	Information is the coin of the realm in biopharmaceuticals-but what will it take to make the vast reams of data now being generated in the transactional tsunami of modern healthcare truly useful to its users? To help answer this question, 

recently hosted an editorial Roundtable with several


	company chief information officers (CIOs) and IMS Health, whose Institute for Healthcare Informatics, together with the Egon-Zehnder executive search firm, recently issued a report on how the CIO role must transform to make the “c-suite” cut as a key driver of internal innovation. The following are excerpts from the discussion-in the plain English CEOs prefer, no algorithms

A single word defines today’s life science industry. That word is “disruption.” And the single biggest driver of this disruption is information. Information and the analytical capabilities that come with it has enabled a major shift in the industry’s business model, from a transactional approach-selling a pill-to an outcomes approach where that pill is only one part of the patient experience. Can we describe and agree on the basic contours of this disruption as it relates to the role of one of the newest entries to the c -suite: the chief information officer (CIO)? More directly, is today’s CIO poised to be a specialist-or a strategist? 

Recently, I was asked how we should respond to the ways that information technology is transforming the financing, delivery and marketing of healthcare. I said that before we could advise clients on how to build and execute a strategy focused on new technology solutions, you first had to understand what a transformed business model might look like. That’s why the IMS Institute and partner Egon-Zehnder, in a joint report released last month, New Strategic Information and Technology Roles in Life Sciences Companies, came up with a metric called the Information Technology and Transformation Scoring (ITTS) framework.  ITTS is designed to help companies assess their progress in meeting customer expectations in five key areas. These are, on the strategy side, Innovation and Disruption and Organizational Transformation, and, on the operations side, Big Data and Analytics, Technology Infrastructure, and the Future of Work.

	Why is it necessary for the industry to align to this new model? We see three factors, each induced by larger environmental trends shaping the IT world.  The first is “exponentiality,” or the rapid compression of the time in which innovations enter markets to displace existing products and services. The trend explains why the life span of any product can now be measured in years or even months, not in decades. It demands that companies keep their gaze firmly on the future, actively studying where the next wave of life sciences products and services is coming from.  

	One way to do this is to focus on your supply chain. It has to be compressed, with most of the non-essential elements contracted out. The areas where supply chain management really counts today are product design; process engineering; and the overall “ownership experience” of the customer. This latter point is often seen as something intangible, but in fact it is an increasingly critical marker of competitive differentiation now that virtually anyone in the business can intervene with products or services that add value to the producer’s original market proposition. 

	The second reason is the nature of innovation, expressed as a platform that can be pursued in two ways: “evolutionary” innovation and “revolutionary” innovation.  Most big pharma organizations remain firmly in the evolutionary camp, where it’s okay for a few projects to fail while a few others succeed, while start-up operations often have little choice but to hedge their entire future around a single bet. When that single bet leads to an approved product you are a hero. So the level of risk to practice evolutionary innovation or revolutionary innovation depends on where you sit. Today’s R&D imperative to “fail fast and early” means different things to big Pharma compared to a start-up operation.   

	The third reason is “disruption,” which we separate into three components: product disruption; process disruption; and experience disruption. Again, we believe this latter element-related to the customer experience-is a critical driver of transformation. An example is Uber, which has grabbed market share from the taxi business by elevating that experience to remove what was ugly about the traditional taxi, especially the confusion and inconsistency around the payment model-fare per mile? Cash or credit?  Tipping? The Uber platform, which surprisingly does not require the expense of operating a fleet of vehicles, has turned out to be a massive disrupting technology because its operating model conforms to all three of these factors-product disruption, process disruption and experience disruption-driving market change.

In practical terms, how will this transformational change shape the future of the healthcare and pharmaceuticals market? Uber is revolutionizing the business of personal transportation without owning any automobiles, while Airbnb is the world’s largest private hoteling business but owns not a single room. Extending the concept, does this mean a company can succeed in biopharmaceuticals without developing a medicine? 

 As the sophistication of information technologies progress, we will witness a democratization of insights, where individuals will be able to better understand and interpret their own health data, motivating the patient to do the right thing for his/her health. If an individual understands the risk/benefit of every decision they make and how it impacts their health, they will be equipped to make better choices. 

	There are significant business opportunities here, premised on manufacturers innovating “beyond the pill.”  Biopharmaceutical companies can expand their service orientation, this time geared to the information needs of the patient rather than just the healthcare provider. Those who commit to this type of ”patient centricity” will thrive through a process innovation that can be just as important  to delivering positive health outcomes as a new drug.

 Disruption is also coming as the health system gets better at collecting, storing and sharing this data.  If patients take ownership of their information, it suggests they will also be more selective about sharing it. Companies and vendors will create new businesses to pull all these disparate streams of information together and render it coherent as real world evidence to different stakeholders. For example, with the appropriate regulatory oversight, clinical trials of the future could be conducted entirely through the internet, a development that by itself will be disruptive. 

 Uber has created a new marker of market success, where the customer experience is more important than the brand-in fact, the experience is the brand. This carries important implications for the biopharmaceuticals business, because we all know that in our sector the opposite is the case:  the brand may be touted as a scientific breakthrough but the actual customer experience in accessing it is roundly criticized by nearly everyone. The industry is filled with product people, yet increasingly today that customer experience-the process-is the instrument by which the industry reputation is measured.

 If the biopharma enterprise can solve the equation calling for the right pill, at the right time, for the right patient, then that’s a formidable process innovation. We need to focus on the “ideal” patient. Companies need this focus because there are still too many misses in attempting to match these three mandates to broad patient populations. 

 We spend a great amount of time talking to patients, payers and other stakeholders about the details of access, drug benefit design and reimbursement criteria. This is another hurdle that hurts the industry-and it is partially due to process. Stakeholders respect our medicines. We all want to engage productively as partners but there is this lack of clarity on how to navigate through the complexity of the healthcare system. 

	UCB is devoting significant resources to helping our customers manage these channels. Technology and data must be leveraged to the point that these investments to help us to prevail on the commercial side are beginning to approach the cost of securing registration approval.

We have a consensus that innovations on the process side can raise the quality of the overall customer experience, the perceptions of which are critical to maintaining a biopharmaceutical company’s edge against the competition. Can you describe how your CIO function contributes to this objective-what are the challenges in advancing the c-suite CIO’s transition from a technical back office function to a strategic asset? And what is the difference between IT strategy and digital strategy-is it just a word play? 

 At UCB, I lead the application of technologies to drive our commercial business objectives with customers like payers as well as the connected patient communities representing those with immunologic and neurologic disorders that drive our key therapeutic franchises. Digital information is an important element here; we go beyond the drug itself by investing in wearables and apps that help patients with a complement to their therapy as well as in data analytics to support the needs of payers, insurers and physicians.   

	We don’t decide what digital technologies should be incorporated into the promotion launch and execution cycles of each brand; that is the responsibility of the brand’s teams. What we do is take a step back and help our commercial teams figure out how a digital or information technology might help them meet their P&L objectives.   

Are there limitations to using digital technology as part of a commercialization strategy?

 Of course. My background is in medical devices, where we know that good data can be obtained with relative ease because the process takes place around a single transaction. Pharmaceuticals are different. There are many touchpoints.

	What we hear directly from customers and patients does not always conform to the information we obtain from market research. It is harder to measure just how much a digital intervention contributes to a superior business result. Again, the proof is ultimately how information technology, as applied, contributes to a better customer experience with the product.  

How else is the overall market environment shaping the mandate for the CIO?

 In my company, the role of CIO has evolved. What was once a position that managed those back-office systems around prosaic things like inventory control or accounting and payroll is now more closely tied to the actual business of developing and selling product. It is all about deploying information as an asset with a direct P&L orientation. In this case, we see less of a role for a chief digital officer because digital can no longer be separated out but instead incorporated within each discipline under this broader strategic mandate.   

 In our experience, we see the CIO position as focused on internal strategies and operations, while the chief digital officer (CDO) is directed toward the external environment, with an emphasis on creating better ways for the company to communicate and interact with customers and other influentials. It’s a service role with an emphasis on innovation in getting your messaging to stand out.   

 The distinction between the internal and external is interesting. Purdue has a new CEO, Mark Timney, who joined us from Merck & Co. Under the previous regime, IT was an inside operation geared to making the trains run on time-standard operating procedure was the overriding goal. And the benchmark was also internal, in the sense that we graded ourselves against our competitors in pharma.  

	Timney immediately took us to another step, asking how Purdue compared to Apple in terms of our user interface experience. Or could we match Amazon in our distribution 

and inventory management? His point: If Purdue expected to keep connecting to customers and patients, we had to up our game and strive to match the performance of outsiders who were actively disrupting the model of the businesses they were in. 

	Timney’s insistence on not just being as good as our competitors but going beyond best in class for the function itself has led to a complete change in what we do-not only are we strategic, we are forward looking and actively seeking to leverage external ideas, constantly looking at precedents that on the surface have little to do with our industry but could be completely disruptive to our business if we fail to see these coming.

 The CIO role is at the center of a discussion taking place in every large business, which is how best to seed a culture of innovation within the organization. One approach is endowing an internal group with a separate line of sight on key strategic challenges-a way to avoid being caught up in the standard operating procedures that tend to quell the creativity, initiative and risk required in trying something new. 

	Another is when the CEO decides a new position is necessary to stretch or test existing organizational boundaries. An example is “chief innovation officer” or, yes, the “chief digital officer.” Often, however, persons in these roles quickly experience what I refer to as institutional organ rejection, where they find it is literally impossible to integrate with support from others in the senior management team. Resistance can be particularly stiff in biopharmaceuticals due to the innate conservatism of business practices that limit the freedom to operate -the IP system is but one example. New drug technologies have to be proven safe and effective beyond a shadow of a doubt and then they have to be protected. This can put a damper on the entrepreneurial mindset.

	Over time, however, I believe organizations do adjust to the reality that market change imposes on them. One thing I hear from the discussion today is the CDO is a stop gap. A decade from now, I expect that position will no longer exist. We just won’t be talking about digital health.  Every corporate function will have mastered the discipline. It will be considered part of health because the technology to do it is so embedded in the healthcare system. Remember those VC funds in the 1990s with a special purpose to invest in mobile-related ventures? Today, these funds can no longer segregate this area of investment because mobile is a ubiquitous technology; it is now, by definition, everywhere.  

 The same is true for social media. It too is embedded in the overall construct of “information.” It will be seen as but one more channel in the data/information platform from which we can derive insights for our product marketing. 

 We need to understand that it is good that positions within large organizations will ebb and flow in tandem with the pace of market change. It is a prism by which we can see whether our organizations are going to be ready for the next generation of clients and customers. Three years ago, if we described the background of a new CDO, it would turn out that most came from media or advertising. That made sense, as the role was seen largely as a listening post and entrée to the murky world of social media. Now the role is all about contributing to the product franchise P&L while defining and co-creating the next generation of products that will also drive P&L. Digital is just one of many marketing channels. 

 One way to better define the position of the CIO or the CDO is to embrace what Richie Etwaru calls “cruciality.” It’s all about centering the function around what’s truly important to the organization. Katherine Wilemon is the founder and leads the FH Foundation, a research and patient advocacy group for a deadly, little known condition called familial hypercholesterolemia (FH). 

	An estimated 1.3 million people in the US suffer from this condition, which is genetic in origin, is readily diagnosable and treatable, yet if left untreated can lead to a 50/50 chance of suffering a heart attack by age 50. We estimate that 90 to 99% of patients with the condition are unaware they have it, so the goal of our FH Foundation is get individuals as young as 10 signed up for a preventive screening and treatment that manages this risk. 

	Led by Katherine’s vision, we created a machine learning algorithm to identify the number of probable FH individuals (those with medical and insurance records consistent with FH) at the provider level to encourage early screening and diagnosis and initiate preventive treatment. I serve as the Foundation’s chief technology officer (CTO), and I found that what helped us achieve this goal was actually the lack of any existing analytics infrastructure that might have seen this initiative as a disruptive threat. 

	It’s ironic: we had no technology infrastructure in place and yet we secured our objective earlier and identified probable FH patients than had we had legacy IT systems to deal with. It is something large organizations should take to heart. In trying something new, you have to account for the burden of replacing what’s already in place. I think that’s an important part of the CIO role that we have not discussed.

 The trend today in IT is to rely on the “incubator” approach to tackle those big change issues, effectively removing the process to a place outside the larger organization. But there is an alternative, which is to leverage external partnerships. At Purdue, we are pursuing this in a structured way by exploring partnering with academic centers, hospitals and other institutions vital to our business. It’s a “supply chain of knowledge” where we approach partners for their ability to offer answers to challenges we can’t solve on our own.

With reference to the priorities of today’s CIO, which would you identify as most critical? One item that comes up frequently is finding a path around those big strategy questions-such as, is the mission of the organization to share information or to protect it?  

 This is hard to separate; the mission of the CIO must be to do both. UCB has to be sensitive to protecting information, particularly patient data, from disclosure that violates legislated guarantees of privacy. We are held in a position of trust that we will do the right thing for patients with the data we collect. At the same time, we have an 

obligation to make our information a financial asset, with insights that can drive the market for our medicines. The CIO has to bring everything together and make these huge volumes of data work to connect with the commercial side.  If you don’t invest in that, you will lag the competition.  

 This is a question that has no precise answer. It is impossible for us to “own” all the data we compile. Some of it we actually purchase from outside vendors. There is also a massive increase in the availability of public data from the government, where CMS has made a commitment to make this flow open and available to anyone. Our industry contributes to that-pharmacovigilance stats are a prominent example-but we don’t own or control it.  

	The priority in this for the CIO is to develop novel-I mean useful-ways to integrate these data streams so that management can make wise, forward-looking decisions to grow the business. Information in biopharmaceuticals is the ultimate ecosystem. And this ecosystem is increasingly centered on the goal of creating more value for industry stakeholders while improving outcomes. Information must be harnessed to do one thing:  improve patient care and, in doing so, deliver a better outcome for the health system. 

	Last year I took the initiative to establish a team to explore the “patient journey” of those using Purdue’s medicines. The objective was, by better understanding how the patient and their caregivers think about pain, we could investigate ways to apply IT and data sets to promote improved patient outcomes. 

 Another, related priority for the IT team is contending with the dilemma of leveraging the data for the business when we don’t know much about that data, or that we don’t control it. An example is making sense of the significant information we are now getting about the patient experience outside the drug setting, such as quality-of-life indices, where it can be said the average patient suffers the most loss. 

	Can we find a means to embed this kind of data into the R&D or clinical trial process so that it benefits product design and strategy at that critical early stage of development?

 It’s all about the interoperability of data systems and the liquidity of the information flow, with the ultimate aim of connecting the dots to get good insights. In the latter case, I believe it’s important to adjust the focus from the abstract idea of the patient to the person. 

	I spend a lot of time talking to commercial teams about a change of mindset, which I reference as “treat the person, not the patient.” How do we do that?  An example is directing more of your advocacy investment to the caregiver, whether it is a spouse or children, because it is this group who really know if the patient is taking the medication or not.   

 Some 80% of the value that information can produce already exists from what is already on hand within the organization.  

 That’s true. We have vast stores of data collected through clinical trials, R&D science, and now from social media. This has already been said, but the problem lies in accessing and then assessing it. 

	Our industry needs to be more innovative; it is hard to break with the old approaches where we limited our range to data that we knew how to handle, using time-honored standards of practice structured on the registration requirements of the regulator. So when someone says let’s start looking at the data from another angle, such as combining data types that have historically not been combined, it raises a red flag. But I think that attitude is fading. It’s only a matter of time, because regulators, payers and patients are demanding it.

As CIOs and CDOs, do you feel that your objectives-on both the information and digital fronts -are aligned around those of the larger organization? Is there a consensus among your peers that what you do fits the requirements of a changing biopharma marketplace?

At the initiative of our new CEO, Purdue for the first time has IT objectives embedded in our overall corporate strategy and operating plan. We are committed to the use and understanding of technology and data from a strategic perspective. So we feel we are getting more aligned. I am also being challenged to reach out to customers and patients. There is less emphasis on back-end IT operations, which are now seen as largely self-sustaining-Microsoft can manage our email and outsourcing firms can handle managed infrastructure services.    

	That’s a big shift from the time I was interviewed at Purdue nearly two decades ago, asked to weigh in on questions like encryption technology and the best desktop standard. No one at my level is talking about that today. The salient theme is designing a distinctive, stand-out digital strategy. Demonstrating how to use data to improve the patient experience and connect to the customer.  It’s actually the same things other industries like consumer goods are figuring out-how information assets can lead to better decisions for customers and ultimately the business. 

	Recently, I participated in a peer group meeting with 20 other biopharma CIOs. We were each asked to share our view on what really matters to the function going forward. Technology itself got zero votes.  Top of mind was finding strategic third parties to help develop and implement big data analytic strategies.  

	We are also on the cusp of a new business role involving data science. Instead of data scientists, this role is embedded in the business. Many who have come up through the IT ranks are systems administrators rather than business analysts. Yes, the trains still have to run on time but that’s just the table stakes. We and most everyone else in IT are developing talent for an entirely different set of capabilities. 

What about the chief digital officer role? How is that changing?

 I would describe it as moving toward the in-house equivalent of Amazon. It is using the customized audience development tools enabled through digital to help the commercial teams broaden their perspective on the customer and finding new ways to 

understand and serve patients. There is an entirely different information ecosystem arising around digital, so in my view it requires special attention.  

What specifically are your clients asking you to help them to do on digital?   

 They want advice on how to execute a program around information innovation. We help them consider an internal project or program that will bring the concept of innovation to life. Another is to build more expertise in predictive analytics, with emphasis on teasing out those leading and lagging indicators around marketing success.  What framework on messaging to physicians, payers and patients might yield the best results?

	A third area of interest is creating the technology that track consumer interests and preferences, just like what happens with those reminder messages after Amazon observes you scrolling its site for shoes. Programmatic software like that doesn’t exist right now in healthcare. 

	Finally, many clients have been operating in the digital space for a decade and want to “clean house.” There is a lot of internal clutter as departmental websites proliferate and product apps number in the hundreds, along with endless visual aids tailored to individual brands.  How do we replace the chaos with order and make all of this connect?   

 Clients want to engineer a shift from rich media to relevant media. This is a vital issue to address if advertisers are to justify their role going forward.  Ninety percent of the videos posted on YouTube are viewed by less than 50 people; the same is true for blogs on the Internet. You are paying for something that delivers little access because it is not relevant.  

 At my most recent interaction with UCB’s commercial leadership, two questions came up. One was on how many interactions we have directly with patients through digital channels. The other was a request from one of our senior executives who was visiting a European country and wanted a recap of what patients were saying about the company’s therapies through digital. I thought it significant that it was not the standard question about the ratio of sales to investment or other issues linked to budgets. To me, it demonstrates that digital is capable of finding its own internal audience, one that appreciates the insights that come from access to the world outside the factory gate.  

	Of course, there is a necessary growth curve. I was not entirely happy with the sum total of digital interactions in that country compared to traditional means of contact, but it takes time to cultivate the audience. 

 What concerns me is whether the CIO/IT community is prepared to address a larger existential threat to the industry. We have talked today about the customer experience as a driving force for change that has to be measured if biopharma companies 

are to remain viable competitors-but what if the best provider of that customer experience comes from outside the industry? There is the risk of an entire industry being disintermediated by a Samsung or a Google. Is the CIO prepared to address this threat and fight it through better understanding of that customer experience? 

 Certainly I see it as part of my job to bring this intermediation issue to light. Samsung, many CROs and of course “the” Google likely have tremendous insight about our patients and customers. We must do a better job at monitoring the patient experience, turning our data into actionable insights to increase the quality of our engagement, or we will discover these non-traditional competitors have literally changed the market.

 Within the decade, the largest healthcare organization may be one with a background in the tech business. Google could become the broker of that superior customer experience. 

 Why not the big pharmacy chains? There are 70,000 pharmacies in the US alone and all are well trafficked by patients. Will Walgreens surpass big Pharma in the customer experience because it can provide the drug along with supplemental support to help raise adherence, pass along cost savings from rebates, and offer a free scan for 

high blood pressure too? Patients are being conditioned in other industries with great consumer experiences, at companies like Amazon, Apple and Nike. Here, they are not patients; just people. This expectation of a “great experience” is being called for today in the life sciences.  A company that takes the current struggling patient experience and turns it around to an experience that is as good as that of these three iconic brands will transform the life sciences industry. A large part of this transformed experience will be digital; hence, the important anchoring role of the CDO. 

Aside from the challenge of disintermediation, what do you see as the impact of technology on the business of information? Is technological progress potentially outpacing your ability to cope?

 There is a proliferation of data coming from every direction-wearables are just one new source. The value is balanced against the difficulty of aggregating data from disparate data sources, including this new inflow, to derive real meaning from it. All these sensor and wearable “passive data collectors” will be ubiquitous. They will be embedded in your clothes, eyewear, and in your home and car. Data will be collected constantly and sent to some kind of health portal, to be aggregated in your individualized electronic health record. All of it can be transferable to the Cloud, to be viewed by multiple health providers regardless of the source of data or your location.   

	The big question is how all this will work in practice. Many in the industry are talking about how to collect patient data and apply it in the clinic in the form of real-world evidence. I am convinced that the wave of the future is more about passive use of technology and data collection than active use. 

 The computation challenge is mind-boggling. If you look at the information embedded in the human body, we have not even begun to discover how big big data can really be. Just look at what it will take to make sense of our genomes, microbiomes and the interplay between them. There are literally billions, if not trillions, of interactions

 within a single person. The individual is the ultimate “big data” project.    

 Cognitive computing is another emerging force. We can give a computer the capability to process information like any human would-in other words, endowing the computer with artificial intelligence (AI), as IBM Watson and Google are doing. As AI gradually comes to life within these large institutions, we have to pay attention to it. And then there is the arrival of ubiquitous broadband.  Information will literally be everywhere and accessible without switching between different platforms or channels.  

 These technology changes will also be available at lower cost. Seven years ago, in my last start-up operation, we had to spend $300,000 on a server room filled with $500,000 worth of equipment. Today, the Foundation’s monthly cloud computing bill is $175, with infinitely more computing power at hand than we had seven years ago. This is the democratization of information technology. Money or even expertise is no barrier. Where we still have to get to is democratizing the insights from the bounty of data. And that’s going to take time along with new skill sets.  

Given these trends, how ready is the CIO to respond? What implications do they hold for the future of this role in the c-suite? 

 The CEO is going to expect that the CIO will respond to these signals and master them rather than demanding the recruitment of still more staff to manage the change. This is not entirely a headcount problem. Instead, what counts is the dynamics of the c-suite executive team in how it interacts as a group. To me, it represents an opportunity for the CIO to make the position a core part of the company’s value proposition to customers. It can certify once and for all that the CIO is a strategic player, not a back-office service vendor. Part of the line business operation, not a staff function. 

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Pharm Exec convenes a roundtable discussion with several company chief information officers (CIOs) and IMS Health to explore ways to turn the vast reams of data now being generated in the transactional tsunami of modern healthcare into truly meaningful insights for its users.

Transforming Technology: The Future of the CIO in the Life Sciences

	Long associated with that very earliest staple of the consumer medicine chest-aspirin-Bayer is today a company with a singular commitment to shortening the horizon line for drug innovations of the future. Leading that repositioning in the US-Bayer’s largest market-is  Habib Dable, a 22-year company veteran and the man behind the launch of some of the 

industry’s most successful brands, including ophthalmology blockbuster,

 sat down with Dable at the company’s expansive New Jersey headquarters to review the first few months since his appointment to the top US pharma position in October 2015, including Bayer’s all-in approach to product partnering and his faith in the positive tailwinds for patients coming from new gene-based therapy tools like CRISPR.

With the adage that past is prologue, can you address the key elements of your personal and professional background. How would you describe the journey to your present status as head of pharmaceuticals for a major multinational player in what is today the world’s largest single market for biopharmaceuticals?

 My story is the classic saga of the immigrant. My family background is Lebanese but I was born in Canada after my father decided to leave Lebanon in 1960 and establish what eventually became a successful business in the Atlantic provinces. In 1994, after receiving an MBA from the University of New Brunswick, I took a job with Bayer Canada as a sales representative. That was 22 years ago. Today, I am still with the company. Basically, it’s the only place I’ve ever worked. That is unusual, especially in today’s world, but it explains a lot about my temperament as well as the positive culture I’ve experienced at Bayer. When I find a supportive environment with the size and scale to allow for professional growth, I tend to stick with it.

	I was very close to my father growing up. What he lacked in formal academic credentials was compensated by a formidable interpersonal awareness that helped him excel at networking and building strong stakeholder relationships. I’ve worked hard at emulating my father’s personal attributes throughout my time at Bayer. I believe in the convening power of great institutions. I am an active listener.  In making decisions, I seek out people with different perspectives as a way to test my own judgment and avoid complacency. 

	In turn, Bayer Canada gave me excellent opportunities, including selection for the Bayer Management Trainee program in Toronto and, subsequently, as sales manager for the pharmaceuticals business in the Atlantic region. Then one of my managers offered me a position at Bayer Japan as head of strategic planning, which I took on with virtually no knowledge of the way business is done there. It was a bolt from the blue: Japan certainly had not figured in my career playbook up to that point. My role was to add more rigor to the marketing components of our commercial development plan for the country and to consider additions to our local pipeline portfolio in consultation with the business development team. That was my job description. But far more important was how quickly I learned that Japan is the most networked country in the world, one where close personal relationships are critical to business success.

Japan is a crucible for many Western managers because of the adjustment required to fit within a unique culture of performance. What lessons did you draw from your three years there? 

 The time I spent in Japan honed the management skills that brought me to my present position. It stretched me in many directions. I was not Japanese, nor did I speak the language, but perhaps more important I was very young in a country that typically defers to age and experience. You cannot do business any way you like. There are rules, including the requirement to inform and consult stakeholders through near constant engagement; the importance, when it comes to decision-making, of pause and reflection versus the Western values of speed and spontaneity. 

	What I appreciated most about my time in Japan is that it takes time to build those relationships. Real investment involving the mind and the heart is expected-it was not an obligation that could be turned “on and off.” Hence, the relationships that result from this investment tended to be trustful, very 

solid and loyal. To be honest, I was able to relate to these values because of the relationship I had with my father while I was growing up. His intelligence was of the emotional type that is now recognized as an asset that cannot be captured in a textbook-it’s a learned behavior, and not every manager is open to it. 

 The US market is seen as the ultimate development assignment for managers at non-US based multinationals like Bayer. What brought you to the US?  

 Another opportunity came up through Bayer’s internal network while I was still in Japan. It too was a stretch assignment: to grow what was at the time Bayer’s premier North Carolina-based biologic drugs division. I arrived in the US in early 2003.  I have been engaged in Bayer’s US biopharmaceutical business ever since, during a revolutionary period of change marked by strong, sustained growth; the US is now Bayer’s single-biggest market for medicines. And my connection became permanent when, along with the rest of my family, I became a US citizen in 2009.  

	The US is where I confronted my first serious management challenge. Although my assignment involved finding ways to expand our biologics business, which at the time centered on Bayer’s recombinant factor VIII anti-hemophilic therapy, 

, it became apparent after several years that extending our range in plasma-derived biologics beyond hemophilia drugs was not going to proceed at the pace required to stay competitive. The conclusion we made was either get big-or go home. So we ended up keeping the recombinant factor VIII 

 franchise, based in our Berkeley manufacturing facility, and divesting the Bayer plasma operations in North Carolina. 

	Thus, in a very short time frame, I moved from a growth strategy, where I was expected to integrate several businesses at once, to a divesting role requiring a painstaking attention to detail as well as a lot of stress in handling the inevitable cutbacks.  In retrospect, however, I find that the hard choices I made in conjunction with the US commercial and regulatory teams helped put us on course for the positive business trajectory in which we find ourselves today.

Do you mean that the learnings from the divestment planted the seeds of future success? 

 Yes, in several ways. Scaling down Bayer’s stake in the plasma business highlighted the necessity of aligning a commitment with the resources necessary to achieve it. I resolved never to approach a task without it being adequately resourced, a premise that we now adhere to in executing around our R&D portfolio. A second key learning for me is the potential in creating partnerships with external players who have assets that complement what we have in-house. We do not necessarily have to do it all ourselves. Even a company with the worldwide resources of a Bayer has to stretch to retain a presence in a market as big and complex as the US. Partnering helps us to do that. 

Bayer Pharmaceuticals has posted steady gains in sales over the course of the decade, from 1% growth in 2011 to double-digits in 2014 and 2015. Five new product launches during this period are undoubtedly a factor here. Is this also the consequence of the accelerated commitment to partnering that came after that re-think of the company’s stake in biologics? 

 Two of Bayer’s biggest selling medicines globally, 

, are the product of external partnerships. Initially, the rationale for negotiating these deals was to better husband our resources. Now, having experienced directly the back and forth around both negotiations, I ascribe to the view that becoming a good partner -a partner of choice-should stand on its own merits.  The benefits are more than making the best use of the resources at your disposal. The real gains come from combining different types of expertise, bringing in fresh human capital, opening up the cultures of both companies to different ideas and enhancing company reputation as a “go-to” source for the best innovations. 

	These are the strategic milestones by which every biopharma company wishes to be measured. Hence, for us, partnering carries weight well above and beyond our resource situation. 

It was only last October that you assumed overall responsibility for the pharmaceuticals business at Bayer US. What was your “script” in handling those critical first 100 days in the top position?  What adjustments are required in management style and behavior when you make the transition from a narrow line assignment to lead driver and spokesman for the entire business?

 It’s obvious that the first 100-day cycle of leadership requires a simple message, spoken directly to colleagues and customers. The higher you go in the hierarchy, the more important it is to communicate well -and to be authentic. 

	My approach was to highlight how far Bayer US had come in building a portfolio of treatments for patients, many of whom have few other options. I emphasized this was secured in two ways: (1) with a well-focused business platform consisting of products that promote plant, animal and human health; and (2) the specific commitment we have in pharmaceuticals to a partnering model that put us in a position of strength as deal-maker of choice in the US. I could point to the strong tailwinds produced by the previous leadership that allowed us to firmly position Bayer as a growth company, with most of that growth centered right here in the US.   

	One of our more important initiatives over the past six months is the opening of our East Coast Innovation Center at Kendall Square in Cambridge, MA, where Bayer scientists will have access to one of the world’s richest stores of academic, teaching hospital and industry research expertise. It’s a complement to the West Coast center we opened in 2011, adjacent to the UCSF science campus at Mission Bay in California.  

	Both areas represent hotbeds for R&D and innovation in the US. In April, we announced a plan to purchase 85 acres here at the Whippany HQ site for future development. All this new architecture really trumpets Bayer’s commitment to growth and strategic partnerships. Pooled expertise drives real value in medicine. If I somehow fail to get that message across to all our stakeholders, then I will have failed as a business leader.  

	The other message I focused on in my first 100 days was my confidence in the talent we have in place throughout the company. I cited many examples of the

 true passion our colleagues have in working for patients. My philosophy is every manager should see him or herself as the president and CEO of the function they are responsible for. That’s how I look at the concept of empowerment. If you want to lead, it is necessary to go all out. Don’t get drawn into the narrow distinctions that perpetuate hierarchy. 

	When I was assigned back in 2008 to manage our co-partnering deal with Regeneron, I did think of myself as the president and CEO of Eylea. It was an ironic self-assessment, because at the time Bayer had no tangible footprint in ophthalmology. There were only a handful of us at Bayer working in this area. It was up to me to lead all launch preparations, create a business plan in the ophthalmology space, and, with Regeneron, establish a productive relationship to turn 

 into a market success. Seeing myself as president and CEO for 

helped instill the confidence and focus required to maximize the potential from the Regeneron partnership, which continues to this day.

How does your role fit into the Bayer US leadership team and the global organization?  

 Our US leadership team is comprised of functional and business leaders, including me and my counterpart commercial heads. This team operates under the direction of Phil Blake, who is president of the Bayer Corporation and leads all of Bayer in the US. The team is focused on Bayer’s business, our people and our reputation as a world-leading life sciences company in the US. We also work closely with Bayer’s global HQ in Leverkusen and the global pharmaceuticals business based in Berlin. There’s an appreciation at Bayer that the US is the largest and most important market in the world and one that embraces innovative companies such as Bayer.

What therapy areas are you most excited about in terms of the future potential for patients?   

 The best example of the success we have had is the expansion of our stake in the hotly contested oncology space. A decade ago, Bayer had only one cancer drug, 

, approved by the FDA in 2005 for one indication: advanced renal cell (kidney) carcinoma. Today, we market three FDA-approved drugs for cancer in six different tumor types. 

 now has approved indications for thyroid cancer and liver cancer, in addition to the kidney indication. 

 is approved for two indications, gastrointestinal stromal tumor and advanced colorectal cancer. Our newest oncologic, 

, is indicated for treatment of advanced metastatic prostate cancer. 

	Although each medicine was developed in partnership with another company, today we are marketing these assets on our own. It entails recognition by the scientific and medical communities that, whereas 10 years ago we were unknown in the oncology space, Bayer US has now arrived as a player of consequence-and a source of hope for many thousands of patients with the hard-to-treat cancers we specialize in.  

	One deal that reflects our increasing appeal as a partner of choice is the partnership we negotiated with Orion Pharmaceuticals of Finland to develop its Phase III asset for prostate cancer. We see it as a complement to Xofigo, our existing therapy for this condition. Orion’s asset, ODM-201, has been well received by the medical community but the small company lacked the bandwidth to take it forward globally. Their management put out a first call for a partner to co-develop and commercialize ODM-201 in the US. It was a competitive process.  And it was we who ended up with an agreement in which Bayer will fund further development costs around the Phase III trials in return for 100% of the US commercial rights to the product, upon FDA approval. 

	The arrangement signifies we have come full circle-to a company that others now look to as someone to help them do the heavy lifting-the partner of choice. I am proud to have helped make this transition.

As a top US representative for a foreign-based company, how do you explain the US commercial pharma environment to senior managers back in Germany? The regulatory and reimbursement cultures are quite different. 

 There are many misperceptions in Europe about the US, mostly around the idea that pricing is simple because it is “free.” The reality is actually quite complex, with many shades of gray. Like other drugmakers in the US, we must allocate a large amount of resources to ensure our medicines are adequately positioned for appropriate use at the patient level. Details on such outlays to commercial insurers and payers often have to be explained when we present our numbers to HQ management.   

	As a counterweight, you have to educate and emphasize the many positives-the US is the heartland of medicines innovation, with the ideas, the money and the talent to bring great new products to patients. Last year, the FDA approved 45 new novel medicines, many for rare diseases where there are few treatments. FDA-approved products are also accessible to patients at a faster pace than elsewhere in the world. Key metrics show that the US remains the dominant, essential market for drug makers everywhere; if you cannot compete here, you are most likely also out of the running globally. This is the story we keep repeating to our colleagues in Europe.

What additional strategic innovations can we expect from Bayer for the remainder of this year, continuing into 2017? 

 I am enthused by the prospect of a number of launch products coming up in the US.   Our most recent launch, in March, of 

 for hemophilia, is in its early building phase and we are confident of strong sales due to its convenient dosing profile. With 

, patients have the option of dosing twice or three times a week. Bayer is totally dedicated to the hemophilia/blood disorder space. Our labs are working on longer acting factor-VIII treatments, and we are investing significant funds in next-generation therapeutics like the CRISPR tool for gene editing. In addition, we have signed a partnership with Dimension Therapeutics where we are looking at a potentially ground-breaking gene-based therapy against hemophilia A.  

	I also want to reiterate our continuing commitment to women’s health, where we intend to defend our leadership role in drug/device interventions. For example, we are preparing for the prospective launch of a new IUD, hopefully by the end of this year. Bayer sees contraception as a critical issue in public health worldwide. We have a reputation to preserve in addressing the spread of unplanned pregnancies. Our R&D pipeline in women’s health also focuses on treatments for endometriosis and uterine fibroids.

	Another area of strength for us is multiple sclerosis (MS). We continue to see the benefits from our flagship therapy, 

. Recently, we launched a new device, Betaconnect, which will add to the convenience of patients with this chronic degenerative condition.

	In the cardiovascular area, we are working hard to build sales and reputation for our recently launched drug, 

, which is indicated for patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)-a major source of costly repeat hospitalizations.

	I have an extensive background in the specialty medicine field, so you can expect to see Bayer moving further toward a portfolio focused on novel specialty medicines, including biologics intended for rare diseases. Innovation is what we do best. That’s what patients with high unmet needs are looking for.  And to me the best examples are Bayer’s trio of oncology drugs. Our latest, 

, is already embarked on a strong growth trajectory for its key indication in metastatic castration-resistant prostate cancer.  

	As noted, there are excellent potential synergies with our partner Orion Pharmaceuticals’ Phase III candidate, ODM-201, which shows potential in preventing progression to metastasis among patients whose cancer remains localized.  

	And we are testing a PI3K inhibitor that trial data indicates might be useful against third-line follicular lymphoma.  

	Putting it another way, Bayer is much more than aspirin. We intend to leverage all the assets we have in our three core fields -plant, animal and human health. Bayer, alone among its peers, is in a unique position to do 

	You will also see a much stronger approach to building our management team and their capabilities. This conforms to our existing commitment to make sure Bayer remains a great place to work. We make investments in people for the long-term, as long lead times are the reality in this industry.

 Reaching out to others seems to be an important value for you as a leader.    

 It certainly is. Right from the time I came to the US, I made it a priority to listen to our customers. Today, I have a meeting with a disease advocate to hear his view about dealing with patients with prostate cancer. What are the gaps in care and how do we fill the spaces where presently there are zero options for pharmacology? What specialized services can we provide that will foster a better patient experience with drug therapy? For example, together with a leading VC firm, Versant Ventures, we have  invested in a start-up called Inception 4 to expand our footprint in ophthalmology by looking at opportunities where the unmet medical need is very high. One example is childhood blindness, where there are no pharmacology solutions available today. These are deep conversations and they are designed to produce a result-for patients. 

What is your perspective on the role of teams in achieving operational excellence within the organization? 

 I spend a good deal of time monitoring the work conducted by our commercial teams. I see my task as setting a clear direction on goals and objectives, while standing back to bit to ensure the groups can think creatively and experiment, even if that means challenging the status quo. It’s this balance between the two aims that we want our teams to strive for.

In addition to investing for growth, are there any major initiatives underway to reduce costs? 

 Finding efficiencies on the operating side is an ongoing priority. But, outside of what we continue to expect from all of our managers in holding down costs, there are no specific initiatives that we feel are necessary at this time. My focus is on successfully introducing new assets to the market, maintaining our positions around existing products and listening carefully to patients and other stakeholders to find additional ways to serve customers and improve our competitive positioning. 

Can you identify a possible “disruptive innovation” that might impact the biopharma business model in the next five years? How might Bayer plan to address it? 

 The good news is that there are many such innovations to choose, as we work in an industry that thrives on innovation and applies it to meeting serious unmet medical needs. The challenge for the industry is to keep pace with the accelerating scientific progress or preferably to be a bit ahead of it. For example, I am particularly excited about the possibilities of gene therapy. 

	In December 2015, Bayer entered into a partnership with CRISPR Therapeutics to investigate the development of gene-based medicines for patients with serious blood disorders, eye diseases and cardiovascular conditions based on the CRISPR/Cas9 technology-a novel approach that allows detection and correction of genetic mutations, opening a new avenue to cure disease.  Blood, eye and heart diseases are areas in which Bayer is already focused, and so we plan to combine our knowledge and experience in these areas with the CRISPR/Cas9 technology and the existing expertise from CRISPR Therapeutics. 

	I’m also enthusiastic about our partnership with Dimension Therapeutics, based in Cambridge, MA, for the development and commercialization of a novel gene therapy for the treatment of hemophilia A. Dimension’s technology allows for systemic intravenous administration of the clotting factor gene 

, which has been shown in preclinical studies to target the liver, resulting in long lasting expression of the factor VIII protein at therapeutic levels. A lot to be excited about.

’s Editor-in-Chief. He can be reached at 

Pharm Exec sits down with Habib Dable, a 22-year veteran of Bayer, to discuss his few first months at the helm of the company’s US pharma operations, where he is leading Bayer’s repositioning as a drug innovator and advancing its “all-in” approach to product partnering.

Keeper of the Name: Bayer's Habib Dable

	Cancer is the ultimate test of a healthcare system’s ability to treat the whole person. Although specific clinical expressions around cell type, tumor size and disease stage remain important, the cancer community also confronts a larger “quality-of-life” dimension that, in addition to unresolved physical symptoms, includes the growing emotional, social and financial burden on patients that care providers fail to address.

 These often persist for long periods post-treatment, reinforcing another new feature in the complicated landscape of cancer: what to do about the needs of a growing constituency of cancer survivors, whose numbers are expected to surpass 15 million this year.  

	The experience of life with and beyond cancer was a strong undercurrent to scientific discussions at the June 3-7 annual meeting of the American Society for Clinical Oncology (ASCO), the world’s largest gathering of cancer practitioners and researchers. ASCO’s theme for 2016 was “Collective Wisdom: The Future of Patient-Centered Care and Research.” The two words were chosen carefully: “collective,” reflecting consensus for a multi-disciplinary approach to cancer treatment and research; and “wisdom,” which highlights the importance of bringing wider, value-based judgments to decisions on therapy.  

	What I saw at ASCO was a growing awareness of the harm of doing things to a patient that, while justifiable on clinical grounds, don’t add much to that patient’s quality of life. A “patient-centered” approach to treatment entails a larger sense of responsibility to the fact that a cancer diagnosis changes the life of every patient, often in profound ways. How to address those life changes-which lay outside the scope of standard medical interventions-is gaining more support as a target for future oncology practice guidelines, policy and research.  

	The push to this more inclusive perspective on what constitutes appropriate treatment within the continuum of cancer care is illustrated in the following three points, drawn from the ASCO proceedings:     

“Cancer survivor” is not just a term, it’s a movement.

 ASCO sessions on managing the transition from cancer patient to survivor were packed. As the number of survivors increase, long-neglected disciplines like maintenance therapy, palliative care and geriatric medicine require more funding support, not only among oncology practitioners but from medical insurers too. Cancer Care, a US NGO that provides support services for cancer patients, made survivorship a key theme of a new 3,000-patient survey, 

,  released at ASCO. The report found high levels of distress among younger cancer survivors aged 25 to 54. Drivers include impact of cancer on family life (48%); financial hardship (40%), with soaring out-of-pocket costs of cancer treatment now a leading cause of personal bankruptcy; ability to work (39%); and addiction to pain medication (38%).   

“Financial toxicity” is cancer’s biggest untreated side effect.

 ASCO released the final iteration of its 

, a tool to help practitioners and patients evaluate a particular drug treatment based on a weighted series of metrics on clinical benefit, toxicity and symptom relief. The result is an individualized scoring called the Net Health Benefit (NHB). Overall survival rates based on comparative clinical trial evidence gets the most attention under the NHB, but the cost of that therapy for the patient is explicitly incorporated in the calculation. Notes ASCO, “this allows for a personalized care plan reflective of the priorities of the patient, especially in considering the relative financial impact of his or her treatment options.” What’s novel about the Framework is that it is not a policy instrument but a prescribing decision aid to be applied in the practice setting. A software package for oncologists will be prepared for roll out of the Framework later this year. 

The ASCO meeting drew attention to resolving design, enrollment and execution bottlenecks in oncology clinical trials that limit reliance on data addressing the real wishes of patients.  New technologies like wearables were cited as an opportunity to leverage input directly from patients. ASCO also endorsed wider use of patient-reported outcomes (PRO) to ensure that pro-patient perspectives get a wider hearing in FDA drug labeling decisions. It promised to push for clarity on including PROs in the new Value Framework tool-for now, PROs are barred in the Framework because their use is too variable for accurate measuring. But many patient advocates beg to differ, contending that the current emphasis on hard, data-validated endpoints is negating the power and eloquence of the individual patient voice.   

	Cancer is testing the historic divide in medicine between what’s 

-all those promising new drugs-and what’s 

-that non-quantifiable mix of ingrained institutional practices and messy human behaviors that really shape the provision of care. Let’s hope we can bridge these two solitudes-it’s the best way that science can serve every patient.

From the Editor

Amid today's growing constituency of cancer survivors, oncology is testing the historic divide in medicine between what’s science and what’s social.

Worlds Beyond the Clinic

	The European Medicines Agency (EMA) has launched an innovative new scheme to enable “

dicines (PRIME)” to be developed quickly within Europe by facilitating closer collaboration between EMA expert committees and sponsor companies. PRIME is an advancement in European regulation of medicines. This program will bring the European Union (EU) closer to the FDA by facilitating early patient access to innovative medicines. PRIME, coupled with the new Clinical Trials Regulation, means Europe will secure its position as a key player for innovative medicines research. This article highlights several accelerated review pathways in the EU and US and discusses how they have evolved to benefit patients.

	A key factor for entry into PRIME is a company’s ability to demonstrate that its investigational treatment will improve a patient’s quality of life based on early clinical development data. The scheme consolidates the existing pathways for accelerated review of medicinal products in Europe, which include: accelerated assessment, conditional and exceptional marketing authorization, compassionate use programs, and the adaptive pathway to faster access. 

 of medicines reduces the review time within the centralized procedure for medicines designated by EMA to be of major public interest or a therapeutic innovation. Under the existing accelerated assessment pathway in Europe, companies approach the EMA at least six months before their marketing authorization application (MAA) is submitted to hold a pre-submission meeting to discuss their application strategy and again two to three months before their application is submitted. This initiative has not been enough on its own to drive access to medicines for patients with an unmet medical need, and very few products have successfully used this route in Europe, which may be due to its complexity and the regulatory expertise required to navigate the process.

 pathway in Europe is for products that treat, prevent, or diagnose seriously debilitating or life-threatening diseases; or are used in emergency situations; or for orphan products. In this process the applicant must demonstrate a favorable benefit-risk ratio and will commit to provide additional data to EMA on a yearly basis. A sponsor is able to discuss the possibility for conditional approval with EMA early on in the product’s development via scientific advice or protocol assistance. The Committee for

 Medicinal Products for Human Use (CHMP) can suggest a sponsor adopt this approval route if they feel it is justified. The sponsor will eventually provide all the data required for a full dossier post-approval, which differs from an exceptional circumstances MAA that is reviewed annually and does not require a full dossier of data. Conditional authorization has not been used by many companies as a route to market.

 in the EU for sponsors to make products available without an authorization for patients who have no other form of treatment and who cannot enter clinical trials. CUPs are governed by different member states in Europe, which separately may ask EMA to provide an opinion on how to establish a CUP for a product on a national basis. There are currently only five ongoing CUPs within Europe that have sought an EMA opinion; however, there are more in operation nationally. CUPs are not well publicized and may not be available to all patients who could benefit from them.

 pilot program in operation, which predates PRIME. The program was developed from the ADAPT SMART consortium in Europe to promote innovation and access to medicines. This group established the adaptive pathway as a pilot to allow companies to seek approval for medicines earlier in the development of their data package. This pathway allows companies to gain conditional approval and then gather data on a rolling basis starting with smaller patient populations, then expanding to 

more patient groups. Data are collated from real-life use of products to add to clinical trial data, and patient groups and health technology assessment (HTA) bodies are involved in an early dialogue to review the development of products. The EMA has received 34 applications for the adaptive pathway and 10 were accepted, highlighting the popularity of the program since 2014.

	Prior to the introduction of PRIME, only a few companies succeeded in accessing the fast-track assessment pathways in Europe. Since 2006, only 22 medicines have been reviewed via the accelerated assessment route and 28 products have received a conditional MAA. This is in contrast to the FDA accelerated assessment pathways, where 110 applicants were accepted into the FDA breakthrough therapy program since 2012 and 30 have been approved. 

	The FDA accelerated assessment pathways are fast track, breakthrough therapy, accelerated approval, and priority review. 

 review is for medicines that target an unmet medical need with a new therapy or improve existing treatments. In this review, there is increased access to FDA experts to discuss development plans and progress, and there is a rolling review of data for new drug applications (NDAs) or biologics license applications (BLAs). Successful applicants in the fast-track path may qualify for accelerated approval or priority review.

 is for medicines that show a substantial benefit to patients over and above existing treatments for a clinically significant endpoint (e.g., irreversible morbidity or mortality) based on clinical data already generated for the product (as early as Phase I and not later than Phase II). This program offers applicants the chance to speak to senior managers at the FDA and, if successful, they may enter the fast-track pathway. Breakthrough designation is very similar to PRIME and has positively influenced European regulators.

 in the US has been in place since the 1990s, but in 2012-two years prior to the EMA adaptive pathway-Congress solidified the FDA approach by approving the use of surrogate endpoints as a basis for product approval. The FDA requires Phase IV confirmatory trials for medicines approved via surrogate or intermediate clinical endpoints and can alter the approval of medicines based on Phase IV data. This process permits medicines that show a significant benefit to be given to patients quickly. 

 in the US is the culmination of the US expedited pathways. The FDA commits to review an NDA or BLA in six months, not the standard 10-month timeframe, if the product demonstrates a benefit to patients.

	Successful products in PRIME will receive support earlier in development, and the EMA will provide access to its expert committees and HTA bodies, which will improve the long term commercial prospects of PRIME medicines. PRIME provides an exciting development pathway in Europe to companies that struggle with the complex regulatory hurdles and development costs of bringing new treatments to market. The mechanism also heavily supports academia and small-to- medium-sized companies that can apply based on non-clinical and tolerability data at an even earlier stage of development. This supports all sectors within the biopharmaceutical industry, fostering faster and better access to innovative medicines within the EU.

 is Global Head of Regulatory Affairs at Novella Clinical. She can be reached at 

Columns

A look at how Europe's new accelerated drug approval scheme can evolve existing review pathways for the better-and take a page from FDA

Pharmaceutical Executive-07-01-2016

Transforming Technology: The Future of the CIO in the Life Sciences

Keeper of the Name: Bayer's Habib Dable

Worlds Beyond the Clinic

'PRIME' Time for Medicines in the EU

Pill Counters

Content Connection: The Push for Story-driven Engagement

Accelerating the Drive for New Antibiotics

Brexit Bombshell: Serious Implications for Pharma

Country Report: Italy, Part 2

Pharmaceutical Executive, July 2016 Issue (PDF)