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Unleashing Pharma’s New Potential In Changing Market Dynamics

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Several pharma majors have started pondering in this space. This is evident from several recent developments, both in India, and also in other places of the world. One such articulation can be heard from the very top of the domestic pharma industry, which could be a pacesetter for many others.

The founder and Managing Director’s Message of India’s top pharma company – Sun pharmaceuticals, was released to the media on June 02, 2021. This speech is a part of the company’s Annual Report 2019-20. It is indeed interesting from overall pharma business operations’ perspective in India amid Covid-19 pandemic. It is also in sync with what many of his global counterparts have also expressed in recent times. To give a sense of Sun Pharma Chief’s reading and understanding of the fast-changing business dynamics, I am quoting below a few critical points of his above message:

  • There is a gradual realization that the COVID-19 virus is here to stay and that all of us will have to learn to coexist with the virus till an effective treatment or vaccine becomes available.
  • There will be far-reaching changes in the way in which organizations are likely to operate going forward.
  • Consumer behavior and consumption patterns are also likely to change due to the global pandemic.
  • Social distancing and maintaining individual hygiene (like using masks and hand sanitizers) have become imperative.
  • Work-from-home (WFH) option has been exercised by most organizations for certain functions and there is a likelihood that it will continue for some more time till the viral infection comes under control.
  • There is a possibility that WFH may become the new-normal for certain categories of corporate work force even after COVID-19 comes under control.
  • Also, there is a higher focus on automation, digitalization as well as an increased dependence on analytical tools for decision making.

Overall, in the global pharma and biotech arena, one can now witness a varied response to opening-up – some quite bold, others are flexible and cautious – as the scenario unfolds. In this article, I shall dwell on the importance of framing a well-thought-out plan, with clearly stated Plan B, C and D in this area, to prevent any business opportunities to slip by due to delayed action.

Key questions to answer – what to open and when to open:

It goes without saying that remote working or WFH for all pharma employees can’t remain in-force for any indefinite period. It will mostly depend on two critical drivers, mainly to avoid any reckless decision with grave consequences. One – how fast several – reasonably strong preventive measures, such as, vaccinations, can provide a reasonable herd immunity to most people around. And also, how most other similar businesses successfully start carrying out their commercial operations in the same environment.

Pharma players would then need to have a clarity on the business functions where selective personal presence of the qualified staff is necessary, as no extent of technological interventions can compensate it. Then follows the question, when to start opening – without being reckless and following all prescribed Covid related health norms. The answer to these questions should be addressed along with Plan B, C and D ready – just in case something doesn’t work out or because of competitive reasons.

To elaborate this point, let me first give an example of what an Indian tech behemoth is planning to get back some employees in the workplace, based on a sophisticated digital model. Thereafter, we will have a glimpse on how several pharma and biotech players are planning in this space. The basic assumption is – the grand show must go on – with collective scientific learnings on how to coexist with the virus, for an indefinite period, if inevitable.

Integrated digital plan to get back more employees at the workplace by TCS: 

Lilly, Amgen, PfizerAs reported on June 02, Tata Consultancy Services (TCS) are working on a plan to get back more employees to the workplace. The tech giant is focusing more ‘on increasing talent fungibility as global clients increasingly require associates with niche skills to be deployed on projects at short notices.

Thus, to evaluate how it will get a certain percentage of people back, TCS has drawn up a risk assessment model, Intelligent Urban Exchange (IUX). To effectively address the new requirements for employees’ safety, regulatory compliance, and operational efficiency, the company has devised this system. It will help TCS to get real-time insights that will help restore operations and ensure safety, while becoming nimbler and more resilient in the new normal.

What some global companies are planning now:

One will witness a mixed approach of global pharma players to get back employees at the workplace, soon. This will be evident from a few examples, as below.

A Bloomberg report on April 27, 2021, highlighted: ‘As vaccine drives ramp up and open the possibility of a return to the office, a growing number of companies have pointed to a continued role for remote work — and less of a need for pricey office space.’ It quoted Novartis CEO saying: ‘“We’ve all learned from the pandemic that we can work from home and work from the office, and it will always be a combination going forward.”

Thus, in Novartis, “hybrid-based working environment” – at-home and in-office work, will persist for the long term – extending beyond the pandemic. The Company CEO also reiterated: “We think this is the future.” The flexibility should allow Novartis to “access talent pools we would not have been able to access in the past,” he believes.

Similar approach, but with specific dates for returning to the workplace: 

By an open announcement on Linkedin, the Chairman and CEO of Eli Lilly declared the Company’s plan at the current stage of Covid pandemic. He said: “More than a year later, I’m pleased to say that we’re actively planning Lilly’s return to our workplace in downtown Indianapolis, and other facilities around the world.”

He further said, on June 1, 2021, Lilly will begin reopening their Indianapolis offices, inviting 25 percent of our workforce back – with masking and distancing indoors, and a requirement for vaccination. Barring a change in the steady downward case rate in the community, the Company will then open to all Indianapolis-based employees on July 12, 2021.

The company’s new work model will be based on the requirements for each job. Some employees will be on site all the time, others most of the time, and some will have even more flexibility. As ‘individual work’, and some ‘transactional work’, is easier done remotely, employees in those roles can choose that option in consultation with their supervisor. But collaboration, innovation and learning are best done in-person at the Company facilities, the Chairman and CEO said.

He reiterated, Lilly is not taking these steps casually, but based on a data-based approach, and will continue to do so. If external factors change, Lilly will adapt. In other countries, the Company offices will continue to follow local guidelines and open as they are allowed based on local circumstances, the Company clarified.

More remote working being planned by many other global majors:

According to another report of May 07, 2021, many other global pharma and biotech majors are now planning in favor of long-term remote working for several critical business than ever before. For example, on May 07, 2021 Amgen announced that the Company will make working from home a permanent policy for much of its international workforce, including locally.

It said, “Most of our employees who are currently working remotely will continue to do so for a majority of their time, even after the pandemic ends. Our intent is to create a more flexible environment that intentionally combines the benefits of remote and in-person working.” The statement further added. “We are not initiating any changes to our Thousand Oaks campus at the time. Though some staff may come to campus less frequently.”

As reported on April 27, 2021, Pfizer has put its large Philadelphia-area campus up for sale, as it considers the future of work. According to the company, as revealed by Fierce Pharma, “The decision to do so is primarily being driven by the company’s evolving – flexible working model, providing employees with greater flexibility to work remotely while still maintaining the ability to connect and collaborate regularly on-site.”

Conclusion:

It’s over a year of business disruptions within the pharmaceutical industry, at varying intensity and in different phases, though. For example, after more than a year since the pandemic hit India, Covid 2.0 has, reportedly, pushed up Indian pharmaceutical sales to a new high. It recorded an exponential growth of 59% year on year in April 2021, against 16 per cent – year on year in March 2021. This is obviously an outlier and is apparently unsustainable. Thus, for a sustainable good growth with greater certainty, Indian pharma players would require working out a well-researched digital blueprint of the future working framework of business operations with ‘what if’ options.

As has been revealed, remote working, wherever it makes robust business sense, will help getting hard-to-reach talent pools regardless of geography. This opportunity needs to be leveraged. However, it’s also a fact that for various reasons, everyone may not be too comfortable to work from home. Thus, the future work plan may call for a balanced and employee specific approaches.

Which is why, the process will require in-depth analysis of key functions where the personal presence of qualified staff is necessary, mainly because, no extent of technological interventions can compensate the human presence. Then follows the question – when to start opening in a responsible way – following all prescribed Covid related health norms. A representative pilot trial may help in this area.

Some of the key factors to consider will include speed of getting the staff vaccinated. Besides, arrangement for quick identification of breakthrough Covid infections among staff through quick tracing, testing, and provisions for appropriate hospitalization, if necessary, need to be put in place. Thus, I reckon, it’s time for the domestic pharma companies to diligently plan for unleashing the new potential of the respective organizations – amid the pandemic-triggered changes in market dynamics.

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.

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.

 

Any Threat To Current Commercial Model Of ‘Gene Therapy’?

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Wish All My Readers A Very Happy, Healthy, Peaceful and Prosperous 2020

 

One of the most complex areas in disease management, is the ailments related to genetic disorders. As these were incurable, over the last four decades, medical researchers are engaged in understanding the complex and intricate process to modify human DNA, using viruses for treatment. This painstaking initiative led to the evolution of ‘gene therapy’ which, according to Mayo Clinic, ‘involves altering the genes inside human body’s cells in an effort to treat or stop the disease.’ In that process, ‘gene therapy’ replaces a faulty gene or adds a new gene, to cure a disease or improve the human body’s ability to safely and effectively treat dreaded ailments, such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDS, it further added.

Several studies, e.g., one titled ‘Gene therapy on the move,’ published in the EMBO Molecular Medicine highlighted, the first gene therapy clinical trials were initiated more than two decades ago. However, initially many of these were impeded by the occurrence of severe side effects in a few treated patients. Nevertheless, over a period of time, ‘highly efficient gene targeting strategies and site-directed gene editing technologies have been developed and applied clinically.’ With over hundreds of clinical trials to date, gene therapy has moved from a vision to clinical reality – offering a powerful treatment option for the correction of monogenic disorders.

It is believed that in the new millennium, ‘gene therapy’ has emerged as one of biotech’s momentous success stories for curing many genetic disorders, which were once considered incurable. But, the cost of ‘gene therapy’ treatment is indeed jaw-dropping – ranging ‘from about US$ 500,000 to US$ 1.5m. And for treatment over a lifetime, some drugs can cost as much as US$ 750,000 in the first year, followed by US$ 375,000 a year after that – for life.

Since, I have already deliberated on ‘gene therapy’ price and associated moral dilemma that it causes, in this article, I shall focus on different concerns that could pose a threat to its ongoing commercial model. Nevertheless, let’s start with the current scenario on ‘gene therapy,’ for better understanding of the issue.

The current scenario:

According to McKinsey & Company’s October 2019 article - ‘Gene therapy coming of age’ - till 2019, the primary focus in development of ‘gene therapy’ has been on monogenic rare diseases with all currently approved therapeutics falling into this category. It is worth noting, rare diseases tend to have clear genomic targets, as well as, high unmet need in a very small patient population, who have generally been under-served by other, more traditional, therapeutic modalities (including monoclonal antibodies)—making them ideal targets for gene therapies.

More than 150 investigational new drug applications were filed for gene therapy in 2018 alone. With this in mind, McKinsey & Company expects this market to grow significantly, with ten to 20 cell and gene therapy approvals per year over the next five years.

Major ‘gene therapy’ launched:

If one takes a broad look at the ‘gene therapy’ treatments launched so far, which I have compiled from different sources, it may appear as follows.

Gene Therapy Company Country Launch Year Indication Price ($M) Current status
Glybera UniQure Europe(EMA) 2012 Pancreatitis caused by absence of a gene - lipoprotein lipase, affecting about 14 people per year in Europe 1.0 Withdrawn (unaffordable)
Strimvels GSK Europe (EMA) 2016 To treat ADA-SCID patients (rare disease) 0.665 Sold to Orchard Therapeutics. Only 5 patients were treated.
Kymriah(CAR-T therapy) Novartis USA 2017 Acute lymphoblastic leukemia 0.475
Yescarta(CAR-T therapy) Kite Pharma USA 2017 Diffuse large B-cell lymphoma 0.373 Gilead acquired Kite Pharma in August 2017 for 11.9 billion dollars
Luxturna  Spark   2017 Rare disease called RPE65 mutation-associated retinal dystrophy. 0.850 for both eyes Novartis is paying $105M up front for the ex-US rights.

The latest being Zolgensma of Novartis. It was approved by USFDA on May 24, 2019 for ‘patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.’ It costs US$ 2.125 million in the US for a one-time treatment.

However, to get a better idea on the industry focus in this area, let us look at the current ‘gene therapy’ pipeline.

Current ‘gene therapy’ pipeline:

To fathom the extent of industry interest in ‘gene therapy’ let’s have a glance at the depth of its pipeline – both in terms of phase-wise clinical study, as well as therapy areas covered. This will help understand the concerns that could pose a threat to its ongoing commercial model.

Clinical Trial Phase Total by phase    Therapy Areas:HematologyOncologySensory OrgansInternal MedicinesOthers
I 574
II 520
III 205
Filed/Approved/Marketed 237
Total 1536

Adapted from: McKinsey article – ‘Gene therapy coming of age’, October 2019

Both large and small companies are entering into the fray:

Besides Novartis and GSK, as mentioned above, other Big Pharma constituents, such as Pfizer, Roche, Gilead and Bristol-Myers Squibb - are also putting their money in developing ‘gene therapy.’ This includes Mergers and Acquisitions too. For example:

Alongside, newer ‘gene therapy’ platforms continue to come up, many funded by venture capitals – further enriching the ‘gene therapy’ pipeline. In tandem, fresh concerns that could pose a serious threat to the ongoing commercial model of ‘gene therapy’ are also being realized. Mainly, the impact of the one-time or curative version of such avant-garde therapy on current pharma business models.

Also facilitates a giant leap towards personalized medicine:

‘Gene therapy’ is also believed to be a giant leap of medical science towards personalized medicine. This is because, in addition to repairing and replacing defective or missing genes of a human body, this therapy can use body’s own cellular immune system to treat the disease. This is because, CAR-T cell therapy can fall in the category of personalized medicine, where a patient’s T cells are changed in the laboratory, empowering them to attack cancer cells.

Concerns that could threaten its ongoing commercial model:

Despite its significant patient-value offerings with long-term benefits, ‘gene therapies’ that have been approved and are already in the market had to confront with tough unforeseen challenges, both from fresh regulatory questions - to therapy withdrawal for commercial reasons. These developments, coupled with a very low and difficult to identify patient population, and affordability related low market access, prompt the need of a transformed marketing model for novel ‘gene therapy.’ This is important for financial sustainability of current ‘gene therapies’ in most pharma markets, globally, including the United States.

Some critical areas:

An article on ‘gene therapy’ by the Managing Directors of L.E.K Consulting, published by Cell & Gene on May 16, 2019, also pointed to some of these critical areas. Even this paper articulated, the fundamental value proposition of ‘gene therapy’, its long-term efficacy with a single-dose treatment, gives rise to a number of unique challenges for its manufacturing companies. Let me paraphrase below just three of those, as I understand, to drive home this point.

Declining number of eligible patients for most doctors: 

The promise of a functional cure is expected to limit ‘gene therapies’ to a single dose per patient, in most cases. Thus, inability to re-treat would lead such therapies to deplete their addressable prevalent populations, for most doctors. This is primarily because, as the number of treated patient accumulates – the number of potential patients who could be treated in a given year is reduced. This leads to demand that would peak early before steadily declining. Once the prevalent population is depleted, the demand for a gene therapy would be driven by incident patients.

However, research has now been initiated targeting larger populations – e.g., those suffering from leukemia and lymphomas. But, the greatest revenue potential for ‘gene therapy’, is expected to be its success in delivering life-changing treatment outcomes in multiple myeloma. When such patients will get to experience better outcomes from cell and gene therapies, the incremental approach the industry has been taking in this area, will be more than justified.

Till then, it could pose a challenge to business sustainability:

As discussed, the ‘gene therapy’ sales curve with an early peak and then steady decline, caused by a depleted addressable patient population within a few years after launch, could pose a serious challenge to business sustainability. This would require launching, possibly another ‘gene therapy’ product before the revenue of the first ‘gene therapy’ starts waning. Consequently, the timing of its life cycle management efforts and subsequent launches would be a critical success factor.

Intricacy of market access dynamics:

Optimal market access of ‘gene therapy’ will call for working in unison with virtually all stakeholders, including regulators, governments, and at the same time, effectively disseminating the real-life treatment-success stories. However, both in the developed countries and also in the emerging markets, such as India, its treatment cost will continue to remain a key barrier, sans some disruptive pricing strategy.

How this tough task remains unresolved, can be sensed from the Wall Street Journal (WSJ) report of December 19, 2019 titled, ‘Novartis to Offer World’s Most Expensive Drug for Free Via Lottery.’ For this purpose, Novartis launched a lottery-style program to provide doses of its pricey gene therapy for Zolgensma, a one-shot ‘gene therapy’ cure, for free of charge. But, this approach drew criticism from patient groups that called it – an inappropriate way to distribute a lifesaving treatment aimed at babies for a deadly inherited disease whose victims cannot control their muscles. At a price of US$ 2.1 million, Zolgensma, is the world’s most expensive drug.

Conclusion:

As I discussed above, ‘gene therapy’, also known as ‘human gene transfer,’ has been one of biotech’s momentous success stories in the new millennium, paving the way for a cure of many genetic disorders – once considered incurable. However, the number of patients on ‘gene therapy’ remains small compared to other therapeutic regimens, mainly because of two factors. One – this therapy, mostly targets rare diseases, and the second – even among those small patient populations, only very few can afford such pricey therapy.

Nevertheless, current research in this complex area, is now targeting larger populations – suffering from leukemia, lymphomas and multiple myeloma. Success in these areas will open the door of significantly greater revenue potential for ‘gene therapy’ by delivering life-changing treatment outcomes. Till then, its current business model, I reckon, would continue to pose a high commercial risk to this venture.

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.

‘Empowered Patients’: The changing dynamics of the pharmaceutical industry

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In good old days, at the time of someone falling sick in the family, a friendly local general medical practitioner, who was also known as a ‘family doctor’, used to be called to provide relief to the patient from pain and agony of the ailment.

Thorough knowledge of the patient’s medical history gained over a period of time, of these almost vanishing breed of caring doctors, was very common and used to come very handy to them while treating the patients. Their smiling or at times admonishing look at the patients for falling sick due to avoidable reasons, a caring approach – just like or even more than a family member and willingness to answer all questions related to sickness, used to instill a great confidence and hope in the minds of the patients for getting well soon, quite often even before the treatment had started.

Today the situation is very different. The concept of a family doctor mostly does no longer exist, even in the urban families of India. Though the elite groups belonging to the creamy layer of the society still talk in terms of ‘my dentist’ – ‘my cardiologist’ – ‘my physician’, patients by and large have started experiencing that their healthcare needs have been greatly compromised.

However in future, may not exactly be like a ’family doctor’, one can perhaps hope to call a doctor home for treatment in India, which will not cost a bomb as it happens today. ‘Times Of India’’, January 18, 2012 edition reports that “IIM-A student to deliver doctors at your door step.” This service is expected to provide both doctors and medicines at our doorstep at a phone call.”

Changing doctor-patient relationship:

The doctor–patient relationship has undergone a vast change over a period of time. The healthcare environment now very often smacks of commercial gain and loss of the service providers.

In India, even recently the government had to intervene to help restoring the ethical standards of both the medical profession and the pharmaceutical industry. That said, medical ethics and compliance, for all practical purpose, are still confined mostly in the text books, codes or in the carefully crafted ‘Standard Operating Procedures (SOPs)’ as a ‘show piece’, as it were, more for bending them at the least possible opportunity for hard commercial gains, rather than their conformance in terms of both letter and the spirit.

Individual ‘Patient Empowerment’:

Under the prevailing scenario, the civil society should encourage individual ‘Patient Empowerment’ by making him/her understand how the healthcare system is currently working on the ground, what and who are the key obstacles in getting a reasonably decent healthcare support and what should be done to uproot these obstacles in civilized ways.

It started in America:

The movement for ‘Patient Empowerment’ started in America in the 70’s, which asserts that for truly healthy living, one should get engaged in transforming the social situation and environment affecting their lives, demanding a greater say in their treatment process and observing the following tenets:

  • Patients’ choice and lifestyle cannot be dictated by others.
  • ‘Patient empowerment’ is necessary even for preventive medicines to be effective.
  • Patients, just like any other consumers, have the right to make their own choices.

The ‘Empowered Patient’ should always play the role of a participating partner in the healthcare process.

The essence of ‘Patient Empowerment’:

‘Natural Health Perspective’ highlighted ‘Patient Empowerment’ as follows:

  • Health, as an attitude, can be defined as being successful in coping with pain, sickness, and death. Successful coping always requires being in control of one’s own life.
  • Health belongs to the individual and the individuals have the prime responsibility for their own health.
  • The individual’s capacity for growth and self-determination is paramount.
  • Healthcare professionals cannot empower people; only people can empower themselves.

‘Patient empowerment’ prompts the ‘Patient-Centric’ postures:

In today’s world, the distrust of patients on the healthcare system, pharmaceutical companies and the drug regulators, is growing all over the world. This situation makes an ‘Empowered Patient’ resolve to actively participate in his/her medical treatment process.

Other stakeholders will have no other option but to take a ‘Patient-Centric’ posture, under the circumstances, which has already started happening. In India, as ‘out-of-pocket’ healthcare expenses are skyrocketing in the absence of a comprehensive and affordable universal health  coverage, ‘Empowered Patients’ will increasingly demand to know more of not only the available treatment choices, but also about the medicine prescription options.

‘Patient empowerment’ as the change agent:

Not so long ago, to generate increasing prescription demand and influence the prescription decision of the doctors, the pharmaceutical players used to provide product information to the medical profession through various persuasive means of the sales forces along with samples and a variety gifts, besides meeting their unmet needs with innovative medicines.

The above approach though still working very well in India, is no longer fetching the desired results to the pharmaceutical companies, especially in the developed markets of the world. ‘Empowered Patients’ have already started demanding much more from the pharma players. As a result, many global companies are now cutting down on their sales force size to try to move away from just hard selling by gaining more time from the doctors.  They have started taking new initiatives to open up a chain of direct communication with their primary and secondary customers with an objective to know more about them to satisfy them better.

In future with growing ‘Patient Empowerment’ the basic sales and marketing models of the pharmaceutical companies are expected to undergo a radical change. At that time, so called  ‘Patient-Centric’ companies of today will have no choice but to walk the talk. Consequently, they will have to willy-nilly switch from the ‘hard-selling mode’ to a new process of achieving business excellence through constant endeavor to satisfy both the expressed and the un-expressed needs of the patients, not just with innovative products, but more with innovative and caring services.

Role of ‘Empowered Patients’ in healthcare decision making process:

In the years ahead, more and more ‘Empowered Patients’ are expected to play an important role in their healthcare decision making process, initially in the urban India, ensuring further improvement not just in the  public and private healthcare systems, but also in inviting the pharmaceutical industry to be a part of that changing process.

In the book titled, “The Empowered Patient: How to Get the Right Diagnosis, Buy the Cheapest Drugs, Beat Your Insurance Company, and Get the Best Medical Care Every Time”, Elizabeth Cohen articulated as follows:

“The facts are alarming. Medical errors kill more people each year than AIDS, breast cancer or car accidents. A doctor’s relationship with pharmaceutical companies may influence his choice of drugs for you. The wrong key word on an insurance claim can deny you coverage.”

‘USA Today’ dated August 31, 2010 in an article titled, “More empowered patients question doctors’ orders,” reported:

‘In the past, most patients placed their entire trust in the hands of their physician. Your doc said you needed a certain medical test, you got it. Not so much anymore.’

Unfortunately in India, the situation has not changed much as on date.

‘Empowered Patients’ can influence even the R&D process:

Reinhard Angelmar, the Salmon and Rameau Fellow in Healthcare Management and Professor of Marketing at INSEAD, was quoted saying that ‘Empowered Patients’ can make an impact even before the drug is available to them.

He cited instances of how the empowered breast cancer patients in the US played a crucial role not only in diverting funds from the Department of Defense to breast cancer research, but also in expediting the market authorization and improving market access of various other drugs.

Angelmar stated that ‘Empowered Patients’ of the UK were instrumental in getting NICE, their watchdog for cost-effectiveness of medicines, to change its position on the Age-related Macular Degeneration (AMD) drug Lucentis of Novartis and approve it for wider use than originally contemplated by them.

Meeting the challenge of change:

To respond to the challenge posed by the ‘Empowered Patients’ pharmaceutical companies, especially in the US are in the process of developing a more direct relationship with the patients (consumers). Creation of ‘Patient Empowered’ social networks may help to address this issue effectively.

For example, to respond to this challenge of change companies like, Novo Nordisk is developing a vibrant patient community named ‘Juvenation’, which is a peer-to-peer social group of individuals suffering from Type 1 diabetes. This program was launched by the company in November 2008 and now the community has over 16,000 members, as available in its ‘Facebook’ page.

To cite one more example, Becton, Dickinson and Co. created a web-based patient-engagement initiative called “Diabetes Learning Center” for the patients, not just to describe the causes of diabetes, but also to explain its symptoms and complications. From the website a patient can also learn how to inject insulin, along with detailed information about blood-glucose monitoring. They can even participate in interactive quizzes, download educational literature and learn through animated demonstrations about diabetes-care skills.

Some other Pharmaceutical Companies, who are in the process of engaging with the customers through social media like Twitter, are Pfizer, Johnson & Johnson, Novartis, Boehringer Ingelheim, AstraZeneca, Bayer, GlaxoSmithKline, Sanofi, Roche and Merck.

Conclusion:

Since so many years from now, especially in the developed countries of the world, pharmaceutical companies have been talking about being ‘Patient-Centric’ to ride squarely the increasingly powerful tide of ‘Patient Empowerment’ in their endeavor to satisfy the assertive demands of the new generation of healthcare consumers – the patients or the patient groups.

However, in many cases the prevailing healthcare provisions, the structure and culture together with stiff resistance of the regulators to let the industry engage directly with the patients, have inhibited the ‘Patient-Centric’ intent of the stakeholders in general, to take off the ground in a meaningful way.

At the same time, the aggressive marketing focus of the pharmaceutical industry and blatant commercialization of the system by the healthcare professionals, have more often than not failed to translate the good intent of ‘Patient-Centric’ healthcare process into reality.

Increasing general awareness and rapid access to information on diseases, products and the cost-effective treatment processes through internet, in addition to fast communication within the patients/groups through social media like, ‘Twitter’ and ‘Facebook’ by more and more patients, I reckon, are expected to show the results of ‘Patient Empowerment’ initiatives… ultimately.

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.