Winning By Creating A Strong Pharma ‘Brand Identity’

Posted on August 8, 2022 by Tapan Ray

Since the beginning of 2022, several top global pharma majors are exhibiting their renewed focus on creating a new corporate ‘brand-identity’. Its key purpose is to chart a new strategic frontier where their brands will stand out in the highly competitive pharma market – gaining a greater share of mind of the customers.

This happened recently with GSK, as reported on June 9, 2022. Prior to this announcement, on February 03, 2022, the French pharma major Sanofi, reportedly, undertook a similar change to refocus on a new brand-identity. It began with a new simplified logo of plain “Sanofi,” apparently, signifying a nod to the tech world.

Against the above backdrop, in this article, I shall deliberate in the process of winning a marketing warfare by creating, and effectively leveraging a strong pharma corporate ‘Brand Identity.’

Instead of starting this discussion with what changes the above companies have made and why, let me try to be on the same page on two important facets in this area. First – what is generally considered as critical ingredients of a ‘brand identity.’ And then – why initiatives of creating a targeted and stronger pharma ‘brand identity’ are gaining increasing importance to pharma marketers of many top companies, across the word.

Some critical ingredients of brand identity:

As defined by the April 11, 2022, issue of Investopedia: ‘Brand identity’ reflects the intent behind branding with the visible elements of a brand, such as color, design, and logo, that identify and distinguish the brand in customers’ minds.

The ‘brand identity’, therefore, encompasses, appropriate brand name selection, designing a logo commensurate to the company intent, well-thought through color selection, use of shapes and other visual elements that will facilitate brand promotion. Above all, employees who are at touch points of patients’ disease treatment process need to be thoroughly explained and appropriately trained to effectively leverage the purpose of change.

‘Brand identity’ is different from ‘brand image’:

It’s important to note that ‘brand identity’ is quite different from ‘brand image.’ While ‘brand identity’ relates to the intent behind the branding – creating and cultivating a strong ‘brand image’ in the customers’ mind – is its purpose. ‘Brand image’ educates customers about both intrinsic and extrinsic values that the brand offers through ‘Omnichannel’ targeted communication. This process helps create customer loyalty.

Increasing importance of stronger pharma ‘brand identity’:

A new trend alerted many pharma leaders, as brand new Covid-19 vaccines started being available to the public. For a vast majority of the population, across the world, vaccines were construed to be the only savior against the unprecedented life and livelihood disruptor – Covid-19 pandemic.

Interestingly, right from the regulatory approval of the first Covid-19 vaccine, although, all such vaccines had brand names – general public, doctors, media, even the World Health Organization, or Governments, started calling vaccines, predominantly, by company names. For example. AstraZeneca Covid Vaccine, Pfizer Covid vaccine, Moderna Covid vaccine, J&J Covid vaccine, and so on. Even the Corporate head honchos of respective vaccines and Covid related drugs, came to the fore with corporate branding to establish a meaningful relationship with the customers. Accordingly, in the marketplace, establishing a strong corporate brand identity has assumed greater importance, more than before.

Studies vindicate this point:

That a strong corporate ‘brand identity’ helps create a differentiable product image, has been captured in several studies. For example, a study published by PharmaVoice on August 28, 2014, came to an interesting conclusion. After analyzing a situation in which multiple pharmaceutical companies developed a similar oncology product for the same indication, it said: “All things about the product being identical, including the price, we asked which company’s product would the oncologists recommend. The companies with the best company brand images scored highest, proving that company image alone would have a significant impact on recommendation behaviors.”

Would pharma’s strong corporate ‘brand identity’ impact the bottom line?

Several independent studies have also proven the same. For example, a mere 5% improvement in the strength of the company’s brand image and reputation could be expected to produce, on average, a 1.5% uplift in the share price over the year, translating to about a $550 million increase in market capitalization.

Acknowledging this point the above paper underscores: “Thus, any pharmaceutical company that wants to succeed and sustain a healthy, long-term competitive advantage, create differentiation in the short term, and insulate itself from weather storms of clinical disappointment, which invariably occur in pharma, would want to invest in corporate brand identity development that includes all drivers of reputation and relationship.”

It is happening more, especially in post Covid-19 pandemic period:

Let me now go back to where I started from. I started by saying: ‘Since the beginning of 2022, several top global pharma majors are articulating their renewed focus on brand-identity.’ I also wrote about deliberating what changes, especially the two pharma majors have made to strengthen their corporate ‘brand identity’ – for different reasons.

Let me start with GSK:

According to June 09, 2022, edition of the ENDPOINT NEWS, GSK – as it transforms into a pure Biopharma company – unveiled the reinvented company and the corporate brand to its employees first – on June 08, 2022, with the intent to bring everyone in the global company together.

The Company says, it’s about a way more than a logo. The Biopharma-only GSK believes, it has adopted a new purpose – “to unite science, technology and talent to get ahead of the disease together,” besides a new strategy, ambitions, and revamped ‘brand identity’.

The new corporate ‘brand identity’ of the corporation is a blend of familiar and modern of its vibrant orange brand color that remains. Now it’s a three letter-only corporate name - all uppercase and standalone - reimagined in a curvy contemporary logo. The new GSK logo “takes inspiration from the visual language of biosciences, genomic sequencing and data analysis, but – still feels warm and human,” as explained on the GSK website.

According to the Company, the new GSK’s ambitions also include people. It’s the final goal in its three debuted ambitions – impact the health of 2.5 billion people in the next 10 years, achieve specific competitive growth goals and make sure employees are thriving.

Coming to Sanofi:

According to Fierce Pharma of February 03, 2022, Sanofi also undertook a similar change at the start of the year. Ditching the Pasteur and Genzyme of old, the Company decided to go for a new ‘brand-identity.’ It rebranded itself as plain “Sanofi.” That switch also came with a new, simplified logo with a nod to the tech world.

According to Sanofi Press Release of February 03, 2022, the French pharma major’s ‘rebranding centers on a clean, lower case new logo. ‘The new logo is a representation of Sanofi’s new purpose and ambition, which is inspired by the simple and motion-oriented codes of the tech industry. The two purple dots embody the scientific journey between a starting point – the curiosity of questioning the status-quo and wondering “what if?” – and a finish line – the eureka moment where innovative solutions are unlocked to impact people’s lives’, it explained.

“With our new brand, we have sought to provide our people, our partners, patients and healthcare professionals with a clear and strong understanding of who we are and what we are set to achieve,” Sanofi highlighted.

The Company further reiterated: “Sanofi’s attitude is humble, authentic—and a little bit unconventional, too. We believe that our new brand and logo carve out a unique space in the healthcare industry that perfectly represents our new purpose to chase the miracles of science to improve people’s lives.”

Conclusion:

The journey of creating corporate pharma ‘brand identity’ initiatives is highly cerebral and originates from the top echelon of pharma management team. The key objective of creating a strong corporate ‘brand identity’ is to ensure that the brand effectively depicts its own unique stance to the customers and differentiate itself from competitors in the marketplace.

I explained above, this process encompasses all branding activities of the company. The aim is to make the company to be perceived in a particular way by the target audience. Which is why, creating a strong corporate ‘brand identity’ is critical in shaping a unique corporate image, especially in generics dominated Indian pharma industry.

It goes without saying, such differentiation, in turn, helps expanding a loyal customer-base for performance excellence, more in the post Covid pandemic environment of India. Even, global pharma majors, are recreating their new brand-identity, for various reasons, and trying to leverage it effectively, to carve out a greater share of mind of more and more customers.

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.

Visible, The Green Shoots of Digital Transformation in Pharma

Posted on July 22, 2019 by Tapan Ray

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

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

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

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

A fact-check:

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

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

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

Industry

Yes (enterprise-wide)

Yes (Within business units) %

Pharma

All industries

The second question is even more specific:

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

Industry

Dedicated CDO

Someone else in that role %

Pharma

All others

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

‘Digital warming-up’ has commenced:

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

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

A soft target – for rationalization:

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

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

In pursuit of holistic outcomes with digitization:

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

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

The initiative intensified in the last two years:

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

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

Is CDO position a temporary one?

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

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

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

Current scope of CDO in a pharma business:

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

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

Now, CDOs will need to prove their value:

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

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

The current status of digitization in pharma:

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

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

Industry	Very effective %	Moderately effective %	Not/Slightly effective %
Pharma	17	37	36
All others	22	42	46

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

Conclusion:

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

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

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

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

By: Tapan J. Ray

While Pharma Leadership Change This Atypical Skill Counts

Posted on July 1, 2019 by Tapan Ray

Effective September 01, 2019, the global pharma major Sanofi will have a new CEO, as the present CEO retires attaining his retirement age of 65 years. This appears to be a mandatory announcement from the company, as is required during the top leadership change in any large and listed organization.

However, there is something novel, as well, in this announcement, especially when specific qualities, skills and experience of the new CEO were highlighted by the company’s Board of Directors. According to Sanofi Press Release, the new CEO – Paul Hudson “has proven his strategic vision, his strong leadership and his ability to achieve the greatest challenges, particularly in terms of innovation and digital transformation.”

Among the stated experience and skills, the one that appeared atypical to me, is the experience of digital transformation, particularly in the position of the CEO of a global pharma major. I In this article, I shall, therefore, explore, why knowledge and experience in this atypical skill is gradually becoming critically important for pharma leadership positions, at all levels.

Why is the need for digital transformation of pharma business?

According to the Internet Trends Report 2019 by Mary Meeker, at 3.8 billion internet users, more than half the world’s population is now online and it is growing. This number would obviously include patients.

As we know, the core purpose of pharma business is to offer a unique patient experience during any disease treatment process. And, the expectations of which from Internet-savvy individuals will be significantly more for various related reasons.

To achieve this objective, drug players would always require to be in sync with customers’ perceptions, expectations and aspirations, among others. Moreover, it’s also not ‘one size fits all’ type of a solution. These will significantly vary for different patient groups, so are the processes of engagement with them – based virtually on real-time information.

Interestingly, the core purpose of digital transformation is also to facilitate this process, with a great amount of precision. The entire process of creating a unique patient experience, involves generation of a massive amount of customized data, customize analysis of which is done through sophisticated analytics, and thereafter, translating and using them as key strategic business inputs, on an ongoing basis. Traditional organizational methods, systems and processes are incapable to deliver the same. Hence arises the crucial need of digital transformation of the organization, across the board.

The transformation is not just about software, hardware and data:

That said, it is also essential to realize that digital transformation is not just about software, high-tech hardware, mobile apps and sophisticated wearables and data. These are, of course, some of the vital tools – used while transforming a company into battle readiness to create and provide a unique customer experience.

Such unique experience for each customer should cover all touchpoints, spanning across – before, during and after treatment with the company’s medication. This, in turn, helps generate an increasing number of prescriptions from doctors, which otherwise would not have been possible, following the conventional means.

Why this atypical skill is in demand today?

Like any other transformation process within an organization, digital transformation should necessarily be driven by the company CEO, having adequate experience in this area. Even the Board of Directors of many pharma players believes that such a CEO can facilitate the process faster and more effectively. Hence, the demand for this atypical skill is increasing, also for a pharma CEO position, besides leaders in various functional areas, as it is being considered as pivotal to achieve the core purpose of a pharma business, in the digital world.

Thus, if a CEO doesn’t properly understand, how the digital world operates with increasing number of visitors in the cyberspace and convinced about its relevance for business excellence, the organization would ultimately lose its competitive edge. One may, therefore, question, did the need for this atypical skill also arise during the selection of the new CEO of Sanofi?

Is this atypical skill for a new CEO more important now?

The answer, I reckon, could be both, ‘probably yes’ and also ‘no’.

‘Probably yes’, mostly because, being an uncommon skill for a pharma CEO, so far, it arrested the attention of many while reading ‘Sanofi Press Release’, for the appointment of their new CEO. Nevertheless, Sanofi is not the first pharma company placing so much of importance on digital transformation, especially for the key leadership positions. In an interview with the Wall Street Journal (WSJ) of February 18, 2018, the CEO of Novartis said: “We need to become a focused medicines company that’s powered by data science and digital technologies.”

Why it is so important for a pharma CEO?

The AT Kearney paper titled, “New Medicine for a New World – Time for Pharma to Dive into Digital,” also captured that an increasing number of pharma customers are now getting engaged and have started interacting in the digital space, more than ever before. This trend is fast going north – becoming an ‘in-thing’ of the industry, as it were. But more probably to be seen as trendy or display that they are also in it, by ‘dipping a toe in the digital waters.’ Whereas, ‘it’s time to take the plunge,’ as the paper cautions them.

‘Plunging into the digital water,’ doesn’t mean sending people to some external training program – with the word ‘digital’ prominently featuring as the course objective. It means bringing out ‘digital transformation’ of the entire organization, spearheaded by the CEO. The leadership of each functional area would then implement from the same playbook, with a structured and custom-made plan designed specifically to achieve the vision, mission, goals and values of the company.

We have recent examples of, at least, two top global pharma majors taking a plunge in the digital water to make the digital transformation of the organization a reality. The key purpose of the same, is to create a unique customer experience, being on the same page with them, in more effective ways, for business excellence. To move in this direction, the organization must imbibe the non-negotiable principle – ‘digital first,’ across the organization.

Only the CEO can decide ‘digital first’ as guiding organizational principle:

None other than the CEO of a drug company, can decide that ‘digital first’ will be the guiding principle of the company, across all the functional areas of the business. As the above paper articulates, it ‘should be explicitly incorporated into core business processes.’ It further says: ‘Top management must challenge any parts of the business that have not explicitly considered the opportunities from digital in their plans.’

Functional leaders to be in sync with digital transformation:

All in the pharma organization, across all functions, must work for the end consumer of any pharma business – the patients. Every single employee in the company should strive delighting them with the company’s products and services, at every touchpoints, during their quest for relief from illnesses. As I said before, this is the single most important factor that determines not just the pace of growth of a drug company, but help enhance its reputation, too. It goes without saying, its ultimately the patients who are playing a catalytic role in the digital transformation of an organization.

It is essential for the CEO to make sure that entire corporate, functional and even departmental leadership teams are in tune with the need of digital transformation of the organization. Despite the detail explanation, if some remain unconvinced about the rationale behind the transformation of the core business process, the right leader should assume the responsibility.

This is because, even with one loose knot at the leadership level in this area, the entire objective can seriously get thwarted – down the line. Such changes, as, if and when required, can be achieved in various different ways, not through attrition alone. For example, by encouraging them to work with members of his peer group who can set good examples to emulate.

Brand promotion to physicians will still remain as important:

In tandem, no company should lose sight of the fact that their face-to-face interaction with physicians, will continue to play an important role in brand promotion. Primarily because, doctors and hospitals help patients to get desired solace from ill-health by prescribing recommended medicines, and consequently, will keep prevailing as an integral part of the pharma marketing process, supported directly or indirectly by every employee in the company.

The key challenge in digital transformation:

The key challenge in the digital transformation of a pharma company is broadly possible inflexible or a rigid mindset of some of its leaders. This is generally fueled by the fear of moving out of their respective comfort zones – rather than resources and expertise required to make the technology put to use. A well-running-business with a grand idea for the future, will generally be able to garner necessary resources and other wherewithal, without much problem.

All pharma leaders should always consider themselves as an important solution for the future success of the organization, Otherwise, he or she may be construed as a part of the problem and a hindrance in achieving the corporate goal and should make way for the capable ones, in this area. Hence, selecting leaders with the right spirit to make digital transformation effective, is so critical for the CEO.

To commence this journey, the leaders may either be willing to acquire the experience of a disruptive digital transformation, guided by the domain experts or may be recruited from outside having the necessary experience. Collective and well-coordinated steps towards this transformation can neither be tentative, nor should it commence without having the right leader at the right place with required will and experience.

Digital players entering into health space with game changing ideas:

Pharma players should also note, how the big technology companies, such as, Apple, Google, Microsoft and Amazon, besides many startups, are trying to create space for themselves in the health care arena. Several of them are also trying to reinvent health care with zest, much beyond what traditional drug companies could even envisage, till recently.

The digital transformation of the organization would help drug players to align the company’s business model with the tech companies in those specific areas to reap a rich harvest. More opportunities will also unfold – either to collaborate with them for targeted projects or moving into the tech space with well-calibrated measures, for business synergy. Without digital transformation of business, either facing such competition or benefitting from the available opportunities, will be challenging for drug companies.

Conclusion:

In the digital world, while patients are emerging as a key driver of change in the health care space, traditional pharma operational systems, including sales and marketing are likely to give a diminishing return on investment. Although, many drug companies can sense this ongoing metamorphosis, several of them are still wondering how to go about it. Moreover, to test the ‘digital water’, some of them have started converting several traditional operational methods, systems and processes in the digital format, as well. Yet, are unable to fathom, why such efforts are not clicking – leading to a quantum increase in the operational efficiency – in pursuit of excellence.

The good news is, global pharma organizations, such as, Sanofi and Novartis, besides several others, have realized that incremental performance improvements with small tweaking here or there, across the organization, aren’t just enough. The corporation needs to move towards a holistic digital transformation, spearheaded by its CEO, having experience in this process. This new breed of pharma CEOs, well-supported by his team of leaders, fostering a burning desire to produce pace setting results, can usher in this ‘disruptive’ transformation. Because, they realize, traditional pharma operational systems, when tempered through the fire of the digital transformation process, can yield game changing outcomes for the organization. The entire process, as it comes to fruition, helps delivering greater customer value, creating a unique customer experience – similar to what customers want – on an ongoing basis.

In fine, strategic intervention of this genre, initiated by the CEO and cascading down the organizational hierarchy, creates a whole new patient-centric outcome, which is much more than what a company can get through re-engineering the operational processes. Hence, especially the young mangers of date, may wish to note note that during virtually every leadership transition, this atypical skill is now likely count much more than ever before – with an ascending trend.

By: Tapan J. Ray

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

For Patient-Centricity: Emerging a C-Suite Role

Posted on August 20, 2018 by Tapan Ray

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Utilizing patients’ input to get a better sense of their needs in order to design and deliver solutions that help fulfill them.

Engaging and supporting patients to ensure the solutions that the company delivers help enhance their lives and improve outcomes.

Involving with the company employees and supporting them to create an engaged community and patient-centric culture.

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

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

Demonstrate integrity and authenticity through all company actions.

Understand all the issues that patients face ‘beyond the pill’ and help in dealing with them.

Transparency in drug pricing policy, research, results, funding relationship.

Ensure that all patients are included in access strategies, regardless of the returns to the company.

Products to provide quantifiable value to patients.

Reliable supply and comprehensive patient safeguard.

Provide quality product information – Consistent, current, balanced and usable.

Patient group relation – good intention, effective governance, communication and training.

Ensure patients are engaged and their opinions are sought at each stage of R&D.

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

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

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

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

In the 2013 survey on ‘Patient-Centricity’ by the research firm ‘Patient View’, ViiV Healthcare (the GSK & Pfizer joint venture focused on HIV therapies), Gilead, AbbVie, Menarini and Janssen occupied the top 5 spots.

However, in the ‘eyeforpharma Barcelona Awards 2016 ’ that too focuses on ‘Patient-Centricity’, none of these companies featured in the “Most Valuable Patient Initiative or Service” category. Whereas, Sanofi took the top spot, and Merck, Roche, Novartis and TEVA were the remaining nominees.

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

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

Conclusion:

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

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

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

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

By: Tapan J. Ray

A ‘Toxin’ Delaying Success of Biosimilar Drugs

Posted on August 6, 2018 by Tapan Ray

The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important biosimilar drugs.

We know, this new genre of drugs has a potential to be a quick game changer, significantly improving access to affordable biologic medicines for many patients. Unfortunately, much desired accelerated progress in this direction, got considerably retarded in the face of a strong headwind, craftily created by the innovator companies, as is widely believed. There are various ways of creating the same. However, the two major ones can be ascribed to:

Getting caught in the labyrinth of complex patent challenge.
General apprehensions of many doctors on the efficacy and safety of biosimilars as compared to reference drugs.

This is happening in major markets, including India, in varying degree, though. In this article, I shall deliberate on this issue, starting with the largest pharma market of the world and then focusing on India.

‘Toxin’ that delays biosimilar drug launch:

“Americans could have saved $ 4.5 billion in 2017, if all of the FDA-approved biosimilars were actually available in the United States, instead of getting delayed because of litigations or other agreements.” The Food and Drug Administration Commissioner of the United States – Scott Gottlieb, reportedly, made this comment on July 18, 2018.

Gottlieb referred to some of these as a “toxin” that have prevented other drug makers from launching biosimilar medicines. He accused the manufacturers of pricey biologic medicines of using “unacceptable” anti-competitive tactics to keep competitors off the market. These cost Americans billions of dollars – the report highlighted.

These tactics, as the US FDA commissioner said, are being deliberately used by the innovator pharma and biotech companies and can be corroborated with several examples. One such is the fact that despite the expiration ofthe ‘composition of the matter’ patent for Humira (adalimumab) in December 2016, its ‘non-composition of the matter’ patent would expire not earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis, delaying the launch of adalimumab biosimilars until January 2023.

Protecting own patents Big Pharma challenging rivals’ patents:

Both these are happening for original biologic and biosimilar equivalents, often by the same manufacturers. For example, the Reuters report of October 02, 2016, titled ‘Big Pharma vs Big Pharma in court battles over biosimilar drugs’ highlighted, although Novartis and Amgen are at each other’s throats in court over the Swiss drug maker’s Enbrel copy, but the two are still cooperating on a drug for migraines.

“One of the biggest surprises has been the number of innovator Biopharma companies, like Amgen, now developing biosimilars to compete with the products of other innovator companies,” the article observes. It also reports that Sanofi, Merck, Eli Lilly, Pfizer, Johnson & Johnson and Biogen are also embroiled in lawsuits over biosimilars.

This trend vindicates that the line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines, Reuters noted. Consequently, they are now doing both – protecting their high-price products from biosimilars drugs,while simultaneously challenging rivals’ patent claims.

There is another interesting side to it. Notwithstanding, biosimilars are a cost-effective alternative to biologic drugs that could improve patients’ access to expensive biological medicines, prescribers’ perception of biosimilar medicines are still not quite positive, just yet.

Doctors’ attitude on biosimilar prescription:

To illustrate this point, let me quote from recent research findings in this area. One such is the May 2017 study on “Medical specialists’ attitudes to prescribing biosimilars.” The key points are as follows:

Between 54 and 74 percent of the specialists are confident in the safety, efficacy, manufacturing and Pharmacovigilance of biosimilars.

71 percent of specialists agreed that they would prescribe biosimilars for all or some conditions meeting relevant clinical criteria.

Specialists are less confident about indication extrapolation and switching patients from an existing biologic.

The most common situations that they would not prescribe a biosimilar was where there was a lack of clinical data supporting efficacy (32 percent), or evidence of adverse effects.

Overall, medical specialists held positive attitudes towards biosimilars, but were less confident in indication extrapolation and switching patients from the original biologic. Several experts believe that constantly highlighting the fear factors against biosimilar drugs, such as possible risks of interchangeability with reference product, or immunogenicity related serious consequences, though very rare, are fueling the fire of apprehensions on the wide use of biosimilar medicines.

However, several reviews, like the one that I am quoting here finds that ‘switching from the reference product to related biosimilar drug is not inherently dangerous.’I discussed this issue, with details in one of my articles, published in this blog on July 31, 2017.

Any therapeutic difference between the original biologic and biosimilars?

As the US-FDA says: “Patients and their physicians can expect that there will be no clinically meaningful differences between taking a reference product and a biosimilar drug when these products are used as intended. All reference products and biosimilar products meet FDA’s rigorous standards for approval for the indications (medical conditions) described in product labeling.”

The key point to take note of is that the US drug regulator categorically reiterates: “Once a biosimilar has been approved by the FDA, patients and health care providers can be assured of the safety and effectiveness of the biosimilar, just as they would for the reference product.”

The invisible barriers to biosimilar drugs in India:

Although, there are no specific data requirements for interchangeability of biosimilar drugs with the reference product, as mentioned in the latest Indian Guidelines on similar biologic, other visible and visible barriers are restricting the rapid growth of drugs belonging to this genre.

An interesting research study finds, like many other drugs, the cost of biosimilars is a major barrier to the rapid growth of the market in India. The Deloitte Report, titled “Winning with biosimilars: Opportunities in global markets” also articulated: “Approximately 70 percent of the country’s population is considered rural and will focus on the cost of therapy – a 20-30 percent discount on originator biologics may not be sufficient.”

Moreover, many patients who are on original biologic drugs, costing higher than related biosimilars and want to switch over to affordable equivalents, are not able to do so. In many cases, doctors’ do not encourage them to do so, for various reasons, including the general assertion that original biologic drugs are more effective. India being considered as the global capital of diabetes, let me cite an example from this disease area, just to drive home the point.

A recent experience on biosimilar drug interchangeability in India:

Just the last week, I received a call from a friend’s wife living in Delhi who wanted to know whether Lantus 100 IU/ml of Sanofi can be replaced with Glaritus 100 IU/ml of Wockhardt, as the latter costs much less. I advised her to consult their doctor and request accordingly. She said, it has already been done and the doctor says Lantus is a better product.

To get a fact-based idea on what she told me, I referred to two circulars of the National Pharmaceutical Pricing Authority (NPPA) – one for Glaritus and the other one for Lantus and found that both are under drug price control and have respective ceiling prices. As both the circulars are of 2009, these may probably be treated as an indicative price difference. NPPA notified price for a 3 ml cartridge of Glaritus reads as Rs.135. 24. Whereas, the same for Lantus was mentioned as Rs.564.84.

Is an original biologic generally superior to Indian biosimilars?

US-FDA has already reiterated, “Once a biosimilar has been approved by the FDA, patients and health care providers can be assured of the safety and effectiveness of the biosimilar, just as they would for the reference product.”

However, to get India-specific, evidence-based information in this area, I checked, whether Lantus has any clinically proven therapeutic superiority over Glaritus. Interestingly, I came across the results of a 12-week study concluding that biosimilar insulin glargine, Glaritus, is comparable to the reference product, Lantus – providing a safe and effective option for patients with T1DM. Nevertheless, the researchers did say that more studies are required in this area.

The core question that needs to be addressed why is the doctor’s perception so different and the reasons for the same?

Conclusion:

In view of all that has been discussed in this article, I find it challenging to fathom that in the absence of any credible and conclusive specific study, how could a doctor possibly infer that higher priced imported original biologic drugs are generally superior to lower priced biosimilar equivalents? More so, when in India, there are no regulatory issues on interchangeability between original biologic and its biosimilar equivalent.

Or for that matter, a branded generic product is superior to all other equivalent generic drugs without a brand name? This can happen, especially when the vested interests actively work on ensuring that such a perception gains ground, boosting the sales revenue and mostly at the cost of patients’ interest.

As one would witness in many other spheres of life that creating a blatantly self-serving, positive target audience perception, by any means, primarily aimed at destroying the same of others, is assuming increasing importance. Are we seeing the reflection of the same, even in the field of evidence based medical science?

I reckon, it raises a flag for all to ponder, particularly after reading the recent candid comments of the US-FDA commissioner, as quoted above.

Could this be one of those ‘Toxins’, which delays success of biosimilar drugs?

By: Tapan J. Ray

Disruptive Digital Innovation To Reduce Medication Need?

Posted on May 1, 2017 by Tapan Ray

Application of digital technology in various spheres of not just business, but in our individual day to life also, promises a disruptive change for the better, from the traditional way of doing things and achieving goals – freeing a lot of precious time for us to do much more, and even faster. An impending tsunami of this digital revolution, as it were, is now all pervasive, with various digital application platforms becoming increasingly more cost effective, quite in tandem with the fast pace of cutting-edge innovation. This is so different from what is generally witnessed in the pharma business.

Interestingly, despite high demand for cost effective health care from all over the world, not much progress in this area is still visible within this industry, in general, and particularly in the pharma business. Various reasons may be attributed to this apathy, which I shall not venture to go into, today.

On the other hand, sniffing a huge opportunity in this largely vacant space, many tech giants and startups are investing heavily to make health care of people easier, and at the same time reap a rich harvest, far outpacing the big pharma players.

As I connect the different dots on world-class digital initiatives in the health space, a clear trend emerges on the global scenario. The way Internet revolution, to start with, followed by smartphones and many other wireless digital services is changing the rhythm of life for many making it much easier, is just amazing. These include a plethora of everyday ‘must-do’ and several other functions, such as, precise need-based information gathering, online banking, tax-filing, shopping, payment, social networking, cloud computing and storage, besides a gamut of other digital services.

Similar disruptive digital innovations are expected in the health care space too, involving many long-awaited patient-centric areas, such as, significant reduction in the cost of medication. I discussed a similar issue in one of my earlier articles, published in this blog. However, today, I shall focus on this specific area, in view of its possible huge impact on the traditional pharma business model.

May reduce need of medication:

That tech startups are developing digital tools that reduce the need of medication, was very recently reported in an article titled, ‘Digital disruptors take big pharma beyond the pill’ published in the Financial Times on April 24, 2017. For example, a California-based startup, has reportedly come out with a digital device, smaller than an iPhone and fitted with a cellular chip, that can keep instant and accurate track of blood sugar levels. If the readings fall in the danger zone, an appropriate text message will be automatically generated for the person, such as – “drink two glasses of water and walk for 15 minutes”. The individual can also seek further help over the telephone from a trained coach – a highly-qualified dietitian for further guidance, the article highlights.

The whiz kid developers of wearable digital devices and apps are now intently working on many innovative health care solutions. Many of these can help early disease detection, and chart the risk profile of persons prone to various ailments, based on an enormous amount of well researched scientific data, significantly reducing the need of medication through effective disease prevention and management protocols. For example, there are umpteen evidences, demonstrating that specific moderate physical exercises help control diabetes just as well as medication, when detected early.

Thus, I reckon, such wearable digital devices and apps carry a huge promise to detect many diseases like, diabetes at its very onset or even before, and influence the person to take the necessary measures. In case of diabetes, it could be like, walking a certain distance every day, along with regular dietary advices from a remote center. Won’t such digital interventions work out far cheaper and convenient than lifelong visits to physicians and administration of anti-diabetic drugs?

The notes of the pharma business playbook need to be rewritten?

Let me quickly elaborate this point with an example of a common chronic ailment, say, diabetes. For effective management of this disease, global pharma players prefer to focus on better and better antidiabetic drug development, and after that spend a fortune towards their effective sales and marketing for generating enough prescription demand. Branded generic manufacturers are no different. This is important for all of them as most patients will have to administer the medicines for chronic ailments for a lifetime, incurring significant recurrent expenses for effective disease control. The first access point of such disease management has always been a doctor, initially for diagnosis and then for lifelong treatment.

Disruptive digital innovation could change the first point of intervention from the doctors to various digital apps or devices. These digital tools would be able to check and capture the person concerned predisposition to chronic diseases like, hypertension and diabetes, besides many other serious ailments, including possible cancer. When detected early, primary disease management advice would be available to patients from the app or the device itself, such as, the above-mentioned device for diabetes. If the preventive practices can manage the disease, and keep it under control, there won’t be any serious need to visit a doctor or pop a pill, thus, avoiding any need of active medication.

In that sense, as the above FT article has articulated, ‘rather than buying a pill, people might buy an overall solution for diabetes’ can’t be more relevant. When it happens, it will have a multiplier effect, possibly impacting the volume of consumption of medicines, just as what disease prevention initiatives do. Consequently, the notes of the pharma business playbook may have to be rewritten with right proactive measures.

As reported, the good news is, at least a couple of global pharma players have started fathoming its impact. This is apparent from Sanofi’s collaboration on digital devices and patient support for diabetics, and to some extent with Pfizer on immuno-oncology, using expertise in data analytics to identify new drug targets.

The key players in this ‘healthcare value chain’:

When the digital health care revolution will invade the current space of traditional-health care, it will create both the winners and losers. This was clearly highlighted in an article titled, ‘A digital revolution in healthcare is speeding up’, published by ‘The Economist’ on March 02, 2017.

From this article, it appears, when viewed in the Indian context that primarily two groups of players are currently ‘fighting a war for control’ of this ‘healthcare value chain’, as follows:

Traditional innovators: These are pharma companies, hospitals and medical-technology companies, such as, Siemens, GE and Phillips.

Technology insurgents: These include Microsoft, Apple, Google, and a host of hungry digital entrepreneurs and startups – creating apps, predictive-diagnostics systems and new devices.

Where is the threat to traditional pharma innovators?

This emerging trend could pose a threat to traditional innovators as the individual and collective knowledge base gets wider and wider – the above article envisages. With the medical records getting increasingly digitized with new kinds of patient data available from genomic sequencing, sensors and even from social media, the Government, including many individuals and groups, can now get a much better insight into which treatments work better with avoidable costs, on a value-based yardstick. For example, if digital apps and wearable devices are found even equally effective as drugs, with the least cost, to effectively manage the menace of diabetes in the country, notwithstanding any strong ‘fear arising’ counter propaganda, as we often read and here and there, those will increasingly gain better acceptance from all concerned.

The moot question, therefore, arises, would the drug companies lose significantly to the emerging digital players in the health care arena, such as, Microsoft, Apple and Google?

Tech giants are moving faster:

In several disease areas like, cancer and diabetes, the tech giants are taking longer and bigger strides than the traditional pharma innovators. For example:

Microsoft has vowed to “solve the problem of cancer” within a decade by using groundbreaking computer science to crack the code of diseased cells so that they can be reprogrammed back to a healthy state.

Apple has a secret team working on the holy grail for treating diabetes. The Company has a secret group of biomedical engineers developing sensors to monitor blood sugar levels. This initiative was initially envisioned by Steve Jobs before his death. If successful, the advance could help millions of diabetes patients and turn devices, like Apple Watch, into a must-have.

Verily – the life sciences arm of Google’s parent company Alphabet, has been working on a “smart” glucose-sensing contact lens with Novartis for several years, to detect blood glucose levels through tears, without drawing any blood. However, Novartis has since, reportedly, abandoned its 2016 goal to start testing the autofocus contact lens on people, though it said the groundbreaking product it is “progressing steadily.” It has been widely reported that this could probably be due to the reason that Novartis is possibly mulling to sale its eye care division Alcon.

Calico, which is also owned by Google’s parent company Alphabet, has US$ 1.5 billion in funding to carry out studies in mice, yeast, worms and African naked mole rats for understanding the ageing process, and how to slow it, reports MIT Technology Review.

No wonder, why an article published in Forbes magazine, published on April 15, 2017 considered these tech giants as ‘The Next Big Pharma’. It said, ‘if the innovations of Google and Apple are another wake-up call for the life science industry, which oftentimes has relied on the snooze function of line extensions and extended-release drugs as the source of income and innovation.’

In conclusion:

An effective disease treatment solution based on different digital platforms has a key financial advantage, as well. This is because the process of generation of huge amounts of credible scientific data, through large pre-clinical and clinical trials, establishing the efficacy and safety of new drugs on humans for regulatory approval, is immensely expensive, as compared to the digital ones. Intriguingly, no global pharma player does not seem to have launched any significant digital health care solution for patients to reduce the overall cost of disease burden, be it prevention or management.

In that context, it’s encouraging to note the profound comment of the Chief Operating Officer – Jeff Williams of Apple Inc., made during a radio show – ‘Conversations on Health Care’, as reported by ‘appleinsider.com’ on January 06, 2016. During the interaction, Williams reiterated that the rapid progress of technology in this direction is very real, as ‘Apple’ and other smartphone health app developers are stretching the commoditization of computer technology to serve health sciences. In not so distant future, with relatively inexpensive smartphones and supporting health apps – the doctors and researchers can deliver better standards of living, even in severely under-served areas like Africa, where there are only 55 trained specialists in autism.

Thus, it now looks reasonably certain to me that disruptive digital innovation on various chronic health care solutions is ultimately going to reduce the need of medication for many patients, across the world, including India, significantly.

By: Tapan J. Ray

Biosimilar Drugs: First Indian Foot Print In An Uncharted Frontier

Posted on April 4, 2016 by Tapan Ray

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

2015: Pharma Industry Achieved Some, Could Achieve Some More

Posted on January 4, 2016 by Tapan Ray

Wish You And All Your Near And Dear Ones Peace, Happiness, Good Health And Prosperity in The Brand New Year 2016

The year 2015 witnessed several noteworthy developments in the pharma industry, just as many other years before. That said, in my view, a few of these happenings were much more impactful, and probably took place for the first time ever, in the year just gone by.

Obviously, one such major development is the overall serious adverse impact on the image of the pharma industry, in general.

During 2015, the image of the pharma industry got further tarnished by reports of high-profile alleged drug price manipulations. This avoidable saga culminated with the arrest of a pharma Chief Executive Officer (CEO) in the United States, amid a federal investigation, in December 2015.

However, I am not going to dwell on this issue in this article. Instead, I shall select some key strategic pharma business areas, which contribute to the largest chunk of the total overall cost, incurred by the global pharma industry, every year. These areas, as I see, are:

Drug discovery research
Sales and Marketing
Supply Chain
Development of new drug delivery systems
Patients care and engagements

I have put all these points in the above order, just for the convenience of my discussion in this article.

With a few examples, I shall give my perspective on these areas of the global pharma industry, dividing them broadly into the following two sub-categories:

Areas where the industry could have done a lot better
Areas where the industry made significant progress

The Pharma industry strategy continues to remain broadly traditional:

Pharma sector is globally considered as an industry, which appears to be more comfortable in maintaining and harnessing its traditional approaches, in almost all its field of activities. Although, some tweaking has certainly been taking place, which are primarily to automate or digitalize the same process, aimed at adding more speed together with virtually real time monitoring of operations.

Let me hasten to add here that, some major and newer types of modern tech based collaborative initiatives with large companies outside the pure pharma space, have also been reported, during the year.

I shall deliberate on both these areas, one after another, hereunder.

A. Areas where the industry could have done a lot better:

Drug discovery research:

With the increasing impact of patent cliff and low productivity in drug discovery research, coming alongside big ticket generic threats, many pharma players seem to be still tweaking with its traditional blockbuster drug discovery model, in 2015.

Slightly changing from this traditional strategic focus, many of them have now started focusing more on ‘Orphan Drug’ research, though with indication of a life threatening disease with low prevalence, intending to go whole hog for very high pricing of these drugs.

By gradually adding more indications, these innovator companies plan to make the ‘Orphan drug’ molecule a money churning blockbuster drug. As a result, the number of venture capitalists, who invest in the early stages of such drug development, has increased significantly in 2015.

According to reports, over 40 percent of all approved orphan drugs are meant for high risk cancer sub-categories with low prevalence rate. Although these drugs are for lifetime treatment, the medicines are frightfully expensive, costing between US$200,000 and US$300,000 per year, for each patient.

Intriguingly, still a very few drug companies are externalizing drug discovery research or even considering on a large scale, the use of the ‘Open Source’ drug discovery model, which is currently widely used in the Information Technology (IT) industry, as one of the main platforms to get new products.

Sales and Marketing:

Similarly, in the pharma sales and marketing space, there has been no game changing developments, during the last year.

Although, some initiatives that can at best be termed as tweaking on the traditional pharma methods, were visible, especially in the fields of digital marketing and e-detailing. The good old and much tried traditional tools, such as, Medical Representatives’ (MR) product detailing to individual doctors or a large number of ‘medical seminars’/ ‘continuing medical education’ events, of varying scale and dimensions, arranged for the medical practitioners, still ranked at the very top of this domain.

Here, again, no signs of a paradigm shift were visible to me during the year, nor do I reckon, any game changer is likely to surface, any time soon.

Supply chain:

The immense importance of ‘Supply Chain’ in the overall pharma business does not appear to have been properly understood by the drug companies up until 2015. This has been well vindicated by various credible studies. I would refer below just two of those:

The Chief Supply Chain Officer Report of September 2014, highlighted that just 39 percent of pharmaceutical respondents see the ‘Supply Chain’ as an equally important part of business success as R&D or sales and marketing. Whereas, 68 percent of consumer packaged goods’ respondents believe that leveraging the true potential of this domain, is one of the key requirements for business excellence.

This is noteworthy, as even ‘The McKinsey report’ of September 2013 stated that supply chains now account for around 25 percent of pharmaceutical costs. The annual spending on it is so staggering of around US$230 billion that even minor efficiency gains in this area could free up billions of dollars for investments elsewhere.

Instead of following its traditional approaches, if the pharma sector adopts even straightforward advances, well established in other industries, the total costs could fall by US$130 billion, ‘The McKinsey report’ estimates.

Ideally, pharma ‘Supply Chain’ should be considered not just a means of getting the products at the right place, at the right time and in the right quantities, but also as a means of delivering additional value to the customers. This can be achieved with radical strategic intervention in this space with the application of the state of art technology, which was still broadly lacking in 2015.

B. Areas where the industry made significant progress:

In this section, by citing examples on two other important strategic business areas of the pharma industry, where significant progress has been reported during 2015, I would try to drive home my point. These two areas are new drug delivery systems and patient care/engagement.

New drug delivery systems:

On the development of new drug delivery systems, some interesting collaborative arrangements have been reported in 2015. As illustrative examples, I would cite just the following two:

A. “Smart Inhaler”

I have picked up this important area of a new drug delivery system, out of many, as it fascinates me immensely. Here again, I would illustrate my point with just two examples – out of several others, as hereunder:

1. On December 2, 2015, the British drug major GlaxoSmithKline (GSK) reportedly entered into a technology deal with Wisconsin-based Propeller Health. Under this collaboration, Propeller will create a custom sensor for GSK’s Ellipta inhaler. The Propeller platform combines sensors, software, and care team services to improve patient outcomes by providing more insightful and efficient care. GSK is the second largest pharmaceutical company to partner with Propeller Health, which in December 2013 announced a deal with Boehringer Ingelheim to develop a custom sensor for BI’s Respimat device.

2. In September, 2015, Teva Pharmaceuticals reportedly acquired Cambridge, Massachusetts-based Gecko Health Innovations, a smart inhaler company.

Gecko’s main product is a platform for chronic respiratory disease management that also combines a sensor device that connects to most inhalers, a data analytics platform, an accessible user interface, and behavioral triggers to help asthma and COPD patients manage their condition, more effectively.

B. Sanofi and Medtronic strategic alliance in diabetes to improve patient experience and outcomes

Although not many large scale commercial ‘drug discovery’ initiatives based on the ‘Open Source’ model is still not known to me, in the ‘new drug delivery system’ area, a major global strategic alliance, between Sanofi and Medtronic in the diabetes therapy area, has been reported based on this model. This alliance is aimed at improving patient experience and outcomes for persons with diabetes, around the world.

As I mentioned, the alliance structured as an ‘Open Innovation’ model, will initially focus on the following key priorities:

Development of drug-device combinations
Delivery of care management services to improve adherence and simplify insulin treatment
Help people with diabetes better manage their condition

Patient engagement and care:

Quite encouragingly, in the ‘patient engagement and care’ area too, some of the global pharma majors have taken notable tech-based strides during 2015. Some of these laudable ventures are as follows:

A. Novo Nordisk and IBM partner to build diabetes care solutions on the Watson Health Cloud

According to a Dec. 10, 2015 ‘Press Release’, Novo Nordisk and IBM Watson Health agreed to work together to create diabetes solutions, built on the Watson Health Cloud.

Under this agreement, by harnessing the potential of the Watson Health Cloud, Novo Nordisk aims to further advance its offerings to people living with diabetes and also their health care professionals.

B. Sanofi collaborates with Google to Improve diabetes health outcomes

Less than a couple of months before the Novo Nordisk – IBM partnership agreement, by a Press Release of August 31 2015, Sanofi and Google announced their collaboration to improve care and outcomes for people with type 1 and type 2 diabetes.

According to the release, this collaboration will explore how to improve diabetes care by developing new tools that bring together many of the previously siloed pieces of diabetes management and enable new kinds of interventions. This includes health indicators such as blood glucose and hemoglobin A1c levels, patient-reported information, medication regimens and sensor devices.

Is the word “Innovation” also being used as a façade?

This important, though contentious issue, is being raised by many today, globally.

In my view, global pharma even in 2015, continued making the mistake of repeatedly highlighting, with high decibel sound bytes that the stakeholders do not understand the value, importance and necessity of innovation, which in any case is far from the truth. Nevertheless, It kept using, rather more misusing, this important word too often to cover up any action of theirs that faced government, general public or media scrutiny.

Additionally, many pharma players seemingly continued to remain contented with a very narrow definition of the word ‘innovation’, limiting its application mostly in the traditional space of drug discovery. While at the same time, many other smarter and more astute innovators, especially in the IT world, besides Google, IBM and Apple, started stepping into the vast healthcare arena, which otherwise could possibly have become pharma’s expanded market.

A am quoting below the names of just five of these amazing innovators, from the published data, just to give you a feel of this interesting area of ‘innovation’ in the health care arena:

Medivation: For finding the value of treatments that others ignored
Beijing Genomics Institute: For making DNA sequencing a mass-market
Medisafe: For using wireless and cloud technology to improve drug adherence
Ginger.IO: For harnessing behavioral data to save lives
Setpoint Medical: For creating a built-in pain-relief platform

Epilogue:

Overall, the year 2015 was a mixed bag for pharma. Many pharma players, I reckon, displayed their self serving intent in a more glaring manner. Several captains of this industry generally talked all right things, which are music to many ears, but mostly acted quite differently, going against the public health interest, as reported by the global media.

Many pharma companies continued trying to woo the media cleverly during the year. Some of them, reportedly, even sponsored trips of a few Indian journalists to their respective overseas headquarters. As I understand, many newspaper readers too, had noticed the small print disclosures in this regard, at the bottom of their stories on those companies, written on the return. I have no intention to be judgmental on such trips. Nevertheless, the global media, including the Indian media, by and large, reported all such deeds, with as much detail as possible, without slightest hesitation.

Encouragingly, a few global pharma majors, such as, Sanofi, Novo Nordisk, GlaxoSmithKline and AstraZeneca challenged this contusing status quo in 2015. They seem to dare to chart into the much uncharted frontier to squarely face the challenge of the changing demands of the changing world order. Probably not so much by trying to change others, but mostly by changing themselves.

It appears, at least, the likes of the above global players have started accepting the new expectations of the aspiring customers and their fast transforming mindsets, including, the tougher governments enacting contemporary laws and regulations in many countries. In tandem, the exorbitantly high cost and usually low profile advocacy initiatives of drug companies seem to becoming lesser and lesser productive, as evident by the increasing number of avoidable issues that the pharma industry is now facing. Added to all this, a modern and major force-multiplier, in the form of social media, has now started unleashing its unfathomable power of shaping laws, regulations and even public opinion.

I wish this wind of change gaining more speed in 2016, and in that process, ushers in the long awaited dawn of a new paradigm. A paradigm of justice and equity in health care for all, across the world, and especially to my own country – India.

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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