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Appears On Radar New L&D Needs For Pharma’s New e-Environment

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As drug companies were desperately trying to navigate through the operational disruptions due to Covid crisis, the Learning and Development (LD) plans of most organizations, considered so important for employees, got badly impacted. This was ably captured in the article – ‘Adapting workplace learning in the time of Coronavirus’, appeared in the March 2020 issue of McKinsey Accelerate.

It highlighted, as businesses around the world postpone and cancel in-person meetings in response to the COVID-19 pandemic, “workplace learning is emerging as one of the earliest and hardest-hit business activities.” The paper further elucidated: “Based on our observations as of early March, roughly one-half of in-person programs through June 30, 2020, have been postponed or canceled in North America. Whereas “in parts of Asia and Europe, the figure is closer to 100 percent.”

Interestingly, no one is talking much about it as much as the need for quick digitalization in the pharma industry, to respond to the challenge of disruptive changes. A quick return to employee L&D initiatives in the new normal, I reckon, would encourage, particularly the hands-on staff members on e-marketing to come out with more innovative digital solutions to reap a rich harvest from remote engagement with customers, on an ongoing basis.

In this article, I shall explore this area from the perspective of increasing employee productivity in the digital work environment of the new normal.

Why is L&D more relevant to pharma employees, now?

To effectively respond to post-Covid changes in customer behavior – aspirations – expectations – other market dynamics, alongside a different genre of competition, new learnings in the digital space, is critical for all employees. Which is why, it is so important for pharma players to quickly refocus on this process, just as digitalization. Without requisite digital skill development, corporate performance may look lackluster, eventually.

It is important for all to recognize that just digital transformation of business isn’t a panacea. For example, e-marketing is certainly a powerful contemporary marketing tool that a company must go for. But, it is no less important to know how making effective use of this versatile technology would appeal to individual customer emotions, with personalized content. Medical Representatives of pre-Covid days may not be generally well-versed in this area, at least, as much as they ought to – now.

Some pace-setting Indian examples in this area:

According to an article, published in leading Indian business daily on June 17, 2020, the Indian pharma major – Lupin, reportedly, used the lockdown as an opportunity to train its sales teams on medical acumen, soft skills, disease knowledge, effective communication etc. They conducted over 200 sessions using Microsoft Teams. In some sessions, the attendance count reached 8000 people.

As the article points out, using digital tools and platforms, the company reps were enabled to record a video of brand detailing and share it with the doctors who can view it as per his or her convenience. It also says, ‘Lupin team reached out to more than 1 lakh doctors through live webinars, ECMEs, e-mailers, webinars to update them with the latest medical and therapeutic advancements.’

The core idea of this initiative is undoubtedly worth imbibing, although, it is still not clear to many, how effective were those digital marketing strategies in the form as it has been described.

The new e-environment needs new sets of L&D models:

From the above perspective, the take home message, I reckon, is - in pharma’s new normal, digitalization isn’t just about a modern and contemporary technology. It is much more profound – signifies the criticality of credible data-based, novel decision-making process, offering high yield solutions to complex sets of disruptive problems in business.  Consequently, now appears on the radar a new set of L&D needs for the new e-environment of the pharma industry.

Ramifications of e-environment changes in pharma business: 

Many studies have pointed out to a number of changes in pharma industry’s e-environment, in the new normal. Just to give a sense of such mega changes, let me quote another recent paper in this regard. The paper on ‘Telehealth’, published by McKinsey & Company on May 29, 2020, writes: “Our claims-based analysis suggests that approximately 20 percent of all emergency room visits could potentially be avoided via virtual urgent care offerings, 24 percent of health care office visits and outpatient volume could be delivered virtually, and an additional 9 percent “near-virtually.”

The paper further adds, ‘up to 35 percent of regular home health attendant services could be virtualized, and 2 percent of all outpatient volume could be shifted to the home setting, with tech-enabled medication administration.’ These changes will overall add up to US$250 billion in healthcare spend in 2020 that could be shifted to virtual or near-virtual care, or 20 percent of all office, outpatient, and home health-spend across all types of health care, the paper highlights.

Although, this article was written against the US pharma industry backdrop, considering the current Indian government’s strong push on telemedicine – as a facilitator, one may envisage similar changes in India too, over a period of time.  

Covid-19 could still be a long-haul battle, pharma should be prepared for it:

Echoing this sentiment, ‘The Washington Post’ flashed a headline in its February 10, 2021: ‘Variants mean the coronavirus is here to stay — but perhaps as a lesser threat.’ Elaborating the point, it said: ‘In early December, the end of the pandemic glimmered on the horizon. Blockbuster vaccine results suggested a clear path forward.’ However, thereafter, ‘the euphoria dissipated,’ as mutation-ridden variants of Covid-19 with concerning new characteristics were detected. ‘The path forward is still hopeful, but longer and more labyrinthine’, the news report added.

It is now becoming increasingly clear that Covid-19 variants can slip past some of the immunity generated by vaccines and prior infections.  Vaccines may have to be updated, perhaps regularly. And the world will have to prepare for the possibility, even the likelihood, that over the long term, the novel coronavirus will become a persistent disease threat.

The World Health Organization (W.H.O) also confirmed this point on January 21, 2021. It said, ‘Yes, this is a very important point that vaccine developers keep in mind. Covid-19 vaccines could possibly be like vaccines against the influenza virus, where ‘scientists have to change the structure of the vaccine every year, based on the circulating strains and WHO coordinates this global network that actually identifies which strain should be used every year.’

Conclusion:

The bottom line, therefore, is, no one can vouch with any degree of certainty, as on date, when exactly Covid crisis will get over completely, despite Covid-19 vaccines being available now. At the same time, even after several disruptive covid related changes in business, the need for rapid adjustment to further changes of similar in nature and scale, may continue to exist.

To properly understand these changes, their implications on business, impact on customers, re-engineering needs of marketing strategies and then thrive, are of fundamental importance. Thus, along with on-the-job learning, contemporary e-learning of employees – is a critical success ingredient for both individual and organizational development, especially in the dynamic digital environment.

It is worth noting that digital initiatives are not confined to modern tech-based apps and platforms. The basic prerequisite of any digital marketing strategy is to understand the versatility of its power and core values. This is essential to effectively influence customer behavior and their expectations, for creating a sustainable ‘doctor-patient- brand or corporate relationship. That’s why L&D remains a critical tool for capacity building, even for e-marketing. It will help ensure, employees are able to deliver expected deliverables by successfully meeting newer challenges in the digital space, in sync with the organizational expectations and goals, in the new normal.

Today, when digitalization has become a buzz word for pharma’ success – occupying virtually everybody’s entire mind space, also appears on the radar today new L&D needs for the new e-environment to make digitalization work, paying rich dividend to the business.

By: Tapan J. Ray      

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

 

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

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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

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 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.

 


Create Greater Patient–Value To Excel With Repurposed Covid Brands

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Regular introduction of new molecules, line extensions or a Novel Drug delivery System (NDDS) has remained the life blood for pharma to rejuvenate a company’s product portfolio for driving organizational growth. But, Covid’s unprecedented and devastating assault on human lives and livelihoods, has pushed many of these initiatives off track. Covid infection was declared pandemic by the World health organization (WHO) on March 11, 2020, compelling the industry to primarily focus on finding solutions for survival, especially in the product development areas.

As the fight against time, the need for survival became so intense, there was no time for pharma companies going back to primary research, to discover new effective Covid specific drug molecules. Vaccines – at the initial stage of the pandemic, were considered by experts could be the only ‘magic bullet’, to get the humanity back again on its feet, after a fierce knockout blow by the virus. As on date, although vaccines seem to be nearer the finishing line of creating adequate initial immunity against Covid, still there are no scientifically proven drugs to predictably cure this infection.

Meanwhile, the focus of all concerned is on the existing drugs, to examine their effectiveness against Covid-19. Accordingly, right from hydroxychloroquine, dexamethasone to a number of already existing antiviral agents were repurposed for Covid treatment, under emergency approval by country regulators, pending detailed clinical trials.

For various critical reasons, experts now feel that the use various NDDS technologies in repurposing existing drugs, would create greater value for patients in Covid treatment. At the same time, this will help pharma companies to create a cutting-edge differentiator for their repurposed brands – being more patient centric. In this article, I shall dwell in this area, starting with the current status and issues with repurposed Covid drugs, as of date.

Current status and issues with repurposed Covid drugs:

According to recent reports, such as one titled ‘Formulation and delivery strategies for COVId-19 drugs,’ published by the AIchE in June 2020, more than 40 different drugs are currently being explored for efficacy against COVID-19. Unfortunately, side effects of many of these repurposed drugs limit their use in most severe cases, besides preventing their use as prophylactics.

A large proportion of repurposed Covid drugs are small-molecule medications, antivirals, and immune-modulating antibodies. These are already approved for other indications (like hydroxychloroquine, ribavirin, favipiravir), or under clinical trials, but not yet approved by the U.S. Food and Drug Administration, FDA (like, remdesivir, galidesivir, leronlimab).

If proven effective, these drugs would offer several advantages from a rapid- response perspective, such as the availability of safety data. In addition, several of these drugs offer broad-spectrum activity that makes it more likely they will remain functional even if the SARS-CoV-2 virus mutates. However, there are also exists some critical issues with repurposed Covid drugs.

Some critical issues with repurposed Covid drugs:

Let me cite below two examples, just to drive home the point of some critical medical issues, now existing with these repurposed Covid drugs:

  • Hydroxychloroquine – the malaria drug, when used as directed, commonly produces nausea, diarrhea, vomiting, besides muscle weakness. Importantly, at higher concentrations – only two to three times the daily dose, it can cause potentially fatal acute cardiovascular toxicity. Thus, the possibility of severe side effects makes the drug unattractive as a preventive measure. Drug formulation and delivery strategies, such as controlled release and targeted delivery could expand the use of such existing drugs, the report recommends.
  • The HIV drug combination lopinavir and ritonavir, which is under evaluation as a COVID-19 treatment, has side effects that include diarrhea, nausea, and liver damage. With a half-life of about 4–6 hours, the systemic concentrations can vary by a factor of eight between peak and trough. Developing a controlled-release formulation that maintains the minimum effective drug concentration, could mitigate side effects by reducing the steady-state drug concentration by as much as eightfold and reducing the burden on the liver by 81%, the above study, published by the AIchE in June 2020, highlighted.

At this point, for greater clarity, let me recapitulate what NDDS really means.

NDDS – clinical and marketing relevance:

Novel Drug Delivers Systems or NDDS generally ‘refers to the approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects.’

This process was lucidly explained in a contemporary article, which also inferred that the method by which a drug is delivered can have a significant effect on its efficacy and safety profile.

Yet another paper underscored, ‘if therapeutic agents can be made more efficacious and safer, using an improved drug delivery system, could achieve both –lucrative marketing opportunities for pharmaceutical companies, alongside advancement in the treatment of diseases of mankind.’ Moreover, NDDS can also help maintain the drug concentration in the therapeutic range for a longer period of time and deliver the content to the site of action if required.

Leaving aside the technical details behind these mechanisms let me underscore - that NDDS will be a boon for the repurposing of drugs, was also discussed in detail in an article titled, ‘Role of Novel Drug Delivery Systems in Coronavirus Disease-2019 (COVID-19): Time to Act Now,’ published on September 09, 2020.

Some broad categories of NDDS and new initiatives:

For this purpose, some of the broad categories of NDDS may include the following:

  • Sustained- or controlled drug delivery systems provide drug action at a pre-determined rate.
  • Localized drug delivery devices for drug release in the vicinity of the target.
  • Rate – pre-programed drug delivery systems.
  • Targeted drug delivery provides drug action by using carries, which recognize their receptor at the target.

It goes without saying that NDDS mechanism may be used both for new molecules that may eventually be developed, and also for the existing repurposed drugs for Covid treatment.

Some encouraging initiatives of NDDS for Covid drugs:

The encouraging news is pharma initiatives in this regard has already commenced. For example, unprecedented interest in inhaled delivery of antiviral drugs has led to Aerogen’s involvement in multiple COVID-19 drug development initiatives, with more than 15 leading pharmaceutical companies - worldwide.

Several of these collaborations are already in clinical trials. Others are also on track to enter studies on moderately and severely ill COVID-19 patients, the Press Information of Aerogen dated October 22, 2020 highlighted. Let me cite below two more examples in this area, to explain the intensity of work that has commenced in the NDDS space for repurposed Covid drugs.

Covis Pharma’s inhaled glucocorticoid, Alvesco (ciclesonide) has entered Phase III safety and efficacy trial in 400 non-hospitalized patients  -12 years of age and older with symptomatic COVID-19. The product is delivered twice daily via a pressurized metered dose inhaler (pMDI).

Senzer Pharmaceuticals - a UK based company, is also in the process of formulating two specific medicines with antiviral properties, to allow them to be inhaled directly into the respiratory tract. The primary aim is to reduce the number of COVID-19 patients requiring intensive care treatment. Senzer is also using a pMDI for targeted drug delivery of actives through inhalation, as it offers potential advantages over oral intake. These include, ease of administration, assisting early treatment, allowing a lower dose by reducing unwanted side effects and supporting the safety profile of the products.

Experts consider preparations of inhalable particles for local delivery is a simpler approach. This is because the lungs comprise only about 2% of the total body weight, targeted delivery could reduce the amount of drug required by a factor of 50 or more, as compared to oral administration.

Be that as it may, the primary purpose of all such initiatives is to ensure more effective and safer drug delivery to Covid patients. It is now up to the pharma marketing leadership to ascertain how to leverage such NDDS opportunities to deliver extra patient-value, simultaneously creating a cutting edge for marketing these repurposed brands.

Impact of Covid on the NDDS market segments:

The May 11, 2020 report titled, ‘Drug Delivery Systems Market Forecast, Trend Analysis & Competition Tracking – Global Market Insights 2020 to 2025,’ presents some interesting details in this area. It forecasts, the global drug delivery systems market shall register an upswing, expanding at a strong CAGR of 7.0% during the forecast period (2020-2025).

The ongoing COVID-19 pandemic is expected to further heighten prospects of NDDS, with the number of infections still increasing every day. Consequently, many leading pharma companies have accelerated production of essential drug delivery systems, as stated above. According to the above report, the key growth drivers of the NDDS market include:

  • Targeted drug delivery - being most dominant, is expected to capture nearly half of the global NDDS market, expanding at a healthy CAGR of 6.8% across the above forecast period.
  • Polymeric drug delivery segment is anticipated to be the second-most lucrative area, expanding at a CAGR of 7.3% across the forecast period. The popularity of this delivery type is attributed to its efficiency in localized drug delivery in large amounts, alongside lowering drug toxicity rate. The polymeric drug delivery segment is expected to capture more than 1/3rd of the global drug delivery systems market during the forecast period.
  • Application of nanotechnology is another key growth determinant for the segment. Insertion of nanoparticles help penetrate the targeted tissue in a much better manner. These particles are easily absorbed by cells, facilitating efficient drug delivery.
  • Microneedle drug delivery helps deliver vaccines or other drugs across various barriers.

Conclusion:

The Covid clock keeps ticking. As on November 22, 2020 morning, India recorded a staggering figure of 9,095,908 of Coronavirus cases with 133,263 deaths. The average number of daily new cases appeared, after the festive season, have started climbing up again. The threat of subsequent waves for further spread of Covid infection now looms large.

In this regard, many experts initially thought that Covid vaccines will be magic bullets to win the war against the new Coronavirus. But in the most recent times, this situation has changed, and it is no longer so – not even Pfizer vaccine. Indian media also deliberated the same on November 05, 2020.

Under this backdrop, Arthur L. Caplan, professor of bioethics at New York University’s Grossman School of Medicine, who wrote a 2017 book on vaccine ethics and policy have also made a profound comment. He said recently: “We’re going to have to continue our behavioral efforts - the masking and distancing and the quarantining and the testing and so on — in parallel with vaccination because it would be very, very surprising if we got a very highly effective vaccine first one out of the box.”

Currently, the world doesn’t have any clinically proven new Covid treatment drugs, either. What we have now is a number of repurposed Covid drugs, many of these are in advanced stage of clinical trials. As and when these are approved by the country’s regulators, pharma marketers will have a task cut to excel with those – among many ‘me-too’ types. In this scenario, there will be a critical need to create greater patient-value with a company’s own repurposed brand, where right application of NDDS technology could play a game changing role. The time to keep pondering is over. Time to decide is – now.

By: Tapan J. Ray     

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

 

 

Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard

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There isn’t even a shade of doubt today that Covid-vaccines are coming. However, some critical questions in this area continue to hang in the air, and are expected to remain so for some more time. Thus, every news on the development of Covid vaccines, particularly in their late stages of clinical trials, fuels billions of hopes and excitement, across the world.

The same thing happened, when Pfizer and BioNTech announced on November 09, 2020, some key details on their vaccine candidate. These include, ‘vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis’ from Phase 3 studies. The release also highlighted, ‘Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.’

Amid these new developments, it is also now beyond doubt that the pandemic will be brought under control, eventually. Interestingly, none possibly knows when it will happen. There doesn’t seem to be any clearly charted – time-bound pathway in place for the same, either – not just yet. That said, from the overall developments in this area for the past 10 months, especially in India, – two other crucial questions also remain elusive, as follows:

  • Has the country started preparing itself against any Covid-like future biological threats? If so, in what manner?
  • As India conducts the world’s largest  Universal Immunization Program (UIP), how robust is the country’s vaccine supply chain to effectively inoculate every Indian with Covid-vaccine?

I have already deliberated on several aspects of the former question in one of my previous articles, in this write-up. Therefore, this write-up will focus on the second query, with a specific reference to the continued relevance of abidance of the defined health norms for some more time, especially for my pharma industry readers. Accordingly, all astute pharma professionals in India, need to accept this new reality, and rewrite their brand demand generation strategies for the new normal. Let me start with how the cold-chain logistics for vaccines, in general, work in the country.

The cold-chain logistics for vaccines:

A paper published by the BBC News, on November 11, 2020, captured how the cold-chain logistics for vaccines, in general, work almost in all countries, including India. The article is titled, ‘Coronavirus: How soon can we expect a working vaccine?’ The steps involved in this exercise are as follows:

  1. Vaccines transported to destination countries (imported varieties).
  2. Refrigerated trucks for transportation to designated cold rooms.
  3. Distribution in portable and appropriate ice boxes to regional centers.
  4. Stored in electric fridges between 2 degree to 10 degree Celsius (for most of the existing vaccines.)
  5. Carried in portable and appropriate ice boxes to local venues for vaccination to individuals.

Associated challenges:

As the above paper highlighted, some important associated challenges in this space, which are mostly faced by the developing countries, like India, are as follows:

  • Adding a new vaccine to the existing mix could pose huge logistical problems for those already facing a difficult environment.
  • According to prescribed norms, all Vaccines in India requires a storage temperature in the range of +2 degree to +8 degree Celsius, except for Oral Polio Vaccine which need to be stored in the frozen state (-25 degree – 15 degree Celsius) at all stores except PHC/ CHC/Health post. The new vaccine ROTAVAC (116E rotavirus) by Bharat Biotech is being recommended to be stored at (-15 to -25 degree Celsius) till the intermediate stores and to be stored in the range of +2 degree to +8 degree Celsius at the last storage points like PHC/ CHC/Health posts. This has not posed much of a challenge. However, expanding it to cover the entire population of the country can be an “immense task.”
  • It is worth noting, although, AstraZeneca vaccine would need the regular cold chain between 2C and 8C, the Pfizer and BioNTech vaccine would need ultra-cold chain – storage at around minus 70C to 80C.
  • ‘Maintaining vaccines under cold chain is already one of the biggest challenges’ that countries face, and this will be exacerbated with the introduction of a new Covid vaccine.
  • Thus, more cold chain equipment will require to be added, making sure that fuel is always available (to run the freezer and refrigerators in absence of electricity) and repair/replace them when they break and transport them wherever you need them.

Curiously, India’s cold-chain logistics that cater to one of the world’s largest immunization programs for children and mothers, may not be enough for Covid-19 vaccination of the country’s 1.3 billion population.

Why India’s cold-chain logistics may not be enough for Covid vaccination:

Before coming to the above question, it is important to note that India is not just the pharmacy of the world, contributing over 20 per cent by value to the global generics market, and over 40 per cent (by volume) of US drugs. According to a recent report of Bernstein Research, Indian vaccine producers, such as, Serum Institute of India supply the bulk – over 40% of the global capacity of 5.7 billion doses annually. Home to some of the world’s biggest vaccine makers, India produces 2.3 billion doses of vaccines yearly, with 74% for export, said the report.

Regardless of this fact, India’s cold-chain logistics may not be enough for Covid vaccination of its entire population, primarily because it is currently geared for children. ‘India Spend’ report of October 13, 2020 titled, ‘India’s COVID-19 Dilemma: Adults Need Vaccines, Supply Chains Geared For Children,’ presents several such interesting facts to ponder over the following points:

  • Being the world’s largest in the Universal Immunization Program (UIP), India targets 26.7 million newborns and 29 million pregnant women every year (55 million people in total, or 4% of the total population). This requires 390 million doses of vaccines, over nine million sessions. But, can this infrastructure effectively handle Covid vaccination of 1.3 billion people?
  • The above question arises, because India has planned to administer 400 to 500 million doses of a COVID-19 vaccine, mostly to its adult population by the first two quarters of 2021. For this effort, the country will have to nearly double the total number of vaccinations given in the public sector program. Thus, one can well imagine, what a humongous task, it will be for vaccination of 1.3 billion population, at the shortest possible time.

Which is why – although, over the last decades, India has created a primary vaccination infrastructure, and gained enough experience in this area, these may not be enough for Covid mass vaccination program, as stated above.

What it would it entail:

As the above ‘India Spend’ report indicates, this effort will entail:

  • Ramping up capacity to administer vaccines,
  • Expanding and further strengthening cold-chain infrastructure and process of storing and transporting vaccines safely, besides logistics,
  • Ensuring adequate availability of ancillary items, such as syringes, glass vials, and intensive training of healthcare workers.

Without these, even if there is a life-saving vaccine available for COVID-19, people will not have access to effective vaccines, the report reiterates. From this perspective, let’s now have a glance to India’s current vaccine cold-chain logistics and infrastructure.

India’s current vaccine cold-chain logistics:

Currently, most vaccines in India are distributed by the Governments UIP mechanism. Accordingly, for the child immunization program, almost the entire vaccine cold chain is publicly funded and managed.

Going by the official statistics, at present there are in total – about 7,645 cold storages in the countrywith 68 per cent of the capacity being used for potato, while 30 per cent is a multi-commodity cold storage. ‘Most of these cater to farm produce in rural areas with ambient temperature storage and therefore are not pharmaceutical ready.’ As the industry sources indicate, ‘only a small part of the remaining 10 per cent of the industry is organized and capable of playing a key role in the distribution of the Covid vaccine.’

The comprehensive multi-year UIP plan for 2018-22 of India also specifies, while India’s UIP is currently supported by more than 27,000 functional cold chain points, only 750 (3 per cent) are located at or above the district level. The rest is located below the district level.

Nevertheless, the ongoing pandemic prompts India to administer Covid vaccines to its entire population of 1.3 billion population, over the shortest possible period of time. To achieve this goal, the cold chain industry of the country is warming up to handle this vaccine distribution challenge, maintaining the integrity of the cold chain.

The only organized pan-India cold chain player with 31 facilities is, reportedly, Snowman Logistics. Other companies, who are mostly the regional operators in this business, include Coldex, ColdStar, Western Refrigeration and JWL. Yet another report indicates, Maersk, is also poised inking a global logistics deal with US-based COVID-19 vaccine candidate COVAXX, including India. Be that as it may, the bottom-line remains, effective Covid vaccination program would not possibly commence until this gap is successfully bridged.

Conclusion:

Meantime, as on November 15, 2020 morning, India recorded a staggering figure of 8,814,902 of Coronavirus cases with 129,674 deaths. The average number of daily new cases appeared to have slowed down in the last few weeks, except Delhi. But, the threat of further spread of Covid infection, in waves, remains as it was before.

Robust and high-quality vaccine cold chain logistics in India assumes so much of importance, because of one critical factor – to preserve its effectiveness till administered to an individual. This is regardless of whether a person is located in cities, small towns or in the remote hinterlands of the country. The successful accomplishment of this task is crucial to combat Covid pandemic, until scientists find any predictable long-term solution.

The good news is, according to a new report: ‘Amid cold chain blues, Pfizer looks to powder vaccine formula in 2021.’ BBC News also reported: ‘A group of Indian scientists are working on such a vaccine. The “warm” or a heat-stable vaccine, they claim, can be stored at 100C for 90 minutes, at 70C for about 16 hours, and at 37C for more than a month and more.’

While the world awaits to witness this happening, we all should recognize a current reality. Tough challenges are still looming large on the way of effective Covid mass vaccination programs, especially for all adult population in India. Thus, the gravity for abidance to basic infection avoidance norms – wearing masks, social distancing and avoiding crowded places, stay unchanged. Accordingly, all astute pharma professionals in India, I reckon, need to accept the prevailing reality, and rewrite their brand demand generation strategies for 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.

 

Creative Pharma Marketers To Unshackle Covid Fetters

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Pharma industry, just as most others, has started recognizing that the business needs to be brought back to normal, despite Covid fetters. Some early evidences suggest, a new breed of pharma marketers is refusing to get confined to Covid triggered operational limits, without breaching any prescribed safety norms.

These pacesetters no longer grapple with finding right answers to the question – when and how the brand building activities can be brought back to the old normal? Truly speaking, none has its answer, as yet. Covid has the power to strike back, anytime – anywhere, in waves, when the guards are even slightly down. Moreover, as and when vaccines will come, these may not be ‘silver bullets’ for many – throughout a lifetime, at least, in the foreseeable future.

Accordingly, these forerunners are effectively leveraging the art of turning challenges into opportunities. They are conceptualizing new business models for making path-breaking progress in contemporary purpose driven branding exercises. For all pharma marketers, I reckon, this is the moment of truth, when what you do reflects what you really are, in this area. Thus, in this article. I shall deliberate, with examples, how these creative new age pharma marketers are trying to unshackle Covid fetters.

Today’s reality on the ground: 

A number of global surveys on how patients’ have reacted to Covid-19 pandemic with reasons behind the same, are now available. One such study was conducted by Medisafe, during March and April, 2020. Some of its key findings are as follows:

  • More than half of the respondents, especially those with comorbidities, worry about getting Covid infected while accessing to in-person treatments.
  • Over 9 out of 10 respondents were practicing social distancing, as a remedial measure.
  • Consequently, they are missing doctors’ appointments, and many are opting for telehealth wherever appropriate and necessary.

In many situations, such as,  common and repetitive health issues, including some mental health conditions, virtual health care are more convenient. It has also been established during the pandemic that telehealth can deliver similar outcomes at a lower cost, than in-person visits. In addition, remote monitoring of some key health parameters, like heart rhythm, blood sugar, weight, respiratory rate, also help people control their chronic conditions better, and assist clinicians with diagnosis and treatment.

More doctors prefer telehealth, but the majority wants some in-person visits too: 

An interesting study – ‘Want Both In-Person and Virtual Visits with Sales Reps,’ published by Bain & Company on June 02, 2020, ferreted out today’s reality, in this space. It found, prior to Covid, about three-fourths of physicians preferred face-to-face engagement with sales reps. In contrast, today more of them are asking for a reduction in Rep visit frequency and more remote support or virtual approaches. Curiously, a majority still prefers, at least some in-person interaction ‘once the pandemic passes.’

Interestingly, no one seems to know, just yet, when exactly will this pandemic get over. Besides, whether or not Covid will keep coming back in waves, for an indefinite period. Or, any similar or even worse global health crisis, in future, could bring greater disruption for the industry.

Driven by such apprehensions, it is possible that more and more patients will prefer telehealth, expanding access to health care for an increasing number of people. Nonetheless, one should also take into consideration that virtual health care has also some significant limitations, especially those which may lead to serious or life-threatening conditions.

Some key limitations to overcome:

Alongside multiple advantages of telehealth, it has some significant limitations, which can’t be wished away, either. This point was also well articulated in the article – ‘Where Telemedicine Falls Short,’ published in the Harvard Business Review (HBR) on June 30, 2020. The author, who is also a primary care physician gave a number of examples in this regard. For example, in one place he wrote:

‘I have found treatable cancers multiple times in routine exams that would be impossible to replicate in the virtual world. Could a Zoom visit detect a lymph node too firm, a spleen or liver too large, or an unexpected prostate nodule (with a normal PSA)?’ The paper also emphasized: ‘Trust and face-to-face encounters are even more important for patients with complex and intertwined problems.’

Be that as it may, the task to encourage patients, even with serious ailments, for in-person consultation and examination by doctors’ in their clinics, won’t be ‘a piece of cake’ too. On the contrary, it will be rather a colossal exercise.

Why will this task be colossal?

One can get a sense of tough challenges involved in this effort from the IQVIA report titled, ‘COVID-19 Pandemic and the Impact on SEA Healthcare Market.’ Along with other areas, the study captured several details of the above area, specifically for the South East Asia (SEA), as follows:

  • Decrease in patient visits (Out-Patient): 2 out of 3 hospital doctors are experiencing >60% decrease in patient visits.
  • Extended period of time before patient load resumes to normal: ~50% of doctors think that it will take 4 to 6 months to resume normal operations.
  • Increase in prescription duration: ~25% of doctors have 2x their standard prescription duration to reduce patient visits.

The study also observed, ‘in order to reduce the risk of getting infected, patients are reducing their visits to the HCPs.’ Such an unusual situation is unlikely to be mitigated, soon, with any traditional or ‘one size-fits all’ type strategy. Particularly when Covid threat still looms large on the population. As is happening today, even after signs of waning, Covid may return in waves – for an indefinite period. Thus, innovative marketing interventions, backed by actionable insights, are essential to help overcome the fear of getting Covid infected, by both patients and doctors.

How to respond to this situation in a creative way?

The creative marketing response to overcoming the possible barriers on the way, would call for predictive rather than reactive pharma strategies. The game plan not only needs to be purpose drivenfor the marketers, but should also be perceived that way by all concerned. For example, the core purpose of marketing in this scenario, will be to provide a life-saving patient ‘service’, with win-win outcomes.

And the additional ‘service’ in this case is encouragement in-person physician visits during early symptoms of life-threatening health conditions – taking all safety precautions and overcoming ‘paranoia’ of getting infected. The win-win outcomes will include – saving lives, preventing deterioration of the disease condition, and of course, facilitation of the brand demand. The good news is some global pharma majors have already started making progress in this direction.

Promoting doctor visits during the pandemic – an example:

Leaving footprints to follow, some pharma marketers have already started creatively working on it. Let me cite a recent example of this unique initiative. This was reported by Fierce Pharma in its November 02, 2020 issue. The marketing process carries all the required ingredients for excellence, as mentioned above.

It wrote, ‘Pfizer and Bristol Myers Squibb are the latest drugmakers to join the swell of campaigns promoting doctor visits during the pandemic.’ This decision was based on data, showing many people haven’t been going to their primary care appointments for symptoms that may lead to potentially serious conditions.

This initiative is focused on three critical health conditions, namely, atrial fibrillation, deep vein thrombosis and pulmonary embolism. The rationale for selecting these three indications is, these are all treated by the partners’ anticoagulant Eliquis.

Accordingly, the BMS-Pfizer Alliance launched a campaign to raise awareness and encourage people to seek prompt medical attention. The American campaign was built around the theme – ‘Your symptoms could mean something serious, so this is no time to wait.’ In tandem, the companies also widely communicated through multiple channels that ‘Decreases in Americans’ Primary Care Visits May Lead to Late Diagnoses of Potentially Serious Conditions.’

According to reports, the net result of this creative marketing, so far, is no less than outstanding, as compared to many other pharma players operating in similar situations. ‘Eliquis’ brand sales for the first six months of 2020 topped $4.8 billion, a 21% increase over the same time period last year. Doesn’t this initiative demonstrate that creative pharma marketers can unshackle even Covid fetters?

Conclusion:

Meanwhile, as on November 08, 2020 morning, India recorded a staggering figure of 8,507,754 of Coronavirus cases with 126,162 deaths. The average number of daily new cases appeared to have slowed down in the last few weeks. But, the threat of further spread of Covid infection, in waves, still looms large in the country.

Most scientists agree – while effective vaccines offer the best chance of reaching zero COVID-19 – eliminating the virus across much of the world, while not unthinkable, could take a significant number of years. Thus, it may be realistic for some time to focus on flattening the curve with stringent control measures, involving efficient contact tracing, testing and isolation, together with social distancing and mask wearing – till it happens, ultimately.

Meanwhile, the business must flourish, even amid a new normal. And this is, in no way, a pipe dream, but a proven reality, as we have seen above. No doubt, this calls for most pharma marketers wearing a fresh thinking cap, equipped with more cerebral power, as it were, to unshackle Covid fetters on their way – effectively.

By: Tapan J. Ray    

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

 

Covid Prompts Pharma To Move Away From Competition Driven Business Model

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

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

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

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

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

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

Flying solo in this situation may not be enough:

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

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

Once strange bedfellows – now partners:

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

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

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

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

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

The rationale and some possible issues: 

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

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

Leveraging the collaborative business model beyond pandemic:

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

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

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

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

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

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

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

Conclusion:

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

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

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

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

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

By: Tapan J. Ray    

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

 

Neutralize Covid-19 Impact on Drug Prices And Market Access For Faster Recovery

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Covid-19 pandemic that has not spared any facet of human lives and livelihoods, has also reignited several ongoing debates related to the drug industry. The need to urgently resolve these issues grows manifold, as the real magnitude of this health crisis doesn’t seem to be clear even to the key Government decision makers.

This is vindicated by the research paper, written by government scientists and other experts, published on September 10, 2020 in the Indian Journal of Medical Research. It reveals, India had nearly 6.5 million cases as early as May 2020. Whereas, according to the health ministry, the total number cases stood at around 180,000 in late May. This happened because, ‘large numbers of cases could have gone under the radar earlier this year, because testing was limited to symptomatic patients or states had varying testing rates,’ the paper highlighted.

From the pharma industry perspective, a pandemic of such magnitude is also causing indefinite delay in pre-planned market access of several important drugs and vaccines. Some are due to technical reasons. However, many others are related to their value-based cost-effectiveness in the new normal, when the pandemic has put enormous strain on health expenditure, across the world.

In this situation, past mechanisms of new drug pricing, are required to undergo significant changes. The new yardsticks, I reckon, will be based on two critical factors. The first – the disease treatment priorities, as will be decided jointly by both doctors and patients. And the second – the paying capacity of both payers and individual patients, based on the value that each treatment will offer – again, as perceived by patients.

As it appears, the impact of Covid-19 on the pharma industry will continue till the medium term, if not beyond. Consequently, the concept of new drug pricing – based on well-documented, differential value offerings of treatments, would need to be revisited and recalibrated. This has to be realigned with evolving patient needs. Considering the emerging scenario, this article will focus on the exigency to neutralize Covid-19 impact on new drug prices and pre-planned ‘market access’ – for faster business recovery.

Covid-19 has increased the drug price sensitivity:

The challenge of increasing drug price sensitivity – triggered by the new Coronavirus pandemic, has now assumed a global dimension. A June 18, 2020 study, flags: ‘Nine in 10 Concerned About Rising Drug Costs Due to COVID-19.’ Although, this particular study (Gallup Poll) was conducted in the United States, general public apprehension is no different in other parts of the world, including India, for various reasons.

Even in America, which is considered Eldorado for pharma business, primarily for unregulated drug pricing, is also changing with the impact of Covid-19. The reason being, reported instances of drug prices are rapidly rising, amid the pandemic. As the above Gallup Poll highlights, today ‘a large majority of Americans support direct negotiations by the federal government with the drug manufacturer on the price of a treatment for the disease itself.” Interestingly, ‘significant support exists across all major demographic groups.’

Other specialists on pharmaceutical pricing and market access, also envisage that pharmaceutical companies will be faced with increased price sensitivity, and are quite concerned with the long-term impact of the pandemic on health care systems.

Covid-19 pandemic would seriously impact pharma spending:

As quoted above, several other specialists for pharmaceutical pricing and market access have also pointed out some critical Covid-19 impact areas, including:

  • Tremendous increase in pandemic related public expenditure, could prompt further austerity measures in already strained health care budgets, besides job losses or pay cuts of scores of people for different reasons.
  • The pandemic is likely to result in a redistribution of health care funding towards infectious diseases (e.g. prioritization of antivirals and vaccines) and chronic diseases associated with worsening COVID-19 outcomes.
  • This may result in more drug pricing pressure in other disease areas, besides push for increasing use of similar cheaper generics and biosimilars, unless absolutely necessary.
  • Stricter monitoring of usage of medicines, especially in private hospitals, to ensure their use within the regulatory label and/or within the reimbursed population.
  • Possibility of mandatory price cuts either across the board or for drugs which have been on the market for a specific duration.

The report also envisages, pharmaceutical companies will be faced with increased price sensitivity and decrease in willingness to pay by authorities. Consequently, the key question in this area becomes: What impact will COVID-19 have on the future of pricing and market access? And how to address this issue, effectively? 

Need for an appropriate drug pricing models in the new normal:

Overall scenario for drug pricing model has not changed much, till Convid-19 pandemic overwhelmed the world. The age-old concept of drug pricing, being treated as almost given, is changing fast. As I wrote earlier, it started in the developed world, with newer concepts, such as, Health Technology Assessment (HTA), besides a few others. However, to illustrate the point, I shall focus only on the HTA model. It includes a multi-faceted assessment of the clinical, economic, ethical, legal, and societal perspectives that may be impacted by a new technology, procedure, drug, or process.

Application of HTA in Medicine Pricing:

The ‘Working Paper 6’ of June 2013, on ‘The Role of Health Technology Assessment in Medicine Pricing and Reimbursement,’ published jointly by the World Health Organization (WHO) and the Health Action International (HAI), is worth referring to.

The paper aims to identify and describe the role of HTA in price-setting and reimbursement of pharmaceuticals, with a focus on its use in low and middle-income countries (LMICs). However, as Covid-19 is now fueling the drug price sensitivity across the globe, and not just in the LMIC, this reference will help drive home the point, as one faces today.

While combating health care resource crunch in the face of the Coronavirus quagmire, many countries are contemplating a variety of approaches to maintain affordable access to healthcare for patients. The concept of HTA is one such common approach. It includes pharmaceuticals, vaccines, medical devices, medical and surgical procedures, besides the systems within which health is protected and maintained.

Relevance of a recalibrated HTA in the new normal:

For a new drug, as the Institute For Clinical And Economic Review (ICER) puts it, a final HTA report would attempt to answer the following questions, besides a few others:

  • Is it safe and effective?
  • Which patients benefit the most?
  • Is there a meaningful improvement in health status?
  • Can all people afford to pay who might need it?
  • Will it offer a good value in the long run?
  • What other considerations make it important?

These points need to be looked at keeping in view that Covid-19 pandemic has seriously impacted the health care spending. Thus, the process needs to be recalibrated in the new normal. In any case, HTA has the potential to play a critical role in new drug pricing, by assessing the intrinsic value of medicines that can significantly expand patient-access to care. In tandem, it could maximize the value for money in health expenditure with most efficient allocation of scarce health resources, that most countries are facing today. Nevertheless, there could well be a few company or country specific barriers to capture the value of a drug or treatment, as well. A robust plan for their mitigation needs to be well-thought through, to ensure effective implementation and achieve desirable outcomes.

HTA in India:

At least, on paper HTA exists even in India. The Government of India had created an institutional arrangement called “Health Technology Assessment in India (HTAIn)”, under the Department of Health Research (DHR). It was entrusted with collation and the generation of evidences on cost effectiveness and safety of health care interventions, including medicines and devices.

The key goals are, to reduce the cost of patient care, overall cost of medical treatment, reduction in out of pocket expenditure of patients, besides streamlining the medical reimbursement procedures. Nevertheless, it remains a million dollar question whether India would leverage this system to ensure fair pricing of new drugs in India.

Some pre-requisites to implement HTA – afresh:

In those countries, where HTA for drug pricing and reimbursement doesn’t already exist, there could be several pre-requisites. These may include, as the above paper indicates, establishing a medicines regulatory system, developing and enforcing legislation, employing the appropriate technical expertise, and the allocation of sector-wide financial resources in accordance with the decisions of the organization using the HTA.

That said, the bottom-line is, the quest to arrive at fair pricing for a new drug, could also help ‘market access’, especially in a difficult time, like today’s health care crisis. In that endeavor, let me briefly dwell on the concept of ‘fair pricing a drug’.    

The concept of ‘fair pricing a drug’:

This issue has been well deliberated by many experts around the world. However, let me quote a recent article – ‘Defining the concept of fair pricing for medicines,’ published by The BMJ on January 13, 2020.

The paper articulates, ‘a fair price for a medicine is affordable to the buyer while covering the seller’s costs and providing a reasonable profit margin. Within a fair pricing zone, a specific price may be higher or lower, possibly reflecting differential value.

Interestingly, the authors also noted: ‘Applying the framework to decision making would require access to data on R&D, manufacturing, and distribution costs, which is generally not publicly disclosed. This lack of transparency about costs undermines efforts to assess the fairness of medicines prices.’

The article underscored, lack of transparency in these areas, ‘also exacerbates information asymmetry to the sellers’ advantage.’ It suggested, disclosure can be enforced through legislation, regulation, and judicial action. Or as a condition of receiving public research funds, tax benefits, regulatory approval. Or listing in a formulary for reimbursement. ‘In the absence of disclosure, decision makers may rely on reasonable estimates based on publicly available information,’ the paper concluded.

Conclusion:

As recorded in the morning of September 13, 2020, total Coronavirus cases in India have reached a staggering figure of 4,754,356 with 78,614 deaths, overtaking Brazil. This trend continues going North, as days pass by.

All-pervasive Covid-19 pandemic is fueling severe resource constraints, especially for health care. Amid this complexity, to combat this deadly virus – alongside other non-Covid related illnesses – value added drugs and treatments could help overcome many hurdles in this area. They could help improve cost-effectiveness of treatments to price-sensitive patients, besides other stakeholders.

Recalibrated HTA mechanism, which I have used in this article as an example to effectively overcome prevailing drug price sensitivity, is one among a few others. Importantly, HTA mechanism exists even in India. It can be appropriately used for new drugs and vaccines pricing, if the Government wishes to.

On the other hand, it’s up to individual companies to choose any other price-value model’ that they will deem appropriate, to arrive at a ‘fair value for new drugs’. However, the goal remains common for all - Neutralizing Covid-19 impact on drug prices and market access, to ensure faster recovery of the business.

By: Tapan J. Ray   

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