Prescription Digital Therapy Now A Reality

Posted on May 7, 2018 by Tapan Ray

The pursuit of offering ‘prescription digital therapeutics’ or ‘digiceuticals’ by Big Pharma, to ensure better clinical outcomes for patients, has apparently come to fruition now.

On April 18, 2018, by a media release, Novartis announced that the Sandoz Division of the Company has entered into collaboration with Pear Therapeutics to commercialize and continued development of digital therapeutics, designed to effectively treat disease and improve clinical outcomes for patients.

The collaboration brings on to the table, a synergy between Sandoz expertise in launching and commercializing various disease treatments, with Pear’s leading experience in digital therapeutics design and implementation. This deal has attracted attention of many. Mainly because, any pharma player will, for the first-time, detail a digital therapy treatment directly to the medical profession, and seek their prescription support.

It is worth noting that Pear’s flagship digital therapeutic – reSET is the first USFDA-cleared mobile medical application with both a safety and efficacy label to help treat patients with Substance Use Disorder, in September 2017. According to published reports, several studies have established that it is two-times more effective than conventional in person therapy sessions. Interestingly, the rate of treatment efficacy increases even up to tenfold, in refractory patients.

Just the beginning of a long run:

The above market launch of a digital therapy by Novartis signals just the beginning of a long run in changing in the disease treatment archetype for better outcomes. Incidentally, prior to this announcement, on March 1, 2018, the same Company had announced, “Novartis and Pear Therapeutics to collaborate on prescription software applications aimed to treat patients with schizophrenia and multiple sclerosis.”

The media release underscored:“Psychiatric and neurodegenerative diseases place a heavy physical, mental and economic burden on patients and their families. With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need”.

The scope and potential:

An article titled – ‘Digital therapeutics: Preparing for takeoff’,published by McKinsey & Company in February 2018, captures its scope succinctly. It says, “digital therapeutics tend to target conditions that are poorly addressed by the healthcare system today, such as chronic diseases or neurological disorders. In addition, they can often deliver treatment more cheaply than traditional therapy by reducing demands on clinicians’ time.”

A separate McKinsey interview article, titled ‘Exploring the potential of digital therapeutics’, published in the same month, elucidated the potential of digital therapy equally well. It highlighted:“A digital therapeutic is an intervention based on software as the key ingredient, which has a direct impact on a disease. This is what distinguishes this category from the broader term digital health. We will see digital therapeutics and digital diagnostics integrate into the health system…”

‘Prescription digital therapy’ are not just ‘Fitness and Well-being’ Apps:

Prescription digital therapy are not just to monitor a person’s general fitness level against pre-identified parameters, and overall well-being. Whereas, digital therapeutics help patients to regularly and consistently monitor relevant and tailor-made disease related data - in real-time to detect behavioral, lifestyle and requisite biological changes on a daily basis. However, this is not ‘a so well-realized necessity’ today, especially, in the treatment of certain serious disease conditions, to ensure significantly better clinical outcomes for patients.

Digital therapeutics can ensure making a favorable change in patient behavior, which is not merely as efficient as administering medicines, but could also ensure greater effectiveness than conventional medications. Further, it assists patients to better understand, manage and control several disease conditions, and more importantly, sans any untoward side-effects.

Besides, with digital therapy, the required treatment interventions will reach patients faster than traditional treatment processes. Both the patient request and the medical response for the same can be quickly exchanged, together with relevant data support, through smartphones or other wearable digital interfaces – either in the form of voice or text or both. I shall dwell on this later in the article. Thus, digital therapy may not require patients to meet the doctor every time a need arises.

Moreover, fitness and wellbeing Apps do not require marketing approval from a country’s drug regulator. Mostly because, they help monitoring general and generic fitness parameters, capturing some low-risk changes. Whereas, a custom-made prescription digital therapy would necessarily require such regulatory nod.

In tandem, various studies are also being conducted on wearables, such as an Apple Watch, as an interface. The following are examples of some of these studies:

Digital therapy study with Apple Watch as an interface:

In February 2017, Takeda Pharmaceuticals U.S.A. and Cognition Kit Limited, announced a collaboration to pilot the use of a specially designed app on an Apple Watch wearable to monitor and assess cognitive function in patients with Major Depressive Disorder (MDD).

In November 2017, they presented results from ‘Digital Wearable Technology Study’ in patients with MDD. The observational study involved 30 participants, aged 18-65, with a clinical diagnosis of mild to moderate depression who have been prescribed antidepressant monotherapy for MDD.

The study also evaluated feasibility and participant compliance with measures of mood and cognition on wearable technology; and compared measures of mood and cognition on wearable technology using traditional neuropsychological testing and patient reported outcomes on depression symptoms at 6 weeks. Participants were provided with an Apple Watch on which brief cognitive and mood tests were administered daily.

The researchers observed that patients were compliant with the wearable Apple Watch device on a daily basis to evaluate mood (95 percent) and cognition (96 percent). The study also demonstrated that abbreviated daily assessments delivered through the wearable Apple Watch device corresponded with objective Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests and full-length patient reported outcomes, PHQ-9 and PDQ-D, assessed during weeks 1, 3 and 6. No adverse events were reported in the study.

According to another report, this user interface with Apple’s smart-watch versions 2 and 3 is now being used in a number of studies for chronic conditions, such as Parkinson’s disease – combining biometric data with user input. Again, in February 2017, Johns Hopkins University announced a project to use the smart-watch for research on possible triggers of epileptic seizures.

When used as an interface with prescription digital therapy, the provision of e-SIM and GPS in Apple Watch Series 3, I reckon, would also help patients to immediately communicate with the remote therapy centers using the same device, anytime – as and when the patients want.

Digital therapy initiatives in India:

Initiative on digital therapy has already started rolling in India, as well. Its pace is also quite encouraging. For example, Wellthy Therapeutics is building a patient centric solution for diabetes through digital intervention and management. On February 20, 2018, the Company, reportedly, shared the interim results of an ongoing real-world pilot to evaluate the effectiveness of the Wellthy Diabetes Smartphone App (WD). The results were shared at the 11th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2018) in Vienna, Austria.

The data demonstrated how the use of WD improved glycemic control. On completion of 16 weeks, participants showed a reduction in their HbA1c by (-0.61%) on average, with 61.5% of participants having showed significant reduction in their HbA1c with an average of (-1.17%) reduction.

Conclusion:

As indicated in my article titled, ‘Digiceuticals: A Force Multiplier to Contain Chronic Diseases’, published in this blog on October 23, 2017,prescription digital therapies are primarily of two types – one for “medication augmentation” and the other for “medication replacement.”

Be that as it may, prescription digital therapyimproves clinical outcomes for patients by manifold. It also shows potential to take over from traditional treatment with medicines in several serious and virtually crippling ailments, mostly related to human behavior and lifestyle, such as a host of chronic diseases, and without causing any side-effects.

Thus, prescription digital therapy is now a reality. It has come to stay for long – can’t be wished away, any longer.

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

Posted on January 22, 2018 by Tapan Ray

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.

Emerging Role of Digital Pathology in Cancer

Posted on January 1, 2018 by Tapan Ray

Dear readers, an unlocked door awaiting all of us with tons of opportunities as we log out of 2017 and log in to 2018. Let’s grab those, bringing changes and smile in many lives. Happy New Year

Cancer is now a leading cause of death worldwide. Every year, across the world 8.2 million people die from cancer. As the World Health Organization (W.H.O) estimates, deaths from this deadly disease will continue to rise, reaching over 13.1 million in 2030.

W.H.O flags that two-thirds of these deaths occur in low and middle-income countries. More than 50 percent of cancer deaths could have been prevented through awareness campaigns, or could have been effectively addressed through expert screening, early diagnosis and affordable treatment.

From this perspective, ‘digital pathology’ offers an immense potential to make a significant difference in the lives of many, who are either high risk individuals, or actually suffering from life threatening ailments. In this article, I shall try to illustrate the above point, in simple language, citing the emerging role of ‘digital pathology’ in cancer, as an example.

Incidence of cancer in India:

W.H.O reports that presently in India, cancer is a major cause of morbidity and mortality. This is vindicated by the 2016 Press Release of the Indian Council of Medical Research (ICMR) stating that, the total number of new cancer cases was expected to be around 1.45 million in 2016, and the figure is likely to reach nearly 1.73 million new cases in 2020.

ICMR expected over 736,000 people to succumb to the disease in 2016 while the figure was estimated to shoot up to 880,000 by 2020. The data also revealed that only 12.5 percent of patients come for treatment in early stages of the disease. Another report estimated that around 2.5 million individuals in India are living with the cancer.

Launch of cancer screening program:

Realizing the increasing incidence of cancer, ‘the National Program for the Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)’ was initiated in 100 districts in 2010, and expanded to about 468 districts in 2012, in tandem with other Non Communicable Diseases (NCDs).

After further review, the Government informed the Indian Parliament on April 01, 2017 about the launch of universal screening of diabetes, hypertension and cancer in 2100 districts, which would be extended across the country. Accordingly, ‘Operational Guidelines for Non-Communicable Diseases’ were worked out and made public.

A large number of cancer cases remain undetected:

It is worth noting, India is still among one those countries where a large number of cancer cases remain undetected or under-diagnosed. The country continues to grapple with a huge dearth of specialists in this area. These include not just cancer specialists, which reportedly is just 1 over 2000 cancer patients, but qualified pathologists, as well. This stark reality assumes greater importance, as early diagnosis with precision is the key to successful treatment of cancer.

It’s more in rural India:

Availability and access to affordable cancer diagnostic facilities, are indeed a major issue much more in rural areas – the home of over 70 percent of the Indian population. Consequently, its late detection, together with low awareness level for disease prevention, is considered to be the major factors attributing to relatively higher cancer mortality rate in the country.

The intensity of this problem increases manifold and gets more complex, due to various other geographic and logistical constraints. This situation makes high-technology based medical interventions a necessity to save many lives.

A unique public-private partnership initiative:

Interestingly, some developed countries are also trying to address the core issue of increasing access to affordable cancer diagnosis and treatment to all. An example of which can be drawn from the United Kingdom (UK), where one of finest Universal Health Care (UHC) system exists, for a long time.

On December 06, 2017, by a media release Roche Diagnostics announced a groundbreaking partnership discussions with the UK Government to transform cancer testing in patients.’ It said that the current shortage of pathologists and geographic constraints can make it difficult or longer for an expert to provide an opinion on a cancer patient case, where ‘digital pathology’ can play a crucial life-saving role.

Roche Diagnostics articulated that once important patient-cases are made available digitally, experts from any location can review them without delay. This would lead to availability of more equal access to experts to provide a timely and accurate diagnosis for cancer patients. It further said, making more information available electronically opens possibilities for the discovery of new treatments and the development of Artificial Intelligence algorithms in pathology diagnosis.

A Public-Private-Partnership (PPP) approach, such as the above can add greater efficiency, especially in tissue pathology services – including the expensive ones, to deliver faster and more accurate test results across the health care space, even in India. It goes without saying, such a PPP initiative has to be fleshed out with considerable details to unleash its true potential.

Thus, ‘digital pathology’, I reckon, has the potential to play a path-breaking role in providing access to affordable and early diagnosis of cancer to a large number patients, even in remote places, leading to better outcomes.

The scope of ‘digital pathology’:

It now brings us to the question of: what exactly is ‘digital pathology’? In simple term, ‘digital pathology’ involves remotely examining the whole slide digital imaging of original pathological slides of a patient, virtually in real time, from anywhere in the world to properly diagnose a disease. In case of cancer, these are digital image of original blood and tissue slides of patients, examined by experts with the application of special ‘digital pathology’ software and hardware, from a distant specialty hospital or laboratory.

According to the article titled ‘Artificial intelligence is aiding pathologists’, published on September 02, 2017 by the ‘Digital Journal’, AI or machine learning is being increasingly used in ‘digital pathology’ for precision diagnosis of a disease.

One such use of AI in ‘digital pathology’ for cancer, is to recognize broad or specific patterns in a whole slide image to interpret the features in the cancerous tissues for accurate diagnosis of metastasis and recurrence, besides the stage or grade of cancer.

Preparation of samples for ‘digital pathology’ is very important, and the requirements may vary with different cancer types. Nonetheless, prescribed procedures for each need to be adhered to, meticulously, even in those areas where there is no qualified pathologist, and paramedics do this job. Hence, those personnel should be thoroughly trained and periodically refreshed by well qualified specialist trainers.

Digital pathology in India:

The article titled, ‘Telepathology at the doorstep of a village’, published by the Department of Atomic Energy in India that was last updated on December 14, 2017, aptly captures the scope of ‘digital pathology’ or ‘Telepathology’ in the country.

The authors recognized in the article, despite the high quality of expertise being available within the country, even for the treatment of cancer, it is not available or accessible to a large section of the population, more in the rural areas. On the other hand, super specialty health care facilities like, Tata Memorial Hospital (TMH) or All India Institute of Medical Science (AIIMS) cannot take the increasing patient load, beyond a point, due to various constraints.

Improving telecommunication infrastructure in the country, can be put to effective use for accurate diagnosis of cancer with ‘digital pathology’ or ‘tele-pathology’. Nevertheless, this application is currently operable mostly in those rural and semi urban areas, where a minimum standard of telecommunication infrastructure is available. However, the good news is, such areas are growing in India.

An interesting example is Barshi – a rural landscape in interior Maharashtra, located around 500 km away from Mumbai. Nargis Dutt Memorial Cancer Hospital (NDMCH) located in this hinterland, with Tata Memorial Hospital’s constant support and guidance, especially in ‘digital pathology’ has become an important cancer center. NDMCH now caters to a sizable population from a number of villages and towns surrounding it – in the districts of Solapur, Osmanabad and Latur.

A Government Press Release of October 19, 2016 states that AIIMS in Delhi has gone digital, becoming India’s first fully digital public e-hospital. More initiatives, such as these, in collaboration with rural health centers, and other related PPP initiatives, are expected to significantly improve access to ‘digital pathology’ to a large population, especially for early cancer detection in India.

More ‘Digital pathology’ initiatives are spreading roots in India, including the private business space. For example, according to a media report, Anand Diagnostic Laboratory in Bengaluru has become the first private diagnostic laboratory in the country to adopt the complete Roche Digital Pathology portfolio to provide better diagnostic insights for physicians and their patients.

“From simply remotely viewing patient slides, to consulting specialists real time within India or even through other parts of the world – the applications of digital pathology are endless” – commented the Managing Director, Roche Diagnostics India, while discussing the new technology at a meeting of pathologists in India.

Conclusion:

Against this backdrop, a wide-network of PPP initiatives of affordable ‘digital pathology’ would be a game changer, particularly for early detection of cancer. With the incidence of cancer rising fast in India, and its effective management getting increasingly more complex – requiring prompt specialists’ intervention right from early diagnosis, such initiatives call for high priority.

A few green-shoots are already visible in this area, but quite sporadic in nature, though. Hoping that its pace of progress will soon gain momentum, the emerging role of digital pathology in cancer brings a fresh hope for survival with dignity to a large population of patients – if and when cancer poses to strike its deadly blow.

By: Tapan J. Ray

Moving Beyond The Pill: No Longer An Option

Posted on November 13, 2017 by Tapan Ray

Many of us would prefer to live, as long as possible, in the comfort zones of old paradigms, hoping to succeed in the same way as we had succeeded in the past. But the wheel of time keeps moving, triggering a significant shift in various paradigms. This includes even the health care space. Most of these changes, as they tend to attain a critical mass, capture the imagination of some in the pharma industry – escaping the attention of many.

One such area of a shifting paradigm is increasing patient preference to get actively engaged in their health care. More specifically, such preferences span across the entire chain of any disease management process – from diagnosis to treatment, often including continuous monitoring, whenever required.

Thus, the creation of well-differentiated value-added patient engagement services, based on credible research data of statistical significance, craftily bundled around the pill, will assume paramount importance. More importantly, such value offerings should lead to demonstrable improvement in treatment outcomes.

This, I reckon, would be the new recipe for pharma marketing excellence in the coming years. In this article, I shall focus on this fast-evolving landscape.

Dawns a new realization:

Early realization of this change is working as an impetus for some global pharma majors to redraw their strategic business models, making appropriate course corrections, which are mostly fundamental in nature.

The article titled ‘How Pharma Can Offer More than Pills’, published in the Harvard Business Review (HBR) on July 23, 2015 identifies the following two realizations as the impetus behind moving beyond the pill initiatives:

Medicines alone are often not enough for patients to achieve optimal clinical outcomes.
As pharmaceutical pipelines dry up, beyond-the-pill businesses can be valuable new sources of revenues.

Joseph Jimenez, the global CEO of Novartis, appears to be one of the first and foremost to recognize this requirement when he said in 2014 that: “Creating value by embedding products into a holistic offering with the aim to improve patient outcomes and provide tangible competitive advantages.” Jimenez said at that time, “Beyond-the-pill is a logical and inevitable path forward for all.”

As this new realization gets effectively translated into cutting-edge business strategies, “Medicines could accordingly reach market with a label that includes an ‘around the pill’ solution such as a wearable or another tracking device”, as the above HBR article foresees.

Shifting success requirements:

Going forward, delivering only the value of a pill won’t be quite enough to make the sales revenue and profit trend moving north, registering a steep gradient.

As more patients want to experience differential values in the entire disease treatment process through greater participation and engagement, business success requirements of pharma players call for a major shift, accordingly. This would involve moving away from the traditional model – from increasing sales through a growing number of treatments, to boosting revenue through patient-centric well-differentiated value offerings. I repeat, the entire process should ultimately lead to quantifiable improvement in treatment outcomes.

Direct ‘patient engagement’ is easier said than done:

Direct patient engagement is easier said than done. It is not just something that is ready to happen at any given point of time. Pharma companies will require to first equip much greater number of patients, through various means, to become actively engaged in health care, as they step into this direction.

It is envisaged that most of these direct patient engagement endeavors of pharma will be on various digital platforms. The process would require accurately identifying the target groups, what exactly they consider of immense value for such engagement – and finally effectively delivering those value offerings in innovative and customized ways to them, for improved treatment outcomes.

‘Patient engagement’ should be measurable:

The level of such engagement needs to be continuously measured through ‘patient activation’ tools to establish cost-efficient improved outcomes. Researchers have established that patients with a lower ‘activation score’ ultimately incur higher costs.

An interesting article on ‘patient activation’ describes this terminology as ‘the skills and confidence that equip patients to become actively engaged in their health care.’ It says that health care delivery systems are now turning to ‘patient activation’ as yet another tool to help them and their patients improve outcomes and influence costs. To establish this point, the paper examined the relationship between ‘patient activation levels’ and billed care costs.

In this analysis of 33,163 patients, the researchers found that patients with the ‘lowest activation levels’ had predicted average costs that were 8 percent higher in the base year and 21 percent higher in the first half of the next year than the costs for patients with the highest activation levels. Both are significant differences.

Following an analogous approach, Novartis has been able to demonstrate better disease outcomes with its cardiovascular drug Entresto, as reported in the Financial Times dated April 14, 2017. Ably supported by remote monitoring and coaching programs for patients with advanced heart failure, Novartis has reportedly been able to establish that its customized disease treatment solution brings down hospitalization and cardiovascular death rate by around 20 percent.

Greater pharma accountability needed for treatment cost versus outcomes:

The authors of this paper, further established ‘patient activation’ as a significant predictor of cost even after adjustment for a commonly used “risk score” specifically designed to predict future costs. This trend, when reaches the decisive moment, is likely to assign greater accountability for costs and outcomes, even to the pharma players.

While moving into this direction:

Accurately knowing patients’ ability and willingness to manage their health will be a critical piece of information for the drug companies. This would prompt the pharma marketers to be highly proficient in generating a huge pool of credible data on target patient groups in various relevant areas, including expectations, aspirations, preferences and treatment related behavior. Thereafter, strategic game plan for business excellence should be based on in-depth analysis of this huge database, created on an ongoing basis.

If any skill gap exists in generating and analyzing the data meaningfully, pharma companies may wish to collaborate with external expertise in this area. A few excellent examples in this area have already started being reported, such as

Astra Zeneca’s partnering with Vida Health to offer free health coaching services to heart attack sufferers, or Sanofi partnering with Verily (previously known as Google Life Sciences) to develop new services for patients to manage diabetes better.

With similar initiatives, pharma players can effectively demonstrate to their stakeholders, details of better health outcomes that their patient-centric disease treatment solutions are offering – eventually taking their brands to a new trajectory of more inclusive success.

Conclusion:

Those days are not too far when many patients, especially with chronic diseases, such as hypertension, arthritis or diabetes, would prefer to buy a comprehensive disease management solution to lead a better quality of life, instead of just buying a pill – and quite often for lifelong.

In a new paradigm, with changing ‘value expectations’ of many patients in the entire treatment process, ‘value creation’ and ‘value delivery’ mechanisms of drug companies are likely to change accordingly. One of the key barriers to this shift is mostly the traditional business culture of most pharma players. Another significant one is its slow pace of moving into the digitized world, as compared to other science and technology driven industries.

Moving ‘beyond the pill’ would necessitate a basic shift in the mindset – from selling a pill to selling better health outcomes. In this endeavor, pharma CEOs require leading from the front. Instilling courage within the organization to ensure this fundamental strategic shift in the company’s business model taking place on the ground, is their prime responsibility. Thus, stepping into this new paradigm with requisite wherewithal, sooner, would no longer be just for business excellence, but for its long-term survival too.

By: Tapan J. Ray

‘Digiceuticals’: A Force Multiplier to Contain Chronic Diseases

Posted on October 23, 2017 by Tapan Ray

There is a growing need for more effective prevention, treatment or management of many serious Noninfectious Chronic Diseases (NCDs), with greater safety and at a lesser cost. As a major step in this direction, ‘digiceuticals’ or ‘digital therapeutics’ are now drawing heightened interest from the medical and scientific communities.

‘Digiceuticals’ are basically custom made digital software working as drugs. These are presented mostly in the form of user-friendly smartphone apps for various disease conditions – both as stand-alone therapy, or to augment other treatment processes for better outcomes.

Increasing usage of digital technology enabled therapy for a gamut NCDs, prompts me to discuss in this article the relevance, scope, promise, and of course, the rationale behind the same. Its importance swells manifold when the risks of lifelong health hazards that such chronic disorders may pose are factored-in, alongside their overall socioeconomic impact.

Chronic diseases – the invisible global epidemic:

Chronic diseases, such as heart disease, stroke, chronic respiratory disorders and diabetes, including cancer, are by far the leading causes of death and disability worldwide. The World Health Organization (W.H.O) also reiterates that this invisible epidemic is spreading out globally – across every region and pervading all socioeconomic classes.

The mortality, morbidity and disability attributed to chronic diseases, as estimated by the W.H.O, is expected to rise to 73 percent of all deaths and 60 percent of the global burden of disease by 2020. Interestingly, 79 percent of the deaths attributed to chronic disorders occur in the developing countries, such as India.

Can chronic diseases be prevented?

W.H.O also emphasizes that four of the most prominent chronic disorders, namely cardiovascular (CVD), cancer, Chronic Obstructive Pulmonary Diseases (COPD), and Type 2 diabetes – are linked by common and preventable biological risk factors, notably high blood pressure, high blood cholesterol and overweight. Most importantly, these relate to major behavioral risk factors, like unhealthy diet, physical inactivity and tobacco use, among several others.

Awaits a radical change – from “Suppliers Push” to “Consumer Pull”:

In the above perspective, a series of well-integrated action related to several human behavioral factors, could help prevent many NCDs, effectively. A fundamental change in mindset of all concerned is critical to avert the merciless onslaught of this epidemic. This calls for a radical change in the existing process of addressing these disorders – from “Suppliers Push” to “Consumer Pull.”

The January 2017 White Paper titled, “Human-Centric Health: Behavior Change and the Prevention of Non- Communicable Diseases”, published by the World Economic Forum (WEF), drives home this point succinctly, as follows:

“Decreasing the burden of NCDs will require a transformation through which the threat of disease is recognized and addressed. The transformation should move us away from the present state of ‘supplier push’, which emphasizes expensive, capital-intensive, hospital-centric interventions that have so far produced disappointing results, to a system that relies on ‘consumer pull’. A consumer-focused system would recognize the principles of behavioral economics to encourage and enable people to adopt healthier behavior across all aspects of their lives. Individuals would be supported in this effort by a network of critical stakeholders ranging from government to private enterprise, from healthcare providers to payers, from the technology developers to local communities.”

NCDs are triggered by behavioral pattern and lifestyle:

Picking up the thread from here, I shall deliberate now, how the state of the art digital technology-developers are playing a stellar role in this space, with greater precision and more cost-effective way. This is because, many NCDs are triggered by consistent behavioral and lifestyle pattern of an individual. Consequently, continuously monitoring of desired changes in individual behavior, are expected to gradually become the first-line treatment to effectively address these conditions. Several published studies indicate that the process has started rolling, aided by smartphone based sophisticated digital tools – in many cases even without any expensive and lifelong medications.

The May 26, 2016 paper titled, “Clustering of Five Health-Related Behaviors for Chronic Disease Prevention Among Adults, United States, 2013”, captures a cluster of five health-related behaviors for chronic disease prevention as – never smoking, getting regular physical activity, consuming no alcohol or only moderate amounts, maintaining a normal body weight, and obtaining daily sufficient sleep. This article was published by the Centers of disease Control and Prevention of the United States.

Preventing chronic diseases with ‘digiceuticals’:

The April 7, 2017 article captioned, “Can ‘Digital Therapeutics’ Be as Good as Drugs?”, published by the MIT Technology Review, dwells on this area. The paper indicates an emerging belief among technology geeks that ‘digiceuticals’, or digital drugs will become ‘the third phase’ of medicine for many disease conditions, being the successor to the chemical and protein drugs that we have today, but without the billion-dollar cost of bringing one such drug to market. The core idea behind this new concept is to develop software that can improve a person’s health as much as a drug can, but without the same cost and side-effects, the author says.

An innovative new class of medicine:

The term digital therapeutics or ‘digiceuticals’, as many calls these, is considered as an innovative new class of medicine that gives participants access to the world’s most effective behavior therapies, enhanced with smart digital technology, and delivered directly to their front door. These can be used both as a replacing medicine, and also for enhancing efficacy of a medical treatment, as a situation would necessitate.

There doesn’t seem to be any clear-cut difference between these two – digital therapeutics and ‘digiceuticals’. Nonetheless, some do believe that there is a difference – quite akin to prescription medication versus nutritional supplements, with consequential differences in regulatory and other areas. Be that as it may, ‘digiceuticals’ when used for prevention, treatment or effective management of any chronic ailments would require to be scientifically evaluated just as any other drugs, devices and treatment processes.

The future of health care will be App-based:

Another article titled “Digital Therapeutics: The Future of Health Care Will Be App-Based”, published in Forbes on July 24, 2017, highlights how several digital technology companies are now focusing on the development of state of art smartphone app-based digital treatment programs that can be delivered at a massive scale and with a low cost to prevent progression of many debilitating NCDs, for a large population across the world, including India.

‘Digiceuticals’ versus other mobile wellness apps:

Unlike many smartphone based wellness apps to keep a regular tab on daily exercises, heart rates, calorie intakes, breathing, sleep pattern among several others; treatment processes with ‘digiceuticals’ are quite different. These softwares are tailor-made to prevent or treat specific chronic disorders, like diabetes, cardiovascular conditions, COPD, insomnia and chronic depression, to name a few. The trend is fast catching up along with an increasing general realization that the influence of individual behavior and lifestyle pattern is so crucial in the prevention, and also in arresting the progression of many debilitating NCDs.

The current status:

The latest scenario in this area has been well captured in several research studies. One such is the 2017 Report of Grand View Research, Inc., which articulated the following key findings:

The global ‘digiceuticals’ or digital therapeutics market size was estimated at USD1.7 Billion in 2016, which is expected to grow at 21.0 percent CAGR from 2017 to 2025.Diabetes is expected to gain the largest market share due to the increasing global prevalence, fueled by the preventive steps taken to reduce them.

The adoption of digital therapeutics offers a reduction in healthcare cost associated with many NCDs, and are thus being used on an increasing scale. Digital tracking, continuous monitoring of various health parameters, management of physical activity and controlling eating habits are some of the important factors expected to propel the market growth.

Ascending trend of its usage for prevention of a wide range of NCDs would further add to the growth momentum. Patients accounted for the largest market share in the end-user segment owing to user-friendly interface and cost-effective management of many NCDs.

The North American region accounted for the highest revenue owing to technological advancement and health care expenditure to curb rise in a number of chronic diseases.

The Asia Pacific region is expected to garner considerable growth during the forecast period owing to increasing adoption of advanced healthcare technologies and rise in the number of NCDs.

The latest development in India:

A similar initiative, though, as augmentation of physician intervention in patients with Type 2 diabetes for better treatment outcomes, has recently been reported by the Press Trust of India (PTI) on June 13, 2017.

The abstract of the report, among other points, says that an Indian digital diabetes leader has announced “the results from a pilot designed to evaluate the feasibility and scalability of an artificial intelligence-led lifestyle intervention to improve self-management of people living with type 2 diabetes as a supporting tool to existing care in India…. The pilot results suggest that continuity of care between physician appointments for people with type 2 diabetes can be achieved with positive outcomes in a clinically significant, scalable and affordable way through this program. Participants that completed the pilot on average dropped their average blood sugar levels (HbA1c) by 0.59%. Amongst the participants that completed and dropped their HbA1c, the average observed was even higher at 1.04%. In addition, the participants showed a daily active usage of 78% for the duration of the 16-week program.”

This is indeed a laudable initiative by an Indian digital tech company. More such ventures are expected to be forthcoming, taking rapid strides in India. Keeping pace with these developments, “digiceuticals,” I reckon, will spread its wings faster to play a crucial role in preventing, if not treating and managing several serious NCDs – and in most cases without even swallowing any pill.

Conclusion:

The key concept behind ‘digiceuticals’ or digital therapeutics is to exert a strong influence on individual behavior and lifestyle pattern, which are crucial both in prevention, and in controlling the progression of many NCDs. The desired level of change in behavior and lifestyle of individuals can be achieved through custom-made digital software. These are expected to deliver the same, or even better results in such disease conditions, at a much lesser cost, sans any serious side effects.

The ball has already started rolling with considerable success and a discernible promise in this direction. However, accelerating its speed further, and ultimately flooring the gas pedal, would depend on how all concerned stakeholders’, especially the technology experts, doctors, pharma industry, and other health care providers work in-sync with each other, leveraging the true potential of ‘digiceuticals’.

The rapid pace of progress in this endeavor will be a force multiplier in arresting the fast spreading ‘invisible epidemic’, as it were, of many serious chronic diseases or disorders, in a much better and cost-effective way than ever before.

By: Tapan J. Ray

A Sine Qua Non to Pharma Success in Digitized World

Posted on October 16, 2017 by Tapan Ray

A wind of change is now blowing at an accelerated speed – encompassing virtually anything, across the world, including India, with a varying degree, though. It leaves a profound impact on the day to day lives of many, including almost free access to a plethora of information of any kind available in the cyberspace. The way we express ourselves – connect with others – meet our various needs and requirements – make hassle-free financial transactions – increasing transparency – containing corruption, besides scores of others.

Fast evolving digital technology is predominantly catalyzing this paradigm shift. Its weighty impact can also be felt across the global business world, sparing virtually none. Digitally enabled recent GST implementation process in India is just one such example.

Newer technology driven transformation process of overall business ecosystem is sending a strong signal to all concerned to shape up – coming out of their respective comfort zones of the old paradigm, and embracing the new one. Squarely facing this challenge of change is equally critical even to one of the most conservative, tradition bound, and well-regulated pharma industry. It’s rather an absolute necessity for pharma, as virtually all its stakeholders, including the patients and governments, have already started stepping on to the digitized world. The fundamental choice is, therefore, between shaping-up and shipping-out.

In this article, I shall argue on this critical need, based on several recent, pertinent and contemporary research findings on this fascinating space.

Indian CEOs take:

The 20^th CEO Survey of 2017 titled, “Being Fit for Growth”, conducted by PwC

reveals that the term ‘digital’ evokes both excitement and a sense of apprehension among CEOs, both globally and locally. The following are some interesting findings involving the Indian CEOs, as captured in this survey:

38 percent observed that over the past 5 years alone, disruptive technological innovations have had a significant impact on competition within their respective industries.

47 percent believe that in the next 5 years, disruptive technological innovations will have a significant impact on competition in their industry.

77 are concerned about the speed of technological change.

76 percent expressed concerns about rapidly changing customer behavior.

77 percent mentioned the need to create differentiation in their products and offerings by managing data better.

Its relevance in pharma:

The relevance of taking this wind of change in stride and embracing it fast, is beyond any reasonable doubt today. The 2017 report of EY, titled ‘Reinventing pharma sales and marketing through digital in India,’ also reaffirms: ‘Digital will play an ever-increasing role in this era of profound transformations, characterized by increasingly informed patients/physicians, new range of customers and new disruptive entrants. To stay relevant, pharma companies need to adopt a nimbler approach and make data the currency of marketing.’.”.

The urgency:

A sense of urgency for this change has also been epitomized in the same report, as it underscores that digital disruption has demolished 52 percent of Fortune 500 companies, since 2000. The study further reiterates: “The pace of transformation has increased, competition has intensified and business models have been profoundly disrupted. This shift is happening at breakneck speed across industries, and pharma can no longer be an exception. Customers have already embraced technological changes, through their many digital touch points, and pharma must look toward digital to re-imagine the customer experience.”

Just changing manual processes to digital won’t suffice:

This is exactly what is mostly happening today in pharma. Concerned employees, in general, are also receiving training inputs accordingly. Vindicating this point, a recent study reiterates that just changing manual processes to digital won’t suffice, any longer. Delivering greater value to the stakeholders continuously through digitization of business is the name of the game.

The above EY report unambiguously endorses that: “Whatever was being done manually earlier is now being done digitally. But we are not adding additional value.”

While capturing in the report Indian pharma’s journey to the digital world, it articulates, though some digitization initiatives are being taken now, Indian pharma companies are still way behind their global counterparts. The survey found 53 percent of the participating companies still at the ‘beginners’ stage, while 40 percent are at the ‘conservatives’ stage and only 7 percent have moved toward the ‘explorers’ stage.

Three fundamental non-technical barriers, and the way forward:

Two important studies – one by EY, as quoted above, flagged three fundamental non- technical barriers in this area, and the other one by McKinsey & Co that proposed three strategic actions for Indian pharma to start on a digital path by leveraging its intrinsic value, meaningfully.

EY study indicated, 86 percent of the senior pharma leaders exhibited a strong positive inclination toward digital as a ‘strategic’ rather than a tactical approach. It then highlighted the following three key barriers to embracing digital:

Lack of clear digital strategy for the organization
Incremental value proposition and effective delivery
Change management

McKinsey & Co in its August 2015 report, titled ‘The road to digital success in pharma’ also indicated, though differently, lack of a clear strategic direction and focus in this area. The study noted: ‘Most pharma companies have started to build some digital capabilities, but the talent and resources for their efforts can be fragmented, often across hundreds of small initiatives. Without clear strategic direction and strong senior sponsorship, digital initiatives often struggle to secure the funding and human resources required to reach a viable scale, and they cannot overcome barriers related to inflexible legacy IT systems.’

Based on the above finding, the paper proposed three strategic actions for pharma companies to place it on the right trajectory, capturing the differential value of digital, as follows:

Develop the right organization for new business models with significant value addition from digital. This, I reckon, would involve a cultural shift.

Focus on two or three flagship initiatives, such as building a digital ecosystem for patient adherence to a blockbuster drug.

Run collaborative experiments, and then scale what works, such as putting the right people from IT, business compliance, and outside partners in a ‘war room’ to run quick test-and-learn cycles of a well deliberated digital strategic initiative. Where results are positive, scale those up.

Personalization in every facet of the value delivery system:

As we move ahead, personalization in virtually every facet of the value delivery system is unlikely to remain optional for the Indian pharma players. With this wind of change gathering further momentum, many will eventually witness a mind-boggling level of personalization – spanning across from personalized diagnosis of serious ailments based on complex genomics, doctors’ writing personalized medicines to tech savvy pharmacists dispensing 3D printed individualized formulations.

This trend will continue evolving with an ascending trend of outcomes, breaking all conceivable barriers. Accordingly, services to patients and physicians would also demand more personalization, along with the other stakeholder engagement process.

Most of these may appear no more than a figment of imagination today, or probably a science fiction to many – just as what the incredible narrative of unleashing unfathomable potential of the Internet appeared to so many, not so long ago. Indian pharma players may prefer to wish away this emerging scenario, but at their own peril.

Conclusion:

The Indian pharma industry is currently passing through a phase of transition to move into the digitized world. Just doing digitally whatever is being done manually now or earlier, won’t suffice, any longer.

Giving shape to a robust, comprehensive digital strategic game plan for the organization, as a whole, is the need of the hour. Pharma CEOs would require leading their respective core teams to the drawing boards for charting out this digital pathway, without further delay.

This would be a game changer, as constantly delighting the stakeholders with the best possible value addition in business, emerges as the primary means for sustainable organizational excellence. Long term success in this effort, would call for constant upgradation of the state of the art digital platforms and tools.

This is sine qua non to pharma success in the digitized world – offering a strong foothold as the new paradigm ushers in. Envisioning, what all-round excellence in business would entail in a rapidly evolving digitized world, and championing its effective implementation on the ground, sooner, is now a critical accomplishment factor for pharma CEOs in India.

By: Tapan J. Ray

Indian Pharma: Optimism, Concern and Retaining Trust

Posted on October 9, 2017 by Tapan Ray

As many would know, the significance of trust is profound. It is virtually all-pervasive. Building trust is fundamental in retaining any relationship – be it in the family, society or even in business, such as pharmaceuticals. For long-term success and sustainability of any enterprise, trust is of strategic importance, and will continue to remain so.

In that sense, it is interesting to note that a growing number of Chief Executive Officers (CEOs) of a variety of corporate business entities, including pharmaceutical and also from India, have started experiencing a new challenge in a new paradigm, more than ever before. The rapid pace of evolution of the state of the art technology is further complicating the quagmire. CEOs, in general, are realizing the hard way that ‘in an increasingly digitalized world, it’s harder for businesses to gain and retain people’s trust’, keeping their nose to the grindstone of the conventional business process.

This feeling has been well-captured, among other issues, in the 20^th CEO Survey titled, “Gaining from connectivity without losing trust”, conducted by PwC. The participating CEOs mostly believe that social media could have a negative impact on the level of trust in their industry over the next five years. With this trend, ‘as new technologies and new uses of existing technologies proliferate, they envisage new dangers emerging – and old ones getting worse.’ 1,379 CEOs were reportedly interviewed from 79 countries, including 106 from India in PwC’s 20^th CEO Survey.

In the context of Indian pharma sector, the above finding is unlikely to raise many eyebrows, rather be construed as an obvious one. In this article, keeping the above as the backdrop, I shall discuss what the Indian CEOs recently expressed regarding their near-term business performance. After analyzing their confidence level on business growth, together with critical concerns, I shall try to gauge the quality of interconnection between the critical success requirements for business growth, and the optimism they voiced, drawing relevant data from PwC’s 20^th CEO Survey, and other important sources.

Indian CEO confidence in business growth:

CEOs confidence, or optimism or pessimism about the business growth prospect of their companies is often used as a measure of ‘Business Confidence’. Financial Times defined ‘Business Confidence’ as “an economic indicator that measures the amount of optimism or pessimism that business managers feel about the prospects of their companies/organizations. It also provides an overview of the state of the economy.” A score above 50 indicates positive confidence while a score above 75 would indicate strong positive confidence.

According to published data, ‘Business Confidence’ in India increased to 64.10 in the first quarter of 2017 from 56.50 in the fourth quarter of 2016 with an. average 58.08 from 2005 until 2017, reaching an all-time high of 71.80 in the first quarter of 2007, and a record low of 45.70 in the third quarter of 2013.

More recently, as per Press Release dated September 22, 2017 of the National Council of Applied Economic Research (NCAER), ‘Business Confidence’ Index fell by 2.5 per cent in July 2017 over April 2017 on a quarter-on-quarter basis, for different reasons.

PwC’s 20^th CEO Survey, by and large, captures similar optimism, as it says: “Nearly three quarters of India’s CEOs are very confident about their company’s prospects for revenue growth over the next 12 months as opposed to 64% in the previous year. In terms of optimism, CEOs in India surpass their global counterparts (38%) and their counterparts in China (35%) and Brazil (57%).”

Interestingly, as the report says, the motivation behind high CEO optimism is primarily driven by those factors, which are being widely discussed, at least, over a decade, such as favorable demographic profile, rising income levels and urbanization.

A mismatch:

Remarkably higher confidence level of the Indian CEOs on business growth, as compared to their global counterparts, is indeed encouraging. Nevertheless, while exploring the reasons behind the same, a glaring mismatch surface between high level of CEO optimism and their concern on uncertain economic growth, as PwC’s 20^th CEO Survey indicates. 82 percent of Indian CEOs expressed concern about uncertain economic growth in the country, in this study. A staggering 81 percent of them perceive over-regulation and protectionist policies and trends, as serious threats to their growth ambitions. Intriguingly, 64 percent of CEOs in India are concerned about protectionism as opposed to 59 percent globally, as the report flags.

The concern about uncertain economic growth in the country has also been voiced by many economists. For example, in an article, published by The Times of India on October 04, 2017, Ruchir Sharma – Chief Global Strategist and head of the Emerging Markets Equity team at Morgan Stanley Investment Management, wrote: “The global economy is enjoying its best year of the decade, with a worldwide pick up in GDP and job growth, and very few economies have been left behind. India is one of the outliers, with GDP growth slowing and unemployment rising.”

Sharma further added: “The Organization of Economic Cooperation and Development (OECD) says that all 45 economies that it tracks will grow this year, the first time this has happened since 2007, the year before the global financial crisis led to a worldwide recession. Moreover, three quarters of all the countries will grow faster this year than they did last year; India is in the slumping minority, with GDP growth now expected to decelerate this year.”

This mismatch throws more questions than answers.

Wherewithal required to meet expectation:

It goes without saying that Indian CEOs must have required wherewithal to achieve whatever growth they think is achievable in their respective businesses. Besides financial resources, this will also involve having both, soft skills – which are basically ‘people skills,’ and the hard skills – that include an individual’s technical skill set, along with the ability to perform specific tasks for the organization.

A. Soft skills:

Indian CEOs identified ‘leadership’, ‘creativity and innovation’, ‘adaptability’ and ‘problem solving’ as the four important soft skills required to achieve the key business goals, according to the 20^th CEO Survey, as quoted above.

A mismatch:

Here again, a strong mismatch is visible between the ‘importance of the skill’ and ‘Difficulty in recruiting people with skill’, as experienced by the CEOs:

Skills	Importance of the skill	Difficulty in recruiting people with skill
Leadership	98	73
Creativity and innovation	95	74
Adaptability	98	66
Problem solving	99	64

(Source: PwC’s 20^th CEO Survey)

B. Hard skills:

Adaptation of any technology involves people with required hard skill sets in any organization. Currently, various state of the art technology platforms and tools, including digital ones, are absolutely necessary not just in areas like, research and development or manufacturing, but also for charting grand strategic pathways in areas, such as sales and marketing.

This is quite evident from PwC’s 20^th CEO Survey data. While 76 percent of Indian CEOs participating in the survey expressed concerns about rapidly changing customer behavior, 77 percent of them highlighted the need to create differentiation in their products and offerings, by managing data better. Both these can be well addressed by digital intervention. Interestingly, 81 percent of CEOs in India have stated that it is important to have digital skills, and 66 percent have already added digital training to their organizations’ learning programs.

A mismatch:

The intent of having adequate hard skill, such as digital technology, within an organization is indeed laudable. However, here too a key mismatch stands out regarding their overall perception of the digitizes word. This is evident when 73 percent of CEOs participating in this survey felt that it is harder for businesses to keep and gain trust in an increasingly digitized world.

On the contrary, a 2017 report of EY, titled ‘Reinventing pharma sales and marketing through digital in India’ says: “Digitization can not only enhance trust, transparency and brand equity, but also generate new revenue streams beyond the pill.”

The report further says: “Since 2000, digital disruption has demolished 52% of Fortune 500 companies. These companies have either gone bankrupt, been acquired or ceased to exist. The pace of transformation has increased, competition has intensified and business models have been profoundly disrupted. This shift is happening at breakneck speed across industries, and pharma can no longer be an exception. Customers have already embraced technological changes, through their many digital touch points, and pharma must look toward digital to re-imagine the customer experience. The urgency of acting is acute. It is time that pharma companies in India took a step back and re-envisioned digital as a core strategic enabler.”

I am, therefore, not quite sure about the thought process behind this perception of the CEOs in the digitized world. Instead, by increasing business process transparency, digitized world helps gaining and retaining trust not just of the customers, but all stakeholders, including the employees and the Government, further strengthening the relationship. This is now a well-established fact.

Conclusion:

While analyzing the optimism of Indian CEOs for business growth in the near future, alongside the key concerns, it appears, they are quite perturbed on retaining trust of the stakeholders, especially the customers. More importantly, a telltale mismatch is visible between their level of business confidence, and the reality on the ground – including wherewithal needed to translate this optimistic outlook into reality.

Such incongruity, especially in the Indian pharma sector, calls for a quick reconciliation. Ferreting out relevant facts for the same, I reckon, will be the acid test for evaluating the fundamental strength behind CEOs’ confidence for near-term business growth in India.

In tandem, reasonable success in creating a high degree of trust and transparency in the DNA of their respective organizations, will undoubtedly be pivotal for this optimism coming to fruition. The name of the game for business excellence in this complex scenario is – breaking status quo with lateral thinking.

By: Tapan J. Ray

Pharma’s Late Realization

Posted on August 14, 2017 by Tapan Ray

Technology, by and large, is impacting almost every part of our life. Interestingly, some of these, like mobile phones and desktop computers, found their initial uses, mostly as trendy status symbols of relatively rich and high ranking corporate honchos, before getting merged as essential tools in our everyday life, as it were.

Today’s digital world empowers people to virtually doing anything – literally, such as getting an online education, communicating with people – both in audio and video format, getting any routine medical test or household work done, transferring money, making any bill or other payments, buying travel-theater-concert tickets, or ordering any item online from home or wherever one chooses to, besides umpteen number of other things. A large global population now spends more time on communication in the virtual world, than face to face communication with physical presence.

Similarly, application of technology, especially digital, has radically transformed for the better, the way several companies in many industries have rewritten their respective playbooks of critical business processes. It starts from the generation credible data of humongous volume, critical analysis of those before initiation of the planning process, spanning across the endpoint of making consumers pay for the products or services willingly, while achieving both financial and non-financial business goals. In tandem, available cutting edge digital technology is being leveraged by these companies for developing both new products and processes, including the rejuvenation of many stagnating businesses.

Whether the pharma industry, as well, has started leveraging digital technology optimally or not, was discussed in the A.T. Kearney Report – “New Medicine for a New World, Time for Pharma to Dive into Digital”. It aptly captured the overall situation in this area for pharma a few years ago, by saying: ‘Pharma’s customers increasingly live and interact in a digital world. The industry has been dipping a toe in the digital waters, but now it’s time to take the plunge.’

In today’s article, I shall discuss on the current-status in this area, as some respected pharma veterans, still nurturing ‘traditional thought pattern’, keep displaying skepticism in this area, though indirectly. Nevertheless, directly they seem to keep their feet in two boats, probably for obvious reasons.

A disruptive change that can’t be ignored:

It’s a reality that we now live in a digital world. The speed of which is fast gaining momentum, and that too as a critical disruptive change agent. Interestingly, this is happening despite the existence of a digital divide, which I discussed in one of my previous articles.

That this trend is so recent has also been underscored by the above A.T. Kearney Report. It reemphasized, the way we interact has changed more in the past 10 years than in the previous 50, and this change is reshaping the society itself. It’s hard to believe that apps, social media, and everything that surrounds them date back to no earlier than 2007. With the expansion of interconnected Internet-enabled devices, the boundaries between the real and the virtual are increasingly getting more obscure.

When it comes to pharma industry, as various research studies highlight, an intriguing cautious approach for embracing digital prevails, unlike many other industrial sectors. This is despite facing numerous challenges in navigating through external business environment, and meeting stakeholders’ changing expectations.

“But the industry has now reached a tipping point: it has to put an end to hiding behind the challenges of engaging with its stakeholders digitally and stop treating digital as an add-on to existing operations. Rather, it needs to embrace a digital first engagement model with fundamental consequences for its organization and capabilities,” suggests the above A.T. Kearney report.

This fast-evolving disruptive change, I reckon, can only be ignored at one’s own peril. Nonetheless, the good news is, some pharma players have now slowly but surely, started embracing digital to transform their business processes, in search of excellence.

‘Digital India’ initiative to facilitate the process:

Recognizing the increasing importance of digital even across the public space, on July 2, 2015, ‘Digital India’ campaign was launched by the Government of India. This is intended to ensure the availability of public services for all, by making everybody in the country digitally-empowered. The campaign is expected to make India a leader in digitally delivering health, education and banking services, according to information released by the government.

It is generally expected that the creation of a robust digital ecosystem within the country, would facilitate the Indian pharma players, as well, while leveraging this state of the art technology for a quantum leap in business productivity.

The current status – Global pharma industry:

The July 11, 2017 article titled, “Pharma turns to big data to gauge care and pricing”, appeared in the Financial Times, highlighted an interesting point. It described, how the global pharma industry, which has been slow in responding to the fast-evolving digital environment, is now realizing its critical importance. This reckoning gets more strengthened, as it confronts tough external challenges, such as pricing pressures, huge volume of patient data, and more empowered consumers. The article also points out, how digitization has started changing the way pharma players used to interact with doctors, patients and other important stakeholders.

The seriousness in approach of several global pharma majors in leveraging digital technology, to take a quantum leap in the business productivity, is fast increasing. It is evident from the leading drug makers seeking out different skills and personality traits in employees to lead such digital transformation.

Moving towards this direction, Germany based Merck appointed its first chief digital officer, last year. The person holds a degree in biomedical engineering, with a tech background. Following a somewhat different approach, Boehringer Ingelheim – Europe’s biggest private pharma player, hired a new Chief Financial Officer from Lufthansa, who oversees a new digital “lab”, recruiting data specialists and software developers.

Similarly, Swiss drug major – Novartis, also appointed its global head of digital business development and licensing. The head of Human Resources of the company has reportedly expressed, “We’re already seeing how real-time data capture can help analyze patient populations and demographics, to make it easier to recruit patients for clinical trials, and how real-time data-capture devices, like connected sensors and patient engagement apps, are helping to create remote clinical trials that aren’t site-dependent.”

GlaxoSmithKline (GSK) too, reportedly employs more than 50 people to run webinars with physicians – a “multichannel media team” that did not exist five years ago. It has also begun hiring astrophysicists to work in research and development, keen to deploy their ability to visualize huge data sets. According to GSK, these qualities are especially important as the company seeks to use artificial intelligence to help spot patterns and connections amid a mass of information.

That said, global pharma industry still has a considerable distance to cover before it exploits digital technology as successfully and automatically as many other sectors, the article concludes.

The current status – Indian pharma industry:

Veeva Systems Inc.– a leader in the cloud based software for the global life sciences industry, has well captured in a recent report the current status of the Indian pharma industry on the adaptation of digital technology in business.

The report titled ‘The Veeva 2016 Industry Survey: Digital in Indian Pharma’ focuses on the current state of application of digital technology in the business processes of pharma companies in the country. The survey represents the views of respondents from commercial excellence, marketing, sales and IT at domestic and multinational pharmaceutical companies operating in India.

It highlighted, though the pharma companies have remained mostly Rep centric, several of them now realize the importance of increasing focus on customer engagement. Moreover, while the desired access to important physicians has gone down, expectations of the Health Care Professionals (HCPs) have increased, significantly. Alongside, the Government is bringing in more regulations, besides price controls.

The report also captures, though digital technology is slowly making way in the pharma marketing tool kit, it has been more an incremental effort to various Sales Force Excellence projects of the respective companies.

The key findings of the study are as follows:

Nearly two-thirds of respondents agree digital is yet to become a part of their overall pharma DNA, and one-third believe digital is well integrated within their organization.

While companies have initiated digital activities in various silos, one-third of the respondents believe these are tactical in nature, rather than strategic.

21 percent of respondents feel digital should be driven by management, along with 24 percent voting for Digital Marketing. However, with customer relationship at the core of business activities, 31 believe Sales Force and Commercial Excellence are also responsible for the transition.

With integrated digital strategy, pharma companies aim to increase customer touch points through multichannel (93 percent) and improve customer engagement (79 percent). The other benefits of integrated approach are a greater competitive advantage, reduce execution gaps, improve content creation and delivery, and enrich customer data.

59 percent of the respondents believe the industry will see a digital transformation in the next 1-3 years.

69 percent of survey respondents agree it’s time for Indian pharma to think about digital strategically.

The top two challenges that pharma companies face in institutionalizing digital were identified as

Organizational readiness
Lack of digital as a strategy

This latest India specific survey brings to the fore that pharma players will have to move over from patching up old systems or building incremental solutions. They need to realize that digital opportunity is not an incremental approach.

Keeping this in perspective, the study suggests that pharma companies’ approach to digital needs to change substantially in India. This is essential to truly leverage the power of digital that will open the new possibilities to more meaningfully engage, communicate, and be relevant to all the stakeholders for business success.

The traditional face to face “visits” are just not enough for desired productivity, and deriving an adequate return on investments. On the contrary, a time has come to critically evaluate whether various Sales Force Excellence programs are producing increasingly diminishing rate of return on investments, Therefore, this communication process ought to be augmented with innovative digital interventions, for the reasons explained earlier.

With a few organizations leading the way, digital is expected to become a mainstream conversation, ultimately. Thus, Indian pharma players need to think about digital from a long-term perspective, as opposed to the current way of setting short term goals, which may actually become barriers in your digital success, as the survey concludes.

Conclusion:

Pharmaceutical industry, in general, is yet to keep pace with many other sectors, first in acknowledging the game changing power of digital technology, and then adopting it with a crafty application of mind. Nevertheless, the good news is, some drug companies, especially in the global arena, have increased their focus in this area, as elaborated above.

In India, as the recent survey indicates, over 66 percent of respondents admit that digital is yet to become a part of the overall pharma DNA, while the remaining ones believe that digital is well integrated within their organization. Interestingly, even in that group, many would require moving over from patching up old systems or building incremental solutions. It is important for them to realize, sooner, that digital opportunity is not an incremental approach.

‘Digital India’ campaign of the incumbent Government, assures fast strengthening of desirable digital ecosystem in the country. Expected consequential strong wind on the sail must be made use of, effectively. As the saying goes ‘better late than never’, pharma’s late realization of the game changing power of digital technology is much better than no realization at all, which many naysayers indirectly pontificate, of course, under a facade.

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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