While Pharma Leadership Change This Atypical Skill Counts

While Pharma Leadership Change This Atypical Skill Counts

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.…continue reading…

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

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

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. …continue reading…

Gene Therapy Price: Commercial Viability And Moral Dilemma

Gene Therapy Price: Commercial Viability And Moral Dilemma

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:…continue reading…

Why D&I Is A Powerful Growth Driver For Pharma Industry

Why D&I Is A Powerful Growth Driver For Pharma Industry

‘Diverse India’ now needs an ‘inclusive society’, vowed the Prime Minister of India, after his massive electoral win on May 23, 2019. Many may consider a part of it as rhetoric, notwithstanding, as and when the government policy of Diversity and Inclusion (D&I) gathers wind on its sail, the realization of its importance would reverberate – even in the corporate world, including the pharma industry, especially in India.

I discussed this subject in my article of June 25, 2018 ,in the context of transforminga pharma company to a customer-oriented, profit-making organization, with implementation D&I within the organization. However, in this article, I shall deliberate, over and above, the current status of D&I in the pharma industry, why most drug companies are still not leveraging it as one of the powerful business growth drivers. While opening this discussion, let me recapitulate what these two words mean to us, and their importance in the drug industry.

Recapitulating D&I:

As there are several, but similar definitions of D&I, I am quoting below just one – from the Ferris State University. It goes, as follows:

• “Diversity is the range of human differences, including but not limited to race, ethnicity, gender, gender identity, sexual orientation, age, social class, physical ability or attributes, religious or ethical value system, national origin, and political beliefs.”

• “Inclusion is involvement and empowerment, where the inherent worth and dignity of all people are recognized.”

The relevance and importance of D&I as a corporate growth policy for the drug industry is immense. It will not just, help them recognize and create business policies, based on diversity in people – a wide range of human differences in their consumers or potential consumers. In tandem, it will also help promote, and sustain a sense of belongingness with the society and communities where it operates – their values, beliefs, expectations and desire for a healthy living.

D&I begins within the company, and for the customers:

There are clear indications that many pharma companies are slowly, but surely realizing that for a consistent and sustainable financial performance the whole approach to business needs to undergo a metamorphosis. One such area of transformation, is a sharp focus on effectively satisfying a set of well-defined expectations of both their external and internal customers.

This journey begins with the creation of a Diverse and Inclusive (D&I) workplace. Nevertheless, the key goal remains – meeting expectations of the society where the drug companies operate, including a diverse set of customers – by saving and improving their quality of life, with affordable and accessible medicines.

While talking about diversity to Business Insider on January 10, 2018, GlaxoSmithKline CEO Emma Walmsley also reiterated, for a future facing employer in an industry, D&I should be a priority corporate strategy – for aggressively modernizing the business.

D&I ‘may be most important in the health care industry’:

This has been well-articulated even in the Workforce – a multimedia publication, where it says: D&I ‘may be most important in the health care industry, where the workforce needs to be both business savvy and socially empathetic to serve their increasingly diverse communities.’…continue reading…

The Game is Changing: Ensure Better Treatment Outcomes: Leverage Technology

The Game is Changing: Ensure Better Treatment Outcomes: Leverage Technology

Today, several pharma players, mostly ‘encouraged’ by many non-pharma tech companies, are trying to gain, at least, a toehold in the digital health care space. It is visible even within the generic drug industry. Such initiatives, as they gain a critical mass, will remold the process of doing – almost everything in the pharma business, catapulting the concerned drug companies to a much higher growth trajectory, as many believe.

This is quite evident from an interview of Fierce Pharma with the senior management of Sandoz – the generic drug arm of Novartis, that was published on May 14, 2019. The honchos said: “We’re looking across the whole value chain to make sure we’re embracing digital and technology wherever we can. So that means from the way that we innovate, to the way that we sell and the way that we operate and do day-to-day business.” The process covers “a whole range of activities from how you use AI and automation, all the way through to prescription digital therapies.”

I discussed about leveraging technology in the pharma space to address many burning issues – both for patients and the pharma industry. One such article, “Focus on Patient Compliance To Boost Sales…And More…”, was published in this blog on May 20, 2019. It establishes that even world-class sales and marketing programs can, at best, ensure higher prescription generations, but can’t prevent over 50 percent revenue loss from those prescriptions, due to patient non-compliance.

Interestingly, the issue of ‘nonadherence to treatment’ is being debated, since several decades. Various conventional measures were suggested and also taken. But the problem still persists in a huge scale, with probably an increasing trend. Thus, fresh measures, preferably by leveraging modern technology, are of high relevance in this area.

In this article, I shall illustrate the above point, with one of the most exciting areas in the digital space – the digital therapeutics. This is a reality today and marching ahead at a much faster pace than many would have anticipated.

Unfolding another disruptive innovation in healthcare:

One of the articles that I wrote on this subject is ‘Unfolding A Disruptive Innovation in Healthcare,’ which highlights a different facet of the same subject. Thus, let me begin today’s discussion with a recapitulation of some important aspects of a drug, particularly the following ones:

• A large number of patients don’t find many drugs accessible and affordable during the entire course of treatment.
• Drugs have to be administered orally, systemically or through any other route
• Alongside effective disease prevention or treatment, many drugs may bother patients with long and short-term side-effects, including serious ones.
• Treatment outcomes can’t often be easily measured by patients.

These are, of course, known to many, but several questions come up in this area, which also deserve serious answers, such as:

• Are drugs indispensable for the treatment of all types of disease?
• Can a holistic disease treatment be made more accessible and affordable with radically different measures?
• Can the same effectiveness of a drug, if not more, be achieved with no side-effects with a non-drug therapy?
• Can outcomes be significantly improved following this process, as compared to drugs?

In search of answers to these questions – arrive digital therapeutics:

In search of answers to the above questions, a number of tech savvy whiz kids. dared to chart an uncharted frontier by asking themselves: Is it possible to treat a disease with a software – having no side-effects, but providing better cost effectiveness and treatment outcomes to patients?…continue reading…

Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India

Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India

“Bottle Of Lies Exposes The Dark Side Of The Generic-Drug Boom” – re-emphasized the book, released in May 2019.  This confirms, the raging debate on the questionable quality of many generic drugs manufactured in India and involving several top domestic pharma companies, is a never-ending one. Numerous articles also ascribe many different reasons to this saga, leaving an overall impression – as if, blindfolded persons are trying to describe an elephant, touching and feeling different parts of the animal’s body, each at a time.

Let me illustrate the point with the Bloomberg article of January 31, 2019. It reported, “Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency.” And further commented: ‘The FDA confronts creative improvisation in the world’s largest generic-drug exporter.’ Curiously, according to the above report it seems to be a general belief among many, even within India.

This article will take into account the above apprehension – specifically raised against Indian drug manufacturers of both branded and non-branded generics. Accordingly, my focus will be on just three points – as possible causative factors for this critical issue:

• Is it an India specific concern – thus related to ‘Indian cultural mindset’? or it’s a global issue, involving both Indian multinational drug manufacturers.
• Is it a systematic attempt to create a perception bias against low-cost generic drugs, worldwide?
• Are generic drug makers resorting to such unacceptable shortcuts due to increasing margin pressure?

Having deliberated these points, I shall try to outline a set possible remedial measures to address this issue in a holistic way, ensuring a win-win outcome. Let me first explore, whether or not this issue is specific to India, involving Indian drug manufacturers.

Is the issue India specific?

Is the issue of questionable quality of generic drugs, irrespective of whether they carry a brand name or not restricted to the shores of India? One can find its answer in the same report, as quoted above. A yearlong investigation by Bloomberg News into the generic-drug industry concluded, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’

One possible reason for such perception could be, since India is predominantly a branded generic market, voices decrying ‘questionable’ safety and efficacy of cheaper non-branded generic drugs, are too loud. Nevertheless, amidst all this, who’s who of branded generic manufacturers continue getting caught on the wrong foot by overseas regulators in the quality quagmire. Ironically, multinationals are also included in it.

Multinationals are also included in such quality quagmire:

There are several examples of non-compliance to requisite drug quality standards by multinational drug companies. Let me illustrate the point with an example that involves a top global pharma player.

The March 04, 2019 ‘Warning Letter’ of US-FDA for the Irungattukottai (Tamil Nadu) plant of Pfizer in India, clearly said: “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

…continue reading…

Focus On Patient Compliance To Boost Pharma Sales…And More…

Focus On Patient Compliance To Boost Pharma Sales…And More…

One high-impact area in the healthcare space that often finds its place in the backseat is – patient noncompliance. A term that is commonly used in regard to ‘a patient who does not take a prescribed medication or follow a prescribed course of treatment.’ It comes with a steep price, for causing serious adverse impact not just on human health and health system, but also in the pharma business. Intriguingly, such incidents are still not scientifically monitored enough and vigorously acted upon, both globally and locally.

The World Health Organization (W.H.O) has also flagged it as a huge problem, as it reports, 10 percent to 25 percent of hospital and nursing home admissions result from patient noncompliance. Furthermore, about 50 percent of prescriptions filled for chronic diseases are not taken correctly, with 40 percent of patients not adhering to the treatment regimen.

In this article, just after giving a flavor to its financial cost to patients, I shall dwell mostly on its impact on the pharma players, as overcoming this important problem doesn’t generally fall in the area of strategic focus for most of them. Finally, I shall explore how drug manufacturers can translate this problem into an opportunity – as the third growth driver for business, creating a win-win situation for all.

Economic and health impact on patients:

Noncompliant patients suffering from both acute and chronic ailments, pay a heavy price, not just in terms of longer suffering arising out of complications, but also incurring significantly more health expenditure for treatment of the same diseases. According to IMS Institute for Healthcare Informatics, on average, less than 40 percent of patients around the world are fully complying with their treatment instructions.

Even in the Indian context, the problem is no different. Let me illustrate the point with the example of a chronic disease, such as Asthma. The article published on June 26, 2018 in ‘Lung India’ – the official publication of Indian Chest Society reported: “The mean annual direct costs among compliant and non-compliant patients were ₹14, 401 and ₹24, 407, respectively. Percentage of hospitalization was less among the compliant group (6 percent) when compared with noncompliant group (17 percent).”

The study concluded, asthma is not only associated with patient-specific impairment, but also creates a significant economic burden for the family and society. The major contributors to the burden are the medication cost and hospital admissions. Patient compliance with prescribed drugs can help keep asthma under control, thereby decreasing the economic burden and emergency hospital admissions – avoiding the economic risk from ill health with high out of pocket payments.  Productivity loss is another under-appreciated source of economic loss contributing to indirect cost. The rising costs of investigations, interventions, and treatment of chronic diseases further complicate the problem.

Economic impact on pharma business:

According to November 16, 2016 report, published by Capgemini and HealthPrize Technologies, globally, annual pharmaceutical revenue losses had increased from USD 564 billion in 2012 to USD 637 billion due to non-adherence to medications for chronic conditions. This works out to 59 percent of the USD 1.1 trillion in total global pharmaceutical revenue in 2015.

The report highlights,…continue reading….