Category Archives: Pharma

India’s Preparedness Against Biological Threats

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Recent Coronavirus outbreak poses a ‘very grave threat to the rest of the world’ – the head of the World Health Organization (WHO), reportedly said on February 11, 2020. Earlier, on January 28, 2020, it had changed the viruses’ risk-status from ‘moderate’ to ‘high’. As it creates a havoc in China, Coronavirus has recorded a limited spread in India, besides France, Canada, US, Japan, Thailand, Sri Lanka. This article will explore how prepared is India to tackle any similar biological threat to protect its citizens from a possible health catastrophe.

Let me begin by assessing pros and cons of the current initiatives of the Indian Government, both at the Center, as well as, in the States, in this regard.

The pros and cons:

Some of the ‘pros’, that the Ministry of Health and Family Welfare promptly initiated are as follows:

  • Updated Travel advisory for travelers visiting China. 
  • Discharge policy for suspected or confirmed novel Coronavirus (2019-nCoV) cases.
  • Guidelines on Clinical management of Severe Acute Respiratory Illness (SARI) in suspect/confirmed 2019-nCoV cases.
  • Guidance on surveillance for human infection with 2019-nCoV.
  • Guidelines for ‘Infection Prevention and Control in Healthcare Facilities’.
  • Guidance for sample collection, packaging and transportation for 2019-nCov.

The above steps are as commendable as some other prompt initiatives of the Ministry to stop Coronavirus from entering the country, such as leveraging technology for both thermal and symptomatic screening, especially at the high-risk airports.

However, according to global experts – India, along with several other countries are still ill prepared to face biological threats of a magnitude that we are now witnessing in China. On the other hand, according to February 12, 2020 publication of The World Economic Forum, there about a dozen of countries in the world who are best prepared for meeting similar health emergencies.

Similar calamity was predicted two years back by W.H.O: 

Interestingly, a similar situation was predicted by none other than Tedros Adhanom, Director General of the World Health Organization and was reported on February 15, 2018. He then said, “We have a problem. A serious one. At any moment, a life-threatening global pandemic could spring up and wipe out a significant amount of human life on this planet. The death toll would be catastrophic. One disease could see as many as 100 million dead.”

“This is not some future nightmare scenario,” he added. “This is what happened exactly 100 years ago during the Spanish flu epidemic.” Again: “A devastating epidemic could start in any country at any time and kill millions of people because we are still not prepared. The world remains vulnerable.”Explaining the reason for the same, the Director General pinpointed: “The threat of a global pandemic comes from our apathy, from our staunch refusal to act to save ourselves — a refusal that finds its heart in our indifference and our greed.”

Now, when the world is grappling with the menace of Coronavirus – may not be at the predicted global scale yet, those comments haunt us again. It flags each country’s preparedness to deal with such pandemic, as and when it strikes, unannounced.

‘Countries best prepared for health emergencies’ – and India:

The February 12, 2020 publication of The World Economic Forum, as indicated above, highlights several important realities of this subject. Let me quote below just two of these, which, I reckon, are the most profound:

  • National health security is fundamentally weak around the world, and none is fully prepared to handle such an outbreak.
  • Global biological risks are in many cases growing faster than governments and science can keep up.

Acknowledging these facts, based on the Global Health Security Index, the most prepared ones for epidemics or pandemics of all types were listed among 195 countries surveyed. Measured on a scale from 0-100, the US ranks as the “most prepared” nation (scoring 83.5). Next comes UK (77.9), the Netherlands (75.6), Australia (75.5) and Canada (75.3) featuring behind it.

Thailand and South Korea are the only countries outside of the West that rank in this category. China, the most populated country in the world – which is also at the center of the Coronavirus outbreak – is in 51st place, scoring 48.2. And, India, the second most populated country ranks 57 with a score of 46.5. The obvious question that comes up: Why India ranks so low in the Global Health Security Index, among 195 countries?

Knowing the risk – not enough, building capability is a must:

The above details will give a sense of risk exposure to pandemic or epidemic, like Coronavirus, for a country. As the experts point out, just knowing the level of risk exposures, is far from enough. Each Government has a fundamental duty to build capabilities for protecting its people from the disastrous consequences of any possible biological threat, as and when it strikes. This will call for taking quantifiable financial and other measures to fill the existing gaps in the epidemic and pandemic preparedness, as captured in many studies. 

India’s budgetary allocation for health remains frugal:

It gets reflected even in the Union Budget 2020-21for the health care sector. Although, the total allocation for the sector was about 10 percent higher from the year ago. The increase seems negligible, considering consumer price index inflation was 7.5 percent in December 2019, as analyzed by the publication Down to Earth on February 02, 2020.

The report said, over 50 percent of the increase will go into offsetting inflation and we don’t seem to be anywhere near achieving the target of allocating 2.5 percent GDP to health by 2025, as envisaged by even the current government.

More relevant to this discussion, the allocation towards schemes dealing with communicable diseases, in general, has remained unchanged, especially when ‘Indians are getting sick mostly due to infections’, according to NSSO study, as reported on November 25, 2019.

India’s ability to contain epidemic is much less than China:

In a relative yardstick, China, reportedly, has built a better health care infrastructure than India to respond to various health related needs of the country’s population, including emergency situation, such as Coronavirus. Some of the key reasons, for example, are as follows:

  • While India shows one of the lowest government-spend on public health care, as a percentage of GDP, and the lowest per capita health spend, China spends 5.6 times more. 
  • When Indians met more than 62 percent of their health expenses from their personal savings, as ‘out-of-pocket expenses’, the same is 54 per cent in China.
  • India’s ability to quarantine a large number of infected people is much limited as compared to China.
  • Health service delivery system, especially for over 70 percent of the rural population of India, lack adequate scientific and skilled manpower, alongside necessary emergency equipment to provide care to a large number of patients at the same time, if epidemics strike.
  • Around 74 percent of health care professionals happen to be concentrated in urban areas, catering to just a third of Indian population, leaving rural areas under-served, according to a KPMG report. Alongside, the country is 81 percent short of specialists at rural community health centers (CHCs).

Conclusion:

The recent Coronavirus outbreak sends a strong signal to public health authorities, across the world, about the task-cut out for them to catch the early signs of possible epidemics. Many countries, especially India, have much ground to cover to ensure the right level of preparedness in countering such unannounced biological threats.

Capacity building for prevention, early detection, taking medical countermeasures – to contain the fast spread of the deadly organisms, and effective treatment response at the earliest, is the need of the hour. India also needs to develop capabilities for rapid development of drugs and vaccines in such a situation, fighting against time. Quoting the National Institute of Virology, some recent reports indicate that India’s scientific expertise and manpower aren’t enough, just yet, to deal with similar crises.

India’s public healthcare system and its delivery mechanism are still not robust enough either to keep in quarantine or in providing effective treatment and care for a large number of patients during any epidemic situation.

Against this perspective, I reckon, India is still grossly underprepared to face any biological threat, if it strikes with all its might. In that sense, the scary Coronavirus episode may be construed as yet another wake-up call to break the perceived slumber of the Government, if not apathy, as it were.

Thus, the question that surfaces: Shouldn’t the country, at least now, deploy enough resources to protect its citizens from any possible biological threats and aggression, just as it does, to provide safety, security and well-being of the population against any other external or internal threats?

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.

An Essential ‘Acrobatic Feat’ Remains Relevant Even In Digital Pharma World

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“A manager must, so to speak, keep his nose to the grindstone while lifting his eyes to the hills — quite an acrobatic feat!” This profound statement was articulated by the Management Guru of all-time – Peter F. Drucker, in his book named “The Practice of Management.” This book was published probably before many management experts of today were even born – in 1954. This epic quote of Drucker is in context of the critical requirement to harmonize management decisions affecting the short and the long-term strategic business goals.

While looking at the pharma industry from the above perspective, one may often find, the quality-time spent, especially by its marketers, on ‘lifting their eyes to the hills’ – looking for the early signals on critical changes in future success requirement – is often minimal. Most seem comfortable in ‘keeping their nose to the grindstone’ to deliver the short-term objectives, with a belief that the future brand success factors will replicate the present ones. Thus, honing the current strategies would automatically ensure achieving the long-term requirements.

This prompts a question, should pharma marketers predominantly concentrate on sharpening their traditional marketing tools for near-term excellence or reach out much beyond that? Today’s article will deliberate on this subject, in the context of changing market dynamics and consumer expectations in the today’s world.

Are the brand success parameters changing?

Scores of data-based assessments of progressive changes in the customer value trend, highlight significant shifts from the past, necessitating an overhaul of the value delivery parameters and the system – not just honing. More often than not, such reconditioning could even be disruptive in nature – as may happen with the change to a well-integrated digital marketing system.

For example, until recently pharma brands used to be differentiated primarily based on its intrinsic key features and benefits, like efficacy and speed of recovery, safety and side-effects profile, ease of compliance and nature of drug interactions during concomitant use and more. Today, the parameters of brand differentiation have gone much beyond that, which could have been captured by an astute marketer while ‘lifting his eyes to the hills’, alongside ‘keeping his nose to the grindstone.’

The evolving parameters of brand-differentiation are not just restricted to the features and benefits, but call for unique customer value creation – such as providing a unique treatment experience to patients – understanding their needs, expectations and preferences. This, in turn, change the traditional pharma marketing ball game, as the success ingredients are so different.

Capturing, conceptualizing and delivering customer value, following the traditional pharma marketing tools and processes will increasingly be a daunting task. New digital tools and platforms – well-integrated into the evolving pharma marketing processes, would be necessary to win customers’ share of mind, more effectively than ever before. Nevertheless, value delivery still remains at the core of the pharma marketing system.

Value delivery still remains at the core – with significant changes: 

Value delivery will always remain the core purpose, and a constant factor in pharma marketing initiatives. It was so in the past, is at present, and will continue to be in the future, regardless of changes in the market and customer dynamics.

Nonetheless, what is construed as ‘value’ to capture a sizeable share of consumers’ mind has changed. Traditionally, it has been mostly intrinsic to the organization, revolving around the product features and benefits, as stated earlier. But, today, it is getting more focused on the extrinsic factor – related to the customers.

Thus, creating a unique experience for them with the brand has become the new challenge of change to pharma marketers for performance excellence, as I discussed in one of my recent articles. Consequently, providing this external and well-researched ‘customer-centric value’ has become the new brand differentiator.

While ‘lifting eyes to the hills’, some interesting findings:

Among many others, Decision Support Group (DCG), as well, while ‘lifting their eyes to the hills,’ well-captured the emerging consumer expectations in health care through a detailed study. This was published as ‘Cybercitizen Health Infographic’ on October 27, 2015. Let me paraphrase below some of the important findings of this study:

  • As customers are expecting pharma to provide best-in-class patient experience and associated services in the disease treatment process, marketers need to differentiate brands through these parameters.
  • 59 percent of health care consumers expect brand experiences and services beyond what the physical brand offers.
  • Only 8 percent of the respondents said pharma companies are providing a better customer experience than 2 years ago, while 30 percent said so for doctors, and 21 percent regarding pharmacists.
  • 40 percent of the consumers who value experience as much as drug effectiveness, would pay a little more for a drug or a health procedure.

How is this extrinsic value measured?

As confirmed by several studies, going beyond what a physical pharma brand would offer, the customers, including individuals who pay from the pocket for a disease treatment, measure the value of a drug today differently. It is now predominately by outcomes, the patients’ overall experience during the treatment, and overall – cost-effectiveness of the entire process, and not just the medicine.

Thus, the pharma market is sending a clear signal to the marketers to ‘shape up’ accordingly, soon and start with measuring care by outcomes – going beyond the product features and benefits – just as patients would do. If not, there could be a strong possibility of being ‘shipped out’, as the marketing productivity could head south, with more capable professionals filling up the void.

Commensurate changes in marketing success measurement:

The emerging changes in measuring ‘marketing success’ were aptly demonstrated in the article, ‘Redefining Value: What Value-Based Care Means for Pharma’, published by the Intouch Solutions on July 07, 2016.

It said: ‘Once, success simply meant a “blockbuster” – a drug that sold enough.’ However, this paradigm is shifting. Soon, it will be measured by the value of outcomes with the brand – the positive impact that it creates on the patient’s health, leaving behind a unique treatment experience.

To be successful with the brand, the marketer will, therefore, need to create a genuine, credible and powerful data-based outcome story. It should effectively demonstrate how the unique brand value offerings, supported by services can make it possible. The services may include, among others:

  • Supporting patients in managing their condition as part of their life.
  • Educating patients and helping them feel empowered in the treatment decision making process.
  • Helping patient access to medication.
  • Assisting patients in developing and maintaining a healthy lifestyle.

For many pharma marketers this exercise will involve a strategic shift in their thinking process. Embracing a fundamental change in the way they have been practicing traditional pharma marketing all these years.

Are some of these changes disruptive in nature?

Several of the aforesaid changes may appear disruptive to many, causing a discomfort of moving out of their comfort zones. Some may even try to wish it away, and continue practicing the traditional pathways as long as these help achieving some results. But, not certainly for a long while. In which case, it will be akin to delaying a greater disruption before ultimately getting caught off-guard.

Dr. Vas Narasimhan, Chief Executive of the Swiss pharmaceutical giant Novartis, puts it nicely. He advised, ‘the key to surviving disruption is understanding that a leader needs to be prepared to embrace it – even if that means willfully disrupting yourself.’

However, the good news is, digital transformation of a business makes embracing this change less difficult. Which is why, a number of companies are trying to seriously engage in digital marketing. Let me hasten to add, the ‘digital transformation process’, regardless of promises that many self-styled experts would make, is tough. It makes the organization chart an uncharted frontier and starts from the very top.

Digital transformation follows an arduous path, starting from the very top: 

There are many descriptions of the ‘digital transformation process’. However, the one that appealed to me is the one that comes from the Agile Elephant. It describes the process as follows:

‘Digital transformation is the process of shifting your organization from a legacy approach to new ways of working and thinking using digital, social, mobile and emerging technologies.  It involves a change in leadership, different thinking, the encouragement of innovation and new business models, incorporating digitization of assets and an increased use of technology to improve the experience of your organization’s employees, customers, suppliers, partners and stakeholders.’

The recent examples in this regard that come at the top of my mind, include:

Does digital marketing transform the brand value delivery process? 

Digital marketing facilitates the new and extrinsic brand value delivery process, as the use of this technology is all pervasive in our everyday life. Interestingly, almost all businesses, mostly in the organized sectors and technology startups, are trying to leverage digital technology to create sets of differential customer values.

And then integrating those to the core marketing strategy, for effective delivery of a crafted solution to the patients’ comprehensive needs, will be a challenging task. Moving in this direction, besides creating interactive websites, many drug players are using a number of digital tools, including social media sites, to start with. These are all serving as integrated digital marketing platforms to engage with targeted customers.

It’s apparently a foregone conclusion today that ‘the traditional one-way relationship in our health care system, will soon change to two-way relationship.’ Where interactive digital marketing, social media and other similar platforms, will facilitate building such relationship for a meaningful exchange of information with the target groups, transforming in the healthcare landscape.

Some key transformation areas with the digital marketing system:

As Agile Elephant puts it, the following are a few examples of key healthcare transformation areas with digital marketing:

  • The efficacy of treatment will be transparent with cost-effective data-based outcomes story.
  • Data transparency will follow data visualization enhancing how patient data is communicated to them, or how certain medications and treatments are affecting different areas of the physiological system.
  • Patients will be empowered to play an active role in their health care.
  • Patients disease treatment experience could be optimized across multiple touchpoints’.

Conclusion:

Currently, it appears, most pharma marketers ‘keep their nose to the grindstone’ to continue honing the traditional processes of brand marketing with an expectation for better return. However, if they could find time for ‘lifting eyes to the hills’ with all seriousness, they will be able to sense a shifting paradigm with a new set of marketing success factors. If not done even now, it could perhaps be too late to make amends for business sustainability.

Many may get carried away by the hype of digitalization as a panacea, but this is just a facilitating technology – to be in sync with, among others, the evolving values of pharma customers, through innovative value delivery systems. Regardless of digitalization all around us, the name of the game that differentiate men from the boys in this game, remains – generation of cutting-edge ideas. Only this can transform – effective delivery of differentiated ‘customer value’ into business excellence.

Interestingly, to accomplish this objective meaningfully, the aforesaid ‘acrobatic feat’, as enunciated by Peter Drucker in 1954, remains relevant and essential for pharma marketers, just as all other managers, even in the digital pharma world.

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.

Criticality of Drug Quality In The Moment Of Truth

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When global health emergencies strike unannounced – in the scale and magnitude of new coronavirus, it shakes the health care system of all countries, in varying degree though, irrespective of the robustness of the economy. In such situation, the robustness of health care infrastructure, stringent manufacturing quality standards, operational flexibility for seamless sourcing of all drug ingredients in the required quantities, besides speed and agility of the delivery system – are put to the acid test.

Anytime readiness to effectively neutralize this crisis is of utmost importance. Accordingly, the key national goal should be to create a robust ‘whole’ that is much more than the sum total of each of each of the above factors – a sturdy ‘drug security system’ for the country. The most populous country of the world – China may have succeeded in building a 1,600-bed hospital coronavirus hospital in just 10 days, completing on February 05, 20120. But it is still looking for necessary drugs from other countries, such as the United States.

Curiously, China hasn’t yet disclosed its reason. More so, when the country is the top global supplier of Active Pharmaceutical Ingredients (API), including antiretroviral (ARV) drugs, along with India, according to the World Health Organization (W.H.O). This draws many to look at the general apprehension on the questionable quality of drugs that China, allegedly, produces. But, could this be the reason?

Nevertheless, regardless of inquisitiveness to know the reason, the question mark on its drug quality remains. And this is also not the risk-taking time for any nation, as it could possibly endanger lives of scores of the impacted population. The criticality of drug quality in ‘The Moment of Truth,’ such as, the new coronavirus emergency, can only be wished away at one’s own peril.

On the other hand, the confidence expressed in India, as we shall see below, in ‘drug security’, just based on adequate ARV drug availability appears to be coming from a different plane, although the drug quality issue is exactly the same in India, if not more concerning. From the above perspective, my today’s article will focus on this subject, purely based on available data, starting with the request of the Chinese authorities for ARV drugs from the United States.

Chinese request for ARV drugs:

‘U.S. Drugmakers Ship Therapies to China, Seeking to Treat Coronavirus – AbbVie, Gilead, others respond to Chinese authorities’ requests for antiviral drugs to test effectiveness against deadly respiratory illness.’ This was reported by The Wall Street Journal (WSJ) on January 27, 2020. It goes without saying that these antiviral drugs also include Anti-Retrovirals (ARVs).

AbbVie Inc. and Johnson & Johnson  are among the drug makers that have begun shipping drugs approved to treat HIV, while Gilead Sciences Inc. is exploring whether it should send an antiviral therapy it is developing.

It isn’t known whether the drugs would be able to help contain the explosion of respiratory virus infections sweeping the country or provide relief to infected patients. Chinese authorities have requested the shipments to test the drugs’ effectiveness in containing the new coronavirus, the report added.

An intriguing difference between India and China:

Interestingly, China is looking for sourcing some of these ARV drugs from the United States and not from India, either – one of the top producers of these drugs, as W.H.O reported.

In contrast, according to an Indian report of February 04, 2020: ‘Leading domestic drug companies have said they are ready with supply of anti-retrovirals (ARVs) that seem to work in treating the novel coronavirus (2019-nCoV).’

As I said earlier, although, China hasn’t yet specified the reasons behind their decision on ARV drug import from the United States, but could it have any link on the internal general apprehension of these drugs quality, safety and effectiveness?

Acknowledging for a moment that this is global allegation on Chinese drugs, in general. So is regarding India, as we shall see below. Then where does India stand on this score, especially in view of the confidence with ARV drugs, as exhibited in the above media report from India? That said, the logical question that surfaces now – why is the request for ARV drugs?

Why ARV drugs?

Although W.H.O said that there is ‘No known effective treatments’ for new coronavirus, as yet, various reports do indicate the use of ARV drugs in the treatment of 2019-nCoV:

  • A combination of flu and HIV medications are helping treat severe cases of the new coronavirus in Thailand.
  • Chinese health officials are already administering the HIV and flu drugs to fight the coronavirus, but the combination of the three together in a cocktail seemed to improve the treatment.

The Scientist, on February 02, 2020 reported that large doses of the flu drug oseltamivir combined with HIV drugs lopinavir and ritonavir, reportedly, improved the conditions of several patients in Bangkok, Thailand.

Global dependence on Chinese and Indian generic drugs:

About 80 percent of the Active Pharmaceutical Ingredients (APIs), including many ARVs, which are used for manufacturing of drug formulations in the United States are said to come from China and other countries like India. This appeared in the article titled, ‘U.S. Dependence on Pharmaceutical Products From China,’ published by the Council on Foreign Relations (CFR) on August 14, 2019.

India’s dependence on Chinese APIs:

Latest statistics from Directorate General of Commercial Intelligence and Statistics tabled in the Parliament show that in 2017-18, Indian imports of APIs and drug intermediates from China increased to 68.36 per cent. The same at 67.56 per cent in 2018-19, still remained the largest share in total Indian imports, with the overall India’s dependence on imports going up by 23 per cent from 2016-17 to 2018-19.

As reported in the media on November 22, 2019, India’s national strategies, such as, “2015 – Year of Active Pharmaceutical Ingredients” or ‘Make in India’ campaign, to promote indigenous means of production continue to be relegated on paper. Even, the current National Security Advisor had warned that Chinese dependence on API can be a national security threat.

According to the Department of Pharmaceuticals (DoP), Chinese API imports are due to economic considerations, which are essentially cheaper and more cost-effective for the Indian drug manufacturers, the above report highlighted.

Against this backdrop, the above local media report indicating, leading domestic drug companies are ready to supply anti-retrovirals (ARVs), may invite more questions than answers. Added to this come the critical quality issues with drugs manufactured in China and India.

Quality issues with Chinese drugs:

Credible documents highlight, as China’s pharmaceutical industry is not effectively regulated by the Chinese government, its regulatory apparatus is inadequately resourced to oversee thousands of Chinese drug manufacturers. Even if Beijing made such oversight a greater priority. This has resulted in significant drug safety scandals.

Although, the drug quality related concerns seem to be even more related to India, the drug industry of the country, reportedly, remains in a denial over most of such charges involving drug-quality.

India tops with the most quality related FDA warning letters in 2019:

The author of the above article reiterates, ‘Americans are expecting India, which supplies a significant percentage of the finished drug supply in the U.S., to get its act together to improve the quality of the medicines it makes, I am afraid they will be waiting a long time for that to happen. The only solution is for American lawmakers to enact new regulations focused on holding those who intentionally put public health at risk to account.’

To avoid ‘your-opinion-versus-my-opinion’ type of a debate with this article, let us look at some hard facts. These are from the ‘warning letters’ on drug quality, issued to various pharma companies, across the world, by the USFDA’s Center for Drug Evaluation and Research (CDER). The details were well captured in an article, titled ‘The country with the most FDA warning letters in 2019,’ published by Pharma Manufacturing on January 20, 2020.

Some key CDER findings:

As I consider, the top three CDER findings may be summarized as follows:

  • In 2019, CDER issued dozens warning letters for manufacturing issues to pharma companies outside the U.S. One country in particular – India – received the highest number of letters.
  • CDER’s office of Manufacturing Quality Letters issued 43 letters to companies outside of the U.S. Of those letters:

-   20 were aimed at facilities in India.

-   With 11, China received the second most manufacturing quality warning letters.

-   The rest of the letters were distributed among plants in Europe, Costa Rica, Singapore, Turkey and others.

  • The data from CDER shows that India has the poorest rate of FDA inspections with acceptable outcomes (83 percent) — much lower than China (90 percent) and the U.S. (93 percent).

Conclusion:

Today, a host of effective drugs and vaccines are available to treat a number of both non-infectious and infectious ailments, including many life-threatening viral diseases. However, the effectiveness of these medicines in treating such diseases, as well as many other illnesses, gets significantly compromised by questionable quality and distribution of these medicinal products. Even way back, a similar concern was deliberated in an article captioned, ‘Substandard drugs: a potential crisis for public health’, published in the British Journal of Clinical Pharmacology (BJCP), on November 29, 2013..

It may ordinarily remain undetected, sans stringent and wide-scale regulatory scrutiny. Additionally, a number of involved countries still remain in a denial mode. It’s also a fact, several governments may not have wherewithal for the same, particularly when the manufacturing units are too many, such as in China and India.

However, when a critical national health emergency strikes, unannounced, like the new coronavirus, the moment of truth dawns. Obviously, the national governments would want to be risk averse and prefer sourcing the best of drugs, to rapidly contain the spread of the disease, saving more lives. It’s not difficult to fathom, either, any country is unlikely to admit this reality, in public, even while taking measures for the same.

China’s sourcing of ARV and other drugs from the United States may or may not be due to the drug quality reasons. Nonetheless, I reckon, the criticality of drug quality issues can possibly be best realized, mostly when the ‘Moment of Truth’ arrives. Unannounced! Just like a bolt from the blue!

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.

China Coronavirus And API Sourcing – A Threat… Or An Opportunity For India?

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‘2015 – Year of Active Pharmaceutical Ingredients’ (API), announced the Government of India by a Press Release on February 25, 2015. This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’.

Two years down the line, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ It reiterated, India has proven capabilities in the generic drug formulations, but over dependence on China for sourcing – 70-75 per cent of APIs does not augur well for the Indian pharmaceutical sector. Because, as any interruption in supply from China can badly impact the sector, jeopardizing the health of millions of people, not just in India, but across the world, as well.

The reason for Indian drug formulation makers depending on China-supplied APIs, is mainly for its low cost, and not for any technological other reason, the article said. Regardless of the India’s announcement – ‘2015 as the year of API’, the API industry continued to struggle without much tangible support. Despite a lot of decisions still being in the pipeline, let me hasten to add, some inconclusive signs of early recovery have been captured in this space by some recent studies.

With the outbreak of the recent ‘coronavirus’ menace, the moment of truth has arrived in the country. On the one hand, it is posing a threat to the country’s API sourcing, on the other it could throw open a door of opportunity for Indian API manufacturers, as the Chinese API prices would start climbing up. But the question is, in which way it would evolve? In this article, I shall focus on this aspect of the new coronavirus menace, starting with a brief description of the background.

China coronavirus – when the alarm bell rang: 

According to the World Health Organization (WHO), on December 31, 2019, it was alerted to several cases of pneumonia in Wuhan City, Hubei Province of China. The virus did not match any other known virus, raising a great concern. No one knows how it affects people who are sick with it – how they can be treated, and what the countries can do to respond. One week later, on 7 January, Chinese authorities confirmed that they had identified a new virus.

What it does?

This new virus is a coronavirus, which is a large family of viruses that cause illnesses ranging from the common cold to more severe diseases, such as Severe Acute Respiratory Syndrome, such as SARS and MERS.

Since the virus, reportedly was first detected in Wuhan in people who had visited a local seafood and animal market, it is likely to have transmitted from an animal to humans. Nevertheless, several known coronaviruses are known to be circulating in animals that have not yet infected humans. The new coronavirus has been named novel coronavirus (2019-nCoV) and is the seventh coronavirus known to affect humans.

W.H.O has been working with Chinese authorities and global experts to learn more about it. However, because this is a coronavirus, which usually causes respiratory illness, the world body has circulated advice to people on how to protect themselves and those around them from getting the disease.

The damage, thus far:

Bloomberg on February 02, 2020 reported the death toll from the coronavirus outbreak has risen to 305, with 14,555 confirmed cases worldwide.  The first death outside of China took place in the Philippines on February 01. Alarmingly, 2019-nCoV infections have also spread to at least 15 other countries. These numbers keep increasing.

Nearer home, India, on January 30, 2020, also announced its first case. “One positive case of Novel Coronavirus – a student studying in Wuhan University — has been reported from Kerala,” said a statement released by the Health Ministry. On February 02, 2020, Reuters reported the second case of coronavirus in Kerala.

This scenario prompted the World Health Organization (WHO) to meet again on the last Thursday and declare the new coronavirus an international public health emergency.

The impact on the pharma industry:

Responding to the criticality of this situation, health authorities across the world are trying to put in place effective ways to overcome this crisis. In the healthcare space, medical scientists are ‘racing to develop a vaccine to protect people from the virus.’ One lab in California, reportedly. has plans for a potential vaccine to enter human trials by June or July this year.

Alongside, many are wondering about the looming threat that it poses on the API sourcing from China by the global pharmaceutical industry, including India. However, as I said earlier, some Indian experts, are also sensing an opportunity for country’s API manufacturers to fill the possible void, as it gets created.

API sourcing concern:

An exclusive survey conducted by Kemiex, titled ‘Coronavirus impact analysis for APIs, feed and food additives,’ among 97 life sciences professionals, published by them on January 20, 2020, reports some interesting findings. Some of the key ones are, as follows:

  • 85 percent experts foresee API and other ingredient supply disruptions, with 35 percent expecting a high and 50 percent envisaging a low impact.
  • Orders planned for the 1st quarter with delivery in 2nd quarter are expected to be mostly affected, while disruptions might continue a quarter. Only a minority believes the disruptions will last until year end or beyond 2020.
  • The biggest impact is expected from extended Chinese New Year holidays and delayed production start.
  • A first impact analysis based on preliminary information shows that only selected products such as amino acids (taurine…), certain vitamins and other APIs and additives could be affected.
  • European and other suppliers report readiness and stocks to secure delivery to end users during interruptions in China, or some of its districts. respectively.

However, other reports also underscore, with the proliferation of the new coronavirus the incidences of confirmed infection with clear symptoms and deaths are also expected to increase. This may lead the Chinese government to extend lock down several commercially important parts of the country. Which, in turn, could impact, among others, manufacturing and shipments of API and pharma ingredients for several months.

Some green shoots are now visible in India?

Quoting a JM Financial analysis, some media reports predicted, a worsening coronavirus crisis may benefit Indian API manufacturers, as it observed some green shoots in the Indian API manufacturing space. Analyzing the stocks of six local API manufacturers – Galaxy Surfactants Ltd., Fine Organic Industries Ltd., Navin Fluorine International Ltd., SRF Ltd., PI Industries Ltd. and UPL Ltd., it found that the stocks of these companies have beaten the market trend in recent years. They observed, the robust growth of these companies was fueled by end-user industries, and exports to China – which has closed many chemical facilities on environmental concerns.

Moreover, the increase in overall API demand – caused by shortages triggered by a serious disruption of API production in China’s Hubei province, and restriction of movement within China, is likely to drive the prices up with the spread of the epidemic. The cumulative impact of all this, would possibly help the Indian bulk drug manufacturers, significantly, helping India to tide over the API sourcing crisis.

Conclusion:

‘Scientists are racing to develop a coronavirus vaccine, but it could take years to reach the market,’ as media reports highlight. Meanwhile, researchers are, reportedly, also looking at ways of quickly repurposing existing antiviral drugs to see whether any might work against the new coronavirus.

The serious health menace caused by the new coronavirus that prompted the W.H.O to signal it as a global emergency, has also raised a serious concern on API sourcing. This is because, around 80 percent of the API used by drug formulation manufacturers is sourced from China.

Looking only at this aspect of the issue, and also from the Indian perspective, the point to ponder – is it all threat? Or a veiled opportunity worth cashing-on to neutralize, at least, a part of the API sourcing threat?

Against the backdrop of the Indian Government’s announcements, such as, ‘2015 – Year of Active Pharmaceutical Ingredients’ (API), alongside the well-publicized ‘Make in India’ campaign, and some recently reported green shoots in this area – the expectation of an ‘opportunity in waiting’, could well be a reality. Who knows? But, a lurking apprehension still lingers!

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.

What Pays More: Creating ‘Innovative ‘Customer Experience’ Or ‘Innovative Drugs’?

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More innovative a drug is, the better is its business success rate. This was the general perception of around 92 percent pharma professionals in the past three years. Whereas the fact is: ‘Having the best product doesn’t guarantee sales anymore’. This was established by a research study of the ‘Bain & Company’ - covering multiple therapeutic areas, and was published on October 14, 2019.

It showed, when physicians prescribe a drug – its efficacy, safety and side-effect profile initially account for only 50 percent to 60 percent of the physician’s choice, with a declining trend over time. Interestingly, the other 40 percent to 50 percent of it, is based on a range of ‘physician and patient experience factors’, which pharma players need to target in innovative ways to differentiate their brands.

Many pharma companies are now experiencing the harsh reality that more innovative drugs, backed by traditional sales and marketing support are not yielding desirable financial returns. Head scratching has already started among astute pharma professionals to understand its reason for remedial measures. Thus, the number of executives who agreed with the above ‘Bain & Co’ study that: ‘Having the best product doesn’t guarantee sales anymore,’ increased to almost fourfold – from 8 percent to 28 percent in the next three years.

Thus, in this article, I shall explore whether innovation in creating a ‘unique patient experience’ during a disease treatment process, is as important, if not more than a ‘new drug innovation’. Curiously, high failure rate of most pharma players to innovate in this area, isn’t discussed as much as high failure rates in the development of innovative new drugs.

‘Customer service’ innovation – high failure rate – falling short of expectations:

Again, another article - ‘How Agile Is Powering Healthcare Innovation,’ published by ‘Bain & Company’ on June 20, 2019, brought out some interesting points related to this area. Let me quote a few of which as follows:

  • 65 percent of ‘customer-service innovation’ fall short of expectations of the target group.
  • The number of health care executives recognizing the need to respond quickly to changing customer-needs, has increased from 38 percent in the past three years to 60 percent for the next 3 years. But, most of them ‘lack the methodology, and even the language to implement it in practice.’
  • ‘Having the best product doesn’t guarantee sales anymore.’ Thus, healthcare companies face growing pressure to innovate in providing unique ‘customer experience’.
  • The critical point to note, customer needs evolve continuously, and leading companies respond rapidly with innovative new solutions catering to changing market demand.

As the core purpose of working for ‘customer-service innovation’ is linked with creating ‘brand loyalty’, let’s have a quick recap on ‘brand loyalty’ really means for pharmaceutical products, in today’s context.

‘Brand loyalty’ for pharmaceutical products in modern times:

There are many similar definitions of ‘brand loyalty’ for a pharmaceutical product. The research article – ‘Brand Loyalty as a Strategy for the Competition with Generic Drugs: Physicians Perspective,’ published in the Journal of Developing Drugs, on August 30, 2016, defined ‘brand loyalty,’ and articulated its advantages.‘ I am paraphrasing a few of which, as below:

  • The extent of the faithfulness to a particular brand, which is a major indicator of a long-term financial performance of companies.
  • The main advantages of brand loyalty can be defined as greater sales and revenue, a substantial entry barrier to competitors, increase in a company’s ability to respond to competitive threats and lower consumer price sensitivity.
  • ‘Brand loyalty’ can protect against price competition, including branded generics, as it gives confidence to physicians on the perceived effectiveness and safety of a brand – which they usually won’t be willing to compromise with for lower prices.

This brings us to a key question. Are traditional pharma methods of creating ‘brand loyalty’ getting replaced by the key consideration of creating a ‘unique customer experience’?

Creating ‘brand loyalty’ through ‘patient loyalty’ – a new equation:

It’s a fact today that traditional pharma methods of creating ‘brand loyalty’ is getting replaced by the key consideration of creating a ‘unique customer experience.’ This, in turn, is increasing the need of building ‘patient loyalty’, both for a pharma brand, as well as respective companies offering these brands. This is a new equation, where offering a ‘unique treatment experience’ to patients assumes a critical role more than ever before. This needs to be clearly understood by today’s pharma marketer, without any ambiguity.

In traditional pharma marketing, physicians remain, virtually, the sole focus of the branding exercise, as they appear to be the only decision makers of writing a brand prescription. Patients, in general, hardly used to have any role to play in that process. In this scenario, brand loyalty for the doctors – assuming the absence of any malpractices, is primarily driven by the following three much known factors:

  • Physicians’ unprejudiced buying-in a brand’s value offerings
  • Evaluation of opinion leaders and the doctors’ professional counterparts,
  • Quality of disease treatment outcomes.

Nevertheless, before getting into this area, let’s have a quick look at the primary drivers that pharma marketers have been using to boost financial performance of a brand.

Traditional sales boosters of a pharma brand:

The primary drivers that pharma marketers have been using to boost financial performance of a brand can broadly be classified as follows:

  • Multiple ways are followed to make important doctors write more prescriptions,
  • Increase the drug price, whenever an opportunity arises.

These factors still remain important, but aren’t just enough to deliver sustainable performance over a period of time. Thus, a new dimension needs to be added to it.

Add a new dimension to create brand and corporate loyalty:

With the emergence of increasingly more informed and demanding patients, there is a need to create a ‘loyal patient population’, by offering them primarily a ‘unique treatment experience’. And this is the new dimension.

For this purpose, off-the cuff approaches or strategies based on mere gut-feelings are unlikely to work. As I indicated in one of my articles, marketers need to acquire deep insights on their customers to make sales and marketing decisions more informed, than what it is today. Currently available state of the art technology can be a great enabler to facilitate this process.

This is easier said than done, because answering the question – how does a drug company create ‘brand loyalty’, is indeed a tough call. Nonetheless, many different industries have realized, since long, that offering a ‘unique customer experience’, is critical to create a pool of ‘loyal customers’.

I also had written earlier, pharma is still a late learner in accepting various new normal, in a holistic way. Accepting this reality, a sharp focus on creating ‘brand loyal doctors’ in various innovative ways, I reckon, will serve this purpose well. It’s only recently, a few companies have started working to offer such ‘experience’ to patients in the disease treatment process - end-to-end. Ironically, a large majority of them prefer to talk about it more than actually translating the same into reality.

Benefits of ‘brand loyalty’ through ‘unique customer experience’:

There are several advantages of building pharma ‘brand loyalty’ by offering ‘unique customer experience, without diluting the focus on ‘increasing prescription generation through doctors’. The benefits, I reckon, include, both new – innovative products and also branded generics. Let me give below one example of each:

  • Innovative new-products – positive word-of-mouth promotion: Satisfied patients having ‘unique end-to-end treatment experience’ with a new, innovative brand, are very likely to share it with others. This may be done by using different modes of communication, including various social-media platforms. This, in turn, may help both – add to take-off speed – post launch and create a snowballing impact on the brand adoption thereafter.
  • Branded generics – extend the product life cycle and increase growth: Patients who are loyal to a particular branded version of a generic molecule, are quite likely to refuse any change to a cheaper equivalent, even if recommended by the physician. Moreover, they will advocate for this brand to others, using different communication platforms, as indicated above. Continuation of this process will extend the life cycle of the branded-generic, with increasing growth and market share.

Conclusion:

Now, it’s time to get back to what we started with - What pays more: Creating ‘Innovative ‘Customer Experience’ Or ‘Innovative Drug?’ From the above perspective, it emerges that bringing innovative product to markets is, of course important. However, to ensure its sustainable financial success, other innovations, such as creating ‘a unique end-to-end patient experience’ with the brand, in all probability, would weigh more. This is an area which did not receive much attention for a long time, moving beyond the creation of increasing numbers of ‘brand loyal’ doctors, for business success.

Today, increasing consumerism in the health care space, besides pricing pressure, unfavorable perception and sinking image of the industry, is creating a strong headwind – impeding desirable growth of many pharma players. Such a challenging business scenario has prompted a few of them to innovate in designing a differentiated ‘customer experience’ – in a true sense.

Although, a large number of companies are talking about it, most are mere lip-services – a ground-swell in this area is yet to take place. The industry priority, in general, still weighs heavily in developing innovative products, and creating ‘brand loyal’ doctors, rather than cultivating ‘brand loyal patients’, alongside.

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.

Any Threat To Current Commercial Model Of ‘Gene Therapy’?

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Wish All My Readers A Very Happy, Healthy, Peaceful and Prosperous 2020

 

One of the most complex areas in disease management, is the ailments related to genetic disorders. As these were incurable, over the last four decades, medical researchers are engaged in understanding the complex and intricate process to modify human DNA, using viruses for treatment. This painstaking initiative led to the evolution of ‘gene therapy’ which, according to Mayo Clinic, ‘involves altering the genes inside human body’s cells in an effort to treat or stop the disease.’ In that process, ‘gene therapy’ replaces a faulty gene or adds a new gene, to cure a disease or improve the human body’s ability to safely and effectively treat dreaded ailments, such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDS, it further added.

Several studies, e.g., one titled ‘Gene therapy on the move,’ published in the EMBO Molecular Medicine highlighted, the first gene therapy clinical trials were initiated more than two decades ago. However, initially many of these were impeded by the occurrence of severe side effects in a few treated patients. Nevertheless, over a period of time, ‘highly efficient gene targeting strategies and site-directed gene editing technologies have been developed and applied clinically.’ With over hundreds of clinical trials to date, gene therapy has moved from a vision to clinical reality – offering a powerful treatment option for the correction of monogenic disorders.

It is believed that in the new millennium, ‘gene therapy’ has emerged as one of biotech’s momentous success stories for curing many genetic disorders, which were once considered incurable. But, the cost of ‘gene therapy’ treatment is indeed jaw-dropping – ranging ‘from about US$ 500,000 to US$ 1.5m. And for treatment over a lifetime, some drugs can cost as much as US$ 750,000 in the first year, followed by US$ 375,000 a year after that – for life.

Since, I have already deliberated on ‘gene therapy’ price and associated moral dilemma that it causes, in this article, I shall focus on different concerns that could pose a threat to its ongoing commercial model. Nevertheless, let’s start with the current scenario on ‘gene therapy,’ for better understanding of the issue.

The current scenario:

According to McKinsey & Company’s October 2019 article - ‘Gene therapy coming of age’ - till 2019, the primary focus in development of ‘gene therapy’ has been on monogenic rare diseases with all currently approved therapeutics falling into this category. It is worth noting, rare diseases tend to have clear genomic targets, as well as, high unmet need in a very small patient population, who have generally been under-served by other, more traditional, therapeutic modalities (including monoclonal antibodies)—making them ideal targets for gene therapies.

More than 150 investigational new drug applications were filed for gene therapy in 2018 alone. With this in mind, McKinsey & Company expects this market to grow significantly, with ten to 20 cell and gene therapy approvals per year over the next five years.

Major ‘gene therapy’ launched:

If one takes a broad look at the ‘gene therapy’ treatments launched so far, which I have compiled from different sources, it may appear as follows.

Gene Therapy Company Country Launch Year Indication Price ($M) Current status
Glybera UniQure Europe(EMA) 2012 Pancreatitis caused by absence of a gene - lipoprotein lipase, affecting about 14 people per year in Europe 1.0 Withdrawn (unaffordable)
Strimvels GSK Europe (EMA) 2016 To treat ADA-SCID patients (rare disease) 0.665 Sold to Orchard Therapeutics. Only 5 patients were treated.
Kymriah(CAR-T therapy) Novartis USA 2017 Acute lymphoblastic leukemia 0.475
Yescarta(CAR-T therapy) Kite Pharma USA 2017 Diffuse large B-cell lymphoma 0.373 Gilead acquired Kite Pharma in August 2017 for 11.9 billion dollars
Luxturna  Spark   2017 Rare disease called RPE65 mutation-associated retinal dystrophy. 0.850 for both eyes Novartis is paying $105M up front for the ex-US rights.

The latest being Zolgensma of Novartis. It was approved by USFDA on May 24, 2019 for ‘patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.’ It costs US$ 2.125 million in the US for a one-time treatment.

However, to get a better idea on the industry focus in this area, let us look at the current ‘gene therapy’ pipeline.

Current ‘gene therapy’ pipeline:

To fathom the extent of industry interest in ‘gene therapy’ let’s have a glance at the depth of its pipeline – both in terms of phase-wise clinical study, as well as therapy areas covered. This will help understand the concerns that could pose a threat to its ongoing commercial model.

Clinical Trial Phase Total by phase    Therapy Areas:HematologyOncologySensory OrgansInternal MedicinesOthers
I 574
II 520
III 205
Filed/Approved/Marketed 237
Total 1536

Adapted from: McKinsey article – ‘Gene therapy coming of age’, October 2019

Both large and small companies are entering into the fray:

Besides Novartis and GSK, as mentioned above, other Big Pharma constituents, such as Pfizer, Roche, Gilead and Bristol-Myers Squibb - are also putting their money in developing ‘gene therapy.’ This includes Mergers and Acquisitions too. For example:

Alongside, newer ‘gene therapy’ platforms continue to come up, many funded by venture capitals – further enriching the ‘gene therapy’ pipeline. In tandem, fresh concerns that could pose a serious threat to the ongoing commercial model of ‘gene therapy’ are also being realized. Mainly, the impact of the one-time or curative version of such avant-garde therapy on current pharma business models.

Also facilitates a giant leap towards personalized medicine:

‘Gene therapy’ is also believed to be a giant leap of medical science towards personalized medicine. This is because, in addition to repairing and replacing defective or missing genes of a human body, this therapy can use body’s own cellular immune system to treat the disease. This is because, CAR-T cell therapy can fall in the category of personalized medicine, where a patient’s T cells are changed in the laboratory, empowering them to attack cancer cells.

Concerns that could threaten its ongoing commercial model:

Despite its significant patient-value offerings with long-term benefits, ‘gene therapies’ that have been approved and are already in the market had to confront with tough unforeseen challenges, both from fresh regulatory questions - to therapy withdrawal for commercial reasons. These developments, coupled with a very low and difficult to identify patient population, and affordability related low market access, prompt the need of a transformed marketing model for novel ‘gene therapy.’ This is important for financial sustainability of current ‘gene therapies’ in most pharma markets, globally, including the United States.

Some critical areas:

An article on ‘gene therapy’ by the Managing Directors of L.E.K Consulting, published by Cell & Gene on May 16, 2019, also pointed to some of these critical areas. Even this paper articulated, the fundamental value proposition of ‘gene therapy’, its long-term efficacy with a single-dose treatment, gives rise to a number of unique challenges for its manufacturing companies. Let me paraphrase below just three of those, as I understand, to drive home this point.

Declining number of eligible patients for most doctors: 

The promise of a functional cure is expected to limit ‘gene therapies’ to a single dose per patient, in most cases. Thus, inability to re-treat would lead such therapies to deplete their addressable prevalent populations, for most doctors. This is primarily because, as the number of treated patient accumulates – the number of potential patients who could be treated in a given year is reduced. This leads to demand that would peak early before steadily declining. Once the prevalent population is depleted, the demand for a gene therapy would be driven by incident patients.

However, research has now been initiated targeting larger populations – e.g., those suffering from leukemia and lymphomas. But, the greatest revenue potential for ‘gene therapy’, is expected to be its success in delivering life-changing treatment outcomes in multiple myeloma. When such patients will get to experience better outcomes from cell and gene therapies, the incremental approach the industry has been taking in this area, will be more than justified.

Till then, it could pose a challenge to business sustainability:

As discussed, the ‘gene therapy’ sales curve with an early peak and then steady decline, caused by a depleted addressable patient population within a few years after launch, could pose a serious challenge to business sustainability. This would require launching, possibly another ‘gene therapy’ product before the revenue of the first ‘gene therapy’ starts waning. Consequently, the timing of its life cycle management efforts and subsequent launches would be a critical success factor.

Intricacy of market access dynamics:

Optimal market access of ‘gene therapy’ will call for working in unison with virtually all stakeholders, including regulators, governments, and at the same time, effectively disseminating the real-life treatment-success stories. However, both in the developed countries and also in the emerging markets, such as India, its treatment cost will continue to remain a key barrier, sans some disruptive pricing strategy.

How this tough task remains unresolved, can be sensed from the Wall Street Journal (WSJ) report of December 19, 2019 titled, ‘Novartis to Offer World’s Most Expensive Drug for Free Via Lottery.’ For this purpose, Novartis launched a lottery-style program to provide doses of its pricey gene therapy for Zolgensma, a one-shot ‘gene therapy’ cure, for free of charge. But, this approach drew criticism from patient groups that called it – an inappropriate way to distribute a lifesaving treatment aimed at babies for a deadly inherited disease whose victims cannot control their muscles. At a price of US$ 2.1 million, Zolgensma, is the world’s most expensive drug.

Conclusion:

As I discussed above, ‘gene therapy’, also known as ‘human gene transfer,’ has been one of biotech’s momentous success stories in the new millennium, paving the way for a cure of many genetic disorders – once considered incurable. However, the number of patients on ‘gene therapy’ remains small compared to other therapeutic regimens, mainly because of two factors. One – this therapy, mostly targets rare diseases, and the second – even among those small patient populations, only very few can afford such pricey therapy.

Nevertheless, current research in this complex area, is now targeting larger populations – suffering from leukemia, lymphomas and multiple myeloma. Success in these areas will open the door of significantly greater revenue potential for ‘gene therapy’ by delivering life-changing treatment outcomes. Till then, its current business model, I reckon, would continue to pose a high commercial risk to this venture.

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.

Is Pharma Industry A Late Learner, Always?

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Several upcoming concepts in the pharmaceutical industry are becoming buzzwords today. But, most of these were recommended by stalwarts several decades ago. Interestingly, the prevailing scenario is no different, even related to wide-scale adoption of a number of cutting-edge technologies, to squarely face the ongoing challenge of changing market dynamics. Various studies point out that other industries are making transformative use of these – to be on the same page with their customers, much faster.

Pharma is considered to be a late entrant in the digital space, too. It’s still not quite clear to many, the extent by which ‘Digitalization’ is transforming the way pharma industry functions – aiming at unleashing huge opportunities for value creation – from supply chain to manufacturing – right up to creating a unique customer experience. As this subject was well deliberated in the August 2016 article on McKinsey Digital, I am not going to delve into that area today.

Therefore, the question that comes up: Is pharma industry, in general, a late learner – always, to be in sync with its contemporary customers? For exploring this point, I shall focus mainly on four areas of current hypes in the pharma business, namely - ‘patient empowerment’, ‘patient-centricity’, ‘customer experience’ and ‘E-Patients’.

In this article, I shall dwell on this subject, ferreting out some critical recent findings on the relevance of these not so recent concepts in today’s perspective. Let me start by diving deep into the time capsule.

How old are these concepts?

Industry watchers may know that these are not new concepts, in any way. The relevance of ‘patient empowerment’, ‘patient-centricity’, ‘customer experience’ and ‘E-Patients’ in the drug industry has not unfolded today, neither are these new ideas. The American medical doctor - Thomas William ”Tom” Ferguson (July 8, 1943 – April 14, 2006) was an early advocate for ‘patient empowerment’.

Since 1975: “He urged patients to educate themselves and share knowledge with one another and urged doctors to collaborate with patients rather than command them. Predicting the Internet’s potential for disseminating medical information long before it became a familiar conduit, he was an early proponent of its use, terming laymen who did so – ‘E-Patients‘.”  

Technology follows a concept and not vice versa:

With ‘E-Patient’ terminology, Dr. Thomas Ferguson talked about empowered, engaged, equipped and enabled patients. I reckon, even after close to 45 years, most of the drug industry, is still not quite there – ‘Digitalization’ initiatives notwithstanding. This is because, technology follows a concept and not vice versa.

Why it’s so?

I reckon, this is primarily because, many stakeholders often don’t pay much importance to a critical fact, which is: ‘Patient expectations and needs can differ considerably from the aims and objectives of health care providers, at both the policy and delivery levels,’ and also by many drug companies. Still, most of these entities are yet to lap up this concept.

Is reviving focus on ‘Patient Centricity’ a realistic proposition today?

Several studies in this area have concluded, to be accepted by patients, the patient experience should be the key driver for the development of solutions.’ These include, medicines, devices, information, support programs and even digital apps. Among many others, one such study was published on March 28, 2017, in the SAGE Journals, titled, ‘Patient Centricity and Pharmaceutical Companies: Is It Feasible?’

The basic question of its feasibility would prompt: ‘Would this approach help pharma players to make enough profit with the drugs?’ While addressing this query, the researchers put across the following points that need to be seriously reflected on:

  • Profit is necessary. But, how drug companies make and use business ‘profit’ is more important for long-term business sustainability.
  • It requires a clear vision at the top of creating and delivering ‘customer value’ as patients will perceive, followed by a robust assertion of ‘Patient Centricity’ across the business domains.
  • This will help break out of the cycle of “recover costs of R&D – make a profit – invest in new drugs – make more profit.” The new ball game will be – profit through customer satisfaction – invest in new drugs for greater ‘customer value and more customer satisfaction’
  • Such commitments, in turn, will help generate not just reasonable profit, but credibility with external stakeholders – such as, patients, regulators, media, etc. – creating an invaluable reputation for the organization, as a future growth booster.

Since old practices have continued for very long, virtually unchanged, a legacy factor has now crept into the system, mostly as a retarding force.

A legacy issue to overcome:

As the above research article underscores: ‘Historically, the pharmaceutical industry’s role has been to develop the science and medicines for prevention or treatment of disease.’ Whereas, ‘Patient Centricity’ involves patients as stakeholders in this scientific process. It calls for an innovative mindset, whereby ‘the industry is challenged to engage and collaborate with patients when deciding the best course of action.’ This need is now palpable within the industry, at the long last. 

Palpable needs for a new focus on designing ‘healthcare solutions’:

With the shift in the environment around the industry and its stakeholders, including patients, are feeling the need to ferret out some old classic concepts for a new focus in designing various ‘healthcare solutions.’ For this purpose, as the above research article reiterated, a better understanding of ‘patient experience’ at critical points, in the course of the diagnosis and treatment of the disease, would help designing more effective ‘health care solutions’ for better patient outcomes.

The commercial necessity for better patient outcomes, merits ‘Patient Centricity’ at the core of the pharma business model, which, in turn, calls for a shift in the cultural mindset within the pharmaceutical industry. Such a shift would involve, among others:

  • Redefining the core strategy, organizational structure, processes and capabilities to focus on transparency and value creation for the patient.
  • A change from a disease-centered to a patient-centered strategy, and from a product-led to a patient-led development process.
  • Listening to and partnering with patients, and understanding the patient perspective, rather than simply inserting patient views into the established process.

Therefore, ‘patient-centric’ initiatives of any company should begin with the basic question: how can the company make a difference for patients?

The new realization: Compete better to win, neutralizing healthcare consumerism:

To better compete and win even in the midst of evolving healthcare consumerism, instead of adding fuel to it around the world, including India, a new book – ‘Making the Healthcare Shift: The Transformation to Consumer-Centricity,’ brings some contemporary ideas where, again, many old ideas seems to have been tested with a new perspective.

Interestingly, the content of this book is based on over 60 executive interviews with the biggest names in healthcare and a quantitative research study. Some of these names include leading academic institutions, such as, the Mayo Clinic, USCF Medical Center; big drug companies like Pfizer, Lilly and Novartis. The book reveals, while healthcare organizations have recognized the need to change to ‘Patient Centricity, they often don’t know where or how to begin.

To help healthcare organizations reinvent how even traditional pharma players engage with consumers in the new paradigm, the authors identify five shifts that pharma players can make to better compete and win in this evolving landscape of healthcare consumerism. 

Need to ‘reinvent the wheel’, is more than ever before!

To ascertain the above point, I shall paraphrase just a few – ‘Patient-Centric’ and ‘Customer Experience’ related areas of the book along with my own views to help you to come to your own logical conclusion:

  • To provide a holistic disease treatment solution, keeping the patients engaged along the entire journey in the disease treatment process, pharma players should bring ‘consumer experience’ at the core of the business model. As I also deliberated in this blog that: ‘Enhancing End-To-End Customer Experience’ is, therefore, considered by many astute pharma marketers, as a vital ingredient of pharma brand building exercise. In that article, I articulated, such initiatives should cover, all the ‘’touchpoints’ and ‘episodes.’ Where ‘touchpoints’ are spots of contact or interaction and ‘episodes’ focus on end-to-end design of a specific customer-need for an organization. Aligning management and the front line around the customer experience, is critical.
  • As things stand today, the entire journey through the disease diagnosis and treatment process, in the current healthcare ecosystem, remains fragmented. Mostly because, it involves many ‘touchpoints’ and ‘episodes,’ comprising of different health care entities. Providers’ inefficiencies, of various types, encountered by patients at different points of this journey often lead to their frustration, causing an unpleasant ‘customer experience.’ To achieve this objective, by effectively addressing the aforesaid common denominator for all – ‘Patient-Centricity,’ is of paramount importance. This entails, as stated before, integrated measures for listening to and partnering with patients, alongside, placing patients’ well-being at the core of all healthcare business initiatives. From this perspective, ‘patient-centricity’ based on customer insights,represents a holistic approach to provide the disease management solutions.
  • With rapid advancement in medical science, culminating into several breakthrough innovations, the world has stepped into a new era of disease treatment solution. Increasingly, ‘one size fits all’ type of population-centric treatment, is giving away a sizeable space for a new ‘patient-centric’ variety of the same. Moving towards this direction would necessitate pharma players, along with all health care organizations to acquire a deep insight on patients. The acquired insights must be based on in-depth analysis of a robust and contemporary sets of data, including demography, attitude towards health, treatment needs and preferred options available to the targeted audience.

This brings me back to where I started from. Dr. Thomas William ”Tom” Ferguson and maybe several others, as well, had recommended similar approaches over four and a half decade ago. We did not learn it then. But, while fighting against all odds, as the industry has been facing over some time, some companies are feeling the need of learning it now. Better late than never!

Conclusion:

It has been universally accepted that market dynamics keep changing in all industries, may be faster in some than others. Looking back, one can sense similar ongoing changes both within the pharma industry and the business and social and cultural environments outside, especially related to its stakeholders. When faster, proactive changes take place within the industry than outside, it delights the customers. Similarly, faster changes in the outside environment that industry fails to keep pace with – deliberately or otherwise, will invite strong headwind impeding growth of the business and even denting its reputation. Although, the former one is desirable, the latter prevails in most areas of pharma business. A Working Paper of the Harvard Business School wanted to understand ‘How do organizations learn?’ It found, among others:

  • Performance outcomes can be augmented, if one deliberately focuses on learning from experience accumulated in the past.
  • The competitive advantage of firms critically depends on the skills of individual contributors. Hence, the centrality of individual and organizational learning is a critical factor for competitiveness of any organization.

This brings us to the question, what is a learning organization. From many similar definitions of the same, let me quote the following one, as it is apt, simple and old enough for all to have learned: “A Learning Organization is the term given to a company that facilitates the learning of its members and continuously transforms itself.” (M. Pedler, J. Burgoyne and T. Boydell, 1997)

Keeping today’s deliberation in perspective, one may possibly conclude, quick individual learners, including the organizations, can offer better performance outcomes than late learners. As the pharma business is encountering a strong headwind for quite some time, it is up to the readers making out, what type of learner the industry, in general, is, and more importantly, why it is so?

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.

Drug Pricing: Why Justify On R&D Cost Rather Than Precise ‘Customer Value’?

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While looking around, it won’t be difficult to spot many types of steep-priced highly innovative products, where high costs aren’t justified by high R&D expenditure, but for unique ‘customer value’ offerings. Many consumers evaluate those and decide to settle for one, instead of opting for cheaper variants – delivering the basic customer requirements in that product class or category. Although, both pharma and electronic goods belong to high tech-based knowledge industries, similar examples are in plenty of the latter, but hardly any in pharma.

Agreed that pharma is a highly regulated industry, unlike electronic goods. But so are banks, financial services, airlines, telecommunication, among many others. Interestingly, all these industries are building great brands without talking about their investment costs in R&D, while doing so.

In this article, I shall focus on – despite facing a formidable headwind, mostly for the same, pharma industry, in general, continue to lack in two critical areas of brand building. But, before doing that let me quote from some recent research papers wondering, how is this situation continuing unchanged, despite all concerned being aware of it.

Two opposing views:

Just to recap, let me put below, two diametrically opposing views that continue to clash with each one, since long:

  • New and innovative drug costs being excessive, globally, lowering their prices will not harm the progress of innovation.
  • Drug industry argues, any restriction of free pricing of innovative drugs, will seriously jeopardize innovation of newer medicines and treatments.

So much of divergence in the views of two key partners within the industry, can’t just continue any longer, without a serious intervention of governments across the world, including the United States.

Pharma does want to talk about ‘Cost & Value of Medicines’. But…

It’s not that pharma doesn’t want to talk about ‘Value of Medicines,’ but not, apparently, to create an ‘emotional connect’ with its stakeholders, including the patients. It appears, more as a general justification for the high cost of new drugs. For example, a pharma trade association’s communication, after acknowledging ‘that many are struggling to access the medicine they need,’ says upfront: ‘Discussions about costs are important.’ It follows a series of much-repeated common justifications, which are no- brainer, such as:

  • Medicines Help Patients Avoid Expensive Hospital Services,
  • Developing New Treatments and Cures is a Complex and Risky Undertaking,
  • Medicines are Transforming the Treatment of Devastating Diseases.

But, the reality is, these justifications are not working on the ground, as these are not quite in sync with ‘customers’ value’ expectations, both from the company as well from the brand. Moreover, instead of establishing an ‘emotional connect’, this approach probably is further alienating many stakeholders, as several governments are now broaching the issue of price control, or some other mechanism to set drug prices.

Pharma marketers need to be eclectic:

Instead of keep following the age-old marketing and communication models, young pharma marketers need to be empowered to be eclectic. They should look around and try to fathom how is ‘marketing,’ as a business domain, changing in other fast-growing industries, and act accordingly. As pharma is a high-tech knowledge industry, let me draw examples from other similar industries, such one that innovates and manufactures electronic products.

Unlike any high-priced, high-tech electronic product companies, such as Google, Apple or Microsoft – pharma marketing communications are more like ‘justification’ centric, for charging high prices for medicines. This approach, apparently, is not just a bit defensive, but virtually negative. Whereas, unlike drug manufacturers, the above tech companies are constantly focusing on the following two areas, for creating a robust ‘corporate brand’ that infuses consumer-trust in each of their products:

  • Establishing ‘emotional connects’ with customers
  • Focusing on the total value of unique value offerings, rather than the high cost of innovation to justify high prices

Let me deliberate briefly on each of the above two.

The importance of establishing ‘emotional connects’ with customers:

With the penetration of technology, almost in every household, with a varying degree, though, access to a gamut of information becomes increasingly easy, so are the options available to customers. This is impacting almost every industry, including pharma and healthcare.

Thus, for corporate performance excellence, customers are now creating a space for themselves at the core of the pharma business strategy. Consequently, a need arises for the pharma marketers to enhance end-to-end customer experience. Besides, brand value offerings, this includes both short and long-term customer service offerings to ensure an ongoing emotional connect with customers, for more intense and longer-lasting engagement with trust, both on the ‘corporate brand’ and also on individual products.

Therefore, creating effective ‘emotional connects’ with customers are assuming a cutting-edge strategic importance – in multiple facets of pharma business. More ‘emotionally connected’ customers also act as a force-multiplier to enhance corporate reputation. Although, it mostly happens through word of mouth, in recent days, value added omnichannel communication by respective companies, is playing a crucial role for success in this area.

In the good old days, reaching patients or patient groups directly, would have been a challenging proposition. Most communications on products, diseases and treatments, used to be through healthcare providers. But, this is no longer so, especially in the digital world, that opened a new spectacle of opportunities for crafting patient-centric strategies – as patients become more digital-savvy, too.

Focus on brand value offerings, not on cost of innovation to justify high prices:

To dwell in this area, a series of questions that one may possibly encounter, such as: ‘How do you define value? can you measure it? What are your products and services actually worth to customers?’ Way back, these points were deliberated in the article – ‘Business Marketing: Understand What Customers Value,’ published in the November-December 1998 issue of the Harvard Business Review (HBR). It said: ‘Value in business markets is the worth in monetary terms of the technical, economic, service, and social benefits a customer company receives in exchange for the price it pays for a market offering.’ From this paper let me pick up just two critical components of value, as follows, for better understanding:

  • Value in monetary terms: Such as, dollars per unit
  • Value for a customer: What the person gets in exchange for the price it pays

Nevertheless, the important point to note: As ‘market offering has two elemental characteristics: its value and its price, raising or lowering the price of a market offering does not change the value that such an offering provides to a customer. Rather, it changes the customer’s incentive to purchase that market offering.’

When applied in the pharma perspective:

When the above concept of value is applied in the pharma industry perspective, it vindicates an important. Which is, tangible value offerings of an exclusive, high-priced patented products, and the same in its off-patent low-priced avatar remains unchanged, regardless of significant change in its monetary value per unit. However, unlike a patent protected drug, options for generic equivalents will be many, with differing prices.

This brings out another important facet of ‘value’. As the above HBR paper states, considerations of value take place within some context. Even when no comparable market offerings exist, there is always a competitive alternative. For example, in the pharma business, one possible competitive alternative for patented products could well be – when the Government decides to issue a Compulsory License (CL) for make the product available at a cheaper price to patients.

The name of the new game:

Thus, for an exclusive new drug, instead of focusing on cost of innovation to justify high prices, a sharp focus on ‘total value offering’ of the brand would possibly be the name of the new game. It will entail persuading the ‘connected customers’ to realize the total value of both the tangible and intangible cost of each benefit that the product offers, rather than simply the cost of a pill. In doing so, a pharma marketer and his entire team, must have an accurate understanding of what its customers value, and also, would value. This calls for a painstaking research, and a mammoth real time data analysis.

Developing a unique ‘Customer Value’ model:

As the above HBR article reiterates, ‘customer value’ models are not easy to develop. Unfortunately, pharma’s ‘value delivery system’ is still tuned to a self-serving mode and not ‘customer value’ centric.Thus, marketers may wish to note some key points in this regard, as below:

  • Many customers understand their own requirements, but do not necessarily know what fulfilling those requirements is worth to them.
  • This leaves an opportunity to demonstrate persuasively, the total ‘customer value’ that the new brand provides, and how it fulfills their requirements.
  • The strategy makers would have to necessarily generate a comprehensive list of ‘customer value’ elements, based on robust data, on an ongoing basis.
  • The acquired insight on – what customers value, and would value, to gain marketplace advantages over competitors, would form the core of the business strategy.

The next stage would be a pilot study to validate the model and understand the variations, if any, in the estimates. It is also vital to note that an improvement in some functionality may appear important, but may not necessarily mean that customers are willing to pay for it. The aim should always be delivering superior value, and get an equitable return for it. Thus, enhancing end-to-end customer experience in this effort, becomes a critical ingredient to brand success.

Conclusion:

After the article – ‘Business Marketing: Understand What Customers Value,’ published in the November-December 1998 issue of the Harvard Business Review (HBR), in June 2000, a similar article was published in the ‘McKinsey Quarterly.’ The paper titled, ‘A business is a value delivery system,’ also emphasized the importance of a clear, well-articulated “value proposition” for each targeted market segment.

This means a simple statement of benefits that the company intends to provide to each segment, along with the approximate price the company will charge for each of those. The paper also underlined, the strength of the buying proposition for any customer is a function of the product value minus the price. In other words, the ‘surplus value’ that the customer will enjoy, once that product is paid for.

Over a period of time, high prices of new and innovative drugs are attracting negative headlines, like - ‘High cost of hepatitis drug reflects a broken pricing system.’ This continues, despite high decibel justification of the ‘exorbitant’ cost of innovation. Undaunted, Big Pharma and its large trade associations remain reluctant to jettison their old advocacy toolkit.

They seem to be still on a – ‘Listen and believe what we are saying’ mode. This is vindicated by the December 14, 2019 report that revealed: ‘The Pharmaceutical Research and Manufacturers of America, the drug industry’s top lobbying group, filed a lawsuit this week against the state of Oregon, claiming two laws it passed requiring greater transparency of drug prices are unconstitutional.’

Continuation of such approaches, on the contrary, is further alienating many stakeholders, especially the patients and the governments. Thus, time appears more than ripe today to focus more on delivering measurable ‘surplus value’ of new products, to well engaged and connected patients, both globally and locally.

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.