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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.

Pharma’s Digital Initiatives In India: A Missing Link

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An interesting study – designed to investigate the challenges that Health and Human Services (HHS) organizations face in implementing digital and data solutions, stands out today – for many reasons. One such being, this ‘multi-country survey’ project team had no inkling about the pandemic when the project was undertaken.

This study was conducted by a research team from Imperial College London’s Institute of Global Health Innovation (IGHI), and was sponsored by EY. The survey comprises of more than 2,000 global HHS professionals – from India, Australia, Italy, UAE, the UK and the US. 359 respondents were from India.

The research passed through the phase when Covid related disruptions was about to put HHS providers through the most extreme stress test in living memory. ‘While the outbreak was catastrophic in its effects, it presented the researchers with an exceptional opportunity to study the sector’s behavior during a pivotal moment,’ the paper noted.

From this perspective, today’s article will explore, from various different sources, across the world, how Covid-triggered rapid development and adoption of digital solutions are in the process of making a paradigm shift in the healthcare space. It spans across – health care service providers, its users, and practitioners – including pharma industry and the tech-solution developers.

Consequently, the question arises, would healthcare industry’s innovative spirit of 2020 is robust enough for taking a quantum leap in this space, as we move on. That space will span across – conceptualization and development of new health care products and services, alongside their consumption pattern and consumer behavioral dynamics. And, right up to the adoption of cutting-edge digital technology for commensurate delivery mechanisms. Let me start with some key findings in this area from the above report.

Some key findings – Global and India:

The findings of the Report titled, ‘Embracing digital: is COVID-19 the catalyst for lasting change?’ published on January 13, 2021, ferreted out some interesting facts, with details. These encompass both global and Indian scenario, in this area.

Some key findings – Global:

  • Pre-pandemic – just 18% of HHS providers had managed to embed digital tools in the way they work – mostly, due to lack of funds, regulatory restrictions, and risk aversion. However, the pandemic outbreak swept away many of these barriers, as 62% of organizations have now started using digital technologies and data solutions, globally.
  • 48% organizations are planning to continue investing in technology during the next three years, with 33% expecting more than 50%, and 19% more than 100% increase in investment.
  • While phone consultations are being offered by 81 % of HHS organizations (up from 39 % before the pandemic), 71 % of organizations offering video consultations (up from 22 % before the pandemic).
  • Respondents’ top objectives for future investment towards rapid adoption of digital solutionsinclude, transforming ways of working and service delivery, improving quality of care, reducing the administrative load, enabling better communications, and streamlining work processes.
  • However, 47% of respondents think, the introduction of digital and data solutions was a temporary measure to address challenges during the pandemic.

Some key findings – India:

The Covid-19 pandemic triggered fast acceleration of the adoption of digital technologies by the HHS in India, as well.

  • 51% of respondents from India reported that their respective organizations have increased the use of digital technologies and data solutions since the Covid-19 outbreak.
  • Increased staff productivity reported for 74 % of respondents’ organizations with 75% reporting that digital solutions have been effective in delivering better outcomes for patients and service users.
  • Remote consultations, such as, phone and video consultations have witnessed a greater increase in India than the global average. 86 % of Indian organizations are now offering phone consultation (up from 48 % before pandemic) and 83 % for video consultations (up from 33 % before pandemic).
  • Around three fourth of the respondents in India reported positive experiences with digital technologies and data solutions with the number of people using online consultations in India recording a threefold increase.

This encouraging trend and pattern needs to be consolidated, analyzed, and leveraged – for sharper actionable insights for the development of more contemporary products and services to delight the pharma and health care stakeholders.

A key missing link in India:

The digital health transformation of India’s healthcare system during Covid pandemic was also captured in another article, published by Elsevier Connect on February 23, 2021. It reiterated, although the pandemic has made an overall detrimental impact impacted on India, ‘it has brought about an avalanche of positive changes, including the adoption of digital health technologies and significant changes to the way care is delivered.’ Looking ahead, ‘With the launch of national public health initiatives, India has an incredible opportunity to become a digital health leader,’ the paper predicted.

However, the author also pointed out, unambiguously, that the health care crisis caused by the pandemic has also brought to the fore a key missing link – the need for updated and near real-time availability of trusted information. This observation is more relevant now than ever before, especially considering India’s National Digital Health Mission (NDHM).

National Digital Health Mission – a new ambition:

While addressing the nation on August 15, 2020, Prime Minister Narendra Modi announced the National Digital Health Mission of India. He said in his speech, “From today, the national digital health mission will begin. It will revolutionize the Indian healthcare sector. Every Indian will be issued a health ID that will act like a healthcare account, storing details of all the tests done, existing diseases, diagnoses, medicines prescribed.”

The objectives of the mission are to establish a core digital health database, creating a system of Electronic Health Records (EHR) based on international standards, establish data ownership pathways, so that patients become the owner of their health records, and promoting health data analytics and medical research. This initiative by any standard, is expected to be a game changer, as and when it comes to fruition.

Subsequently, on June 25, 2020, the Union Ministry of Health, reportedly, wrote to the principal secretaries (health) of all states and union territories, asking them to extend full support to the NHA to create four registries — doctors, health infrastructure, health IDs and personal health records of patients. It also instructed the states to send the required details within the stipulated timeline without breaching the norms of data privacy.

Need to avoid any possible missing link in the NDHM:

However, the Harvard Business Review article, published on June 12, 2020, asserted that the emergence of the COVID-19 pandemic not only presented a “mind-boggling array of challenges” exposed the limitations of the electronic health record (EHR) in helping physicians deliver care, especially in the United States.

It suggested: transformation of the EHR from an emphasis on a ‘person’s medical record’ – to an emphasis on their ‘plan for health’ and from a focus on ‘supporting clinical transactions’ to a focus on ‘delivering information’ to the provider and the patient, will be more meaningful.

Thus, it’s time for a new kind of EHR system in today’s perspective, as suggested by the HBR article, besides other domain experts. I am sure, competent authorities will take note of this transformation required in EHR initiatives to avoid any missing link in the new digital healthcare space in India.

As the above Elsevier Connect paper also observed, with the launch of national public health initiatives, such as, Ayushman Bharat and National Digital Health Mission (NDHM), India harbors an incredible opportunity to showcase its world class digital health ecosystem for all in the country.

To help fructify these projects, all key stakeholders – health care service providers, its users, and practitioners – including the pharma industry and the tech solution companies, need to get intimately involved with a common agenda in place. Falling behind may invite regrets, later.

Nonetheless, well before that – the common missing links in India - near real-time availability of credible data, trusted and verified information for adopting digital health for patients that will need to be provided by clinicians in a seamless manner, should be carefully identified and addressed.

New steps into digital healthcare are on the way:

Several new steps into digital healthcare have been taken in various countries of the world. One such initiative is ‘Internet Hospitals.’ These are basically an internet-medical-platform combining online and offline access for medical institutions to provide a variety of telehealth services directly to patients.

A Deloitte paper – ‘Internet Hospitals in China: The new step into digital healthcare,’ published on March 16, 2021 says: ‘Online hospitals are typically offshoots of offline medical organizations. The combination of Internet with health care will drive the medical industry’s transformation into a health service provider from a health care supplier, distributing resources equally and enhancing efficiency,’ moving ‘towards future smart health care.’

Conclusion:

Covid-19 has created a new focus on the digital health ecosystem in India, for accelerating the use of digital technology to radically advance health care systems and save lives. Today, many are experiencing that, big data, analytics, artificial intelligence, remote learning, and data inter-connectivity, can make a real difference to the work of HHS professionals in India.

Embracing digital with accelerated speed during the pandemic, has reportedly started making a significant positive impact on the cycle of the patient’s clinical assessment, treatment, and monitoring. With increasing use, it would reduce the cost of health care, improve patient access to affordable treatment and care services, when many patients’ journey for disease treatment will start online, and get directed to the optimal care setting either physically or virtually.

The article on health-tech, published in the Fortune India on February 20, 2021, has aptly concluded: ‘Eventually health technology infusion in the Indian healthcare ecosystem will be the route to enhance patient-centric healthcare accessibility, affordability, and sustainability. The advent of 5G technology in the country is poised to further catalyze this momentum.’ This, in turn, will facilitate ushering in more game changing steps into digital healthcare, creating a new ecosystem, greater awareness and a keen desire to remain healthy for all.

Thus, from the GIGO perspective, as defined by the Cambridge Dictionary, I reckon, in pharma’s digital initiatives, especially in India, a key factor needs to be carefully addressed. This is – fathoming existence of any missing link involving near real-time availability of trusted information and credible data generation, which could indeed be a great spoiler of any painstaking digital adoption project.

By: Tapan J. Ray     

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

 

 

Pharma Marketing: The New Normal: Challenges of Change

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A lot has changed in healthcare marketing prompted by the Covid pandemic. Apace with these, lots of old problems continue to remain very much the same. The aforesaid was observed in a recent article, published by WARC, on May 21, 2021. Although, this analysis was done in the United States, it has a global footprint, as the disruptions are broadly similar, with a varying degree from country to country.

Healthcare marketing leadership, including the pharma industry in India, presumably, is taking notes of these critical changes, along with their degree of impact. These are the basics for required responses in India, while managing its snowballing effect, both global and local.

Today’s article will provide a bird’s eye view of this area, to encourage marketers continue with their ongoing deep-dive data gathering exercise. Then, comes sieving the ‘catch’ with cerebral power – before using modern analytics to draw meaningful inferences for strategy making.

Some macro-changes stand out:

Some of these widely visible changes, also captured in the above WARC article, include the following:

  • An emerging trend of re-orientation of the healthcare industry around patient outcomes.
  • Need to realize that health and safety are the currency that can be used to rebuild consumer trust across categories.
  • Increasing need to build deeper emotional connections with customers, going beyond product-oriented features, benefits, and intrinsic brand values.
  • Providing healthcare consumers more data and behavioral science-driven, personalized solutions to their problems – to drive better outcomes.

More people are realizing that: ‘Healthcare, after all, is about life and death, and those stakes have been tragically reaffirmed during the pandemic,’ as the above paper underscores. Thus, affordable “health and safety will continue to be a currency that brands can use to re-establish trust with anxious consumers,” the author reiterates. To steer a company in that direction the marketers need to create a pathway for success by joining several emerging dots in the new normal. Let give just a flavor of these emerging dots with three examples, as below.

‘The end point – the price point’ - re-emerging as a core value expectation: 

Interestingly, ‘The end point – the price point’ for quality treatment outcomes is re-emerging as one of the core values and expectations of the consumers, especially facing an uncertain future that everybody is witnessing today. The health system is also transitioning from ‘pay for healthcare product and services’ – to ‘pay for integrated value-based care offerings.’ In the changing environment, many pharma players seem to have realized that customers are no longer interested in paying for brand values that serve mostly self-serving interests of the respective companies.

More healthcare customers are digitally savvy now:

Today’s brand values need to be in sync with what the perceived value of the customers, enhancing their end-to-end experience of the disease treatment process, more than ever before. For example, increasing number of patients are now choosing between F2F – in-clinic consultations and remote or virtual consultations, for non-life-threatening ailments. Some often do data-driven online assessment for different treatment value offerings, against what these would cost to them.

Purpose driven corporate branding is making better impact:

Pharma industry’s purpose-driven branding initiatives, in tandem with creating robust corporate brands, are drawing much greater public attention amid the pandemic. The list includes both the original product developers and their contract manufacturers. Even in India, many held with esteem – Corporates, such as, AstraZeneca and Serum Institute of India (SII) for Covishield, or Bharat Biotech for Covaxin.

The same thing has happened world-wide with many other Covid vaccine and drug manufacturers, such as, Pfizer, Johnson &Johnson, Moderna, Eli-Lilly, Roche, and others. Interestingly, from the available data in the cyberspace or from word-of-mouth, several people have also inferred about comparative value offerings of each. At least 4 Covid vaccine manufacturers are showing-up in this year’s ‘Conscious Brands 100’ list of 2021. This is, apparently, unprecedented.

Demonstration of ‘patients’-problem solving skill’ with resilience pays: 

As we all know by now, the drug industry as such – across the world, instead getting overwhelmed by the problem, pulled up socks and rolled the sleeves to find out scientific means of saving as many lives as possible, soonest.

Almost overnight, repurposing old drugs for Covid treatment and development Covid vaccines, racing against time, were initiated. The entire healthcare industry including, Medical Diagnostic and Devices companies and others, did not fall behind to offer reliable tests for Covid diagnosis, and other life support systems and equipment.

Alongside, Omnichannel digital campaigns of many companies, and favorable news reports amid the pandemic, made people realize the stellar role of the industry in saving lives and livelihoods – from the Covid menace.

Such examples include Pfizer’s What to know About Coronavirus webpage; Merck Inc’s Podcast: How Merck is looking at past epidemics and science to respond to the coronavirus outbreak; and India’s Mankind Pharma’s Mask My India digital campaign. It captures the stories of heroes, who are setting examples and doing more than their call of duty during the COVID-19 pandemic in India. The campaign also spreads the message that ‘together we can all fight with deadly Coronavirus.’

Some pandemic-triggered India-specific challenges:

According to the April 2021 KPMG paper, Covid pandemic has brought to the fore some of the following challenges for the India pharma industry, some due to years of neglect:

  • Fragile public health care system and laboratory testing infrastructure and supplies of life support items. This primarily due to one of the lowest Government spend (1.56% of the GDP) on health. As a result, India currently ranks 155th out of 167 countries, in terms of hospital bed availability (Human Development Report 2020) with just 5 beds availability per 10, 000 Indians.
  • Changes in health care consumption pattern – especially with the increasing use of e-health or telehealth, besides, online ordering of medicines through e-pharmacies.

Apart from these, it’s also noteworthy – how pharma demonstrated its healthcare ‘problem solving’ skill to save billions of lives from deadly Covid-19 and its mutants, attracting unprecedented kudos from all corners. To keep this initiative going – meeting customers’ core expectations, in my view, could indeed be yet another challenge of change.

Conclusion:

There won’t be any ‘one size fits all’ sort of solution to address such challenges of change. Neither is all company’s challenges the same, in a relative yardstick. Each company would, therefore, need to understand what the pandemic triggered changes in market dynamics and customer expectations mean to them to pursue sustainable business excellence.

Thus, each player would require to elaborately make data-based assessment and analysis, to figure out where they currently stand, so far are the pandemic-triggered changes are concerned. With similar analysis, they should also try to fathom what are their customers’ specific value expectations, which may now go beyond the value that their brands can deliver, but critical for branding success.

Accordingly, a value delivery strategy to be worked out, taking all concerned on-board – with a carefully crafted employee and customer engagement blueprint – and mostly Omnichannel digital platforms.

To successfully navigate through the challenges of change, pharma marketers need to wear a different thinking cap. They would also need to realize that treating pharma marketing as an intrinsic product value delivery system, and by just doing digitally whatever traditionally used to be done manually, may not help generate an adequate return in the new normal. From this perspective, giving shape to a robust, comprehensive, integrated and Omnichannel digital strategic game plan for the organization, is the need of the hour.

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.

With Changing Customer Behavior Pharma To Leverage AI For Better Engagement

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More than 55 million doses of Coronavirus vaccines were administered in India, reportedly, at the beginning of the last week of March 2021, in what is the world’s biggest inoculation drive. Notably, amid this mega initiative, the news media simultaneously reported that ‘India is facing a second wave of coronavirus because it let its guard down too soon.’ I also reiterated in my article of November 16, 2020 that in the thick of ‘Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard.’

From the pharmaceutical industry perspective – as I had written on July 06, 2020, in the midst of this pandemic, there appears to be a break in the clouds that pharma should effectively leverage. There isn’t an iota of doubt that Covid pandemic, for-all-practical-purposes, has propelled healthcare into a virtual world, primarily for survival of business, maintaining the continuity.

Most pharma players, especially in the sales and marketing domain, either were not or, were using e-marketing, in a selective way, as a key strategic tool in their brand prescription generation process. The pace of this shift in the digital space is now getting accelerated to more than neutralize the long-term impact of unprecedented business disruptions that overwhelmed the industry, last year.

Interestingly, a large number of pharma marketers weren’t focusing much beyond syndicated retail and prescription audit data, in the old normal. Whereas, to make digital strategies work effectively during rapidly changing customer behavior and business environment, ‘customer centricity’ is no longer an option today. It’s rather a key business success factor for effective customer engagement, in the prevailing environment. Thus, unlocking the ‘Herculean Power’ of targeted data of many types and genre, is a pre-requisite for acquiring deep insight in this area, while moving in this direction.

Alongside, comes the need to unleash the power of Artificial Intelligence (AI) to ensure pinpoint accuracy in targeted strategy formulation for the same. Well before Covid struck, I wrote on April 01, 2019 – ‘A New Pharma Marketing Combo That Places Patients At The Center of Business,’ flagging a slowly emerging need. Covid, unexpectedly, has provided a strong tailwind to it, increasing its urgency manifold in the new normal.

Consequently, pharma marketers should have, at least, a working knowledge in this area – such as ‘machine learning’ and other analytics-based processes of AI that can help them enormously. In this article I shall discuss, why it is so important for today’s astute pharma marketers to hone their knowledge in this area for making a strategic shift towards ‘real-life’ Patient-Centricity. No wonder, why top pharma leaders now consider this transformation so critical for pharma strategy formulators, to acquire a cutting-edge in the digital marketing warfare.

Patient needs aren’t really at the center of a business strategy, today:

Despite so much hype on patient-centricity – in a true sense, patient-expressed needs aren’t generally placed at the center of a business strategy, as on date, unlike most non-pharma companies. That pharma players, by and large, don’t have a robust online feedback mechanism in place to capture ‘patient-experience’ with medications – directly from patients, vindicates the point.

As I reiterated in my article of March 21, 2021: ‘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 PharmEasy, or even for availing a service through Urban Company.’

Thus, patient-experience, in their own words, with prescribed medications, is generally expressed to the physician, if at all. The process, generally, doesn’t get extended to drug companies’ strategy formulators for taking a patient-centric amendment, wherever needed.

However, assuming that doctors would convey the same to concerned medical representatives, it becomes a third hand (patient-doctor-Rep-Company) feedback, with commensurate distortions in each verbal transfer of communications. The outcome of this strategic gap has been captured in several research studies.

Outcomes of absence of online direct ‘patient experience’ feedback system:

Let me elaborate this point by quoting an example from a contemporary research in this area. This study was conducted by DrugsDisclosed.com in August 2020 with a total of 3,346 patients all taking medicine on a daily basis – aged between 18 and 80. The key findings are as follows:

  • 72% of patients feel ignored by pharma companies.
  • 76% don’t trust advice from them.
  • 81% feel that drug players influence prescribing decisions.
  • 63% would like to give product feedback to directly to companies.
  • 69% find their medication effective.
  • 81% feel their medication is needed.
  • 77% feel confident with their medication.
  • 82% don’t feel bothered by side effects from their medicine.
  • 73% take the medicine as agreed with their doctor.
  • 74% feel that the benefits of their medication outweigh the disadvantages.

The study concluded – the above insights show the need for patients’ voices to be heard by the pharma companies. If medicines are to solve health problems for billions of people who need them, listening to real-life patient-experience with medication, is the key to unshackle the full potential of the world’s health systems. Thus, pharma companies need to directly listen to what patients experience and express with their medicines. It will help them earn customer-trust and greatness in business, while gaining new and important insights for performance excellence.

I hasten to add, although, this study was conducted among patients residing in the UK, Ireland and Denmark, the core issue, even in India, is unlikely to be much different from what appears above. This genre of pharma marketing approach would warrant extensive use of AI, much more in the coming days – than ever before.

The above genre of pharma marketing calls for extensive use of AI:

The above genre of pharma marketing calls for extensive use of AI, much more in the coming days than ever before. For example, as new generations of Covid vaccines will come – with some without the use of needles, like a nasal drop, machine learning tools may be necessary for pinpoint accuracy in market segmentation. I reckon, there will be many such areas, where those companies who would use AI to orchestrate a cohesive customer experience, will drive stronger differentiation, better customer access and higher sales impact.

In that process, creating opportunities and empowerment for deserving marketers to reap the benefits of AI based digital tools and systems, such as machine learning with human integration within sales and marketing, will be the need of the hour. Gaining actionable insights from this endeavor, marketers need to go whole hog to unleashing the power and value of AI for achieving business excellence. I wrote about it, even during pre-Covid days – on July 15, 2019. But, this approach has assumed much greater importance in the new normal, when innovative e-marketing is gaining momentum to gain a competitive edge. However, this would require more investment in AI than what it is today.

The process has accelerated during the Covid pandemic:

This has come out clearly in the results of McKinsey Global Survey 2020 on AI. The paper is titled – ‘The state of AI in 2020’ and was published on November 17, 2020. The findings of the study ‘suggest that organizations are using AI as a tool for generating value. Increasingly, that value is coming in the form of revenues.’

Although, the number of these companies is small, they are planning ‘to invest even more in AI in response to the COVID-19 pandemic and its acceleration of all things digital.’ The paper emphasizes that this could create a wider divide between AI leaders and the majority of companies who are still struggling to capitalize on the technology.

Pharma’s increasing use of AI during the pandemic:

The above trend gets reflected in the ‘AI In Pharma Global Market Report 2021: Covid-19 Growth And Change.’ The report underscores, the global AI in pharma market is expected to grow from $0.91 billion in 2020 to $5.94 billion in 2025 at a CAGR of 47%. The initial spurt in growth was mainly due to companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, the report underscores.

Although, the number of pharma entrants in this space isn’t yet very many, major players includePfizer, Novartis, IBM Watson, Merck, AstraZeneca and Bayer. Gradually, some Indian drug companies are also testing water in this area, as discussed in the article – ‘The Increasing Use Of AI In The Pharmaceutical Industry,’ published by Forbes on December 26, 2020.

Conclusion:

“Patient-Centricity” emerging as a hallmark, fueled by rapidly changing expectations and behavior of pharma customers, especially doctors and patients. To be effective with such changes in market dynamics – capturing ‘patient experience’ with medication – directly from them – to the respective companies online, is a necessity today.

Most other industries involved in digital marketing are already doing so. Pharma companies while embracing e-marketing can’t just wish it away, any longer. Today, when digital marketing has commenced in the pharma industry, with accelerated speed – machine learning alongside the creative application of AI powered analytics, can immensely help gaining actionable insights on customers. These include customer experience, their perception and pattern of usage of brands, besides channel preferences, preferred contents for effective engagement.

Thus, the consequences of not directly listening to patients’ voice on structured digital platforms – supported by analytics, can be ignored at pharma marketer’s own peril. Many of them may not yet be able to fathom the depth of its potential, opportunities and possible roadblocks, or simply unable to figure out where to begin with and – how. Experts’ hand-holding will be pivotal for them in the transition phase of this endeavor. From this perspective, I reckon, to keep pace with fast-changing customer behavior, pharma marketers need directly listen to patients’ voice online. And based on which, develop customized strategies by leveraging AI – for more productive engagement with them.

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.

How Pharma To Stay Relevant To Customers In The New Digital World

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Covid-19 vaccination has commenced in India on January 16, 2021, as in several other countries of the world. A few million Indians, across the country have already received their first shot, according to media reports. But, this isn’t the endgame of pandemic by any measure. Covid-19 will get over – only when it gets over.

Interestingly, on March 07, 2021, the Union Health Minister claimed, ‘the country is in the end game of the COVID-19 pandemic. Curiously, the very next day – the Indian Medical Association IMA termed it as: ‘Unauthorized political statements on Covid-19 pandemic invokes a false sense of security.’ Moreover, vindicating the IMA statement, the Coronavirus trend report, updated as on March 05, 2021 clearly demonstrated that ‘The pandemic is far from over.’

As a fallout of this pandemic, alongside many other nations of the world, most industries in India are going through a recovery process of disruptive changes in the business processes, after a harrowing time. Pharma industry is no exception in this area. Recreating contemporary operational processes to excel in the new normal, would call for not only jettisoning many practices from the old normal by the new ones, but also the creative deployment of the precious resources, by each pharma players.

Accordingly, the need for avant-garde digital-based customer engagement services, is gathering winds on the sails of the ships of pharma marketers, signaling a ‘never before’ urgency to move in this direction. It’s a new business imperative to survive, perform, and excel in pharma. At the same time, the industry also should examine other critical changes required in its primary interfaces with customers, in today’s fast evolving scenario.

This process would involve redefining the new roles of some critical positions in the organization. Today’s article will explore how pharma will stay relevant to its customers, increasingly getting more and more involved in the new digital practices.

Some key challenges in pharma digital strategy:

One of the key challenges for a productive ‘company – physician engagement’, in the new normal, is to be available at any preferred time of customers’ choice and the way they want. This may include, both virtual and in-person F2F engagements, along with customized contents for the same. This need is universal and, by and large, remains the same for key stakeholders of all drug companies.

This point was further reinforced, in the February 22, 2021 article on capacity building in the digital space, published in Reuters Events, Pharma. It focused on demands in new era of ‘digital-first customer engagement’, where content creation and omnichannel engagement also play equally vital roles.

Besides, the paper emphasized, today’s need is investing in the type of contents that add clinical value, as opposed to overtly commercial marketing type material. The primary task for marketers is now, therefore, to use updated, high-quality, neutral content on customer engagement platforms that will offer value – the customers are looking for – and not just values from a company’s self-serving perspective. From this angle, the new content model prompts greater customer involvement for meaningful outcomes.

In tandem, company staff members – including medical representatives, need to acquire multi-tasking expertise, being equipped with – required digital knowledge, skills on using digital platforms and ascertaining individual key customers’ engagement needs. Whereas a company’s digital strategist will work on “digital initiatives, solutions, products and how those will be integrated locally.” Thus, this is not about making everyone a digital expert, as the article underscores.

Need to redefine work processes and realigning the staff members:

As the above article from Reuters Events reconfirms, the digital approach that several pharma players were taking even a year or two ago is redundant in the new normal. Amid rapid transformation in the drug business, ‘pharmaceutical industry can no longer act like ostriches. Digital is no longer a fancy add-on, it’s an integral part of everything we do,’ the study highlighted.

Thus, to move in this direction effectively, pharma companies would require redefining many work processes and realign the staff members in sync with their new roles, accordingly. Further elaborating this point, the Accenture study – ‘A digital booster dose for health care,’ identified a few such roles that will undergo a metamorphosis to meet with post Covid challenges. Following are some, where urgent transformations required are, as follows:

 A.   ‘Intelligent representatives’ – not just ‘medical representatives’: 

In the current scenario, rep’s engagement process with the medical profession calls for leveraging specific intelligence based on behavioral preferences. This is fast emerging as a key requirement. Thus, the paper underscores: “Armed with a closed-looped CRM, representatives can effectively use data insights to plan, deliver and report calls.” I also indicated earlier – to succeed in this effort, individual skill sets, such as digital awareness and analytics will be of great use. The core objective is, looking through physicians’ eyes to understand their needs and solve problems by ‘serving customers as individuals, not as numbers in a call roster,’ the study emphasized.

B.  ‘Customer experience managers’ – not just ‘brand managers’: 

While using omnichannel digital platforms, doctor-patient interactions become more content dependent. Accordingly, brand managers’ role will be pivotal to facilitate a uniform interaction experience across all channels.

Therefore, for targeted communication, better understanding of doctors and patients and how they want to be engaged, is a key requirement. Which is why, brand managers will have to acquire skills, such as content management for continuous engagement across multiple channels. This is now absolutely necessary for effective branding in fostering a new genre of ‘customer-brand relationship’ model, across the company.

C. ‘Helping doctors manage their practice and patients better’ – not just ‘brand marketing’: 

‘Think beyond the patients’ – suggests the Accenture survey. This is because, virtualization of healthcare is all about doctors making further customizations into how they operate, both clinically (teleconsultation) and commercially (payments). This is, another important area where pharma companies can further differentiate themselves, by helping doctors manage their practice and patients better. The process entails acquiring critical skills in disease awareness, identifying key gaps that impact patient experience and clinical outcomes, alongside various digital engagement tools to perform these functions.

Conclusion:

The current year is expected to witness flooring of the gas pedal, as it were, in pharma’s digital transformation process, while navigating through humongous challenges on the way. The process includes, redefining work processes and realigning the staff members to establish a new customer-brand relationship’, based on Covid triggered changes in the customer behavior.

A quantum improvement in the usage of digital tools and platforms, alongside targeted content creation will be pivotal in pharma’s customer relationship management to excel in the changing business environment. Many doctors and patients have already signaled their acceptance for digital or virtual interactions, besides some well identified F2F engagements with relevant and personalized data-driven content as they expected from each drug company.

This need arises when one considers the findings of another Accenture Survey. It reported, while 39% of doctors want all medical representative meetings to be virtual, even post pandemic, ‘around 10% of key doctors still want to go back to pre-COVID-19 norms for in-person meetings.’ Thus, the point to ponder in this area is how to structure these F2F meetings for highly productive outcomes.

However, it’s also a reality that during Covid days, doctors wanted to interact with the Medical Reps more than what they used to do in the past. This offers a huge opportunity to drug companies in leveraging pharma rep’s interaction to accurately understand their customer-insight. Consequently, the new approach will help pharma companies, not only in staying relevant to its customers in the digital world, but also, to keep themselves prepared to face similar challenges in the future, proactively.

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.

 

More Challenges For Brand Launch Success In The New Normal

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The drug manufacturers’ life blood to drive business growth has always been successful new product launch. However, this task has always remained a tough challenge to crack, since last so many years for various reasons. According to McKinsey & Company: “About two-thirds of drug launches don’t meet expectations. Improving that record requires pharmaceutical companies to recognize the world has changed and adjust their marketing accordingly.” Several research studies have been carried out by now to gain actionable insight on this issue.

Existing challenges for successful drug launch got further amplified, as Covid-19 pandemic added a novel dimension in this space. It involves disruptive changes in many facets of customers’ new product-value expectations. Similar changes are witnessed in the product value delivery process, doctor-patient engagement, content development and delivery platforms, among others. This article will explore this area from successful new product launch perspective, in the days ahead.

Dismal outcome of many new drug launches – more for primary care:

According to a recent study, published by L.E.K Consulting on December 18, 2020: ‘About half of all products launched over the past 15 years have underperformed pre-launch consensus forecasts by more than 20%.’ This is quite in line with what McKinsey & Company found in 2014, as quoted in the beginning of this article.

However, in a relative yardstick, the primary care market has been the most vulnerable, which continues even during the ongoing pandemic. For example, according to an April 2020 Evaluate Vantage analysis, ‘Covid-19 adds a new danger to drug launches.’ The study emphasized, new drug launches, especially those targeting the primary care market, are particularly vulnerable as the pandemic continues. The key reason being, besides widespread disruptions in the health care system, sales teams will be physically unable to reach frontline physicians, as much as, and also the way they could do the same in the old normal. The studies underscore that a strong launch is critical to achieving maximum commercial potential, despite odds.

Some pivotal factors demand a greater focus than ever before:

After in-depth analysis of various studies in this area, some pivotal marketing factors appeared critical to me, in order to reduce success uncertainty while launching new products.

Alongside, unbreachable and agile supply chain alternatives also assumed a never before-frontline-importance in the new normal, unlike pre-Covid days. Another recent study, titled ‘Competitiveness During Covid-19 Pandemic: New Product Development and Supply Chain Agility’, published by ResearchGate in October 2020, vindicated the point.

As the title indicates, the above study examined the effect of new product development and supply chain agility to gain competitiveness during the Covid-19 pandemic and probably beyond. Thus, while developing and launching new products in the new normal, some pivotal factors, such as the following, appeared critical to me, in order to reduce success-uncertainty while launching new products:

  • Early planning for launch with a robust market access strategy, better sales forecasting with stretch goals – supported by state-of-the art forecasting tools and relevant learnings from the past.
  • Gaining actionable insight on changing customer needs, market dynamics and competitive threats in the new normal – by generating credible and contemporary data and leveraging the power of analytics – to offer differentiated stakeholder value.
  • Driving home patient-centric coeval product values that will delight customers – through flawless execution of stakeholder engagement strategies.
  • Working out virtual, innovative, personalized and impactful alternatives to some critical launch related physical events, such as, conferences, seminars, webinars and the likes, for doctors and other customers.
  • Developing creative and contemporary content and other marketing assets for significant online or omnichannel presence of new brands – supported by video clips and other tools, aiming at the target audience.
  • Differentiating the launch product clearly from those of the nearest competitors, where a focus on price-value relationship of the brand – from the patients’ perspective, could play a game changing role. As McKinsey & Company also highlighted, launching an undifferentiated product in an unestablished disease area carries a greater risk of failure.
  • Creating a robust and agile supply chain to navigate through unexpected market changes – as all experienced recently.

Delivering ‘patient-centric’ real value of the brand together, is critical:

Interestingly, L.E.K Consulting has also emphasized in its recent study that to drive and effectively deliver ‘patient-centric’ real value of new products, it is imperative for drug companies to execute the launch process flawlessly.

To make it happen on the ground – at the moment of truth, careful selection of a team of self-motivated people is necessary. This needs to be followed by intense training in all aspects of the specific launch, including effective use of modern digital tools and platforms – and above all – by creating a ‘can do’ team spirit to deliver the deliverables.

This requirement has been epitomized in the recent article, titled ‘Beyond the Storm: Launch excellence in the new normal,’ published by McKinsey & Company. Therein, the authors articulated, ‘Intangible though it may sound, great launches have a different feel from normal launches. There is a real sense that – we’re all in this together.’

Pharma’s current way of using digital platforms doesn’t satisfy many doctors: 

Over the last one year, as the pandemic brought all human activities virtually to a grinding halt, there has been a significant shift towards digital tools and online platforms, including in the way medical practitioners interact with drug companies. As recent surveys indicate, pharma customers don’t seem to be quite satisfied with the way many pharma players are currently making use of this technology.

This is happening even with those doctors who are open to virtual engagement and in favor of remote patient consultations. The issue needs to be resolved soon, particularly for new product launch successfully – using digital platforms, as reported in recent surveys.

The survey reports retraining of ‘sales reps to become digital orchestrators’:

One such recent survey, conducted by Indegene, which was also reported by Fierce Pharma on February 01, 2021, digital dissatisfaction of doctors with pharma companies, has jumped during the pandemic. The rates of dissatisfaction with pharma digital interactions, across media channels, ranged from 23% to almost 50% of physicians. Some of the key findings of the study include:

  • 49% of physicians are not happy with pharma’s social media engagements – perceived as less sophisticated when compared to expectations set by consumer companies.
  • Pharma is far from providing a satisfactory digital experience, as compared to other industries. The current dissatisfaction level where a higher percentage of doctors were dissatisfied, include marketing emails – 46%, telephone sales calls with sales reps – 42% and both webinars and websites – each at 39%.
  • In-person meetings dropped from 78% to 15% during the pandemic, but even now only 48% of doctors surveyed expect in-person engagements to continue in the post-COVID world.
  • Attendance at medical conferences also dropped from 66% to only 16% during the shutdowns and travel restrictions, but only 50% of HCPs now expect to resume in-person congresses after it’s safe to hold them.
  • The number of physicians engaged in remote sales visits increased from 11% to 47% during the pandemic, probably because there weren’t other alternatives available. Interestingly, one-third of physicians still plan to continue with virtual sales meetings even after the pandemic.
  • Most stakeholders are realizing, this is going to be the new normal, with senior pharma leadership also saying, ‘it’s never going to be the same as before.’
  • About 5 of the top 15 global pharma players are retraining their sales reps to become “digital orchestrators” and working to help them create clear and comprehensive digital communications for doctors.

Speedy resolution of these issues is likely making a substantial difference in improving pharma-to-physician interactions, particularly during new drug launches, in the days ahead.

Conclusion:

Success uncertainties in new product launches have always been a cause of concern for the drug industry, especially after having invested a substantial resource towards innovation and clinical developments. Interestingly, pharma players were mostly following ‘stick to the knitting’ dogma, as it were, in their launch planning. Despite the availability of sophisticated digital tools and analytics over the last several years, particularly in generating and accurate analysis of contemporary and credible data to gain insights, not much had changed radically. Suddenly Covid pandemic disrupted most market traditions, business processes, and the general belief on decision makers’ ‘gut feelings’ on customer behavior, market dynamics. Besides, the mindset of ‘doing better that what you have been always doing’, prevailed in many cases. In India, market research for most companies remained within the ambit of syndicated retail and prescription audit, despite frequent grumbling of many marketers on some critical findings of these reports.

The last one year has created more challenges in this area, although with a silver lining. A large number of drug companies have now stepped into the area of digital marketing – in varying degree, scale and resource deployment. This shift is expected to help reduce launch success uncertainties of new drugs. It will again, depend on how effectively the technology is leveraged by the cerebral power of astute markers.

Another article on pharma product launch, published by McKinsey & Company on December 15, 2020, also vindicated this point. It underlined: ‘As pharmaceutical companies reshape their commercial model to prepare for the uncertainties ahead, personalization and digital enablement will be crucial to launch success in the new environment.’

Amid these, as some surveys highlight, many doctors are not satisfied with the way digital technology is being currently used by pharma companies – to interact with them and cater to their information needs. With these ‘teething troubles’ being properly and promptly addressed, many drug companies, I reckon, will be able to remarkably reduce success uncertainties of new drug launches 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.

 

A Rare Strategic Acrobatic Feat in Covid Time

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

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

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

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

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

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

The acquisition:

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

Some key aspects of rare diseases: 

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

Impact of some rare diseases in Covid infected patients: 

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

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

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

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

The study noted, among others:

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

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

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

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

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

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

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

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

Will developing such drugs be profitable for the pharma industry?

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

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

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

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

Conclusion: 

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

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

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

By: Tapan J. Ray     

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