Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship A report from the Economist Intelligence Unit Sponsored by Agilent Technologies Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Contents Preface Interviewees Executive summary About the survey Introduction: rapid growth, evolving challenges The rise of a bifurcated market and its strategic implications Disruptive innovation: are CROs agents of change? Making the most of new relationships Information technology will be part of the evolution 12 13 Conclusion 15 Appendix: survey results 16 © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Preface Finding Alignment: Opportunities and Obstacles in the Pharma/CRO Relationship explores the increasingly critical role of contract research organisations (CROs) in the transformation of the drug discovery and development (D&D) process at pharmaceutical and biotechnology companies The Economist Intelligence Unit conducted the survey and analysis and wrote the report The findings and views expressed in this report not necessarily reflect the views of the sponsor The author was Paul Kielstra Gilda Stahl edited the report, and Mike Kenny was responsible for layout We would like to thank all of the executives who participated in the survey and interviews for their valuable time and insight January 2012 © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Interviewees Karin Wingstrand Vice-president and Head of Clinical Development AstraZeneca Richard Connell Head of External Research Solutions CoE Pfizer Kiran Mazumdar-Shaw CEO Biocon John Ratliff President Chief Operating Officer Quintiles John Watson President of Strategic Partnering Chief Commercial Officer Covance Dr Jason Hwang Executive Director of Healthcare Innosight Institute Tycho Peterson Industry analyst JP Morgan © Economist Intelligence Unit Limited 2012 Dr Ajit Nair President, India SIRO Clinpharm Dr Robert Ahlbrandt Senior Vice-president Global development operations for the Pharmaceutical Development Division Takeda International Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Executive summary A fter years of painfully diminishing return on investment (ROI) from discovery and development (D&D) programmes, pharmaceutical and biotechnology companies are taking a calculated risk at the heart of their businesses with the production of their most valuable asset—intellectual property Within the last decade, outsourcing to contract research organisations (CROs)—companies that offer the industry a wide range of research services—has grown to such an extent that it now encompasses over 40% of the entire sector’s D&D More than one-half of drug makers conduct their Phase I, II and III trials primarily through CROs This is no longer outsourcing at the margins, but a fundamental shift away from the industry’s tradition of strong vertical integration In making this change, however, biotechnology and pharmaceutical companies are betting on a model that is not only unproven, but is still being defined The ability of this approach to deliver improved innovation at a reduced price will require strategic vision rather than simple cost cutting Finding Alignment: Opportunities and Obstacles in the Pharma/CRO Relationship, an Economist Intelligence Unit report sponsored by Agilent Technologies, draws on a survey of 251 senior executives from the life sciences industry, as well as in-depth interviews with corporate leaders and industry experts Its key findings include the following: l The interest of biotechnology and pharmaceutical companies in global alliances with contract research organisations has reshaped an important part of the CRO market Pharmaceutical and biotechnology companies are increasingly entering into global alliances with CROs as they seek to improve their ROI in D&D; in the last two years, 22 such major alliances have been formed About the survey A total of 251 senior executives from the life sciences industry participated in the September 2011 survey, including respondents from pharmaceutical companies (44%), biotechnology firms (22%) and contract research organisations (15%), with others in the industry comprising the remainder (19%) In terms of seniority, 51% of respondents are members of the C-suite, with the remainder drawn from senior management positions Thirty-five percent are based in North America, 28% in Asia-Pacific, 27% in Western Europe and the others in the Middle East, Africa, Latin America and Eastern Europe Forty-eight percent of participants represent companies with more than US$500m in annual revenue; 26% work for companies with more than US$2bn © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship According to Economist Intelligence Unit survey respondents, although the most common client-CRO relationship remains one that involves ad-hoc contracts, the preferred relationship on both sides would be global alliances or partnerships that are regional or disease-specific Yet smaller biotech and pharma firms—defined here as those with annual revenue of less than US$100m—lack the volume of business to make such arrangements worthwhile These firms prefer continued arm’s-length relationships with CROs with local operations John Ratliff, president and chief operating officer (COO) at Quintiles, an integrated biopharmaceutical services company, says, “You almost need two different types of service for two different types of client.” l CROs and their potential clients have different expectations of the shape of partnerships A striking perception gap exists between CROs and their clients as to the direction of the market in future In order to become more attractive partners and tap into the potential market such relationships provide, many CROs are expanding services across the D&D spectrum, particularly in the earlier stages Forty-eight percent of CRO respondents, for example, intend to begin or expand assay development services and 64% screening services Other companies in the life sciences industry, however, expect to increase their use of CROs largely in fields in which they are already most frequently used, such as drug trials It appears that the dominant model in the industry has yet to be defined l CROs will continue to consolidate and gravitate towards becoming either all-purpose partners or niche specialists Contract research remains a fragmented industry ripe for further consolidation: 74% of CRO survey respondents say that the trend towards alliances with biotechnology and pharmaceutical companies will drive consolidation in the short term Moreover, 41% say that in the next three years they will expand their range of services to become better potential partners Highlighting the industry’s duality, the same percentage will focus on a small number of specialised areas (29%) or a single niche (12%) A striking perception gap exists between CROs and their clients as to the direction of the market in future l All sides still have work to in shaping partnerships and alliances to their own broader interests As the nature of alliances and partnerships is redefined, CROs will need to demonstrate to biotechnology and pharmaceutical companies the value of working with the former as partners rather than as sources of cheap labour John Watson, president of strategic partnering and chief commercial officer at Covance, a US-based CRO with global operations, says, “Supplier consolidation can create short-term value It is up to the CRO industry to put forward a broader value proposition.” Pharmaceutical interviewees indicated that companies within the industry are open to new ideas Such firms, however, need to approach the use of CROs as an opportunity for strategic renewal rather than mere cost cutting © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Introduction: rapid growth, evolving challenges C ontract research organisations (CRO) are an integral part of drug development According to Contract Research Annual 2011, a yearly study of the pharmaceutical industry, the market for CRO services increased to US$28bn in 2010 This represents over 40% of the approximately US$68bn the industry spent on D&D that year CROs have attained this position only recently In 2000 the market for their services was US$5.2bn and in 1993 a mere US$1.6bn During these years spending on internal pharmaceutical and biotech D&D also grew, albeit more slowly The Tufts Center for the Study of Drug Development (TCSDD) notes that spending on CROs over the last decade increased on average by 13.4% per year, while global D&D spending rose by 9.1% The CRO market looks set to continue to grow The reason is straightforward Kiran Mazumdar-Shaw, CEO of Biocon, an India-based biotechnology company, says that a lack of productivity is creating “serious concern about return on investment in R&D” Respondents to an Economist Intelligence Unit survey of senior industry executives worldwide conducted in September 2011 agree: 71% of non-CRO respondents say their companies will increase the use of CROs in the next three years, against just 7% who foresee a cutback Even while the industry grows, client-service provider relationships are changing Previously, sponsors would typically contract out specific work to CROs on an ad-hoc basis Such arm’s-length relationships offer flexibility but they also have drawbacks For example, the purchaser of services may not be able to draw on the CRO’s expertise in shaping the requested service, eg, helping to design a trial strategy The sponsor also might not be able to benefit directly from the specific knowledge of a compound a CRO may have gained as the drug underwent the development process Increasingly, therefore, pharmaceutical and biotech firms, especially the largest ones, seek closer links with CROs in alliances or strategic partnerships These involve, in some cases, provision by the CRO of a wide range of D&D services for all of the sponsor’s products globally, or may be restricted to certain types of disease or geography The relationships require much closer integration of the CRO with the sponsor, providing the former with a steady stream of work and the latter with ongoing access to the CRO’s expertise, potentially across the D&D spectrum In the last two years, 13 big pharmaceutical companies have announced 22 such pacts with CROs, such as Pfizer’s agreement with ICON and PAREXEL and Sanofi’s with Covance Although the focus is on big pharma’s adoption of these arrangements, John Watson, president © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship of strategic partnering and chief commercial officer of Covance, expects mid-sized pharmaceutical companies to favour alliances as well, to avoid being frozen out by larger competitors “There is a limited amount of high-quality services from stable, financially sound CROs,” he says While the number of financially secure CROs may be small, the industry is experiencing intense competitive pressures goBalto, a global directory of CROs, lists 1,122; the total number may run higher The industry is concentrated at the top—the leading ten companies boast a 75% market share However, fragmentation is affecting profits even at the biggest companies, where overcapacity has squeezed margins In 2009, JP Morgan estimated that excess physical capacity in certain preclinical areas had reached 20-25% Since then toxicology in particular has seen significant facility closures and price discounting “We expect further consolidation,” says Tycho Peterson, an industry analyst at JP Morgan “It is still a fragmented industry.” The number of mergers and acquisitions (M&A) is growing, with the biggest recent example being INC Research’s purchase of Kendle for US$232m in July 2010 However, Dr Jason Hwang, executive director of healthcare at Innosight Institute, a social innovation think-tank, warns that consolidation will be difficult With low barriers to entry, new companies may come into the market as quickly as old ones disappear © Economist Intelligence Unit Limited 2012 “We expect further consolidation It is still a fragmented industry.” Tycho Peterson, Industry analyst, JP Morgan Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship The rise of a bifurcated market and its strategic implications H “Big pharma will go towards preferred relationships, but mid-size and smaller pharma and biotechs will look towards working with partners that can so in a costeffective manner and provide individualised attention.” Ajit Nair, President Global Operations SIRO Clinpharm eadline-grabbing global alliances are only part of the evolving CRO marketplace The strategy is most appropriate for big pharmaceutical and biotechnology companies: indeed, 66% of CROs polled say their relationships with large and small clients are increasingly differentiated Ajit Nair, President Global Operations at SIRO Clinpharm, an India-based, multinational CRO, sees “two major markets Big pharma will go towards preferred relationships, but mid-size and smaller pharma and biotechs will look towards working with partners that can so in a cost-effective manner and provide individualised attention.” Smaller biotechnology and pharmaceutical companies—those with annual revenue of less than US$100m—lack the volume of business to make broad alliances attractive to both sides Facing greater resource constraints, these companies are more likely to list low costs as a leading attribute when selecting a CRO (47%) than are larger companies, those with annual revenue over US$2bn (38%) The opposite is true of global reach: 47% of larger companies say this is among the top attributes they look for in a CRO compared with 27% for smaller companies CROs still have a large market with smaller pharmaceutical and biotech companies, many of which may be virtual Ms Mazumdar-Shaw says that Biocon’s two CROs—Syngene and Clinigene—seek to create a “hybrid” model that meets the differing needs of both types of clients Worldwide partnerships, though, are the bigger prize, bringing a steady stream of potentially high-margin work CROs in our survey are even more interested in pursuing global alliances than are pharmaceutical and biotech respondents (26%) Only 9% of CROs prefer arm’s-length arrangements To tap into the growing partnership market, CROs should make a strategic decision: expand so as to engage in wide-ranging partnerships or focus on one or several niche areas Mr Peterson of JP Morgan predicts “a bifurcated market At the high end a handful of large global CROs with a substantial geographic presence and, at the low end, niche providers (in areas such as oncology) should be OK Those in the middle tier that are not unique enough or not have appropriate breadth or scale will have difficulty.” Profitability is feasible using either approach Indeed recent research conducted by the TCSDD found that small, niche providers experienced higher average growth over the last five years than other CROs When asked directly about their strategy, CRO respondents are divided: in the next three years 41% will expand their range of services, while the same percentage will focus on a small number of specialised areas (29%) or a single niche (12%) A closer look at the findings, however, shows that companies that speak of specialisation will not shed certain capabilities to focus on others Only a small number (14%) intend to reduce their service provision on any part of the discovery and development spectrum, while © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Disruptive innovation: are CROs agents of change? The life sciences industry, and big pharma in particular, has long favoured an integrated approach to D&D because of the importance of intellectual property to the company In moving rapidly towards outsourcing, is it possible they are actually enabling future competitors rather than partners to grow up around them? The possibility certainly exists Fortyfive percent of survey respondents believe the largest CROs are developing sufficient competencies to become competitors of traditional pharmaceutical businesses in the near future; only 37% disagree Moreover, 40% of respondents from potential CRO clients believe that a significant risk of outsourcing is that it allows a potential competitor to develop capacities; only 16% think this risk is not significant Life sciences companies are not the first science-based business to outsource important functions and the PC industry offers potential lessons In The Innovator’s Prescription, Jason Hwang, Clayton Christensen and Jerome Grossman explore the parallels of transformation in life sciences to other technology industries that experienced what the authors call “supply chain disruption” In this process, sectors with highly integrated production—such as traditionally practised by big pharma— outsource more and more functions because, once such activities can be commoditised, buying in makes more economic sense than retaining them in-house One danger of this process is that, by outsourcing enough functions, a company might create a competitor The Innovator’s Prescription describes how PC-maker Dell contracted out more of its operations to the Taiwanese manufacturer ASUSTek, which assimilated these skills and began producing its own machines, thus becoming a direct competitor to Dell The authors see CROs as a potential source of supply chain disruption in the life sciences industry As they develop integrated capabilities across the entire D&D value chain—and as margins on their existing work are squeezed—some will move into highermargin areas, thereby becoming competitors of biotech and pharmaceutical companies How likely is this, though? Currently, only 18% of CRO respondents say their companies plan to create and market their own pharmaceutical products Almost all of these companies have annual incomes under US$500m These seem to represent small CROs transforming themselves into biotechs rather than ones that have grown substantially and are disrupting the supply chains of former clients Bigger CROs not appear interested in making this shift Mr Peterson of JP Morgan warns that such a move is “very risky This is what happened to several CROs in India that moved into generics They burned a lot of bridges, and you can’t necessarily go back.” Similarly, John Watson, president of strategic partnering and chief commercial officer at Covance, acknowledges that his company is about the same size as the D&D function of a major pharmaceutical firm Yet Covance has consistently said “it is not in the best interests of our shareholders to compete with our clients We’ve seen it backfire on some of our competitors.” Dr Hwang, who was also interviewed for this study, stands by his position On the one hand, “it is still a bit early to see the disruption we describe,” he says “The waves of consolidation in the last decade indicate an industry that is ripe for disruption, but the prevailing business model is still trying to consolidate its power and there are still plenty of pharma players in the industry.” On the other hand, he continues, whether in alliances or not, pharmaceutical companies are turning to CROs to low-margin work that is “a very commoditised form of R&D If traditional pharma passes on its cost pressures to CROs, they will eventually seek higher ground.” The threat of disruption lingers, not because of current intentions, but because of how other industries have evolved Dr Hwang therefore advises CROs to consider how they will adjust if margins become unsustainably squeezed He also suggests that life sciences companies retain in-house the likely core competencies of tomorrow rather than those of today 86% intend to expand their existing offerings and 31% will enter D&D areas where they not yet provide services Apparently the major emphasis among CROs will be the expansion of services in order to become more attractive partners Yet a shift towards partnerships also brings challenges Dr Nair notes that, except for one or two companies, the CRO business is largely segmented between discovery and clinical development “The two require different skill sets,” he says, and different types of capital investment “I think that if a company © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship can cover the entire spectrum from the lab to the patient, it will be a big advantage.” Risks can also increase with partnerships Mr Ratliff of Quintiles says, “[in partnerships, CROs] are in the middle of what they [clients] are attempting to in terms of drug development You have the heart of their portfolio in your hands If one CRO fails, we all get tainted.” Ms Mazumdar-Shaw points to a more fundamental issue: the industry is betting on an untried approach “CROs have aspired to move up the value chain from services to product development,” she says, “and pharma looks at alliances in order to reduce risks and costs, but still retain commercialisation rights On the face of it, it sounds like a great model Yet it remains to be seen how long it can deliver on cost and performance efficiency.” Not only is the model unproven, our survey indicates CROs and their clients have mismatched expectations The CRO industry as a whole will expand its capacity across the D&D spectrum, hoping to lure clients into more integrated partnerships Respondents from the rest of the life sciences industry, however, may have different ideas Although a majority say they will expand their use of CROs, only 37% say they will so “greatly” Moreover, most of this increase will be in the areas where CROs are already frequently used, such as pre-clinical and phase I through III trials More often than end-to-end partnerships, which are certainly being created, pharmaceutical and biotechnology firms expect to partner with CROs on development, not discovery Potential clients not appear to be looking to depart from their current D&D strategy: only 11% say they will use CROs to restructure how they engage in drug discovery and development Moreover, companies that are looking to use CROs more in the area of discovery tend to rank their financial performance as poorer than those that are not This suggests that successful firms see less need to evolve in that direction At your company, which of the following stages of D&D are conducted primarily internally, primarily by CROs, or primarily through some other means? Please select one for each row (% respondents) Internally By CROs Other Target discovery 68 11 22 Target validation 62 18 20 Assay development 63 18 18 Screening 59 20 21 Lead optimisation 61 19 20 Pre-clinical testing 34 47 19 Phase I & II testing 26 55 18 Phase III testing 20 59 21 D&D overall 55 22 24 Source: Economist Intelligence Unit survey 10 © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Do you expect a shift in the next three years so that a greater proportion of work in these areas will be done internally, by CROs, or through some other means? Please select one for each row (% respondents) Greater proportion done internally Greater proportion done by CROs Greater proportion done in other ways No change Target discovery 33 15 43 Target validation 30 19 45 Assay development 31 20 42 Screening 35 19 37 Lead optimisation 33 19 39 36 39 39 39 Pre-clinical testing 17 Phase I & II testing 14 Phase III testing 13 39 38 D&D overall 29 21 11 39 Source: Economist Intelligence Unit survey Does the trend towards alliances represent merely a wave of supplier consolidation and is some of the capacity expansion of CROs misguided? That is possible, but so too is the likelihood that some biotechnology and pharmaceutical companies not understand the implications of the path they have chosen Dr Hwang of Innosight Institute explains that when talking about suppliers in most industries companies “would never believe that they are fundamentally changing their model” The dominant shape of the CRO-client alliance is still malleable as both sides learn how best to work together © Economist Intelligence Unit Limited 2012 11 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Making the most of new relationships W “If the pharma clients don’t think about transforming their work flow around the outsourced activity, they may not get the full benefit of the outsourced transaction.” Richard Connell, Head of External Research Solutions CoE, Pfizer 12 hat should companies as these increasingly common relationships evolve? For clients of CROs, the first step is to see an alliance as a strategic opportunity rather than outsourcing writ large For example, AstraZeneca has developed data-management partnerships with information technology (IT) experts that previously would not have played such a role in drug development Similarly, Richard Connell, head of external research solutions CoE at Pfizer, believes that although some companies may initially look at CROs purely in terms of cost reduction, “if the pharma clients don’t think about transforming the work flow around the outsourced activity, they may not get the full benefit of the outsourced transaction.” Indeed, one of the dangers facing the industry is confusing alliances with supply chain simplification: 57% of survey respondents say big pharma too often sees CROs as necessary sources of cheap labour rather than valuable partners Mr Ratliff warns that “the term ‘strategic partnership’ is overused Some customers still want to use companies for pure outsourcing.” Mr Watson adds, “There is a difference between alliances or partnerships and supplier consolidation The latter, when heavily driven by procurement and a focus on price, has not necessarily been good for either company because it does not allow the creation of additional value possible when focusing on other aspects than cost.” Pursuing supplier relationships strategically requires, at a minimum, gaining the attention of management Robert Ahlbrandt, senior vice-president, global development operations for the Pharmaceutical Development Division of Takeda Pharmaceuticals International, says that in the past “we didn’t have strong enough senior management ownership of CRO relationships, both internally as well as from the CRO.” One of his roles is now to focus on these partnerships To take full advantage of CRO partnerships, pharmaceutical and biotechnology companies should also think about reshaping the way they conduct D&D internally to remove redundancies that can remain after outsourcing Mr Connell says, “When you outsource an activity that is central to the value stream, if you don’t restructure the overall workflow, you get legacy activities that add nothing but cost to the overall process Those looking to transform need a more strategic perspective.” While internal shifts need to be informed by company strategy, pharmaceutical and biotechnology firms should also allow relationships to evolve where useful Pfizer previously outsourced the synthesis of high-volume chemistry, leading to huge numbers of compounds being shipped to the company from the supplier for testing When it became clear that the provider could also test the compounds in question and immediately send just the resultant data—a considerably less expensive proposition—it made sense to allow the CRO to so © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Information technology will be part of the evolution Contract research is an information-intensive business As John Watson, president of strategic partnering and chief commercial officer at Covance, puts it, “At the end of the day everything we is to generate data and provide it to the client Our finished product is data.” According to survey respondents, investment in the technology to exploit these data will grow over the next three years Sixty-five percent of CROs will expend resources on improved analytical capability and 62% on data management capability As the chart shows this is part of a broader trend of investing in a range of IT capabilities that will be far more widespread than seen in the previous three years This shift partly reflects a need to keep up with the requirements of clients Dr Ahlbrandt notes that in its data interfaces with CROs, Takeda seeks “transparency and to move towards a seamless interchange This is partially in place, but remains an area of significant focus.” A substantial number of survey respondents from the rest of the life sciences industry are also investing in IT, and they will expect CROs to the same Faced with intense competition, however, CROs are also looking to their IT investments to differentiate themselves in several ways The first is to provide faster, more accurate services and better communication with their customers Quintiles, for example, has spent extensively on a range of hardware and software, including data factories and client dashboards that provide real-time information simultaneously to the company and its client President and COO John Ratliff says, “We have been investing in IT with a particular mission over the last five years More than infrastructure and applications, we have tried to put our money in places that allow for differentiation [from other CROs] based on data and analytics You have to have that in mind.” Some CROs are also looking to use their IT investment to expand into new services, in particular management of clinical data The market may be more difficult than CROs expect: IT companies with little previous pharmaceutical experience have been expanding into this market as well Ajit Nair, President India SIRO Clinpharm, explains, however, that his company is “very bullish on working with data services As a CRO we have a clinical edge: IT companies deliver from a data perspective, we deliver from a clinical data perspective.” In which of the following areas has your company increased investment in the last three years? In which of the following areas will your company increase its investment over the next three years? (% CRO respondents) Technology to better manage data and information 35 62 Technology to improve analytical capabilities 43 65 Attracting talented scientific researchers 24 62 Technology to help speed screening for drug candidates 30 57 Staff training relevant to managing partnerships 24 54 Access to a wider variety of information 24 60 Technology to automate capture of data at more points in development process 22 43 Networking capacity to create a more virtual D&D organisation 16 54 Allow easier sharing of data within and between companies 19 54 Technology to automate more decisions in development process 19 41 Technology to integrate diverse data types to better analyse or mine 19 46 Source: Economist Intelligence Unit survey Equally important, with alliance partners increasingly at the heart of what life sciences companies do, it is crucial that the fit be right Karin Wingstrand, vice-president and head of clinical development at AstraZeneca, says that in addition to a CRO’s technical capacity, “when you enter into a relationship, you need to make sure you evaluate the cultural fit with a partner If you don’t have that, you won’t be able to get the full benefit of process, quality and cost improvements.” Our survey findings bear this out: respondents that have been involved on one side or the other of an unsatisfactory client-CRO relationship cite cultural barriers as one of the leading difficulties Once these relationships are formed, they require tending Pfizer has appointed alliance management professionals within the company, as has AstraZeneca Ms Wingstrand says this involves not just focusing on the “hardware” of the alliance, but on the experience of staff and whether those on both sides are © Economist Intelligence Unit Limited 2012 13 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship “CROs need to move away from a service-provider mindset, and the challenge for us is to move from a buyer mindset.” Karin Wingstrand, Vice-president and head of clinical development, AstraZeneca 14 treated with respect and equality “CROs need to move away from a service-provider mindset, and the challenge for us is to move from a buyer mindset,” she says The challenges are different for CROs They need to find and sell services their clients not yet know they want Mr Connell says, “For the astute CRO that identifies opportunities, there is the chance to expand the business.” While doing so, CROs must also remember what attracted clients in the first place: services provided competently and quickly at a cost lower than could be done in-house According to survey respondents, the leading attributes potential clients look for in a CRO are talented staff (49%), ability to deliver at low cost (44%) and speed (42%) In a slightly different order, CROs consider the following attributes as leading differentiators from the competition: low cost (49%), experienced staff (43%) and speed (31%) Looking ahead, only 20% of CRO respondents expect the ability to keep costs down to be a leading differentiator Instead, respondents think that expertise in specific areas of drug development will become far more important (34%), while having experienced staff in general will come in second (29%) This does not mean CROs believe cost will cease to be a major factor Dr Nair of Siro Clinpharm says, “Having low costs is definitely going to be important in the years ahead Big pharma is cutting jobs That work will be done by somebody else, and the expectation is it will be done at a lower price.” In an ongoing alliance, however, the initial low cost is not as attractive as the ability to keep innovating Mr Ratliff of Quintiles notes that once you have won the contract, “two years down the road, they want you to be innovative If you aren’t changing, getting to a faster commitment and to a better probability of success, then you have failed.” All this obviously requires talent Both Covance and Quintiles say that one of a handful of key ways they are preparing for the future is hiring a significant number of experts across the range of D&D They are not alone: 62% of CRO respondents say they will invest significantly in attracting talented scientific researchers, up from 24% in the last three years CROs also recognise the importance of alliance relationship management: over the next three years 54% will invest in staff training in partnership management, against just 24% in the last three years The survey suggests that poor communication between parties is a particular weakness: 40% of those who experienced an unsatisfactory client-CRO relationship cited this as the leading problem An oft-repeated complaint among interviewees is the failure of CROs to alert partners when trials experience problems Covance takes a comprehensive approach to alliance management with a formal group of senior executives overseeing all partnerships Its detailed alliance model covers a number of areas—from human resources to operations Covance seeks to interact with the partner in all these areas The company also has change management specialists to help clients institute the internal changes necessary to take advantage of greater outsourcing Mr Watson, though, cautions that this remains a work in progress: “The industry is in the infancy stage as it relates to building these [relationship management] tools It is a new area for us and for pharma.” © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Conclusion B iotechnology and pharmaceutical companies are laying a big bet on the future of drug D&D CROs are already taking on a substantial percentage of this work and that proportion looks set to grow Although a move away from integrated, in-house D&D represents a historic shift for the pharmaceutical world, outsourcing on its own is not enough Both CROs and their sponsors need to determine the type of relationship that will be most beneficial to both parties The evolution has begun, with a growing number of alliances starting to replace simpler fee-for-service models CROs and their clients, however, have different views of where these developments could or should lead Here the automotive industry provides a cautionary tale Car makers famously fluctuate between programmes to treat suppliers as valued partners and unilateral cutbacks that make it difficult for their suppliers even to survive This is ultimately self-defeating Most automotive industry research indicates that developing more trusting relationships with suppliers leads to lower costs as well as enhanced communication and innovation This holds an important lesson for biotechnology and pharmaceutical companies, which must decide whether their interests in suppliers—CROs—primarily involve cost reduction or improved innovation, twin challenges confronting the industry Life sciences companies face other strategic challenges Extensive outsourcing requires a company to decide on its own core competencies—which it should retain—and to restructure other parts of the company in order to shed legacy structures that are no longer necessary Moreover, when a firm brings outsiders into so central and sensitive an operation as D&D, ongoing relationship management—beginning with finding partners with compatible cultures—must be a priority The challenge for CROs is to shape the relationships to suit their strengths The ability of these companies to provide new, higher-value services will not be self-evident to the client Instead, while continuing to provide ever-improving, high-quality, lower-cost services that led to the relationship in the first place, CROs should identify new areas where they can work and convince clients of the benefits Alliances and partnerships provide the ideal forum for such an expansion of sales, but it is up to CROs to seize the opportunity The stakes are high for both sides If the growing number of alliances evolves into little more than costfocused outsourcing of commoditised D&D, pharmaceutical and biotechnology companies are likely to find that their innovation problems remain, albeit at a lower price They may also find disgruntled suppliers with squeezed margins that have no alternative but to become competitors Meaningful partnerships, in contrast, hold out the promise of the kind of change needed to restock diminished pipelines © Economist Intelligence Unit Limited 2012 15 Appendix Survey results Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Appendix: survey results Percentages may not add to 100% owing to rounding or the ability of respondents to choose multiple responses How does your company compare with its peers in the following areas? Please select one for each row (% respondents) Well above average Above average Average Below average Well below average Don’t know Revenue generated per capital invested 18 31 28 15 Efficiency of drug discovery and development (D&D) in terms of new molecules developed per money spent 13 23 24 11 26 Ability to engage in successful partnerships 15 41 29 Ability to create innovative products 26 30 23 11 Ability to innovate D&D processes 19 26 26 17 Ability to adopt and use latest technology effectively 18 38 28 Considering the biggest relationships in which your company is involved between CROs and pharmaceutical or biotechnology companies, what form these take in practice? Considering the biggest relationships in which your company is involved between CROs and pharmaceutical or biotechnology companies, what would be your preferred form? (% respondents) (% respondents) Arm’s-length business relationship (ie, outsourcing of specific work on an ad-hoc basis) Global alliance 27 21 Partnership that is exclusive for a given disease area or geography Global alliance 17 17 Arm’s-length business relationship (ie, outsourcing of specific work on an ad-hoc basis) Non-exclusive partnership 17 16 Partnership that is exclusive for a given disease area or geography Non-exclusive partnership 16 16 Joint venture Joint venture 10 Members of same corporate group Members of same corporate group We are not involved in any such relationship We are not involved in any such relationship 13 10 Please indicate your level of agreement with each of the following statements Select one for each row (% respondents) Agree strongly Agree Neither agree nor disagree Disagree Disagree strongly The largest CROs are developing enough competencies that they could become competitors of traditional pharmaceutical and biotechnology companies in the near future 11 34 18 31 18 The shift towards “virtual” organisations among pharmaceutical and biotechnology firms remains more hype than substance 37 32 The reduction in technology costs is removing the advantage that big pharma once had in data availability and analytics 10 43 27 17 It is difficult to differentiate medium to large CROs on any criteria other than price 26 25 36 Too often, large pharma companies see CROs as necessary sources of cheaper services at a difficult time rather than valuable partners that they would be approaching regardless of circumstances 16 49 27 12 © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship In which of the following areas has your company increased investment in the last three years? In which of the following areas has your company decreased investment in the last three years? (% respondents) (% respondents) Technology to better manage data and information Appendix Survey results Staff training relevant to managing partnerships 48 Technology to improve analytical capabilities 17 Networking capacity to create a more virtual D&D organisation 44 16 Attracting talented scientific researchers Technology to help speed screening for drug candidates 40 16 Technology to help speed screening for drug candidates Technology to automate more decisions in development process 37 16 Staff training relevant to managing partnerships Attracting talented scientific researchers 33 16 Access to a wider variety of information Technology to better manage data and information 32 15 Technology to automate capture of data at more points in development process Technology to improve analytical capabilities 32 15 Networking capacity to create a more virtual D&D organisation Access to a wider variety of information 32 14 Allow easier sharing of data within and between companies Technology to integrate diverse data types to better analyse or mine 31 14 Technology to automate more decisions in development process Technology to automate capture of data at more points in development process 25 14 Technology to integrate diverse data types to better analyse or mine Allow easier sharing of data within and between companies 22 12 In which of the following areas will your company increase its investment over the next three years? Select all that apply In which of the following areas will your company decrease its investment over the next three years? Select all that apply (% respondents) (% respondents) Networking capacity to create a more virtual D&D organisation Technology to better manage data and information 14 55 Technology to automate more decisions in development process Technology to improve analytical capabilities 14 53 Technology to help speed screening for drug candidates Attracting talented scientific researchers 14 53 Staff training relevant to managing partnerships Access to a wider variety of information 14 49 Attracting talented scientific researchers Technology to help speed screening for drug candidates 13 47 Technology to integrate diverse data types to better analyse or mine Access to a wider variety of information 12 47 Allow easier sharing of data within and between companies Technology to integrate diverse data types to better analyse or mine 11 45 Technology to improve analytical capabilities Staff training relevant to managing partnerships 11 45 Networking capacity to create a more virtual D&D organisation Technology to automate capture of data at more points in development process 11 45 Technology to automate more decisions in development process Allow easier sharing of data within and between companies 10 43 Technology to automate capture of data at more points in development process 41 © Economist Intelligence Unit Limited 2012 Technology to better manage data and information 17 Appendix Survey results Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Has your company been involved in an unsatisfactory relationship between pharmaceutical/biotechnology companies and CROs in the last three years? What were the biggest challenges for successful relationships between pharmaceutical/ biotechnology firms and CROs? Select up to three (% respondents) (% respondents) Poor communication Yes 46 33 No 49 Don’t know 18 Excessive expectations by one or both sides 29 The culture of one or both companies impeded necessary information sharing/co-operation 25 Lack of skills in maintaining partnership 22 Lack of technical ability by one or both sides 19 Incompatible technology 18 Lack of clarity in the terms of the agreement 13 One or both sides was unable to manage the internal changes necessary as a result of the partnership What were the biggest barriers to success in the unsatisfactory relationship? Please select up to three 10 We have not engaged in such a partnership 23 (% respondents) Poor communication 40 The culture of one or both companies impeded necessary information sharing/co-operation 35 Lack of technical ability by one or both sides 32 Lack of skills in maintaining partnership 28 Lack of clarity in the terms of the agreement 24 One or both sides was unable to manage the internal changes necessary as a result of the partnership 22 Incompatible technology 18 Excessive expectations by one or both sides 17 How important are the following for biotechnology and pharmaceutical companies in considering the location of CROs with which to partner? Rate on a scale of to 5, where 1=Very important and 5=Not important (% respondents) Very important Not important Don’t know Global reach of CRO 22 31 20 11 Presence of CRO near to pharmaceutical and biotechnology companies’ operations 15 21 28 15 15 Presence of CRO in least-costly country 17 18 15 28 13 19 © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Appendix Survey results In which areas you expect to begin to offer, expand, or reduce service provision in the next three years? Select one for each row (% respondents) Begin to offer Expand Reduce No change/ we already offer No change/ we don’t offer Target discovery 26 29 29 Target validation 41 18 38 Assay development 39 18 27 Screening 55 12 21 Lead optimisation 15 41 32 Pre-clinical testing 44 21 26 Phase I & II testing 46 23 17 17 17 Phase III testing 11 49 D&D overall 50 21 24 At your company, which of the following stages of D&D are conducted primarily internally, primarily by CROs, or primarily through some other means? Please select one for each row Do you expect a shift in the next three years so that a greater proportion of work in these areas will be done internally, by CROs, or through some other means? Please select one for each row (% respondents) (% respondents) Internally By CROs Other Greater proportion done internally Target discovery 68 11 22 Target validation 62 18 20 18 18 Assay development 63 Screening 59 20 21 Lead optimisation 61 19 20 Pre-clinical testing 34 47 19 55 18 Phase I & II testing 26 Phase III testing 20 59 21 D&D overall 55 22 24 Greater proportion done in other ways No change Target discovery 33 15 43 Target validation 30 19 45 Assay development 31 20 42 Screening 35 19 37 Lead optimisation 33 19 39 36 39 39 39 39 38 11 39 Pre-clinical testing 17 Phase I & II testing 14 Phase III testing 13 D&D overall 29 © Economist Intelligence Unit Limited 2012 Greater proportion done by CROs 21 19 Appendix Survey results Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Which of the following attributes does your company currently use to differentiate itself from competitors in attracting business from pharmaceutical and biotechnology companies? Select up to three Which best describes your company’s strategy over the next three years? (% respondents) (% respondents) We will seek to develop our own pharmaceutical products and produce and market them through partnerships 18 Currently Next three years Ability to deliver lower cost We will seek to expand the variety of services that we offer in order to become a more attractive research partner 49 20 41 Global reach We will focus closely on a number of highly specialised areas 29 23 29 Speed in completing studies/contracts We will seek to become a leading provider of a single, specialised service 12 31 20 Range of services provided 11 Which best describes your company’s strategy in using CRO services in the next three years? 20 Experienced, talented staff in general 43 29 (% respondents) Expertise in specific areas of drug development 26 It will expand greatly as part of a restructuring of how we engage in drug discovery and development 34 Willingness to engage in risk sharing 11 9 It will expand greatly, but our drug discovery and development model will stay fundamentally the same Provide access to specialised, cutting-edge technology 26 20 It will expand somewhat 34 14 It will stay the same 22 It will decrease somewhat 23 Provide access to high-quality data and advanced data-integration capacity 20 Ability to focus on target populations, conditions 11 It will decrease noticeably as we bring more research in-house What are the most important attributes that you look for in selecting a CRO with which to business? Select up to three (% respondents) Experienced, talented staff in general 49 Ability to deliver lower cost 44 Speed in completing studies/contracts 42 Global reach 35 Expertise in specific areas of drug development 34 Range of services provided 20 Provide access to specialised, cutting-edge technology 16 Willingness to engage in risk sharing 15 Provide access to high-quality data and advanced data-integration capacity 14 Ability to focus on target populations, conditions 20 © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship Appendix Survey results Please indicate your level of agreement with each of the following statements Select one for each row (% respondents) Agree strongly Agree Neither agree nor disagree Disagree Disagree strongly Low barriers to entry and a large number of small CROs mean that the industry will likely need to see consolidation in the near to medium term 11 43 23 23 The search by big pharma for partners rather than dispersed outsourcing will drive consolidation in the short term 69 14 11 The rapid growth in business from pharma in recent years has left our company struggling to keep up with the opportunities 11 60 23 The ease of attracting business in recent years has dampened the drive for business model innovation within the CRO sector 21 26 44 Finding a way to differentiate our offerings in a crowded market is a growing challenge and crucial to business success 60 11 14 We increasingly have a different type of relationship with large and small pharmaceutical and biotechnology companies 14 51 20 11 How significant are the following risks in the greater use of CROs for your company? Rate on a scale of to 5, where 1=Very significant and 5=Not significant (% respondents) Very significant Not at all significant CRO services will be of unsatisfactory quality 36 21 26 10 Leakage of our intellectual property 34 27 22 12 Outsourcing could lead to loss of internal capacity necessary to our organisation 13 22 34 19 11 Outsourcing will help develop capacity within a CRO that could make it a competitor 11 29 27 17 15 Cultural clashes and other partnership management issues 28 33 18 11 13 11 Loss of tight control over drug development process, costs and time line 14 34 28 What is your primary industry sector? In which country are you personally located? (% respondents) (% respondents) United States of America Pharmaceutical 29 44 India Biotechnology 12 22 Germany Other life sciences 19 Contract research organisation (CRO) Canada, China, France, United Kingdom 15 Generic drug maker Singapore Switzerland, Nigeria Malaysia, Spain, Philippines, Saudi Arabia, South Africa Australia, Italy, Finland, Hungary, Pakistan © Economist Intelligence Unit Limited 2012 21 Appendix Survey results Finding Alignment Opportunities and Obstacles in the Pharma/CRO Relationship In which region are you personally based? Which of the following best describes your job title? (% respondents) (% respondents) Board member North America 35 CEO/President/Managing director Asia-Pacific 28 27 CFO/Treasurer/Comptroller Western Europe 27 CIO/Technology director Middle East and Africa Other C-level executive Latin America SVP/VP/Director Eastern Europe 17 Head of business unit Head of department What are your company’s annual global revenues in US dollars? (% respondents) Manager 17 Other Under $100m 36 $100m to $499m 16 $500m to $999m 16 $1bn to $1.9bn $2bn to $4.9bn Over $5bn 18 What are your main functional roles? Choose up to three (% respondents) Strategy and business development 48 General management 47 Marketing and sales 22 Drug discovery and development 17 Operations 15 Finance 14 Data management IT Customer service Human resources Supply chain management Risk Manufacturing Legal Procurement Other 22 © Economist Intelligence Unit Limited 2012 Cover illustration: Dan Page Whilst every effort has been taken to verify the accuracy of this information, neither The Economist Intelligence Unit Ltd nor the sponsors of this report can accept any responsibility or liability for reliance by any person on this white paper or any of the information, opinions or conclusions set out in the white paper © Economist Intelligence Unit Limited 2012 23 LONDON 26 Red Lion Square London WC1R 4HQ United Kingdom Tel: (44.20) 7576 8000 Fax: (44.20) 7576 8476 E-mail: london@eiu.com NEW YORK 750 Third Avenue 5th Floor New York, NY 10017 United States Tel: (1.212) 554 0600 Fax: (1.212) 586 0248 E-mail: newyork@eiu.com HONG KONG 6001, Central Plaza 18 Harbour Road Wanchai Hong Kong Tel: (852) 2585 3888 Fax: (852) 2802 7638 E-mail: hongkong@eiu.com GENEVA Boulevard des Tranchées 16 1206 Geneva Switzerland Tel: (41) 22 566 2470 Fax: (41) 22 346 93 47 E-mail: geneva@eiu.com [...].. .Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship can cover the entire spectrum from the lab to the patient, it will be a big advantage.” Risks can also increase with partnerships Mr Ratliff of Quintiles says, “ [in partnerships, CROs] are in the middle of what they [clients] are attempting to do in terms of drug development You have the heart of their portfolio in your hands... model” The dominant shape of the CRO- client alliance is still malleable as both sides learn how best to work together © Economist Intelligence Unit Limited 2012 11 Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship Making the most of new relationships W “If the pharma clients don’t think about transforming their work flow around the outsourced activity, they may not get the full... relationships are formed, they require tending Pfizer has appointed alliance management professionals within the company, as has AstraZeneca Ms Wingstrand says this involves not just focusing on the “hardware” of the alliance, but on the experience of staff and whether those on both sides are © Economist Intelligence Unit Limited 2012 13 Finding Alignment Opportunities and Obstacles in the Pharma/ CRO. .. The industry is in the infancy stage as it relates to building these [relationship management] tools It is a new area for us and for pharma. ” © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship Conclusion B iotechnology and pharmaceutical companies are laying a big bet on the future of drug D&D CROs are already taking on a substantial... sense to allow the CRO to do so © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship Information technology will be part of the evolution Contract research is an information-intensive business As John Watson, president of strategic partnering and chief commercial officer at Covance, puts it, “At the end of the day everything we do is to... Economist Intelligence Unit Limited 2012 Technology to better manage data and information 9 17 Appendix Survey results Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship Has your company been involved in an unsatisfactory relationship between pharmaceutical/biotechnology companies and CROs in the last three years? What were the biggest challenges for successful relationships... margins that have no alternative but to become competitors Meaningful partnerships, in contrast, hold out the promise of the kind of change needed to restock diminished pipelines © Economist Intelligence Unit Limited 2012 15 Appendix Survey results Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship Appendix: survey results Percentages may not add to 100% owing to rounding or the. .. consolidation in the near to medium term 11 43 23 23 The search by big pharma for partners rather than dispersed outsourcing will drive consolidation in the short term 6 69 14 11 The rapid growth in business from pharma in recent years has left our company struggling to keep up with the opportunities 6 11 60 23 The ease of attracting business in recent years has dampened the drive for business model innovation... model innovation within the CRO sector 6 21 26 44 3 Finding a way to differentiate our offerings in a crowded market is a growing challenge and crucial to business success 6 60 11 14 9 We increasingly have a different type of relationship with large and small pharmaceutical and biotechnology companies 14 51 20 11 3 How significant are the following risks in the greater use of CROs for your company?... Canada, China, France, United Kingdom 5 15 Generic drug maker Singapore 4 0 Switzerland, Nigeria 3 Malaysia, Spain, Philippines, Saudi Arabia, South Africa 2 Australia, Italy, Finland, Hungary, Pakistan 1 © Economist Intelligence Unit Limited 2012 21 Appendix Survey results Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship In which region are you personally based? Which of the ... Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship Preface Finding Alignment: Opportunities and Obstacles in the Pharma/ CRO Relationship. .. © Economist Intelligence Unit Limited 2012 Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship Interviewees Karin Wingstrand Vice-president and Head of Clinical Development... Takeda International Finding Alignment Opportunities and Obstacles in the Pharma/ CRO Relationship Executive summary A fter years of painfully diminishing return on investment (ROI) from discovery and