Self-made Barriers To Business Transparency Impacting Drug Access

Posted on August 5, 2019 by Tapan Ray

A recently published book on pharma industry tried to expose the deceit behind many generic-drug manufacturing—and the consequent risks to global health. This publication is described as an ‘explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale.’ However, I reckon, this is just a part of the story, and its huge adverse impact on public health flows generally from the following facts:

Greater use of generic drugs is hailed as one of the most important public-health developments of the twenty-first century.
Today, almost 90 percent of global pharma market, in volume terms, is comprised of generics.
These are mostly manufactured in China and India.
The drug regulators continuously assure patients and doctors that generic drugs are identical to their brand-name counterparts, just less expensive.

No question, such deceit, blatant fraud and data manipulation – seriously affecting drug quality of generic medicines, shake the very purpose of making affordable drugs accessible to many. But, simultaneously, lack of transparency – right across the various functions of a pharma business, is also making a host of modern life-saving drugs unaffordable and inaccessible to even more patients. Although, both are despicable acts, but the latter one is not discussed as much.

Thus, in this article, I shall dwell on the second one – how attempts for pharma business ‘transparency’ for expanded drug access to patients, getting repeatedly foiled, especially in light of what happened on May 28, 2019, in the 72^nd World Health Assembly (WHA).

Does pharma want low business transparency to continue?

Despite so many encouraging initiatives being taken in the pharma industry over a period of time, gross lack of transparency in its business continues, since long, despite this is being a raging issue. The obvious question, therefore, remains: Does pharma want low business transparency to continue? Thus, to give a perspective to this pertinent point, I shall quote two important observations, appeared in ‘MIMS Today’ – the first one on April 17, 2017, and the other came a year before that, on November 20, 2016, as follows:

“A market cannot function when purchasers have limited information and, in the case of prescription drugs, pricing is a black box. Prices for drugs are clearly rising at rates that far exceed inflation and the level of any rebates or discounts offered by manufacturers,” experts opined. They further said, to hold the industry accountable, Access to Medicine Foundation (AMF)’ regularly compiles an index to rank the progress made by each large drug maker in the area of business transparency. Curiously, they concluded, ‘the number and quality of evaluations for the effectiveness of these programs are lacking.’

“Lack of transparency of drug makers was also identified. Their policy positions, political contributions, marketing activities and memberships in associations and the associated financial support provided and board seats held were all analyzed. And only then, the ‘AMF’ reached a consensus that transparency remains low in all areas. The analysts further added, ‘there is a lack of transparency and rigor in monitoring and evaluating the access-to-medicines initiatives as well as the link between prices and development costs. Thus, ‘greater transparency from manufacturers to disclose R&D costs for drugs and evaluation of the initiatives’ is imperative.

Despite key policy makers’ favoring transparency, it remains elusive:

To illustrate this point, let me draw a recent example from the United States.

Alex M. Azar II, who is currently the Secretary of Health and Human Services of the United States, also served as president of Eli Lilly USA. LLC from 2012 to 2017 supports the need of business transparency in the pharma industry. Last year, he also emphasized:

“Putting patients in charge of this information is a key priority. But if we’re talking about trying to drive not just better outcomes, but lower costs, we also have to do a better job of informing patients about those costs. That is where our emphasis on price transparency comes in.” By naming the key health care product and service providers, Azar added, “So this administration is calling on not just doctors and hospitals, but also drug companies and pharmacies, to become more transparent about pricing and outcomes of their services and products.”

Like Secretary Azar, policy makers in several other countries, including India, are also talking and seemingly in favor of transparency in health care business systems, but it remains elusive, as we shall see below.

Do vested interests create over-powering pressure to maintain status-quo?

The above examples give some idea about the pressure created by vested interested to maintain a status-quo in this important area. Although, business transparency is a must, pharma influence on policy makers is so powerful that even a recent global resolution on the subject, had to dilute its original version in its final avatar, significantly, which I shall now focus on, as yet another vindication on this issue.

The final version of the 2019 WHA resolution made weaker in transparency:

On May 28, 2019, by a News Release in Geneva, the World Health Organization (W.H.O) announced, to help expand access to medicines for all, the72^nd World Health Assembly (WHA) adopted a significant resolution on improving the transparency of markets for medicines, vaccines and other health products, globally. I repeat, this was a global effort to expand access. The assembly brought together delegates from 194 Member States of the W.H.O, including India – from 20 to 28 May 2019, in Geneva, Switzerland.

Intriguingly, as several reports highlighted, ‘the final resolution is considerably weaker than the original draft.’ Nevertheless, it still provides, at least, some measures, which have potential to make an impact on market access, globally.

What exactly was the 2019 WHA original resolution?

The original WHA draft resolution, titled ‘Roadmap for access 2019-2023 – Comprehensive support for access to medicines and vaccines’, urged the Member states the following:

To enhance public sharing of information on actual prices paid by governments and other buyers for health products,
Greater transparency on pharmaceutical patents, clinical trial results and other determinants of pricing along the value chain from laboratory to patient.
Requests the WHO secretariat to support efforts towards transparency and monitor the impact of transparency on affordability and availability of health products, including the effect of differential pricing.

Highlighting that access to medicines is the key to advancing the Universal Health Coverage (UHC), the resolution aims to help the Member States:

To make more informed decisions when purchasing health products,
Negotiate more affordable prices
And ultimately expand access to health products for the populations.

Palpable discomfort of large pharma associations:

The May 30, 2019 article of the Pharm Exec Magazine on this resolution, carried a headline with a query: Is it ‘A Watershed on Transparency and International Collaboration in Drug Pricing?’ The paper brought out some important points that may help explain why the 2019 original WHA resolution, could not be adopted as such. Apparent discomfort in this regard of some top industry associations, which were created and fully funded by large global drug companies, was palpable, according to this report.

For example, “the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), warned governments ‘to carefully consider potential risks to patients, particularly in less developed countries, of sharing outcomes of confidential price negotiations across countries.’ The implication is that prices in less-affluent countries could rise if the wealthier nations used international transparency to demand lower prices for their markets.”

Why couldn’t the original resolution on business transparency be adopted?

To instantiate the level of discomfort of vested interests, let me highlight some critical changes made in the 2019 in final WHA resolution at the international level, as I get from the above paper. A few of which are as follows:

	In the original draft	Changes in the final resolution
1.	“Undertake measures to publicly share information on prices and reimbursement cost of medicines, vaccines, cell and gene-based therapies and other health technologies.”	Refers to publicly sharing of information only on net prices.
2.	“Require the dissemination of results and costs from human subject clinical trials, regardless of outcome or whether the results will support an application for marketing approval.”	“Take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and, if already publicly-available or voluntarily-provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval.”
3.	“Require the publication of annual reports on sales revenue, prices, units sold, and marketing costs for individual products, as well as details of the costs of each trial used to support a marketing authorization application and information on financial support from public sources used in the development of a drug.”	Calls on the member states to “work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives.”
4.	Wanted the WHO Director-General to “propose a model/concept for the possible creation of a web-based tool for national governments to share information, where appropriate, on medicines prices, revenues, units sold, patent landscapes, R&D costs, the public sector investments and subsidies for R&D, marketing costs, and other related information, on a voluntary basis.”	Diluted only to “assessing the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for health products, including investments, incentives, and subsidies.”
5.	Proposed the creation of a forum to “develop suitable options for alternative incentive frameworks to patent or regulatory monopolies for new medicines and vaccines” that would both promote universal health coverage and adequately reward innovation.	This point doesn’t find any place in the final resolution.

It appears, the final 2019 WHA resolution has been able to remove the key points of discomfort for the drug industry – caused by greater business transparency. It is largely due to the fact that the final pledges ‘consist largely of recommendations for voluntary action rather than the requirements for comprehensive disclosure proposed in the original draft.’

Conclusion:

To arrive at a consensus, especially over promoting transparency in costs incurred towards R&D of drugs and health-related technologies, appeared challenging for the W.H.O Member States, inthe 72nd World Health Assemblythat concluded on May 28, 2019.Overall resolution changed the narrative from a mandatory process to a voluntary initiative. As I said before, it still prescribes several measures, which can help expand access to medicines for all, across the world.

In tandem, it also comes out clearly that barriers to business transparency to ensure better access to drugs for all, across the world, are not easy to uproot, either. Especially, when it comes to fighting against concerted efforts of powerful pharma lobby groups, other vested interests and some looney fringes.

The process of adoption of the May 2019 WHA final resolution of the world’s most relevant public health issues, is just an example.

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 ‘Chatbots’: For Better Stakeholder Engagement

Posted on July 29, 2019 by Tapan Ray

The critical value of meaningful interaction and engagement with individual customers – responding to their specific needs, is fast drawing attention of many businesses, for sustainable performance excellence. The same is happening in the pharma industry, as well. Creative use of this process leveraging modern technological support systems, would also provide a unique scope of cutting-edge brand service differentiation, in well researched areas.

That, it is a very important focus area for the pharma players, is no-brainer. Nonetheless, what really matters most is the novelty in strategizing such interactions and engagements, especially with patients and doctors. I also wrote about it in my article, titled ‘Indian Pharma To Stay Ahead of Technology Curve,’ published in this blog on May 22, 2017. Over two years ago, I clearly indicated there that application of AI via digital tools, called ‘Chatbots’ – the shorter form of ‘Chat Robot’, is one of the ways that pharma may wish to explore this area.

Illustrating this point in that article, I mentioned that on March 05, 2017, a leading bank in India announced the launch of an AI-driven Chatbot named Eva, coined from the words Electronic Virtual Assistant (EVA), to add more value to their services for greater customer satisfaction. ‘According to reports, Eva is India’s first AI driven banking Chatbot that can answer millions of customer queries on its own, across multiple channels, immediately.’

In this article, I shall dwell on this interesting area, with a primary focus on pharma sales and marketing, and assess the progress made in this space, thus far, by several drug companies, including some Indian players. Let me start by recapitulating the basic function and purpose of ‘Chatbots’ in pharma.

Pharma ‘Chatbots’ – the function and purpose:

Simply speaking, pharma ‘Chatbots’ are also AI-powered, fully automated virtual assistants. Its basic function is to mimic one-to-one human conversation on particular areas, as desired by the user. Likewise, its basic purpose is to genuinely help and assist the customers who are in search of right answers to specific disease related questions, in a one-to-one conversational format, having a higher source-credibility.

In that process, ‘Chatbots’ can effectively satisfy the patients and doctors by providing them the required information, immediately. In tandem, pharma companies also reap a rich harvest, by developing not just a trust-based healthy relationship with them, but also in building a robust corporate brand – creating a long-term goodwill that competition would possibly envy.

Effective customer satisfaction is an area that can’t be ignored:

In the digital age, a new type of general need is all pervasive, with its demand shooting north. This is the need to satisfy a voracious appetite among a large section of the population for all types of information, with effortless and prompt availability of the required details – as and when these come to one’s mind.

When such information need relates to health concern of a person, such as – available treatment options against affordability, or drug price comparisons – factoring in effectiveness, safety concern – exactly the same thing happens. Most individuals won’t have patience even to write an email and wait for an answer, even the wait is just for a short while.

In the current scenario, it will be interesting to fathom, how would a pharma company, generally, interact or engage with such patients, to further business and creating a possible long-time customer? Some companies have started responding to this need – effectively and efficiently, by providing easy access to information through ‘Chatbots’, created on advances AI platforms. But, such players are a few in number.

Can pharma also think of ‘Chatbots’, like ‘Siri’ or ‘Alexa’?

Today, several people are using standalone and branded Chatbot devices in everyday life, such as, Siri (Apple), Alexa (Amazon), Cortana (Microsoft) or Google Now (Android). Interestingly, many industries, including a few companies in pharma, have also started developing their own version of ‘Chatbot dialog application systems.’

Industry specific ‘Chatbots’ are designed to meet with some specific purpose of human communication, including a variety of customer interaction, information acquisition and engagement – by providing a range of customized services to the target group.’ ‘Siri’ or ‘Alexa’ or the likes, on the other hand, are all-purpose general Chatbots, though, for everyday use of individuals. Thus, the question that comes up, in which areas pharma companies can use Chatbots to add value to their interactions and engagements with patients, in general, and also doctors.

Where to use ‘Chatbots’ as a new pharma marketing channel?

Some of the findings on the application of ‘Chatbots’, especially in pharma sales and marketing, featured in the CMI Media publication in December, 2016. It found that drug companies have a unique scope to leverage this new sales and marketing – channel, by developing ‘Chatbots’ in the company represented therapy areas. Following are just a few most simple illustrations of possible types ‘Chatbots’ for interaction and engagement with patients, which can be designed in interesting ways:

That can answer all types of patient questions on specific diseases, educate them about the disease and available treatment options with details.

That allows patients or physicians to get all relevant information about the prescription drugs that they require to prescribe for patients to start treatment, including potential side effects, adverse events, tolerability, dosing, efficacy and costs, besides others.

Once a treatment option is chosen, a third kind of Chatbot can help with patient adherence to treatment, provide reminders when the treatment should be administered, explain how to properly dose and administer the treatment, and other relevant information.

Chatbots could also be useful for doctors and nurses:

As the above paper finds, ‘Chatbots have value for serving healthcare professionals as well, for example:

When, physicians and nurses want to understand the pathogenesis, pathophysiology, and/or progression of a specific disease in their patients.

Although, such content may also be available on disease state awareness sites, but branded Chatbots would make that content readily available in more of an FAQ format.

When health care professionals would like to get data around safety/toxicity, or information about dosing strengths, calculations, and titrations, while using specific brands.

Chatbots can also be effectively utilized by the drug manufacturer to gain deep insights into customer behavior across all touchpoints, to enhance end-to-end customer experience, as I wrote in this blog on July 02, 2018. The data created through this process, can also be put to strategic use to design unique brand offerings.

Need to chart this frontier with caution:

Pharma, being a highly regulated industry in every country of the world, with a varying degree, though, the ‘Chatbot’ development process should strictly conform to all ‘Dos’ and ‘Don’ts’, as prescribed by the regulators of each country. Each and every content of the ‘Chatbot’ should pass through intense, not just regulatory, but also legal and medical scrutiny. Yet another, critical redline that ‘Chatbots’ should never cross is the ‘privacy’ of any individual involved in the process.

Three critical areas to consider for pharma ‘Chatbots’:

Effective pharma ‘Chatbots’ are expected to get ticks on all three of the following critical boxes:

Meeting clearly defined unmet needs of patients in search of a health care solution or most suitable disease treatment options.
Brand value offerings should match or be very close to the targeted patients’ and doctors’ expectations.
Should facilitate achieving company’s business objectives in a quantifiable manner, directly or indirectly, as was planned in advance.

Pharma has made some progress in this area, even in India:

To facilitate more meaningful and deeper engagements with patients, some drug companies, including, in India, are using ‘Chatbots.’ Here, I shall give just three examples to drive home the point – two from outside India and one from India.

October 23, 2018 issue of the pharma letter reported, a study from DRG Digital Manhattan Research found, ‘Novo Nordisk and Sanofi brands rank best for the digital type 2 diabetes patient experience.’ The article wrote, about some pharma players ‘facilitating deeper engagement through the use of automated tools like Chatbots to triage inquiries and get patients the answers they need faster, and through interactive content like quizzes and questionnaires that pull patients in and help them navigate health decisions,’ as follows:

Novo Nordisk‘s diabetes website includes an automated Chat feature dubbed “Ask Sophia,” helping patients access disease and condition management information more quickly.

Likewise, Merck & Co‘s website for Januvia employs interactive quizzes to educate patients and caregivers.

Similarly, on November 23, 2018, a leading Indian business daily came with a headline, ‘Lupin launches first Chatbot for patients to know about their ailments.’ It further elaborated, the Chatbot named ‘ANYA’, is designed to provide medically verified information for health-related queries. The disease awareness bot aims to answer patient queries related to ailments,’ the report highlighted.

Chatbots – global market outlook:

According to the report, titled ‘Healthcare Chatbots – Global Market Outlook (2017-2026),’the Global Healthcare Chat bots market accounted for USD 97.46 million in 2017 and is expected to reach USD 618.54 million by 2026 growing at a CAGR of 22.8 percent.

The increasing demand for Chatbot ‘virtual health assistance’, is fueled primarily by the following two key growth drivers, the report added:

Increasing penetration of high-speed Internet.
Rising adoption of smart devices.

Conclusion:

With the steep increase of the usage of the Internet and smart phones, general demand to have greater access to customized information is also showing a sharp ascending trend, over a period of time. A general expectation of individuals is to get such information immediately and in a user-friendly way.

Encouraged by this trend, and after a reasonably thorough information gathering process, mainly from the cyberspace, many patients now want to more actively participate in their treatment decision making process with the doctors. This new development has a great relevance to drug companies, besides other health service providers. They get an opportunity to proactively interact and engage with patients in various innovative ways, responding to individual health needs and requirements, thereby boosting the sales revenue of the corporation.

The unique AI-driven technological platform of pharma ‘Chatbots’, is emerging as cutting-edge tools for more productive stakeholder engagement – so important for achieving business excellence in the digital world. The recent growth trajectory of ‘Chatbots’ in the health care space, vindicates this point.

By: Tapan J. Ray

Visible, The Green Shoots of Digital Transformation in Pharma

Posted on July 22, 2019 by Tapan Ray

Currently, one gets a mixed feeling about the progress of digital transformation in the pharma industry. This is despite various reports confirming that a number of major initiatives in this field have been taken, especially by Big Pharma, globally. Moreover, these are primarily driven by the company CEOs, as it should be, and adequately backed by heavy investments.

Another recent trend can’t also be wished away, as corporate C-suites find a new breed of leadership – Chief Digital Officers (CDO) as occupants. It has already happened in several top pharma companies. Alongside, one can spot in this milieu, a plethora of private ‘digital trainers’ – wearing interesting titles and offering courses of many types, especially for pharma line managers.

On the flip side, many experts feel that ‘digital transformation of business’ is currently more a buzz in the drug industry than reality. These are, apparently, piecemeal attempts of converting analogue formats to digital, in a number of functional areas to improve operational efficiency of the same process.

Thus, it’s time to go for a reality-check at the ground zero, to ascertain the overall progress of the industry in this area, at least, in the last five years. While doing so, in this article, I shall try to hear the views of the top company CDOs on the nature of the challenge, alongside examine some credible research findings. Let me begin this discussion by looking at where exactly does the pharma industry stand today in this space, as compared to other industries.

A fact-check:

That many players in the drug industry, continue to have no clear digital vision and strategy, was established in the ‘Harvey Nash/KPMG CIO Survey 2018.’ This survey is claimed to be the largest on IT leadership in the world, with almost 4,000 participants across 84 countries, representing over USD 300 bn of IT budget spend.

The report provides a snapshot of the pharma industry in several areas, particularly where the industry’s responses differed significantly from those across other industries. As I go along with my submission, I shall fact-check and quote from this data. Let’s find below the industry response to the following two key questions:

A.‘Does your organization have a clear digital business vision and strategy?’

Industry

Yes (enterprise-wide)

Yes (Within business units) %

Pharma

All industries

The second question is even more specific:

B.‘Does your organization have a Chief Digital Officer or someone serving in that capacity?’

Industry

Dedicated CDO

Someone else in that role %

Pharma

All others

That said, let me also acknowledge, enough evidences suggest that a sort of ‘digital warming-up’ has commenced in the industry for some time now.

‘Digital warming-up’ has commenced:

That the process has just begun, was captured in several reports. Let me illustrate the point, citing an example of the article, titled ‘Marketing outside the box’, published in the Pharma Times Magazine of May 2017.

Considering blistering pace of progress and rapid adaptation of digital technology in businesses, it is interesting that a couple of years ago, the above article highlighted exactly what many would articulate even today. The author noted: ‘Think pharmaceutical marketing these days and the buzz words digital, consumer engagement, multichannel, and closed-loop all come to mind.’ Focusing on the possibility to make it happen, sooner, the paper added, ‘There is now a dizzying array of tools, technologies and tactics that can be combined in various permutations to create marketing campaigns unheard of a mere five to 10 years ago.’ Thus, the ‘digital warming-up’ notwithstanding, the key question, I reckon, is, about two years down the line, how many drug companies have started maintaining an enterprise-wide digital business strategy?

A soft target – for rationalization:

To rationalize the leisurely progress of this key initiative, one may possibly choose the soft target and say,drug companies being a part of a highly regulated and tradition-bound industry, are late to fathom the indispensability of digital transformation of business. But this justification is open to many probing questions. One such counter-query could be – in that case, why many constituents of as stringently regulated industry, if not more, – financial services business, including banking, are galloping ahead with digitization?

Even if, the above rationalization is accepted at its face value, the other question won’t also be too easy to answer: Why digitization is not gaining momentum in the pharma industry, as much as it should, particularly as compared to other highly regulated industries? Such probes understandably may not attract too many affirmative answers. However, the crux of this issue was reported in the headline of Fierce Pharma on June 25, 2019 – ‘Pharma’s got its chief digital officers. Now let’s see the results.’

In pursuit of holistic outcomes with digitization:

The August 2015 paper of McKinsey, titled ‘The road to digital success in pharma’, also acknowledged, just as other related one, the drug industry can play a pivotal role in the digital transformation of healthcare – changing lives of many. While pointing out, capturing this opportunity requires identifying the right initiatives, the article cautioned the industry, it needs to run harder ‘to keep pace with changes brought about by digital technology.’

There are indications that some top pharma decision makers have also realized that this change has to happen, sooner – assigning top organizational priority, and demanding sharp focus of all. As I wrote in my article of October 29, 2018, several companies have created a brand-new C-Suite position, to ‘lead the company’s digital efforts across research, discovery and business processes.’

The initiative intensified in the last two years:

According to May 13, 2019 edition of Biopharma Dive, seven of the nearly thirty pharma and biotech companies valued at more than USD 10 billion has named a Chief Digital or Information Officer (CDD/CIO) on their executive committee. Such placements facilitate greater influence for organization-wide changes and signal that they are taking the potential of digital technologies seriously to transform their respective business models.

Interestingly, six of those individuals were appointed to top management within the last two years. This shift comes, as tech companies like Amazon and Apple inch further into medicine, in a different form, though. Taking a cue from this emerging trend, some pharma majors are also merging research and development of new medicines with digital technology and big data. Thus, even CDO responsibilities are going through a curious metamorphosis.

Is CDO position a temporary one?

This question is aptly answered in the 2019 Report on the study of CDOs conducted byStrategy &, PwC’s strategy consulting group. The paper finds, the elevation of CDO at the Corporate Executive Committee or the Board level, ‘reflects the growing recognition that the digital transformation agenda now has strategic importance to most organizations, and that, unless it is driven from the top of the enterprise, it will not have the required momentum to drive business change.’ Overall in business: ‘More than half (54 percent) of CDOs have board-level status today, up from 40 percent in 2016’, the report highlights.

Although, it is construed as a general industry trend today, the report however, captures a clear dissonance. It found that leaders at many companies believe that putting a single person in charge of digital transformation may not be the best approach, as it is an intrinsic strategic priority, across the whole business, where agility becomes critical for survival. Thus, the researchers felt, as digital transformation becomes part of the core business, the next step will possibly be for the CDO to disappear. When it happens, digital transformation will become the responsibility of every member of the executive team of the organization.

Be that as it may, we shall cross that bridge when we come to it. At present,the basic groundswell for digital transformation of the entire business, is created from the C-Suite of the CDO. Thus, let us dwell on the scope of CDO in a pharma company.

Current scope of CDO in a pharma business:

Let me illustrate this point by quoting from the Press Release of Sanofi, dated February 12, 2019, appointing their CDO. It said, the CDO will be responsible for enhancing Sanofi’s strategy to integrate digital technologies and medical science to ultimately improve patient outcomes. His mandate will include scaling up Sanofi’s ongoing portfolio of digital initiatives by developing broad external partnerships, building out internal infrastructures, and exploring new business opportunities for the company in the digital space.

Thus, the role of a CDO is primarily focusing on both - developing a digital health strategy and improve internal capabilities, to effectively use new technologies and advanced analytics to deliver the deliverables, more effectively. As many would know, last year, both Pfizer and Merck announced appointments of CDOs for the first time in the company. In 2017, Novartis and GlaxoSmithKline (GSK) also created similar C-Suite positions.

Now, CDOs will need to prove their value:

Yes. That’s exactly what the Sanofi CDO said in the above Fierce Pharmaarticle – appeared on June 25, 2019. He was forthright in admitting, after a few years, pharma and biotech companies would be ‘kind of pressuring’ CDOs to ask, ‘Well, what have you really achieved? And show me the results. Have you made us more efficient? Have you transformed the way we work? Have you created new business? Have you really given us new tools, new technologies, new drugs which are digitally enhanced? And show me where they are.’

Hence, the pace of digital transformation of companies needs to be much faster now than ever before.

The current status of digitization in pharma:

Since, proof of the pudding is in the eating, let’s get a feel of the company employees in this area from their response to the query from the same ‘Harvey Nash/KPMG CIO Survey 2018.’:

‘Overall, how effective has your organization been in using digital technologies to advance its business strategy?’

Industry	Very effective %	Moderately effective %	Not/Slightly effective %
Pharma	17	37	36
All others	22	42	46

The above details may not reflect a great progress for the pharma industry in digital transformation. Nevertheless, this space doesn’t remain barren either, not any more. Some signs of progress – some green shoots, I reckon, are indeed discernable.

Conclusion:

As I see it, the need for digital transformation is an existential issue for the pharma industry. No one can afford to let this initiative die. In any case, the technological wave of such dimension, power and relevance for all, will always prevail – getting stronger – as the days pass by.

That said, there isn’t much doubt, either, that many drug companies are finding it challenging to keep pace with the rapid progress of technology, where obsolescence is also equally fast. Some are also facing tough barriers to scale up digital transformation across the organization. The rest seems to be not very sure how and where to start it from.

On the other hand, as I also wrote in my article in this blog on April 08, 2019, fueled by, among others, Internet of Things, the health care environment, including in India, is moving towards a ‘connected healthcare’ regime. This disruptive change will demand the best value offerings from each brand for better patient outcomes.

The good news is, at least, some green shoots of digital transformation in the pharma space are certainly coming up. But its pace needs to be considerably accelerated and now, creating an optimal groundswell – always being on the same page with customers – for path-breaking outcomes.

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.

Disruptive Impact of AI on Pharma Sales And Marketing

Posted on July 15, 2019 by Tapan Ray

Artificial Intelligence (AI) that refers to the ability of machines to perform cognitive tasks like thinking, perceiving, learning, problem solving and decision making, is poised to disrupt our world. Initially conceived as a technology that could mimic human intelligence, AI has evolved in ways that far exceed its original conception. This was articulated in the June 2018 Discussion Paper, titled ‘National Strategy for Artificial Intelligence’ of NITI Aayog, India.

The paper further highlights: With intelligent machines enabling high-level cognitive processes like thinking, perceiving, learning, problem solving and decision making, coupled with advances in data collection and aggregation, analytics and computer processing power, AI’s capability has dramatically expanded. So is its game-changing utility in a growing number of fields to enhance productivity – dramatically.

I also expressed this need in my article, “Indian Pharma To Stay Ahead of The Technology Curve,” published in this Blog on May 22, 2017. Nevertheless, despite galloping progress of AI, a kind of ‘Ostrich Syndrome’ still prevails in some sections of the industry. This attitude, if continues, may catch many drug companies off-guard, with serious repercussions on business. In this article, I shall focus on the possible impact of AI on pharma business, specifically on pharma sales and marketing, instead of being prescriptive in my deliberation.

A disruptive impact on pharma value-chain:

Currently, only a few drug companies have embraced AI-driven technologies to transform pharma value-chain elements, across functional areas of the organization. However, in the next few years, effective adaptation of AI, in the true sense, will be the key success factors for any player – nurturing a burning desire to succeed, consistently. This was, again, an important conclusion of the 2019 FICCI Report titled, ‘Use of Artificial Intelligence and Advanced Analytics in pharmaceuticals.’

While explaining its rationale, the report emphasizes – catalyzed by an exciting range of new, disruptive technologies a paradigm shift is taking place, challenging the status quo with the traditional pharma business model. AI is in the process of disrupting this status quo, especially in the following two areas:

Increasing stakeholder pressure to reduce costs and demonstrate greater value of drugs,
Evolving swing from treatment to prevention, and patient-centric treatments.

Prompts a critical need to re-imagine the future:

These inevitable shifts prompt a critical need to re-imagine the future, for each drug manufacturer. However, the good news is, some of them, predominantly the global ones, have started making sizeable investments on AI. On a deeper scrutiny, the FICCI paper finds that applications of AI are mostly taking place in the new drug discovery and the supply chain area.

Besides individual company initiatives in the R&D area, important collaborative arrangements on AI with academia, have also been announced, such as, ‘Machine Learning for Pharmaceutical Discovery and Synthesis Consortium (MLPDS). This is a collaboration between the pharma/ biotech industries and the departments of Chemical Engineering, Chemistry, and Computer Science at the Massachusetts Institute of Technology (MIT).

MLPDS is expected to facilitate the design of useful software for the automation of small molecule discovery and synthesis. As on July 02, 2019, reportedly, ‘33 Pharma Companies Using Artificial Intelligence in Drug Discovery.’That said,let me hasten to add that some companies are also testing the water, with all seriousness, in pharma sales and marketing functions. So, the AI wave is fast catching up, driving the drug industry to chart uncharted frontiers. In this scenario, would there be any scope of survival for laggards?

Should it happen faster in pharma sales and marketing, as well?

In my view, the answer is an emphatic ‘Yes.’ This is primarily because, the disruptive impact of AI won’t be any less in pharma sales and marketing. It will, therefore, be prudent for these professionals, not just to understand how AI works in their respective functions, but also the ways to effectively use various AI platforms and applications, to transform the traditional processes, fundamentally.

Moreover, when stakeholders, including patients, doctors, hospitals, health insurance companies and even governments, are directly or indirectly using a host of AI-enabled tools and applications for better outcomes, does pharma have any other option?

Areas in which the impact could be transformative:

The recent publication titled, ‘Boosting Pharmaceutical Sales and Marketing with Artificial Intelligence’ of ZS, analyzed this issue quite well. It emphasized, those functions in the drug industry where there exists a significant reliance on human functions, such as expertise and reasoning, the impact of AI can be transformative.

Sales and marketing are two such focus areas, besides other functions. Companies that use AI to orchestrate a cohesive customer experience, will drive stronger differentiation, better customer access and higher sales impact, the report highlighted. Thus, creating specific opportunities and requisite empowerment, are necessary for deserving people, to foster machine learning and human integration in sales and marketing. This, in turn, will help them gain insight into how to unleash the power and value of AI for achieving business excellence.

Some early adopters of AI in sales and marketing:

Recent reports indicate that some global pharma majors have started using AI in sales and marketing. Let me illustrate this point with two examples – Pfizer and Novartis.

In May 2017, Pfizer Australia, reportedly, adopted AI-powered digital analyst tool for sales and marketing decision making.This ‘What-if Simulator’, allows Pfizer to test and optimize a range of scenarios based on internal and external data sets. It helps simulate the impact of sales and marketing strategies, investigate assumptions and hypothesis difficult to test in the real world, and compare the outcome of various what-if scenarios in order to understand what’s contributing to business results. According to Pfizer, ‘the software will also help to understand deterministic and non-deterministic factors presented in its business operations, as well as see how variables within different questions impact one another’.

Another recent media report titled, ‘Novartis puts AI on the job to help reps say the right things to the right doctors,’ appeared in Fierce Pharma on January 09, 2019. It also confirms the keen interest of pharma in this area. Called “virtual assistant,”this application helps salespeople to make sure when they visit a specific doctor that they are talking about exactly what that doctor is absolutely interested in. “When you turn up at the right time with the right things to say, they’re more interested and put more value in it, and our people like the fact that AI is running in the background helping them plan their day,” Novartis official further elaborated.

Accept the dictum – ‘there is always enough room for improvement’:

Following this dictum, is the starting point for pharma marketers to seriously accept AI as a game changer in this industry, regardless of how successful the company is – in doing what they do, following the traditional business models. The core purpose of a drug company is to make sure that patients get what they want, in those disease areas where the company represents.

If a brand strategy is prepared based on research data collected a few months back, there could probably be a flaw in your strategy. This is because any recent offering to patients by a competitor, may have considerably changed what the patients want now. If a strategy is not based on virtually real-time information on what exactly the customers are looking for now, the result could be far from satisfactory.

The elements which are critical in creating ‘great brands,’ were nicely captured in the May 13, 2019 issue of Customer THINK on ‘AI in Digital Marketing.’ It articulated, ‘Great brands will be those that can think creatively, design effectively, and execute flawlessly to deliver seamless experiences woven together by machines and humans. Using this approach, marketers and their marketing machines will stay gainfully employed.’ Thus, creative application of AI by astute pharma marketers will help achieving this goal.

Will AI ultimately replace pharma sales and marketing people?

This is a lurking fear in the minds of many. A related article appeared in the pharmaphorum on July 02, 2019, also wrote about a similar apprehension. The paper is titled, ‘Will AI make pharma marketers obsolete?’ It said: ‘Artificial intelligence, is sometimes seen as either a panacea or a destroyer – the fix for all humanity’s problems, or the apocalyptic scourge that will turn on us.’

I too reckon, AI can never replace people in pharma sales and marketing operations. This is because, there are two distinct elements in both these functions. One, the creative power of a professional that creates, develops, hones, and executes new ideas, strategies. It even decides how effectively AI can be used. The second element is the technological power behind AI. This can carry out a host of different very important, but routine and repetitive tasks – with a great amount of precision and virtually flawless. As the key sales and marketing professionals will need both, the AI can’t completelyreplace people in these two critical operational areas.

Some uses of AI in sales and marketing:

Eularis, in its ‘Blog, Comment & Insight’ of January 15, 2018, deliberated on this area. Just to give a feel of possible use of AI in different very important, but routine and repetitive tasks – with a great amount of precision, I am summarizing some of those points, as follows:

‘Identification and Mapping’ of’ Key Opinion Leader (and up-and-coming Key Opinion Leader), which is constantly changing. Alongside, it can help scan and analyze all relevant journal articles, coming out each week, besides the same for ongoing clinical trials in the chosen field – flagging how changes and new additions can impact the KOL database.

Disease specific patient identification and physician targeting, especially in rare disease areas.

Helps identify individual preferences for content, channels and timing of information, that leads to allowing personalization at scale, and ensuring every customer is receiving what they want, when they want, and in the channel they want.

Facilitates utilizing the power of big data, AI tools and apps to identify which patients will cease adherence and how this can be addressed, thereby minimizing the loss of business for non-adherence.

Helps create custom messaging for sales reps to use for individual physicians based on what that physician needs at that particular moment in time.

Conclusion:

Use of AI-based technology in the pharma industry, basically means automated algorithms with the capability to perform all those tasks that are now being done mostly with heavy dependence on human intelligence. Thus, its possible use spans across almost all functional domains – from drug discovery, clinical development, supply chain and right up to sales and marketing.

Although, it is still challenging to figure out to what extent AI will transform the industry, one gets a strong signal that it is not just another ‘buzz word’ or a new kid on the block. The technology is surely spreading its roots across the health care space, pharma being an integral part of it. Which is why, according to ‘Executive Insight’ (Volume XX, Issue 60) of L.E.K. Consulting, ‘all of the largest 10 pharmaceutical companies are investing in AI, and developments in applications are occurring across the spectrum of pharma business.’

In fine, to fathom the disruptive impact of AI on pharma business, I shall conclude by quoting from March 18, 2019issue of Healthcare Weekly. After a thorough analysis, the paper acknowledged thatAI is already redefining biotech and pharma. It concluded by stating, ‘ten years from now, pharma will simply look at artificial intelligence as a basic, every day, technology. The only question is how long pharma executive will wait till they jump on the wagon and leverage AI to improve their operational efficiency, outcomes and profits.’

By: Tapan J. Ray

Changing – The Key Differentiator To Boost Pharma Market Share

Posted on July 8, 2019 by Tapan Ray

Health problems, affecting populations of any country, are many. So are the issues related to the delivery of effective health care solution, that most patients would consider satisfying and meaningful. From this perspective, prevention, treatment and effectively managing any disease is basically a problem-solving situation, for all, as we see around.

Interestingly, an ailment, per se, may not necessarily be the only problem that needs to be solved by a doctor, hospital or a pharma company with its drugs. Other associated factors, playing a key role in the process of patients’ search for a meaningful solution – could often post to be tougher barriers in finding the solution. Therefore, patients’ problem during any disease treatment process, is much more than the disease or availability of required drugs.

Consequently, it is very important for all, especially the pharma marketers, to properly understand what these specific influencing factors are, for each patient-groups or types, if not each patient. Obviously, it would call for generation of relevant data to precisely define the problem, or a set of problems, as the patients feel and envisage. Conversely, these problems should not be defined by the company, based mostly on gut feel, just as it’s so difficult to fathom how another person would feel in a distressing situation. Thus, the need to chart a strategic roadmap to provide a solution to those problems will arise only thereafter.

In pharma context, there are several critical elements in this problem-solving process. However, in this article, I shall focus only on two areas. As these could provide a cutting edge, if used in creative ways by drug manufacturers in arresting patients’ and other stakeholders’ attention on this crucial process.

Three critical elements to the problem-solving process:

Among several others, I reckon, the following three elements would play critical roles in the problem-solving process that is specific to the pharma industry:

The mindset to follow the problem-solving approach with all sincerity.
Communicate the problem-solving process in a creative way to patients and others.
Walk the talk, earning patients’ delight and enhancing the corporate reputation.

Since, the third element, although very important, is involved with the strategic roadmap of the organization, let me discuss here the first two elements to justify the need for this stratagem.

The key differentiators are changing:

A clear shift is underway that will influence what drug will be prescribed and the treatment process that individual patients would prefer.

Not so long ago, and to a large extent even today, one of the key differentiators to sell high price patented products used to be the narrative of ‘billions of dollars’ of investments that go behind time-intensive and high-risk R&D. Nevertheless, this age-old recital now finds lesser and lesser number of takers, largely within patient groups.

Alongside, run several other product-centric differentiators, such as claims and counterclaims on technological and clinical superiority, or how a new drug prolongs life of some cancer patients by a few months over other drugs. These are the old workhorse of differentiators, which are just not enough to increase brand market share, in today’s fast-changing environment.

Brand differentiating factors should reach much beyond the product:

As more patients are getting increasingly interested in their personal health interests and rights, the differentiating factors should reach much beyond products. Some drug companies are already sensing that more patients have started looking for a desired and effective solution, whenever they face a health-related problem. Accordingly, the ability of a pharma player to provide a custom-made solution, as it were, to patients, is emerging as a crucial differentiating factor. This has immense potential to boost the brand market share faster.

Let me underscore, yet again, that this change is surfacing due to changing demands of patients in this area. Thus, soon pharma companies would require shifting their focus from product-centric brand differentiation to patient-centric ones, with problem-solving offerings for patients in creative ways.

Communicate the problem-solving offerings in creative ways to patients:

That the core purpose of pharma business is to prevent, cure or effectively manage illness, is known to many. However, that doesn’t explain one critical parameter that patients now value most. This is, how a drug company provides effective solution to specific health problems of individuals – making the company’s product and services most meaningful to him or her.

Encouragingly, some top pharma advertising companies dealing with pharma, healthcare and wellness products, have started advising so, to their respective clients, as reported by Fierce Pharma on June 17, 2019.

One such ad agency honcho said: “The reality is that pharma and health are closer to doing good anyway, that’s just part of what they do. Looking for opportunities to serve the patient in a creative way is what we need to do in pharma as well, not just, ‘let’s go and sell this drug.’ Admitting the current issues with most pharma players, he further articulated: “But there’s a huge trust gap because people think pharma companies are just out to make money. The more they can do that supports their customer base, which is patients, the more quickly we’ll erode that.”

As reported in the same article, this advice was given to the pharma industry at the Cannes Pharma Lions Awards function on June 17, 2019. It is one of those top award functions, where one gets to know about the best creative communications of pharma and health care companies, designed to facilitate understanding and awareness on various health problem-solving processes for patients.

An interesting platform to know about pharma’s problem-solving offerings:

One of the well-respected platforms where one can witness creative and innovative communications in the pharma industry, is during Cannes Pharma Lions Awards. This ‘is considered the largest gathering of the advertising and thecreative communications industry. The five-day festival, incorporating the awarding of the Lions awards, is held yearly at the Palais des Festivals et des Congrès in Cannes, France.’

New age creative pharma communication, bringing science and innovation to life, compete in the Pharma Lions award functions. These facilitate not only disease awareness – both mitigation or management, diagnosis and patient’s-need-based prescriptions, but also add value while engaging with healthcare professional and patients, more effectively.

Some of the entries vindicate that creativity in pharma communications has started moving ahead and faster than expected, with special focus on patients’ problem-solving. As an illustration, let me cite the example of top Pharma Lions Winner at Cannes 2019.

GlaxoSmithKline GSK) and its ad agency McCann Health picked up this coveted award in pharma advertising with a mobile application called Breath of Life. This is a diagnostic tool for COPD developed for GSKand is aimed at raising awareness and increasing diagnoses of the disease in China. COPD affects an estimated 100m adults in China, but only around 7 percent is properly diagnosed, as the report highlights.

Now, an example from the wellness area:

This specific approach for a Vitamin D fortified dairy product, is also equally innovative, as quoted in the above Fierce Pharma article. Many may be aware that Vitamin D deficiency is not uncommon in India – 80 percent of children in Delhi, reportedly, suffer from this deficiency. The manufacturing company launched its campaign in schools to move the traditional, outdoor morning assembly to noon, when brief sun exposure could have a big effect on vitamin D levels. The campaign invited schools to a launch event, providing a solution to the problem of Vitamin D deficiency in children. The idea clicked with excellent media coverage.

As the ad agency said: “We didn’t make a TV commercial or run print ads. We looked at a problem and how we could solve it and showed that the brand cares about kids.” Nevertheless, he added, make no mistake, it was also an ad, which made parents want to buy the brand.

India and Cannes Lions Awards in health and pharma categories:

The good news is, Indian companies are also participating to showcase their creative communication skills, in problem-solving areas of health, wellness and pharma domain. Although, one doesn’t find the names of any large domestic pharma players in the list, India had put up a good show by bagging a total of four awards, including a gold, two silvers and a bronze in the health and pharma categories on Day 1 of the Cannes International Festival of Creativity, in 2018.

In the years ahead, one hopes that Indian drug manufacturers will show greater interest in this area, to sharpen their critical differentiating tool in disease awareness, brand marketing focused on problem-solving for patients, who search for an appropriate solution while addressing a disease condition.

Is pharma in search of a different approach?

Instances, such as, Cannes Pharma Lions Award, indicate that an increasing number of pharma players have, at least, started recognizing that old ways of differentiating brands, would no longer fetch desired outcomes, as patients’ mindsets are changing – fast. Patients’ outlook for prevention, treatment and managing chronic ailments are also changing – empowered by a plethora of unlimited free information – as and when they require.

Accordingly, drug companies who are partnering with creative pharma ad agencies are being persuaded more to look for a radically different approach to be on the same page with their customers. It also requires the top management mindset to be in sync with this fundamental change, inviting full commitment from all. The new communication package, then becomes a fine blend of top-class creative inputs and modern technology platforms for delivery. The core purpose is to effectively connect with patients, doctors, hospitals and governments, being an integral part of their problem-solving process in health care.

Conclusion:

The article titled, ‘Solving Problems Is More Important Than Selling Your Differentiators,’ published in Forbes on June 14, 2018, highlighted a very important point. It wrote, if a company keeps zeroing in on its traditional brand differentiator, as discussed above, the business is likely to miss out on potential new customers and the revenue they could bring with them.It then elaborated: ‘The real trick to getting noticed comes down to shifting your focus. It’s not about you. And it’s definitely not about you versus them. It’s all about solving problems and evoking the right emotions.’

The short list of Cannes Pharma Lions Awards, signals that this process has just begun, but yet to gain a critical mass within the industry. In this area, as yet another head honcho puts it: “Given the shortlist for the Innovation Lions, you can already see a trend where agencies have focused on making work that impacts patient lives on a day-to-day basis, through more meaningful use of technology for practical and life-changing purposes.”

Thus, it is important for new age pharma marketers to note that their business environment is changing – faster than ever before. The traditional brand differentiators, however much honed, may not fetch desired increase in the market share, in the future.

The new crucial differentiator in this area, isthe ability of a pharma player to conceive, design, provide and effectively communicate, virtually a custom-made disease treatment solution to patients. Equally important is the skill to communicate this ‘problem-solving process’ to the target audience in creative ways, for top of mind recall, at least, the company’s name. In turn, it would also facilitate the prescriber choosing a company’s brand, that rings a bell to the patient. And that’s the new way for pharma marketers to boost their brand market share, faster.

By: Tapan J. Ray

While Pharma Leadership Change This Atypical Skill Counts

Posted on July 1, 2019 by Tapan Ray

Effective September 01, 2019, the global pharma major Sanofi will have a new CEO, as the present CEO retires attaining his retirement age of 65 years. This appears to be a mandatory announcement from the company, as is required during the top leadership change in any large and listed organization.

However, there is something novel, as well, in this announcement, especially when specific qualities, skills and experience of the new CEO were highlighted by the company’s Board of Directors. According to Sanofi Press Release, the new CEO – Paul Hudson “has proven his strategic vision, his strong leadership and his ability to achieve the greatest challenges, particularly in terms of innovation and digital transformation.”

Among the stated experience and skills, the one that appeared atypical to me, is the experience of digital transformation, particularly in the position of the CEO of a global pharma major. I In this article, I shall, therefore, explore, why knowledge and experience in this atypical skill is gradually becoming critically important for pharma leadership positions, at all levels.

Why is the need for digital transformation of pharma business?

According to the Internet Trends Report 2019 by Mary Meeker, at 3.8 billion internet users, more than half the world’s population is now online and it is growing. This number would obviously include patients.

As we know, the core purpose of pharma business is to offer a unique patient experience during any disease treatment process. And, the expectations of which from Internet-savvy individuals will be significantly more for various related reasons.

To achieve this objective, drug players would always require to be in sync with customers’ perceptions, expectations and aspirations, among others. Moreover, it’s also not ‘one size fits all’ type of a solution. These will significantly vary for different patient groups, so are the processes of engagement with them – based virtually on real-time information.

Interestingly, the core purpose of digital transformation is also to facilitate this process, with a great amount of precision. The entire process of creating a unique patient experience, involves generation of a massive amount of customized data, customize analysis of which is done through sophisticated analytics, and thereafter, translating and using them as key strategic business inputs, on an ongoing basis. Traditional organizational methods, systems and processes are incapable to deliver the same. Hence arises the crucial need of digital transformation of the organization, across the board.

The transformation is not just about software, hardware and data:

That said, it is also essential to realize that digital transformation is not just about software, high-tech hardware, mobile apps and sophisticated wearables and data. These are, of course, some of the vital tools – used while transforming a company into battle readiness to create and provide a unique customer experience.

Such unique experience for each customer should cover all touchpoints, spanning across – before, during and after treatment with the company’s medication. This, in turn, helps generate an increasing number of prescriptions from doctors, which otherwise would not have been possible, following the conventional means.

Why this atypical skill is in demand today?

Like any other transformation process within an organization, digital transformation should necessarily be driven by the company CEO, having adequate experience in this area. Even the Board of Directors of many pharma players believes that such a CEO can facilitate the process faster and more effectively. Hence, the demand for this atypical skill is increasing, also for a pharma CEO position, besides leaders in various functional areas, as it is being considered as pivotal to achieve the core purpose of a pharma business, in the digital world.

Thus, if a CEO doesn’t properly understand, how the digital world operates with increasing number of visitors in the cyberspace and convinced about its relevance for business excellence, the organization would ultimately lose its competitive edge. One may, therefore, question, did the need for this atypical skill also arise during the selection of the new CEO of Sanofi?

Is this atypical skill for a new CEO more important now?

The answer, I reckon, could be both, ‘probably yes’ and also ‘no’.

‘Probably yes’, mostly because, being an uncommon skill for a pharma CEO, so far, it arrested the attention of many while reading ‘Sanofi Press Release’, for the appointment of their new CEO. Nevertheless, Sanofi is not the first pharma company placing so much of importance on digital transformation, especially for the key leadership positions. In an interview with the Wall Street Journal (WSJ) of February 18, 2018, the CEO of Novartis said: “We need to become a focused medicines company that’s powered by data science and digital technologies.”

Why it is so important for a pharma CEO?

The AT Kearney paper titled, “New Medicine for a New World – Time for Pharma to Dive into Digital,” also captured that an increasing number of pharma customers are now getting engaged and have started interacting in the digital space, more than ever before. This trend is fast going north – becoming an ‘in-thing’ of the industry, as it were. But more probably to be seen as trendy or display that they are also in it, by ‘dipping a toe in the digital waters.’ Whereas, ‘it’s time to take the plunge,’ as the paper cautions them.

‘Plunging into the digital water,’ doesn’t mean sending people to some external training program – with the word ‘digital’ prominently featuring as the course objective. It means bringing out ‘digital transformation’ of the entire organization, spearheaded by the CEO. The leadership of each functional area would then implement from the same playbook, with a structured and custom-made plan designed specifically to achieve the vision, mission, goals and values of the company.

We have recent examples of, at least, two top global pharma majors taking a plunge in the digital water to make the digital transformation of the organization a reality. The key purpose of the same, is to create a unique customer experience, being on the same page with them, in more effective ways, for business excellence. To move in this direction, the organization must imbibe the non-negotiable principle – ‘digital first,’ across the organization.

Only the CEO can decide ‘digital first’ as guiding organizational principle:

None other than the CEO of a drug company, can decide that ‘digital first’ will be the guiding principle of the company, across all the functional areas of the business. As the above paper articulates, it ‘should be explicitly incorporated into core business processes.’ It further says: ‘Top management must challenge any parts of the business that have not explicitly considered the opportunities from digital in their plans.’

Functional leaders to be in sync with digital transformation:

All in the pharma organization, across all functions, must work for the end consumer of any pharma business – the patients. Every single employee in the company should strive delighting them with the company’s products and services, at every touchpoints, during their quest for relief from illnesses. As I said before, this is the single most important factor that determines not just the pace of growth of a drug company, but help enhance its reputation, too. It goes without saying, its ultimately the patients who are playing a catalytic role in the digital transformation of an organization.

It is essential for the CEO to make sure that entire corporate, functional and even departmental leadership teams are in tune with the need of digital transformation of the organization. Despite the detail explanation, if some remain unconvinced about the rationale behind the transformation of the core business process, the right leader should assume the responsibility.

This is because, even with one loose knot at the leadership level in this area, the entire objective can seriously get thwarted – down the line. Such changes, as, if and when required, can be achieved in various different ways, not through attrition alone. For example, by encouraging them to work with members of his peer group who can set good examples to emulate.

Brand promotion to physicians will still remain as important:

In tandem, no company should lose sight of the fact that their face-to-face interaction with physicians, will continue to play an important role in brand promotion. Primarily because, doctors and hospitals help patients to get desired solace from ill-health by prescribing recommended medicines, and consequently, will keep prevailing as an integral part of the pharma marketing process, supported directly or indirectly by every employee in the company.

The key challenge in digital transformation:

The key challenge in the digital transformation of a pharma company is broadly possible inflexible or a rigid mindset of some of its leaders. This is generally fueled by the fear of moving out of their respective comfort zones – rather than resources and expertise required to make the technology put to use. A well-running-business with a grand idea for the future, will generally be able to garner necessary resources and other wherewithal, without much problem.

All pharma leaders should always consider themselves as an important solution for the future success of the organization, Otherwise, he or she may be construed as a part of the problem and a hindrance in achieving the corporate goal and should make way for the capable ones, in this area. Hence, selecting leaders with the right spirit to make digital transformation effective, is so critical for the CEO.

To commence this journey, the leaders may either be willing to acquire the experience of a disruptive digital transformation, guided by the domain experts or may be recruited from outside having the necessary experience. Collective and well-coordinated steps towards this transformation can neither be tentative, nor should it commence without having the right leader at the right place with required will and experience.

Digital players entering into health space with game changing ideas:

Pharma players should also note, how the big technology companies, such as, Apple, Google, Microsoft and Amazon, besides many startups, are trying to create space for themselves in the health care arena. Several of them are also trying to reinvent health care with zest, much beyond what traditional drug companies could even envisage, till recently.

The digital transformation of the organization would help drug players to align the company’s business model with the tech companies in those specific areas to reap a rich harvest. More opportunities will also unfold – either to collaborate with them for targeted projects or moving into the tech space with well-calibrated measures, for business synergy. Without digital transformation of business, either facing such competition or benefitting from the available opportunities, will be challenging for drug companies.

Conclusion:

In the digital world, while patients are emerging as a key driver of change in the health care space, traditional pharma operational systems, including sales and marketing are likely to give a diminishing return on investment. Although, many drug companies can sense this ongoing metamorphosis, several of them are still wondering how to go about it. Moreover, to test the ‘digital water’, some of them have started converting several traditional operational methods, systems and processes in the digital format, as well. Yet, are unable to fathom, why such efforts are not clicking – leading to a quantum increase in the operational efficiency – in pursuit of excellence.

The good news is, global pharma organizations, such as, Sanofi and Novartis, besides several others, have realized that incremental performance improvements with small tweaking here or there, across the organization, aren’t just enough. The corporation needs to move towards a holistic digital transformation, spearheaded by its CEO, having experience in this process. This new breed of pharma CEOs, well-supported by his team of leaders, fostering a burning desire to produce pace setting results, can usher in this ‘disruptive’ transformation. Because, they realize, traditional pharma operational systems, when tempered through the fire of the digital transformation process, can yield game changing outcomes for the organization. The entire process, as it comes to fruition, helps delivering greater customer value, creating a unique customer experience – similar to what customers want – on an ongoing basis.

In fine, strategic intervention of this genre, initiated by the CEO and cascading down the organizational hierarchy, creates a whole new patient-centric outcome, which is much more than what a company can get through re-engineering the operational processes. Hence, especially the young mangers of date, may wish to note note that during virtually every leadership transition, this atypical skill is now likely count much more than ever before – with an ascending trend.

By: Tapan J. Ray

Continues ‘The Cat And Mouse Game’ In Pharma Business?

Posted on June 24, 2019 by Tapan Ray

Many are already aware of the critical factors that make generic drugs so important for patients – virtually for all. These don’t just facilitate greater access to health care – offering affordable alternatives to high-priced off-patent innovative drugs. This is as relevant in the largest pharma market in the world – the United States (US), just as in India. Let me illustrate this point with two examples – one from the US and the other from India.

According to US-FDA, ‘9 out of 10 prescriptions filled, are for generic drugs’ in the United states, as off-patent branded generic drugs cost more than their generic equivalents. The US drug regulator explains, ‘Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients.’

However, unlike the US, there prevails a unique perception difference even within generic drugs – between branded and unbranded generics. The Indian Survey, undertaken to review and analyze various facts on branded and equivalent unbranded generic medicines, found a huge difference in prices between them in the country. Interestingly, as the researchers also noted, although, more consumers want an economical alternative to high priced branded generics, most physicians do not prefer unbranded generic medicines.

There is another important point worth noting regarding India made generic drugs. Although, Indian pharma sector caters to around 40 percent of generic demand in the US, as IBEF reports, many Americans nurture serious apprehensions on the quality of generic drugs manufactured even by India’s top drug companies.

This is quite similar to apprehension that exists in India between the quality branded and unbranded generic medicines in India. The only difference is – the above perception in India is not based on impartial and credible scientific studies, whereas it is not so in America. The New York Times report, published on May 11, 2019 vindicates this point. It questioned: “Americans Need Generic Drugs. But Can They Trust Them? The fake quality-control data, bird infestations and toxic impurities at the overseas plants that could be making your medication.” Incidentally, there aren’t any such large-scale accusations regarding dubious quality of drugs manufactured by Big Pharma.

On the other hand, big pharma players have long been accused of drug price gouging or price-fixing of life-saving drugs, primarily to maximize earnings by ‘extending’ product patent-life. Curiously, in recent times, even the generic drug players are being accused of following a similar practice. Thus, in this article, I shall explore how generic drug players are also trying to hoodwink measures to bring down the drug price, either through price control or through the encouragement of intense competition – playing a ‘cat and mouse game’, as it were, whenever an opportunity comes. If it continues and probably it will, what is the way ahead? Let me begin by recapitulating a historic pace-setting move in the global generic market by an Indian drug player.

A historic pace-setting move by an Indian generic drug player:

Being a major exporter of generic drugs in many developed, developing and even poor countries around the world, India is often termed as ‘the pharmacy of the world.’ That apart, a historical move in this space, by a top domestic player – Cipla, earned global accolades, at the turn of this new millennium. In 2001, Cipla slashed the price of its triple-therapy drug ”cocktails” for HIV-AIDS – being sold by MNCs, ranging from USD 10,000/ USD 15,000 a year to USD 350 a year per patient to a doctors’ group working in Africa.With the generic industry’s focus on a deeper bottom line, the scenario has changed now. Finding ways and means for the price increase, evading both competitive pressure and also drug price control, as in India, has turned into a ‘cat and mouse game’, as it were.

Generic drug pricing – ‘a cat and mouse game?’

Pricing pressure, especially for generic drugs, from patients, payers, politicians and governments, is gradually becoming more intense. More the pressure greater is the effort of affected players to come out of it, in any way –akin to a ‘cat and mouse game’, as it were. Although, it has recently started in the USA, the same exists in India, since 1970, when the first drug price control was introduced in the country. Intriguingly, in the midst of this toughest ever drug price control, phenomenal rise of almost all top Indian companies, including the top ranked company in the Indian pharma market commenced – from scratch. Nonetheless, to get a feel of how is this game being played out, let me start with the Indian scenario.

How this game is played in India to evade price control:

Instead of taking a deep dive into the history of drug price control in India, let me give a bird’s eye view of a few mechanisms, out of many, used to evade price control, since it commenced. The idea is to give just a feel of how this ‘cat and mouse game’ game pans out, with a few of such examples in a sequential order, since 1970, as much as possible, by:

Including price decontrolled molecule in the FDC formulations.
Replacing a price-controlled molecule by a similar decontrolled one, keeping the brand name unchanged, when the number of controlled molecules came down.
Making a major shift towards selling more of higher-priced decontrolled molecules, jettisoning low priced controlled molecules.
Resorting to vigorous campaigns, when the government started encouraging prescription of low-priced generic molecules, to ensure further shift to branded FDC prescriptions, alongside image enhancement of branded generics over equivalent unbranded ones. Its outcome is visible in the above Indian Survey on the image of branded and unbranded generics.

Has Indian pharma industry succeeded in this game?

It appears so and gets reflected in the CAGR of the industry. According to IBEF, “The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach US$ 55 billion.” I underscore, this is value growth.

Thus, the point, I reckon, that the government should ponder: How both can happen, at the same time – price control is bringing down drug prices, extending real benefits to patients on the ground, and at the same time the industry is recording an impressive growth rate in value terms? Whatever it means, let’s now try to explore, how such ‘cat and mouse game’ is being played to increase generic drug prices in the United States.

How similar game is played in the US to increase generic drug price:

On May 10, 2019, international media reported that ‘44 US states announced a lawsuit alleging an anti-competitive conspiracy to artificially inflate prices for more than 100 drugs, some by more than 1,000 percent.’ This lawsuit is based on an investigation involving a number of generic drug companies. The process, which took five-years to complete, accused twenty generic drug players. Teva Pharmaceuticals USA, whose parent company is based in Israel was, reportedly, named as the ringleader of the price-fixing. The company raised prices of around 112 generic formulations.

Other companies, reportedly, named in the complaint, include Pfizer, Novartis subsidiary Sandoz, Mylan, and seven Indian drug companies, including Lupin, Aurobindo, Dr. Reddy’s, Wockhardt, Taro Pharmaceutical Industries (a subsidiary of Sun Pharma) and Glenmark. Some of the 15 senior company executives who were individually named in the lawsuit for their involvementin this alleged “multibillion-dollar fraud ”belong to Teva, Sandoz and Mylan.

The ‘cat and mouse game’ in this case is slightly different. Instead of government price control, the US drug regulator encouraged intense generic competition to bring down the price. When the priced did not come down as expected, the State of Connecticut, reportedly, began investigating select generic drug price increases in July 2014. Subsequently, other states also joined the investigation, and uncovered the reason for prices not coming down.

According to the complaint, between July 2013 and January 2015, Teva significantly raised prices on approximately 112 different generic drugs. Of those 112 different drugs, Teva had colluded with its competitors on at least 86 of them. The complaint noted: “Teva had understandings with its highest quality competitors to lead and follow each other’s price increases, and did so with great frequency and success, resulting in many billions of dollars of harm to the national economy over a period of several years.” In this way, the impact of intense competition on drug prices, was made ineffective.

Not the first time, it was detected:

The 2019 anti-trust lawsuit against the generic drug makers may be ‘the biggest price-fixing scheme in the US history’, but not the first lawsuit of this kind in America. A similar lawsuit for illegal price-fixing against six generic companies, was filed by the states in 2016, as well, which is still being litigated. The 2019 case is a sweeping version of the same and is the result of a much wider investigation. It indicates, instead of taking corrective measures, the ‘cat and mouse game’ still continues. However, almost all the companies have vehemently denied this allegation.

Is this game existential in nature of the business?

One may well argue that such ‘cat and mouse game’ with the government is existential in nature, for the generic drug business. When price control or intense market competition brings down the price to such a level, it becomes a matter of survival of most businesses. There doesn’t seem to remain enough financial interest for them to remain in the market. If and when it happens, causing shortage of cheaper generic drugs, patients’ health interest gets very adversely affected. It also prompts the manufacturers to find a way out for the survival of the business. This is understandable. But it needs to be established, supported by scientific studies.

An off the cuff solution:

A general and off the cuff solution to the above issue would naturally be, there should be a right balance between affordability of most consumers and the business interest of the drug makers. This broad pointer is also right and understandable. But again, no one knows the expected upper limit of the generic drug profit margin for their manufacturers – where hardly any breakthrough and cost-intensive R&D is involved. Equally challenging is to know – below what margin, generic players, by and large, loose interest in this business?

What do some available facts indicate?

According to the year-end report of the Pharmaceutical Export Promotion Council (Pharmexcil) the total pharma exports from India has been pegged at USD 19.14 billion for 2018-19. This represents a growth of 10.72 per cent over USD 17.28 billion in thelast year. It further reported, “The top 25 export destinations contribute 76.52 per cent of the formulation exports amounting to USD 10.38 billion. Among these, the US continues to be the largest export destination with over 38.62 per cent of the total generic exports to that country at USD 5.24 billion.” Does it mean business as usual, despite ‘price-fixing’ law suits in the US, since 2016?

Similar impression one would probably get from the Indian scenario, as well. Notably, despite price control, which is continuing since last five decades, the growth rate of the Indian pharma market, which is dominated by branded generics, remains very impressive.According to the January 2019 report of IBEF: “The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach USD 55 billion.” So also the same game, probably!

Conclusion:

It appears, there is certainly a huge reputation or image crisis for the generic drug industry, as such, due to such alleged delinquencies. However, from the business perspective, the manufacturers are still having enough leeway to move on with similar measures, supported by fresh thinking. At the same time, it seems unlikely to have any form of drug price control in the United States, at least, in the foreseeable future. Nevertheless, price pressure due to cut-throat competition could even be more intensive, as it gets reflected even in the US-FDA statements.

Nearer home, the Indian generic drug business has been hit with a double whammy – allegations for dubious drug quality standards, on the one hand, and price manipulation on the other, besides dented reputation and image – widening trust gap with patients and governments.

Moreover, unlike the best export market even for generic drugs – the United States, India has been following some patchy policy measures for health care, as a whole. The drug price control system is one such. Till a holistic policy on health care is put in place for all, backed by an effective monitoring system, The Indian price control system may remain like a ‘maze’, as it were, with several ways to hoodwink it.

Hence, the ‘cat and mouse game’, albeit in a different format, is likely to continue, until one gets caught, or till all concerned puts their act together – putting patients at the center of the core business strategy.

By: Tapan J. Ray

Gene Therapy Price: Commercial Viability And Moral Dilemma

Posted on June 17, 2019 by Tapan Ray

On May 24, 2019, Novartis announced the US-FDA approval of ‘the first and only gene therapy’ – Zolgensma, for a type of Spinal Muscular Atrophy (SMA), a lifesaving treatment for infants of less than 2 years of age. This unique drug halts disease progression with a single, one-time intravenous (IV) infusion.

On value offerings of Zolgensma,the Novartis CEO said: “The approval of Zolgensma is a testament to the transformational impact gene therapies can have in reimagining the treatment of life-threatening genetic diseases like spinal muscular atrophy. We believe Zolgensma could create a lifetime of possibilities for the children and families impacted by this devastating condition.”

Unquestionably, this development in medical science is indeed commendable. But, the jaw-dropping price tag – USD 2.125 millionattached to this product, has brought back gene therapy at the center stage of the incensed debate on access and affordability of such treatment for a vast majority of the population, across the world. Besides, two important issues related to gene therapy need to be effectively resolved – long-term commercial viability and the ‘moral dilemma’ that its market launch would prompt. And both are interconnected and also associated with the pricing rationale of such therapies.

I am terming the second factor as a ‘moral dilemma’ rather than an ‘ethical dilemma’ because, “ethics is a more individual assessment of values as relatively good or bad, while morality is a more intersubjective community assessment of what is good, right or just for all.”In this article, I shall deliberate on these two interrelated issues. But, before delving into it, let me recapitulate in simple terms, what exactly is ‘Gene Therapy.’

What exactly is ‘Gene Therapy?’

According to US-FDA, human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.

Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms:

Replacing a disease-causing gene with a healthy copy of the gene
Inactivating a disease-causing gene that is not functioning properly
Introducing a new or modified gene into the body to help treat a disease

Gene therapy products are now being studied to treat diseases including cancer, genetic diseases, and also infectious diseases.

Gene therapy price has been going higher than highest, thus far:

‘At USD 2.1 million, newly approved Novartis gene therapy will be world’s most expensive drug,’ says another report of May 24, 2019.It is noteworthy that Zolgensma price has been kept higher than the highest priced drug before this product came. If his trend continues, the future gene therapy cost is likely to exceed even Zolgensma price, the implication of which for patients who will need such treatment to save life or manage the disease, will be huge.

Intriguingly, the high treatment cost for a rare ailment like, SMA - a degenerative disorder that usually kills an infant within two years, is not limited to just gene therapy. According to the April 04, 2019 article titled, ‘Biogen SMA drug price, Novartis estimates for its treatment far too high – U.S. group’ of Reuters, the price of another drug for SMA – Biogen’s Spinraza, which is not a gene therapy, is also very high. Its list price is USD 750,000 for the initial year and USD 375,000 annually. As reported, ‘Spinraza, an important growth driver for Biogen, took in USD 1.7 billion in 2018 sales.’

What should have been the actual prices of these drugs?

Interestingly, to determine the value of these drugs, the nonprofit Institute for Clinical and Economic Review (ICER) ‘used a measure known as “quality-adjusted life year” (QALY), in which each year of healthy or near-healthy life resulting from the treatment is worth USD 100,000 to USD 150,000.

Using the QALY benchmark, ICER, reportedly, said Spinraza should cost between USD 72,000 and USD 130,000 for the first year of treatment, and cost USD 36,000 to USD 65,000 per year after that, for infants not yet showing symptoms of the disease.

Further, with an alternative benchmark, known as life-year gained (LYG) based on the additional number of years a person lives due to a treatment, Spinraza is, reportedly, worth USD 83,000 to USD 145,000 in year one, and USD 41,000 to USD 72,000 annually thereafter, as ICER determined.

Zolgensma, on the other hand, would, reportedly, be worth USD 310,000 to USD 900,000 for Type 1 SMA patients based on the QALY assessment, and USD 710,000 to USD 1.5 million using the LYG calculation, ICER said.

Notwithstanding, whether one takes the QALY assessment or LYG based price of Zolgensma and Spinraza, the treatment cost of rare diseases, such as SMA for infants, is beyond the affordability of most people – whenever these drugs become the only choice to save lives. Thus, the question comes: Is gene therapy commercially viable or sustainable?

Is gene therapy commercially sustainable?

Undoubtedly, the development of gene therapy signifies yet another milestone in medical science to save lives, which is highly commendable. Nevertheless, the question arises, who will be able to afford this treatment? Thus, is development of gene therapy commercially viable and could be a money churner for a company on a long-term basis? There doesn’t appear to be a clear answer to these questions, just as yet. There are several reasons for this apprehension. But, I am citing below just two examples – related to their humongous treatment cost.

According to the article, published in the Scientific American, in the past five years, two gene therapy drugs have been approved in Europe and one in the United States. The name of this article is ‘Gene Therapy Is Now Available, but Who Will Pay for It?’ Interestingly, only three patients have so far been treated commercially with gene therapy, in Europe.

UniQure’s Glybera, used for a very rare blood disorder, costing around USD 1 million per patient, has been used just once since approval in 2012. However, in 2017, due to commercial reason UniQure decided to withdraw Glybera from the market. Similarly, Strimvelisof Orchard Therapeutics – used for severe Combined Immunodeficiency, costing USD 700,000, ‘has seen two sales since its approval in May 2016, with two more patients due to be treated later this year.’ Interestingly, these apprehensions have not deterred many companies. The ball keeps rolling.

But the ball keeps rolling:

That the ball keeps rolling, and at a faster pace, is evident from what US-FDA envisages in this field. According to US-FDA, by 2025, they are likely to approve 10 to 20 cell and gene therapy products a year. This is based on an assessment of the current pipeline and the clinical success rates of these products.

Importantly, despite apprehension of many, even some of the top pharma players, are fast moving into this space – based on their own assessment of the market. But, to move meaningfully in this direction, there are many several critical success factors, most of which are quite challenging and cost-intensive. A few of these, for example, are – a right collaborative model, ability to develop a scalable manufacturing process and overcoming various technical and regulatory challenges on the way. Interested pharma players, apparently, have realized these needs.

Big Pharma players joining ‘Gene Therapy’ bandwagon:

Big Pharma players, such as, Pfizer and Johnson & Johnson (J&J) have started moving into this space. Let me illustrate the point with just a couple of examples.

On March 20, 2019, Pfizer announced: ‘Pfizer has acquired a 15 percent equity interest in Vivet Therapeutics and secured an exclusive option to acquire all outstanding shares.’ Both the companies will collaborate on the development of Vivet’s proprietary treatment for Wilson disease – a rare and progressive genetic disorder, if remains untreated may cause liver (hepatic) disease, central nervous system dysfunction, and death.

Just before this, on January 31, 2019, Janssen Pharmaceutical of Johnson & Johnson (J&J) announced a worldwide collaboration and license agreement with MeiraGTx Holdings plc – a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia. Even prior to this, on January 05, 2018, J&J had announced that the company has established an exclusive research collaboration with the University of Pennsylvania’s ‘Gene Therapy Program’ for fighting Alzheimer’s disease with gene therapy. There are several such instances of gene therapy collaboration for Big Pharma.

With a slightly different collaborative model for gene therapy, on April 12, 2018, GlaxoSmithKline (GSK) signed a strategic agreement to transfer rare disease gene therapy portfolio to Orchard Therapeutics, taking a 19.9 percent stake in the company and a seat on the board. Simultaneously, this agreement strengthens Orchard’s position as a global leader in gene therapy for rare diseases.

What could be the moral dilemma in gene therapy pricing?

The dilemma with gene therapy is that they are frightfully expensive, but at the same time is ‘life-transforming’ for many, across the socioeconomic spectrum. This could be another ‘moral dilemma,’ as such exorbitant, if not seemingly ‘vulgar pricing’, as it were, would raise many questions on the company’s own principles regarding right and wrongin saving lives of patients with its gene therapy.

The reason for this moral dilemma in, especially gene therapy pricing is aptly elucidated in an article titled, ‘How to pay for gene therapies in developing nations,’ published in Evaluate Vantage on March 22, 2019. Admitting that discrepancies in healthcare between rich and poor nations are nothing new, the article also raises a flag, indicating: ‘The potentially curative nature of many gene therapies heightens the moral conundrum that companies will face if and when these projects get to market.

Acknowledging that gene therapies are hot right now, with their developers taking aim at everything from hemophilia to rare eye diseases prevalent in rich nations,the author raises a pertinent question: ‘With rich countries like the US finding it hard to fund gene therapies, it is worth asking whether these projects will ever reach patients in developing countries. And if they do how will companies cope?’

Intriguingly, to create a larger market some are also targeting disorders, largely seen in poorer areas, such as sickle cell disease that could prove valuable also in the developing world. Expectedly, the pressure will mount from many corners to provide gene therapy at an affordable price. Big pharma players are likely to face this strong head wind, adding further fuel to fire of the moral dilemma of gene therapy pricing, especially for the developing world. As on date, no one knows what percentage of people in the developing world will have access to gene therapy. Even Novartis, reportedly, does not seem to have any plan to make its product available in the developing nations.

Conclusion:

Despite what has happened so far, as described above, looking around, we find a steady flow of gene therapy, some even promise remedial treatment outcomes. Big pharma companies, as well, have commenced a long-haul journey in this direction, with big stake investments.

Regarding, not achieving a huge commercial success with gene therapy, so far, one point is common for all, these are for the treatment of very rare diseases. Probably, because of this reason, some companies, having taken a cue from it, are moving away from ultra-rare diseases. Illustratively, GSK is still looking to use gene therapy in a collaborative platform, to develop treatments for more common diseases, including cancer and beta-thalassemia – another inherited blood disorder – as the above Scientific American article reported.

That said, the point to ponder now, if the effort to come out with a remedial gene therapy for these indications fructifies, would it ensure a long-term commercial viability, alongside giving rise to a moral dilemma on the rationale for gene therapy pricing? This seems to be akin to a ‘chicken and egg’ situation. It will be interesting to witness how it pans out, as we move on.

By: Tapan J. Ray

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Gene Therapy Price: Commercial Viability And Moral Dilemma