’s annual look at what’s ahead for the biopharma industry, where we hope the eight trends singled out for this year capture the pulse of change and opportunity impacting leaders and decision-makers in the life sciences the most. From technology and digital health (see accompanying 

), to integration of healthcare delivery, to new-and big-competitors at the pharmacy level, to the tenuous countdown and aftermath of Brexit, these topics, profiled ahead and chosen with input from our Editorial Advisory Board, all represent key tipping points of sorts for the industry in the coming year. And with some, such as “emerging” biopharma, perhaps already tilted toward definitive change. Whatever the case may be, watching these areas unfold should be an interesting ride in 2019.

Vertical integration of payers, PBMs, and specialty pharma

Playing field for smaller biopharma has emerged

Gene therapies change pricing and payment model dynamics

Fight for Pharmacy: Amazon, Google’s immediate impact

Facing the realities of a ‘no-deal’ Brexit

Finding the Right Digital Health Partner

	Broadly, industry’s uptake and optimization of artificial intelligence (AI) technologies and data analytics has failed to match the hype that has surrounded the topic. While a September 2018 Frost & Sullivan report predicts that AI and cognitive computing will generate savings of over $150 billion for the healthcare industry by 2025, it also noted that uptake in healthcare IT has been slow due to strategic and technological challenges. So far, the 

 said, “only 15%–20% of end users have been actively using AI to drive real change in the way healthcare is delivered.”  

	With the industry moving tentatively into AI, 

tapped into expert opinion that suggests company activities in this space over the next couple of years could be crucial in forging their path ahead. Those who are embracing and seeking to understand the true potential of AI and data may see their efforts begin to pay off. Others may find themselves facing that ominous decision: “Adapt or die.”

	Mark Lambrecht, director of the health and life sciences global practice at SAS, told 

that he sees “a lot more realism coming along” from companies that began establishing in-house capabilities and data warehouses a couple of years ago, with company efforts now “maturing to the point where organizations understand what techniques they want to use,” with different architectures and technologies in place for different purposes. “They are following where the data is coming from and how it can help them move forward with clinical development or gain an understanding of what value their therapy brings to the market,” he adds.

	Smaller biotech and pharma companies continue to be more innovative, however. For companies with smaller budgets, “automation is definitely a big driver in making the best use of the data and AI-whether that’s natural language processing or image analysis or newer techniques.” Small companies “don’t have armies of people to manually filter out the meaningful signals,” says Lambrecht, “so they want to deploy AI techniques on those big data sets. That leads to more efficient ways of looking at information and helps ensure that their scientists are looking at high-priority problems.”

	While the absence of mature healthcare standards and the global variations in how data is structured and used remain “big problems” for pharma, there is positive news in that globalizing policies are driving harmonization, adds Lambrecht. “One example is the EU’s GDPR (General Data Protection Regulation), which is having an effect globally in the way that the people are thinking about patient privacy. One of the downstream effects will be data harmonization and standardization. Another example is that the FAIR (Findability, Accessibility, Interoperability, and Reusability) data principles, initiated in academia, are also becoming more important in the industry.” 

	Looking at the short-term future of clinical development, Lambrecht predicts that n-of-1 trials, or single-patient trials-randomized controlled crossover trials in a single patient-will come further to the fore from a data and AI perspective. N-of-1 trials investigate the efficacy or side-effect profiles of different interventions, with the goal of determining the optimal or best intervention for an individual patient using objective data-driven criteria. The hope is that every patient can have a specific therapy geared toward their genetic background and their disease, and patients can be matched with the right trial and the right therapies. “These n-of-1 trials offer the opportunity to gather a lot of data-genomics data, proteomics data-and do a lot of real-time analytics,” says Lambrecht.

	Indeed, he adds, we are reaching a point when no clinical trial will be run without first consulting real-world data. “It will be part of the whole clinical development effort, from modeling and simulation and predicting where you need to go with your trial, in terms of geography and therapeutic area, to really understanding what the medicine under investigation does for patients.” Using real-world data generated from an abundance of sources-such as video data, demographic data, claims data, financial data-“will help companies understand more about the average patient and create therapies that improve patient outcomes and are impactful for society,” says Lambrecht. 

	Video data, particularly, will bring more analytics activity, with “streaming analytics becoming more pervasive.” Lambrecht explains: “Take a hospital that is using a robot for a surgical procedure; a lot of video data comes from that. Streaming analytics can be applied to that video data to help support the physician as he or she performs the surgery. In a similar manner, streaming analytics can be used for clinical development. It will help companies to trim down and keep just the data and information that is relevant.”

	Margaretta Colangelo, partner at Deep Knowledge Ventures, notes that biopharma companies were skeptical of the disruptive potential of AI in drug discovery (AI in DD), but by 2018 were showing “more interest in the sphere.” However, she says, companies are still moving very slowly in embedding advanced AI technologies into their internal R&D processes. 

	“The majority of biopharma professionals did not have AI or well-developed IT technologies integrated into their education,” says Colangelo. “Although biopharma companies have sufficient budgets to hire really strong AI specialists to start understanding this field, they are the most resistant to adopt new AI in DD technologies.” 

	Noting that the industry famously takes a long time to make decisions, and even longer to transform its operating procedures in the face of new advancements and technologies, Colangelo adds, “Biopharma giants are just that-slow and lumbering entities, incapable of the kind of agility shown by the smaller and younger companies.” These smaller companies will continue to push advancements in AI in DD. Deep Knowledge Ventures expects, for example, to see 10–20 new AI in DD companies emerging in 2019, with the total number increasing from 125 in 2018 to around 140–150 by the end of 2019.  

	Colangelo points to generative adversarial networks (GANs) as the most significant AI technique to gain widespread traction in 2018. GANs pit a pair of neural networks with machine intelligence-one generative, the other discriminative-against each other in a “competition,” potentially producing outputs over time that are beyond human capability. While GANs have been used in the generation of images and music, in 2017, scientists from Mail.Ru Group, Insilico Medicine, and MIPT applied a neural network to create new pharmaceutical medicines with the desired characteristics. 

	GANs, Colangelo explains, “grew from an extremely new, next-generation technology at the beginning of 2018 to being embraced as the leading frontier of AI and deep learning-and the de-facto standard for modern, advanced AI-by the end of the year.” She predicts that in 2019–2020, GANs will be surpassed by the next generation of novel AI technologies, “resulting in new techniques that are as far advanced in relation to GANs as GANs are currently to normal recombinant neural networks.” 

	So far, only a “select few” AI in DD companies are applying GANs as a core part of their R&D processes, because the high level of expertise required means hiring very strong AI specialists-“a scarce resource in the industry right now,” says Colangelo. In order to survive in the coming years, the major biopharma companies will need to “reinvent themselves completely,” adopting AI as the core component of their R&D, allocating substantial budgets to hire the best AI specialists and proactively keeping pace with new AI advancements. 

	While a few existing biopharma corporations will prove capable of surmounting this challenge, “the rest will prove incapable and will be fated to die out as a result,” warns Colangelo. She adds, portentously, “No area of biotech and healthcare will be untouched by AI techniques. They will disrupt all niches entirely.”

Vertical integration of payers, PBMs, and specialty pharma 

	In early December 2017, CVS Health and Aetna announced their intent to merge in a $69 billion deal. Soon after, in March 2018, Cigna and Express Scripts announced their vertical integration at a $52 billion price tag. As of this writing, both mergers have yet to close. CVS Health/Aetna is much closer, having been approved by a number of state regulators and a divesture of Medicare Part D prescription drug plan business for individuals required by the US Department of Justice. Cigna/Express Scripts extended its merger deadline from December 9, 2018, to June 8, 2019, but has also gained some state approvals. While the extension now makes the vertical integration of payers, pharmacy benefit managers (PBMs), and specialty pharma too early to call a homerun 2019 trend, with the forward motion of the merger approvals and already set-in-motion programs by each of these PBMs, the impact of the vertical integrations on pharmaceutical manufacturers is well in sight. Outside of the big two, other integrations include UnitedHealthcare/OptumRx and Blue Cross Blue Shield with Prime Therapeutics. However, because Prime is owned by a number of BCBS plans but not all of them, it is slightly different.

	According to Cathy Kelly, who regularly reports on PBMs in her role as senior editor for 

, the newest mergers are not likely to result in significantly more members or covered “lives” for any of the players. CVS had already been managing some duties for Aetna’s pharmacy benefit along with its own internal PBM, and Express Scripts had recently lost Anthem as its largest client, so the addition of Cigna members more or 

	But what the combinations could lead to is a greater allocation of PBMs managing medical benefit drugs, rather than just drugs covered under the pharmacy benefit. Kelly suggests that with their ability to see the claims coming across the insurers database, the PBM insight into how to better manage or control the costs of the more complicated physician-delivered drug landscape, which is usually in the scope of the specialty drugs, is a potential. 

	On the other hand, one challenge for the PBMs involved in the pending mergers is that the combinations lose clients because of the actual or perceived competition. For example, insurers that don’t want to use Express Scripts as their PBM because of the Cigna relationship. 

	PBMs and manufacturers are bracing for a major disruption in the current system of drug contracting, with possible regulatory action coming from the Trump administration to restrict the use of rebates. In the meantime, the major PBMs are introducing programs that aim to reduce the reliance on rebates. The most apparent trend emerging that warrants pharmaceutical executive attention are those programs. 

, “PBMs have been taking a lot of heat the past couple of years over rebates.” And our own Editorial Advisory Board (EAB) suggested that the increased pressure on the PBM is leading many to challenge or question PBMs’ power in the supply chain. Kelly acknowledged that pressure is due, in large part, to manufacturers’ efforts. “The manufacturers have worked very hard on educating the public on how the supply chain works, how they have to build money back into their list prices to account for the rebates. They have done a very effective job.” 

	But PBMs came back swinging at the end of 2018, and seem to be swaying government opinion, if not public opinion. Express Scripts announced that as of Jan. 1, it will offer employers the option of using a formulary that would prefer lower-cost alternatives to expensive brands and would exclude the brands from coverage as a way to effectively lower prices without violating the terms of rebate agreements already in place. A press release stated, “The Express Scripts’ National Preferred Flex Formulary provides a way for plans to cover lower list price products, such as new authorized alternatives that drugmakers are bringing to the market and reduce reliance on rebated brand products.”

	The CVS response, announced in early December, is its new approach to pricing, called guaranteed net cost pricing, described in a press release as guaranteeing “the client’s average spend per prescription, after rebates and discounts, across each distribution channel-retail, mail order, and specialty pharmacy…with the guaranteed net cost model, clients continue to have the option to implement point-of-sale rebates to provide plan members visibility into the net costs of their medication.”

	As Kelly explains, both the Flex Formulary and the guaranteed net cost pricing are options for employers, so the uptake of the programs may not be known for some time. “PBMs are usually not forthcoming about clients, but these are high-profile programs, so they may want to put that information out there.” However, the net overall effect of the PBM programs, as well as their mega-mergers, will only start to be realized this year. 

	Will PBMs be able to improve their overall public perception in 2019? Again, time will tell. As Merck & Co. CEO Kenneth Frazier was quoted in this 

, “I mean no disrespect to anyone else in the supply chain, but I know how hard it is to make my 50 cents on the dollar. I have to invent something that’s never existed in the history of the world. And I have to ask my shareholders to be patient with their capital. I think that the system has got to change.”

Playing field for smaller biopharma has emerged 

	The FDA is now approving more drugs and biologics coming from companies that have never had an FDA approval before. 

Editorial Advisory Board (EAB) member Kenneth Kaitin, director and professor, Center for the Study of Drug Development (CSDD) at Tufts University, says, “The landscape is shifting now beyond the tipping point and what that means to the traditional drug development ecosystem. How do these smaller companies get feedback on development and on launch?”

, the FDA is also approving more new molecular entities (NMEs) that serve the orphan or unmet disease space, much of which is dominated by the biotech and smaller or emerging biopharma (EBP) market.

 tackled this topic, outlining the following facts: 

		Since 2002, pharma partnerships have been the largest funding source for biotech development, providing 44% of all biotech financing last year.

		Biotech products most recently accounted for 41% of annual revenue for the top 20 pharma companies. Author of the report, Ronald Evens, PharmD, adjunct research professor at Tufts CSDD, noted: “The biotech-pharma relationship is likely to grow, as the demand for innovative treatments to address a host of unmet medical needs expands.” 

		Biotech products now account for more than 30% of all new US drug and biologic approvals.

		From 2007 through 2017, biotech sales as a share of all company sales have almost doubled, from 23% to 41% among the top 20 pharma.

		As of August, Phase III clinical trials were underway on 532 biotech products spanning 264 indications.

		Biotech products accounted for 31% of the 457 drugs with orphan designations that have won US marketing approval since 1983, a share that is expected to grow in the medium to long term.

	With the increase in smaller biopharma launches and targeted therapies, the logical progression would be a lessened need for big pharma’s salesforce. However, the Tufts numbers don’t back that up. Sanjiv Sharma, vice president, North America Commercial Operations for HLS Therapeutics, and also an EAB member, says that big pharma will not lose its role, in that “they have the ability to break through the noise and if they need a Phase IV, where large pharma dominates in the KOLs (key opinion leaders), then that will still work. As a buyer or partner, large pharma still has the upper hand.” 

	While the traditional pharma market has covered its own bases with licensing, sales, partnerships, and the like 

with biotech and EBPs, where do the third-party providers meet the needs of the small achievers? Some speculate that because of smaller patient pools and more complex drug delivery requirements, these EBPs don’t require the level of scale that traditional contract manufacturing organizations (CMOs), contract research organizations (CROs), or market access offer. 

	CROs are facing a similar criticism that they have faced all along when contracting with smaller pharma, and that is the lack of attention if the company’s product portfolio is not large. Big pharma equals big CRO is the mantra, and the outcome of the preferred provider contracting relationships. This whole new world of biotech and EBPs that need CROs’ help for drug development is causing some concerns among their C-suites. As noted in this 

, based on a roundtable from CBI’s Finance and Accounting for Bioscience Companies conference held in Boston in late September, CFOs have common concerns of being billed for patient tests not even within their protocol or compounds relevance; not delivering on time or on budget; and requiring a lot more oversight than originally thought or planned for. CBI is hosting a 

 specific to EBPs and CROs oversight in Boston in early March.

	With all the forward motion with biotechs and EBPs and the clear positive performance with FDA approvals, the only challenge is in the markets. Les Funtleyder, portfolio manager for Esquared Asset Management, and EAB member, says, “The last two years have had record capital-raising for the biotech/emerging biopharma. If there is any volatility, or capital sources dry up, the ultimate downstream effect on large pharma would change.”

	The continued advancement of curative cell and gene therapies onto the market stage is clearly challenging traditional pharmaceutical payment and reimbursement structures, driving new strategies, and ultimately moving this topic well beyond simply the initial price-or wholesale acquisition cost (WAC)-of a treatment.

	While there remains many publicized developments focused purely on pricing, including the return this month of price hikes by several big pharma companies after holding the line on increases for a period last year amid pressure from the Trump administration; Medicare Part B drug reform, where the Centers for Medicare & Medicaid Services (CMS) is considering a new reference/“International Pricing Index” (IPI) payment model that would link reimbursement to the average price paid in foreign industrial nations; and more state laws passed seeking greater pricing transparency, at the heart of this issue, experts say, is the emergence in recent years of novel and expensive treatments with potential one-time administration and lifelong benefits. CAR-T drugs for cancer, other immuno-oncology and immunotherapy agents, gene therapy, and vaccines-many addressing orphan and ultra-rare diseases-have changed the paradigm of how the current healthcare payment/reimbursement system operates, one built on high-volume transactions. Curative-type products approved so far typically have front-loaded or high upfront pricing.

	 “[These drugs] are pushing the issue to, ‘how do I, as a payer, know that I’m actually going to get the value that you’re asking me to pay for this?” Debbie Warner, vice president, commercial consulting, Kantar Health, told 

	In 2019, the Institute for Clinical and Economic Review (ICER), which provides clinical and cost-effectiveness analyses of treatments and other medical services, will be examining that same question more closely as it applies to curative-intended therapies and whether it needs to adjust its value assessment framework accordingly. For example, should more latitude be allowed for the cost per quality-adjusted life year in certain cases? After mixed cost-value evaluations of gene therapies last year, ICER has taken some criticism for needing to update its framework to better gauge these kinds of therapies. 

	Ron Philip, chief commercial officer for Spark Therapeutics, which, in late 2017, won approval for Luxturna, the first-ever targeted gene therapy approved in the US, says new modalities such as gene therapy-in Luxturna’s case, a one-time treatment for inherited retinal blindness for patients with the rare RPE65 gene mutation-are disrupting the current healthcare ecosystem, where the tendency for most stakeholders is to get stuck on the upfront pricing element.  

	“When you think about the lifetime costs of that patient on therapy and compare it to a one-time treatment that [a company] gets a certain amount of money for upfront, the savings to the healthcare system could be tremendous,” Philip told 

. “We’re advocating for the changes that we think are needed in order to make these one-time therapies progress in a more viable healthcare system. …Our intention is to get coverage for the patient. Every day that goes by is one more day with the retinal cell that could be degenerating. Speed is of the essence for us.”

	Philip, a former Pfizer executive, who joined Spark in 2017, says the biotech is championing for changes in Medicaid best price and US price-reporting regulations, addressing aspects such as portability, which is when patients move from one health plan to another. Treatment durability-and restrictions on how many years out companies will want to structure durability reads-is also a concern when assessing one-time therapies. 

	Last January, Spark announced a list price for Luxturna of $850,000 per one-off treatment, or $425,000 per eye. To ease costs for patients and payers, Spark has a rebate deal in place with Harvard Pilgrim, which ties Luxturna’s cost to clinical outcome. Specifically, it will pay back 20% of the price in the form of a rebate if visual improvement objectives are not reached within two and a half years. Spark has also created what it calls Path, a flexible contracting arrangement between payers and treatment centers, where they can bypass the traditional buy-and-bill process, which can sometimes be taken advantage of in the form of price markups. In addition, Spark has submitted a proposal to CMS to allow Luxturna payments to be spread out over time. With commercial payers, Luxturna has 85% percent coverage, according to Philip, achieving that over a nine-month period. The last public update by Spark cited 50% coverage for Luxturna on the government side and the company plans to add more coverage in the coming months.

	Some believe Spark’s value framework for Luxturna, which was approved in November in Europe (Novartis will commercialize the product in that region), can serve as a model or blueprint for innovative pricing plans for curative-intended therapies. “It’s a model based on the current system. We, as well as other manufacturers, I think it’s safe to say, would like there to be a new model that would allow us to provide more flexibility to help address some of the needs within the healthcare system,” says Philip, noting, in terms of rebates, that Spark would like its one for Luxturna to be higher to “show to the insurers that we have good faith in this product,” but are constricted by best-price and average manufacturer price-reporting restrictions. “With anything else, when you’re bringing in a new innovation, the world takes a little while to catch up. We need it to catch up to fully value what these treatments are bringing to the landscape.” 

	Though not a one-time therapy, the accelerated approval granted by FDA in November of Bayer and Loxo Oncology’s targeted cancer drug, Vitrakvi, is another example of the sticker shock related to the costs of orphan treatments. Vitrakvi, the first-ever agent to receive a “tumor-agnostic” indication at the time of approval, treats patients with solid tumors that have neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. The oral version, according to published reports, is priced at $32,800 per month before discounts. Like Spark, Bayer provides access programs-one which refunds payment when patients don’t respond to Vitrakvi within 90 days, and another that provides reimbursement support and patient assistance services.

	Payers have also put new strategies in place to respond to growing orphan-drug expenditures. For example, a report in 

notes that insurers have employed benefit design changes to manage utilization and the cost associated with these products. Changes include formulary restriction and specialty tiers, shifting from copayments to coinsurance, and prior authorization.

Articles

Features

Pharm Exec’s annual look at what lies ahead for the biopharma industry in the coming months examines eight key trends that are seemingly at tipping points in their evolution and poised to shape the life sciences landscape in 2019.

8 Tipping Points: Pharm Exec’s 2019 Industry Forecast

 American-born David Meek, today CEO of Paris-based multinational Ipsen, takes stock of his two-plus years at the helm of the specialty-driven drugmaker-where through revamped leadership, fostering a biotech mindset, and promoting external innovation, he has helped Ipsen grow in the US and China markets, while looking for ways to boost France’s profile on the life sciences world stage 

partner PharmaBoardroom, whose “Country Report” series is regularly featured in these pages, spoke recently with David Meek, CEO of Paris-based Ipsen, where they discussed the pharmaceutical 

ecosystem in France, Ipsen’s bold global expansion and R&D transformation, open innovation as a cultural driver, and digital health, among other topics. 

	A New England native, Meek was appointed CEO of Ipsen in July 2016, relocating to the company’s headquarters in Boulogne-Billancourt, a Paris suburb. Meek came over from Baxalta, where he was executive vice president and president of its oncology division. Meek began his biopharma career at Johnson & Johnson and Janssen Pharmaceutica and also spent seven years with Novartis. He is a former officer in the US Army, and a graduate of the University of Cincinnati. 

You were brought to Ipsen with two specific tasks: transforming the company’s R&D activity and establishing a presence in new, high-growth markets like the US and China. What is your assessment of the progress made on these two fronts?

We have blossomed from our base as a French company into a growing international player within the areas of oncology, neuroscience, and rare disease. At the outset, we were very clear in our minds that we needed to unleash a profound and ambitious transformation right at the heart of the company that would equip Ipsen to face the future with zeal and confidence. This entailed reconfiguring the leadership team, instilling a biotech mindset, and nurturing a culture of external innovation with a view to driving our research, development, and commercialization.

	So far our efforts have met with success. Not only have we proved able to build a global organization and international presence across three hubs (France, the US, and the UK), we have also achieved therapeutic leadership in our target areas. Over the past two years, Ipsen and its partners have received six FDA approvals, four European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinions, six EMA validations/European Commission (EC) approvals, and one Medicines and Healthcare products Regulatory Agency (MHRA) approval. Moreover, we rank as one of the industry’s fastest-moving players. You will struggle to identify many other drug developers with over $2 billion in revenue that are expanding at a pace of over 20% per annum.

	We are very pleased with this growth profile, especially in the way that we are broadening our reach globally: the US market now makes up 25% of our overall business and our Chinese affiliate is also thriving. Our growth figures were over 21% in the first half of 2018, with over 40% growth in the US. 

	We have simultaneously made strides in optimizing our portfolio, having successfully launched two oncology indications within the past two years, with our third potential EC approval imminent. Even our established products, like Dysport®, which is the number two neurotoxin on the market, and Decapeptyl®, which was launched 30 years ago for prostate cancer, are bringing significant patient benefit and registering very healthy sales growth. 

How easy has it been to reorganize your top team?

Overall, I consider the biggest transformation within Ipsen has been the people and the culture. A pharmaceutical company’s fortunes are often determined by three core variables: people, products, and pipeline. When you have the right people and the right leaders, positive transformation can occur. What we have been able to do is reconfigure the leadership team, which we knew needed to happen if we were going to strengthen our R&D programs and pivot toward assuming leadership in our targeted therapeutic areas, notably specified areas of oncology with high unmet need. These new leaders, both within our executive

 committee and our broader global teams, have made sure that our strategy gets executed. 

Presumably, the dynamism and ambition that Ipsen is currently exhibiting is helpful when trying to attract top talent? 

That is precisely what is so exciting about working for Ipsen. Leaders gain the chance to come, drive progress, and bring game-changing medicines to patients. One of my first actions as CEO was to increase our ambition in terms of R&D productivity, raising the bar; so we are now shooting for one new NDA (new drug application) or meaningful new indication every year. That has given our team a sense of purpose in bringing drugs to patients and treating some of the world’s most serious diseases.

	Meanwhile, we increased the number of oncology experts across the R&D value chain; and also brought oncology expertise onto our radiopharmaceutical franchise, alongside nuclear medicine expertise. In the neurotoxin business, we’ve also been having great success in attracting world-class experts to work on our programs at Milton Park in Oxford (England), a site which has positioned itself right at the vanguard of designing next-generation recombinant toxins.

Practically, how have you gone about the arduous task of engineering a change in company mindset? 

It really all begins with the company ethos and collective sense of mission. We have a very clear vision-Ipsen is a global biopharmaceutical company focused on innovation and specialty care. This vision inspires the leaders and the leaders inspire the change. Ipsen has been a great company for many years, but our recent success can be largely attributed to our newfound resolve and sense of purpose. When you commit your company to being a global leader in biopharma, especially innovative care, the entire workplace really takes it to heart and they enact the change.

	We distinguish ourselves by placing the patient front and center. It can be difficult, from the standpoint of a pharma company’s headquarters, to flip the triangle upside down to where the patient is at the top and the corporation is on the bottom. 

	We need to start every day with the patients’ best interests in mind. With this kind of mindset, the “walls” that could be preventing corporate cohesion start to come down and we get what I call “a one Ipsen” in which we all work for the patients. Yes, we need each department to be functional, but working cross functionally, both internally and externally-with academic centers, other companies, etc.-toward what is in the best interest of the asset and the company. With that in mind, people collaborate more. 

	In an era of globalized drug development, the “one Ipsen” mindset is essential, ensuring a spirit of solidarity and joined-up action takes precedence; this has been one of my priorities. 

One of the elements of Ipsen’s R&D transformation has been the pivot toward “open innovation.” How has this come about?

We are built around a culture of open innovation. This approach is making us a partner of choice from early stage development and academic partnerships, through to late stage and product commercialization. Our external innovation strategy that we started to roll out a few years ago explicitly targets the volume of global partnerships that we seek to enter into. While we want to develop our own pipeline, we also strive to supplement it with external assets. At the same time, we are keen to help others bring drugs to the market. In particular, we are ready and able to assist companies that may not have the capacity to manufacture or commercialize their own new products. 

	So far, we have placed dedicated teams in three innovation hotspots-Boston, the UK, and Paris-and equipped them with “search and evaluate” capabilities for scouting out new partnership possibilities with biotechs and academia. By ramping up our hiring of physicians and PhDs, we are now able to deepen our interactions with these types of communities.

	Ipsen is completely agnostic as to where the innovation comes from. There will be instances when we realize that somebody outside the company has developed something better: a therapy that can be properly termed “best in class.” In such circumstances, we need to be comfortable and at ease with halting our own proprietary program and, instead, going after the best one because we realize that the patients, payers, and we, ourselves, demand the best. 

	Working with external partners helps keep us sharp. It renders us aware of all the great science that is going on out there, not just within small biotech companies, but within the large pharma companies, too. My belief is that the industry needs to reach a point in which you can walk into a room and you don’t really know where anyone works -and, moreover, you don’t care! Everybody is just trying to do what’s right for the patient. I think that if patients saw that, they’d be highly impressed. 

	After all, patients don’t look at a label of a drug and ask, “where is this made?” They just care if it does what it says on the tin. The country of origin or the manufacturer is an irrelevance to them.

How about your commitment to digital innovation and your partnering with actors like IBM Watson?

We are increasingly witnessing the incursion into the biopharma space of tech giants and software and gamification companies, as well as the increased role of AI as a disruptive technological force in drug discovery. There is a change of paradigm whereby one no longer needs to necessarily test a new treatment to produce data. We can start with data through automated biometric processes. 

	Ipsen’s digital transformation has accelerated since 2014, and the company intends to stand among the leading companies in this area, implementing three significant changes: speeding up drug discovery, improving patients’ and HCPs’ user experience, and inspiring a culture of digital innovation.

	The new digital odyssey begins, for us, in drug discovery, where we are harnessing digital means to identify the best drug targets. Our researchers look at data collected from various sources-for instance, real-world data collected from providers such as Flatiron Health-and identify what molecules or treatments will have the highest impact. We can also rely on data to answer some scientific questions, which in the past could be answered only by key opinion leaders (KOLs) and health specialists.

	We are simultaneously deploying AI and machine learning in drug development and clinical trials. AI can be a true game-changer not only in helping developers generate a targeted therapy, but also in forecasting drug failure. 

	I am convinced that by embracing digital disruption, we can massively upgrade and optimize our 

for drug development, diagnosis, prescribing, and care delivery. 

Furthering “patient centricity” has become a key tenet of Ipsen’s new vision. What does this buzz-word actually mean to you? And how do you measure your performance on this issue?

There really isn’t a quantitative way to measure our success with the patient, 

. The closest you get to such a thing is surveying advocacy groups. What Ipsen has done, though, is to appoint a chief patient officer, explicitly dedicated to ensuring the primacy of the patient and that the patient is positioned right at the forefront of all of our activities. In new drug development, for example, we are attentive to incorporating patient feedback loops early on in the process, with a view to rendering the delivery mechanisms as user-friendly as possible.

	As a company with a strong footprint in specialty care, we are compelled to establish strong relationships with our advocacy groups. Meanwhile, we have been working in conjunction with a coalition of advocacy groups, key centers, and regulators in trying to establish an infrastructure to support personalized precision medicine whereby treatments can be tailor-made to each patient’s genetic makeup.

You have been in your current role for over two years now. How would you describe your first impressions of the French market?

My overall impression is that all of the prerequisite ingredients for a great recipe are at hand. France demonstrates great potential for innovation thanks to the country’s excellent academic centers and hospitals, an educated workforce, a solid economy, and a strategic geographic location for business. This is a market that enjoys outstanding underlying fundamentals and, as such, France remains an attractive location for the entire industry from big pharma to small, innovative biotechs and startups.

	That said, those very same ingredients can also be found in some other places. The big question for France going forward is how the country can leverage these qualities to the maximum and deliver upon its full potential. Quite frankly, there are alternative ecosystems out there at the moment that are managing to achieve more with a comparable resource base and where the pace of advancement has been astonishingly rapid. At the end of the day, investment flows will always gravitate toward the markets offering the optimal value proposition, so there is no room for complacency if France, or indeed any country, seeks to remain in the game. 

What steps, then, should France take to properly deliver upon its true potential in life sciences?

There is no single, simple way to optimize the system. There is no magic fix or silver bullet. There are many different types of stakeholders in the mix and genuine collaboration will admittedly be tough to engineer. However, if we do not improve, others will continue to pass France by. As we sit, ponder, and deliberate, the world is not waiting for France. Believe me, I [recently] came back from a trip to China and they are not waiting for anybody. On the contrary, the Chinese demonstrate a formidable readiness to effect change very rapidly. 

	Frankly speaking, contemporary drug development is a tremendously hard task. It is a highly risky endeavor and the failure rate can be extreme. We, as an industry, cannot develop innovation on our own in a vacuum anymore. In the old days, a basic research laboratory and bench scientist could identify a molecule and commercialize it all within one company. That way of operating has categorically gone with the advent of cutting-edge, sophisticated biologics. Innovation now comes from all directions, and companies have to prove open to ideas from anywhere across the globe. Furthermore, collaboration between industry, patients, researchers, payers, and other actors across the care continuum is ever more critical as health systems battle financial constraints that can only be remedied by acting in concert.

	What we need is for the major stakeholders to band together and lay out a comprehensive vision for what the French life sciences community wants to become. What I, and many of my in-country peers, have in mind is for France to assume its place as an innovative center of excellence on a global standard where we develop drugs that benefit the entire world. I think that I can speak for many of my colleagues in the industry when I say that we are super motivated to bring this about. We want the other stakeholders to be equally motivated and energetic. We are going to need a serious private-public partnership to attain these goals. 

What was your feeling about the vibe at the Strategic Council of Health Industries (CSIS) in July, and French Prime Minister Edouard Philippe’s speech on the Macron administration’s agenda for the life sciences industry?

For me, it’s not about one speech, but the subsequent actions that ensue. If we follow through on the plans that we make, then we begin to establish credibility. Predictability has all too often been absent from the French ecosystem. There have been many false dawns. Having a clear sense of the future operating environment is not just a precondition for an enterprise to be able to formulate business plans and place big-ticket investments, but also for the researchers, the academic institutions, and the rest of the life sciences community to perform their tasks competently. If one part of the value chain says one thing, but then does something completely different a few months later, it compromises everyone’s productivity. 

	I think that what was said this summer at the CSIS was certainly encouraging and the posture of the new administration is rather more collaborative and pro-innovation than its predecessor. We’re looking forward to seeing this positive mindset in the social security budget bill for 2019 and the forthcoming decisions on government health policy.

As an industry, we strive to be constructive and are committed to helping to shape the future, but as commercial entities, we also have to be mindful of our capital allocation and take actions that we believe will help us bring great products to patients around the world as fast as possible. I would describe the present mood as hopeful and there is a general appreciation that we have entered a golden window of opportunity in which different stakeholders’ objectives are increasingly aligned.

It is rather rare to find an American leading a French pharma company like Ipsen. How have you dealt with being in this situation?

It certainly has placed me in a unique position. I actually hold the distinction of being the only American CEO in the entire SBF 120 (

Société des Bourses Françaises 120 Index

), the stock index provided by the Paris Bourse. Nonetheless, given my global experience with large multinationals and biotechs, as well as living and working in Italy, Switzerland, France, and Canada, and my familiarity with the mindsets and internal dynamics of these markets, I am pretty comfortable in such an international environment. 

	I am always keen to stress to people that Ipsen is a global company that happens to have a French headquarters and heritage. We are very proud of our 90-year history in France, but we have, over time, established ourselves as a multinational entity fit for taking on the challenges of contemporary drug development, which is an increasingly globalized endeavor. 

	The domestic market, though important, is only one component of our overall business. We have strategically established global hubs in Paris, the UK, and the US, and we are continuing to expand across high-growth markets in Asia. Meanwhile, part of my brief is actually to leverage my experience on both sides of the Atlantic to propel the company to the next level by deepening our presence in the US.

What are your main priorities, hopes, and aspirations looking ahead?

We remain at a critical juncture in our company’s life cycle. Understanding that our future strength is in drug development, we have set about trying to put in place a “light” research organization that recognizes that research can be done externally. We are changing the way that new treatments are researched, developed, and brought to market-pushing an open innovation approach, promoting partnerships, and involving patients every step of the way.

	Right now, we are firmly on track to meet our 2020 objective for group sales of over €2.5 billion, equating to over 30% growth over the next two and a half years. Our intention is to sustain this momentum by bolstering the internal pipeline and through the acquisition of therapeutic assets that fit with our strategy.

	Our future is bright. Our leadership and culture are strong. Our specialized portfolio of innovative and differentiated assets-combined with our strong clinical and regulatory skillset, will allow us to continue to expand indications across existing therapies and to bring new treatments to market.  

is the UK-based, independent publisher of 

In this Q&A, American-born David Meek, today CEO of Paris-based multinational Ipsen, discusses the drugmaker's bold global expansion and R&D transformation-driven by revamped leadership, a biotech mindset, and promoting external innovation.

Ipsen’s David Meek: Tasked to Transform

	It will be a challenge for FDA to match or exceed its success this past year in approving record numbers of innovative and generic drugs. These achievements reflect the ability of biopharma companies to capitalize on important advances in science, as well as strong support from the regulators in clarifying requirements and R&D policies. While FDA’s Center for Drug Evaluation and Research (CDER) will strive to further enhance its

 operations, it also will support initiatives to ensure that all medicines are safe, effective, and of high quality.

	Amidst these advances, CDER Director Janet Woodcock cites the importance of addressing the nation’s deadly opioid epidemic as FDA’s top priority for the coming year. The immediate need is to reduce the over 200 million outpatient prescriptions for these drugs each year. Recently enacted legislation instructs FDA to develop evidence-based prescribing guidelines and to explore how manufacturers can provide pain medicines in more secure packaging, Woodcock pointed out at the FDA/CMS Summit in December. At the same time, FDA will develop guidelines on developing non-opioid medicines for acute and chronic pain to improve treatment for patients. 

	Woodcock also aims to advance the safety and quality of medicines. CDER has launched a two-year program to improve oversight of drug safety, featuring new methods to evaluate the more than two million adverse event reports received this year on marketed drugs. The agency is pressing drug companies to comply more fully with good manufacturing practices (GMPs) through more targeted inspections and recalls for those failing to meet standards. 

	Drug compounding pharmacies and outsourcing facilities will remain in the spotlight, as FDA inspectors continue to find violations at these operations. A related initiative is to continue to implement requirements for tracking drugs through the supply chain to detect unauthorized medicines, an effort designed to have “a big impact on the gray market,” Woodcock commented. CDER’s Office of Pharmaceutical Quality (OPQ) will continue to seek more timely inspections of manufacturing facilities, a process that should be facilitated by a new inspection protocol for drugs, beginning with sterile drug manufacturing facilities. 

	These efforts may be enhanced by visible progress in industry implementing advanced manufacturing systems. Woodcock noted at the Summit that five firms have filed applications with continuous manufacturing components, and that generic drugmakers are moving in this direction. Other federal agencies support such efforts as a way to enhance surge capacity when additional treatments are needed to manage infectious disease outbreaks or bioterrorism attacks. 

	OPQ also aims to launch a structured approach to the manufacturing supplement review process to better manage product changes through the drug lifecycle. 

	An important goal for Woodcock is to complete the overhaul of the new drug review process to better manage CDER’s growing volume of applications. She recently named Peter Stein director of the Office of New Drugs (OND), and long-time CDER guru Bob Temple will become OND senior advisor, positioned to address the more controversial and difficult drug development and review issues. Woodcock hopes to finalize the OND reorganization by next summer, but it has been delayed by difficulties in gaining Congressional approval of a new user-fee program for improving the regulation of over-the-counter drugs. 

	Modernizing the review process will involve implementing new automation tools for managing drug applications, study data, and review documents under a “multi-disciplinary, issue-based review document” system. CDER also will continue to carry out provisions of the 21st Century Cures Act and reauthorized user-fee programs to further advance patient-focused drug development, expanded use of real-world evidence, novel clinical trial design, and added authorities to hire more experts needed to carry out these multiple drug regulatory programs. 

’s Washington Correspondent. She can be reached at 

Columns

CDER priorities for 2019 include opioids, quality, safety, and innovation.

Drug Research and Review Issues on Radar at FDA

	Pharma manufacturers are expanding their portfolios into digital health solutions. To find the right partners, there are a number of key considerations that inform their evaluation and selection.

	Depending on the key business drivers for a given digital health project (e.g., digital therapeutics, digital endpoints/biomarkers, remote monitoring, etc.), there is a typical structure and approach to take from project initiation to final selection of a partner. First, define the business need. This may be driven by a franchise team, a therapeutic area, or even an individual molecule or brand team and should include a preliminary view on the target geographies for launch. From there, establish an evaluation lead and form a cross-functional team. Typically, the leads are from the corporate business development function, but may also involve a procurement organization. To select the members of the cross-functional team, consider the nature of the business need to determine the mix of representation from: commercial, clinical, technical, legal, regulatory, and IT. This team is then accountable for any due diligence and evaluation activities.

	Once the team is formed, define the solution’s target product profile. This is especially critical for digital therapeutics where there is a clinical endpoint. For non-therapeutic digital solutions, this may simply be a requirements document. Once there is some product definition, perform a landscape assessment to look for any possible existing solutions, companies, or products that may be worth considering. Finally, establish the evaluation criteria and weighting, meet with the companies as a team, evaluate them against the criteria, and make a final recommendation.

	As part of the commercial strategy, define the business need and provide commercial input to the target product profile. Further, the commercial strategy should include a preliminary launch strategy that includes target markets and launch sequencing, and business models (e.g., standalone reimbursable solutions vs. brand-supportive solutions), to help guide other team members in their evaluation. Alignment with regional affiliates and their preliminary reimbursement strategies is critical at this point.

	For the clinical development aspects, evaluate potential solutions against the molecule/brand portfolio requirements and define the target indication for use and patient population. Establish the efficacy success criteria against a standard of care in the selected therapeutic area. Then, focus on assessing the clinical viability of potential solutions. This is critical when evaluating licensing or acquisition of existing solutions. Define a preliminary clinical strategy that describes the likely efficacy-directed and registration-directed clinical studies, and health authority registrations.

	The technical development team should evaluate the potential partner’s development organization, structure and development approach, as well as seeking evidence of their capability to comply with health authority and other standards and regulations (e.g., IEC 62304, ISO 13485, IEC 62366, ISO 14971, GDPR, HIPAA, HITRUST, etc.). Further, this team should evaluate the partner’s quality systems, design controls, risk management, and other lifecycle management processes and procedures. Key to digital projects is assessing the partner’s support of mobile OSs, handsets, browsers, etc. for clinical and launch platform support.

	The legal team typically focused on contracts and intellectual property at this stage. They define the licensing/purchasing strategy and evaluate the partner’s existing agreements and encumbrances. Define the preliminary IP strategy (e.g., patenting approach, trade secret expectations, etc.), perform a preliminary IP landscape evaluation based on the target product profile, and assess the relevant patents held by potential partners.

	The IT cybersecurity/data privacy team develops a preliminary solution architecture in order to understand the roles and responsibilities of each party and any data interfaces between the partner and the pharma company . This team should also evaluate the partner’s existing IT infrastructure to understand their organization, technical design, outcome of recent evaluations or audits, and generate a preliminary gap analysis against the pharma company’s corporate/global standards.

	Due to the novelty of the some of these digital health solutions, there is often a lack of regulatory clarity in many markets. The regulatory team should develop a preliminary strategy based on the target product profile to establish: is the solution regulated as a medical device; the registration strategy (e.g., 510(k), CE Marks, 

, etc.) A thorough evaluation of the partner’s regulatory capabilities and capacity is critical to determine how much of the regulatory work the pharma team must own.

	As digital health solutions proliferate, pharma is taking an increased interest in partnering or acquiring technologies that are synergistic with their portfolios. As such, it is critical for pharma to define the business need and strategic approach in order to guide a cross-functional team in the evaluation and selection of technology providers and solutions. While the regulatory framework is unclear in some cases, we have an opportunity to shape the environment to enable these technologies to transform our industry.

is Director, Smart Device Technology Center, Roche/Genentech

Pharma companies are increasingly expanding their portfolios into digital health solutions. To find the right partners, there are several key considerations that inform their evaluation and selection.


Finding the Right Digital Health Partner

Leaders at Novartis share how the big pharma is laying the foundations for a potential new operating model as a "medicines and data science company"

	At the beginning of 2018, Novartis CEO Vas Narasimhan spoke of reimagining Novartis as a medicines and data science company. The drugmaker was sitting on a “goldmine” of vast datasets, “built from having conducted countless studies in thousands of diseases.” Taking advantage of this “wealth of clean, curated, longitudinal, and interventional data,” Narasimhan explained, “has the potential to completely transform the way we develop medicines.” 

	Novartis had already begun signaling its commitment to the plan with a series of high-profile appointments of data science experts from outside the industry. In August 2017, the company hired Bertrand Bodson to the new role of chief digital officer. Bodson had no pharma background; he had previously served as chief digital and marketing officer for the UK retailer Sainsbury’s Argos, where he played a pivotal role in guiding the company’s digital transformation from a


	catalogue business “into a multichannel online powerhouse with more than a billion visits online annually.” Earlier, he had spent three years as Amazon’s senior group product manager. “The pharma space in particular is ripe for disruption,” Bodson commented in October. “Looking forward, data science will drive more of our decisions and more of our programs-including our medicines-will be digital.”

	Following more appointments of data experts from outside the industry in 2018, 

talked to two key players in Novartis’s push for digital transformation-Mimi Huizinga, vice president of strategic data and digital, and Miriam Donaldson, head of HR Digital-about how this influx of new talent is fueling a cultural change that is set to define the future of the drugmaker’s data science activities.

Can you outline Novartis’s mission to transform itself into a medicines and data science company?

Novartis associates are learning to be data curious and more agile in how they approach their work. We are seeking ways to use data and digital to support every aspect of the company-drug discovery, trial planning, manufacturing, commercial operations, talent management, and many more. It is truly a transformative time. 

Through our digital transformation, we aim to be the leading medicine company powered by data and digital. If you look at external research about what leads to successful digital transformations, a common theme is capability building. This is a priority for us as well. We are looking at capabilities across three different populations at Novartis: all associates, our leaders, and our digital practitioners. We are building different capability solutions for each, as they have different needs from general awareness and understanding of the potential of digital to leading teams who feel empowered to experiment, to having world-class data and digital expertise.

	Importantly, we want to encourage all of our associates to be curious, and feel comfortable around data and digital, and help us to see how these things can work better for us. We need to set them up for success to be part of that journey, so investing in their digital awareness and capabilities is really critical.

What are the challenges in achieving this transformation? And what advantages do you have?

: We want data and insights to drive our digital solutions, but healthcare data is difficult-the data is siloed with no single source of a complete, longitudinal record. This means that we have to deeply understand the data and its limitations to ensure we use the right dataset for the question at hand-and that our analytics help to minimize the risk of false conclusions from the inherent biases in the data. We are not able to understand patient barriers in the care journey as rapidly as we would like and that slows our development of potential digital solutions.

To lead a digital transformation, you have to be comfortable with failure. You have to be excited to experiment, learn from what works and what doesn’t and then act on it. You have to do it quickly and build solutions that you can scale. But that’s not the culture we’re starting from at Novartis. We have to help shape an environment where curiosity can really thrive and we have leaders who support their teams, not by telling them what to do but by creating a space where they can experiment and learn and not be frustrated if things don’t work the first time. Novartis is also transforming from being a collection of seven interdependent companies into one integrated company. This idea of building solutions that scale across Novartis is new for us. There’s a cultural aspect to this as well, we’re moving from rewarding individual heroes to teams that systemically solve problems and design innovations that scale.  

Novartis does have many advantages-our mission, our people, and our commitment to data and digital. As an MD and former epidemiologist, I joined Novartis because of the core focus on patients. That focus really clarifies how we make decisions and set priorities. There is a fantastic set of data, analytics, and digital experts within Novartis. We are working now to create more connectivity across the company. Finally, having leaders that understand the importance of data, analytics, and digital makes a tremendous difference.

You’ve made key new hires from companies such as Google and Amazon. Can you talk about the importance of hiring from other industries?

We approached this as choosing people with the portfolio of skills and experiences that will be important for the transformation. It started with the hiring of Bertrand Bodson as our first chief digital officer, who came from Amazon and retail, and had no experience in pharma prior to joining Novartis. For other key roles, such as our head of data strategy and head of data science, it was important to us that the folks we hired at this level had experience leading transformations. 

	That’s what led us to Raj Patil (head of data strategy) and Shahram Ebadollahi (head of data science and advanced analytics). Raj, for example, worked in the financial industry, which is also highly regulated and has some of the same challenges. He had successfully built data strategies in several banks and also worked at Google. Shahram helped to build the IBM Watson Health organization, a 4,000-person team. Through his work there, he experienced many of the use cases we are looking to address and has learned what works and what doesn’t. We believe that pairing that experience with our incredible in-house team of healthcare experts is going to be a powerful combination. Possibly most important with both of these leaders is that they have leadership styles consistent with the culture we aspire to and which we feel will engage our teams to work together in new ways to innovate in data and data science in close partnership with the business. 

	With the new talent we’re acquiring, especially in the data science area, the questions we ask ourselves when they come into the company are: How do we set them up for success? How do we help them to understand our organization while also asking them to help evolve it? We’re not trying to build a separate digital business, we want to transform our business using data and digital, which means integrating and influencing both what we are doing and how we do it. Specifically, we’re focusing now on how we elevate data science at Novartis, which in the past has maybe been viewed more as a supporting function to our clinicians, and other types of scientists and reposition the organization as a true strategic partner to the business.

What specific initiatives and policies are you implementing to drive technological and cultural change?

Broadly speaking, our activities fall into three buckets: data, analytics, and impact. For data, we are seeking to optimize the use of internal and external data while looking for new types of data that might provide value. We are working to organize the data and enable access to all appropriate employees while keeping data privacy top of mind. In the analytics bucket, we are automating our core analytics so that we can free up our analysts to think about the business issues and more complex analysis. We are also using artificial intelligence and learning how to industrialize AI models in our daily work. In order to see impact, we use design thinking concepts to ensure that results are meaningful and that visualization tools are intuitive. We also look to see how we can automate pull-through and build digital solutions that fit within an associate’s workflow and support the patient journey.

	I am working to promote a data curious culture in our US Oncology group. I work in all of the areas-data, analytics, and impact. I love seeing the “ah-ha” moments and hearing about how we helped someone think differently about a potential opportunity. My job is to ensure that when we build the data infrastructure or the analytics framework, that it will be able to meet our evolving needs three to five years from now. To do that, I have to understand our business strategy and be able to translate the commercial and medical leaders’ needs to our IT and analytics colleagues. On any given day, I may have conversations about our metadata management plan, detailed review of a Markov model we are bringing into production, brand level launch strategy, real-world evidence needs for a cost-effectiveness model, clinical trial feasibility, ideas for our next visualization product, and our website content management strategy. All of this makes my job challenging but very fun.

One of the things we’re doing in our capability-building is around teaching our leaders how to help teams who need to work differently, such as agile working, which has been really important in software development in other tech companies. It’s a completely different way of organizing teams and pursuing the work that needs to be done. This is one of the ways that we’re trying to get teams more comfortable with the rapid innovation cycles, customer-centric solutions, and building solutions we can scale. 

	For things this agile to work at Novartis, our leaders need to lead differently. We’re building a program that we call Digital Immersion for Leaders, which is a three to four-hour experience for teams. It’s kind of a “choose your own adventure,” where we build cases around different scenarios at Novartis. We show leaders how digital is already changing the work we are doing and provide them with some leadership challenges, so that they see the impact that they have on teams who are trying to innovate, and work in the way that we aspire to-and all while seeing how these solutions address their real business challenges. We launched a beta version of this program to our top 300 leaders back in September, and we will be rolling it out to the larger company over the next several months.

How will the next couple of years play out in terms of the transformation?

Now that we have our heads of data strategy and data science onboard, we are ramping things up quickly. So, I expect in 2019 that we’re going to be making a lot of hires in that space. And as our associates, leaders, and practitioners benefit from our investments in their capabilities and our culture and ways of working evolve, we think it will feel really exciting to work at Novartis. Almost every element of our business can be touched by this transformation, so that we can make smarter decisions based on data that help us bring meaningful medicines to patients faster. 

I have been amazed at how much we have accomplished since I joined in August 2017, but that work was largely foundational. We have really gained momentum over the last three months. We have a few tools deployed to the business and great engagement of our leaders. We are planning to launch an internal visualization tool [this month] that will provide deep insights to our commercial leaders. Our goal is that these tools will help the leaders ask better questions faster.

	We have industrialized one AI model and over the first half of 2019, we will be testing the limits of that model to understand when we need to refresh and rebuild. We will also place the outputs of a second AI model into pilot mode during that time.

	By mid-2020, our goal is that everyone in US Oncology will have a unique visualization product that supports their work and that stems from a common set of data and analytics.

European and Online Editor. He can be reached at 

Leaders at Novartis share how the big pharma is laying the foundations for a potential new operating model as a "medicines and data science company."

Future Pharma: Data Science as a Strategic Partner

	Today, reports of organizations mishandling data are as common as political scandals or celebrity feuds. Yet every revelation about Facebook’s treatment of consumer data always seems jarring. The company, positioned as a champion of friendship, connection, and community, has been repeatedly exposed as the mammoth tech machine that it is. It is this unsettling juxtaposition that has sparked consumer, political, and media outrage. And it all starts in the uncanny valley.

	The uncanny valley is the eerie point at which machines take on many human characteristics, but still can’t quite pass for being human. Think Transformers versus Disney’s animatronic Hall of Presidents: the former are clearly identifiable robots, the latter awkward approximations of humanity, inner-workings masked. Like Facebook, many of today’s companies are feverishly trying to become more like people, despite being anything but.

	In attempts to be more relatable, brands are focusing on developing 

, while sweeping activities like data collection under the rug. The problem becomes magnified when it involves healthcare companies – organizations that trade in some of the most sensitive and intimate information. Trendy healthcare startups like Hims and Roman may have cheeky advertisements, but according to a recent article in 

, the consumer data they collect “can still be sold to data brokers or used for third-party marketing services if anonymized, which could allow tech giants like Facebook, Google, and Amazon to make their ad targeting algorithms even more scarily accurate by incorporating huge swaths of medical data.” The article further explains that the websites for these brands have either Facebook social plugins or Facebook tracking pixels, allowing the platform to track how frequently users visit. The contrast of these companies’ playful marketing tactics with their hidden data capabilities produces the same uneasy feeling that robot Abraham Lincoln does.

	One positive aspect of these newer brands is that they lean into consumers’ growing involvement in their own healthcare. From ordering home-delivered medications and supplements to tracking activity via wearables-not to mention having access to countless resources, articles, and forums online-people are now able to question established practices and take control of their care. While the healthcare industry clumsily attempts to be more human, consumers are becoming more industrious about caring for themselves.

	Perhaps it’s this independent care and tracking of personal data that has shifted the public’s perception of larger companies. Ernst & Young’s 2013

 report, which deftly predicted the end of the “Golden Age” of free data at 2018, found that 78% of consumers believe companies collect personal data to make money, rather than to make improvements for their customers. Despite this cynicism, the fact that they

Being more human in brand engagement doesn’t mean being less transparent

Pharmaceutical Executive-01-01-2019

8 Tipping Points: Pharm Exec’s 2019 Industry Forecast

Ipsen’s David Meek: Tasked to Transform

Drug Research and Review Issues on Radar at FDA

Finding the Right Digital Health Partner

Future Pharma: Data Science as a Strategic Partner

Ascending the Uncanny Valley in Healthcare

Pharmaceutical Executive, January 2019 Issue (PDF)

Country Report: Turkey

Don’t Ignore These Trend ‘Leftovers’