Sandeep Kishore, HCL Technologies, explores digitalisation and the role that a Chief Digital Officer can play in leading digitalisation projects.

Everywhere you look businesses are being reinvented and rejuvenated, utilising new technologies and tools in an effort to tap into the digital advantage. This process of digitalisation is as unstoppable as it is irreversible; businesses are investing heavily to stay afloat in the new digital age. As such, digitalisation has moved way beyond high-concept discussions at the board level, to the creation of detailed roadmaps and the implementation of new ways of working and service delivery. This change is bringing with it the ability for businesses to create unique customer-facing experiences, whilst driving greater back-office efficiencies.

Spending on digitalisation over the remainder of the decade is forecast to be enormous; contributing to over 80% of incremental IT expenditure. Indeed, IDC estimates that spending on cloud, social, mobile and analytics technology will reach around $940 by 2017. The compound annual growth rate is set to be three times greater in comparison with spend on traditional IT over the same period. This level of investment indicates that digital technologies will clearly have a major direct impact on businesses in the coming years.

Playing with the new kids on the block
Those that are most well suited to thrive in the digital era are perhaps unsurprisingly those businesses that were born digital and have none of the legacy infrastructure of more well-established companies. The savviest enterprises are looking to tap into this expertise, by working with native digital companies to better deliver unified, reliable and seamless customer experiences across a multi-platform environment. Furthermore, this approach can help to ensure better integration with suppliers and partners, such as payment providers; which delivers further operational efficiencies.

For example, in the media and entertainment industry, Netflix has emerged as an alternative to regular satellite and cable television services. For a fraction of the cost of the traditional alternatives, subscribers are able to watch any number of shows, at any time, on any screen. The success of this model speaks for itself; Netflix currently has 44 million subscribers globally. Low pricing is of course a key factor in this success, but just as importantly, Netflix is using analytics to deliver customised recommendations to each subscriber, suggesting additional content they may enjoy based on their viewing history. All this is made possible by cloud computing; which enables Netflix to deliver a previously impossible to achieve standard of service at such a low price without jeopardising its profits.

Enter the Chief Digital Officer
Of course, it is no mean feat for a traditional enterprise to achieve full digitalisation. There must be a significant commitment from within every level of the business to ensure that all teams are working towards a shared vision and goals. This means that the CEO and board-level executives must have direct visibility over the process to ensure the necessary levels of support and investment are made available.

In order to facilitate this process more effectively, many organisations have created the new role of Chief Digital Officer (CDO) to oversee digitalisation. The CDO is responsible for developing a clear roadmap for the enterprise in its transition to the digital era; clarifying the role of every business unit and securing the buy-in from each individual.

As you would expect, IT has a significant role to play on the road to digitalisation for any organisation. The IT team will be responsible for modernising applications and integrating all data across the enterprise. They must also enable access to the corporate network and resources through mobile devices, build cloud platforms and enhance the security architecture to enable all of this without introducing new vulnerabilities. It is also critical to ensure that users receive a consistent experience across all enterprise services; so digital architects and product strategists too have a significant role to play.

Of course, digitalisation is not a silver bullet to solve all of an enterprise’s problems. There is also no simple, one-size-fits-all approach to rolling out a digital strategy. Those beginning the journey to digitalisation must consider the individual circumstances of their business and identify the desired impacts and how they can best be achieved. This is a strategic decision and will need the involvement of the highest echelons of the company. It is also important to consider which functions can deliver the greatest value in the short-term, who will take the lead and whether it will be necessary to hire new talent to better oversee digital best practices.

It must also be decided whether to start by digitalising customer-facing services to improve their experience, or back-office systems to create greater efficiencies. Perhaps most importantly, businesses must consider how the culture of the organisation will need to adapt in order to deliver the best impact from its digital revolution.

Digitalisation is a continuous journey and will be a long-term commitment for those embarking upon it. However, it has huge potential to deliver significant business benefits and create strong competitive advantages in today’s challenging environment. Digitalisation is therefore not so much a choice as an imperative. Ultimately, it is a simple evolutionary principle; businesses will either adapt or die as the digital age continues to surge forwards.

By Sandeep Kishore, Corporate Vice President for Life Sciences, Healthcare, and Public Services, HCL Technologies

In an article titled, “How big data can revolutionize pharmaceutical R&D”, the McKinsey Global Institute estimates that applying big-data strategies for better informed decision making could generate up to $100 billion in value annually across the U.S. health-care system, by optimizing innovation, improving the efficiency of research and clinical trials, and building new tools for physicians, consumers, insurers and regulators to meet the promise of more individualized approaches.

A lot has been inked about the pharma and healthcare industry lagging behind the retail and financial services industries in the use of big data.  Our premise is that deep data, and not big data, is critical for healthcare.  Deep data is about combining the relevant data streams with domain knowledge and analysis, not merely pursuing data acquisition while hoping that “insights” emerge from correlation.  With the availability of new data streams like clinical trial performance, climate, adverse events reporting, personal medical devices, and more, the trick is to identify value in these data streams and merge the appropriate streams to gain new insights.  Determining value in the data streams and knowing which ones to merge requires domain expertise to visualize the use-cases.

When improving clinical trial efficiency, the key focus areas would be site selection, investigator selection, and patient recruiting.  Clinicaltrials.gov is an important data stream that provides a rich view of various trial sites, study parameters, investigators and site performance.  Mapping the competitive activity for trials can be built to identify white spaces for site selection.  Fig 1 below shows the trial locations for various solid tumor studies being conducted in California for a Sponsor and its competitors.  While the Sponsor seems to be active in Southern California, the competition seems to have a higher density of locations in Northern California.  If we were to drill down further and examine the number of studies per location being conducted for solid tumor (Fig 2), it presents a totally different picture for the Sponsor.  Competition is conducting more studies at the same or similar locations as the Sponsor, which could lead to challenges in patient retention.

Source: Clinicaltrials.gov, HCUP California 2011

Taking the next data stream – Hospital Discharge, can help identify patients with tumors at various hospitals (Fig 3).  When this information is overlaid on the trial sites, we can evaluate potential sites with lower competitive density.

Investigator performance can now be evaluated based on study parameters and trials across competitors.  When data streams across Clinicaltrial.gov and social media are combined we can get a fair measure of investigator experience (Fig 4) and any compliance or regulatory issues (Fig 5)

Fig 4: Investigator Experience

Fig 5: Compliance/Regulatory Issues

Domain knowledge is critical in creating the problem statement and evaluating data streams for incremental gain.  Deep data allows for an optimal way to structure problems, analyze data and evaluate results, as opposed to the big data approach of hoarding data and performing analytics to get insights.  As seen in the above example, while Clinicaltrial.gov is a thin data stream, its content allows for rich evaluation of competitive and investigator landscapes for trials.  Layering additional data streams like Hospital Discharge, the FDA site and other social sites allows us to build a nuanced view of potential sites/investigators for trials.  Similarly, deep data techniques could be utilized for better targeting of physicians, hospital key account management and patient therapy adherence.

Dynamic changes in legislation, patent expiry of block buster drugs, and increasing healthcare costs call for significant changes in the global pharmaceutical industry. These changes are driving pharma companies to explore pharmerging markets for personalized medicines, biopharmaceuticals and biosimilars, which are opening up opportunities for further growth. The pharmerging markets offer tremendous opportunities for pharmaceutical manufacturers facing mounting pressures in developed markets.

IMS defines pharmerging countries as those having more than $1 billion in spending growth from 2012 to 2016 and a per capita gross domestic product of less than $25,000. A few of the 17 pharmerging countries include China, Brazil, Russia, India, Latin America and others.

Global pharmaceutical sales are expected to grow about 3% annually from $955 billion in 2011 to nearly $1.2 trillion in 2016, with 17 pharmerging countries. These countries are estimated to represent 30% of the total sales in 2016, up from 20% of the total in 2011. The BRIC nations will account for $248 billion in pharmaceutical sales by 2016. It is anticipated that as economies grow and mature, they begin to spend more on health related issues.

Global pharma majors have been witnessing sluggish growth in developed markets and as part of their strategic vision they have made significant organic and inorganic investments into emerging markets in recent years.

In the recent decade there have been focused investments on China, Brazil, Russia and India, which has started yielding results. Some of the world’s leading pharmaceutical companies have already started realizing more than 25% of their growth from pharmerging markets.  All of the top 15 global pharmaceutical companies are accelerating efforts to strengthen their presence within them – either through R&D investments, licensing deals, co-marketing, and mergers and acquisitions.

One clear, outcome is that Pharma companies are very keen to make inroads into pharmerging markets. They also understand that a well-planned strategy with a good understanding of new regulatory norms is absolutely essential for long term success.

With dynamic changes in the regulatory norms being set by individual nations, data management and regulatory submission is becoming increasingly complex and would be a major challenge to pharmaceutical companies going forward. To overcome these challenges and avoid rejection from regulatory agencies, Pharma companies are today exploring options for a unified data management and submission platform /tool especially for managing data for pharmerging markets.

References:

http://www.dddmag.com/articles/2012/10/pharmerging-markets-drive-future-sales

http://www.imshealth.com/imshealth/Global/Content/Pharmerging/Document/Launch%20Evolution%20Across%20Pharmerging%20Markets.pdf

B2B marketing has been viewed as the process of marketing one’s offerings to corporations in contrast to B2C marketing which targets and markets to end consumers directly. Consequently, B2B marketing is thought to be bland and lacking in glamour compared to B2C marketing. While these notions have generally held true for a long time, B2B marketing as a practice has come a long way in the past ten years. Like so many other areas, B2B marketing has been significantly affected by the rise and proliferation of the internet. Several B2B industries have progressed from being oligopolistic to a state of healthy competition. B2B companies have had to adjust to this evolution, with the successful ones embracing the changing times, and sometimes, capitalizing on them.

A number of B2B companies such as Google and Alibaba have become household names. Intel is one of the most reputed and widely known brands. However, the myths associated with B2B marketing have continued, which I will humbly try and bust one by one.

Myth 1 – B2B marketing is not cool

Elon Musk’s SpaceX corp is a B2B company, which is founded on a vision to colonize Mars. This vision, coupled with a smart marketing strategy to get mindshare by leveraging the right forums, has made SpaceX one of the most admired brands in the world, and one of the coolest ones, too.

As compared to B2C marketing, B2B marketing deals with products and offerings that are often complex, which limit the number of buyers and decision makers. However, constraints are a seedbed for innovation. Intel entered into a deal with the football club FC Barcelona to have their logo inside the jerseys of the players – Intel Inside!

Similarly, when we realized that information dissemination could prove to be one of the challenges for two of the biggest verticals at HCL, we decided to take the whole content ecosystem to a mobile platform by launching state-of-the-art mobile apps which can be used by the customer as well. This is a first for the industry, which we expect will become the norm in years to come.

Myth 2 – B2B marketing is not active

The reasons why B2C marketing seems a lot more active than B2B are two-fold. Firstly, B2C marketing is targeting a large mass of customers at a go, and secondly, you are one of those customers.

B2B marketing is concerned with reaching the right audiences, and for those audiences, we are as active as we can be. We understand that 60% of the buying process is complete even before the customer meets a sales representative, and we strive to build a brand that helps us during the customer’s due-diligence process. At HCL, we work on a host of activities such as positioning, thought leadership, account-based marketing, digital and social, PR, and analyst relations. Speaking of positioning, we also invest a lot of effort in accurately segmenting our customers and striking the right positioning for us in the market. HCL’s Life Sciences and Healthcare vertical recently transitioned from a benefits-driven positioning to an emotional one.

Myth 3 – B2B marketers cannot do everything a B2C marketer can

A marketer is guided by the nature of the business and the people he/she is trying to reach. On these counts, B2C marketers do have a bigger playing field. At the same time, over the years, some of the biggest brands have been built in the B2B segment. IBM has proven to be one of the few technology brands that have stayed relevant over the years. ‘Smarter Planet’ is one of the most resonating positioning statements of today’s times. Caterpillar’s equipment playing a game of Jenga was one of the most viral videos of the year, and it fit like a glove in their value for precision. GE is a brand that has become the benchmark on newer social media platforms like Pinterest and Instagram. There are also a few things that B2B can do better. Marketing to a limited yet decision-making set gets HCL visibility right at the top level. For example, we got a chance to engage the CEO of one of the world’s leading pharmaceutical companies, which for us is the holy-grail of marketing.

Myth 4 – B2B marketing is about corporations and not people

It is a cliché but also true – corporations do not do business with corporations, people do business with people. A B2B marketer, just like his B2C counterpart, needs to understand the people who he is addressing. He needs to know their drivers, motivators, tastes, preferences, and the entire demographic and psychographic profile before planning a custom outreach plan.

At HCL, programs like CARS (Customer As A Rockstar) take this factor into account. We also ensure and keep in touch with the various influencer communities. #CoolestInterviewEver was a groundbreaking innovation on Twitter, where the entire recruitment process was conducted on Twitter; how’s that for transparency? Our Relationship Beyond the Contract (RBtC) Coffee Table Book is a unique asset which is aimed at the leaders of various organizations to directly engage them.

There are different ways to market a company. All companies do not need to spend money on Superbowl advertisement slots or YouTube campaigns for people to know about them. Elon Musk’s SpaceX is a fine example of this, with the mission and vision of the company ensuring that people talk about it. At the end of the day, a marketer – B2B or B2C – can only succeed if he understands the product and the customer thoroughly and plans timely interventions to capture the mindshare, and eventually the market-share.

The FDA’s regulatory requirements mandate the conduct of pre-clinical studies and clinical trials to establish product safety and efficacy of drugs, before they are launched in the market. Data from clinical trials represents the most pragmatic method of detecting possible new Adverse Drug Events (ADEs). They can be conveniently assessed by officers at the FDA and may be used to mark the drugs’ safety positioning / profile. These ADEs are listed, and the information about them is readily available on FDA’s website.

Once the drug is marketed, a healthcare practitioner, who suspects the prevalence of Adverse Drug Reactions (ADRs) or possible ADEs to a medicament, is obliged to share that data with the broader medical fraternity e.g., by submitting an article, report, data or letter to a medical journal or notifying the manufacturer of the suspect drug. In the case of a Serious Adverse Event (SAE), the same should be conveyed to the FDA as per the procedures. These spontaneous reports are a source of valuable evidence about drugs and medical   devices; predominantly about their rare, infrequent or delayed effects, and their safety in vulnerable subject populations. While pre-marketing and post-marketing trials deliver information about almost all safety issues with respect to population health, the only inherent drawback with the process is its diminished capacity to identify rare or unexpected effects of the investigational product.

Individual ADR reports to the FDA (by the medical practitioners or from the concern person), can make a substantial variance in the safety profile of a drug after it has been approved for use by a varied population group. However, experts have warned that even with the conduct of clinical studies with large sample sizes in a diverse population, there is a possibility that some of the safety issues may remain unidentified. One of the possible reasons for this is the extremely low occurrence of infrequent ADEs/ ADRs of prime public health concerns. Once the medicament is approved for marketing and is utilized by millions of individuals across geographies, the rare manifestation of these issues can transform into a substantial number of cases.

With worldwide digitalization, pharmaceutical industry is looking upon another channel to collect the information about possible ADEs of approved products, i.e. from the social media websites. This is now the need of the hour, as it is inevitable to avoid  the said data. Social media tools, which were not present till a few years ago, have become part of an individual’s life. Trends suggest that most adults in the US (>90%) have searched online for health information; this percentage has increased to more than 75% as compared to the previous year.

Thus, there is an immense possibility, yet to be explored in a ‘big way’ by the industry, to utilize the data on these social media sites for information on possible ADEs. This will help in further investigating and reinforcing the safety profile of the medicament. It is expected that if the data about possible ADEs exists in social media, then it shall be helpful for proactively mining, maintaining, building, and protecting information, which may be further leveraged to report to the FDA.

HCL’s in-house pilot analysis of data on social media – has been a testimony to the fact that this data can help to highlight and point-out the safety issues.  Also, it cannot be avoided or left unheard!

HCL has the required solution for effectively exploring this information. The solution is expected to have the positive impact in driving industry trends by extracting information about the possible ADRs/ ADEs from social media with precise accuracy.

A prospective industry view suggests that the role of CDM personnel is in a state of flux. This role is not only about accomplishing routine activities like designing case report forms (paper CRF/eCRF), annotating CRFs, designing databases, entering, validating and coding data, locking databases, and creating CDISC/analysis datasets, but also about stepping forward to meet all the expectations of the pharma fraternity. Here’s a quick list of some of these expectations:
■Augment the process of subject recruitment and retention in clinical trials
■Establish a vision for subject care, by maintaining subject profile and population health outcomes based on classifications such as – geography, gender, race, and more
■Extrapolate trial information for future use, with respect to medicine safety and efficacy, subject profile/disease information/drug price
■Evolve as a main subsidiary for risk based monitoring, centralized monitoring, and study site support
■Coalesce clinical trial data with Big Data, to help forecast trial success or to establish brand positioning, etc.
■Optimize the cost of clinical research with predictive analysis techniques
■Effectively manage links, alliances, associations and CRO data, based on historic performance and user friendly classifications, in order to help retrieve information by other teams of clinical research
■Enhance study digitalization for an overall boost in the processes

In most of the organizations, CDM managers have already established the procedural activities. They are, however, still struggling to find the right, most adaptable solution, which is made up of the right IT infrastructure that can support regulatory mandates.

The available software packages cannot sustain all activities at one time and are not adaptable enough to address constantly evolving regulatory requirements. Hence, these are not the preferred choice. But if chosen, the cost of licensing, validating, implementing and supporting them are high. When implemented, it takes considerable time to complete the training, and production time also increases because of complicated programming.

Stakeholders believe that primarily two work models can be adopted, to achieve desirable results:
■Work model 1: Develop a new, customized, low-cost software with all the capabilities built into it
■Work model 2: Integrate all individual (existing in-house) software into one common functional platform

The good news is that HCL can deliver tailored and regulatory-compliant support for both models. HCL can handle every contingency, help enhance data quality and enable timely regulatory submissions, cost-effectively. HCL helps organizations achieve their study/project/program objectives through the use of adaptable technology and the seamless integration of all their processes. And by taking on some of the tasks of the data managers, we free them up to focus on more crucial and strategic missions.