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Visible, The Green Shoots of Digital Transformation in Pharma

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Currently, one gets a mixed feeling about the progress of digital transformation in the pharma industry. This is despite various reports confirming that a number of major initiatives in this field have been taken, especially by Big Pharma, globally. Moreover, these are primarily driven by the company CEOs, as it should be, and adequately backed by heavy investments.

Another recent trend can’t also be wished away, as corporate C-suites find a new breed of leadership – Chief Digital Officers (CDO) as occupants. It has already happened in several top pharma companies. Alongside, one can spot in this milieu, a plethora of private ‘digital trainers’ – wearing interesting titles and offering courses of many types, especially for pharma line managers.

On the flip side, many experts feel that ‘digital transformation of business’ is currently more a buzz in the drug industry than reality. These are, apparently, piecemeal attempts of converting analogue formats to digital, in a number of functional areas to improve operational efficiency of the same process.

Thus, it’s time to go for a reality-check at the ground zero, to ascertain the overall progress of the industry in this area, at least, in the last five years. While doing so, in this article, I shall try to hear the views of the top company CDOs on the nature of the challenge, alongside examine some credible research findings. Let me begin this discussion by looking at where exactly does the pharma industry stand today in this space, as compared to other industries.

A fact-check:

That many players in the drug industry, continue to have no clear digital vision and strategy, was established in the ‘Harvey Nash/KPMG CIO Survey 2018.’ This survey is claimed to be the largest on IT leadership in the world, with almost 4,000 participants across 84 countries, representing over USD 300 bn of IT budget spend.

The report provides a snapshot of the pharma industry in several areas, particularly where the industry’s responses differed significantly from those across other industries. As I go along with my submission, I shall fact-check and quote from this data. Let’s find below the industry response to the following two key questions:

A.‘Does your organization have a clear digital business vision and strategy?’

Industry

Yes (enterprise-wide)

%

Yes (Within business units)                      %

No

%
Pharma

23

28

49
All industries

32

27

41

The second question is even more specific:

B.‘Does your organization have a Chief Digital Officer or someone serving in that capacity?’

Industry

Dedicated CDO

%

Someone else in that role                            %

No

 %
Pharma

4

37

59
All others

11

39

50

That said, let me also acknowledge, enough evidences suggest that a sort of ‘digital warming-up’ has commenced in the industry for some time now.

‘Digital warming-up’ has commenced:

That the process has just begun, was captured in several reports. Let me illustrate the point, citing an example of the article, titled ‘Marketing outside the box’, published in the Pharma Times Magazine of May 2017.

Considering blistering pace of progress and rapid adaptation of digital technology in businesses, it is interesting that a couple of years ago, the above article highlighted exactly what many would articulate even today. The author noted: ‘Think pharmaceutical marketing these days and the buzz words digital, consumer engagement, multichannel, and closed-loop all come to mind.’ Focusing on the possibility to make it happen, sooner, the paper added, ‘There is now a dizzying array of tools, technologies and tactics that can be combined in various permutations to create marketing campaigns unheard of a mere five to 10 years ago.’  Thus, the ‘digital warming-up’ notwithstanding, the key question, I reckon, is, about two years down the line, how many drug companies have started maintaining an enterprise-wide digital business strategy?

A soft target – for rationalization:

To rationalize the leisurely progress of this key initiative, one may possibly choose the soft target and say,drug companies being a part of a highly regulated and tradition-bound industry, are late to fathom the indispensability of digital transformation of business. But this justification is open to many probing questions. One such counter-query could be – in that case, why many constituents of as stringently regulated industry, if not more, – financial services business, including banking, are galloping ahead with digitization?

Even if, the above rationalization is accepted at its face value, the other question won’t also be too easy to answer: Why digitization is not gaining momentum in the pharma industry, as much as it should, particularly as compared to other highly regulated industries? Such probes understandably may not attract too many affirmative answers. However, the crux of this issue was reported in the headline of Fierce Pharma on June 25, 2019 – ‘Pharma’s got its chief digital officers. Now let’s see the results.’

In pursuit of holistic outcomes with digitization:

The August 2015 paper of McKinsey, titled ‘The road to digital success in pharma’, also acknowledged, just as other related one, the drug industry can play a pivotal role in the digital transformation of healthcare – changing lives of many. While pointing out, capturing this opportunity requires identifying the right initiatives, the article cautioned the industry, it needs to run harder ‘to keep pace with changes brought about by digital technology.’

There are indications that some top pharma decision makers have also realized that this change has to happen, sooner – assigning top organizational priority, and demanding sharp focus of all. As I wrote in my article of October 29, 2018, several companies have created a brand-new C-Suite position, to ‘lead the company’s digital efforts across research, discovery and business processes.’

The initiative intensified in the last two years:

According to May 13, 2019 edition of Biopharma Dive, seven of the nearly thirty pharma and biotech companies valued at more than USD 10 billion has named a Chief Digital or Information Officer (CDD/CIO) on their executive committee. Such placements facilitate greater influence for organization-wide changes and signal that they are taking the potential of digital technologies seriously to transform their respective business models.

Interestingly, six of those individuals were appointed to top management within the last two years. This shift comes, as tech companies like Amazon and Apple inch further into medicine, in a different form, though. Taking a cue from this emerging trend, some pharma majors are also merging research and development of new medicines with digital technology and big data. Thus, even CDO responsibilities are going through a curious metamorphosis.

Is CDO position a temporary one?

This question is aptly answered in the 2019 Report on the study of CDOs conducted byStrategy &, PwC’s strategy consulting group. The paper finds, the elevation of CDO at the Corporate Executive Committee or the Board level, ‘reflects the growing recognition that the digital transformation agenda now has strategic importance to most organizations, and that, unless it is driven from the top of the enterprise, it will not have the required momentum to drive business change.’ Overall in business: ‘More than half (54 percent) of CDOs have board-level status today, up from 40 percent in 2016’, the report highlights.

Although, it is construed as a general industry trend today, the report however, captures a clear dissonance. It found that leaders at many companies believe that putting a single person in charge of digital transformation may not be the best approach, as it is an intrinsic strategic priority, across the whole business, where agility becomes critical for survival. Thus, the researchers felt, as digital transformation becomes part of the core business, the next step will possibly be for the CDO to disappear. When it happens, digital transformation will become the responsibility of every member of the executive team of the organization.

Be that as it may, we shall cross that bridge when we come to it. At present,the basic groundswell for digital transformation of the entire business, is created from the C-Suite of the CDO. Thus, let us dwell on the scope of CDO in a pharma company.

Current scope of CDO in a pharma business:

Let me illustrate this point by quoting from the Press Release of Sanofi, dated February 12, 2019, appointing their CDO. It said, the CDO will be responsible for enhancing Sanofi’s strategy to integrate digital technologies and medical science to ultimately improve patient outcomes. His mandate will include scaling up Sanofi’s ongoing portfolio of digital initiatives by developing broad external partnerships, building out internal infrastructures, and exploring new business opportunities for the company in the digital space.

Thus, the role of a CDO is primarily focusing on both - developing a digital health strategy and improve internal capabilities, to effectively use new technologies and advanced analytics to deliver the deliverables, more effectively. As many would know, last year, both Pfizer and Merck announced appointments of CDOs for the first time in the company. In 2017, Novartis and GlaxoSmithKline (GSK) also created similar C-Suite positions.

Now, CDOs will need to prove their value:

Yes. That’s exactly what the Sanofi CDO said in the above Fierce Pharmaarticle – appeared on June 25, 2019. He was forthright in admitting, after a few years, pharma and biotech companies would be ‘kind of pressuring’ CDOs to ask, ‘Well, what have you really achieved? And show me the results. Have you made us more efficient? Have you transformed the way we work? Have you created new business? Have you really given us new tools, new technologies, new drugs which are digitally enhanced? And show me where they are.’

Hence, the pace of digital transformation of companies needs to be much faster now than ever before.

The current status of digitization in pharma:

Since, proof of the pudding is in the eating, let’s get a feel of the company employees in this area from their response to the query from the same ‘Harvey Nash/KPMG CIO Survey 2018.’:

‘Overall, how effective has your organization been in using digital technologies to advance its business strategy?’ 

Industry

Very effective          %

Moderately effective  %

Not/Slightly effective %
Pharma

17

37

36
All others

22

42

46

The above details may not reflect a great progress for the pharma industry in digital transformation. Nevertheless, this space doesn’t remain barren either, not any more. Some signs of progress – some green shoots, I reckon, are indeed discernable.

Conclusion:

As I see it, the need for digital transformation is an existential issue for the pharma industry. No one can afford to let this initiative die. In any case, the technological wave of such dimension, power and relevance for all, will always prevail – getting stronger – as the days pass by.

That said, there isn’t much doubt, either, that many drug companies are finding it challenging to keep pace with the rapid progress of technology, where obsolescence is also equally fast. Some are also facing tough barriers to scale up digital transformation across the organization. The rest seems to be not very sure how and where to start it from.

On the other hand, as I also wrote in my article in this blog on April 08, 2019, fueled by, among others, Internet of Things, the health care environment, including in India, is moving towards a ‘connected healthcare’ regime. This disruptive change will demand the best value offerings from each brand for better patient outcomes.

The good news is, at least, some green shoots of digital transformation in the pharma space are certainly coming up. But its pace needs to be considerably accelerated and now, creating an optimal groundswell – always being on the same page with customers – for path-breaking outcomes.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Holistic Disease Treatment Solution: Critical For Pharma Success

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The speculation over quite some time has ended now. The most important C-suite office of the world’s top pharma company will find a brand-new occupant at the dawn of a brand-new year, on January 01, 2019. Albert Bourla will now be on the saddle to lead Pfizer moving towards a new horizon of success, in place of Ian Read.

What makes this change interesting to me, is the new leader’s not just shaking up the top team at Pfizer, but his simultaneous announcement for another brand-new C-Suite role in the company – The Chief Digital Officer (CDO). She will ‘lead the company’s digital efforts across research, discovery and business processes.’

Merck & Co. also joined ‘the chief digital officer parade’ on October 17, 2018 when it announced the appointment of chief information and digital officer, also as a member of the company’s Executive Committee. Notwithstanding a few global pharma companies’ have already started creating this role, the timing of this initiative by the top global pharma player, sends an interesting signal to many. Undoubtedly, it is a strategic move, and is surely backed by a profound intent. In this article, while exploring this point I shall try to fathom whether or not any fundamental change is taking shape in the strategic space of pharma business.

A fundamental change is taking shape:

This fundamental change, I reckon, is driven by realization that just discovery of new medicines, high quality manufacturing and high voltage marketing can no longer be regarded as success potent in the industry. There emerges a palpable and growing demand for holistic solutions in the disease treatment process, for optimal clinical outcomes and reduction of the burden of disease.

That several top global pharma companies have recognized this fact, is vindicated by what the Sandoz Division of Novartis acknowledged on its website. It quoted Vas Narasimhan – CEO of Novartis saying: “We are on the verge of a digital revolution across every aspect of the healthcare sector, from the lab bench to the patient’s bedside.”

Interestingly, pharma stakeholders’ interests and expectations, including those of patients, are also progressing in the same direction. This, in turn, is changing the way of leading and managing a pharma business – requiring a kind leadership with specific expertise in several new areas. The new C-suite position for a CDO is a proof of this change gathering strong tailwind.

What prompts this change?

As I see it, besides scores of other associated factors that digital technology offers to all, a single characteristic that stands out is the changing patients’ expectations for optimal clinical outcomes out of an affordable and involved disease treatment process.

This has always been so, but is now changing from mere expectations or just a hope, to patients’ demand, from both physicians and the pharma companies. This is a clear writing on the wall in the days ahead, and all concerned should take note of it, seriously. Does it mean that the broad flowchart of the disease-treatment-process, as I call it, has changed? Before delving into that area, let me briefly explain what exactly I mean by saying so.

A flowchart of the disease-treatment-process:

The broad flowchart for most of the disease-treatment-process, have primarily 6 ‘touchpoints’ or points of references, as I see it, which may be summarized as follows:

Patients – Signs & Symptoms – Doctors – Diagnosis – Medicines – Clinical outcomes

This means, patients with signs and symptoms of a disease come to the doctors. With various diagnostic tests, the disease or a combination of diseases is diagnosed. Then, doctors prescribe medicines or any other required medical interventions for desired clinical outcomes.

Has it changed now?

There doesn’t seem to be any fundamental change in this flowchart even today. But, the way the pharma players cherry-pick their areas of focus from its various touch points, is undergoing a metamorphosis.

As it stands today, to sell medicines – innovative or even generic pharma companies primarily focus on the doctors and off-late on patients – but just a few of them, to offer clinical outcomes better or same as others. In the evolving new paradigm, a successful drug companies would need to focus on each of these six elements of the flowchart with great expertise and sensitivity, from the patients’ perspective.

The position of CDO is expected to be a great enabler to facilitate the process of integrating all the touchpoints in the disease-treatment-flow. This will, in turn, offer a holistic treatment solution for patients – selling more medicines being the endpoint of this objective. If it doesn’t happen, the touchpoints where pharma is not focusing today would be captured soon by the non-pharma tech players. This will make achieving the financial goals of the organization even more difficult.

Let me illustrate this point by adding just one important area from this flowchart to the traditional pharma focus areas. This touchpoint goes hand in hand with the prescription of medicines – medical diagnosis. Providing patient- friendly disease prevention and monitoring tools may be yet another such area.

Current accuracy of medical diagnosis – ‘only correct in 80 percent of cases’:

The above was quoted by Sandoz (a Division of Novartis) in its website. It highlighted that the researchers at John Radcliffe Hospital in Oxford, UK found that several medical diagnoses based on a limited range of factors are only correct in 80 percent of cases. It means ‘a diagnosis may miss imminent heart attacks, or it may lead to an unnecessary operation,’ it said.

The January 31, 2018 article published by Futurism.com - the publishing arm of Futurism, based in New York City, also underscores some interesting facts in this regard, including the above example. Some of these are fascinating, as I quote hereunder:

  • Researchers at the John Radcliffe Hospital in Oxford, England, developed an AI diagnostics system that’s more accurate than doctors at diagnosing heart disease, at least 80 percent of the time.
  • At Harvard University, researchers created a “smart” microscope that can detect potentially lethal blood infections with a 95 percent accuracy rate.
  • A study from Showa University in Yokohama, Japan revealed that a new computer-aided endoscopic system can reveal signs of potentially cancerous growths in the colon with 94 percent sensitivity, 79 percent specificity, and 86 percent accuracy.
  • In one study, published in December 2017 by JAMA, it was found that deep learning algorithms were able to better diagnose metastatic breast cancer than human radiologists when under a time crunch. While human radiologists may do well when they have unrestricted time to review cases, in the real world a rapid diagnosis could make the difference between life and death for patients.
  • When challenged to glean meaningful insights from the genetic data of tumor cells, human experts took about 160 hours to review and provide treatment recommendations based on their findings. IBM’s Watson took just ten minutes to deliver the same actionable advice.

Thus, the bottom-line is: Medical or clinical diagnosis is a crucial area where the tech savvy environment can add significant unmet needs to save lives of many. Consequently, this space is emerging as an Eldorado, as it were, for all those who are seriously interested in diving deep in search of a golden future in the related business.

Technological players are making forays:

Several tech companies have sensed the reward of a pot of gold in the above space, despite the journey being quite arduous. Consequently, many of them are coming up with user-friendly and disease-specific digital tools and health apps, compatible with smart phones or smart watches. These help patients monitoring their own health data, independently, and be aware of the disease progression, if any. Simultaneously, it also enables physicians not only to accurately diagnose a disease, but also to keep a careful vigil on the progress of the treatment.

To illustrate the point with an example – say about Apple. The company began making inroads into the healthcare space with health apps and fitness-tracking via iPhone and Apple Watch. Interestingly, riding on partnership and acquisition initiatives, it is now carving a niche for itself to provide complete health records of the users by capturing relevant disease-specific clinical data.

Apple Watch Series 4, for example, has ECG feature and the ability to detect irregular heart-rhythm, which is US-FDA approved. Reports indicate the company is also in the process of developing a non-invasive glucose monitoring tool, besides many others. Curiously, the company has already given a signal to extend the usage of iPhone to a reliable diagnostic tool for many disease conditions. Most important to note is, this concept is fast gaining popularity.

Calls for of a holistic approach in the disease-treatment process-flow: 

As this trend keeps going north, many pharma companies are realizing the underlying opportunity to adopt a holistic strategic business approach to move into the new frontier. This would encompass the entire disease-treatment-process-flow with digital technology, across the organization. Before other non-pharma companies firmly position themselves on the saddle while entering into this area, pharma needs to move fast. This calls for an urgent action to collaborate with tech companies in all the critical touchpoints of this flow, including diagnosis. That this realization gas dawned in pharma is evident from a number of related developments. Let me quote just a couple of examples, as follows:

  • Onduo, a US$500-million diabetes-focused joint venture between Sanofi and Verily Life Sciences, an Alphabet company was founded in September 2016. Onduo recently launched its first product – an app plus, a continuous glucose-monitoring device plus an insulin pump that are all linked together. The Onduo app has a built-in coach (i.e., an electronic assistant) to help patients better manage their diabetes and accomplish their health goals.
  • GlaxoSmithKline (GSK) and Verily (formerly Google Life Sciences) have formed a joint venture to develop and commercialize bioelectronic medicine – miniaturized nerve implants that modulate electrical impulses to treat certain diseases.

Lack of digital leadership talent within the pharma industry?

It is interesting to note that both the Pfizer and Merck CDOs were recruited from non-pharma companies – Pfizer’s from Quest Diagnostics and Merck’s from Nike.  Earlier, in mid 2017, former Walmart CIO was named the Chief Digital and Technology Officer of GlaxoSmithKline. This trend probably brings to the fore, the lack of top digital leadership talent within the pharma industry.

Conclusion:

Increasingly pharma companies are realizing that enormous efforts and money spent in just marketing a drug, is producing a lesser and lesser yield, as the new paradigm unfolds. As we move on, patients no longer will want to buy just a medicine from the pharma players. They will want an integrated solution for prevention, cure or management of a disease.

At the same time, strong technology players, such as Apple, Google, IBM’s Watson are on the verge of capturing a sizeable ground, offering a gamut of patient-friendly offerings in the healthcare space. This would eventually make prescription of digital therapy a new reality. These tech companies are now entering through several virtually open doors in the disease-treatment-flow process, as I call it, primarily covering – diagnosis, disease monitoring and preventive care.

To effectively compete and grow in this environment, drug companies have to cover all the touchpoints of this process, not just the selective ones as are generally happening even today.

Creation of a new C-suite position of Chief Digital Officer to address this issue in a holistic away, across the organization, gives a clear signal to this realization. Thus, I reckon, offering a holistic treatment solution, covering all the touchpoints in the disease-treatment-flow process will be a new normal for pharma, not just for excellence in business, but for a long-term survival too.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

For Patient-Centricity: Emerging a C-Suite Role

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Regardless of skepticism of many, the formidable power of physicians to take all treatment decisions for patients, is gradually getting moderated, globally. Although, its pace may vary from country to country. An increasing number of more informed patients are carving out a greater role for themselves in this important process.

The central focus for brand demand generation can no longer remain just on the doctors. This is because, as I wrote this in my article, published in this Blog on July 06, 2015: “Slowly but steadily the process of taking treatment decisions for the patients is undergoing a metamorphosis, where well informed patients no longer want to play just a passive role. These patients want the doctors to take a final decision on their treatment only after meaningful interactions with them.” Besides a broad prescription pattern, this includes the medicines that they will consume, including meaningful details on product cost against the benefits to be accrued.

The age-old practice of doing a little bit on patient education or compliance, are grossly inadequate in an evolving new scenario. The good news is, many pharma companies have started realizing that appropriate engagement with patients to deliver what they want and more, can lead to better financial performance.

Consequently, the ball game for prescription demand generation is showing early signs of a change – somewhat radical in nature. To spearhead this unavoidable metamorphosis for the organization, there surfaced a brand-new role of a CxO – The Chief Patient Officers (CPO).

This new senior management position is expected to direct organizational focus on patients. Understand their concerns, needs, wants and goals, particularly in the disease areas where the company represents. And finally, give shape to new multichannel well-coordinated platforms of patient engagement, for better commercial returns. In this article, I shall try to explore how this transformation pans out, if at all.

The direction is right, but patients must feel the change:

As I said before, some pharma players have started accepting the reality. The crucial need for an organization to become ‘Patients-Centric’ can’t be wished away anymore. For example, a 2015 “Industry Healthcheck” survey where 1600 pharma executives participated, found that 85 percent of respondents agreed that ‘Patient-Centricity’ is the best route to improve profitability, in the fast changing business environment.

It is perhaps well understood that the pharma industry has arrived at this point due to increasing access of the general population to easily available, all-kind of information on the cyber space, including health care. The enabling facility has already prompted many patients evaluating various treatment options for a disease, including choice of drugs and their cost.

As a result, pharma companies felt the necessity to have a new leader who will give a new perspective and direction in creating a new value for the organization, for a sustainable progress. This involves charting a comprehensive pathway to gradually shift the entire company focus on ‘patients for products’, and not on ‘products for patients.’

According to reports, a few global pharma majors, such as Merck and Sanofi already have their CPO in place, but patients are yet to feel any difference on the ground even for these companies, as many say.

What exactly is ‘Patient-Centricity?’ – Two perspectives:

It won’t be a bad idea to get to know two different perspectives on what ‘Patient-Centricity’ exactly is – one from a CPO and the other from patient groups, as follows:

A. 3 three pillars of ‘Patient-Centricity’ from the CPO perspective:

To get a ringside perspective to this question from the industry, let me quote from the first CPO - Anne C. Beal appointed in a top-10 pharma – Sanofi, on March 31, 2014, though the CPO position is in existence, since 2012.

On December 2014, at the 11th annual Patient Summit USA conference, Anne Beal, reportedly deliberated on the three pillars of her company’s patient-centric strategy, which I shall describe, as follows:

  • Utilizing patients’ input to get a better sense of their needs in order to design and deliver solutions that help fulfill them.
  • Engaging and supporting patients to ensure the solutions that the company delivers help enhance their lives and improve outcomes.
  • Involving with the company employees and supporting them to create an engaged community and patient-centric culture.

B. 9 attributes of ‘Patient-Centricity’ from the patients’ perspective:

‘Patient View’ – a UK-based research, publishing, and consultancy group, arrived at the ‘9 Key Attributes’ of ‘Patient-Centricity’. This is based on the analysis of feedbacks (2016-17) from 2,000 patient groups worldwide, 50+ different medical specialties in 100+ countries. The critical attributes of the same that patients want to see in a drug company can be summarized, as follows:

  • Demonstrate integrity and authenticity through all company actions.
  • Understand all the issues that patients face ‘beyond the pill’ and help in dealing with them.
  • Transparency in drug pricing policy, research, results, funding relationship.
  • Ensure that all patients are included in access strategies, regardless of the returns to the company.
  • Products to provide quantifiable value to patients.
  • Reliable supply and comprehensive patient safeguard.
  • Provide quality product information – Consistent, current, balanced and usable.
  • Patient group relation – good intention, effective governance, communication and training.
  • Ensure patients are engaged and their opinions are sought at each stage of R&D.

On a broader canvas, the two perspectives on ‘Patient-Centricity’ – one from the CPO and the other from the patients’ groups, do have some important similarities. Nevertheless, I reckon, the CPOs would still need to cover more ground to match patients’ expectations from a ‘Patient-Centric’ pharma company. 

Claimants of ‘patient-centric’ focus are many, but few deliver consistently:

Quite expectedly, there are many claimants for a ‘patient-centric’ organizational focus. Interestingly, few actually deliver consistently. This was vindicated in the article – ‘How patient-centric is the pharma industry’, published by PDD - a design and innovation consultancy firm on June 06, 2016.

The paper indicates both the up and downside of pharma company claims on ‘Patient-Centricity.’ The upside is that the hype has influenced, at least, some drug players to openly talk about the need to shift the company focus more on patients. A few have initiated some tangible action, as well. Whereas, the downside of it is the lack of consistency in the enthusiasm of ‘patient-centric’ actions by these companies. To illustrate the point, let me quote the following two examples from the article:

  • In the 2013 survey on ‘Patient-Centricity’ by the research firm ‘Patient View’, ViiV Healthcare (the GSK & Pfizer joint venture focused on HIV therapies), Gilead, AbbVie, Menarini and Janssen occupied the top 5 spots.
  • However, in the ‘eyeforpharma Barcelona Awards 2016 ’ that too focuses on ‘Patient-Centricity’, none of these companies featured in the “Most Valuable Patient Initiative or Service” category. Whereas, Sanofi took the top spot, and Merck, Roche, Novartis and TEVA were the remaining nominees.

The criteria of the two selection processes, apparently being similar, this is interesting. More so, when the ‘patient-centric’ focus of an organization is an ongoing strategy, with a ‘top priority’ tag attached to it.

Be that as it may, that some serious efforts being made by a few companies in this area, can’t be brushed aside, either, regardless of the fact that the CPO position came into existence, since 2012. It flagged, at that time, the criticality of ‘Patient-Centricity’ in the pharmaceutical business and possibly, sent a signal to pharma players for a course correction, in this direction, soon enough.

Conclusion:

In an interview, published in December 2016 issue of McKinsey Quarterly, LEO Pharma’s president and CEO, Gitte Aabo, aptly summarized the process of ‘Patient-Centricity’, as follows:

“Patient-Centricity means being deeply entrenched in the patient’s needs, not just thinking about how to develop new products and new features. It means reaching out to patients and considering treatments that will help them in whatever situation they find themselves in.”

However, since long, most drug manufacturers are apparently solely driven by commercial considerations, both for new drug discovery and also in generic product development. Subsequent marketing strategies are obviously an integral component of the same organizational thought leadership and value chain. Several examples from the current status of the R&D pipeline for multi-drug resistant antibiotics, or what is happening even with the generic drug pricing in many countries, including the United States, will vindicate this point.

That said, a mild wind of change on the sails of traditional pharma mindset seems to be slowly catching up, as some CPOs position themselves in the saddle. Hopefully, this will  ultimately make patients the centerpiece of pharma business. Can more of this kind of actions be construed as signals for imbibing ‘Patient-Centricity’ by the drug companies? Will its impact be visible and felt by all – in real life, soon?

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Blockchain: Pharma Keeps An Eye On The Ball

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On April 24, 2017, The Wall Street Journal (WSJ) came out with an interesting headline, “Dubai Aims to Be a City Built on Blockchain.” Some may have taken note of it seriously. However, a vast majority of its readers possibly equated the article with something, which is far from reality – like a distant dream.

However, looking at the rapid transformational phase of digital technology, nothing apparently is a dream – not even ‘a distant one.’ The following recent example, in a similar but not exactly the same context, would vindicate this point.

On January 09, 2018, Reuters reported with a headline, “JPMorgan’s Dimon regrets calling bitcoin a fraud.” Interestingly, at a conference held in September 2017, the same Dimon – the Chief Executive of JPMorgan, had commented: “The currency isn’t going to work. You can’t have a business where people can invent a currency out of thin air and think that people who are buying it are really smart.”

I cited the example of ‘Bitcoin’ while deliberating on ‘Blockchain’, primarily because ‘Bitcoin’ – an unregulated virtual or cryptocurrency was built on ‘Blockchain’ technology. This technology reportedly facilitates absolutely transparent, smooth, safe and corruption-free transaction of ‘Bitcoin’, without any third-party intervention at any stage.

Currently, moving beyond Bitcoin, many industries – including pharma, have started finding various uses of Blockchain in their respective businesses. Domain experts envisage, this technology has the potential to offer game changing values – revolutionizing various business processes.

In this article, I shall focus on how the healthcare industry, in general, and more specifically some global pharma players are contemplating to leverage the path breaking ‘Blockchain’ technology to add unprecedented value in the business. The technology being rather a complex one, I shall put it across in a way that an ordinary man like me can easily absorb. Which is why, I start with the first basic question that comes to the fore: ‘What exactly is ‘Blockchain’?

‘Blockchain’:

‘Blockchain’ is a technology that was reportedly conceptualized by an anonymous individual or a group known as Satoshi Nakamoto, in 2008. It was implemented in 2009, as a core component of ‘Bitcoin’ transactions – in an altogether different form of Internet. The technology provides in its network access to transparent digital information that no user can corrupt or probably even hack, leave aside taking copies. The December 13, 2017 article, featured in the Computerworld on this ‘Most disruptive tech in decades’, describes Blockchain as:

  • “Blockchain is a public electronic ledger – similar to a relational database – that can be openly shared among disparate users. It creates an unchangeable record of their transactions, each one time-stamped and linked to the previous one. Each digital record or transaction in the thread is called a block (hence the name), and it allows either an open or controlled set of users to participate in the electronic ledger. Each block is linked to a specific participant.”
  • “Blockchain can only be updated by consensus between participants in the system, and when new data is entered, it can never be erased. The Blockchain contains a true and verifiable record of each and every transaction ever made in the system.”
  • “As a peer-to-peer network, combined with a distributed time-stamping server, Blockchain databases can be managed autonomously to exchange information between disparate parties. There’s no need for an administrator. In effect, the Blockchain users are the administrators.”

Blockchain has, therefore, been meticulously designed to reveal any interference with the contents, ensuring a very high level of data security and access for all its users. Thus, many domain experts justifiably believe, what ‘open-source’ software did almost two and half decades ago, ‘Blockchain’ technology is possibly on a similar threshold of changing much of the ball game in Information Technology (IT), globally.

Big corporate houses of several industries, such as Fintech, Healthcare and Shipping envisage that ‘Blockchain’ technology has a great potential, as they start making limited use of it. It is still in its infancy for scalable use in most industries, probably other than ‘Bitcoin’ transactions.

Use of ‘Blockchain’ in pharma and healthcare:

Let me now explore the potential of ‘Blockchain’ in healthcare and pharma. A paper titled, “Healthcare rallies for Blockchains: Keeping patients at the center” by IBM Institute for Business Value, provides some important insight on its application in healthcare sector. This study is based on a survey of 200 healthcare executives in 16 countries, conducted by The Economist Intelligence Unit. The key highlights are as follows:

  • 16 percent of pharma and healthcare respondents expected to have a commercial Blockchain solution at scale in 2017, as compared to 15 percent of the Banks and 14 percent of Financial enterprises. Thus, it appears, the adoption of Blockchain by healthcare entities are taking place at a faster pace than the other two.
  • 6 in 10 anticipate Blockchains will help them access new markets, and new and trusted information they can keep secure.
  • 7 in 10 of them expect the greatest Blockchain benefits to be in clinical trial records, regulatory compliance and medical/ health records.

Accordingly, the authors posed a few questions: How valuable would it be to have the full history of an individual’s health? What if every vital sign that has been recorded, of all the medicines taken, information associated with every doctor’s visit, illness, operation and more, could be efficiently and accurately captured – and securely stored?

If and when all this is put to scalable use, the designated users will get access to the historic and real-time patient data of various types, of high credibility. In turn, it is expected to significantly reduce many other costs, including the cost towards data reconciliation. Consequently, the quality and coordination of care would rise manifold, with lesser risk, if at all. I shall give below just a couple of examples to drive home the point:

I. Adds credibility and value to Clinical Trials:

The issue of not reporting around half of all clinical trial data, conducted by pharma players while obtaining marketing approval for innovative products, has become a topic of raging debates, across the world. The reason for the same is apparently the intent for the deliberate creation of an information-gap, by cherry picking more favorable trial data. This could eventually lead to compromising patient safety, seriously.

Allegations continue for not just mostly favorable trial data being presented to drug regulators and policymakers to obtain marketing and other approvals, but also for product promotion to doctors. This prompts many believing, “if the clinical trials are supported by Blockchain solution, all results, protocols, and other related information would be time-stamped and immutable, resulting in less data snooping and errors.” Consequently, it would help enhance the dwindling public trust on pharma, especially in this area.

II. Adds unprecedented security and transparency in SCM:

Another example of its effective use is in making a tamper-evident pharma Supply Chain Management (SCM), with unprecedented built-in security features to prevent drug counterfeiting and circulation of substandard drugs. Moreover, ‘Blockchain’ would ensure supply chain tracking even at the individual Stock Keeping Unit (SKU) level by establishing proof of ownership for specific sources of any product. This is especially important in the backdrop of the WHO report, highlighting that 30 percent of such drugs are sold primarily in developing countries.

Global pharma keeping an eye on the ball:

An article titled, ‘Big Pharma Seeks DLT Solution for Drug Costs’, published on January 09, 2018 by the CoinDesk – a digital media and information services company, discussed on this fascinating subject.

It reported, at least, three global pharma heavyweights – Pfizer, Amgen and Sanofi, are pondering, whether ‘Blockchain could be used to actually save lives?’ To achieve this goal with combined efforts, they are now exploring a Blockchain framework to streamline the process of developing and testing new drugs. These early initiators believe, as areas such as this, are of industry-wide importance, there is a need to create a growing momentum for collaboration on foundational issues. And, Blockchain framework that can address the current issues in drug development and clinical trials, will fetch a win-win outcome, both for the innovators and patients, besides other stakeholders.

To reduce the time and cost of bringing new drugs from research labs to patients, improved data management and movement is critical. Blockchain technology could hasten this process, by automating communication between pharma companies, researchers and patients. At the same time, it will ensure a very high level of data integrity, which is so important for health and safety interest of patients.

This area has assumed greater relevance in the recent years, when pharma innovators are facing different challenges to bring new, more personalized drugs to market – faster and at affordable prices, the paper highlights.

Areas of initial use by Indian pharma:

In my article “SCM: Embracing Technology For Patients’ Safety”, published in this Blog on December 18, 2017, I discussed a similar point, not in context of ‘Blockchain’, though. I wrote that by a notification dated January 05, 2016, the Directorate General of Foreign Trade (DGFT) has made encoding and printing of unique numbers and bar codes as per GSI Global Standard mandatory. This would cover tertiary, secondary and primary packaging for all pharmaceuticals manufactured in India and exported out of the country to facilitate tracking and tracing.

Although, the ‘Track and Trace’ system in India for drugs is currently applicable only to pharma exports, will ultimately cover drugs in the domestic market, as well. This is evident from a draft proposal of the Government to the stakeholders in June 2015, in this regard.

Blockchain-based public electronic ledgers that can be openly shared among disparate users, creating an unchangeable record of their transactions, with each one time-stamped and linked to the previous one, would be of immense importance for all concerned towards the reliability of medicines in India.

Similarly, as Indian players venture into more complex clinical trials, such as with biosimilars, Blockchain could catapult the narrative on reliability of Indian clinical data to a much higher level of trust.

Blockchain has come to stay:

As I said in the beginning, ‘Blockchain’ technology has started coming to the fore of many discussions and debates, mainly for its critical role in transparent transaction and distribution process of the cryptocurrency – Bitcoin.

December 16, 2017 issue of the Gulf News reported that UAE’s central bank is working on a joint cryptocurrency, based on Blockchain, with its counterpart in Saudi Arabia. Just prior to that, in August 31, 2017 issue of the Financial Times also reported: “Six of the world’s biggest banks have joined a project to create a new form of digital cash that they hope to launch next year for clearing and settling financial transactions over Blockchain, the technology underpinning bitcoin.”

And just this month, we got to know about the combined efforts of Pfizer, Amgen and Sanofi, to use a Blockchain framework for streamlining the process of developing and testing new drugs.

Besides many other industries, even several Governments are envisaging to unleash the transformative potential of Blockchain in various Governance processes. It may include the confidential data procured and used by Governments to confirm the identity or identification of individuals for different purpose, or even to ensure that the country’s election process is transparent and beyond corruption.

An expression of interest on the use of Blockchain by some State Governments in India, gets reflected in what the Chief Minister (CM) of Maharashtra said while inaugurating the Maharashtra Technology Summit (MTECH), jointly organized by FICCI and Govt. of Maharashtra in Mumbai on January 17, 2018.

The CM clearly indicated, as Blockchain can transform the e-governance, the State Governments must start interacting with technology providers to make Public delivery of goods and services transparent. This will reduce the trust deficit between businesses, and citizens with government departments. He admitted, in the space of technology, ‘Blockchain is one level up and it’s not just Internet of Thing, but it is Internet of trust, Internet of values, that can change the entire space of governance’.

Conclusion:

Blockchain may be just a technological component, but, nonetheless, a game changing one. Thus, the good news is, several pharma players are also taking great interest to step into this never ever experienced – and a new kind of digital paradigm.

It is heartening to note that a number of global pharma head honchos, such as of Novartis, Takeda, and several others, are creating a new global position of chief digital officer. GSK, reportedly, is the latest one to initiate similar step.

Indian pharma players, I reckon, can also reap a rich harvest, both tangible and intangible, by putting ‘Blockchain’ technology in place. It may start with building a transparent, incorruptible ‘Track and Trace’ system for medicines, in addition to achieving high degree of international reliability in its clinical trials, especially on biologic drugs.

The benefits built into the Blockchain technology for pharma, apparently, are far too many than perceived constraints to leverage it effectively. Encouragingly, global pharma seems to be keeping an eye on the ball – but what about Indian pharma?

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Democratization of Healthcare: An Evolving Trend Driven By Cutting-Edge Technology

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We have stepped on to a fascinating era of yet another disruptive innovation in a newly carved out space of the healthcare domain.

Such initiatives are driven by path breaking ideas, which are being translated into reality with the application of cutting-edge technology. All these are aimed at providing a plethora of unique healthcare related solutions in the cyberspace to various stakeholders, especially to patients through inexpensive smartphones of various types.

Although the process has just begun, but is moving at a rapid pace. In virtually no time, as it were, it is showing a great potential of delivering more accurate and affordable healthcare solutions to a large number of the population globally, particularly in the developing nations.

‘Democratization of Healthcare’: 

The ‘patient empowerment’ of such kind, with technology enabled the power of personalized healthcare knowledge and information in an organized manner, has been termed as ‘The Democratization of Healthcare.’

The critical point to ponder, therefore, whether this fast developing state of art technological advancement has the potential of delivering a novel and much affordable process of disease treatment and management, in the real world. As it happens, the new paradigm would shift the focus of key stakeholders from doctors to patients, in a genuine sense, and almost irreversibly.

In this article, I shall deliberate on this wonderful emerging scenario.

A recent reiteration raises hope:

The following reiteration of one of the largest and most reputed tech giant of the world raises general hope that this process would soon come to fruition:

‘The democratization potential of healthcare interests most of us, as the injustice of fantastic healthcare available in some parts of the world, and others suffering needlessly.”

The above profound comment was made on a radio show – ‘Conversations on Health Care’, by none other than the Chief Operating Officer, Jeff Williams of Apple Inc. on January 4, 2016 and was reported accordingly by ‘appleinsider.com’ on January 06, 2016.

Jeff Williams also indicated in his talk, how smartphone technology can be harnessed for therapeutic purpose in disease treatment, as well. Citing an example, he said, detecting autism at an early age is a key to future treatment, as doctors can intervene – albeit to a limited degree – as long as the brain is still developing. 

He referred to a study that found not just the potential in app-based smartphone screening of children, but can even go much further by delivering therapy and treatment.

The rapid progress of technology in this direction is very real, as ‘Apple’ and other smartphone health app developers are stretching the commoditization of computer technology to serve health sciences. In not so distant future, with relatively inexpensive smartphones and supporting health apps – the doctors and researchers can deliver better standards of living in severely under-served areas like Africa, where there are only 55 trained specialists in autism, Williams said.

Triggers a key shift in focus: 

As I said before, unleashing the power of technology in healthcare solutions through smartphones will bring a fundamental shift in focus of all concerned, from medical doctors to ordinary patients. 

This transformation seems to be rather imminent now, as equipped with detailed knowledge of various types of individual health and disease related information through their smartphones, the patients would position themselves in the driver’s seat, demanding more for affordable treatment of diseases. 

Dr. Eric Topol, the author of the book titled, “The Patient Will See You Now”, thus very appropriately said, “MDs will no longer be considered ‘medical deities’, but rather professionals with whom patients will consult to get the proper treatment on the path of least resistance.” 

Consequently, the pharma players and other related service providers would require to ‘walk the talk’ by being ‘patient centric’ in the true sense, and definitely not by using this profound term, as one of the tools of their mostly self-serving, advocacy campaigns.

Empowering patients:

As Dr. Eric Topol said, smartphone applications that can monitor throughout the day, such as, heart rate and rhythm, blood pressure, take and interpret an electrocardiogram, capture X-rays and analyze ultrasound, have the potential to reduce patient visits to doctors, cut costs, speed up the pace of care and give more power to patients. He emphasized though, digital apps won’t replace physicians. The patients would still be seeing doctors, but the doctor-patient relationship will ultimately be radically altered.

As an illustration, it is worth mentioning here, that taking a significant step forward in this direction, the U.S. Food and Drug Administration (USFDA) has already approved ECG apps by for consumers, which have been validated in many clinical studies.

Examples of Smartphone Apps for patients:

Smartphone apps are now available for different user segments. In this section, I shall focus only on patient-centered apps capable of performing a wide array of functions, such as managing chronic disease, lifestyle management, smoking cessation and even self-diagnosis.

I am quoting below just a few of these interesting apps, as reported in an article published by ‘The Online Journal of Public Health Informatics (OJPHI)’ on February 5, 2014:

A. For diabetic patients, over 80 apps on the Android platform alone, offer a variety of functions. These include self-monitoring blood glucose recording, medication or insulin logs, and prandial insulin dose calculators.

Yet another diabetes intervention app integrated communication between patients and a healthcare provider. Here, the patient would log fasting blood sugars, daily eating behaviors, medication compliance, physical activity and emotions into a mobile online diary. A remote therapist with access to these diaries would then formulate personalized feedback to the patient.

‘WellDoc’ is reportedly one such company that has already received approval of the US FDA for its mobile-enabled diabetes management program, and is being paid for by health insurers as they would for a pharmaceutical product.

B. For smoking cessation and alcohol addiction apps are also available. At least 47 iPhone apps for smoking cessation and another one called – ‘A-CHESS’ (Alcohol Comprehensive Health Enhancement Support System) helps preventing relapse in alcoholic dependency and harnesses mobile technology to improve treatment and motivation.

C. For asthma and allergic rhinitis patients, an app called ‘m.Carat’, developed at Faculdade de Medicina da Universidade do Porto, Portugal, , helps recording their exacerbations, triggers, symptoms, medications, lung function tests and visits to the doctor or the hospital. The users of this app can also receive disease education, medication information, task notifications, and synchronize records with an online database to better control their symptoms.

D. For psychiatric patients, available smartphone apps offer benefits of ambulatory monitoring, that randomly prompts the patient to self-report psychotic symptoms multiple times throughout the day.

E. For sickle cell disease another app allows patients access to an online diary for recording pain and other symptoms.

F. For patients with dementia, ‘iWander’ app assists the affected individuals with daily living, by providing audible prompts to direct the patient home, sending notifications and GPS coordinates to caretakers, or by calling local 911 (US emergency) services.

G. For HIV (human immunodeficiency virus) and STD around 55 unique smartphone apps are available. These are used for education, prevention, testing and to provide other resources.

Self-diagnosis without a medical visit:

The above article also states that patients may even use smartphone apps to attempt self-diagnosis without a medical visit. Patients with a camera-enabled smartphone can use apps to take photographs of skin lesions and send these to a remote server for computer analysis and/or review by a board certified dermatologist. However, such apps are still not without their pitfalls, which are being addressed by the scientists, expeditiously.

Nevertheless, informed debate has already started in search of an appropriate direction for self-diagnosis with the help of robust smartphone apps, without any in-person medical visits.

Need for ‘Regulatory control’ and ‘certification’ of health apps:

I hasten to add, all such smartphone health apps should not be allowed to come to the market without stringent regulatory control and a well thought out the certification process.

As in the United States, where the health apps are being assessed by the U.S. Food and Drug Administration (US FDA), in India too the Drug Controller General of India (DCGI) or any other appropriate and designated authority should approve and certify all such smartphone health apps, before the market launch.

‘Trust deficit’ poses a critical challenge to pharma industry:

Since the health apps opportunity is new, and still in its evolutionary stage, pharma industry, in general, does not seem to have fully accepted yet, that the process of ‘Democratization of Healthcare’ has already commenced. I reckon, the progress in this direction is unstoppable now. Nevertheless, many drug companies apparently continue to prefer sticking to the same proven path that had fetched enormous success for them in the past and, of course, also its associated business models.

Besides health apps, the democratization process of healthcare includes other technological platforms too, such as, social media and video communications, which have started to bring healthcare into patients’ homes. To be successful in a situation like this, gaining ‘patient trust’ has become more important today than ever before, for all concerned. 

Unfortunately, the drug companies, generally speaking, continue suffering from an increasing ‘trust deficit’ of the key stakeholders. This has been vindicated by a September 9, 2013 study of Makovsky Health, which found:

  • Pharma websites continued to rank low in terms of traffic, with just 9 percent of Americans visit them for health information.
  • WebMD is the most frequented online source for healthcare information (53 percent)
  • Almost a fourth of consumers (24 percent) use at least one or a combination of social media channels – including YouTube video channels, Facebook sites, blogs, and Twitter feeds with links to other resources – to seek healthcare information  

The writing on the wall:

Some major global pharma players apparently have clearly seen the writing on the wall, and started collaborating with the developers of various types of digital health apps.

Quoting from the May 02, 2014 edition of ‘MobileHealthNews”, I am citing below, just as an illustration, the initiatives taken in this space by some of the drug majors: 

Pfizer (2014) had backed startup Akili in the development of a mobile game to help diagnose patients with Alzheimer’s. The game could also be used in the treatment or detection of ADHD and autism, among other conditions.

Johnson & Johnson’s subsidiary, Janssen Healthcare Innovations (2013), launched the new version of its free Care4Today medication reminder app and platform – Care4Today Mobile Health Manager 2.0. It has also overhauled Care4Today medication adherence app.

Sanofi US (2013) and the Prostate Cancer Foundation announced the creation of Prost8Care, an SMS system to help prostate cancer patients and their families understand treatment processes.

AstraZeneca (2013) announced a pilot with Exco InTouch to help patients suffering from Chronic Obstructive Pulmonary Disease (COPD), with mobile and online tools. 

Sanofi’s (2012) iBGStar device became the first US FDA cleared iPhone-enabled blood glucose meter.

GlaxoSmithKline (2012) offered a free asthma management app called MyAsthma, for iPhone and Android users. The app’s core offering is an Asthma Control Test (ACT), which is a simple 30-second test providing users with an index score of how well they are managing their asthma overall.

The potential in India:

In India, ‘Democratization of Healthcare’ is believed to be more broad based, with a third of all Indian mobile users expected to own a smartphone by 2017.

This is vindicated by the Press Release of Telecom Regulator TRAI, India, pharma, drug, playersy Authority of India (TRAI) of December 30, 2015. It states, the Wireless Tele-density in India is 79.39 as on October 31, 2015. The shares of urban and rural wireless subscribers were 57.61 percent and 42.39 percent, respectively, during the same period.

Conclusion:

The process of ‘Democratization of Healthcare’ is gaining momentum with the digital health app developers flooring the gas pedal. Even the global tech giant – Apple, has expressed its support and vow of taking rapid strides in this direction.

As this fascinating process unfolds, the final disease treatment decision, from various medical options available, is expected shift from doctors to patients, and may be their closest relatives. In tandem, patients would learn to take ownership of their physical and mental health conditions for disease prevention of various types, besides general fitness.

The patients, empowered with relevant digital information and knowledge, on their health status, including the pace of disease progression, would play a pivotal role not just in reducing disease burden, but also in making overall cost of individual healthcare more affordable. Additionally, access to healthcare, especially in the developing world like India and in its hinterland, will be improved significantly.

Digital apps are not just limited to patients’ use, these are being developed with equal speed for doctors, diagnostic centers, and clinical trials, just to name a few. All these would substantially reduce healthcare costs and add speed to various disease treatments.

In this golden pathway, there are some thorns too, mostly in the form of important regulatory issues, which need to be sorted out, expeditiously. Increasing ‘Trust Deficit’ of stakeholders on the drug companies is yet another hurdle, especially when the primary focus of all would shift from doctors to patients. However, it appears, the pharma players will eventually have no other choice, but to willy-nilly mold themselves accordingly, primarily for survival and thereafter progress.   

As I see it today, the fast evolving trend of ‘Democratization of Healthcare’, driven by cutting-edge technology, is virtually unstoppable now. The only question is how soon will it happen?                                                                          

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.