industry to the healthcare system as well as its contribution to overall economic performance.

To what extent is Lilly capitalizing on

Patricia LanssiersManaging Director Lilly Belgium and The Netherlands

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Belgium’s R&D strengths and innovative capacities to reinforce its own capabilities?

Considering that Belgium boasts one of Europe’s most favourable and rapid approval process for clinical trials, it comes as no surprise that it hosts Europe’s high-est number clinical trials per capita. Need-less to say, we are taking full advantage of this situation, shaping the Belgian affiliate as one of the most attractive destinations for clinical studies across Europe. One of the key drivers of our strong presence in the clinical research sector is the high-quality standard of the universities and research institutions. Furthermore, Bel-gium is home to several well-known key opinion leaders in the therapeutic areas that we are focused on. This combination of Belgium’s outstanding academics and our dedication to innovation makes the country a highly attractive landscape for investment in clinical trials. To put this into perspective, the pharmaceutical indus-try invests on average 16% of its revenues in R&D, the highest among all industries.

FR: At the same time however, Lilly invested in 2011, 21% of our turnover in R&D, illus-trating our commitment to innovation. Can you tell us more about the developmental focus of the company’s pipeline?PATRICIA LANSSIERS: Indeed, at this point in time, Lilly does have a very rich and diverse product pipeline and we are certainly very excited about that. In fact, we currently have the richest mid-to-late stage pipeline in our history, representing a variety of therapeutic areas including cancer, diabe-tes, neuroscience and autoimmunity. We’re focused on developing a complementary mix of small and large molecules across our pipeline in order to address the diverse needs of the patients we serve.

Considering the company’s 43 year history in the country, could you highlight some of Lilly’s local philanthropic activities?PATRICIA LANSSIERS: We are participating in global activities that are rolled out locally. In fact, we are currently implementing a global initiative that will have one hundred of our local employees, including myself, offering help throughout the day to differ-ent centers dedicated to helping children, such as treatment centers, youth centers, and child shelters. Another global initiative we have implemented since last year is “Connecting Hearts Abroad”. This is a pro-gram where up to 200 employees from 38 countries can voluntarily participate in helping communities abroad. For instance, one of our selected employees was sent to Russia for a two week period to freely sup-port and help children in psychiatric hos-pitals as well as elderly people in a day care centre. Furthermore, we also organize a number of locally inspired support initia-tives. One example is the Brussels 20 kilo-metres running race in which we have pledged to donate a given amount of money for every participant representing Lilly to a charitable organization.

FR: Where would you like to take the Belgian operations of Eli Lilly over the next 2 to 3 years?PATRICIA LANSSIERS: Our common vision for the future is really to achieve a “wow” effect towards our customers. This is also met by applying the highest ethical standards to our behaviours and interactions with external partners. This does not only apply to our customers but also to the patients because at the end of the day our main goal is to improve patient lives and ensure that patients, who need our drug, live longer, healthier and more active lives. n

34 Interview with: Jan Hendrickx – General Manager, Benelux of Sanofi

INTERVIEW WITH:

Jan Hendrickx – General Manager, Benelux of Sanofi

Focus Reports: Mr Hendrickx, considering that you have been with Sanofi for over a decade, what would you describe as the sin-gle most important change in Sanofi’s busi-ness model? JAN HENDRICKX: In essence, it is the diversi-fication of Sanofi into a wide range of busi-ness activities. In the past, Sanofi was very successful at focusing on blockbusters products, which explains why we had one of the densest blockbuster portfolios in the pharmaceutical world. However, with time came the patent cliff and we experienced a few setbacks.

Since the arrival of Chris Viehbacher as global CEO of Sanofi in 2008, the company has made great strides in overcoming these obstacles by diversifying its activi-ties. Personally, I think what we have achieved in the last four years is nothing short of amazing. Today, we have become a completely diversified organization that is focused on a number of growth plat-forms. These include innovation through R&D (particularly in oncology and diabe-tes), emerging markets, consumer health-care, vaccines and animal health (Merial). In addition to this, the acquisition of one of the world’s largest biotech companies, Genzyme, in 2011 has endowed us with a major presence in the biotech industry. Naturally, one positive consequence of this is that we are now better shielded against the patent cliff.

At the same time, I would say that Sano-fi’s transformation into a truly patient focused company is another cornerstone

in its evolution, facilitated by the integra-tion of Genzyme into its structure. Con-sidering Genzyme’s focus on rare diseases with relatively minor patient pools across the world, it is easy to see how they have developed an organizational structure and culture that is highly focused on serving their patients. Illustrative of its intense patient focus, Genzyme’s Myozyme(r) drug (for the treatment of Pompe disease) serves approximately 1,600 people world-wide. I think this is remarkable and never ceases to amaze me. By contrast, Sanofi has been serving millions of different patients across a range of therapeutic areas. Of course, we did have the patients in mind but not at the same individual patient level as with Genzyme. Hence, we are delighted to be able to make this shift towards making a real impact in people’s lives and Genzyme has aided us in learn-ing how to do so. Similarly, in many coun-tries we have launched some devices for

Jan Hendrickx – General Manager, BENELUX OF SANOFI

Jan Hendricx of Sanofi meets Focus Reports

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diabetes patients (iBGStar(r)) as well as diagnostic tests for cancer patients. Even-tually, we would like to offer a holistic approach to the patient, going beyond medication and provide them with a com-plete solution for their disease by making products, services, devices or a combina-tion of these available to them.

In addition to this, as a highly diversified company, Sanofi is also operating under a new business model. More specifically, we are operating in a matrix structure that has many interconnected activities crisscrossing each of our departments and business units. Needless to say, this requires us to work in closer collaborations and in a more open and dynamic environment. That said, Sanofi today is much more complex and diversified but it also offers a more satisfying and inter-esting work environment.

FR: What is the strategic importance of the Belgian affiliate to Sanofi’s regional opera-tions and performance?JAN HENDRICKX: Sanofi is among the top five companies in Belgium and as such, the country is a very important market for the company. Furthermore, the Belgian affili-ate of Sanofi is considered to be among the top 10 affiliates across Europe for the group.

In particular, the Belgian affiliate is an important provider of clinical studies for Sanofi, investing heavily in these activi-ties. Today, we are conducting studies for 15 distinct new medicines in about 100 study centers with more than 400 partici-pating patients. Put differently, we have a presence in clinical activities in one out of every two to three hospitals in Belgium.

Interestingly, Belgium represents one of those countries in which the group deploys almost all of its activities. That is,

Sanofi Belgium is composed of a commer-cial organization, a clinical study unit and production facility. Moreover, we are also present in each of the group’s business divisions (including Merial and Genzyme of course) and are active in all the com-pany’s growth platforms. In addition to this, we are also in charge of a world class production facility in Geel which exports its production globally. What’s more, as part of a huge expansion project, known as the ‘Stella’ Project, we are in the process of extending the Geel production site. Of course, this makes us feel very proud and fortunate to have all these activities on Belgian soil.

FR: Considering that last year, Sanofi launched its new logo and shortened its name, how would you say the company would like to portray itself to its stakehold-ers and the world at large? JAN HENDRICKX: Sanofi’s new logo includes a symbol, called the “Bird of Hope”, symbol-izing the hope that it brings to the 7 billion people around the world and our focus on the patient. The symbol is made up of three shapes which represent the three princi-ples that sum up Sanofi’s strategy: Innova-tion, Adaptability, and External Growth. The shapes equally represent the diversity of Sanofi’s divisions, subsidiaries, affiliates and various teams, whose culture and know-how around the world illustrate how the company achieves its ambitions. On the other hand, we want to portray our-selves as a responsible organization in terms of good governance and social responsibility. To this end, all of our employees across the world are well aware that compliance and good citizenship are among our key priorities and are actively working towards these goals. n

36 Interview with: Chris Juliam – Managing Director of TAKEDA, Belgium

INTERVIEW WITH:

Chris Juliam – Managing Director of TAKEDA, Belgium

Focus Reports: Takeda Belgium, formerly Nycomed, has enjoyed a rich and dynamic history in the country. Can you provide our readers with a brief overview of the com-pany’s growth path so far?CHRIS JULIAM: Although Nycomed was ini-tially a company of Scandinavian origin, the Belgian affiliate has local roots having been founded in 1831 by a pharmacist, Mr Christians. Nycomed in Belgium was a large affiliate in relation to other European or international offices.. The company instilled a decentralized management cul-ture based on values of trust, courage, respect and empathy. These values helped to ensure Nycomed’s success in the region however the issue was that the company was experiencing a shortage in its pipeline of products. The timing of Takeda’s acquisi-tion in 2011 was ideal as it helped tofill the gaps in the pipeline.

Owing to Takeda’s rich R&D portfolio, Nycomed in Belgium has now grown to become market leader in gastrointestinal diseases along with a strong presence in the cardiovascular and thyroid domains. Similarly, the Takeda acquisition of US-based Millennium, has been a key driver for the increasing focus on oncology to improve the treatment of cancer around the world. Today, our pipeline has more than 15 oncology investigational com-pounds including a number of orphan drugs that target a broad range of cancers. In 2011, Takeda’s oncology assets place it as the 6th largest oncology company in Europe and Canada.

FR: Earlier, you mentioned that Takeda was focusing its R&D on areas including Oncol-ogy and Cardiovascular diseases. Can you elaborate more on the strategic heading of Takeda’s upcoming pipeline?CHRIS JULIAM: Takeda’s decisions on its R&D strategy are in accordance with the latest medical needs. A passion for discovery is at the core of Takeda’s ability to deliver superior healthcare solutions to make a dif-ference to patients’ lives and drive company success, targeting areas where there are urgent unmet medical needs, we are focus-ing our resources on a range of core thera-peutic areas to maximize existing R&D experience and platform. These include Metabolic and Cardiovascular, Oncology, Central Nervous System (CNS), Respiratory and Inflammatory, General medicine and Vaccine.. Takeda will expand its vaccine business on a global scale through the Vac-cine Business Division that was established in January 2012. More personally, I am rather excited about a very promising upcoming molecule in our pipeline, Vedol-izumab. This experimental biological has so far shown to be effective in phase-III tri-als for patients with Crohn’s disease and ulcerative colitis, a form of inflammatory bowel disease (IBD) and is poised to be a big advance in the treatment of IBD .

Finally, in addition to enhancing drug discovery by reinforcing in-house research, Takeda will also use the lifecycle manage-ment approach to maximize the Group’s R&D assets in an effort to deliver medi-cines matching the needs of various types of patients.

Chris Juliam – Managing Director of TAKEDA, BELGIUM

37

FR: Considering that Takeda expects part of its future products to originate from the outside, what role do partnerships in Bel-gium play in the development of your future products? CHRIS JULIAM: Partnerships are at the heart of what we do, almost one third of Takeda revenues come from partnerships and stra-tegic acquisitions; expected to rise to 50% by 2015. Prior to the acquisition, Nycomed was a highly diversified company that engaged in a wide range of country specific acquisitions. This meant that its portfolio was different from country to country and each affiliate had to make its own in-licensing decisions. As a consequence, a majority of the new products we had over the past three years were a result of col-laborative activities. Similarly, Takeda’s appetite for partnerships extends beyond R&D activities into our local production facilities. As such, I believe that a culture of partnerships is ubiquitous in our orga-nization today, a result of the inherent development of the company over time and its alignment with Takeda’s dedication to collaboration.

FR: How would you rate the market envi-ronment in Belgium? What makes the coun-try unique?CHRIS JULIAM: Belgium has a unique set of market and policy features that distinc-tively characterize it. We are adept at operating in a highly complex and strict environment. For instance, pharmacies represent the only legitimate sales points for OTC drugs in Belgium. In sharp con-trast to the Netherlands, where OTC drugs are freely sold in general stores in addition to pharmacies. Despite this strict environ-ment our OTC products enjoy strong per-formance in Belgium.

Additionally I am convinced that the key issue is market access. Belgium has

always been a challenging destination for market access, and this is a trend we are seeing across many European countries.

FR: How would you describe the govern-ment authorities’ attitude and openness towards working with the industry in order to realize their common goals while foster-ing a sustainable environment?CHRIS JULIAM: I am convinced that the key missing element in Belgium’s regulatory environment is a set of sound and long-term orientated stable rules.

As a Japanese company, reliable plan-ning is crucial component for the com-pany.

Nevertheless, I am adamant that the Minister of Health, Mrs Onkelinx, is doing an excellent job at providing for the needs of patients. Although I praise her for these efforts, I still maintain that new novel drugs can bring about much added value to patients. In addition, the European Health Survey, an annual report examin-ing the healthcare industry across the EU, currently ranks Belgium as 12th. Needless to say, for a country with a well developed healthcare system as Belgium, this is a rather low score. In fact, the situation has been deteriorating over the past couple of years with our ranking slipping. Interest-ingly, when you take a closer look and examine the real underlying factors driv-ing this low performance, it quickly becomes apparent that delays in market access hold the country back in terms of ranking. By contrast, countries such as France have gone as far as introducing an ATU system that grants patients access to new molecules before they have even obtained reimbursement. Such a system does not exist in Belgium and would be a great step forward in helping patients with high unmet needs to benefit much earlier from real innovative drugs. n

38 Interview with: Eduardo Bravo – CEO of TiGenix

INTERVIEW WITH:

Eduardo Bravo – CEO of TiGenixMr. Bravo, you were appointed CEO of TiGe-nix in 2011 following its combination with Cellerix to create a new European leader in cell therapy. Can you tell our readers more about the strategic objectives of this combi-nation and the expected synergies from this union?EDUARDO BRAVO: What distinguishes TiGenix and Cellerix from other companies is its common vision: that cell therapy will be the next revolution in healthcare. Both TiGenix and Cellerix decided to develop their prod-ucts as drugs - conducting clinical trials to demonstrate their potential as value added products.

Moreover, both companies had the ambi-tion to become worldwide leaders in cell therapy. Put differently, we aspired to become the Genentech of cell therapy. Of course, there is always the possibility of becoming an acquisition target but that was never our goal. Instead, we have the ambi-tion to build a solid and leading company within our field, rather than building a com-pany with the intention of simply attracting acquisition interests.

As both companies were confronted with the same challenges, the merger helped us to share our technology platforms and our regulatory and scientific expertise. Another advantage was that TiGenix was already a listed company with a very strong base of investors, facilitating finance needs. More-over, at the time TiGenix also had the only cell therapy approved in Europe, contribut-ing to the company’s revenue stream.

In conclusion, I think the merger has turned out extremely well, and has resulted in a “new” TiGenix that is much more than

the sum of its parts. I am also very optimis-tic about our growth prospects, and am pleased that our customers and other stake-holders agree that the companies form a perfect combination.

FR: Not only does ChondroCelect(r) represent the company’s lead product but it also the first and only approved cell-based product in Europe. Can you provide our reader with a brief description of this product and what its expected benefits are to patients in need of cartilage repair in the knee?EDUARDO BRAVO: ChondroCelect® is not for any cartilage defect. The cartilage is a stiff yet flexible connective tissue that does not regenerate itself and is found in many areas in the body, such as the elbow and the knee. If a person suffers a defect after a sports injury or a trauma, for instance, and develop a hole in the cartilage, they are then faced with two options: to do nothing and risk developing osteoarthritis over time which often ends with requiring synthetic joint replacement, a major and traumatic inter-vention.

An alternative for patients is micro-frac-ture surgery. This involved performing a repair of cartilage that works by creating tiny fractures in the underlying bone. This fills the gap in the cartilage, helping to decrease their pain levels. However, this procedure simply delays the problem and does not offer a cure.

On the other hand, it was discovered in the University of Leuven that it is possible to grow the cells of the cartilage to create new cartilage. Of course, this process has been patented and led to the creation of

Eduardo Bravo – CEO of TiGenix

39

TiGenix. After obtaining positive animal data, TiGenix decided to test it applicability to humans and so took the tough road of five years clinical trials comparing micro-fracture surgery with ChondroCelect®. Within one year we managed to demon-strate that the cartilage obtained with ChondroCelect® is almost identical to natu-ral cartilage while the cartilage coming from micro-fractures is not. Moreover, after three to five years there is a significant dif-ference in improvement between micro-fracture and ChondroCelect(r). So far, ChondroCelect(r) is the only product in the world that has demonstrated such results.

Importantly, by the end of 2007, legisla-tion related to cell therapy was introduced. It was decided that when cells are either modified or used for a different tissue than when extracting the cells, they become a pharmaceutical drug. Since there were sev-eral drugs like this on the market a transi-tion period has been created. Meaning that suppliers of these drugs have been provided with a period of five years to conduct trials in order to get the product approved before the end of the transition period - 31 Decem-ber 2012. As a consequence ChondroCelect(r) is competing with products that have not demonstrated safety and efficacy in well controlled clinical trials and that are pro-duced on a less stringent quality system. Fortunately for us, now that the end of the transition period is approaching these com-peting products will be removed from the market, since ChondroCelect(r) is the only drug in its class that received approval by the European Medicines Agency and the European Commission.

FR: Considering the relatively f ledgling nature of the stem cell industry and TiGe-nix’s pioneering role within it, what would

you highlight as the main lessons learnt as you progressed?EDUARDO BRAVO: The first thing that comes to mind is that biotech companies in general are underfunded, especially in Europe. Indeed, we certainly would have been better off doing more things in parallel with more capital.

Furthermore, one of the main differ-ences between companies in Europe and the United States is that European companies are always probing for sources of capital, while in the US companies are generally funded for three years to provide them the freedom to concentrate on their core busi-ness.

FR: Healthcare systems around the world are changing, increasingly taking added value and health-economic benefits into consider-ation. In your experience, what is your view on the state of the healthcare systems? EDUARDO BRAVO: The problem that we are fac-ing is that as life expectancy increases, peo-ple want to live healthier lives and the industry keeps introducing new products that require more investments. At one point however, governments will have to decide whether to reimburse certain drugs or not and can lead to a philosophical discussion on the subject. For instance, should we pro-vide a smoker patient, with a donor heart? Or should the drugs of overweight related diseases be reimbursed for patients who lead unhealthy eating habits or lifestyles?

This debate is surely ahead of its time but government budgets are shrinking and the cost of healthcare is rising. Responsibility will have to be shifted to the population. Instead, the healthcare sector should place more emphasis on preventative healthcare rather than curing diseases. It is a huge debate and a big issue that is inevitable. n

40 Interview with: Dr. Patrik De Haes - CEO, ThromboGenics

INTERVIEW WITH:

Dr. Patrik De Haes - CEO, of ThromboGenics

Focus Reports: Dr De Haes, as the CEO of ThromboGenics for the last five years, can you provide us with an overview of the com-pany’s main achievements that you are most proud of? DR. PATRIK DE HAES: At the moment, Throm-boGenics basically has one key product, Ocriplasmin, which has recently completed phase-III clinical studies. Initially, this drug was being developed for use in cardio-vascular diseases however it has now been repositioned for use in ophthalmology. More specifically, Ocriplasmin targets the treatment of symptomatic vitreomacular adhesion (VMA) eye disease for which there is no alternative remedy other than surgery. Naturally, this is a complex proce-dure that involves removing the vitreous from the eye which is then followed by a distressing two week recovery period. This is in sharp contrast to the relatively straight forward treatment that Ocriplasmin offers which involves administering an injection to the back of the eye. Needless to say, for patients in the early stages of symptomatic VMA, Ocriplasmin delivers significant ben-efits in terms of an enhanced and more con-venient treatment choice while also being markedly less expensive.

FR: In 2006, ThromboGenics became a pub-licly listed company on Brussels Euronext through its IPO which raised €35 million of capital for the company. What was the stra-tegic decision behind the listing and what adaptations did the company have to make to accommodate this new structure? DR. PATRIK DE HAES: Considering that Throm-boGenics is yet to market its first product

and produce a revenue stream, the risk of running out of capital is always a motivat-ing factor.

The company’s founder established ThromboGenics using funds that he was receiving from Genentech after having licensed tissue plasminogen activator (tPA) to them. However, this revenue stream ended in 2004 prompting the company to seek alternative sources of finance. Since we wanted to maintain the company’s inde-pendent status, we opted to seek financing by taking the company public as opposed to venture capital, for instance. Hence, ThromboGenics’ IPO in 2006.

In general, I would not say that the IPO had any dramatic effects on the company’s structure or organization. At that time, ThromboGenics was merely a laboratory based in a university and staffed by R&D scientists. If anything, the IPO provided the funding to attract people with interdis-ciplinary skills, and further professionalize the company. It also increased our capacity to carry out developmental studies.

FR: Recently in July, the FDA advisory com-mittee recommended Ocriplasmin for the treatment of symptomatic VMA while also applying for its marketing authorization in Europe. Can you elaborate on the signifi-cance to your company and how much closer does this bring you to its commercializa-tion? DR. PATRIK DE HAES: In the US, the FDA puts together a committee for innovative prod-ucts where there is a medical need, and we are certainly the first biotech company in Belgium to go through this procedure.

Dr. Patrik De Haes - CEO, THROMBOGENICS

41

Moreover, if you look at these advisory committees, their outcomes can be rather unpredictable. For that reason, we had pre-pared our team quite intensively to brave their investigation. Ultimately our efforts paid off since we obtained an impeccable 10-0 positive vote in favour of Ocriplas-min. Although, this is a recommendation by an external panel, the statistics indicate that the FDA tends to follow their recom-mendation as much as 90% of the cases.

On the other hand, at this side of the ocean in Europe, we have already made the relevant submissions to the European Medicines Agency (EMA). We expect to receive their feedback by the year-end and assuming everything goes as planned, we anticipate the EMA’s approval by the first half of next year.

FR: Along with being active in ophthalmic medicines, ThromboGenics is also focused on the commercialization of innovative drugs in the oncological therapeutic area. Can you illuminate our readers on your products pipeline and their prospects?

DR. PATRIK DE HAES: The first compound we developed is TB-403 which is a monoclonal antibody directed against Placental Growth Factor (PlGF). In other words, the antibody inhibits the growth of tumour vessels and prevents tumour growth. In fact, in 2008 we had licensed this drug to Roche which earned us a ‘Licensing Deal of the Year Award’ and injected approximately €50 million into our company. More recently however, Roche handed back the rights to this drug. We are certainly very excited about this since we now have the opportu-nity to study this drug in both the ophthal-mological and oncological fields which has so far been demonstrating some highly promising results. Currently, the drug is

undergoing phase-II trials in both fields of applications.

FR: ThromboGenics is very active in terms of partnerships with both industrial orga-nizations and academic. What is the stra-tegic importance of these partnerships to your operations and can you highlight some of the key partnerships formed and the real-ized synergies?

DR. PATRIK DE HAES: Considering the rela-tively small size of the company, we engage in partnerships in order to capitalize on the synergies they create. Since the beginning, we have been partnering with various aca-demic institutions and this trend continues to this day. In addition to this, we also maintain a number of commercial partner-ships with companies including Alcon - the eye care products specialist, BioInvent - a company that produces antibodies in Swe-den - as well as with Roche in the past. To be more specific, our partnership with Alcon entails a commercialization agree-ment for Ocriplasmin outside of the US, where Alcon plans to introduce the drug in more than 40 countries worldwide. On the other hand, with Sweden’s BioInvent, we are jointly developing our PlGF compound.

Overall, our main objective with respect to partnerships in general is to seek out efficiencies and opportunities that could be gained. After all, although ThromboGenics has a market capitalization of over €1 bil-lion, we have only 120 people. I believe this illustrates the level of efficiency that we like to operate at. Instead of investing in the acquisition of office spaces or produc-tion facilities, for instance, we like to direct our focus and resources towards the research and development of our pipeline. That is, at ThromboGenics, we do not do the execution, we do the thinking. n.

42

Company indexAMGEN ..................................... 8, 16, 20

ASTRAZENECA .............................. 8, 21

BAKER & MCKENZIE ......................... 20

BECRO ................................................. 7

BOEHRINGER INGELHEIM ...... 8, 14, 18

BIOCODEX ............................................ 4

DELOITTE .................................... 2, 6, 18

ELI LILLY .......................... 7, 8, 14, 32, 33

EUROGENTEC .............................8, 9, 10

FLUIDDA ..............................................11

IMS HEALTH ....................................... 20

JANSSEN 6, 7, 13, 18, 19, 24, 25, 26, 27

MINISTRY OF HEALTH................. 18, 23

MSD .......................................... 8, 13, 16

NOVARTIS ................................ 8, 30 ,31

PHARMA.BE .............. 6, 7, 14, 18, 32, 33

PHARMA INSIGHT ............................. 13

PROMOMED ..................................11, 19

SANOFI ............................ 12, 13, 34, 35

S.M.B LABORATORIES ................ 10, 16

TAKEDA .................................. 18, 36, 37

THROMBOGENICS ............... 6, 7, 40, 41

TIGENIX .................................... 6, 38, 39

WORLD COURIER .............. 4, 13, 14, 15

UCB .................................... 6, 7, 8, 28 ,29

UPS ..................................................... 13

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