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Deliver Patient-Perceived Value – Not Incrementally But In Quantum Measure

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Many critical functional areas of most drug companies, such as, marketing, manufacturing, supply chain, medical affairs, human resource, R&D, quality assurance, information technology – traditionally work in silos. It doesn’t mean, though, that there isn’t any interaction between them. Nevertheless, a large majority of them don’t work as a team with a purpose or to achieve a shared goal of delighting customers with value delivered. Such a silo-mindset could often be detrimental to smooth and sustainable business operations. This was also vindicated during the recent pandemic.

Having gone through the harrowing experience of recent disruptions in the lifesaving pharma business operations, a fresh realization has dawned on many leaders’ mind. This point also came to the fore in many studies. One such is the article on ‘Overcoming industry obstacles with a cross-functional strategy’, published by the strategy&, which is a part of PwC network.

The paper came out with some thought-provoking findings. It said, while in the pre-Covid days, mostly competing business pressures used to drive the operational strategies, today the drivers are quite different. ‘Factors such as the COVID-19 pandemic, inflation, geopolitics, new therapeutic modalities, and new ways of working make it vital’ for pharma players to make such transformational operational overhaul for long term excellence.

The spotlight needs to shift from continuous incremental improvement, such as, cost savings, quality assurance, and readiness to deliver—to long-term external challenges. ‘These include high inflation and an increase in complexity and risk, as well as the compounding effects these forces have on each other.”

Several studies have underscored that this approach can ‘make sure operations can protect enterprise continuity while still delivering to patients.’ this article will venture to simplify this complex, yet critical issue. The aim is to achieve a quantum increase in value offering to customers that this strategic approach can potentially deliver to accelerate growth momentum the pharma business.

Some see pharma business as usual, astute leaders see a unique opportunity for change:

An interesting point to note. As the disruptions caused by the Covid pandemic are fading away, some critical health safety norms are also being eased by the authorities. Apparently, the overall daily working-life seems to be limping back to normal. Many pharma leaders are, therefore, considering that the industry operations are going back to pre-pandemic normal, and the business operations will soon revert to the old normal mode soon.

On the other hand, we find some astute leadership who could derive a long-term lesson from the above disruptions and are already in the process of executing those operational changes. This leadership mindset gets reflected in two recent media reports related to two pharma majors – Sanofi and GSK.

On November 28, 2022, it was reported, ‘Sanofi moves into swanky new Paris HQ designed around hybrid work and sustainability.’ Again, on December 12, 2022, another media headline flashed as ‘GSK embraces hybrid work for the long haul at new London HQ.’

To me these are interesting examples to convert problems into opportunities for long-term business success and sustainability, in the new normal. These tasks entail the transformation of business infrastructure alongside its operational strategies.

The need for re-strategizing reverberates across several recent studies:

The need for such an action, as captured by researchers, is prompted by more waves of innovation coming in various operations and functions of pharma business, mostly triggered by the pandemic. The spectrum of innovation, as reports reveal, ranges ‘from new treatment modalities, to smart machines, advanced analytics, and digital connectivity.’

Hence, the future of pharma operations strategy needs to be different now from the past. This finding was also published by the McKinsey & Company on October 10, 2022. It reiterated, as pharma companies are emerging from two years of intense firefighting, now is exactly the right time for their renewed emphasis on a new operations strategy. It emphasized: ‘Succeeding in pharma under these new and challenging conditions will require succeeding in operations.’

This point was further vindicated by the results of the latest McKinsey Global Survey, which states:‘Less than one-third of the surveyed respondents, all of whom had been part of a transformation in the past five years, said their companies’ transformations had achieved a sustained performance improvement.’

Another study very specific to India:

Another survey on ‘Indian consumer sentiment during the coronavirus crisis,’ published by theMcKinsey & Company on October 13, 2022, also reconfirms the subtle changing trend in Indian consumer behavior. Its findings include some of the following areas:

  • More than 70 percent consumers are engaging in modified out-of-home behavior, even as social gathering returning to almost normalcy.
  • Digital continues to hold sway with more than 75 percent consumers using either digital or omnichannel while purchasing across categories.
  • Social media continues to be an important influence while shopping.
  • Gen Z and millennial are leading in new shopping behavior, with value being the top reason and sustainability as an emerging factor.

Hence, to engage with such healthcare consumers and deliver the value as they perceive, pharma operational strategies may call for a rejig – for longer term success and sustainability. That said, a key point to remember is that the marketing function is central while redrawing new operational strategy.

The marketing function is central while redrawing new operational strategy:

The need for the above was well articulated in another study published by ResearchGate in May 2020. It pointed out that many drug companies invest lots of funds to be more productive in various key operational areas, like R&D, manufacturing, or supply chain. However, if marketing strategies are not in sync with contemporary market dynamics and customer behavioral trends, despite game changing improvements in those areas, achieving business growth objectives will be challenging.

Based on the study, the researchers concluded, “an effective marketing in the organization has significant impact in achieving Organizational goals and Operational Excellence in Pharmaceuticals.” The study further emphasized, ‘Operational Excellence and marketing are always interlinked. Therefore, marketing plays a vital role in achieving Operational Excellence in Pharmaceuticals or any other industry.”

Conclusion:

As we know, market dynamics keep changing with time. Generally, some strong trigger factors, such as, Covid related disruptions of lives and livelihoods, may hasten the process of this crucial change. Such changes necessitate long-term transformation of pharma operational strategies, as initiated, for example, by GSK and Sanofi.

As McKinsey & Company articles have articulated, the transformation process and scale may differ from company to company with common long-term challenges remaining the same. Such operating model transformations – involving digital tools, data science with analytics capabilities across the company, often ‘help companies interact with healthcare professionals and other stakeholders more effectively’.

Consequently, the company garners greater capabilities to deliver new patient-perceived value – not just for incremental, but quantum business growth. This, I reckon, could be a game changer for long-term success and sustainability in the pharma business.

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.

 

Leverage Increased Focus On ‘Self-Care’ For Better Patient Outcomes

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‘People have been practicing self-care for thousands of years. Now an increase in self-care interventions is shifting the way health care is perceived, understood, and accessed, and adding to the many medicines, diagnostics, and technologies available for people to use by themselves.’ This was articulated in an article titled, ‘Self-care during the COVID-19’, published by the World Health Organization (W.H.O) on June 12, 2020.

That COVID-19 prompts increased focus on self-care was also vindicated by several research studies, including some conducted by global pharma majors, such as GSK, Johnson & Johnson, Sanofi as you will find below. In this article I shall, therefore, deliberate whether an increasing focus on ‘self-care’, as a critical service to patients can fetch better disease treatment outcomes with respective pharma brands in the new normal. Moving in that direction, let us first be on the same page about the definition of ‘self-care’.

‘Self-care’ and its key benefits?

The W.H.O defined self-care as: ‘Your ability to promote health, prevent disease, maintain health, and cope with illness and disability with or without the support of a healthcare provider is known as self-care.’ Regular practice of self-care offers a holistic interlinked benefits to its practitioners, which many people have started experiencing during the COVID-19 pandemic.

As observed by BMI Healthcare, some of these benefits include:

  • Improving your physical health: By committing to looking after your body and becoming more attuned to its needs.
  • Reducing stress and anxiety: By making time for relaxing activities.
  • Boosting self-esteem: By helping to calm your nerves, taking time to relax and look after yourself can have a positive impact on the way you see yourself. Treating yourself with kindness can also make you look upon yourself kindlier. Studies have found that people with higher self-esteem find it easier to deal with setbacks and are more likely to achieve goals of self-improvement.
  • Protecting mental health: By making changes to prioritize self-care can help to manage mental health issues and might even prevent them from getting worse.
  • Fostering better relationships: Happier and healthier you are, the more you can give to a relationship. This is especially important if you are a parent or career. It can be so easy to put someone else’s needs first, but you must look after your own health too.

Pharma companies also echoed that COVID-19 has boosted self-care:

As I wrote above, besides W.H.O, several global pharma majors have also recently conducted their own research studies this area, for several reasons. One such research, shared by GSK Consumer Healthcare and IPSOS on 20 July 2020, reiterated that ‘the COVID-19 pandemic has had a significant impact on people’s behavior and attitudes to self-care.’ The study also endorsed, the pandemic has impacted attitudes towards personal wellbeing and self-care. This gets reflected on the increased importance that many people are now placing on looking after their own and others’ health.

Another article, published in the  Johnson & Johnson website on September 16, 2021, emphasized the same point. The Company reiterated, self-care – a holistic and preventive way to look after one’s health and wellness – is more than a passing trend. It’s a lifestyle shift that’s here to stay – one that has only been accelerated by the COVID-19 pandemic. The paper highlighted, ‘According to one recent national survey, 80% of adults said they intend to be more mindful about practicing self-care regularly after the pandemic. And global research conducted this year found that consumers’ prioritization of wellness has jumped as much as 65% in the past two to three years.’

Recently, even Sanofi in its website acknowledged, ‘COVID-19 highlights Value of self-care as a first line of defense.’ The article added, although, ‘there has been a global trend towards wellness for some time now, but the onset of the COVID-19 pandemic has accelerated it.  It also endorsed that defensive wellness is growing exponentially with people trying to protect their own health alongside their families. So, there has been a shift in attitudes in how people are practicing self-care, especially, as face-to-face consultations with doctors are now more difficult.

Why ‘self-care’ concept got a boost during COVID-19 pandemic?

There are several reasons behind such unprecedented boost in practicing self-care within the global population. The key ones include intense and continuous public messaging by various governments in response to the COVID-19 pandemic, has emphasized the importance of self-care by manifold. Some of these self-caring activities, such as, social distancing, wearing face masks and other preventative hygiene measures, which have been pivotal in the disease control process.

The national campaigns to tackle the virus with various social measures deployed by citizens, in tandem with traditional public health interventions, like testing and contact tracing, have been widely supported by NGOs, media and key influencers in many sectors. The core message has been, staying home or working from home, and observing government guidelines is – ‘doing your bit’ for others, as well as yourself. The same was also well-articulated in a paper – ‘Self-care and health: by all, for all. Learning from COVID-19’, published by the Mitchell Institute, Victoria University, in July 2020.

 ‘Self-care’ messaging in the old and new normal – the key difference: 

Several pharma companies have tried to understand what factors prompted to accelerate the ‘self-care’ process during the pandemic, as compared to the old normal. And what is the key difference in the core messaging content. For example, Sanofi construed that the self-care messages in pre-pandemic period were generally ‘positive’ ones, such as benefits of practicing yoga and other changes in the general lifestyle activities. Whereas, during the pandemic, the message has been very different. It generally revolved round the ‘fear of the unknown’ that can jeopardize lives and livelihoods.

This factor emerged as a powerful motivator in accelerating a shift to life-saving preventative wellness – not just for self, but also for others. An overwhelming sense of uncertainty put a different perspective altogether to ‘self-care’, especially, for people with co-morbidities or pre-existing health conditions, being more vulnerable to die from COVID-19 infection.

Can pharma leverage the win-win opportunity?

A global study by  McKinsey & Company in this area, published on April 08, 2021, vindicated the increasing trend of self-care among global population. Elaborating the point, it said: ‘These days, consumers view wellness through a much broader and more sophisticated lens, encompassing not just fitness and nutrition but also overall physical and mental health and appearance.’ The Company estimated ‘the global wellness market at more than $1.5 trillion, with annual growth of 5 to 10 percent.’ If pharma marketers can leverage this win-win opportunity creatively, brand related self-care measures would also come under this market.

Leveraging increased focus on patients’ self-care:

The fact that an opportunity exists for pharma players to leverage a new opportunity in the ‘self-care’ space, creating win-win treatment outcomes for all, isn’t a new concept. Over a decade, this is being deliberated in the healthcare space. This is evident from an interesting article titled, ‘Helping patients help themselves’, published in the ‘Modern Healthcare’ on June 21, 2010. Acknowledging that “Self-management is critical,” it wrote: “The patient spends one-tenth of 1% of their time in the doctor’s office and the rest of the time on their own. Coming up with good ways to engage them and encourage them to take control and make changes is very important.”

Interestingly, another article carrying exactly the same title – ‘Helping patients help themselves’ – penned by another author, was published after more than a decade – in the ‘Reuters Event’, on November 19, 2021. This author also emphasized: ‘Self-care offers a new way for health care companies to serve patients better, globally and industry collaboration will drive faster progress.’ It reiterated: ‘There’s an opportunity here for healthcare companies to put patients even more at the center of care and to help them achieve better outcomes.’ Pharma marketers, wearing their best creative hats, will find several novel strategic ways to reap a rich harvest from this opportunity. I shall, therefore, won’t step into that area in this article.   

Conclusion:

Ongoing awareness campaigns, encouraging people to take primary ownership of their own health to prevent any serious medical interventions – both for infectious and non-infectious ailments, can be a force multiplier to protect a nation’s health.

Several ‘self-care’ practices during the pandemic like, wearing face masks, maintaining social distancing, hand washing and self-isolation to contain spread of infection, continues. In tandem, as many experts reported, more people are now using digital tools, wearables, symptom trackers – for self-care. Alongside, virtual medical consultation, home care and telehealth services, purchasing medical products and diagnostic services from e-pharmacies, digital health solutions and the likes are also increasing significantly, for the same reason.

Collectively, self-care initiatives have paid rich dividend – in varying degree, almost in every country, notwithstanding some catastrophic onslaught of the virus in many nations, including India. Otherwise, the numbers could have been worse, as many experts project. That said, as the McKinsey & Companysaid: ‘If the pandemic has taught us one thing, it’s that physical and mental health will remain a priority for millions of people across the globe for a long time to come.’ Being in the thick of this process, the drug industry, by and large, has also realized that ‘self-care’ is crucial to ensure better treatment outcomes. This, I reckon, opens a new vista of opportunity for pharma to leverage, with increased focus on most of these ‘self-care’ practices – for business excellence.

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.

Pharma Not To Let Go This Never Before Opportunity To Reposition Itself

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‘While the COVID-19 pandemic has placed unparalleled demands on modern healthcare systems, the industry’s response has vividly demonstrated its resilience and ability to bring innovations to market quickly.’ This appeared in the McKinsey & Company article – ‘Healthcare innovation: Building on the gains made through the crisis,’ published on November 12, 2020.

Just a couple of days before that, on November 09, 2020, an interesting article appeared in The Wall Street Journal (WSJ) on the resilience of the pharma industry. It also discussed on how ‘an often-disparaged industry is finding a rare opportunity to promote its value,’ to turn around public perception of its image and reputation during the pandemic. The article elaborated this point by quoting: “It was a fight between pharma, tobacco companies and the government for who would be at the bottom in terms of reputation,” – now “Covid is giving them an opportunity to step out of that world and into the world of ‘we can help,’ and it’s giving pharma a comeback.”

As is known to many, pharma industry was long vilified for its many self-serving objectives. But the Coronavirus pandemic helped immensely to highlight its role in developing medications and vaccines to save the humanity. It happened never before – ever, with this intensity and scale. Thus, the shift is inspiring many pharma giants to reposition their marketing and communications, the WSJ report added. This article will deliberate on how pharma marketers can leverage this once in a lifetime opportunity, with actionable insights on Covid pandemic-induced – changing needs of healthcare customers.

Covid-19 to change the way companies do business - A recent survey:

In this McKinsey & Company survey, published on June 17, 2020, more than 200 organizations across industries had participated in this study. Notably, over 90 percent of the participating executives expect the fallout from COVID-19 to fundamentally change the way companies do business over the next five years, with a lasting impact on their customers’ needs. In the pharma industry too, these trends are clearly visible and undergoing a metamorphosis. I quote below a few important points from this study, as illustrations:

  • Nearly 73 percent respondents from the pharma and medical supplies industries agree that the changes brought about by Covid-19 will be a big opportunity for growth.
  • Only 21 percent of the same executives feel that they are prepared with resources, expertise and commitment to address the changes they see coming, for harvesting the new growth opportunities.
  • Curiously, only 25 percent of respondents reported that capturing new growth was a top priority today, compared to roughly 60 percent before the crisis hit.
  • Notably, across the industries only pharma and medical product industries have increased their focus on innovation during Covid crisis. Although, many are still playing safe, which may be a shortsighted decision, the research paper observed. 

Understand the shifts and the opportunities with actionable insights:

That the current Covid crisis has significantly exacerbated and accelerated many disruptive forces, is vindicated by another survey: ‘Global B2B decision-maker response to COVID-19 crisis.’ This was published by the McKinsey & Company on October 20, 2020. It also reiterated, ‘B2B decision-maker preferences and behaviors have shifted dramatically since the onset of COVID. The GTM revolution is here and B2B sales is forever changed.’ I shall quote two of these areas, as follows:

A. Changes to pharma sales models: Companies with significant field forces can no longer rely on in-person coverage to outcompete. This is because:

  • The tide has turned: digital self-service and remote rep interactions are likely to be the dominant elements of the B2B go-to-market model, going forward.
  • Don’t count on returning to a pre-COVID-19 level of in-person sales coverage, as only 20–30% of B2B buyers want to ever interact with reps in person even in their ideal/post-COVID-19 model.
  • Around 90% of B2B decision makers expect the remote and the digital model to stick around for the long run, and 3 in 4 believe the new model is as effective or more so than before COVID-19 (for both existing customers and prospects).
  • 97% of B2B buyers claim they will make a purchase in an end-to-end, digital self-serve model, with the vast majority very comfortable spending more online.
  • Video-conference connections are critical and are preferred over audio/phone by almost 4 out of 5 B2B buyers.

B. Influx of competitors from different industries: Medical-device firms historically had a narrow competitive set and were insulated by a complex and highly technical regulatory approval process. They are now facing competition from previously unexpected new entrants, including Wearable Health Devices (WHDs) makers, such as Google, Apple among several others. As I also wrote about a year ago, on December 02, 2020, this is mostly because, WHDs help improve disease outcomes, creating a unique disease treatment experience.

Which is why, in the new normal, creating a holistic and innovative ‘Customer Experience’ is as important and challenging as creating ‘Innovative Drugs’.

Reposition pharma to create a holistic ‘Customer Experience’ in the new normal:

At the very beginning of this year, on January 13, 2020, I asked: What Pays More: Creating Innovative ‘Customer Experience’ Or ‘Innovative Drugs’? Although both are crucial for pharma, in the current scenario, the former, I reckon, is no less important or less demanding than the latter for pharma marketers. The question, therefore, arises, what new insights it will entail to meet the unmet changing needs of healthcare customers? The answers may point towards several areas, which are worth pondering over.

Leaving this exhaustive search for pharma professionals to gain the necessary insights for action, let me give an example of only one such area to drive home the point. An interesting article deliberating this area was published by Reuters Events on November 17, 2020. Especially in the new normal, finding solutions to unmet customer needs would prompt harnessing the combined and synergistic power of medical and marketing skills, creating a culture to match, as the article highlighted.

Elaborating this need, the author stressed, the traditional model of medical and marketing functions working in silos is often a barrier to a holistic customer approach. This is because it stifles the opportunity for co-creation of well-synchronized solutions on a number of medico marketing issues during patients’ disease treatment journey mapping. These customer-centric medico-marketing issues, I reckon, are coming more often now with the increasing number of more informed patients, especially about their personal health care and treatment needs.

Traditionally, in the pharma industry ‘working in silo culture’ is quite prevalent – medical and marketing functions are no different. Encouragingly, during this pandemic, several companies have formed cross-functional teams of medical and marketing professionals. They also create brand plans, develop content and communication strategies in the new digital platforms, as preferred by the customers. Let me hasten to add, most companies, especially in India will need to catch up with this new way of working, creating a new culture, soon.

Two interesting examples of medico-marketing during Covid Crisis:

There will be several examples in this area. However, to illustrate the point of creating a holistic ‘Customer Experience’ in the new normal, let me cite two examples of medic-marketing in this area, during Covid crisis. Coincidentally, both the examples are from the global pharma major Pfizer – the Company (along with BioNTech) that offered the first Covid-19 vaccine to the western world for public use under ‘Emergency Approval’ by the British drug regulator.

The first example is a website for Pfizer prescription medicine assistance program – called Pfizer RX Pathways. It mentions at the very top, ‘Pfizer recognizes the public concern in relation to COVID-19, which continues to evolve. Click here to learn how we are responding.’ When clicked, it takes the viewers to another website, where Pfizer says, ‘we are committed to helping keep people safe and informed.’

The second one tackles the uncertainty and anxiety that many people feel during the Covid pandemic – reassuring the viewers that “science will win.”  It starts with: “At a time when things are uncertain, we turn to the most certain thing there is—science. Science can overcome diseases, create cures and yes, beat pandemics. It has before; it will again.”

There are many other examples, including a social media series on Covid-19 of the Company, which help enhancing holistic ‘customer experience’ in the contemporary situation, for which the concerned companies’ brands are also rewarded by the customers.

Conclusion:

As of December 13, 2020 morning, India recorded a staggering figure of 9,857,380 of new Coronavirus cases with 143,055 deaths. The threat of subsequent waves for further spread of Covid infection still looms large in many states. The good news is, at least, one Covid-19 vaccine is expected to be available in India within a month’s time. Meanwhile, as many people believe, when a company or an industry does most things right, as experienced by its customers, its reputation goes up, and vice versa. For example, the Gallup Poll, published around a year ago – on September 03, 2019 said: ‘The pharmaceutical industry is now the most poorly regarded industry in Americans’ eyes, ranking last on a list of 25 industries.’ Interestingly, similar Gallup Poll, published a year later – on September 08, 2020 noted, ‘the pharmaceutical industry’s image has improved modestly since last year, and it has yielded the “worst rated” distinction back to the federal government.’

So, something good must have happened during this one-year period, the most influential of which being Covid Pandemic. We have seen above, how some pharma players have repositioned themselves to provide a holistic ‘Customer Experience’, through innovative multichannel communication – being on the same page with customers. Medico-marketing approach played a stellar role in these efforts. As more healthcare customers get enlightened on their health and treatment needs by charting through the cyberspace, they are expected to lap-up such multichannel communication, alongside other equally cerebral pharma initiatives.

Undoubtedly, Covid pandemic is a triggering factor for this change, both among the healthcare customers and the pharma players. This trend is not going to disappear soon, as various top research studies have highlighted. Well-deserved pharma image and reputation boost has started gaining speed, following what some companies are demonstrating to customers during the Covid crisis. Pharma marketers, I believe, will not let go this never before opportunity to reposition their respective companies. It will help them achieve well-cherished brand excellence, supported by a robust Company image and reputation. As the good old saying has proved again to the pharma industry – even during the Covid pandemic, ‘as you sow, so shall you reap.’

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.

Covid Prompts Pharma To Move Away From Competition Driven Business Model

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As deliberated in my just previous article in this blog, Covid has been a watershed in several areas of pharma business. One such key area is its competition driven strategic business model. It aims to deliver significant value for a longer time than the competition, protected by a patent thicket driven TINA factor – and only for those who can afford such patented drugs. It didn’t matter, if a vast majority of patients are denied access to these medicines, with a dangerous pricing trend acting as an insurmountable barrier. Flying solo has been the motto of most players in this ball game, to delight the stock markets.

Interestingly, Covid pandemic seems to be changing this model. Pharma industry, by and large, is now trying to demonstrate its core value for the society – moving away from displaying competition driven one-upmanship. In this article, I shall deliberate on this area.

Covid poses both – a humongous challenge and a great opportunity:

As the article, published in the MIT Sloan Management Review on April 16, 2020 highlights: ‘The COVID-19 pandemic may well prove to be the biggest challenge for humankind since World War II.’ The same holds good for the pharma industry, as well. The drug companies are now expected by all, to play a pivotal role in the fight against the pandemic ‘that is bringing health care systems to their knees and sending shock waves through economies across the globe.’

This is generally because, pharma industry possesses wherewithal to develop effective drugs and vaccines to combat this health crisis – if not alone, but certainly collectively. It also offers a great opportunity for pharma to ‘walk the talk,’ by demonstrating upfront that meeting all patients’ unmet needs lie at the core of the pharma business. As I quoted a global CEO in one of my articles articulating, this crisis also comes as ‘a Shot at Redemption in Pharma Industry.’

Thus, if the industry reacts quickly and responsibly, it may have the chance to also redeem a reputation that’s been tarnished for years. Some of these instances are, illegal marketing practices, corruption scandals, and obscene pricing of vital drugs, the MIT Sloan article underscored. Flying solo in this situation may not be just enough, if not foolhardy.

Flying solo in this situation may not be enough:

Taking this initiative won’t be a piece of cake, either, if pharma companies prefer to do it alone during this unprecedented health crisis.  The drug players will need to be willing and able to successfully collaborate with other players in the race to develop treatments and vaccines. Otherwise, their legitimacy will be fundamentally questioned, especially when the entire world is running against time.

The rationale of two top drug companies entering into collaborative arrangements is obvious – the realization that pooling of all resources together is the best way of delivering effective Covid related solutions to the society at the shortest possible time. The good news is, pharma has already taken the first step in this direction, even when some of them are competitors, in several areas – moving away from their competition driven business models, as of now.

Once strange bedfellows – now partners:

The article published in the Bloomberg Law on June 05, 2020 very aptly observed: ‘The race to address the pandemic has brought together strange bedfellows as big-name companies’ partner with their rivals.’ The Scientist also wrote on July 13, 2020: ‘The urgent need for tests and therapeutics has brought companies together and pushed researchers to work at breakneck speeds.’

One can find this happening on the  ground now, as some major pharma and biotech companies, including Eli Lilly, Novartis, Gilead, and AstraZeneca, formed a group called COVID R&D to share resources and expertise to try to accelerate the development of effective therapies and vaccines for COVID-19. Besides, Roche Holding AG and Gilead Sciences Inc. have teamed up on trials for a drug combination to treat Covid-19.

There are several instances of such collaboration also in the Covid vaccine area. For example, GlaxoSmithKline plc struck a deal with Sanofi to produce 1 billion doses of a coronavirus vaccine booster. Besides, Pfizer from the US and BioNTech from Germany are joining hands to co-develop and distribute a potential Coronavirus vaccine, aimed at preventing COVID-19 infection.

It’s a reality today that Covid-19 has brought not just the strange bedfellows within pharma and biotech companies together. Academia and governments have also moved on to the same collaborative platforms, to save people from a deadly and super contagious infection, in the shortest possible time. We have witnessed this

in India, as well. For example, the Council of Scientific and Industrial Research (CSIR) and Aurobindo Pharma Limited have also announced a collaboration to develop vaccines to protect against SARS-CoV-2 or COVID-19.

The rationale and some possible issues: 

Each of these players is bringing some expertise and intellectual property to the table. “As they work together, they’re going to create more, so you have the ‘yours,’ the ‘mine,’ and the ‘ours’ of collaboration,” as the Bloomberg Law points out. That said, any collaboration of such nature and scale will have its own share of legal issues, such as, patents, trademarks, trade secrets, revenue sharing models, and more.

The collaborators, in pursuit of saving mankind from Covid-19, are expected to find enough alternatives to resolve these glitches for a win-win outcome – not just for now, but much beyond – with the dawn of a new collaborative model. The rapid general acceptance of this collaborative model by more and more drug companies to meet unmet medical needs in many other areas – much faster, in all probability, will delight the health care consumers and also be appropriately rewarded.

Leveraging the collaborative business model beyond pandemic:

E that as it may, it still remains an open question to many, whether such collaborative model will be leveraged for an accelerated rate of drug, vaccine and diagnostics development beyond the pandemic.

The good news is, as The Scientist article reported, some pharma players are seriously pondering how to continue working in this new way – with the same sense of urgency and purpose, for other disease areas too. They believe, the lessons being learned with the collaborative models, may help expedite development of therapeutics in other serious conditions, such as, Alzheimer’s, intractable cancers and autoimmune diseases.

If and when it happens as a predominant business model, suffering patients and the society, in general, would lap it up and the innovators would be suitably rewarded. However, the paper also says, there are still some drug companies who prefer to continue working in a more insular fashion, as was happening in the old normal. But, experts also feel, that should not cause any worry, as long as majority prefers to continue following the collaborative models, in the new normal, as well.

Pharma would make a good profit from collaborative business models too:

For those who say that drug companies won’t make good profit from Covid drugs and vaccines, Pfizer CEO has an answer. Albert Bourla, Pfizer’s CEO, reportedly, has no patience for the argument that pharmaceutical companies should not be making a profit on the drugs and vaccines they introduce to fight Covid-19. This article highlights, at $19.50 per dose, the 1.3 billion doses of Pfizer BioNTech Covid vaccine that the Pfizer plans to make by the end of next year, could translate to nearly $13 billion in sales, after the company splits its revenue with its partner BioNTech. It is roughly the same as Pfizer’s all-time best-selling drug Lipitor sold in its best year.

Adding to it, another article on the same issue, published by Fierce Pharma on August 13, 2020, further reinforced the above expectation. It wrote, the longtime Evercore ISI pharma analyst haspredicted the total market for COVID-19 vaccines would be worth $100 billion in sales and $40 billion in post-tax profits. It assumed frontrunner Moderna would supply about 40 percent of the market, Novavax would take 20 percent and the other vaccine developers would split the rest. “One could look at the field under this base scenario and conclude it is reasonably valued in total,” the analyst concluded.

Nonetheless, there could still be several points that remained unanswered in this analysis. But the bottom line is, the collaborative model is not just profitable, it starts generating profit earlier and faster – virtually eliminating the cost of possible delays when a company flies solo.

Conclusion:

With a seemingly flattening curve, the Covid pandemic still continues, alarmingly. As of October 25, 2020 morning, India recorded a staggering figure of 7,864,811 of Coronavirus cases with 118,567 deaths.

With this backdrop, COVID-19 has provided the pharma industry a new opportunity to demonstrate its true value to the society – not the self-serving ones. It’s now clear that no one can rule out, there won’t be a similar unprecedented health catastrophe in the future too. It may come in various different forms, or may even be from a rapid and complex mutation of the same lethal virus.

Moreover, such crisis may not come and go in just a few months – may even linger for a long time. In any case, these may again be equally disruptive – or even more disruptive to lives, livelihoods and the economic growth engine. In such a scenario, putting the brightest scientific brains of the world together will be critical, and adding top speed to the process being the essence to come out of the crisis with least possible damages.

Covid pandemic has also demonstrated that the competition-based model of the drug could be a serious retarding force in that endeavor. What will matter, is a well-structured collaborative model that can create a win-win situation – both for patients and the business. I reckon, it’s about time to move into this model to find most effective drugs and treatment solutions for many other unmet needs related to a host of intractable diseases, much sooner.

There could, of course, be some business issues with this model. But those can be resolved amicably for an all-weather greater success in business, along with protecting the society – for all. From this overall perspective, it appears, Covid pandemic now sends a strong signal to pharma companies to move away from predominantly competition driven business models, expanding more into collaborative ones.

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.

 

Pharma To Leverage The Art of Turning Challenges Into Opportunities, Now

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Since, the dawn of the year 2020, the human population living in different countries, across the world are facing ‘lockdowns in different forms. Although essential, it severely restricts normal daily essential and other important activities of all. A large number of populations in India, is also experiencing the same – for nearly 4 months, almost at a trot, as on date.

The fear of getting infected by COVID-19, fueled by uncertainty about a comprehensive way to surely avert infection and apprehension about what happens if someone gets infected, have been haunting many for several months. Moreover, the possible impact of several related essential measures, such as, social distancing and wearing a mask mostly while being outdoors, on both life and livelihood, is profound. It has already started causing an unprecedented – both physical and mental stress on many individuals, besides the economy of the nation.

Living amid ‘lockdown’ conditions is not just an unpleasant experience for all, it’s almost a ‘prison like’, experience for a vast number of people – particularly, both young and old with comorbidly. “It’s very similar to being trapped in a bunker with no access outside,” as expressed by a person with similar issues, which, may be construed as a universal feeling of common individuals. Interestingly, this was quoted in an article -  ‘What patients need right now’, published in the Reuters Events Pharmaon July 07, 2020. The article also highlighted that many other fellow sufferers, especially non-Covid-19 patients, are enduring pandemic enforced isolation without much hope. “They are staying in limbo until help is available and adapting to the worsening of their health conditions,” the article added.

Further, as captured in the McKinsey article – ‘COVID-19 and commercial pharma: Navigating an uneven recovery,’ published on April 21, 2020 – not just patients, health care professionals including doctors, are also facing unprecedented challenges. Especially, because of the need to address fundamental changes in the treatment of patients with conditions other than COVID-19. This is happening across medical specialties and therapeutic areas, besides of course in advising and treating patients with suspected and confirmed cases of COVID-19.

In some instances, some doctors do also worry about their financial security, as practices and health systems face unprecedented financial issues, the above article emphasized. However, at the same time, many of them are now rapidly adjusting how they deliver care, such as through increased use of telemedicine in different forms and ways, the survey found. Which is why, the support they need from pharma companies is also changing.

Taking cognizance of these critical developments, pharma players would require rewriting their playbook for business operations and for its urgent implementation. This article will focus on this important area of pharma business, by leveraging the art of turning a problem or a challenge into an opportunity.

Leveraging the art of turning a challenge into an opportunity:

Turning a problem or challenge into an opportunity in managing business operations, isn’t a cup of tea of all managers, across domains. More so, when it’s caused by an unprecedented disruptive change, such as the Covid-19 pandemic.

The first and the foremost prerequisite from a manager is a mindset to make it happen – driven by uncluttered thinking, with a clear focus on what needs to be achieved, how and when – step by step. Each element of a change has to be analyzed in-depth – supported by credible data, with possible barriers envisaged on the way. In tandem, weighing the chances of success in these initiatives based on data – and not gut feeling, within a predetermined timeframe will be critical. The net outcome of this process will help pharma players acquire a differentiated competitive edge for excellence, amid today’s all-pervasive quandary.

Under this backdrop, leveraging the art of turning a problem or challenge into an opportunity – in an organized manner, for a successful outcome of the present and future pharma business, appears to be a crying need.

The points to ponder:

Effectively moving in this direction will call for – at its very onset, a careful and unbiased data-based assessment of several critical areas, which will include:

  • Whether customer engagement platforms, medium, processes and also the core content of communication of pre Covid-19 days remain equally relevant today, and will remain so in the foreseeable future, for productive business outcomes.
  • Mapping changes with the extent for each, in all touchpoints of disease treatment processes is important – involving both patients and doctors, and simultaneously capturing their new preferences in those areas.
  • Arriving at what strategic and tactical changes the new normal calls for, to effectively engage with especially, non-Covid patient treating doctors and non-Covid infected patients, for other disease areas.
  • How doctors are delivering care, particularly to these patients today?

Accordingly, the pathway for required changes has to be charted out in detail, specifying the end point of each, on a time-bound and ongoing basis. The good news is, several pharma players have already taken several praiseworthy initiatives to combat this crisis.

What pharma companies have done so far:

So far, many pharma companies – both global and local, have taken some commendable steps to address the immediate fallouts of the crisis. These include,

  • Repurposing old medicines – starting from hydroxychloroquine, remdesivir to dexamethasoneand probably beyond. All these drugs are currently being used for the treatment of Covide-19, although conclusive scientific evidences are still awaited – for most of such repurposed drugs.
  • Covid-19 vaccine development started almost immediately, including the homegrown ones.

As the above McKinsey article – ‘COVID-19 and commercial pharma: Navigating an uneven recovery,’ also reconfirms, now most pharma companies are largely focusing on ‘the immediate crisis, including by facilitating access to medicine; supporting HCP, institution, and patient needs in new ways; safeguarding employees; and enabling employees to operate in a new environment.’

The areas where pharma needs to focus more amid immediate crisis:

Another, responsibility of pharma to help tide over the immediate crisis, is to ensure that critical drugs, such as remdesivir, do not go in short supply. And also, avoiding unnecessary hype on a COVID-19 vaccine, which a global CEO termed as a grave disservice‘ to the public.

Nearer home, it also happened – not by any pharma company, but by the country’s premier, state-run medical research organization – the Indian Council of Medical Research (ICMR). The head of the ICMR has announced that India is planning to launch the Covid-19 vaccine by August 15, 2020. This was later retracted under heavy adverse criticism.

Future focus areas need to be in sync with the changing customer behavior:  

While converting several challenges into opportunities in sync with the future requirements of their business operations, drug companies should try to derive the first mover advantages. For this purpose, creative use of almost real-time data will be vital. In this endeavor, I reiterate, one of the top priorities will be to ensure that all touchpoints of the consumer engagement process take into account the changing customer behavior, as captured by data.

To have a productive value delivery system in the new normal, cerebral use of modern technology-based tools and platforms could provide a sharp cutting edge. A similar process may be adopted – even a stage earlier – during the differential value creation process of the business. Nevertheless, the name of the game for the future, would still remain delighting the customers at all the touch points, especially while navigating through strong headwinds.

Another major impact area of pharma business:

The onslaught of Covid-19 pandemic has also resulted in some significant behavioral changes among many health care consumers. These spans across several areas, as I wrote earlier. For example, a number of surveys have revealed that fewer number of non-Covid-19 patients are now visiting doctors’ clinics.

The study quoted by the above McKinsey article highlights some important points in this regard, such as:

  • Among surveyed HCPs, 82 percent report declines in patient volumes, with more than half describing the declines as “significant”.
  • 40 percent of the surveyed patients reported having a doctor cancel an appointment, while an additional 30 percent or so canceled the appointments themselves.
  • Half of surveyed physicians worry that their patients will not be able to receive timely care for new or existing conditions, particularly those that are not COVID-19 related.
  • The overall reduction in volume is widespread, but variation exists. For example, the number of oncology-related visits have declined far less than those related to cardiology or dermatology, perhaps reflecting patient or physician perceptions of urgency.
  • Such data represent a snapshot of a time still early in the trajectory of this crisis, but the HCPs surveyed expect the trends to continue—and to accelerate, potentially.

Another challenge is surfacing, the talent gap to squarely deal with the crisis.

The problem of talent gap, an opportunity? 

While preparing a company to succeed amid new challenges of the new normal, pharma leadership will notice some critical talent gaps in important areas of business. This is indeed a problem or a challenge. But can this also be converted into a new opportunity? … I guess, this is an opportunity of reskilling the company to meet with the future challenges, to move ahead at a faster pace.

In pursuit of this goal, top pharma decision makers may wish to evaluate a well-balanced mix of two approaches:

  • Reskilling competent existing employees for the new world.
  • Hiring new and ready – suitable talents, for immediate results.

Conclusion:

Reuters reported last Friday, with over 1 million Covid-19 cases, ‘India joins U.S., Brazil in the grim Coronavirus club.’ As on July 19, 2020 morning, the recorded Coronavirus cases in the country reached 10,77,874 with 26,828 deaths. According to the Indian Medical Association (IMA), the spike in the number of Covid-19 cases in India has resulted in the community spread of the Coronavirus disease. It further added: “This is now an exponential growth. Every day the number of cases is increasing by more than around 30,000. This is really a bad situation for the country.” The pace of climb continues going north.

Meanwhile, the Prime Minister of India has also urged all concerned to convert Covid-19 related challenges into opportunities. He said, it’s time to initiate reforms in several areas of governance by all the Indian State Governments.

Call it, the Prime Minister’s advice, or a basic management tool – most appropriate to leverage at this hour, the concept is worth considering by pharma players, as well, instead of getting overwhelmed by the crisis. Thus, in my view, it’s about time for pharma companies to identify critical Covid-19 related challenges, both immediate and also of the future – and convert those into opportunities – powered by technology-based cerebral inputs, in the new world order.
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

 

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.

Pharma’s Late Realization

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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

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.

Biosimilar Drugs: First Indian Foot Print In An Uncharted Frontier

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A homegrown Indian biologic manufacturer is now about to leave behind its first foot-print, with a ‘made in India’ biosimilar drug, in one of the largest pharma market of the world. This was indeed an uncharted frontier, and a dream to realize for any Indian bio-pharma player.                                                      

On March 28, 2016, by a Press Release, Bengaluru based Biocon Ltd., one of the premier biopharmaceutical companies in India, announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved its biosimilar Insulin Glargine in a prefilled disposable pen. The product is a biosimilar version of Sanofi’s blockbuster insulin brand – ‘Lantus’.

The Company claims that Glargine is a high quality, yet an affordable priced product, as it will reportedly cost around 25 percent less than the original biologic brand – Lantus. This ‘made in India’ biosimilar product is expected to be launched in Japan in the Q1 of 2017. Incidentally, Japan is the second largest Glargine market in the world with a value of US$ 144 Million. Biocon will co-market this product with its partner Fujifilm.

Would it be a free run? 

Although it is a very significant and well-deserved achievement of Biocon, but its entry with this biosimilar drug in Japan’s Lantus market, nevertheless, does not seem to be free from tough competition. This is because, in 2015, both Lilly and Boehringer Ingelheim also obtained Japanese regulatory approval for their respective biosimilar versions of Lantus. In the same year, both these companies also gained regulatory approval from the US-FDA, and the European Medicine Agency (EMA) for their respective products.

Moreover, Sanofi’s longer acting version of Lantus – Lantus XR, or Toujeo, to treat both Type 1 and Type 2 diabetes, has already been approved in Japan, which needs to be injected less, expectedly making it more convenient to patients.

Key barriers to a biosimilar drug's success: 

Such barriers, as I shall briefly outline below, help sustaining monopoly of the original biologic even after patent expiry, discourage investments in innovation in search of biosimilars, and adversely impacts access to effective and much less expensive follow-on-biologics to save patients’ precious lives. 

These barriers can be broadly divided in two categories: 

A. Regulatory barriers:

1. Varying non-proprietary names:

A large number of biosimilar drug manufacturers, including insurers and large pharmacy chains believe, just as various global studies have also indicated that varying non-proprietary names for biosimilars, quite different from the original biologic, as required by the drug regulators in the world’s most regulated pharma markets, such as, the United States, Europe, Japan, and Australia, restrict competition in the market for the original biologic brands. 

However, the innovator companies for biologic drugs hold quite different views. For example, Roche (Genentech), a developer of original biologic, reportedly explained that “distinguishable non-proprietary names are in the best interest of patient safety, because they facilitate Pharmacovigilance, and mitigate inadvertent product substitution.”

Even, many other global companies that develop both original biologic and also biosimilar products such as, Amgen, Pfizer and others, also reportedly support the use of ‘distinguishable nonproprietary names’.

That said, the Biosimilars Council of the Generic Pharmaceutical Association argues that consistent non-proprietary naming will ensure robust market formation that ultimately supports patient access, affordability, Pharmacovigilance systems currently in place and allow for unambiguous prescribing, 

2. Substitution or interchangeable with original biologics:

Besides different ‘non-proprietary names’, but arising primarily out of this issue, automatic substitution or interchangeability is not permitted for biosimilar drugs by the drug regulators in the major pharma markets of the world, such as, the United States, Europe and Japan.

The key argument in favor of interchangeability barrier for biosimilar drugs is the fact that the biological drugs, being large protein molecules, can never be exactly replicated. Hence, automatic substitution of original biologic with biosimilar drugs does not arise. This is mainly due to the safety concern that interchangeability between the biosimilars and the original biologic may increase immunogenicity, giving rise to adverse drug reactions. Hence, it would be risky to allow interchangeability of biosimilar drugs, without generating relevant clinical trial data.

On the other hand, the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council, vehemently argue that a biosimilar drug has a lot many other unique identifying characteristics “including a brand name, company name, a lot number and a National Drug Code (NDC) number that would readily distinguish it from other products that share the same nonproprietary name.”

Further, the interchangeable status for biosimilar drugs would also help its manufacturers to tide over the initial apprehensions on safety and quality of biosimilar drugs, as compared to the original ones.

3. 12-year Data Exclusivity period for biologics in the United states:

Currently, the new law for biologic products in the United States provides 12 years of data exclusivity for a new biologic. This is five years more than what is granted to small molecule drugs. 

Many experts believe that this system would further delay the entry of cost-effective biosimilar drugs, restrict the biosimilar drug manufacturers from relying on the test data submitted to drug regulator by the manufacturers of the original biologic drugs while seeking marketing approval.

A rapidly evolving scenario in the United States:

The regulatory space for approval of biosimilar drugs is still evolving in the Unites States. This is vindicated by the fact that in March 2016, giving a somewhat positive signal to the biosimilar drug manufacturers, the US-FDA released another set of a 15-page draft guidelines on how biosimilar products should be labeled for the US market. Interestingly, it has come just around a year of the first biosimilar drug approval in the United States – Zarxio (filgrastim-sndz) of Novartis.

The US-FDA announcement says that all ‘comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.’ Besides labeling issues, this draft guidance document, though indicates that the ‘interchangeability’ criteria will be addressed in the future, does not still throw enough light on how exactly to determine ‘interchangeability’ for biosimilar drugs.

That said, these key regulatory barriers are likely to continue, at least in the foreseeable future, for many reasons. The biosimilar drug manufacturers, therefore, would necessarily have to work within the set regulations, as applicable to different markets of the world.

I deliberated a related point in my article of August 25, 2014, titled “Scandalizing Biosimilar Drugs With Safety Concerns” 

B. Prescribers’ skepticism:  

Initial skepticism of the medical profession for biosimilar drugs are, reportedly, due to the high voltage advocacy of the original biologic manufacturers on the ‘documented variability between original biologic and biosimilars. Which is why, any substitution of an original biologic with a related biosimilar drug could lead to increase in avoidable adverse reactions.

‘The medical platform and community QuantiaMD’, released a study just around September 2015, when by a Press Release, Novartis announced the launch of the first biosimilar approved by the US-FDA – Zarxio(TM) (filgrastim-sndz). However, in 2006, Novartis after suing the US-FDA, got the approval for its human growth hormone – Omnitrope, which is a biosimilar of the original biologic of Genentech and Pfizer. At that time a clear regulatory guideline for biosimilar drugs in the United States, was not in place.

The QuantiaMD report at that time said, “Only 12% of prescribing specialists are ‘very confident’ that biosimilars are as safe as the original biologic version of the drug. In addition, a mere 17% said they were ‘very likely’ to prescribe a biosimilar, while 70% admitted they were not sure if they would.” 

Since then, this scenario for biosimilar drugs is changing though gradually, but encouragingly. I shall dwell on that below.

The major growth drivers:

The major growth drivers for biosimilars, especially, in the world’s top pharmaceutical markets are expected to be:

  • Growing pressure to curtail healthcare expenditure
  • Growing demand for biosimilar drugs due to their cost-effectiveness
  • Rising incidences of various life-threatening diseases
  • Increasing number of off-patent biologics
  • Positive outcome in the ongoing clinical trials
  • Rising demand for biosimilars in different therapeutic applications, such as, rheumatoid arthritis and blood disorders. 

This in turn would probably usher in an unprecedented opportunity for the manufacturers of high quality biosimilar drugs, including in India.

Unfolding a huge emerging opportunity with biosimilars: 

This unprecedented opportunity is expected to come mainly from the world’s three largest pharma market, namely the United States, Europe and Japan, due to very high prices of original biologic drugs, and simultaneously to contain rapidly escalating healthcare expenditure by the respective Governments. 

Unlike in the past, when the doctors were apprehensive, and a bit skeptic too, on the use of new biosimilars, some new studies of 2016 indicate a rapid change in that trend. After the launch of the first biosimilar drug in the US, coupled with rapidly increasing incidences of various complex, life-threatening diseases, better knowledge of biosimilar drugs and their cost-effectiveness, doctors are now expressing much lesser concern, and exhibiting greater confidence in the use of biosimilars in their clinical practice.

Yet another, March 2016 study indicates, now only 19.5 percent of respondents feel little or no confidence in the use of biosimilar monoclonal antibodies compared to 61percent of respondents to a previous version of the survey undertaken in 2013 by the same market research group. The survey also shows that 44.4 percent of respondents consider that the original biologic and its biosimilar versions are interchangeable, as compared with only 6 percent in the 2013 survey.

As a result of this emerging trend, some global analysts of high credibility estimate that innovative biologic brands will lose around US$110 billion in sales to their biosimilar versions by 2025.

Another March, 2016 report of IMS Institute for Healthcare Informatics states that lower-cost biosimilar versions of complex biologic, could save the US and Europe’s five top markets as much as US$112 billion by 2020,

These encouraging developments in the global biosimilar arena are expected to encourage the capable Indian biosimilar drug players to invest in this high-tech format of drug development, and reap a rich harvest as the high priced blockbuster biologic brands go off-patent.

Conclusion:

Putting all these developments together, and considering the rapidly emerging scenario in this space, it now appears that challenges ahead for rapid acceptance of biosimilar drugs though are still many, but not insurmountable, at all.

The situation necessitates application of fresh and innovative marketing strategies to gain doctors’ confidence on biosimilar medicines, in total conformance with the regulatory requirements for the same, as they are, in the most important regulated markets of the world.

It goes without saying that success in the generation of enough prescriptions for biosimilar drugs is the fundamental requirement to benefit the patients, which, in turn, would lead to significant savings in health care cost, as estimated above, creating a win-win situation for all, in every way.

As more innovator companies start joining the biosimilar bandwagon, the physicians’ perception on these new varieties of medicines, hopefully, would also change, sooner.

Biocon’s grand announcement of its entry with a ‘made in India’ biosimilar drug in one of the word’s top three pharma markets, would probably be a great encouragement for all other Indian biosimilar drug manufacturers. It clearly showcases the capabilities of an Indian drug manufacturer to chart in an uncharted and a highly complex frontier of medicine.

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.