Tag Archives: Strategic

Being Eclectic – A Pharma Leadership Quality In The New Normal

Posted on by
Reply

It’s no-brainer that since the onset of Covid pandemic, digitalization initiative of many pharma companies in critical facets of business operations, has reached a new high. The process is now fast accelerating with the adoption of avant-garde ideas, and scalable digital tools and platforms. Some of these initiatives may be incremental in nature, but several others possess game changing potential in delivering business outcomes.

This period of transformation is also an opportune time for pharma leadership to be more eclectic, while working out strategies to gain business momentum – outpacing the competition. As is being revealed, strategic inputs from a diverse range of sources – often from totally different areas, to meet fast changing customer needs and expectations, would immensely help in the new normal.

In this article, I shall argue on the need of being eclectic for pharma leadership to gain competitive edge, especially in the trying times. I shall elaborate this point with the example of an eclectic idea – Gamification. If used where it ought to be, eclectic ideas may help organizations to successfully navigate through unprecedented disruptions, especially, caused by Covid pandemic, in various critical areas of pharma business.

Gamification – an eclectic strategic tool for pharma:

Gamification – an eclectic strategic tool, ‘incentivizes people’s engagement and activities to drive results with game-like mechanics.’ Various companies, across the industries, are leveraging this technique for greater effectiveness in different business domains. This includes, driving employee motivation for sustainable performance excellence.

I discussed ‘Gamification in Pharma’ in this blog – about a year before the onset of the pandemic. However, its potential is being increasingly realized with virtual engagement becoming more common during Covid pandemic. Several drug companies are now imbibing Gamification techniques to offer greater value in several areas of business. These include, among others, chronic disease management, adherence to the prescribed dosage regimen, and also for training and development.

The core purpose and value: 

The core purpose of Gamification is to effectively engage with both internal and external customers of an organization, with clearly captured details of their changing needs and expectations in the new normal. Game mechanics are basically the rules and rewards that build the foundation of game play. Game dynamics involve a set of emotions, behaviors and desires found in game mechanics that help foster engagement and motivate participants.

The broad process of Gamification entails integration of game mechanics on various existing platforms. These include, a website, online community, learning tools - providing target audiences with proactive directives and feedback through game mechanics that lead to the accomplishments of business goals and objectives.

According to BI Worldwide - a global engagement agency, ‘Gamification is about driving engagement to influence business results.’ When people participate and engage with gamification initiatives, they learn the best way to interact with the business, its products, services and in thereby in the brand building process.

It further says, the business value of Gamification doesn’t end with the participant. Engagement with game mechanics provides insightful data that can help influence marketing campaigns, platform utilization and performance goals. Every employee or customer interaction gives a better sense of where a participant is spending their time and what activities drive interest.

Application of ‘Gamification’ in pharma is a decade old now:

Gamification isn’t totally a new concept in the pharma industry. It was successfully tried by some pharma majors, at least, about a decade ago. Let me give below just a couple of examples from that period to get a feel of it:

Way back in 2011, Pfizer created the Back in Play game for European patients, to boost knowledge of ankylosing spondylitis, a disease that causes inflammation in the spine and pelvis joints. Interestingly, the game delivered a simple healthcare message to a notoriously difficult to reach audience 38 million times.

In 2012, Boehringer Ingelheim launched its pharma game – ‘Syrum’ on Facebook platform. This particular initiative is considered as an evolution in the pharma industry’s use of the social media platform. It gave the Company a new tool to educate and expand the knowledge of the general public about the challenges of its business. It also helped to improve disease awareness, besides allowing the company to conduct its market research.

Besides these two, other interesting Gamification initiatives taken around that period include, Zec Attack (Novartis), Silence Your Rooster (Sanofi).

Its potential in pharma marketing – and what to avoid:

Applying game mechanics to healthcare marketing could also help ensure that patients are activated, educated, and engaged throughout the duration of their care, driving both – business performance and patient outcomes. This observation was made in an article on ‘Gamification’, published in the Pharmaceutical Executive on February 28, 2019. Another article titled, ‘Gamification is Serious Business’ also reiterates, ‘Research and case studies from both the academic and healthcare space bring forth ample evidence that games can improve patient compliance and healthcare outcomes.’

However, if any pharma marketer enters into the gamification arena with greater focus on the desired outcome than on patient goals, or the games themselves don’t excite, engage, and motivate the users, the efforts may not succeed.

Gamified e-learning helps during Covid pandemic:

An interesting study on ‘The Impact of COVID-19 on Learning,’ conducted by find courses, noted some interesting points. A few of which, are as follows:

  • Covid pandemic is fueling an unprecedented interest and opportunity for many people to acquire more job knowledge and skills, mainly to protect their future in uncertain times.
  • In tandem, people’s priorities when it comes to learning are also changing. Health-safety being at the forefront of many learners’ minds, they prefer mostly online courses, or heavily reduced classroom sizes - to maintain social distancing.

It has also been noted that many such learners often find virtual learning programs uninteresting and lackluster. Sensing this issue, many organizations, which include some pharma companies, are now using Gamification to augment learning effectiveness and build greater team harmony. Let me illustrate this point with an example from the pharma industry during the ongoing pandemic.

It’s more relevant in the new normal:

On June 04, 2021, Fierce Pharma featured an article on Pharma companies’ getting into gaming to boost retention, recall – and fun. There, it quoted a top official of the global pharma major AbbVie, who said: “Gamification has become more important and more impactful in the virtual environment.”  The honcho further said: “The pandemic showed we need this now more than ever. – It’s given an extra push to what has always been core to what we do, which is retention and recall in a fun and engaging manner.”

The report elaborates, AbbVie Canada uses gamification to onboard new reps, district managers and brand managers as well as for national sales meetings. Instead of studying or reading up, AbbVie asks employees to do the advance work through gamification tasks and then follows with more tasks after the meetings to boost retention and recall.

The Global Healthcare Gamification Market Report 2021-2027, also vindicates this point. As it reported, utilization of new healthcare gamification applications based on mobile tablets and laptops, witnessed a good growth during Covid pandemic. It reported, ‘Healthcare Gamification Market’ is expected to reach US$35,982.7 million in 2027 from US$ 3,072.5 million in 2019 with an estimated CAGR of 36.2% from 2020-2027.

Gamification is now being used by pharma in India, as well:

Abbott India is using elements of gamification in its customer services through a: care program. As the company Press Release says: ‘This new healthcare service is designed with games, quizzes and recognition programs to support patients, doctors and pharmacists throughout the entire healthcare journey, from awareness and prevention to motivation to get and stay healthy.’

In India, since quite some time, many well-known non-pharma companies are successfully using gamification for employee engagement and hiring.

Conclusion:

Unprecedented disruptions caused by Covid pandemic have considerably impacted the business operations of virtually every industry in India – just as other nations, across the globe. Since the onset of the pandemic, non-covid related medical centers, fitness institutions or gyms remained shut. Getting F2F – in clinic or hospital care, especially for non-Covid patients were also challenging for several reasons, with virtual care being the only options for many.

Interestingly, with most interactions and engagements – including learning, training and development programs going virtual, ‘Gamification’ initiatives started gathering wind on the sail, in some of those areas. This happened mainly because, organizations, institutions and people were driven to look for digital and app-based solutions for all needs and necessities, for a sustainable progress in an uncertain future.

An article on gamification, published in the PharmaPhorum on March 21, 2021, reiterated the same. It said, “Gamification” – adding game-like elements into non-game or real-world settings – has become a popular concept in the pharmaceutical, healthcare, and event industries, especially as virtual engagement becomes more common during COVID-19.’

With diverse applications and approaches, Gamification is quickly becoming a promising tool in various areas of pharma service and operations. These include, patient adherence, chronic disease management, preventive medicine, rehabilitation, besides better customer engagement, medical education, training, hiring and more.

From this perspective, in my view, pharma leadership now needs to more eclectic, and try using methods and approaches, such as, ‘Gamification’ – drawn from various other disciplines, in pursuit of excellence in the new normal.

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.

Focus On Core Competencies – Regardless of Generic Or Innovative Drug Business

Posted on by
Reply

On February 11, 2021, by two different Press Releases, two global pharma majors – GSK and Novartis simultaneously made interesting announcements. Both were related to three generic cephalosporin antibiotics.

GSK revealed, ‘it has reached an agreement with Sandoz – a division of Novartis, to sell its Cephalosporin antibiotics business. Sandoz will pay GSK USD 350 million at closing, plus additional milestone payments up to USD 150 million, subject to the terms of the transaction.’

While articulating the purpose of hiving of its generic cephalosporin brands, the company reasoned: GSK is now dividing itself into two companies – one with core competencies focused on OTC products, and the other – prescription drugs and vaccines. The company emphasized: ‘The transaction aligns with GSK’s strategy to prioritize and simplify its portfolio and invest in the company’s innovative R&D pipeline and new product launches.’ Other brands in GSK’s antibiotics portfolio, are not impacted by this divestment. In other words, this would possibly mean that the generic drug business doesn’t fall within the core competencies of GSK, any longer.

Whereas, Novartis disclosed, the company’s Sandoz division, ‘has signed an agreement to acquire GSK’s cephalosporin antibiotics business, reinforcing its leading global position in antibiotics.’ Its noteworthy that Sandoz’s core competencies lie in the generic drug business.

While explaining the purpose of this acquisition, Novartis explained, cephalosporins being the largest antibiotic segment by global sales, acquiring these 3 leading brands - Zinnat, Zinacef and Fortum,“will further position Sandoz as a global leader in antibiotics – truly essential medicines that are the backbone of modern healthcare systems.”

The above transactions bring to the fore the criticality of focusing on core competencies for business excellence, regardless of innovative drug business and in multiple situations, such as:

  • Bringing organizational focus back on core competencies when these tend to get diluted.
  • Increasing the focus on core competencies as opportunities arise.

In this article, I shall revisit this critical management concept in the current perspective.

A brief recap:

The concept of core competencies of a business organization was introduced by two global pioneers in business management – C.K. Prahalad and Gary Hamel with the article – ‘The Core Competence of the Corporation.’ This was published in the May-June 1990 edition of the Harvard Business Review.

The relevance of focusing on ‘core competencies’:

The quality and quantum of commercial dividend in consistently focusing on ‘core competencies’ in any space, spanning across individual professionals to business organizations, have been profound. This calls for defining these in detail and collectively, at the top rungs of organizational leadership. Then, cultivate, and leverage the core competencies to differentiate an organization from its competition, creating a company’s long-term competitive and sustainable advantage in the marketplace – for business excellence.

What constitutes core competencies to gain strategic strength?

Core competencies – whether for individuals or for businesses, comprise primarily of resources, such as, special skills, capabilities and rewarding experience in those activities as strategic advantages of a business. Garnering financial resources would usually follow, thereafter. Thus, core competencies are always considered as a strategic strength, everywhere. That said, core competencies require continuous monitoring to always be in-sync with changing market dynamics. Otherwise, the strategies are likely to fail.

Broad examples – from pharma perspective:

Broadly speaking, discovering, developing and successfully marketing new drugs, identifying repurposed drugs for new clinical trials, and churning out novel vaccines quickly, may be considered as core competencies for innovative drug makers. They have demonstrated this skill even during Covid-19 pandemic. Similarly, immaculate skills in reverse engineering of existing drug molecules and high efficiency in process research to gain price-competitiveness, may be construed as core competencies of generic drug companies.

Examples of shifting focus on core competencies:

Although, it is desirable that pharma players stick on core competencies for sustainable long-term performance excellence, regardless of being in primarily innovative or generic drug business, we have witnessed this focus shifting on several occasions for both. However, expected success did not generally follow those companies with such tweaking in the strategic business models.

Nevertheless, some drug companies did get tempted to deviate from their core competencies. For example, innovative drug players tried to expand into low-risk generic medicines, which, in the long run, did not deliver expected results for many companies. However, this deviation wasn’t without any compelling reasons.

There were some valid reasons, though:

As is much known, traditionally, global R&D companies prefer to focus only on the business of innovative prescription medicines. Low margin generic business wasn’t their cup of tea. Subsequently, this trend shifted. Especially in those cases, where the pipeline of high potential new drug molecules did not meet the concerned company’s expectations. To stick to the knitting, some companies with deep pockets, explored another model of Mergers and Acquisitions (M&A) of innovative patented products and companies with rich new drug pipelines. Interestingly, in this M&A business model, low risk, low cost and high-volume turnover of generic business also started attracting several R&D based companies, alongside.

Which is why, an increasing number of R&D based companies started planning to expand their business in less risky generic drug business. This appeared to be a quick fix to tide over the crisis, as the generic drug business model won’t require going through lengthy R&D processes. Besides, compliance with ever increasing stringent regulatory approval protocols, particularly in the developed markets of the world.

Examples of why focus on core competencies matter, even in new normal: 

There are several examples of large companies to illustrate this point – both from the old and the new normal. Just to give a flavor of the relevance of focusing on core competencies of organizations, I shall draw upon three interesting examples. Each of these, highlight different organizational visions and perspectives at different times, particularly the relevance of focus on core-competencies for a corporation. These are as follows:

  • The first one is Daiichi Sankyo of Japan’s acquisition of India’s generic drug major of that time – Ranbaxy, in June 2008. The parent company claims: “We provide innovative products and services in more than 20 countries around the world. With more than 100 years of scientific expertise, our company draws upon a rich legacy of innovation and a robust pipeline of promising new medicines to help patients.” It is much known today, what happened to this acquisition, thereafter, for various reasons, including faulty pre-acquisition due diligence. However, later on, the domestic pharma leader – Sun Pharma, acquired Ranbaxy. Nonetheless, at least from Daiichi Sankyo’s narrative, its areas of core competencies, appear closer to any R&D-based drug company.
  • The second example is US-based Abbott Laboratories acquisition of domestic formulations business of Primal Heath care in India in May 2010. Like Daiichi Sankyo, this acquisition was also a part of Abbott’s strategy to enter into ‘generic drug business’ -dominated emerging markets. Abbott, at that time, apparently decided to expand its strategic focus beyond its core competencies in business, primarily of patented products. However, by the end of 2012, the company separated into two leading healthcare companies. Abbott became a diversified medical products company. The other one – a totally separate company was formed, with the name – AbbVie, as a new researched-based global biopharmaceutical organization. AbbVie now operates in India, as well – with erstwhile Abbott’s innovative brands. In this case, by an innovative restructuring of the parent organization, Abbott brought back its sharp focus on core competencies of both the companies with both doing well in India.
  • The third example is a recent move of reverting to the original focus of core competencies, when moving beyond these did not yield results. In that sense, this example is different from the second one. On November 16, 2020, Pfizer also announced the creation of ‘the new Pfizer’, as it reverted to its original core competencies of “developing breakthrough treatments and delivering innovative, life-changing medicines to patients around the world.” On that day, Pfizer completed transaction to spin off its Upjohn generic drug business and combined it with Mylan to create a new entity – Viatris Inc. Earlier, the company had sold its veterinary business, a baby formula unit and its consumer products division as part of a deal with GSK – for similar reasons. Earlier, the company’s moving beyond its core competencies to pluck low hanging fruits of generic drug business, did not yield dividend, as Pfizer’s profit in the generic drug sector, reportedly, had gone South.

Conclusion:

According to Pharma Intelligence, several large players, such as, Novartis, Sanofi, AstraZeneca are now focusing on core competencies, as they start recovering from their unsettling patent cliff and other headwinds. Meanwhile, one may expect to witness more of Spin-offs, Carving-out, Splitting-off or further strengthening of core-competencies of organizations – for a sustainable long-term business excellence in the years ahead.

Spin-off and acquisition of Cephalosporin generic business by GSK and Sandoz Division of Novartis, respectively, is a part of the same ball game. Thus, maintaining or reverting focus on core competencies – regardless of generic or innovative drug business, I reckon, are the new imperatives of commercial success, even in the new normal.

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.

 

2020: Learnings From A Yearlong Catastrophic Disruption And Crystal-Gazing 2021

Posted on by
Reply

 Wishing All My Readers A Very Happy, Healthy, Peaceful and Prosperous 2021

Just a few days left for the year 2020 to merge with history. It will be remembered by all – as a year of all-round catastrophic global disruption. With unprecedented impact on human lives, livelihoods, economy, and ways of doing things – sparing virtually nothing. The sole cause of which is an unprecedented single event – Covid-19 pandemic. As of December 27, 2020 morning, India recorded a staggering figure of 10,118,392 new Coronavirus cases with 147,659 deaths. The threat of subsequent waves for further infection of Covid-19 infection continues.

In this article, I shall focus on some critical lessons learnt from the 2020 health crisis, while crystal-gazing 2021. I’ll do this purely from the health care perspective, in general, and the pharmaceutical industry, in particular. Keeping this in view, some of the lessons learnt during the pandemic are as follows:

A. Never allow a sense of hubris setting in:

This is easier said than done. Nonetheless, before the Covid pandemic played havocs with all, many top pharma leaders were, apparently, in a hubris. It was often laced with excessive confidence, if not arrogance. The predominant belief was nothing can go so wrong sans unfavorable policy decisions by the governments. This was against a much-known management dictum for all – always anticipate future probabilities that may impact the business and keep prepared for the worst, while hoping for the best. On a hindsight, this was, obviously jettisoned – lock, stock and barrel. No one was prepared for any biological threats, such as, Covid pandemic, till the deadly virus caught the humanity off-guard around December 2019, as we see below:

The pandemic was expected, but struck unexpectedly:

A pandemic wasn’t totally unexpected either. Therefore, they question that surfaces - Experts warned of a pandemic decades ago. Why weren’t we ready? Just in 2015, even Bill Gates, during a Ted talk titled, “The next outbreak? We’re not ready,” also predicted - based on available facts that an epidemic would kill millions in the future.

He further added: “If anything kills over 10 million people in the next few decades, it’s more likely to be a highly infectious virus rather than a war – not missiles, but microbes.” Gates further emphasized: “We have invested a huge amount in nuclear deterrents, but we’ve actually invested very little in a system to stop an epidemic. We’re not ready for the next epidemic.”

B. Research on anti-infective drugs shouldn’t be pushed to the back burner: 

These warnings were, apparently, ignored by the pharma industry. For example, as reported in the first quarter of 2020, many research-based pharma companies shifted ‘resources away from emerging infectious diseases into more lucrative areas like cancer treatment. Their business decisions risk leaving gaping holes in the fight against epidemics, such as the one caused by the novel Coronavirus.’

Let’s now take a pause for pharma players to ponder. Are they ready, at least now, with a robust plan – based on almost a year’s experience of an unprecedented agony along with its customers, specifically to counter any future biological threat? Be that as it may, there have also been some good outcomes out of the Covid crisis, both for the pharma industry and also for the health care customers.

C. The pandemic hastened pharma’s digital transformation process:

As is known, compared to many other industries, pharma industry was a late learner in the digitalization process of organizations. The new realities of disruptions caused by the pandemic had significantly expedited this process to keep the business going. There were no other effective options available, either, but to move beyond business stabilization and redefine how they do business. The IQVIA article, ‘Digital transformation in a post-Covid-19 world,’ published in the Pharmaceutical Technology, on August 31, 2020, also reiterated this point.

Elaborating the point further, the article pointed out: ‘As a result, acceleration of three key capabilities is occurring to create sustainable competitive advantage,’ as follows:

  • Digital capabilities with modern technology are enabling companies doing the right things during the pandemic and accelerating the process.
  • Providing access to granular data to support the extraction of precise insights into the needs of patients and physicians.
  • Ensuring capabilities for sustaining relationships. While face-to-face interaction has been dramatically reduced, relationships with HCPs and patients are taking new shapes and are of more importance than ever before.

D. Telemedicine came under mainstream care, supported by Government:

Finding no other viable alternatives during the Covid lockdown period and the need to stringently follow prescribed health measures, many patients were pushed to search for a robust digital solution for health care needs. Just as many of them were already using online platforms to meet other regular needs. In that sense, Covid propelled health care into a virtual world, bringing telehealth or telemedicine toward mainstream care, supported by the Government with a policy, for the first time, ever.

E. Quality of pharma response to pandemic enhanced industry image:

As I had discussed before in this blog, Consumer centric communications, driven by the  ‘hope and confidence as companies rushed to come up with COVID-19 vaccines and treatments’ of all, helped to significantly enhance the industry’s image during the year. In my view, pharma shouldn’t let go this opportunity to reposition itself, to reap a rich harvest in the years ahead.

Crystal-gazing 2021: 

A. A lurking fear will keep haunting:

Moving away from the outgoing year – 2020, if one crystal gazes the incoming – yet another brand-new year – 2021, a lurking fear still haunts most peoples’ minds. Will the all-round disruptions of 2020 be the new normal in 2021 – with no further escalation of the current situation?

B. Vaccine rollout will reduce rapid spread, but not eliminate Covid-19:

Gradual rolling out of vaccines may reduce the rapid spread of pandemic, provided Covid-19 doesn’t throw more surprises, such as, complicated mutation, blunting this initiative. However, currently available evidence indicates, the new variant could be more transmissible, yet vaccines may work very well against it.

 C. Masking, physical distancing, hand washing, etc., will continue:

Besides, many yet unknown side effects, the duration of immunity following coronavirus vaccination is still largely unknown due to the simple lack of time we’ve had to study such immune responses. Moreover, the trials do not tell us if the vaccines can block the transmission of the disease from those who are asymptomatic and have been vaccinated. Thus, masking, physical distancing, hand washing, testing, treating and contact tracing, reportedly, will continue to be important in the global campaign against COVID-19, even after vaccine rollout.

D. NDDS for Covid drugs and vaccines may come: 

New formulations, new Covid drug delivery systems, newer methods to bring Covid vaccines, like nasal sprays, in a powder form for easy transportation and to reach more people around the world, are expected to commence in 2021.

E. Waiting for going back to pre-Covid game plan is a losing strategy:

Vaccines are unlikely to take us back to pre-Covid time, any time soon. Even McKinsey & Companypredicted the same in its article: ‘‘How COVID-19 is redefining the next-normal operating model,’ published on December 10, 2020. It emphasized: “With everything disrupted, going back to the same old thing is a losing strategy. The strongest companies are reinventing themselves by embracing pandemic- driven change.”

Many pharma majors are also echoing the same, even as Covid-19 vaccines have started rolling out for public in different parts of the world. After weighing-in the pros and cons of waiting, many of them have articulated: ‘We will not return to the old ways of working.’ They believe, it’s too early to put a specific timeline on turning that page now. Hence, the year 2021, working of the pharma companies is unlikely to be significantly different from the year 2020.

F. Need to capture and respond fast to changing customer behaviors:

Covid-19 pandemic is fast changing many human attitudes and behaviors, forcing organizations to respond. ‘However, the need to respond won’t end when the virus’s immediate threat eventually recedes,’ reaffirmed the Accenture article ‘COVID-19: 5 new human truths that experiences need to address.’ The massive behavior changes of key pharma stakeholders, at a never before scale and speed, will continue to prompt many leading drug companies to respond to them with well thought through digital tools, to gain competitive advantages.

G. Virtual meetings with reps, doctors and others will continue:

As witnessed in 2020, often for the first time – virtual meeting of sales reps, key opinion leaders and others will continue in 2021, even after ‘live’ ones return, but with more innovative structure and content. Pharma marketing’s long awaited and comprehensive digital foray will continue gaining a strong foothold, entering into new areas, without glancing back over the shoulder, in 2021.

H. More new drug launches will move entirely digital:

It began in 2020. For example, dozens of new drug launches moved entirely to digital, for the first time in 2020. As a pharma leader remarked, with the traditional launch framework gone during the pandemic, “we had to throw out the playbook and really embed into people’s heads that playbook is no longer meaningful. It no longer works, and we have to think outside the box.” She further added: “There’s truly no bigger place for a marketer right now. This is the new world.” None can deny this fact as we enter into the new year.

I. Success requirements of pharma professionals will be different:

With significant transformation of pharma’s operational strategies, success requirements of pharma professionals will also be significantly different in the new normal. Quick capturing and fast adaptation to the changing customer behavior for multi-channel engagement digital platforms, will be fundamentally important – not just for business excellence, but for its long-term sustainability, as well. This is a totally new and highly cerebral strategic ballgame, where obsolescence of cutting-edge technology is much faster than anything in the tradition driven old normal.

J. More pharma companies will explore inorganic growth opportunities:

More pharma companies will look for acquisitions to bridge the strategic gaps, as AstraZeneca did in 2020.

Conclusion:

In 2021, Covid Mayhem may possibly be over with a gradual rollout of vaccines. But, the impact of utter disruptions that the pandemic has caused in multiple areas of businesses in 2020, especially within the pharma industry, would continue, as we step into 2021. As the drug industry overwhelmed by Covid-19, reset themselves with the digital transformation in the new normal -for growth beyond Coronavirus, one may also view this much awaited metamorphosis, as a blessing in disguise, as it were.

Overall, as the W.H.O observed very rightly on December 27, 2020: “We throw money at an outbreak, and when it’s over, we forget about it and do nothing to prevent the next one. This is dangerously short-sighted, and frankly difficult to understand.” He further added: “History tells us that this will not be the last pandemic, and epidemics are a fact of life.” I hope, all concerned will realize this point in 2021. Alternatively, we may need to keep ourselves prepared to move, in a similar way, from the current new normal to yet unknown next normal.

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.

 


A Rare Strategic Acrobatic Feat in Covid Time

Posted on by
Reply

‘Keep nose to the grindstone while lifting eyes to the hills.’ Quite a while ago, all-time global management guru – Peter Drucker used this essential acrobatic feat as an example, for the business strategists. This illustration signifies the criticality of harmonizing decisions affecting both the short and the long-term goals of an organization, for a sustainable business excellence.

In most recent times, the pharma major AstraZeneca that has virtually become one of the household names, for developing a Covid-19 vaccine candidate with the University of Oxford, has performed the above acrobatic feat – with precision. During the prevailing unprecedented health crisis, the Company has unequivocally proven that it remains on course – in achieving its dual objectives, as Drucker had prescribed in his management classic – ‘The Practice of Management.’

It happened in tandem – without getting overwhelmed by the disruptive forced of Covid pandemic, unlike most others. Immediately, the Company focused on an urgent objective of saving the humanity – by developing, manufacturing and delivering a Covid vaccine to the world, in a record time. This was possibly a relatively short-term goal. And closely followed the other – a critical strategic decision for the organization’s long-term sustainable business excellence.

I have discussed before, the Company’s first initiative – developing a Covid vaccine candidate with the University of Oxford. Hence, in this article, I shall focus on two other related areas:

  • Deadly impact of rare diseases in some Covid infected young patients.
  • Why not some large Indian companies also explore similar strategies as demonstrated by AstraZeneca – and the reasons behind the same?

Before going into those areas up front, let me start with a brief description of AstraZeneca’s intent to expand its footprint in the of area of rare diseases, besides immunology area to help treat rare types of cancer.

The acquisition:

On December 12, 2020 AstraZeneca announced that to accelerate its strategic and financial development, the company will acquire Alexion valuing $39 billion. Subject to all statutory approvals, the deal is expected to close in the third quarter of 2021. Interestingly, Alexion’s top brand – Soliris, is the world’s one of the most expensive drugs in the world. It is prescribed to treat a rare – life-threatening blood disease paroxysmal nocturnal hemoglobinuria (PNH). Incidentally, rare diseases have also some significant relevance for Covid infected patients. Let me now recapitulate, some key aspects of rare diseases.

Some key aspects of rare diseases: 

Rare Diseases (RD) – also referred to as Orphan Disease (OD), are diseases affecting a small percentage of the population, and include genetic diseases, rare cancers, infectious tropical diseases and degenerative diseases. There is no universally accepted definition of a rare disease, yet. Different countries define these differently. However, the common considerations in the definitions are, primarily, disease prevalence and to a varying extent – severity and existence of alternative therapeutic options.

Impact of some rare diseases in Covid infected patients: 

Since the beginning of the Covid pandemic, people with underlying diseases, such as, hypertension, diabetes, cardiovascular and kidney disorders, are considered to fall in the high-risk group. They are more likely to have severe disease and complications and need to be extra cautious of the infection. Importantly, it has been recently reported that some rare diseases also increase risk of dying during Covid-19 pandemic at a younger age.

For example, as reported on December 07, 2020, recent studies indicate, rare autoimmune rheumatic diseases increase risk of dying during Covid-19 pandemic for younger patients. The researchers also found that women with rare autoimmune rheumatological diseases (RAIRD) had a greater increase in all-cause mortality rates during the pandemic when compared to men with RAIRD. However, there seems to be an India specific issue also in this situation, as well.

India specific issue for Covid infected patients with some rare diseases:

Some India specific issues on RD, could have a significant adverse impact on Covid infected patients in the country. One such critical issues is the ‘Baseline Knowledge of Rare Diseases in India.’ This fact was well captured in an important survey that was published with the same name, as an original article, in the ‘International Journal of Rare Diseases & Disorders,’ on November 06, 2019.

The study noted, among others:

  • Although, rare diseases have recently received worldwide attention, the developing countries are seriously behind in regard to awareness, drug development, diagnosis, and social services, in this area. India, which has one-third of the world’s rare disease population, has no accurate assessment of the problem.
  • The drugs for ‘Rare Diseases (RD), also called Orphan Drugs (OD)’, often cost exorbitant with difficulties in diagnosis and treatments.
  • Indian policymakers want to find out the number of RD and the extent of the population suffering from them and help provide treatment for them, which is a challenging task with 1.45% GDP health care budget for 1.3 billion people.
  • The health care professionals appear to have some awareness as compared with non-healthcare professionals, but even among health care professionals, only one third had a rudimentary understanding of RD and OD, whereas three-fourths have virtually no knowledge of RD.
  • Forty-three percent of health professionals had not seen rare disease patients, and a large percent of practicing physicians had not seen even one rare disease patient in their entire professional practice.

Thus, it is clear from this survey that the most important issues are awareness and diagnosis, as many rare diseases are not diagnosed or possibly misdiagnosed. Besides, the survey also observed, since 1983, many global companies started developing orphan drugs after the Orphan Drug Act implementation. There is none at this time in India, although in 2017, the Drugs & Cosmetic Act. 1945 has been amended to include “rare diseases and orphan drugs”.

The National Policy on Rare Diseases flagged some of these facts:

The ‘National Policy on Rare Diseases 2020,’ for India, released by the Union Ministry of Health on February 07, 2020, acknowledged many of these important facts. It also said, ‘Considering the limited data available on rare diseases, and in the light of competing health priorities, the focus of the draft policy is on prevention of rare diseases as a priority as identified by experts.’

Interestingly, the first of such policy was prepared by India in 2017 and a committee was appointed to review it in 2028. However, recently published the National Policy on Rare diseases, has also noted one more important point. It noted: ‘Paradoxically, though rare diseases are of low prevalence and individually rare, collectively they affect a considerable proportion of the population in any country, which according to generally accepted international research is – between 6% and 8%.’ Currently, India, reportedly, doesn’t have any registry of rare disease, which has now been entrusted to the Indian Council of Medical Research (ICMR) in the National policy.

Common symptoms can hide underlying rare diseases, leading to misdiagnosis:

The above policy has also noted, rare diseases are characterized by a wide diversity of signs and symptoms that not only, reportedly, vary from disease to disease, but also from patient-to-patient suffering from the same disease. Importantly, relatively common symptoms can hide underlying rare diseases, leading to misdiagnosis.

During Covid treatment, similar circumstances could lead to a serious life-threatening situation. The 2020 RD Policy also reiterates: “Early diagnosis of rare diseases is a challenge owing to multiple factors that include lack of awareness among primary care physicians, lack of adequate screening and diagnostic facilities etc.” That said, yet another key question arises – will developing and marketing such drugs be profitable for the pharma industry?

Will developing such drugs be profitable for the pharma industry?

It is worth noting that the National Policy on Rare Diseases 2020, aims more at lowering the incidence and prevalence of rare diseases based on an integrated and comprehensive prevention strategy, rather than ensuring patient access to affordable treatments. Nonetheless, it also says, within the constraints on resources and competing health care priorities, India will try to enable access to affordable health care to patients of rare diseases which are amenable to one-time treatment. In general, the policy suggests, ‘voluntary crowdfunding for treatment’ of rare diseases.

With this being the prevailing situation in India, even during Covid pandemic, an interesting article – ‘How Orphan Drugs Became a Highly Profitable Industry,’ published in The Scientist, noted some important facts in this area. It highlighted: ‘Government incentives, advances in technology, and an army of patient advocates have spun a successful market—but abuses of the system and exorbitant prices could cause a backlash.’

It also articulated, despite higher costs and less-certain returns, investments in drug development on the rare diseases side appear to ‘be bucking the trend.’ The result of the global focus on RD nowadays is: ‘Firms with marketing authorization for orphan products, are now more profitable than those without.’

This also partly explains the financial rationale behind AstraZeneca’s recent acquisition of Alexion Pharmaceuticals, valuing $39 billion.

Conclusion: 

As of December 20, 2020 morning, India recorded a staggering figure of 10,031,659 of new Coronavirus cases with 145,513 deaths. The country has already crossed 10 million in Covid cases as the vaccine approval remains pending. The threat of subsequent waves for further spread of Covid infection continues to loom large in many states. Meanwhile, many studies indicate that comorbidity should now include rare diseases, as well, especially to prevent deaths in younger patients. From this perspective effective diagnosis and treatment of RD are also coming under spotlights. Curiously, the National Policy on Rare Diseases 2020 focuses more on awareness and prevention of RD rather than access to affordable treatment, particularly in Covid infected patients to save precious younger lives. As I wrote previously and still believe, the ‘National Policy on Rare Diseases’ becomes more meaningful with ‘Orphan Drugs Act.’

Vaccines to prevent Covid infections are also expected to get emergency approval in India, shortly. At lease, some of these being available at affordable prices, including AstraZeneca-Oxford vaccine, according to reports. As recent reports indicate the same company, is also entering into RD therapy areas, through a key acquisition, yet another hope looms large. A hope for availability of relevant RD drugs at an affordable price for Covid infected patients, despite other apprehension, as I wrote before.

That apart, purely from the business management perspective, as well, this rare strategic acrobatic feat of AstraZeneca - ‘Keep nose to the grindstone while lifting eyes to the hills,’ during the Covid crisis, I reckon, is exemplary for the practicing managers.

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.

 

Enhancing Pharma Brand Experience In The New Normal

Posted on by
Reply

In these days of unprecedented and all-pervasive disruptions – almost in every facet of life – caused by an unknown virus, scramble to find an effective solution for saving lives and livelihoods, still continue. The discomfiture seems to be omnipresent across the healthcare space.

On its upside, pharma witnessed an unparalleled surge in various collaborative activities both in the search for a cure and also in preventing the infection. The downside is, conclusive scientific evidences are still not available for these drugs – except one that was unraveled just on June 16, 2020. On the contrary, after granting emergency authorization on March 30,2020, for use of hydroxychloroquine and chloroquine in Covid-19 infection, the US-FDA on its own, revoked it on June 15, 2020 for lack of conclusive evidence.

Amid initiatives of saving lives, pharma industry – besides trying to be a part of saving livelihoods – alongside others, is also gearing up to restart its demand generation activities, and move ahead, as the looming crisis continues, unabated.

From the pharma industry perspective, this new beginning, as it were, in a scenario that was never envisaged in the past, would require two most critical ingredients, amongst several others, more than ever before. It is another major transformation, where pharma leadership would require encouraging:

  • A change in mindset with a fresh pair of eyes to find game-changing opportunities in the new normal.

This article will focus on the relevance of these two areas, for the drug companies to come out with flying colors, yet again, in a difficult situation.

Evolving changes in the pharma ecosystem:

That the evolving ecosystem is changing the life sciences value chain and creating new opportunities to capture future value by providing end-to-end solutions, was also highlighted in the EY report - “Today for tomorrow: realizing the potential of Life Sciences 4.0.” This was released in February 2020, as Covid-19 started changing the world and the way businesses operate.

To successfully navigate through such fast-changing healthcare landscape, ‘companies need to develop an exponential mindset that leverages technology for business model reinvention and empowering the workforce,’ the report emphasized.

As moving in this direction with agility is critical, drug companies will require a leadership team of a different mindset, who can ferret out path-breaking opportunities amid ‘never before’ problems. Mainly because, the strategy for success will be quite different from the traditional recent practices. Enhancing contemporary and personalized value of product and service offerings to healthcare consumers – with end-to-end solutions, won’t be everybody’s cup of tea in the shifting paradigm.

Let me explain some basic changes in the traditional sales and marketing domain to drive home this point. 

Some basic changes in the traditional sales and marketing practices:

Until Covid-19 battle is decisively won by a vast majority in the planet earth, by acquiring either a vaccine-induced or herd-immunity – maintaining social distancing and strict compliance with other health norms will remain in force. Besides, a palpable fear among a large population from getting infected by the Coronavirus, is unlikely to vanish soon. From this angle, many traditional pharma demand generation activities may not be as productive as they used to be, such as:

  • Meeting doctors the way one used to in the past for a face to face prescription demand generation activity, will be different. Moreover, per doctor call time may increase significantly – with a commensurate increase in cost, impacting average yield per call.
  • All marketing events, requiring the participation of many doctors under one-roof, namely – large symposia, Continuing Medical Education (CME) or even sending doctors by air for educational group-tours or even sponsoring any other medical events, may be challenging now.
  • Changing mindset of doctors, triggered during a long national ‘Lockdown’ period to remain updated from different sources in the cyberspace, may continue, prompting lesser interaction with drug company representatives.

There are many other areas, which different companies may consider a great commercial value, would also need to be identified – as the pharma companies restart their prescription demand generation activities. Nonetheless, equally important is to zero-in to alternative strategic approaches, soon.

Zeroing-in to alternative strategic approaches with a new mindset is critical:

There could be several strategic approaches for this area. One such is, mapping the end-to-end customer journey in the changing situation, to enhance their brand experience during this process. As the time is very limited now, being ‘right the first time’, will be crucial for pharma marketers. Otherwise, competition will prevail.

Any game-changing approach at this time, will call for a fresh pair of eyes, having a contemporary mindset. ‘I did it this way before’ approach will not work, as the situation is unprecedented, and there are no footsteps to follow. Thus, I reckon, the organization will require taking the following measures based on a predictive mindset and actionable insight:

  • Creating a ground swell of the need for the proposed changes – explaining the benefits of each.
  • Prompt mitigation of any resistance that may surface during this process.
  • Identifying the loose knots in the process of strategy implantation.
  • Choosing the implementation team with right competence, mindset and agility in achieving the set goals, across the business domains.
  • Providing continuous training, problem-solving support – ensuring an all-time learning mindset for all in the selected team.
  • Initiating an emotional omnichannel engagement to take all stakeholders on board – with aligned messages – for desired outcome.
  • Assigning accountability to each one, for achieving agreed results.

The biggest hurdle in the business transformation process:

In tandem, another key point also to be borne in mind. Because, with each passing day, some new finding in Covid-19 disease area – some good news for drug and a vaccine development, or could even be another crisis, may keep unfolding. The team should always remain on course, despite limited resources and other business challenges.

Many will know, the biggest hurdle for any transformation process is culture. Open minds of all concerned will make the process easier. With traditional business practices, it will be complex to navigate through the current situation. Therefore, a change in people’s mindset in the new situation, is a fundamental requirement to restart the pharma industry – in full steam.

The core objective needs to be understood by all:

The core objective during the entire process of such transformation, is to enhance a patient-centric brand experience – throughout its customers’ journey, seeking an end-to-end disease treatment solution. The process would, in turn, require a deep understanding of the emotions, requirements and related preferences of the customers. This is critical to establish a meaningful human connection, virtual or otherwise, with them.

Nevertheless, it will entail data-based and detail mapping the customers’ journey, while seeking an effective treatment solution for the disease that one is suffering from. Accordingly, creating a patient-centric content to build a brand persona, alongside crafty dissemination of the same for the target groups, through omnichannel platforms, will need to be diligently worked out. More important is its execution with military precision, by emotionally connecting the intended stakeholders to deliver a unique brand experience.

Conclusion:

Like many other countries, ‘unlock down’ process related to Covid-19 pandemic has already started in India, with varying degree at different places, though, depending on the nature of intensity and spread of the infection. However, the number of Coronavirus infected cases continues to maintain a steep ascending trend. As on June 21, 2020 morning, the recorded Coronavirus cases in the country reached 411,727 with 13,277 deaths.

The unlocking process of critical pharma industry activities has also started rolling. However, the new beginning has to be in sync with the fast-evolving changes in the pharma ecosystem. Many processes and deliverables, including formulation and implementation of an effective strategy for the same, will no longer be a replica of the traditional ones, as it were.

Similarly, to find game-changing opportunities in the pharma sales and marketing space, the marketers will need a change in their current mindset and having a fresh pair of eyes. This will be essential for an unbiased and effective mapping of end-to-end customer journey to enhance their unique brand experience. In tandem, it will help create key brand differentiators with cutting edges, for business excellence in the new normal.

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.

Would ‘Complex Generics’ Attract More ‘Authorized Generics’?

Posted on by
Reply

Despite increasing numbers of alleged scams involving generic drugs, both in the United States and also in India, even involving many large generic drug manufacturers, the traditional generic drug market, keeps growing globally. Although, the current growth is in mid-single digit, the market can’t be ignored, either.

That apart, enormous pricing pressure, squeezing bottom line and cutthroat competition, are prompting many companies, including Big Pharma, to craft different strategies to excel in this market. One such involves a shift in business focus from relatively low priced traditional generic drugs to comparatively higher priced complex or specialty generic medicines with a few competitors.

In this emerging situation, a lurking apprehension does surface for many. If the margin is good and the prices of these complex or specialty generics, are much higher than traditional ones, won’t it prompt more ‘Authorized Generics’ coming into the market? Won’t that jeopardize the interest of other generic drug makers? In this article, I shall explore this area, along with its possible consequences. Before doing that, it will be worthwhile to give an overview of the generic market, before recapitulating what are ‘Authorized’ and ‘Complex’ generics.

How lucrative is the generic drugs market now?

According to the latest report by IMARC Group, the global generic drug market size reached US$ 340 Billion in 2018 and is expected to be at US$ 475 Billion by 2024, growing at a CAGR of 5.3 percent during 2019-2024 period.

The key market growth drivers remain, increasing number of product patent expiration, higher prevalence of chronic diseases and different government initiatives to encourage faster generic launch, including the United States. The pace of increase is faster in the emerging markets, like India. However, unlike India, non-branded generic drugs, rather than branded generics, are dominating most the markets.

Although, Central Nervous System (CNS), cardiovascular, dermatology, oncology and respiratory are among the dominant segments in the market, CNS and Cardiovascular segments are the two largest ones in this market. North America holds the largest market share, with more than 88 percent of total prescriptions being written for generic drugs in the U.S., as the report highlights. Despite this scenario, to mitigate huge pricing pressure, cutthroat competition and low margin, many drug players are preparing to move into specialty or complex generics.

The size and growth of complex or specialty generics market: 

The April 2019 report by Research and Markets- “Specialty Generics Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024″ states, the global specialty generics market reached a value of US$ 44.8 Billion in 2018. By 2014, its value is expected to reach US$ 88.9 Billion with a much higher CAGR of 11.9 percent, in 2019-2024 period.

Which drugs would belong to this market?

According to the ‘White Paper’ titled, ‘Complex Generics: Maximizing FDA Approval Prospects’ of Parexel, the following are some examples of complex generics; the list continues to grow as more products are being added in this category every day:

  • Complex Active Pharmaceutical Ingredients (APIs), examples being Enoxaparin, Low Molecular Weight Heparin, Glatiramoids, Iron Carbohydrate Complexes etc.
  • Complex Formulations, examples being Liposomes, abuse-deterrent generics, parenteral microspheres.
  • Complex Route of Delivery, such as topical ointments and locally acting GI drugs.
  • Complex Drug-Device Combinations, such as DPI, MDI, nasal sprays, and transdermal systems.

These types of complex and high-cost generics, besides some off-patent biologic products and even Biosimilar drugs, are often used to treat complex and life-threatening diseases, such as, cancer, Hepatitis C, and many others. Complex generics are expected to eventually own a significant percentage of the total generic drugs market, as a number of big-ticket specialty drug molecules will go off patent in the ensuing years.

The major advantages of complex generics:

Some of the major advantages of the complex generics market over traditional generics are as follows:

  • Complex manufacturing requirements with higher capital costs – thus, higher price, better margin, fewer players, lesser competition.
  • Increasing prevalence of life-threatening diseases, besides, cost containment measures from the government and healthcare providers, are pushing the demand of these drugs.

Indian companies are also entering the fray: 

As the share of specialty medicines in global spending in 2017 increased to 32 percent from 19 percent in 2007, Indian drug players also could sniff the opportunity in this space. Just as Sun Pharma, reportedly shifted its focus from once lucrative traditional generics medicines to specialty drugs, amid continued price erosion in its biggest market – the US, many others are also joining the fray.  The Indian players who are, reportedly, investing in complex generics include, Aurobindo Pharma, Dr. Reddy’s Labs, Cipla, Lupin, Glenmark and Cadila.

More specifically, with the contribution of specialty medicines to overall pharmaceutical spend in the US, Germany, France, Italy, UK, and Spain – almost doubling over the last 10 years, this trend is likely to gather momentum, as the above report indicated. Accordingly, commensurate strategic actions aimed at this segment by many companies, both global and local, are clearly now visible.

Some strategic initiatives:

In preparation of a major shift in the strategic focus on complex generics, key examples of some of the important initiatives of different companies will include the following:

  • Big generic players wanted to be bigger in the global market through M&A, such as Teva acquired Allergan’s generic business, Mylan bought Abbott Laboratories’ generics businessAbbott Laboratories’ non-U.S. developed markets specialty and branded generics business. Similarly, Endo International acquired Par Pharmaceuticals. In India the mega deal of Sun Pharma acquiring Ranbaxy in 2015. In the same year, Lupin acquired New Jersey-based generic drugs firm GAVIS to boost its presence in the US.
  • Novartis sold its 300 ‘troubled’ U.S. generics to India’s Aurobindo for US$ 1B, as the entire generics industry faced unrelenting pricing pressure in the U.S.’ Whereas, Novartis’ wants to focus higher-margin assets like Biosimilars and complex generics.
  • Pfizer is set to combine its off-patent drug unit Upjohn with Mylan, to create a new business with its own off-patent branded and generic drug lines. The merger will bring together Pfizer medications such as Lipitor and Viagra with Mylan’s EpiPen, used to halt life-threatening allergic reactions.
  • Owing to margin pressure and other reasons, some of the Indian drug players also decided to enter into higher margin complex generics space, pursuing both organic and inorganic routes. There are several such examples, such as: In January 2017, Zydus Cadila announced acquisition of Sentynl Therapeutics Inc., a US based specialty pharma company specialized in marketing of products in the pain management segment. And in October 2017, Lupin acquired US-based Symbiomix Therapeutics LLC to expand Lupin’s US women’s health specialty business in the highly complementary gynecological infection sector.

Any flip side of complex generics business for the Indian players? 

Although, driven by mainly higher profit margins and tough entry barriers, many generic players with the requisite wherewithal, find complex generics business more attractive to focus on, there’s a flip side to it, as well. This is, post patent expiry, innovator companies may be encouraged to introduce more ‘Authorized Generics’, creating a tough competitive environment for other generic players to compete with them. This brings us to the question of what are ‘Authorized Generics?’

Authorized Generics:

According to the USFDA, the term ‘Authorized generic’ is used to describe an approved brand name drug that is marketed without any brand name on its label. It is exactly the same product as the branded one, and may also be marketed by another company with the innovator company’s permission. Generally, an ‘Authorized Generic’ is launched at a lower price than the brand name drug.

Moreover, ‘Authorized Generics’, despite being the generic version of patented molecule, are mostly marketed by the patent holders themselves, both pre and post patent expiry. While a separate NDA is not required for marketing an ‘Authorized Generic’, USFDA requires that the NDA holder notify the FDA, if it markets an ‘Authorized Generic. The NDA holder may market both the ‘Authorized Generic’ and the brand-name product at the same time. Interestingly, the USFDA has approved around 1215 ‘Authorized Generics’ as of September 30, 2019.

Advantages of ‘Authorized Generics’ over ‘Traditional Generics’:

The key advantage of ‘Authorized Generics’ over traditional generic drugs is, while traditional generic drugs can be marketed only after patent expiry of the innovator drug, ‘Authorized Generics’ can be marketed even before patent expiry. In other words, innovator companies or their authorized collaborators can make lower priced ‘Authorized Generic’ versions available on their behalf, under their own new drug application (NDA). ‘Authorized Generics’ may be made available to patients even before patent expiry to out-maneuver the conventional generic drug makers, in advance, on price, quality and doctors’ confidence in the original drug.

According to several reports, over the past years, ‘many innovator drugs companies have been launching Authorized Generics, simultaneously with the first Abbreviated New Drug Applications (ANDA) filer’s launch of its generic drug product.’ However, the question remains how do the stakeholders perceive the ‘Authorized Generics’?

Perception of ‘Authorized Generics’:

Studies are available analyzing the impact of ‘Authorized Generics’ on the pharma market and also on the stakeholders. In this article, I shall refer to a comprehensive research study, titled ‘Authorized Generics: Effect on Pharmaceutical Market,’ published in the International Journal of Novel Trends in Pharmaceutical Sciences (IJNPTS), on February 29, 2012, which came out with the some notable findings.

Generally, there isn’t any doubt, either on the fact that ‘Authorized Generics’ provide the identical experience that the patient receives from the brand drug but at a lower price. Nor is there any question over greater confidence of doctors while prescribing these drugs. However, the researchers wrapped up the discussion by stating: It is difficult to conclude that the ‘Authorized Generics’ practice should be continued or banned. Though Indian pharmaceutical companies are dealing with generic drugs – 42 percent of the respondents were in favor of ‘Authorized Generics’ practice, whereas 58 percent opposed it. Thus, the overall perception of ‘Authorized Generics’, appears to be a mixed bag.

Conclusion:

There are free flowing arguments both in favor and against the ‘Authorized Generics.’ The article titled, ‘Drugmakers Master Rolling Out Their Own Generics to Stifle Competition,’ published in the Kaiser Health News (KHN) on August 05, 2019, captures it well.

It quoted the spokeswoman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, a powerful pharma lobby group saying, an Authorized Generic drug “reduces prices and results in significant cost savings.” Whereas the critics say, “Authorized Generics hurt long-term competition and often perversely increase costs, even in the short term.”

The detractors further expressed, ‘Authorized Generics’ don’t just steal sales from existing generic rivals, they erode incentives to make generic drugs. A professor at the University of California, Hastings College of the Law, who studies pharma was also quoted in this article saying, this practice can “stave off generic competition and make sure that generics can’t get much of a foothold when they do get to market.” Adding further he said: “That’s the game. And drug companies have become masters at this.”

As the Kaiser Health News highlighted, Eli Lilly announced launch of the ‘Authorized Generic’ version of Humalog insulin in March 2019 for US$137 a vial, at half the price of its brand name version costing US$237. This was reasoned by the company as a considerate move to address the need of those patients who can’t afford the price of the brand – Humalog. Curiously, even some analysts believe that ‘Authorized Generics’ may help explain why relatively few true generics are reaching the market despite a surge in approvals, especially in the United States.

Against the above backdrop, the drug policy makers need to ponder, would ‘complex generics’ of different companies face greater challenges from ‘Authorized Generics,’ playing a spoilsport for the rest in this ball game?

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.

 

 

‘Data-giri’: Critical For A Rewarding New Product Launch

Posted on by
Reply

Success in new product launches is a fundamental requirement to excel in pharma business – regardless of whether the drug is innovative or a generic one. For a novel, innovative molecule, associated risks are much higher, as it carries a huge amount of associated R&D expenditure.

The launch plan for a generic formulation or even a ‘me-too’ patented variety, can broadly replicate the first in the class molecule. Whereas, for any breakthrough innovative medicine – it’s a whole new ball game. There are virtually no footsteps to follow. Nonetheless, there is one thing common in both – a robust launch plan is pivotal to success, across the board.

In this regard, the March 2014 article titled, ‘The secret of successful drug launches’, of McKinsey & Company captures an interesting scenario: “About two-thirds of drug launches don’t meet expectations. Improving that record requires pharmaceutical companies to recognize the world has changed and adjust their marketing accordingly.”

On the same issue, Bain & Company also drew a similar outline with its article titled, ‘How to Make Your Drug Launch a Success,’ published about three and half years later – on September 06, 2017. It reported: “Our research shows that nearly 50 percent of launches over the past eight years have under-performed analyst expectations, and more than 25 percent have failed to reach even 50 percent of external revenue forecasts.”

The bottom-line, therefore, is – even if the success rate of new product launches has marginally improved, for various reasons, there still isn’t much to write home about it. In this article, I shall deliberate what type of approaches, when used with powerful cerebral inputs, could possibly improve this rate – significantly and sooner. Could it be with ‘Data-giri’?

What is ‘Data-giri’?

A good question. ‘Data-giri’ is quite an unheard-of terminology, probably was first used by the Chairman of Reliance Industries – Mr. Mukesh D. Ambani, on September 02, 2016. This happened when he announced the forthcoming launch of his mobile network ‘Jio’. At that time, light-heartedly he said:”We Indians have come to appreciate and applaud ‘Gandhigiri’. Now, we can all do ‘Data- giri’, which is an opportunity for every Indian to do unlimited good things, with unlimited data.”

As is known to many, the word ‘Gandhigiri’ is generally used in India to express the power in the tenets of Gandhism. Similarly, the expression ‘Data-giri’ may symbolize the power that the effective use of the right kind and quality of ‘data’ could provide. Unleashing the potential of relevant and requisite data for value creation, would assume critical importance, even in drug launches, more than ever before.

‘Data-giri’ in drug launches:

Right kind and volume of relevant ‘Data’ is fast becoming an important marketing weaponry. Its variety and quality of usage in business, would ultimately differentiate between success and failure.

Today, data usage in pharma marketing can no longer be restricted to just retail and prescription audits, supported at times by a few custom-made marketing research initiatives. The data that I am talking about here, covers mostly real-life and ongoing data in many areas, such as customer behavior, their practices, thinking pattern, aspirations, together with associated changes in trend for each – captured right from the early stages. The cluster of customers includes doctors, patients, healthcare providers and all other stakeholders.

To unleash the hidden power of data for gaining a productive space for brands in customers’ mind, building an arsenal of data for engagement in pharma marketing warfare, is emerging as a new normal for pharma players.

Accordingly, the bedrock of any strategic plan is shifting from – key decisions based mostly on gut feelings, to all such decisions standing on pillars of a large pool of well-analyzed data. From a new product-launch perspective, the basic data requirements would encompass some critical areas, which need to be focused on. I would illustrate this point with a few examples, as below.

Basic data requirements for a new product launch:

One such example in the above area, comes from United BioSource LLC (UBC) – a leading provider of pharmaceutical support service. It highlights 4 real-time basic data insights as critical to a successful drug launch, which I summarize as follows:

  • What market share I want to achieve?
  • Where are my potential high-volume prescribers?
  • What are the characteristics of patients who will receive my drugs?
  • Which physician specialties would prescribe my drug – immediate, medium and long term?

Successful companies do three things right:

Another example on what successful companies do right comes from the above research report of Bain & Company. It found that companies with successful launches do the following three things right:

  • They differentiate their drug through messaging, post-launch data and services.
  • They create broad customer advocacy via a superior customer experience.
  • They organize their launch as a micro-battle and ensure continuous ‘frontline feedback’.

The paper included a few other factors as, comprehensive market research, key opinion leader advocacy and competitive resourcing. The authors observed that pharma executives grossly underestimate several key success ingredients, including customer advocacy and organizing each launch as a micro-battle, with a real-time dual-feedback mechanism involving all concerned, to facilitate prompt intervention whenever required.

From both the above examples, none can possibly refute that without a meticulously created ‘data arsenal’, these exercises are feasible, in any way, for a rewarding new product launch outcome.

Data is fundamental to create a Unique Customer Experience (UCE):

As I wrote in my previous article, the expertise in creating a Unique Customer Experience (UCE) or aUnique Patient Experience (UPE) for a brand, would eventually separate men from the boys in the game of gaining product ‘market share’. Crafty use of data is fundamental for moving towards this direction.

One of the crucial requirements for UCE or UPE is taking a significant share of mind of consumers. This is possible by designing data-based cutting-edge differential advantages of the brand over others. In pharma marketing battleground, this could be done either – with only tangible brand features, or mostly with intangible benefits and perceptions, or an astute mix of both.

Data – essential to measure deviation against the strategic plan:

During any new product launch-phase, it is essential to capture and accurately measure all actual deviations against plan, taking place on the ground at each pre-defined milestone. The exact reasons for each need to be ferreted – both below or above expectations, for immediate necessary actions. This is important, as various studies indicate that the performance trend of a new product in the first six months from its launch, is a good indicator of its future performance.

All types of customer engagements, including selection of communication channels and platforms, should be ongoing research data-based. I emphasized this point in my previous article, as well. It was reiterated that ‘omnichannel content strategy’ for improving patient engagement and providing UPE, across all touchpoints in the diagnosis and treatment process, should be created over the bedrock of high-quality data.

Time for a switch from SOV to SOC:

Creating greater ‘Share of Voice (SOV)’ for a new brand, especially during its launch phase, would no longer work in pharma. This approach is based on the key premise of ‘Jo dikhta hai wo bikta hai’. This often-used Hindi phrase when translated into simple English, may be expressed as: ‘That which is seen is sold.’

In the pharma context SOV may be explained, as I understand: The percentage of total sales promotion and marketing activities for a brand within the sum total of the same in the represented therapy area. It is usually determined by measuring some key parameters, such as frequency and reach of doctors-call, or customer-contact, or even its rank in ‘top of mind brand recall.’

Greater SOV can make marketeers believe that enough is being done by the company to benefit potential brand consumers, which would help reaping a rich harvest. It may also reflect how busy they are with the execution of all planned-activities. On the other hand, consumer-experience may not be quite in sync with the intent and belief of the marketeers. They may not find enough value in the conventional brand marketing process. This is likely to happen much more in the future, as most consumers will want to experience a unique feeling of being cared enough by the company, while moving through all the touch points of the treatment process.

This trend calls for a major shift in pharma marketeers’ approach – from creating a greater SOV to offering greater SOC (Share of Care). I highlighted the importance of providing ‘care’ through several of my articles in the past, published in this blog. One such is titled “Creating A ‘Virtuous Cycle’ Through Patient Reach and Care”, published on April 09, 2018.

Conclusion:

The critical switch from SOV to SOC involves imaginative application of complex data of high quality.

A well-thought-out plan to fetch out critical answers aiming to provide UCE or UPE, will involve in-depth analysis of voluminous data of high quality, through modern-day analytics. From this perspective, fast learning of the art of ‘Data-giri’ is becoming a critical requirement for new product launch success in pharma, as we move on.

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.

Increasing Consumerism: A Prime Mover For Change in Healthcare

Posted on by
Reply

Increasing ‘consumerism’ has already become a strong prime mover to reckon with, even in healthcare, including the pharma industry, across the world. Patients’ longing for better participative treatment experience at an affordable cost, has started gathering momentum as a major disrupting force in the healthcare space of India, as well.

In this article, which discusses a different topic from what I said in my last article that I will write this week, let us try to fathom today’s reality in a fast expanding area, primarily by connecting the emerging dots, both globally and locally. However, before doing so, it won’t be a bad idea to recapitulate, in the general term, what exactly is ‘consumerism’ – and then looking at it in context of healthcare.

What it really means?

The Oxford dictionary defines ‘consumerism’ as: ‘The protection or promotion of the interests of consumers.’ As an example, it says, ‘The impact of consumerism emerges as a factor of stabilization, as do the different understandings of stability and stabilization.’ Whereas, consumerism in healthcare is an assertion of patients’ right to be a key participant in their healthcare decision making process. As aptly put by Healthcare Success: “It is a movement from the ‘doctor says/patient does’ model, to a ‘working partnership’ model.”

Should pharma strategic marketing process, not take care of it?

When the above question is asked differently as: If the pharma strategic marketing process is effective, why is healthcare consumerism increasing across the world, including India? To find an answer to this, let’s go the basic of the definition of ‘marketing’. American Marketing Association (AMA) defines it as: ‘‘Marketing is the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large.’ A more specific definition of pharma marketing (Olszewska A. Strategic management in pharmaceutical marketing. Chemik 2006: S91-4.)is: ‘A management process that serves to identify and meet patients’ needs in a profitable way.’

This prompts the key question, if the above basic process of ‘marketing’ is followed by the pharma industry as it ought to be, why should there be an increasing trend of ‘consumerism’ in Healthcare, in general, and the pharma industry in particular?

The major drivers:

NRC Health through various surveys, has captured the major drivers of consumerism in healthcare. I am listing below a few of those, as I understand, just as examples:

  • Significant increase in health care cost to payers, including the patients.
  • Consumers are the fastest growing payer in the industry.
  • They foot most costs of their health premiums and out-of-pocket co-pays.
  • As consumers have more money at risk, they want to get more engaged with their own treatment decision for the best value for money.
  • One-way monologue for treatment doesn’t not enough for most patients.
  • 3 of 10 patients defer necessary treatment to avoid self-confusion and expense.
  • 4 out of 5 find difficult to compare costs Vs. drug quality.
  • 3 out of 4 feel their health care decisions are the most important and expensive
  • Patients face difficulty to compare cost, quality, and access to physicians.

In my view, sooner than later, the emerging situation in India will also be no different, especially with its increasing digitally empowered population.

Is pharma marketer cognizant of this emerging trend?

It will be unfair to make any sweeping statement that they are not. This is based on what I see and experience around, mostly in the global arena. But locally, although significant publicity of a large number of pharma training programs appear in the social media, most of these are apparently based on the ‘buzz of the time’.

Besides a few sporadic exceptions, generally the Indian pharma marketers still appear to believe in the same age-old model – what the ‘doctor says/patient does’. As a result, increasing consumerism keep haunting the industry – the Government often responds – mostly with sound bites, though, the industry keeps lamenting on the ‘ease of doing business’ or the lack of it, in India. The much avoidable cycle continues.

A prime mover for change in healthcare:

Increasing health care consumerism is a prime mover to usher in significant changes in this space. These changes are mostly unexpected and disruptive, but usually good for the patients. I shall illustrate this point here with just two examples, out of many. The first one comes from three global corporate head honchos of unrelated business, aimed at their own employees. And the other is related to all patients with the initiative coming from within the healthcare industry, including pharma.

The first example of an unexpected move comes from the announcement of three corporate behemoths – Amazon, Berkshire Hathaway and JPMorgan Chase, saying they would form an independent health care company for their employees in the United States. This was reported by The New York Times (NYT) on January 30, 2018. The alliance signals how frustrated American businesses are not just with their health care system, but also rapidly spiraling cost of medical treatment – the report said. The NYT also quoted Warren E. Buffett of Berkshire Hathaway as saying:“The ballooning costs of health care act as a hungry tapeworm on the American economy.”

The initial focus of the new venture, as announced, will be on “technology solutions” that will provide U.S. employees and their families with “simplified, high-quality and transparent healthcare at a reasonable cost.”  They also plan to “bring their scale and complementary expertise to this long-term effort.Nevertheless, it is unclear how extensively the three partners would overhaul their employees’ existing health coverage to reduce healthcare cost and improving outcomes for patients. They may simply help workers find a local doctor, steer employees to online medical advice or use their muscle to negotiate lower prices for drugs and procedures. While the alliance will apply only to their employees, these corporations are so closely watched that whatever successes they have could become models for other businesses – NYT commented.

The second examplecomes from an article, titled ‘Consumerism in Health Care’, published in NEJM Catalyst on January 11, 2018. It says, another important change that is a direct outcome of the consumerism of health care is personalization of care to facilitate health outcomes. However, ultimate personalization, that is, a “one-to-one relationship” between a company and an individual appear increasingly possible with the data and analytics that are now within the reach of many global pharma players, the paper says. However, most Indian pharma players, I reckon, still lack wherewithal that’s required to build capabilities to deliver high degree of personalization for patients.

As a result, pharma industry, in general, is still charting in the primary stages of delivering personalization, although, progress made by some global players in this direction is quite encouraging.

Consumerism in healthcare to gather momentum in India:

A September 2016 paper, titled ‘Re-engineering Indian health care’, published jointly by FICCI and EY points to this direction. The results of their survey done as a part of this study indicates, the aspirations of the middle and upper classes are evolving and their demands for convenience, participation and transparency in the health care delivery process are indicative of the shift from being a docile patient to an informed “health consumer.”

Thus, it is irrefutable today that digitally empowered patients are fast increasing, even in India. This is fueled by rapid expansion of broadband Internet in the country – a bottomless source of information. In this scenario, would the general pharma marketing assumption in India - what the ‘doctor says/patient does’, still yield results? Indian pharma marketers may need to possibly do some crystal gazing in this area – sooner the better.

Conclusion:

Accepting the reality of increasing consumerism in the healthcare space, both globally and locally, pharma players, especially in India, need to clear all clutter in the pathway to reach out and directly interact with their end-customers – the patients, aiming at improving clinical outcomes, the way patients would want – individually or in a cluster.

In a nutshell, what do patients want through increasing consumerism: Personal and meaningful involvement in their healthcare decision making process, based on requisite credible information from independent expert sources. Thus, what pharma the players should gear up to be: Cultivating a truly patient-centric approach in their business. And, there lies the real challenge for many in the industry, as it will mean all marketing and related organizational decisions will revolve around in-depth understanding of the patient’s mindset, along with their associated needs, want and health aspirations.

While moving towards this direction, providing personalized care by leveraging optimally selected modern technological platforms, will be a cutting-edge tool for pharma business excellence and achieving sustainable all-round growth – over a long period of time. As I see it, increasing consumerism will continue to remain a prime mover for unexpected, but welcoming changes in the healthcare space, at least for a medium term. It is to be taken rather seriously, with as much care as it deserves.

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.