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Blockchain: Pharma Keeps An Eye On The Ball

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On April 24, 2017, The Wall Street Journal (WSJ) came out with an interesting headline, “Dubai Aims to Be a City Built on Blockchain.” Some may have taken note of it seriously. However, a vast majority of its readers possibly equated the article with something, which is far from reality – like a distant dream.

However, looking at the rapid transformational phase of digital technology, nothing apparently is a dream – not even ‘a distant one.’ The following recent example, in a similar but not exactly the same context, would vindicate this point.

On January 09, 2018, Reuters reported with a headline, “JPMorgan’s Dimon regrets calling bitcoin a fraud.” Interestingly, at a conference held in September 2017, the same Dimon – the Chief Executive of JPMorgan, had commented: “The currency isn’t going to work. You can’t have a business where people can invent a currency out of thin air and think that people who are buying it are really smart.”

I cited the example of ‘Bitcoin’ while deliberating on ‘Blockchain’, primarily because ‘Bitcoin’ – an unregulated virtual or cryptocurrency was built on ‘Blockchain’ technology. This technology reportedly facilitates absolutely transparent, smooth, safe and corruption-free transaction of ‘Bitcoin’, without any third-party intervention at any stage.

Currently, moving beyond Bitcoin, many industries – including pharma, have started finding various uses of Blockchain in their respective businesses. Domain experts envisage, this technology has the potential to offer game changing values – revolutionizing various business processes.

In this article, I shall focus on how the healthcare industry, in general, and more specifically some global pharma players are contemplating to leverage the path breaking ‘Blockchain’ technology to add unprecedented value in the business. The technology being rather a complex one, I shall put it across in a way that an ordinary man like me can easily absorb. Which is why, I start with the first basic question that comes to the fore: ‘What exactly is ‘Blockchain’?

‘Blockchain’:

‘Blockchain’ is a technology that was reportedly conceptualized by an anonymous individual or a group known as Satoshi Nakamoto, in 2008. It was implemented in 2009, as a core component of ‘Bitcoin’ transactions – in an altogether different form of Internet. The technology provides in its network access to transparent digital information that no user can corrupt or probably even hack, leave aside taking copies. The December 13, 2017 article, featured in the Computerworld on this ‘Most disruptive tech in decades’, describes Blockchain as:

  • “Blockchain is a public electronic ledger – similar to a relational database – that can be openly shared among disparate users. It creates an unchangeable record of their transactions, each one time-stamped and linked to the previous one. Each digital record or transaction in the thread is called a block (hence the name), and it allows either an open or controlled set of users to participate in the electronic ledger. Each block is linked to a specific participant.”
  • “Blockchain can only be updated by consensus between participants in the system, and when new data is entered, it can never be erased. The Blockchain contains a true and verifiable record of each and every transaction ever made in the system.”
  • “As a peer-to-peer network, combined with a distributed time-stamping server, Blockchain databases can be managed autonomously to exchange information between disparate parties. There’s no need for an administrator. In effect, the Blockchain users are the administrators.”

Blockchain has, therefore, been meticulously designed to reveal any interference with the contents, ensuring a very high level of data security and access for all its users. Thus, many domain experts justifiably believe, what ‘open-source’ software did almost two and half decades ago, ‘Blockchain’ technology is possibly on a similar threshold of changing much of the ball game in Information Technology (IT), globally.

Big corporate houses of several industries, such as Fintech, Healthcare and Shipping envisage that ‘Blockchain’ technology has a great potential, as they start making limited use of it. It is still in its infancy for scalable use in most industries, probably other than ‘Bitcoin’ transactions.

Use of ‘Blockchain’ in pharma and healthcare:

Let me now explore the potential of ‘Blockchain’ in healthcare and pharma. A paper titled, “Healthcare rallies for Blockchains: Keeping patients at the center” by IBM Institute for Business Value, provides some important insight on its application in healthcare sector. This study is based on a survey of 200 healthcare executives in 16 countries, conducted by The Economist Intelligence Unit. The key highlights are as follows:

  • 16 percent of pharma and healthcare respondents expected to have a commercial Blockchain solution at scale in 2017, as compared to 15 percent of the Banks and 14 percent of Financial enterprises. Thus, it appears, the adoption of Blockchain by healthcare entities are taking place at a faster pace than the other two.
  • 6 in 10 anticipate Blockchains will help them access new markets, and new and trusted information they can keep secure.
  • 7 in 10 of them expect the greatest Blockchain benefits to be in clinical trial records, regulatory compliance and medical/ health records.

Accordingly, the authors posed a few questions: How valuable would it be to have the full history of an individual’s health? What if every vital sign that has been recorded, of all the medicines taken, information associated with every doctor’s visit, illness, operation and more, could be efficiently and accurately captured – and securely stored?

If and when all this is put to scalable use, the designated users will get access to the historic and real-time patient data of various types, of high credibility. In turn, it is expected to significantly reduce many other costs, including the cost towards data reconciliation. Consequently, the quality and coordination of care would rise manifold, with lesser risk, if at all. I shall give below just a couple of examples to drive home the point:

I. Adds credibility and value to Clinical Trials:

The issue of not reporting around half of all clinical trial data, conducted by pharma players while obtaining marketing approval for innovative products, has become a topic of raging debates, across the world. The reason for the same is apparently the intent for the deliberate creation of an information-gap, by cherry picking more favorable trial data. This could eventually lead to compromising patient safety, seriously.

Allegations continue for not just mostly favorable trial data being presented to drug regulators and policymakers to obtain marketing and other approvals, but also for product promotion to doctors. This prompts many believing, “if the clinical trials are supported by Blockchain solution, all results, protocols, and other related information would be time-stamped and immutable, resulting in less data snooping and errors.” Consequently, it would help enhance the dwindling public trust on pharma, especially in this area.

II. Adds unprecedented security and transparency in SCM:

Another example of its effective use is in making a tamper-evident pharma Supply Chain Management (SCM), with unprecedented built-in security features to prevent drug counterfeiting and circulation of substandard drugs. Moreover, ‘Blockchain’ would ensure supply chain tracking even at the individual Stock Keeping Unit (SKU) level by establishing proof of ownership for specific sources of any product. This is especially important in the backdrop of the WHO report, highlighting that 30 percent of such drugs are sold primarily in developing countries.

Global pharma keeping an eye on the ball:

An article titled, ‘Big Pharma Seeks DLT Solution for Drug Costs’, published on January 09, 2018 by the CoinDesk – a digital media and information services company, discussed on this fascinating subject.

It reported, at least, three global pharma heavyweights – Pfizer, Amgen and Sanofi, are pondering, whether ‘Blockchain could be used to actually save lives?’ To achieve this goal with combined efforts, they are now exploring a Blockchain framework to streamline the process of developing and testing new drugs. These early initiators believe, as areas such as this, are of industry-wide importance, there is a need to create a growing momentum for collaboration on foundational issues. And, Blockchain framework that can address the current issues in drug development and clinical trials, will fetch a win-win outcome, both for the innovators and patients, besides other stakeholders.

To reduce the time and cost of bringing new drugs from research labs to patients, improved data management and movement is critical. Blockchain technology could hasten this process, by automating communication between pharma companies, researchers and patients. At the same time, it will ensure a very high level of data integrity, which is so important for health and safety interest of patients.

This area has assumed greater relevance in the recent years, when pharma innovators are facing different challenges to bring new, more personalized drugs to market – faster and at affordable prices, the paper highlights.

Areas of initial use by Indian pharma:

In my article “SCM: Embracing Technology For Patients’ Safety”, published in this Blog on December 18, 2017, I discussed a similar point, not in context of ‘Blockchain’, though. I wrote that by a notification dated January 05, 2016, the Directorate General of Foreign Trade (DGFT) has made encoding and printing of unique numbers and bar codes as per GSI Global Standard mandatory. This would cover tertiary, secondary and primary packaging for all pharmaceuticals manufactured in India and exported out of the country to facilitate tracking and tracing.

Although, the ‘Track and Trace’ system in India for drugs is currently applicable only to pharma exports, will ultimately cover drugs in the domestic market, as well. This is evident from a draft proposal of the Government to the stakeholders in June 2015, in this regard.

Blockchain-based public electronic ledgers that can be openly shared among disparate users, creating an unchangeable record of their transactions, with each one time-stamped and linked to the previous one, would be of immense importance for all concerned towards the reliability of medicines in India.

Similarly, as Indian players venture into more complex clinical trials, such as with biosimilars, Blockchain could catapult the narrative on reliability of Indian clinical data to a much higher level of trust.

Blockchain has come to stay:

As I said in the beginning, ‘Blockchain’ technology has started coming to the fore of many discussions and debates, mainly for its critical role in transparent transaction and distribution process of the cryptocurrency – Bitcoin.

December 16, 2017 issue of the Gulf News reported that UAE’s central bank is working on a joint cryptocurrency, based on Blockchain, with its counterpart in Saudi Arabia. Just prior to that, in August 31, 2017 issue of the Financial Times also reported: “Six of the world’s biggest banks have joined a project to create a new form of digital cash that they hope to launch next year for clearing and settling financial transactions over Blockchain, the technology underpinning bitcoin.”

And just this month, we got to know about the combined efforts of Pfizer, Amgen and Sanofi, to use a Blockchain framework for streamlining the process of developing and testing new drugs.

Besides many other industries, even several Governments are envisaging to unleash the transformative potential of Blockchain in various Governance processes. It may include the confidential data procured and used by Governments to confirm the identity or identification of individuals for different purpose, or even to ensure that the country’s election process is transparent and beyond corruption.

An expression of interest on the use of Blockchain by some State Governments in India, gets reflected in what the Chief Minister (CM) of Maharashtra said while inaugurating the Maharashtra Technology Summit (MTECH), jointly organized by FICCI and Govt. of Maharashtra in Mumbai on January 17, 2018.

The CM clearly indicated, as Blockchain can transform the e-governance, the State Governments must start interacting with technology providers to make Public delivery of goods and services transparent. This will reduce the trust deficit between businesses, and citizens with government departments. He admitted, in the space of technology, ‘Blockchain is one level up and it’s not just Internet of Thing, but it is Internet of trust, Internet of values, that can change the entire space of governance’.

Conclusion:

Blockchain may be just a technological component, but, nonetheless, a game changing one. Thus, the good news is, several pharma players are also taking great interest to step into this never ever experienced – and a new kind of digital paradigm.

It is heartening to note that a number of global pharma head honchos, such as of Novartis, Takeda, and several others, are creating a new global position of chief digital officer. GSK, reportedly, is the latest one to initiate similar step.

Indian pharma players, I reckon, can also reap a rich harvest, both tangible and intangible, by putting ‘Blockchain’ technology in place. It may start with building a transparent, incorruptible ‘Track and Trace’ system for medicines, in addition to achieving high degree of international reliability in its clinical trials, especially on biologic drugs.

The benefits built into the Blockchain technology for pharma, apparently, are far too many than perceived constraints to leverage it effectively. Encouragingly, global pharma seems to be keeping an eye on the ball – but what about Indian pharma?

By: Tapan J. Ray  

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

With ‘Cutting Corners’ Going North, Pharma Reputation Dives South

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Just a few months ago, on October 24, 2017, ‘New Jersey Law Journal’ came out with an eye-catching headline – “Sanofi Set to Pay $ 61M Settlement in Antitrust Suit Over Vaccine Bundling.” The suit says: “Sanofi-Pasteur allegedly suppressed competition for its pediatric meningococcal vaccine, Menactra, by charging physicians and hospitals up to 35 percent more for its product, unless they agreed to buy Sanofi’s pediatric vaccines exclusively. Sanofi-Pasteur is the vaccines division of French drug manufacturer Sanofi.”

Nevertheless, a statement from the company said: “Despite Sanofi’s strong defenses, Sanofi recognizes that continued litigation is likely to be extraordinarily expensive and time-consuming and thus has agreed to enter into this Settlement Agreement to avoid the further expense, inconvenience, risk and distraction of burdensome and protracted litigation. Sanofi is finally putting to rest this case by obtaining complete dismissal of the action and a release by settlement class members of all released claims.”

When such incidences – of various scales and dimensions, continue being reported by both the global and local media, over a long period of time, one can fathom the potential of their cumulative impact on public and other stakeholders. Severely dented image and reputation of pharma, in general, before the eyes of so many, across the world, is a testimony to this phenomenon. Considering these as ‘cutting corners’ syndromes, I shall discuss in this article, how fast is pharma reputation diving South, with incidences of ‘cutting corners’ keep going North.

‘Cutting Corners’:

The Oxford dictionary defines ‘cutting corners’ as: ‘Doing something perfunctorily so as to save time or money’. Putting it in the context, I reckon, legally or ethically questionable actions with a deliberate intent of making quick profits, if not profiteering, can be termed as ‘cutting corners’ or business malpractices.

‘Cutting Corners’ going North:

This is no way a recent phenomenon. Gradually increasing number of new reports on pharma’s alleged malpractices are not uncommon, either. On the contrary, these keep coming rather too frequently – baffling many industry watchers and its well-wishers, for different reasons.

The details of 20 largest settlements in this area reached between the United States Department of Justice and various pharmaceutical companies from 1991 to 2012, as available from Wikipedia, provide a glimpse to its magnitude and dimension. The settlement amount reportedly includes both the civil (False Claims Act) settlement and criminal fine. Glaxo’s US$ 3 billion settlement is apparently one of the largest civil, False Claims Act settlement on the record, and Pfizer’s US$ 2.3 billion settlement includes a record-breaking US$ 1.3 billion criminal fine. A federal court also recognized all off-label promotion as a violation of the False Claims Act, leading to a US$ 430 million settlement during that period, as this report highlights.

In one of my articles, titled ‘Big Pharma Receives Another Body Blow: Would Indian Slumber End Now?’, published in this blog on May 19, 2014, I quoted a few more examples from 2013 and 2014, as well. A few of these are as follows:

  • In March 2014, the antitrust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
  • Just before this, in the same month of March 2014, it was reported that a German court had fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
  • In May 2013, Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix. 

Pharma reputation dives South:

That pharma reputation is diving south, is well captured in the ‘Business and Industry Sector Ratings’ by Gallup, dated August 2-7, 2017. According to this public rating, the top 5 and bottom 5 industries came up as follows:

Top 5:

Industry Total Positive % Neutral % Total Negative % *Net positive or negative %
Computer

75

15

8

+67
Restaurant

72

21

7

+65
Farming and agriculture

70

17

12

+58
Grocery

60

23

17

+43
Internet

59

21

18

+41

The bottom 5, including the federal government:

Industry Total Positive % Neutral % Total Negative % *Net positive or negative %
Airline

41

20

35

+6
Oil and gas

38

21

40

-2
Healthcare

38

18

45

-7
Pharmaceutical

33

16

50

-17
Federal Govt.

29

19

52

-23

*Net Positive is % Positive minus % negative (in percentage points)

Image rejuvenation campaign not yielding results:

Arguably, the richest and the most powerful pharma industry lobby group in the largest pharmaceutical market of the world, is incurring a mind-boggling sum of expenditure to mend the severely dented collective reputation and image of its members.

Vindicating this point, a January 18, 2017 media report articulated that a major pharma industry lobby group – PhRMA, is gearing up for a new image building campaign by spending in the “tens of millions” each year to drum up support for the reputationally challenged pharma industry. Such initiatives by PhRMA, as I understand, are not totally new, but rather ongoing. Be that as it may, as the Gallup survey confirms, pharma reputation keeps diving South, unabated.

Mending pharma’s reputation surfaces as one of the top concerns of the pharma industry. It, therefore, demands commensurate priority in working out a meaningful strategic plan, and its effective implementation on the ground, collectively. More so, when the POTUS – Donald Trump, has also emerged as a vocal pharma critic. He has already proclaimed that drug companies “are getting away with murder,” – as the above media report highlights.

Where is this campaign going off the mark?

On this subject, an article of September 5, 2017, published by Ars Technica – a technology news publication aptly epitomized, what is happening today with these campaigns, against what should have happened, instead. The column carries a headline ‘Big Pharma hopes research spending – not reasonable pricing – will improve image’.

The columnist wrote: “To scrub down their filthy reputations, drug makers could try lowering prices, a public mea culpa, or pledging to make pricing and marketing more responsible and transparent. But they seem to have taken a different strategy.” On this score, a relevant example, out of several others, was of Biogen introducing a drug in 2016, for a rare spine disorder and priced it at an eye-popping US$ 750,000 for the first years’ worth of treatment.

In pharma image revamp campaign, the focus on R&D spending or drug innovation, including blatant self-serving demands, such as strictest product patent and data exclusivity provisions, is rather overwhelming. It is understandable that all this fits in well with various pharma lobby group’s mission and mandate, but is unlikely to deliver what consumers would consider good behavior on the part of drug companies.

Is Indian pharma out of this loop?

The answer to this question is an emphatic – ‘No’. Alleged ‘dubious product quality’ related ongoing saga, is known today by all concerned. This had often culminated into US-FDA import bans of many drugs, manufactured by several Indian drug manufacturers – starting from the very top. Nonetheless, that’s not ‘the all’ or ‘end all’ in the ballgame of ‘cutting corners’ in India, as I explained above.

On September 26, 2017, a media report flashed: ‘The Income Tax (IT) investigation wing claims to have unearthed a nexus between a leading pharmaceutical company and doctors, and the evidence showing payments running into Crores to the latter for prescribing the company’s medicines.’

Close on the heels of ‘compromised drug quality standard’, such malpractices come as a double whammy for patients. But, the saga continues. In my article, titled ‘Healthcare in India And Hierarchy of Needs’, published in this blog on November 06, 2017, I mentioned about the October 31, 2017 public notice of the State Attorney General (AG) of Connecticut. The notice cited several instances of alleged drug price fixing in the United States. Interestingly, this lawsuit includes name of several large Indian companies, such as Dr. Reddy’s Laboratories, Emcure, Glenmark, Sun Pharma, and Zydus Pharma. The expanded complaint also names two individual defendants, one among them is the promoter, the chief executive officer and managing director of a large Indian pharma manufacturer.

Further, as I wrote before, the Maharashtra government’s recent announcement on enactment of a new law called the “Cut practices in Medical Services Act, 2017”, casts a darker shadow, not just on the doctors’ reputation, but also over the health care industry, in general, including pharma.

Today’s patients are more informed:

In today’s world, wider access to the Internet for a large number of global population has a profound implication in every sphere of life. News, discussions, opinions, comments and a plethora of other information on various industries, including pharma, are available from different credible websites, just as anything else.

Additionally, the social media, collectively, have made exchanges and interpretations of such information within various groups and communities, as fast as these could be. Just as many other different things, wrongdoings or malpractices, if any, of various industries, also get quickly captured and shared by the Netizen with ease and élan. These include incidences of ‘cutting corners’ by constituents of the pharma industry too.

Conclusion:

The Public Relationship campaigns of pharma lobby groups, with a hope to bridging the industry’s ‘trust deficit’, have been reported from the United States and other countries. However, any such campaign for the pharma industry in India hasn’t arrested my attention, as yet.

It’s beyond any reasonable doubt or debate that the pharma industry, in general, has saved and is still instrumental in saving more lives, in every nook and corner of the world. Ironically, the same industry, for its own deeds prompted mostly by the self-serving needs, has been suffering a massive collateral damage.

The industry’s long unblemished image and reputation have been severely tarnished,   requiring rejuvenation with an inclusive approach. This may call for a mindset, at least, nearer to the same of George W. Merck – the legendary President and Chairman Merck & Co., Inc. He articulated a vision – “Medicine Is For The Patient, Not For The Profits”, and practiced it religiously. In today’s context, this may sound rather utopian in letters, but surely not in its spirit… be that as it may….

Pharma lobby groups hope to reverse the current trend by focusing only on R&D spending, drug innovation and strictest patent protection and data exclusivity ecosystem is apparently a non-starter. That ongoing multi-million-dollar pharma image revamp campaigns haven’t yet captured any tangible positive outcomes – not even in the United States, is possibly a testimony to this fact.

The status quo is expected to continue. More so, when ‘reasonable pricing’ of drugs is one of the top most demands of patients, patient groups and even many governments – and that’s exactly where the buck stops in pharma business.

In my view, pharma reputation restoration process isn’t merely a one-sided communication issue, as it appears today. A strategic blue print of this critical industry need, deserves to be drawn on a much broader canvass with a patient-serving mindset, instead of just a self-serving one. Otherwise, with incidences of ‘cutting corners’ going North, pharma reputation will keep diving South… till it finds its very bottom.

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.

 

Digitization or Digitalization: What’s Seen More in Indian Pharma?

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Just before this New Year, a doctor friend from a large city of India invited me for dinner, as I happened to be there for a couple of days. Dr. Srikanth Kashikar (name changed) is one of my longtime friends, and a super specialist in the field of oncology.

As Srikanth planned to come for dinner straight from his clinic, I was keen to observe a few pharma  company representatives making professional calls to him, if possible. Srikanth agreed. as that was one of those days when he meets them, after seeing all his patients. 8 pm was the mutually agreed time.

I was there a little before the scheduled time. However, as Srikanth was still examining a patient, he came out and asked me to wait for a few minutes in his assistant’s room. Right around 8.15 pm I was in his office. He sent a message through his secretary that he won’t be able to see more than two representatives, as he needs to go out.

What I experienced?

Sometime back, I had a similar experience of sitting incognito in the clinic of another doctor friend, practising in another major city. Hence, I had a heightened level of interest in getting a ringside view of changes in the professional discourse, if any, especially involving the science and art of persuasive medical communication of the modern world.

Meanwhile, the first representative – a pleasant personality, and wearing a smile on his face, entered the room. As he greeted, my friend reciprocated with a brief smile. The young man was representing a large global pharma player. He seemed to be a bit nervous, though, probably apprehending the time constraint to do his job effectively.

I was delighted to see him taking out a tablet computer. He commenced detailing a complex oncology product, but apparently was going a bit faster than any normal communication process. Digitally captured impressive visuals, sound and medical references flashed in and out. It reminded me the age-old approach of Medical Representatives’ (MR) detailing from well-designed folders, printed on art cards.

Dr. Kashikar did not ask any question, neither during nor after the presentation. His face was rather expressionless – difficult to fathom what was going in his mind, at that time.  Nonetheless, having completed his detailing, the young MR explained the procedure for the patients to get his expensive cancer product at a concessional price. This also did not appear much novel to me, either. Requesting for prescription support, the young man left the clinic, a bit hurriedly, though.

The second MR came in, accompanied by a not so young gentleman, whom he introduced as a manager. They were from a large Indian company. As the MR was about to take his detailing aid out, my doctor friend asked him to make his presentation brief. This apparently unsettled the person. Highlighting just a few points for different products from his folder, he requested the doctor to prescribe a particular oncology brand, and looked at the manager. At that stage, his manager took out a tablet PC demonstrating a product price comparison chart, and also the results of some local clinical trials that his company has conducted on the product. My friend shifted his posture on the chair several times till the manager was done with his presentation.

After they left, I looked at my friend, as he looked at me. He smiled, and said let’s go. I did not enquire anything about the two just concluded calls, either. Thereafter, it was purely laughter and fun between two of us and our wives, as we all were catching up with each other.

My overall impression?

My impression? These will obviously be based on just two interactions, involving some big pharma names, though. It appeared to me, top and busy doctors, such as my friend, continue remaining mostly passive during product detailing. MRs usually switch into a mode of hurry, when asked for making a brief presentation by the specialists, just as what was happening in the past.

The only visible change, I guess, is in a few areas of digitization of detailing tools. I hope, considerable time-gap between my two such experiences, was filled-up by expensive external and internal training inputs of all kinds, including digitization in some areas. Thus, the moot question that surfaces: Are these training programs significantly improving per field staff average productivity on the ground?  In case the answer is ‘no’, there arises an urgency to know ‘why’ and what is the way forward?

Zeroing-in:

The answer to the above question of productivity would entail an enormous amount of data to analyze, which I don’t have access to, right now. Nonetheless, as an illustration, let me zero-in on to just one change that I noticed on that day –  the use of tablet computer during field staff interaction with the doctors. This brings me to the subject of today’s discussion – ‘Digitization or Digitalization: What’s Seen More in Indian Pharma?’ In this article, I shall deliberate on this fascinating area during the changing phase of pharma business dynamics.

More of ‘Digitization’ or ‘Digitalization’?

Both ‘Digitization’ and ‘Digitalization’ are important, and often used as interchangeable words. Although, these two are significantly different, it’s not possible to bring in a digital transformation in business sans digitization.

A.   Digitization:

Digitization basically means automation of currently followed manual systems, records and processes, from analog to digital formats. These cover different types of paperwork or paper-based information systems, including photos or sound or even movement. The simplest example of this is scanning a paper document or photograph and storing them as soft copies, or even converting a movie from a celluloid format to DVD.

Digitization in context of pharma:

In the pharma industry, it may mean converting a detailing folder into digital format and delivering a similar product message to the medical profession through a tablet computer. It may also include field staff reporting system or customer call planning, replacing the manual ones, among many others.

The changes that digitization may ensure are generally incremental in nature. It can help doing many routines much easier, at a lesser cost and in lesser time, facilitating business activities and operations. However, just as any other industry, digitization is unlikely to fetch any fundamental transformation – or help taking a quantum leap in productivity or overall effectiveness of a pharma business, as well.

B.   Digitalization:

Digitalization is defined as the use of digital technologies to change business models and provide new revenue generating opportunities with significant value-creation. It is, therefore, the process of moving a business into the digital world. Similarly, in pharma business ‘Digitalization’ or digital transformation can be achieved by digitalizing everything that can be digitized through integration of digital technologies in different platforms to create and deliver game changing values to patients and other stakeholders.

Interactive question and answer of ‘Siri’ – built into iPhone of Apple Inc. is an important example of digitalization – going way beyond digitization. Another interesting example of digitalizing business, creating path breaking values, can be drawn from the entertainment space – e.g. film and television industry. These businesses offer streaming or downloading facility for movies or TV-serials to viewers, anywhere at any time, at a reasonable price. A few important examples in this area may include, Netflix, Amazon Prime or Hotstar. For digitization, an equivalent example, as I said before, could be DVDs.

In fact, one of the largest vendors of Enterprise Resource Planning (ERP) software and related enterprise applications – SAP made an interesting statement in this regard. It said, having done digitization for many decades, which has immensely increased the efficiency of its processes, SAP is now on its way to digitalization.

Digitalization in context of pharma:

The May 30, 2017 article on ‘Pharma Digitalization’, published in the European Pharmaceutical Review (EPR) says pharma business is undergoing a concurrent transformation on multiple, unrelated areas changing the whole product lifecycle from early drug development to manufacturing and patient care.

Consequently, improving patient outcomes is becoming a key challenge for the pharma companies. Garnering capability to provide real-time information about the disease condition to patients, and collecting patient data for care analytics to improve the treatment process, are emerging as critical ingredients for quantum value addition to pharma business.

Digitalization of business processes with integrated technology can help pharma players to address several major patient care challenges. These may include good compliance to treatment and effective chronic disease management, which can also help them to create hundreds of billions of dollars in value.

Reading the writing on the wall clearly, some pharma giants, like Novartis, GSK and Novo Nordisk have started investing in partnerships and new business models with technology companies, such as Google, IBM and Qualcomm. Even the traditional device manufacturers – Apple, Samsung and Nokia are now researching beyond the wellness products, looking to the patient care market. All this will substantially improve the patient care processes, where the patient care data will become the new source of innovation and competitiveness.

Likewise, digitalization of pharma sales and marketing would entail transformative value creation through integrated digital technologies in all the related functions. As stated above, it should reach right up to the patient and other stakeholder needs, meeting expectations in effective prevention, management and treatment of a a plethora of disease conditions.

Conclusion:

To effectively compete and be winners in the new paradigm, Indian pharma players will necessarily need to step out of the comfort zone. Venturing into the complex world of digital transformative processes will eventually become an essential quality – not just for excellence, but survival too. This is a highly specialized area of qualified experts, both for training and hand-holding.

The clock has started ticking for pharma CEOs to lead from the front. In tandem, they would require empowering a team of the right people with hands-on experience, expertise and passion. The team should ideally consist of individuals, both from within and outside the organization. Their only mandate should be to translate the digital transformation of the organization into reality, with quantum value creation, within a given time-frame.

The choice is, therefore, not between digitization and digitalization, regardless of their often use as interchangeable words. The meaning of each is significantly different, which needs to be properly understood. Although, ‘Digitization’ is more visible in the Indian pharma industry than ‘Digitalization’, as on date, this is also a reality that ushering in digital transformation in any business, such as pharma, is not possible sans digitization – but one should not stop there.

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.

Emerging Role of Digital Pathology in Cancer

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Dear readers, an unlocked door awaiting all of us with tons of opportunities as we log out of  2017 and log in to 2018. Let’s grab those, bringing changes and smile  in many lives. Happy New Year

Cancer is now a leading cause of death worldwide. Every year, across the world 8.2 million people die from cancer. As the World Health Organization (W.H.O) estimates, deaths from this deadly disease will continue to rise, reaching over 13.1 million in 2030.

W.H.O flags that two-thirds of these deaths occur in low and middle-income countries. More than 50 percent of cancer deaths could have been prevented through awareness campaigns, or could have been effectively addressed through expert screening, early diagnosis and affordable treatment.

From this perspective, ‘digital pathology’ offers an immense potential to make a significant difference in the lives of many, who are either high risk individuals, or actually suffering from life threatening ailments. In this article, I shall try to illustrate the above point, in simple language, citing the emerging role of ‘digital pathology’ in cancer, as an example.

Incidence of cancer in India:

W.H.O reports that presently in India, cancer is a major cause of morbidity and mortality. This is vindicated by the 2016 Press Release of the Indian Council of Medical Research (ICMR) stating that, the total number of new cancer cases was expected to be around 1.45 million  in 2016, and the figure is likely to reach nearly 1.73 million new cases in 2020.

ICMR expected over 736,000 people to succumb to the disease in 2016 while the figure was estimated to shoot up to 880,000 by 2020. The data also revealed that only 12.5 percent of patients come for treatment in early stages of the disease. Another report estimated that around 2.5 million individuals in India are living with the cancer.

Launch of cancer screening program:

Realizing the increasing incidence of cancer, ‘the National Program for the Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)’ was initiated in 100 districts in 2010, and expanded to about 468 districts in 2012, in tandem with other Non Communicable Diseases (NCDs).

After further review, the Government informed the Indian Parliament on April 01, 2017 about the launch of universal screening of diabetes, hypertension and cancer in 2100 districts, which would be extended across the country. Accordingly, ‘Operational Guidelines for Non-Communicable Diseases’ were worked out and made public.

A large number of cancer cases remain undetected:

It is worth noting, India is still among one those countries where a large number of cancer cases remain undetected or under-diagnosed. The country continues to grapple with a huge dearth of specialists in this area. These include not just cancer specialists, which reportedly is just 1 over 2000 cancer patients, but qualified pathologists, as well. This stark reality assumes greater importance, as early diagnosis with precision is the key to successful treatment of cancer.

It’s more in rural India:

Availability and access to affordable cancer diagnostic facilities, are indeed a major issue much more in rural areas – the home of over 70 percent of the Indian population. Consequently, its late detection, together with low awareness level for disease prevention, is considered to be the major factors attributing to relatively higher cancer mortality rate in the country.

The intensity of this problem increases manifold and gets more complex, due to various other geographic and logistical constraints. This situation makes high-technology based medical interventions a necessity to save many lives.

A unique public-private partnership initiative:

Interestingly, some developed countries are also trying to address the core issue of increasing access to affordable cancer diagnosis and treatment to all.  An example of which can be drawn from the United Kingdom (UK), where one of finest Universal Health Care (UHC) system exists, for a long time.

On December 06, 2017, by a media release Roche Diagnostics announced a groundbreaking partnership discussions with the UK Government to transform cancer testing in patients.’ It said that the current shortage of pathologists and geographic constraints can make it difficult or longer for an expert to provide an opinion on a cancer patient case, where ‘digital pathology’ can play a crucial life-saving role.

Roche Diagnostics articulated that once important patient-cases are made available digitally, experts from any location can review them without delay. This would lead to availability of more equal access to experts to provide a timely and accurate diagnosis for cancer patients. It further said, making more information available electronically opens possibilities for the discovery of new treatments and the development of Artificial Intelligence algorithms in pathology diagnosis.

A Public-Private-Partnership (PPP) approach, such as the above can add greater efficiency, especially in tissue pathology services – including the expensive ones, to deliver faster and more accurate test results across the health care space, even in India. It goes without saying, such a PPP initiative has to be fleshed out with considerable details to unleash its true potential.

Thus, ‘digital pathology’, I reckon, has the potential to play a path-breaking role in providing access to affordable and early diagnosis of cancer to a large number patients, even in remote places, leading to better outcomes.

The scope of ‘digital pathology’:

It now brings us to the question of: what exactly is ‘digital pathology’? In simple term, ‘digital pathology’ involves remotely examining the whole slide digital imaging of original pathological slides of a patient, virtually in real time, from anywhere in the world to properly diagnose a disease. In case of cancer, these are digital image of original blood and tissue slides of patients, examined by experts with the application of special ‘digital pathology’ software and hardware, from a distant specialty hospital or laboratory.

According to the article titled ‘Artificial intelligence is aiding pathologists’, published on September 02, 2017 by the ‘Digital Journal’, AI or machine learning is being increasingly used in ‘digital pathology’ for precision diagnosis of a disease.

One such use of AI in ‘digital pathology’ for cancer, is to recognize broad or specific patterns in a whole slide image to interpret the features in the cancerous tissues for accurate diagnosis of metastasis and recurrence, besides the stage or grade of cancer.

Preparation of samples for ‘digital pathology’ is very important, and the requirements may vary with different cancer types. Nonetheless, prescribed procedures for each need to be adhered to, meticulously, even in those areas where there is no qualified pathologist, and paramedics do this job. Hence, those personnel should be thoroughly trained and periodically refreshed by well qualified specialist trainers.

Digital pathology in India:

The article titled, ‘Telepathology at the doorstep of a village’, published by the Department of Atomic Energy in India that was last updated on December 14, 2017, aptly captures the scope of ‘digital pathology’ or ‘Telepathology’ in the country.

The authors recognized in the article, despite the high quality of expertise being available within the country, even for the treatment of cancer, it is not available or accessible to a large section of the population, more in the rural areas. On the other hand, super specialty health care facilities like, Tata Memorial Hospital (TMH) or All India Institute of Medical Science (AIIMS) cannot take the increasing patient load, beyond a point, due to various constraints.

Improving telecommunication infrastructure in the country, can be put to effective use for accurate diagnosis of cancer with ‘digital pathology’ or ‘tele-pathology’. Nevertheless, this application is currently operable mostly in those rural and semi urban areas, where a minimum standard of telecommunication infrastructure is available. However, the good news is, such areas are growing in India.

An interesting example is Barshi – a rural landscape in interior Maharashtra, located around 500 km away from Mumbai. Nargis Dutt Memorial Cancer Hospital (NDMCH) located in this hinterland, with Tata Memorial Hospital’s constant support and guidance, especially in ‘digital pathology’ has become an important cancer center. NDMCH now caters to a sizable population from a number of villages and towns surrounding it – in the districts of Solapur, Osmanabad and Latur.

A Government Press Release of October 19, 2016 states that AIIMS in Delhi has gone digital, becoming India’s first fully digital public e-hospital. More initiatives, such as these, in collaboration with rural health centers, and other related PPP initiatives, are expected to significantly improve access to ‘digital pathology’ to a large population, especially for early cancer detection in India.

More ‘Digital pathology’ initiatives are spreading roots in India, including the private business space. For example, according to a media report, Anand Diagnostic Laboratory in Bengaluru has become the first private diagnostic laboratory in the country to adopt the complete Roche Digital Pathology portfolio to provide better diagnostic insights for physicians and their patients.

“From simply remotely viewing patient slides, to consulting specialists real time within India or even through other parts of the world – the applications of digital pathology are endless” – commented the Managing Director, Roche Diagnostics India, while discussing the new technology at a meeting of pathologists in India.

Conclusion:

Against this backdrop, a wide-network of PPP initiatives of affordable ‘digital pathology’ would be a game changer, particularly for early detection of cancer.  With the incidence of cancer rising fast in India, and its effective management getting increasingly more complex – requiring prompt specialists’ intervention right from early diagnosis, such initiatives call for high priority.

A few green-shoots are already visible in this area, but quite sporadic in nature, though. Hoping that its pace of progress will soon gain momentum, the emerging role of digital pathology in cancer brings a fresh hope for survival with dignity to a large population of patients – if and when cancer poses to strike its deadly blow.

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.

Health Care in India And ‘Development For All’ Intent

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‘Development for All’ has become a buzzword, especially in the political arena of India, and is being used frequently during all recent elections as no one can deny its crucial importance in a country like ours.

Nonetheless, some do feel that there should be greater clarity on what all it encompasses. There is no scope for assumption, either, that it definitely covers the economic growth of the nation. But, does it include health care for all, as well? This is a relevant question, since health care plays a crucial role in maintaining high growth of Gross Domestic Product (GDP) by any country, over a long period of time.

The ideal answer to this question would, of course, be an emphatic ‘yes’? However, on the ground is it really so? I explored that subject in my article published in this Blog on November 06, 2017 titled, ‘Healthcare in India And Hierarchy of Needs’.

In this article, I shall focus on health care and the ‘Development for All’ agenda of the Government, as witnessed by many in recent elections. Let me illustrate the point using one of the most recent state assembly elections as an example – Gujarat Assembly election of December 2017. I am citing this example, because it generated so much excitement among many, across the country, for different reasons, though.

Who is responsible for public health care in India?

A recent submission made on the floor of Parliament by the Government, explains the point unambiguously. It goes, as hereunder:

“Public health is a state subject. Under the National Health Mission, support is being provided to States/UTs to strengthen their health care systems to provide accessible, affordable and quality health care to all the citizens. Moving towards Universal Health Coverage wherein people are able to use quality health services that they need without suffering financial hardship is a key goal of 12th Plan.” This is what the Minister of State, Health and Family Welfare, reiterated in the Lok Sabha, just about a year ago, on November 25, 2016.

Since, public health is predominantly a state subject, and so important for each individual, besides being one of the key indicators for long-term socioeconomic progress of a country and, one expects health care to be a key issue during the state Assembly elections. This is necessary to maintain the pace of development in this area, be it a state or the country.

Intriguingly, it appears to have no more than a ‘me-too’ reference in the election manifestos of political parties.

Does health care scenario in a state matter?

Now, zeroing on to Gujarat election as an example, the media report of March, 2017 highlighted, gradually reducing budget allocation percentage of health care in Gujarat. It elaborated, the State has reduced its budgetary allocation for health care from 5.59 percent of the total budget in 2015-16 to 5.40 percent of the revised budget of 2016-17, and now to 5.06 percent in 2017-18.

Consequently, the health care budget and spending on the proportion to the Gross State Domestic Product (GSDP) is going down year after year. Whereas, globally, the percentage of GSDP spent on health and education is considered a key parameter of human development, the report states.

According to a report of the Observer Research Foundation dated December 06, 2017, Gujarat still has a high dependency to the private sector for both outpatient (84.9 percent cases) and also the inpatient (73.8 percent cases). As a result, the out of pocket spending on health care of the state stands at 63.7 percent. This makes Gujarat climbing up the ladder of per capita income, while slipping down the slope of health and social indicators,” the article states.

Just as what happens in all other Indian states, the recent state assembly elections offered an opportunity for the political leadership, cutting across the party line, for a significant course correction. Making health and nutrition one of the top priority focus areas, would have also ensured sustain economic development for Gujarat, in a more inclusive manner, for a long time to come.

What we are witnessing, instead:

The ‘best’ intent of a political party on any area of governance, if it comes to power, generally gets reflected in the respective election manifestos. From that perspective, let’s take a quick look at the key promises on health care, made in the respective election manifestos of the two principal political parties, on the eve of December 2017Gujarat election. I found these, as follows:

Key highlights on health care in BJP Manifesto:

  • The party promised to open more generic medicine shops
  • Introduce mobile clinics and laboratories
  • Making Gujarat free of vector-borne diseases.

Key highlights on health care in Congress Manifesto:

  • Universal health care card

That’s all?… Yes, that’s it.

India is ‘developing’, but public health care is not:

‘The Lancet’ editorial titled, ‘Health in India, 2017’, published on January 14, 2017, discussed about the current status of public health care in India. It underscored that the government expenditure on health being one of the lowest in the world at 1·4 percent of GDP, is totally inadequate to train staff, buy necessary equipment, or efficiently run public health facilities.

Corruption and an unregulated private sector usually fill this vacuum, and in so doing, fuel irresponsible prescribing, and global export of antimicrobial resistance, besides misery and medical bankruptcy for those within the country, lacking financial protection.

The editor articulated that the solution of this important issue is clear. Publicly financed Universal Health Coverage (UHC) has not only been deliberated in India since the dawn of the nation, but has also been highly recommended by both the domestic and the external stakeholders.

Nevertheless, successive governments seem to be lacking either the spine or the heart to act. As recently as 2011, progressive universalism was included in the government’s 5-year plan, but was never funded – the editorial commented.

Both the States, and also the national election campaigns, offer an opportunity for the politicians who the prospective lawmakers, to steer the States, and in that process the country as a whole, moving towards the UHC.

Conclusion:

As heath is a state subject, the issue of providing access to high quality and affordable health care to all should ideally become one of the core issues for all voters, at least, in the State Assembly elections. More so when the sound bite on ‘development for all’ reaches a feverish pitch. There can’t be any holistic ‘development for all’, sans health care and education.

Nonetheless, the reality is, unlike the United States, Europe or Japan, besides a few other countries, the voters in India are also not expressing their concerns in this area, meaningfully. In all probability, ‘development for all’ slogan of the politicians doesn’t include health care to all Indians.

This is likely to continue, in the same way, till the awareness of the socioeconomic impact on health care carves out a niche for itself in the popular political agenda for the voters. Just as what happens with many other economic, technological necessities and other aspirations of people. The recent assembly elections are important pointers to this long persisting trend.

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.

SCM: Embracing Technology For Patients’ Safety

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Supply Chain Management (SCM) in the pharma industry is generally perceived as a logistic function, just in most other industries, involving the distribution of medicines from manufacturing plants, right up to pharma distributors. Thereafter, it becomes the responsibility of the respective distributors to reach these to the wholesalers, who cater to the needs and demand of retail chemists.

In tandem, pharma SCM is also playing a key role in reducing overall cost of drugs, improving the profit margin, and to some extent their affordability to a larger number of patients. This process involves efficient procurement of right products of the right quality, transporting them in the right condition, delivering them at the right location in right time, with optimal inventory carrying cost.

That said, today’s reality demands the SCM to cover much larger space. This calls for taking in its fold even those critical parameters that go beyond the realm of business performance – protecting the health and safety interests of patients, effectively. In that sense, SCM plays a pivotal role pharma business operation, having a potential to make a profound impact in the lives of many, quietly.

Coming out of the cocoon of narrowly defined distribution or logistic functions, pharma SCM, in many countries, has started rediscovering itself, as a multi-dimensional and multi-factorial business necessity, keeping patients within its core focus area, always.

I wrote on ‘The importance of Supply Chain Integrity’ and ‘Maximizing value of a new product launch with an innovative Supply Chain Management System’ in this blog on November 29, 2010 and August 30, 2010, respectively. Thus, in this article, I shall dwell on the role of pharma SCM in ensuring patients’ health and safety, embracing modern technology.

Current concerns:

Gradual transformation of SCM with high-tech interventions is visible now, but in a sporadic way. Speedy development initiatives in this area need to be more inclusive, everywhere. This is a paramount requirement of the pharma business, that has been prompted by serious breaches in the SCM process, affecting patients’ health, safety and security, besides impacting the brand image.

Manifestations of these get reflected in the instances like, availability of substandard and counterfeit drugs, or large product recalls, or quality issues with APIs and excipients escaping SCM scrutiny.

W.H.O says, it’s now all-pervasive:

The availability of substandard and falsified medical products, although is a menace to the society, seems to be all pervasive. The November 2017, Fact Sheet of the World Health Organization (W.H.O) recognizes this fact. The paper categorically states that no country has remained untouched by this issue – from North America and Europe to sub-Saharan Africa, South East Asia, and Latin America. Thus, this hazard, once considered a problem limited to developing and low-income countries, is no longer so.

The leading factors: ‘poor governance and weak technical capacity’:

The W.H.O study titled “Public health and socioeconomic impact of substandard and falsified medical products” released in November 2017 invited rather embarrassing media headlines, such as “India among countries where 10% of drugs are substandard.” Some of the most common medicines consumed in India, such as Combiflam and D-Cold were also found as sub-standard by Central Drugs Standard Control Organization (CDSCO) – as this news item reports.

Commenting on the possible reasons for this menace, W.H.O underscored that such substandard and falsified medical products are most likely to reach patients in 3 important situations. These are, constrained access to high quality and safe medical products, poor governance, and weak technical capacity.

The most important and viable option to effectively address this drug-safety threats is innovative applications of state of the art technology platforms. Many pharma players, are gradually realizing it through experience. Quite in unison, various Governments, India included, are also contemplating to follow the same path. Some nations are enacting robust laws for strict compliance of the remedial measures, as charted out by the respective drug authorities.

Harnessing technology as an enabler:

I reckon, harnessing modern technology will facilitate putting in place a robust ‘Track and Trace’ in the SCM, through product ‘serialization’, to effectively address this menace. As many would know, pharma serialization broadly means that each medicinal product pack will carry a Unique Identifier (UID), that can be tracked and traced till the same reaches the end-user.

The process may start with the key ‘touch points’ of a drug before it reaches the patients, such as suppliers, formulators, carrying and forwarding agents (C&FA) or distributors, wholesalers and retailers. This can be extended backwards, as well, to make the drug-sourcing process safer, which is also of crucial importance.

Leveraging technology for patient safety:

Realizing the importance of drug-safety needs of patients, many drug regulators, even in the developed markets, are leveraging technology as a key enabler in the SCM value chain to effectively address this issue. There are several recent global examples of achieving this specific objective. One such example comes from the top pharma market in the world – the United States.

Where the ‘Track and Trace System’ came as a law:

To ensure greater drug-safety for patients in the country, the oldest democracy of the world decided to introduce the ‘Track and Trace System’ in the SCM process by enacting a robust law. Accordingly, in December 2016, the US-FDA released the final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA).

Under this law an electronic ‘Track and Trace System’, through product ‘serialization’, will be put in place in the United States. As reported in the ‘Pharmacy Times’, DSCSA comes into force to regulate transactions between dispensers, pharmacies, and also among manufacturers, repackagers, wholesale distributors, third-party logistics providers, and trading partners, from November 24, 2017.

Following DSCSA, on June 30, 2017, the agency issued a draft guidance for the industry, titled Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. It informed the manufacturers and other supply chain stakeholders that “although manufacturers are to begin including a ‘product identifier’ on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions.”

The US-FDA explains ‘product identifier’, as follows:

  • A unique identity for individual prescription drug packages and cases, which will allow trading partners to easily trace drug packages as they move through the supply chain.
  • Includes the product’s lot number, expiration date, a national drug code (or NDC), and a serial number. The serial number is different for each package or case. This creates a unique identifier – human and machine readable – to enable product tracing throughout the supply chain and enable all trading partners to better detect illegitimate products within the supply chain.

The US drug regulator clarified that the compliance policy outlined in the draft guidance applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017 and November 26, 2018.

Several other countries also realizing its criticality:

Besides the United States, several other countries are harnessing high technology to make the SCM system more robust to ensure patient safety. Some of these include, EU, South Korea, Brazil and China, South Korea and Argentina. India too has initiated action in this area, but only for exports, as on date. Intriguingly, drug-safety for patients within the country doesn’t seem to be on the ‘must do’ list of the law and policy makers of the country, just yet.

‘Track and Trace’ system in India:

As stated above, the ‘Track and Trace’ system in India for drugs is currently applicable only to pharma exports. By a notification dated January 05, 2016, the Directorate General of Foreign Trade (DGFT) made encoding and printing of unique numbers and bar codes as per GSI Global Standard mandatory. This would cover tertiary, secondary and primary packaging for all pharmaceuticals manufactured in India and exported out of the country to facilitate tracking and tracing.

However, for drugs in the domestic market, although a draft proposal was circulated to the stakeholders in June 2015, but no significant progress has yet been made on its implementation in India.

Conclusion:

Availability of potentially harmful substandard and counterfeit drugs is posing a threat to public health and safety, almost in all countries across the world, with a varying degree, though. The November 2017, Fact Sheet of the World Health Organization (W.H.O) also highlighted this issue with a great concern.

A robust SCM systems, built on modern technological platforms are now receiving encouragement from the Governments in many countries, to contain this menace. Accordingly, lawmakers are formulating tough laws, and the drug regulators are specifying the requirements that need to be built into the pharma SCM mechanism.

Some pharma players, on their own, are further raising this bar, while framing their internal compliance norms for SCM. They realize that besides responding to patients’ health and safety needs, it is necessary for the commercial consideration too, alongside the company’s reputation.

Although, India is included among those countries where 10 percent of drugs are substandard, as the W.H.O reports, no such regulatory mechanism has been made mandatory within the Supply Chain to cover drugs in the domestic market, as yet. Interestingly, the DGFT has made the ‘Track and Trace’ mechanism only for the exporters, probably for patients’ health safety of the importing countries! Neither has the majority of domestic pharma manufacturers voluntarily implemented it, demonstrating ‘Patient-Centricity’.

Making SCM robust, weaving into it the drug-safety needs of patients, is a necessity in India too. When a large number of countries, including BRICS nations, are embracing modern technology to achieve this goal, why isn’t India doing so – intriguing…No…?

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.

 

Leveraging Artificial Intelligence For Greater Patient-Centricity

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‘Artificial Intelligence (AI)’ – the science of simulation of intelligent behavior in computers, has the potential to leave a transformational impact on virtually everything that we see and feel around us. As many will know, the modern definition of AI is “the study and design of intelligent agents where an intelligent agent is a system that perceives its environment and takes actions which maximizes its chances of success.”

Let me begin with a couple of exciting examples on the application of AI for general use. One such is Siri the voice-activated computer in the iPhone that one can interact with as a personal assistant, every day. The other is the self-driving features with the predictive capabilities of Tesla cars; or even the well-hyped Google driver-less car. Alongside, Google is also in pursuit of creating AI with ‘imagination’ through its ‘DeepMind’. It develops algorithms that simulate the human ability to construct plans.

Pharma’s emergence in the AI space:

The unfathomable potential of AI is being slowly recognized in the healthcare arena, as well, including pharma industry. It’s gradual emergence in the space of ‘intelligent learning’, often called ‘machine learning’, ushers in a new paradigm of learning from a vast pool of highly credible real-time data. Innovative applications of this process can fetch a game changing business performance. Its scope spans right across the pharma value chain – from Drug Discovery, including Precision Medicine; Clinical Trials; Pharmacovigilance; Supply Chain Management, and right up-to Sales and Marketing.

Pharma’s emergence in the AI space is quite evident from Reuters report of July 3, 2017. It wrote that GlaxoSmithKline (GSK) has inked a new USD 43 million deal with Exscientia to help streamline the company’s drug discovery process by leveraging AI. With this deal in place, Exscientia will allow GSK to search for drug candidates for up to 10 disease-related targets. GSK will provide research funding and make this payment, if pre-clinical milestones are met.

Again, on July 27, 2017, Insilico Medicine – a Baltimore-based leader in AI, focusing on drug discovery and biomarker development, announced a similar agreement with the biotechnology player Juvenescence AI Limited. According to this agreement, Juvenescence AI will develop the first compounds generated by Insilico’s AI techniques, such as Generative Adversarial Networks in order to generate novel compounds with desired pharmacokinetic and pharmacodynamic properties.

Several other pharmaceutical giants, including Merck & Co, Johnson & Johnson and Sanofi are also exploring the potential of AI for streamlining the drug discovery process. It would help them to significantly improving upon the hit-and-miss business of finding new medicines, as Reuters highlighted.  Eventually, these applications of AI may be placed right at the front-line of pharma business – in search of new drugs.

I have already discussed in this blog – the ‘Relevance of AI in creative pharma marketing’ on October 31, 2016. In this article, I shall mainly focus on leveraging AI in health care for greater patient-centricity, which is emerging as one of the prime requirements for excellence in the pharma business.

Imbibing patient-centricity is no longer an option:

In an article published in this blog on the above subject, I wrote that: ‘providing adequate knowledge, skills and related services to people effectively, making them understand various disease management and alternative treatment measures, thereby facilitating them to be an integral part of their health care related interventions, for better health outcomes, are no longer options for pharma companies.’

The craft of being ‘patient-centric’, therefore, assumes the importance of a cutting-edge  of pharma business for sustainable performance.

What exactly is ‘patient-centricity’?

BMJ Innovations – a peer reviewed online journal, in an article titled, ‘Defining patient centricity with patients for patients and caregivers: a collaborative endeavor’, published on March 24, 2017, defines ‘patient-centricity’ as: “Putting the patient first in an open and sustained engagement of patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.”

Thus, to deliver the best experience, and treatment outcomes to patients, their participation and engagement, especially with the doctors, hospitals and the drug companies assume significant importance.

The June 2017 ‘Discussion Paper’ of McKinsey Global Institute, titled ‘Artificial Intelligence the Next Digital Frontier’ also captured this emerging scenario, succinctly. Recognizing that health care is a promising market for AI, the paper highlighted the enormous potential in its ability. The power of which can draw inferences by recognizing patterns in large volumes of patient histories, medical images, epidemiological statistics, and other data.

Thus, AI has the potential to help doctors improve their diagnoses, forecast the spread of diseases, and customize treatments. Combined with health care digitization, AI can also allow providers to monitor or diagnose patients remotely, as well as transform the way we treat the chronic diseases that account for a large share of health care budgets, the paper underscored. This poses the obvious question: what exactly AI can possibly do in the space of health care?

What can AI do for health care?

In a nutshell, the application of AI or ‘machine learning’ system in health care generally uses algorithms and software to approximate human cognition in the analysis of relevant, yet complex scientific and medical data. In-depth study and interpretation of these in a holistic way would be of immense use in many areas. For example, to understand the relationships between prevention or treatment processes and outcomes, or various debilitating conditions affecting people with the advancement of age, to name just a few.

This necessitates the generation of a huge pool of relevant and credible data from multiple sources, storing and analyzing them meaningfully, and then garnering the capabilities of ‘machine learning’ with the application of AI. Such a process helps in zeroing-in to a series of complex, interdependent strategic actions to go for the gold, in terms of business results. Using conventional methods, as exist today, other than imbibing AI or ‘machine learning’, may indeed be a Herculean task, as it were, to achieve the same.

Invaluable business insights thus acquired need to be shared, across the various different functions of a company, for greater patient-centricity within the organization.

Moving from ‘patient-engagement’ to ‘patient-centricity’:

While making a significant move from just ‘patient engagement’ to being ‘patient centric’, one-size-fits-all strategy is unlikely to yield the desired results. The process of gathering adequate knowledge and understanding of any individual’s disease management skills, which mostly depend on complex multi-factorial, interrelated and combinatorial algorithms, will be a challenging task, otherwise.

Thereafter, comes the need to deliver such knowledge-based value offerings to target patients for better health outcomes, which won’t be easy, either, in the prevailing environment.

Considering these, AI seems to have an immense potential in this area. Some global pharma players are also realizing it. For example, GSK is reportedly engaged with IBM’s Watson in the development of AI-enabled interactive digital Apps for its cold and flu medication to provide relevant information to patients.

Conclusion:

Patient-centricity would soon be the name of the game for pharma business excellence. However, to be truly patient-centric, especially in the sales and marketing operations, pharma players would require to source, process and analyze a huge volume of relevant data in several important areas. These include, target patients, target doctors, environmental dynamics, demographic variations, regulatory requirements, current practices, competitive activities, to name a few.

In this strategic business process, AI or ‘machine learning’ will help accurately mapping the ongoing dynamics and trends in virtually all critical areas. It will help ferret out the nuances of turning around the competitive tide, if any, and that too with immaculate precision. In that sense, AI is likely to emerge as a game changer in imbibing patient-centricity, in the real sense. Consequently, it carries a promise of delivering significantly better outcomes, yielding higher financial returns, alongside.

Although, some concerns on AI are being expressed by several eminent experts, it is generally believed that on the balance of probability, it’s crucial potential benefits far outweigh the anticipated risks. In my view, this holds good even for the pharma industry, especially while leveraging AI for greater patient-centricity, better disease prevention, and more desirable treatment outcomes – improving the quality of life of many, significantly.

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.

 

Patent Expiry No Longer End of The Road

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Who says that the phenomenal success of blockbuster drugs is mostly eaten away by  ‘look-alikes’ of the same, immediately after respective patent expiry? It doesn’t seem to be so any longer, not anymore! Several examples will vindicate this emerging trend. However, I shall quote just a few of these from the published reports.

In 2016, the patent of AbbVie’s Humira (Adalimumab), indicated in the treatment of autoimmune diseases and moderate to severely active rheumatoid arthritis, expired in the United States (US). It will also expire in Europe by 2018. This event was expected to create significant opportunities for lower priced Adalimumab biosimilars in the US market, increasing the product access to many more patients at affordable prices. Just as it happens with patent expiry of small molecule blockbuster drugs. One of the classic examples of which, is a sharp decline in sales turnover and profit from Pfizer’s Lipitor (Atorvastatin), as its patent expired on November 30, 2011.

However, Humira topped the prescription-drug list of 2016 with an annual growth of 15 percent, accounting for USD 16 billion sales, globally. More interestingly, according to a recent report of EvaluatePharma, AbbVie’s Humira will continue to retain its top most ranking in 2020 with expected sales of USD 13.9 billion. Nevertheless, possible threat from biosimilars has slightly slowed down its growth. Although, there are many other similar examples, I would quote just three more of these to illustrate the point, as follows:

  • Rituxan (Rituximab, MabThera) indicated in the treatment of cancer and co-marketed by Biogen and Roche, went off-patent in 2015. However, in 2016, the product held 4th position in the prescription drug market with a revenue growth of nearly 3 percent. Even five years after its patent expiry, Rituxan is still expected to occupy the 17th rank with an estimated turnover of over USD 5 billion in 2020, according to the EvaluatePharma report.
  • Remicade (Infliximab) indicated for autoimmune diseases and manufactured by J&J and Merck, lost market exclusivity in 2015. But, in 2016 it still held 5th place in the global ranking. Five years after it goes off patent, Remicade is expected to feature in the 6th rank in 2020, with an estimated turnover of over USD 6.5 billion, according to the same report as above.
  • The US product patent for Lantus – a long-acting human insulin analog manufactured by Sanofi, expired in August 2014. However, in 2016, clocking a global turnover of USD 6.05 billion, Lantus still ranked 10 in the global prescription brand league table. Six years after its patent expiry – in 2020, Lantus will continue to feature in the rank 20, as the same EvaluatePharma report estimates.

These examples give a feel that unlike small molecule blockbuster drugs, patent expiry is still not end of the road to retain this status for most large molecule biologics, across the world. In this article, I shall discuss this point taking Humira as the case study.

What about biosimilar competition?

In any way, this does not mean that related biosimilars are not getting regulatory approval in the global markets, post-patent expiry of original biologic drugs, including the United States. Nonetheless, biosimilar makers are facing new challenges in this endeavor, some of which are highly cost intensive, creating tough hurdles to make such drugs available to more patients at an affordable price, soon enough. It happened for the very first biosimilar to Humira, as well. On September 23, 2016, almost immediately after its patent expiry in 2016, the USFDA by a Press Release announced approval for the first biosimilar to Humira (adalimumab). This was Amgen’s Amjevita (adalimumab-atto), indicated for multiple inflammatory diseases.

The second biosimilar to AbbVie’s Humira – Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), was also approved by the USFDA in August 2017. So far, six biosimilars have been introduced in the United states. But, none of these got approved as an ‘interchangeable’ product. Some of these, such as Cyltezo could not even be launched, as yet. I shall discuss this point later in this article. Thus, Humira is expected to retain its top global prescription brand ranking in 2020 – over 4 years after its patent expiry.

In Europe, two marketing authorizations were reportedly granted by the European Commission (EC) in March 2017 for Amgen’s biosimilars to Humira, named Amgevita (adalimumab) and Solymbic (adalimumab). Later this year, in November 2017 Boehringer Ingelheim’s – Cyltezo also received its European marketing approval.

It is worth noting that in December 2014, the Drug Controller General of India (DCGI) reportedly granted marketing approval for Zydus Cadila’s Adalimumab biosimilar (Exemptia) for treating rheumatoid arthritis and other autoimmune disorders in India. The company claims: “This novel non-infringing process for Adalimumab Biosimilar and a novel non-infringing formulation have been researched, developed and produced by scientists at the Zydus Research Centre. The biosimilar is the first to be launched by any company in the world and is a ‘fingerprint match’ with the originator in terms of safety, purity and potency of the product.”

Several important reasons indicate why a full throttle competition is lacking in the  biosimilar market early enough – immediately after patent expiry of original biologic molecules. I shall cite just a couple of these examples to illustrate the point. One is related to aggressive brand protection, creating a labyrinth of patents having different expiry dates. And the other is a regulatory barrier in the form of drug ‘interchangeability’ condition, between the original biologic and related biosimilars:

In the labyrinth of patents:

The most recent example of innovator companies fiercely protecting their original biologic from the biosimilar competition by creating a labyrinth of patents is Boehringer Ingelheim’s Cyltezo. This is biosimilar to AbbVie’s Humira, approved by the USFDA and EC in August 2017 and November 2017, respectively.

According to reports: “BI does not intend to make the drug commercially available in Europe until the respective SPC (supplementary protection certificate) for adalimumab, which extends the duration of certain rights associated with a patent, expires in October 2018. Cyltezo is also not yet available in the US despite its approval there in August, because of ongoing patent litigation with AbbVie. AbbVie reportedly holds more than 100 patents on Humira, and believes that Boehringer could infringe 74 of these with the launch of its biosimilar. Similarly, the firm has also taken Amgen to court to block the launch of its proposed Humira biosimilar.”

Another interesting example is the epoch-making breast cancer targeted therapy Trastuzumab (Herceptin of Roche/Genentech). The patent on Herceptin reportedly expired in 2014 in Europe and will expire in the United States in 2019. The brand registered a turnover of USD 2.5 billion in 2016. However, a November 21, 2017 report says that creating a series of hurdle in the way of Pfizer’s introduction to Herceptin biosimilar, Roche has sued Pfizer for infringement of 40 patents of its blockbuster breast cancer drug. Pfizer hasn’t yet won approval for its Herceptin biosimilar, though, USFDA accepted its application in August 2017 – the report highlights

‘Interchangeability’ condition for biosimilars:

In the largest global pharma market – the United States, USFDA classifies biosimilars into two very distinct categories:

  • Biosimilars that are “expected to produce the same clinical result as the reference product”
  • Biosimilars that are “interchangeable,” or able to be switched with their reference product

According to reports, experts’ argument over ‘interchangeability’ in the US range from “whether pharmacists should be allowed to switch a biologic for its biosimilar without a doctor’s notification, to whether interchangeable biosimilars might be perceived as better or safer than their non-interchangeable counterparts.” This debate has somewhat been resolved by the US Food and Drug Administration’s (FDA) issuance of draft guidance in January 2017, specifying what should be submitted to support an interchangeable application, the report says.

The article also indicates, “the draft makes clear that switching studies to help gain this designation should evaluate changes in treatment that result in two or more alternating exposures (switch intervals) to the proposed interchangeable product and to the reference product. Study design, types of data and other considerations are also included in that draft.” Nonetheless, compliance with this regulatory requirement is expected to be highly cost intensive, too.

Quoting a senior USFDA official, a report dated June 26, 2017 mentioned: “interchangeable biosimilars will come to market within the next two years, though possibly sooner. And the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.” Still the bottom line remains no biosimilar has yet been approved by the USFDA as ‘interchangeable’. Hence, the optics related to desirable success for biosimilars continue to remain somewhat apprehensive, I reckon.

Patent related litigations on Trastuzumab (Herceptin) were filed by Roche in India, as well. However, it’s good to note that on December 01, 2017, by a Press Release, USFDA announced the approval of Mylan’s biosimilar variety of Roche’s blockbuster breast cancer drug – Herceptin. Mylan’s Ogivri was co-developed with Biocon in India to treat breast or stomach cancer, and is the first biosimilar approved in the United States for these indications. It is noteworthy that Ogivri also has not been approved as an interchangeable product.

The global and local scenario for biosimilars:

Be that as it may, the July 26, 2017 study of Netscribes – a global market intelligence and content management firm estimates that the global biosimilar market will be worth USD 36 billion by 2022. Some of the major findings of this study are as follows:

  • With a cumulative share of nearly 85%, North America, Europe, and Japan are the major contributors to global biological and biosimilar sales. Asia and Africa account for 13.2% and 1.2%, respectively.
  • Pfizer is the leading player in the biologic market, with sales of nearly USD 45.9 billion in 2016 followed by Novartis (41.6 billion) and Roche (39.6 billion).
  • Biosimilar approvals are estimated to be around of around 16 to 20 biosimilars between 2018 to 2021 in both US and EU.
  • The US is not a favorable market for biosimilars due to a number of reasons, such as poor access to biologic drugs and an unfavorable regulatory environment.
  • South Africa is one of the best-suited markets for biosimilars due to a favorable regulatory environment and prescriber acceptance.

According to the April 2017 analysis of Research And Markets, biosimilars have started winning key government tenders in countries like Mexico and Russia, and being purchased by a growing number of patients in self-pay markets such as India. The aggregate sales of ‘copy biologics’ in the six BRIC-MS (Brazil, Russia, India, China, Mexico, and South Korea) countries would now almost certainly exceed USD 1.5 billion. Yet Another estimate  expects the Indian biosimilar market to increase from USD 186 million in 2016 to USD 1.1 billion in 2020. It is up to individual experts to assess whether or not this growth trend for biosimilars is desirable to adequately benefit a large number of patients, the world over.

Conclusion:

In my view, if what usually happens to sales and profit for small molecule blockbuster drugs post patent expiry, would have happened to the large molecule biologic drugs, the market scenario for biosimilars would have been quite different. In that scenario, one would have witnessed a plethora of biosimilar competition against high priced and money churning biologics, such as Humira, being launched with a significantly lesser price than the original brand.

Prices of biosimilars would have been much lesser primarily because, the litigation cost, now built into the biosimilar prices for successfully coming out of the labyrinth of patents after the basic patent expiry, would have been minimal. Moreover, restrictions on drug ‘interchangeability’ would not have made the target market smaller, especially in the United states.

Alongside, compliance with the regulatory need to meet the ‘interchangeability’ condition in the US, would drive the product cost even higher. More so, when this specific regulatory requirement is not necessary in other developed markets, like Europe. Both these factors would adversely impact affordability and access to sophisticated biologic drugs for patients, even after the fixed period of market exclusivity.

That said, a virtually impregnable patent labyrinth mostly ensures that going off-patent isn’t end of the road for blockbuster biologic drugs to continue generating significant revenue and  profit, any longer – and it would remain so at least, in the short to medium term.

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.