Tag Archives: Drug

Unfettered ‘Access To Drug Innovation’ – An Oxymoron?

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The mass paranoia, as it were, over Covid pandemic has now started fading with drug regulators’ ‘emergency approval’ of several Covid -19 vaccines, and its free of cost access to all, generally in most countries. As the endgame of the pandemic, supposedly, depends on the speed of Covid-19 vaccination, the drug industry’s public reputation in the interim period, driven by its rapid response to the crisis, got an unsurprising boost (62%). This was captured by the Harris Poll, released on March 15, 2021.

Interestingly, soon after the high of 62% approval rating, the decline began. It came down to 60% in May and then 56% in June 2021—and now down three more percentage points, according to the Harris Polls that followed. No wonder, why the FiercePharma article of August 24, 2021, carried a caption: ’Pharma’s reputation drops again. Could it foreshadow a return to the bottom?’

Further, in the new normal, especially when customer expectations and requirements from drug companies have significantly changed, MNC Pharma industry still appears to be in the old normal mode in this space. It still, reportedly, ‘believes that the need for innovation must be balanced with the necessity for more accessible medicines, within a robust IP and regulatory environment,’ in India.

The hidden purpose of the same could possibly be, as several industry watchers believe – availing benefits of greater access to one kind innovation, making access to other kind of innovation more difficult. Consequently, two critical points are reemerging, even in the new normal, as follows:

  • Aren’t Indian IP and regulatory ecosystems still conducive enough for MNC pharma players’ access to drug innovation?
  • In the name of greater access to pharma product innovation, are they creating barriers to pharma process innovation, delaying market access to complex generics and Biosimilar drugs – besides systematically eroding consumer confidence on such products?

In this article, under the above backdrop, I shall try to explore why the epithet – ‘access to drug innovation’ is considered an oxymoron – with contemporary examples from around the word, including India.

Aren’t Indian IP and regulatory ecosystems conducive to drug innovation? 

This allegation doesn’t seem to hold much water, as several successful local initiatives in Covid-19 vaccine development will confirm the same. Besides, already marketed Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and Zydus Cadila’s ZyCov-D, there are several others waiting in the wings. These include domestic drug makers like, Hyderabad based Biological-E, Bengaluru-based medical pharma startup’s – Mynvax, and Pune-based Gennova Biopharmaceutical’s m-RNA vaccine candidates. However, only critical difference is – Indian made Covid vaccines are more affordable and accessible to patients, as against those manufactured by MNCs, such as, Pfizer, Moderna and J&J.

If we look back to the old normal, one will also find similar instances of new drug discovery in India, which deliberated in my article of September 02, 2013. Let me give just a couple of examples below:

  • Ranbaxy developed and launched its first homegrown ‘New Drug’ for malaria - Synriam, on April 25, 2012
  • Zydus Cadila announced in June 2013 that the company is ready for launch in India its first New Chemical Entity (NCE) for the treatment of diabetic dyslipidemia –Lipaglyn.

Hence, meager wherewithal for R&D notwithstanding, as compared to the MNCs, Indian pharma players don’t seem to find the country’s IP and regulatory ecosystems not conducive to innovation of affordable new drugs with wider patient access.

Off-patent drugs also involve another type of major innovation:

Discovering an NCE is, unquestionably, a product of drug innovation. Similarly, developing a new – cost-effective, non-infringing manufacturing process to market off-patent drugs, like biosimilars, also involve another type of major innovation. Intriguingly, when the MNC pharma industry talks about ‘access to innovation’, the latter type of innovation isn’t publicly acknowledged and included in their drug innovation spectrum. This practice, reportedly, remains unchanged in their advocacy campaign, even in the new normal.

However, the fact is, the manufacturers of off-patent drugs, such as biosimilars, also need to follow a major innovative process, for which they require access to innovation. This was also captured in an editorial of the newsletter – Biosimilar Development. The deliberation addressed the question - Do biosimilars fit into the innovation paradigm? The editor began by articulating – hardly anyone publicly argues that the development of new manufacturing process of Biosimilar drugs is not an innovation. The industry can’t call them as a copy of an existing innovation, either.

This is also vindicated in the Amgen paper, published on February 11, 2018. It acknowledges, “Unlike small molecule generic drugs, biosimilars are not identical to the reference biologic or to other approved biosimilars of the same reference biologic, because they are developed using different cell lines and undergo different manufacturing and purification processes.” Moreover, biosimilars also carry a different International Nonproprietary Name (INN), because of their molecular differences from the reference drug. This has been specified in the nonproprietary naming Guidance document of the US-FDA of January 2017.

From this perspective, the next question that logically follows: Is process innovation as important as product innovation?

Is process innovation as critical a capability as product innovation?

This question was unambiguously answered by a pharma industry-centric Harvard Business Review(HBR) article – ‘The New Logic of High-Tech R&D’, published in its September–October 1995, issue. The paper emphasized, for the commercial success of a product ‘manufacturing-process innovation is becoming an increasingly critical capability for product innovation.’

When to meet patient-needs ‘access to innovation’ an oxymoron: 

‘Access to innovation’ is an interesting epithet that is often used by many drug companies for meeting unmet needs of patients. However, the same is also often used to create barriers to meeting unmet needs of more patients with cheaper biologic drugs, like Biosimilars, immediately after their basic patent expiry. This is mostly practiced by creating a patent thicket. Hence, drug companies’ advocacy for greater access to innovation is an oxymoron to many.

The same was echoed in another article – ‘How originator companies delay generic medicines,’ published by GaBI. It wrote, such practices delay generic entry and lead to healthcare systems and consumers paying more than they would otherwise have done for medicines. These include the following:

  • Strategic patenting
  • Patent litigation
  • Patent settlements
  • Interventions before national regulatory authorities
  • Lifecycle strategies for follow-on products.

A very recent piece on the subject, published by Fierce Pharma on August 31, 2021, vindicates that the patent life extension through the patent thicket is happening on the ground – denying patients access to cheaper equivalent, especially of off-patent biologic drugs within a reasonable time period. It highlighted:

  • The exclusivity of AbbVie’s Humira, which hit the market in 2002 and generated nearly $20 billion in sales last year was extended by 130 patents.
  • The same company has applied for 165 patents for its another blockbuster Imbruvica. Launched in 2013, Imbruvica has already generated sales of $5.3 billion for AbbVie.

No wonder, why in February 2021, during a Senate Finance Committee hearing, Sen. John Cornyn blasted the company saying:

“I support drug companies recovering a profit based on their research and development of innovative drugs,” Cornyn said. “But at some point, that patent has to end, that the exclusivity has to end, to be able to get it at a much cheaper cost.”

More reports are also available on attempts to erode consumer confidence in Biosimilar drugs, as compared to the originals.

Work for innovation sans eroding consumer confidence in Biosimilars: 

Making affordable new drugs and vaccines available to patients with ‘access to innovation’, deserves inspiration from all concerned. Curiously, even in the new normal, some big companies continue trying to erode consumer confidence in off-patent drugs, especially Biosimilars and complex generics.

For example, an article on Biosimilars moving to the center stage, published in the Pharmaceutical Executive on August 12, 2021, quoted an interesting development in this space. The article highlighted that US legislators are now ‘eyeing measures to deter innovator promotional messages that disparage follow-on competitors.’ This initiative was spurred by US-FDA criticism of an Amgen promotional communication for undermining consumer confidence in Biosimilars to its Neulasta (pegfilgrastim) injection.

On July 14, 2021, US-FDA’s Office of Prescription Drug Promotion (OPDP) sent a letter to Amgen carrying a caption ‘FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or  misleading promotional communication about its product’s benefit.

The letter, as reported in the above article, criticized the company for making a false claim of greater adverse events with the injection system used by Biosimilars compared to the Amgen product. OPDP advised Amgen and other firms to “carefully evaluate the information presented in promotional materials for reference products, or Biosimilar products” to ensure correct product identification and avoid consumer confusion.

Conclusion:

When the point is, creating a conducive ecosystem to promote access to innovation, it should be patient-centric – always, and, more so in the new normal, considering changing needs and expectations of health care customers.

The innovation of usually pricey new molecular entities, no doubt, meets unmet needs of those who can afford these. Whereas, manufacturing process innovation expands access to the same molecule, particularly when they go off-patent, by making them affordable to a vast majority of the population.

But powerful industry lobby groups continue pressing harder for unfettered ‘access to innovation’ with greater relaxation of the IP and regulatory framework of countries, like India. The situation prompts striking a right balance between encouraging more profit by helping to extend patent exclusivity and encouraging greater access to off-patent cheaper Biosimilars as soon as the basic patent expires.

The bottom-line is, both need to be actively encouraged, even if it requires new laws to discourage practices like, creating patent thickets or undermining the use of generics or Biosimilars, and the likes. The good news is lawmakers have started deliberating on this issue – along with increasing public awareness, which gets reflected in the pharma industry’s current reputation ratings.

Left unresolved soon, such piggyback ride on ‘access to drug innovation’ bandwagon to serve self-serving interests, would continue denying speedy entry of cheaper Biosimilars. From this perspective, it isn’t difficult to fathom, why unfettered access to drug innovation is considered an oxymoron, by many.

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.

Using Selling Simulator For New Drug Launch In The New Normal

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The reverberation of unparalleled business disruptions in healthcare caused by Covid pandemic, extends across its value chain – from patients and families to clinicians and pharmaceutical companies. Consequently, even many diehards or staunchly tradition-bound pharma marketers were being prompted to reimagine their marketing model, to keep the business going.

Some of these areas include, customer preferred engagement channels, platforms and associated remote or virtual training inputs – necessary for effective execution of new strategic marketing models for the evolving new normal. A few of them are also moving in this direction – garnering requisite wherewithal.

“But it has also left some of them paralyzed by uncertainty. Should they invest now in transforming their commercial model or wait to see how things play out?” This palpable dilemma of many pharma marketers, was well captured in a recent McKinsey & Company article - ‘Reshaping pharma’s strategy in the next normal,’ published on December 15, 2020.

In a situation like this, one of the critical challenges is the successful launch of new pharma products amid changing customer behavior, product expectations and other associated uncertainties. ‘As pharmaceutical companies reshape their commercial models to prepare for the uncertainties ahead, personalization and digital enablement will be crucial to launch success in the new environment,’ underscored the above article.

As many of us will know, quality training and development inputs for the same, remain a vital prerequisite before the sales force hits the marketing battle ground. Isn’t that also a challenge in the prevailing market situation? Could digitalization of the company provide a solution to this critical sales force training issue for the same, in the new normal? This article will delve into this area.

Digitalization is a basic step – the challenge is much beyond that:

As I wrote in my article dated October 07, 2019, disruptive digital transformation in pharma sales and marketing is indeed a necessary basic step. It will also help to leapfrog in the field staff training and development process by imbibing leading-edge technologies, such as AI, for giant leaps to higher growth trajectories. But, ‘Digitalization’ isn’t a panacea, either.

This was also echoed in another recent article on ‘Pharmaceutical Marketing in The New Normal’, published in the Forbes magazine on August 11, 2021. It wrote, ‘even the best, most advanced digital tools won’t help if reps are not properly trained.’ This is due to multiple factors. Let me elaborate the point from a new product launch perspective.

New normal brings unprecedented changes – no footsteps to follow:

The extent and depth of personalization required in any effective customer engagement process for successful outcomes, has undergone a fundamental shift. Today, personalization of content, channels and platforms is a necessity and no longer an option. In the new normal one size doesn’t fit all. Consequently, sales force training process, particularly for a new drug launch, has also become personalized, with simulation of new expectations and requirements of each market becoming a key ingredient, more than ever before.

Simulated sales training still not too common in pharma:

That personalized and simulated sales force training is still not too common in the pharma industry, was also captured in the February 2020 ‘The Voice of the Sales Rep study’ of the sales research firm – SalesFuel. It reported, just 30% of sales reps in the pharma industry are now getting personalized sales training based on individual needs. This study was done in the United States, and the same percentage is expected to be much less in India.

In this context, the above Forbes article also noted that at an elementary level, reps should be proficient in video conferencing and virtual CME basics, such as, screen sharing, lighting, cameras, and the likes. There could also be occasions when they may need to teach even some of the physicians for whom, as well, this type of engagement is new. Thus, simulation training may possibly play a critical role to make the sales force future ready, always.

Besides, gaining deeper insights of customers, market dynamics, and tailoring the content of personalized engagement, accordingly, will be a critical part of personalized training through simulation, especially for new product launch in the new normal.  

Doctors availing product and treatment related online services: 

While navigating through acute disruption of life during Covid pandemic, several doctors have learnt to use digital channels and platforms to avail product or new therapy related information directly, instead of through sales reps. And that too, as they want, when they want and the way they want, gaining a discretionary choice. Several surveys, such as,  2020 Accenture research, also reported many doctors want either virtual or a mix of virtual and in-person meetings with pharmaceutical reps, even after the pandemic ends.

Available studies also give a sense that the future overall trend in pharma is unlikely to be a replication of pre-Covid time, prompting the players to reimagine their customer engagement format. For example, a contemporary ‘Real Time Covid-19 Barometer Survey of physicians,’ by Sermo, found that ‘67% believe pharmaceutical companies could improve communications with HCPs and could do more to help physicians make prescribing decisions.’

Hence, even with the much-reduced threat from Covid infection, as and when it will happen, the same trend is likely to change the scope and traditional toolkit for future new brand launch, as well. Hence, pharma companies would, need to change their sales training architecture, accordingly – like simulation training – always keeping one ear on the ground.

Proven edge of simulation training in healthcare during Covid-19:

There are several studies in this area in different parts of the world. To illustrate the point, let me quote a Canadian study, published by ResearchGate in December 2020. It made several important points, which I summarized, as below.

The study elucidates, healthcare resources were strained to previously unforeseeable limits because of COVID-19 pandemic, in most countries. The unprecedented nature of disruption in health systems prompted the emergence of rapid simulation training for critical just-in-time COVID-19 education. The aim was to improve preparedness for giving high quality care to rapidly increasing number of Covid infected patients, including caregivers, across all healthcare sectors.

The researchers found that simulation training was pivotal for healthcare provider learning, alongside new systems integration, development of new processes, workflows, checklists, protocols, and in the delivery of quality clinical care to all concerned.

To cope with the new reality, triggered by the Covid pandemic, as also demonstrated by several other studies, simulation training has the potential to deliver the best learning outcomes. Some may obviously would seek a little more clarity in understanding what exactly is a simulation training that I am referring to.

What exactly is simulation training?

It won’t be terribly difficult for pharma marketers to understand what exactly simulation training in pharma sales and marketing is. As the name suggests, simulation is a replication of what happens or may happen in a real-life situation. In this particular case, it involves the simulation of changing pharma customers and market behavior and expectations, in the new normal.

Thus, a simulation training process, say for a new brand launch, would create virtual market scenarios by replicating all recent changes in customer behavior/expectations and the market dynamics – of a specific territory. This is usually done with AI based computer software, designed to help sales force learning of a real-life situation, without being in the thick of it on the ground. In simulated training, the selected trainees interact with technology, rather than reading notes or listening through the lectures of persons having similar insights.

The selling simulators are cost-effective and provides better outcomes:

Besides being cost-effective, simulation training is also considered a 24-carat way of developing new skills, and also assessing how well the trainees are translating the new learnings into practice. No wonder why even the US National Library of Medicine, after evaluation and review of several research studies, has acknowledged that simulation training imparts learning ‘just like a real thing.’

How will it work on the new product launch?

In pharma sales and marketing area, the simulation of customers’ post-pandemic new needs and expectations, can be simulated by developing a ‘selling simulator’ for new product launch, in the new normal. These simulators will integrate AI-based software with game dynamics or gamification, creating a virtual field situation for sales reps to continuously learn and hone their new-product launch skills. The required contemporary skills may often be unique in nature, beyond the traditional pathways, even where there are no footsteps to follow.

Why simulation training for a new drug launch will add greater value?

This  query is also well deliberated in the McKinsey & Company article - ‘Reshaping pharma’s strategy in the next normal,’ published on December 15, 2020, with the Covid pandemic as the backdrop. It underscores, ‘it is clear that major shifts in the way that healthcare professionals (HCPs) interact with pharma companies will present a challenge for the traditional launch model, with its reliance on face-to-face meetings with physicians and its “one size fits all” approach to engagement.’

The study further points out that “the traditional pharma commercial model will likely struggle to adapt to a different world. When reps venture back into the field, they will need to address the plurality and access challenges of the new interaction landscape. To do that, they will need to consider a new approach to launches: one that is digital, local, and personalized.”

This changing need will call for a new genre of training, and I think, simulation training for pharma reps will prove to be more productive in this area.

Conclusion:

Many uncertainties in the pharma business continue, even after the second wave of Covid pandemic, with the Damocles sword of its third wave hanging over the head, including the Indian population. In the current volatile pharma business environment, as an article on the subject, published by the Pharmaceutical Executive on July 30, 2021, articulates – the challenges of remote work mean that training approaches must be adaptable and engaging.

Simulation training, with its power to engage learners, and developed for strategically minded, and data-literate sales teams, would become a key component of the future pharmaceutical sales training landscape. This is destined to happen regardless of whether delivered on site or in remote training formats. From this perspective, I reckon, with a well thought-out – AI-driven selling simulator, especially for new product launch, to start with, could be a potential game changer in yet mostly untried 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.

Why Pharma Need To Connect Better With Patient Organizations Now?

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A good number of patients (63%), especially those with chronic ailments would look for Patient Support Services, revealed a survey by Human Healthcare Systems, released on February 25, 2020. Alongside, drug companies are also, reportedly, investing billions of dollars in every year, for several types of patient support programs, according to the Fierce Pharma article of July 06, 2021, on this subject. It emphasized: ‘Pharma companies spend more than $5 billion on patient support programs every year.’

Thus, it will be interesting to explore – when patients are looking for Patient Support Services (PSPs) and pharma companies are also trying to deliver the same, what’s really happening on the ground? Today’s article will focus on this area to help pharma marketers to get a ringside view of this area, and take necessary action in this area to make this investment more productive.

The aim is to help create a cutting-edge marketing strategy, while delivering best patient value and outcomes in the new normal. Let me start by recapitulating what exactly is a PSP to ensure that we all are on the same page, during this discussion.

Patient Support Services (PSPs):

According to IQVIA, a key challenge in deliberating with PSPs is that they have broad definitions, and consequently, may often give rise to multiple interpretations, misunderstandings and even bias. Be that as it may, IQVIA defines PSP as ‘An umbrella term to describe initiatives led by pharmaceutical companies to improve access, usage, and adherence to prescription drugs. These programs can have a financial component, support clinical investments, focus purely on education, or a combination.’

As we also see around, such programs include – disease awareness campaigns, helping patients use their drugs at the right dose for the right duration for best outcomes, to help patients use their drugs with disease education, financial support and more.

Relevance of PSP in the new normal:

Although PSPs aren’t a new concept, studies unfold – value that PSPs deliver to the community is so significant that when created with a clear understanding of motivators and drivers of patient behavior, can fetch equally significant return on investments for the pharma players.

A recent IQVIA White Paper concludes by noting: ‘One of the major trends seen from the COVID-19 global pandemic, is an increase telehealth. As the point of enrolment into a patient support program goes digital, PSP programs need to adjust.’ This seismic shift in the way we seek and receive treatment will require companies to revisit and potentially update their actionable insight in this space, The paper further notes: ‘With an increase in digital enrolment there are now more opportunities to capture data points and utilize technology.’

Thus, I reckon, it will be worthwhile to fathom, when patients are looking for health care support services and pharma companies are also spending considerably towards the same, what exactly is happening on the ground.

Interestingly, according to the 2021 findings of Phreesia Life Sciences, which surveyed nearly 5,000 patients checking in for doctors’ appointments during the past February and March, found, ‘just 3% were using patient support programs (PSPs).’

Some key highlights of the survey findings:

The support programs in the above survey of Phreesia Life Sciences, broadly includes, services, such as, financial assistance, disease education and specifics about medicine – offered by pharma companies. Based on these, some of the key findings of the study were as follows: 

  • Just 3% of eligible patients are currently using support programs, and 8% have used them in their lifetimes.
  • 59% of patients have little to no knowledge of patient support programs.
  • 61% of patients feel that patient support programs of pharma companies would be “somewhat,” “a little,” or “not at all helpful” for them.
  • Most patients who had used support programs, used them either at first diagnosis, or when starting medication.
  • Only 10% of patients said they had learned about support programs online, but 44% said they’d like to learn about support programs online

Further, as one of the senior officials involved in this research, reportedly, said, ‘nine out of 10 qualified patients were not using the brand’s copay card—even though more than half (53%) said they would likely use one if they had it.’ Moreover, ‘two out of three patients reported it was the first time they were learning about it.’

Likely reasons for low usage of pharma’s PSPs: 

Some of the most likely reasons for low usage of pharma’s PSPs were deliberated in another article of Fierce Pharma dated December 04, 2020. A domain expert commented there, ‘pharma companies simply have missed the mark in developing useful, durable tools for patients. Elaborating this point further, she said, ‘Focusing just on specific adherence tasks, like medication reminders, isn’t providing enough value for patients over a long period of time.’

Another contributing factor could be, patients suffering from multiple diseases and those who are on multiple medications of different pharma companies, are unlikely to download four different apps to track each one.

One more reason could well depend on patients’ generally preferred sources to avail such services, which may not necessarily be pharma companies.

Patients generally preferred sources for patient services:

This point was discussed in the Accenture study – ‘Uniting pharma companies and patient organizations,’ published on August 07, 2019. This survey was done on 4000 patients and some broad findings of this study include the following:

  • Patients generally prefer services from patient organizations over those from pharma companies.
  • Patients feel that patient organizations have a better understanding of their emotional, financial, and other needs than many pharma companies.
  • Patients also want pharma companies to coordinate with patient organizations to provide better care.

The survey also captured details of patient preferences regarding availing required services from patient organizations, rather than the drug companies, as below:

  • Over 50% of patients have greater trust in and better experiences with patient organizations.
  • 64% of patients are willing to share their health data with patient organizations to get better care.
  • 52% of patients are willing to share their health data with patient organizations to get better care.
  • 72% of surveyed patients call or talk to someone at patient organizations on the phone.
  • 58% of patients attend in-person events hosted by patient organizations.

Are PSPs commercially useful to pharma companies?

The very fact that drug companies are currently spending over $5 Billion annually for PSPs, reflects their direct and indirect influence in pharma’s branding strategy and image building process. Otherwise, why would they spend so much? That said, the above survey details send a clear message to pharma marketers to maximize their marketing investments on PSPs, more than ever before. Consequently, the question arises, how to achieve that goal? 

Maximize marketing investments on PSPs:

Echoing and paraphrasing some points from the above IQVIA White Paper, let me highlight, especially for the marketers, 3 clear steps for maximizing returns from pharma’s investments on PSPs, as follows:

A. Gain beforehand deeper insights of patients’ PSP need and expectations: 

37% of patients surveyed said, pharma companies with actionable insights, will better understand their needs through collaboration with Patient Organizations (PO), leading to meaningful engagement in a more personalized way and more frequently.

B. Deliver patient expected value thorough close coordination with the POs:

This is because, 84% of patients think pharma companies – with closer coordination with, at least, a couple of influential patient groups or organizations (PO), will deliver greater value. This will also create a seamless and more cohesive patient experience, while filling gaps in the patient treatment process, to enhance end-to-end customer experience - in an unbiased way.

C.  Creating and delivering new and seamless patient experiences:

The newness is important – not just to delight the patients, but also for strategic differentiation in this ball game. This is possible by working closely with Patient Support Groups (PSGs) as partners, seeking ways to rethink for creating and delivering a unique patient experience from patients’ perspective, and outcome first basis.

Use of data, analytics and insights will be essential while creating care experiences that will better meet the patients’ needs, and would also help measure the impact of PSPs on an ongoing basis.

PSGs are helping to transform health care also in India:

Some PSGs are helping to transform healthcare with prudent use of PSPs in India, as they raise awareness about diseases, help people recover psychologically, and more, have been captured by Indian media, as well. One such report titled, How patient support groups are revolutionizing health care’ says: ‘Because of these networks, patients and their families have become better organized, and are equipped to handle emergency situations and advocate for access to treatment.’

Conclusion:

Echoing the ZS article, published on August 17, 2020, I too concur that COVID-19 has pushed the drug companies to define new ways to deliver care and reach patients. It is quite possible that patient organizations are moving faster in this direction than many pharma companies. Which is why, more patients, reportedly, prefer PSPs from patient organizations, over those from pharma companies.

Further, a course-correction in PSP, would also offer pharma marketers an additional opportunity. Because, PSPs have hidden potential to create an exceptional patient support base that marry brand’s key attributes with the new reality of patients, living with their conditions in the new normal.

Pharma companies will, therefore, need to move from typical reactive support programs – to delivering proactive patient experiences in a post-COVID-19 world, in partnership with PSGs. To ensure maximum number of patients use PSPs, it’s critical for pharma marketers to redefine – the “new normal” patient journey, and meet their current unmet needs in this space. That’s why, I reckon, to succeed in this ball game, pharma would need to effectively connect with patient organizations, more than ever before.

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.

Rebalance KOL-Mix As Covid-19 Redefines Pharma Marketing

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‘It’s safe to say that 2020 was a year like no other and that 2021 will certainly not revert back to the old normal,’ reiterated the Harvard Business Review Article - ‘10 Truths About Marketing After the Pandemic,’ of March 10, 2021. Amid Covid 2.0, several astute pharma marketers, I reckon, have also realized the same by now. The recent Government announcement on the impending third wave of Covid-19, coupled with slow vaccination pace in the country, further strengthens this possibility.

That said, making all internalize that pharma marketing, and specifically the brand building process will no longer remain – as it traditionally was, may still be a tough task. Mere digitalization of the traditional marketing processes won’t be a magic wand, either, to excel in the rapidly transforming market situation. The task ahead is fundamentally cerebral – ahead of any Artificial Intelligence (AI) tools and applications.

With the market dynamics going through a metamorphosis, pharma marketing needs to be redefined. Capturing the nuances of this redefinition is essential also to ensure the right focus on the right Key Opinion Leaders (KOLs) – for successful branding with long-term image building. Today’s article will focus on this less charted area during the pandemic. Let me begin with a few examples of the redefined areas of marketing triggered by disruptive changes in the current pharma business environment.

Traditional pharma marketing axioms need to be redefined:

To give a flavor of this redefinition, I shall pick up the following two examples from the above Harvard Business Review Article and then zero-in on just one, to explore the recasting and rebalancing need of the KOLs, for business excellence in the new normal:

A.  Technology and human enablement:

Pre-pandemic belief: The right tech stack to drive modern marketing success.

Post-pandemic need: The right balance of factors (including tech stack) to drive modern marketing success.

In pre-pandemic days, focus on “tech stack” was emerging as an end-all game changer for marketing. But in the pandemic days there emerges a need to take a step back. The right approach to human enablement is becoming the key to properly understand the changes and their implications in the pharma business environment. Human enablement includes, making sure that people have the right skills to select and employ the most appropriate environment specific technology tools, effectively. The system should also ensure that the right measurement approaches are in place to motivate innovation and rewarding success.

B.  Relationship building to drive marketing success

Pre-pandemic belief: Relationships matter to drive marketing success

Post-pandemic need: Relationship building is everything to drive modern marketing success

Building relationship with customers rests on the bedrock of trust. Covid-19 has placed a new emphasis on relationships, faced with a near virtual sales environment. New findings indicate, the teams with existing relationships have been able to maintain revenue momentum, capitalizing on the strength of their prior bonds. In contrast, prospecting for new customers has required an evolved set of skills focused on selling solutions, not products, as the Harvard Business Review Article emphasized.

Trust, credibility, and integrity are fundamental to driving market momentum. These are foundational to the value exchange between a company and a consumer. As the Harvard paper writes, this has necessitated ‘a serious recasting of talent to identify people best suited to driving relationships in this new world of online interactions — a world that relies less on charm (and even an expense account) and more on insights and solutions. Trust will be built by and rewarded to those that listen to customer needs and then craft solutions to meet those needs.’

Thus, I believe, in the redefined pharma market, the marketers need to have a fresh look with fresh a pair of eyes to expand and select their KOLs to achieve their business goals – consistently, in the years ahead.

Pandemic impacted pharma’s KOL outreach:

Pharma marketers are well-aware how much they rely on their KOLs in several areas of a brand building strategy, including the creation of widely acknowledged brand reputation, winning key stakeholder trust on brands.  Thus, a robust strategy for engaging with stakeholders – based on KOL inputs, continue to remain an area of paramount importance for drug companies.

From this perspective, as I wrote before, during the early days of national lockdown triggered by Covid-19 pandemic, many marketers felt that in-person KOL outreach activities in physical events have only got disrupted temporarily. As the disruption prolonged, some companies hurriedly shifted online. Others hopefully kept waiting for some more time, and then tried to figure out how to catch up quickly by switching over to a more effective, interactive – and situation-specific contemporary communication channels and platforms, for them.

Marketers require recasting their KOL outreach strategy:

No doubt, KOL engagement remains a high priority area for pharma marketers - for guidance with fresh inputs while charting a new marketing pathway, mainly based on their:

  • Therapy area expertise where the company represents, and the sphere of influence
  • The span of influence to further business progress, gaining stakeholder trust and building brand reputation.

As the market environment and stakeholder expectations have altered significantly, in several marketing related areas, pharma marketers require quickly recasting their KOL outreach strategy, including virtual communication models and platforms. Many may consider, for valid reasons, though, that virtual events may not be as effective as effective as F2F physical events.

Notably, some well-researched digital outreach strategy for the KOLs – tailor-made according to their new expectations in the changing market dynamics, are trying to fetch the best out of them. The new initiative is also improving the effectiveness of virtual interactions manifold, steadily – with the ongoing honing of the processes. However, this would involve fresh mapping, and identification of a contemporary set of KOLs, soon, with in-depth understanding of their needs and interests.

Pharma KOL-mix need to include ‘influencers’ also:

Just to recap, KOLs are experts in their respective fields. Each one of them is also a well-regarded and influential voice, whose expert advice is respected and followed by many others – related to that field. These may include authorities in the same industry, whose opinion or decisions may have significant influence or impact on the business. In that sense, KOLs play the role of influencers, too.

Traditionally, in the drug industry KOLs are selected from accomplished and well-decorated medical experts who are often early adopters of new brands, playing a significant role in the prescription decision of other doctors.

Leveraging two other key roles of KOLs in the changing environment: 

The other two roles that need to be leveraged by pharma companies in the in the changing environment may include:

  • Making more people aware of the critical roles of pharma brands, e.g., what people have witnessed recently with Covid-19 drugs and vaccines.
  • Improving brand credibility and corporate reputation by gaining stakeholder trust. This is usually triggered a favorable word-of-mouth awareness of the role that the company is playing to save and improve the quality of human lives – and, in that process, the livelihoods.

This gets reflected in the most recent annual Axious Harris 100 survey, where two widely publicized Covid-19 vaccine makers – ‘Moderna and Pfizer leaped into the top 10 best-regarded companies in the U.S,’ among all other industries. This clearly highlights ‘Americans love their vaccine makers’. As reported, Moderna ranked third, while Pfizer featured at No. 7 on the strength of its product and innovation scores, nabbing high marks for vision and culture along the way.

‘They’re the first biopharma companies to crack the top 10 in the ranking’s 20-year history.’ Interestingly, Johnson & Johnson, which featured in the top 10 before; this year, it ranks 72 on the list with a reputation score roughly the same as 2020’s,’ the report adds.

KOL outreach needs to be more focused and well-targeted on even niches: 

This is an important need and has been vindicated by Deloitte focus group studies in the U.S., India, South Africa and the U.K and published on May 06, 2021. The studies found that the pandemic did improve overall pharma reputation score with a ‘reason to hope for more.’

However, still many respondents used phrases like, “profit-making” and “harmful”, as reasons of why they don’t trust pharma. Curiously, in the U.S., 29% of people cited “questionable moral integrity of biopharma executives” as a problem. Only about one-fourth (26%) of participants agreed that their trust in drug makers increased during the pandemic, even when Deloitte mentioned vaccine development.

Conclusion:

To mitigate such reputation, trust, and credibility related issues, besides transparency in drug pricing, besides efficacy and safety related research-data, pharma needs to work closely with a wider span of KOLs, who may help in explaining complex science in simpler words.

As the above Deloitte studies bring to the fore, the pandemic could be yet another fresh starting point for pharma to gain long-term trust of customers, and other stakeholders. In that endeavor, a fresh set of KOLs need to be identified through well-structured mapping. This initiative should ideally include, besides top medical and regulatory experts of high repute, globally acknowledged academics, top domain experts, and key members of the government.

Thus, in my view, as the pandemic redefines pharma marketing, there is an important need of rebalancing the KOL-mix of each company, based on their specific needs, especially in the virtual space, as the situation will unfold.

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.

 

Creating A Unique Patient Experience By Listening To Patients Voice – An Imperative In The New Normal

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Acquiring deeper insight on the patient journey through a disease treatment process to create and enhance end-to-end patient experience, never assumed such critical importance, ever in the past. Without this realization, I reckon, even digitalization of any scale in the pharmaceutical industry, is unlikely to yield desired results. The term ‘Patient experience’ is generally considered as ‘the summation of interactions that influence patient perceptions across the continuum of care, until now,’ as defined in an article, published by Aranca on February 28, 2020.

This isn’t a new concept. This subject was well-deliberated even before the pandemic crisis. For example, an article, published in the Pharma Voice on April 2014, had also highlighted this point. It wrote: “Too many companies continue to view the world as a physician-centric, and do not recognize the growing influence of the patient in treatment decisions. The evolution toward a fully integrated commercialization approach centering on the patient experience will continue to crystallize over the next five to 10 years. Within a few years the industry will universally have one goal that supports the patient experience, as there is a tremendous amount of attention being put on the patient today.”

Even thereafter, another paper, published in the Reuters Event Pharma, on August 17, 2017, also reiterated: ‘A greater understanding of the patient journey is rapidly becoming an essential tool for market access.’ It further elaborated that the use of patient journey data stands to benefit everyone:

  • Patients: through empowerment programs,
  • Pharma marketers and more widely, the Company: by targeting the right patient segment and the company more widely.

The paper concluded: ‘Given the potential benefits, pharmaceutical companies should develop a robust mechanism to design effective patient journeys, which could prove instrumental when it comes to bridging treatment gaps and improving quality of life for countless patients around the world.’

From this perspective, Covid-19 pandemic seems to have hastened the process with changing customer behavior and expectations in the new normal, thorough understanding of customer needs emerged as a key success requirement for pharma marketers. That said, customer experience has to be measured both qualitatively and quantitively through credible market research initiatives, capturing the patients’ views. Guessing the same, as was generally the common practice in the old normal, would no longer suffice. This article will dwell in this area.

The pandemic played a catalytic role:

That Covid-19 pandemic played a catalytic role to hasten the process of providing a unique patient experience during a patient’s journey through a disease treatment process in the digital world. This was vindicated by a ZS study, published on July 05, 2020. The analysis found – over the last three months several companies started looking at new ways to engage with patients. These include:

  • Forming patient panels – to continually check and monitor the quality of patient experience that the company is providing,
  • Connecting with patient advocacy groups – to get a pulse on critical needs
  • Leveraging the field force – to hear from physicians where their patients need the most help.

These are laudable initiatives for dovetailing patients’ views in the drug marketing strategy to provide a unique experience to patients during their end-end-to journey through a disease treatment process.

Measuring patient-experience – an integral part of digital sales and marketing:

Measuring patient-experience has always been an integral part, virtually of all types of sales and marketing using digital platforms. We experience it almost every day, such as, while buying a product through Amazon, buying grocery items through D-Mart, scheduling a doctor appointment through Practo, buying medicines through PharmaEasy, or even for availing a service through Urban Company.

The November 15, 2020 research report of DT Consulting has also reiterated this need. It found, patients seeking and receiving care, depend on a complex system of health providers—an environment in which pharmaceutical companies play an important role. ‘When seeking care, patients gravitate to experiences that other patients rated well; when receiving care, they prefer experiences that consistently meet or exceed their expectations,’ it underscored.

Why then all pharma digital initiatives for its customers aren’t in sync with such practices? It’s about time that pharma players also follow a similar path, to continually improve company offerings, based on what the customers expect from a company’s brand and services – regardless of whether they are doctors, patients or any other key stakeholder.

I re-emphasize, this initiative has to cover end-to-end of a customer journey starting from clinical development, brand launch and expansion of market access. In each of these stages, loose knots, if any, require to be tightened, after thorough deliberations, to delight the customers – and consequently rewarded by them, appropriately. While some progress can be seen in this area, pan industry progress in this space, still falls much short of other industries. A pharma company may continue to ignore its importance, even in the new normal, at its own peril.

The way forward won’t be a bed of roses, expect thorns to overcome:

The above ZS study also brought out some interesting facts, as follows:

  • 43% of participants cited difficulty identifying quantitative, measurable KPIs that fit within the organizational structure and practices,
  • 29% indicated a lack of tools and resources to help communicate tangible outcomes and the case for change
  • 22% cited organizational silos as the true barriers.

The good news is, as the study highlights, Covid-19 has proven that it’s quite possible to actually be more patient centric to create an exclusive brand experience for patients. But, many ‘organizations still have work to do, in getting there.’

Sermonizing what patients’ need, without involving them, may be counterproductive:

Things were quite different in predominantly a physician-centric world for patients, in the old normal. At that time, sermonizing the treatment needs of patients, blended with a heavy dose of respective company’s self-serving interest, sans patient involvement in the treatment decision making processes – worked. The same approach may not yield desired cost-effective outcomes, when the customer behavior, triggered by the pandemic, is fast changing, for various reasons.

‘Patients want more services before they are treated’ for a disease: 

Many patients have been asking for more services, especially from the pharmaceutical companies, even before they undertake the journey of getting a disease well treated by medical professionals, regardless of disease types. Till Covid-pandemic, this remained mostly an unmet need for many patients, as this is an arduous for most pharma players. Which is why, most drug companies did not want to jettison the traditional approach, in favor of being ‘patient-centric.’ Thus, the entire decision-making process for any disease treatment continued to remain ‘doctor-centric.’

This wasn’t an unknown need for most patients, either, as it was well documented through several research studies. For example, an Accenture survey of 10,000 patients had examined their unmet needs in seven different therapeutic areas across the entire patient journey. Its findings concluded, ‘patients want more services before they are treated for a disease, regardless of disease type.’ Interestingly, even when such services were available in some places, the vast majority of patients still are not aware of the availability of these patient services, the paper added.

The situation is different today:

Overall, the situation is different today, mostly because, during a long Covid-19 lockdown period, many patients started visiting the cyberspace to manage their health, in increasing numbers. With the experience thus gained, a large population, even in India, now consider digital as a primary channel to initiate the journey for their disease treatment, such as telehealth.

As judicious assimilation of knowledge has always been a source of wisdom, patients have now become wiser to demand more services from a drug company that will help them to get cured of diseases and maintain good health – the way they want. More importantly, patients have also realized that in most cases treatment alternatives to choose from, are plenty.

Thus, the above study of Accenture raised the following question for the pharma companies to ponder that is more relevant today than ever before: ‘Are pharmaceutical companies missing a significant opportunity to provide services at the earliest possible point in the patient journey – before they are even being treated for a disease?’ That’s why, ‘patients deserve as much focus, if not more, in pharma market research as ‘physicians.’

‘Patients’ deserve as much focus on market research as ‘physicians’:

In the old normal, medical reps, in general, used to expect their target physicians to educate the patients about the disease while prescribing their respective company’s brands. With many patients getting more and more informed in the digital world, pharma companies need to strategize a comprehensive patient engagement and educational campaigns, enabling patients to actively participate in their treatment decision making process, exactly the way they want, to improve quality of life.

From this perspective, collecting first-hand data on patient-experience, straight from the voice of patients, isn’t too common a practice for the drug companies, even today. It will rather be a new venture for many, to gain meaningful insights on the impact of their operational endeavor – from the patients’ perspective. This will, in turn, help organizations strategize more productive engagements with them, reaping a rich harvest.

The process starts with ferreting out patients’ needs from a variety of credible sources – after cross-checking and getting it vetted by focus groups of patients, in due course. Some pharma majors, reportedly, invite patients to narrate their experience in the disease treatment process, directly to medical reps at their sales meeting on virtual platforms. A few others have started patient-groups in the selected therapy areas, for the same purpose.

Nonetheless, pharma marketers to please ensure that their organizations need to genuinely care about the patients, making this onerous task deliver a win-win outcome for both. The key point to take note of is that its real purpose, in no way, should be achieving any company’s self-serving objectives, under this creative façade.

Conclusion:

Creating and enhancing the unique customer experience has been recognized as one of the key success factors in any industry, pharma business is no exception. Curiously, it could not draw as much focus as it should have been, until Covid-pandemic struck, triggering disruptive changes in the customer behavior and the overall commercial environment. The good news is, in tandem with their digital transformation process, several drug majors are now mulling about patient experience-driven marketing strategies.

For this purpose, the pre-requirement is to put in place a comprehensive patient experience measurement framework, to accurately understand the end-to-end journey of the patients in their disease treat processes. This would include, capturing their key unmet needs from various sources, including focus group studies of real patients, in various formats.

Prudent use of connected health applications and AI platforms may be of great help – supported by state-of-the-art analytics, to gain meaningful access to patients’ behavioral and attitudinal data for strategic use, in various digital platforms. This has the potential to deliver a quantum leap in business outcomes. From this perspective, I reckon, for creating a unique patient experience, listening to patient voice, is an imperative 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.

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.