'Learnings From A Yearlong Catastrophic Disruption of 2020 - And Crystal-Gazing 2021'

''Learnings From A Yearlong Catastrophic Disruption of 2020 - And Crystal-Gazing 2021' 

Wishing All My Readers A Very Happy, Healthy, Peaceful and Prosperous 2021

Just a few days left for the year 2020 to merge with history. It will be remembered by all – as a year of all-round catastrophic global disruption. With unprecedented impact on human lives, livelihoods, economy, and ways of doing things – sparing virtually nothing. The sole cause of which is an unprecedented single event – Covid-19 pandemic. As of December 27, 2020 morning, India recorded a staggering figure of 10,118,392 new Coronavirus cases with 147,659 deaths. The threat of subsequent waves for further infection of Covid-19 infection continues.

In this article, I shall focus on some critical lessons learnt from the 2020 health crisis, while crystal-gazing 2021. I’ll do this purely from the health care perspective, in general, and the pharmaceutical industry, in particular. Keeping this in view, some of the lessons learnt during the pandemic are as follows:

A. Never allow a sense of hubris setting in:

This is easier said than done. Nonetheless, before the Covid pandemic played havocs with all, many top pharma leaders were, apparently, in a hubris. It was often laced with excessive confidence, if not arrogance. The predominant belief was nothing can go so wrong sans unfavorable policy decisions by the governments. This was against a much-known management dictum for all – always anticipate future probabilities that may impact the business and keep prepared for the worst, while hoping for the best. On a hindsight, this was, obviously jettisoned – lock, stock and barrel. No one was prepared for any biological threats, such as, Covid pandemic, till the deadly virus caught the humanity off-guard around December 2019, as we see below:

The pandemic was expected, but struck unexpectedly:

A pandemic wasn’t totally unexpected either. Therefore, they question that surfaces - Experts warned of a pandemic decades ago. Why weren’t we ready? Just in 2015, even Bill Gates, during a Ted talk titled, “The next outbreak? We’re not ready,” also predicted - based on available facts that an epidemic would kill millions in the future.

He further added: “If anything kills over 10 million people in the next few decades, it’s more likely to be a highly infectious virus rather than a war – not missiles, but microbes.” Gates further emphasized: “We have invested a huge amount in nuclear deterrents, but we’ve actually invested very little in a system to stop an epidemic. We’re not ready for the next epidemic.”

B. Research on anti-infective drugs shouldn’t be pushed to the back burner: 

These warnings were, apparently, ignored by the pharma industry. For example, as reported in the first quarter of 2020, many research-based pharma companies shifted ‘resources away from emerging infectious diseases into more lucrative areas like cancer treatment. Their business decisions risk leaving gaping holes in the fight against epidemics, such as the one caused by the novel Coronavirus.’

Let’s now take a pause for pharma players to ponder. Are they ready, at least now, with a robust plan – based on almost a year’s experience of an unprecedented agony along with its customers, specifically to counter any future biological threat? Be that as it may, there have also been some good outcomes out of the Covid crisis, both for the pharma industry and also for the health care customers.

C. The pandemic hastened pharma’s digital transformation process:

As is known, compared to many other industries, pharma industry was a late learner in the digitalization process of organizations. The new realities of disruptions caused by the pandemic had significantly expedited this process to keep the business going. There were no other effective options available, either, but to move beyond business stabilization and redefine how they do business. The IQVIA article, ‘Digital transformation in a post-Covid-19 world,’ published in the Pharmaceutical Technology, on August 31, 2020, also reiterated this point.

Elaborating the point further, the article pointed out: ‘As a result, acceleration of three key capabilities is occurring to create sustainable competitive advantage,’ as follows:

• Digital capabilities with modern technology are enabling companies doing the right things during the pandemic and accelerating the process.

• Providing access to granular data to support the extraction of precise insights into the needs of patients and physicians.

• Ensuring capabilities for sustaining relationships. While face-to-face interaction has been dramatically reduced, relationships with HCPs and patients are taking new shapes and are of more importance than ever before.

D. Telemedicine came under mainstream care, supported by Government:

Finding no other viable alternatives during the Covid lockdown period and the need to stringently follow prescribed health measures, many patients were pushed to search for a robust digital solution for health care needs. Just as many of them were already using online platforms to meet other regular needs. In that sense, Covid propelled health care into a virtual world, bringing telehealth or telemedicine toward mainstream care, supported by the Government with a policy, for the first time, ever.

E. Quality of pharma response to pandemic enhanced industry image:

As I had discussed before in this blog, Consumer centric communications, driven by the  ‘hope and confidence as companies rushed to come up with COVID-19 vaccines and treatments’ of all, helped to significantly enhance the industry’s image during the year. In my view, pharma shouldn’t let go this opportunity to reposition itself, to reap a rich harvest in the years ahead.

Crystal-gazing 2021: 

A. A lurking fear will keep haunting:

Moving away from the outgoing year – 2020, if one crystal gazes the incoming – yet another brand-new year – 2021...continue reading at …continue reading…

A Rare Strategic Acrobatic Feat in Covid Time

A Rare Strategic Acrobatic Feat in Covid Time 

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

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

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

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

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

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

The acquisition:

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

Some key aspects of rare diseases: 

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

Impact of some rare diseases in Covid infected patients: 

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

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

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

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

The study noted, among others:...continue reading @ A Rare Strategic Acrobatic Feat in Covid Time http://www.tapanray.in/a-rare-strategic-acrobatic-feat-in-covid-time/

 

Pharma Not To Let Go This Never Before Opportunity To Reposition Itself

Pharma Not To Let Go This Never Before Opportunity To Reposition Itself 

While the COVID-19 pandemic has placed unparalleled demands on modern healthcare systems, the industry’s response has vividly demonstrated its resilience and ability to bring innovations to market quickly.’ This appeared in the McKinsey & Company article – ‘Healthcare innovation: Building on the gains made through the crisis,’ published on November 12, 2020.

Just a couple of days before that, on November 09, 2020, an interesting article appeared in The Wall Street Journal (WSJ) on the resilience of the pharma industry. It also discussed on how ‘an often-disparaged industry is finding a rare opportunity to promote its value,’ to turn around public perception of its image and reputation during the pandemic. The article elaborated this point by quoting: “It was a fight between pharma, tobacco companies and the government for who would be at the bottom in terms of reputation,” – now “Covid is giving them an opportunity to step out of that world and into the world of ‘we can help,’ and it’s giving pharma a comeback.”

As is known to many, pharma industry was long vilified for its many self-serving objectives. But the Coronavirus pandemic helped immensely to highlight its role in developing medications and vaccines to save the humanity. It happened never before – ever, with this intensity and scale. Thus, the shift is inspiring many pharma giants to reposition their marketing and communications, the WSJ report added. This article will deliberate on how pharma marketers can leverage this once in a lifetime opportunity, with actionable insights on Covid pandemic-induced – changing needs of healthcare customers.

Covid-19 to change the way companies do business - A recent survey:

In this McKinsey & Company survey, published on June 17, 2020, more than 200 organizations across industries had participated in this study. Notably, over 90 percent of the participating executives expect the fallout from COVID-19 to fundamentally change the way companies do business over the next five years, with a lasting impact on their customers’ needs. In the pharma industry too, these trends are clearly visible and undergoing a metamorphosis. I quote below a few important points from this study, as illustrations:

• Nearly 73 percent respondents from the pharma and medical supplies industries agree that the changes brought about by Covid-19 will be a big opportunity for growth.

• Only 21 percent of the same executives feel that they are prepared with resources, expertise and commitment to address the changes they see coming, for harvesting the new growth opportunities.

• Curiously, only 25 percent of respondents reported that capturing new growth was a top priority today, compared to roughly 60 percent before the crisis hit.

• Notably, across the industries only pharma and medical product industries have increased their focus on innovation during Covid crisis. Although, many are still playing safe, which may be a shortsighted decision, the research paper observed. 

Understand the shifts and the opportunities with actionable insights:

That the current Covid crisis has significantly exacerbated and accelerated many disruptive forces, is vindicated by another survey: ‘Global B2B decision-maker response to COVID-19 crisis.’ This was published by the McKinsey & Company on October 20, 2020. It also reiterated, ‘B2B decision-maker preferences and behaviors have shifted dramatically since the onset of COVID. The GTM revolution is here and B2B sales is forever changed.’ I shall quote two of these areas, as follows:

A. Changes to pharma sales models: Companies with significant field forces can no longer rely on in-person coverage to outcompete. This is because:

• The tide has turned: digital self-service and remote rep interactions are likely to be the dominant elements of the B2B go-to-market model, going forward.

• Don’t count on returning to a pre-COVID-19 level of in-person sales coverage, as only 20–30% of B2B buyers want to ever interact with reps in person even in their ideal/post-COVID-19 model.

• Around 90% of B2B decision makers expect the remote and the digital model to stick around for the long run, and 3 in 4 believe the new model is as effective or more so than before COVID-19 (for both existing customers and prospects).

• 97% of B2B buyers claim they will make a purchase in an end-to-end, digital self-serve model, with the vast majority very comfortable spending more online.

• Video-conference connections are critical and are preferred over audio/phone by almost 4 out of 5 B2B buyers.

B. Influx of competitors from different industries: Medical-device firms historically had a narrow competitive set and were insulated by a complex and highly technical regulatory approval process...continue reading at While the COVID-19 pandemic has placed unparalleled demands on modern healthcare systems, the industry’s response has vividly demonstrated its resilience and ability to bring innovations to market quickly.’ This appeared in the McKinsey & Company article – ‘Healthcare innovation: Building on the gains made through the crisis,’ published on November 12, 2020.

Just a couple of days before that, on November 09, 2020, an interesting article appeared in The Wall Street Journal (WSJ) on the resilience of the pharma industry. It also discussed on how ‘an often-disparaged industry is finding a rare opportunity to promote its value,’ to turn around public perception of its image and reputation during the pandemic. The article elaborated this point by quoting: “It was a fight between pharma, tobacco companies and the government for who would be at the bottom in terms of reputation,” – now “Covid is giving them an opportunity to step out of that world and into the world of ‘we can help,’ and it’s giving pharma a comeback.”

As is known to many, pharma industry was long vilified for its many self-serving objectives. But the Coronavirus pandemic helped immensely to highlight its role in developing medications and vaccines to save the humanity. It happened never before – ever, with this intensity and scale. Thus, the shift is inspiring many pharma giants to reposition their marketing and communications, the WSJ report added. This article will deliberate on how pharma marketers can leverage this once in a lifetime opportunity, with actionable insights on Covid pandemic-induced – changing needs of healthcare customers.

Covid-19 to change the way companies do business - A recent survey:

In this McKinsey & Company survey, published on June 17, 2020, more than 200 organizations across industries had participated in this study. Notably, over 90 percent of the participating executives expect the fallout from COVID-19 to fundamentally change the way companies do business over the next five years, with a lasting impact on their customers’ needs. In the pharma industry too, these trends are clearly visible and undergoing a metamorphosis. I quote below a few important points from this study, as illustrations:

• Nearly 73 percent respondents from the pharma and medical supplies industries agree that the changes brought about by Covid-19 will be a big opportunity for growth.

• Only 21 percent of the same executives feel that they are prepared with resources, expertise and commitment to address the changes they see coming, for harvesting the new growth opportunities.

• Curiously, only 25 percent of respondents reported that capturing new growth was a top priority today, compared to roughly 60 percent before the crisis hit.

• Notably, across the industries only pharma and medical product industries have increased their focus on innovation during Covid crisis. Although, many are still playing safe, which may be a shortsighted decision, the research paper observed. 

Understand the shifts and the opportunities with actionable insights:

That the current Covid crisis has significantly exacerbated and accelerated many disruptive forces, is vindicated by another survey: ‘Global B2B decision-maker response to COVID-19 crisis.’ This was published by the McKinsey & Company on October 20, 2020. It also reiterated, ‘B2B decision-maker preferences and behaviors have shifted dramatically since the onset of COVID. The GTM revolution is here and B2B sales is forever changed.’ I shall quote two of these areas, as follows:

A. Changes to pharma sales models: Companies with significant field forces can no longer rely on in-person coverage to outcompete. This is because:

• The tide has turned: digital self-service and remote rep interactions are likely to be the dominant elements of the B2B go-to-market model, going forward.

• Don’t count on returning to a pre-COVID-19 level of in-person sales coverage, as only 20–30% of B2B buyers want to ever interact with reps in person even in their ideal/post-COVID-19 model.

• Around 90% of B2B decision makers expect the remote and the digital model to stick around for the long run, and 3 in 4 believe the new model is as effective or more so than before COVID-19 (for both existing customers and prospects).

• 97% of B2B buyers claim they will make a purchase in an end-to-end, digital self-serve model, with the vast majority very comfortable spending more online.

• Video-conference connections are critical and are preferred over audio/phone by almost 4 out of 5 B2B buyers.

B. Influx of competitors from different industries: Medical-device firms historically had a narrow competitive set and were insulated by a complex and highly technical regulatory approval process...continue reading of Pharma Not To Let Go This Never Before Opportunity To Reposition Itself 

India Not To Vaccinate All For Covid Control: Upsides And Unknowns

India Not To Vaccinate All For Covid Control: Upsides And Unknowns 

With 9.46 million cases and 137,621 deaths, India has currently the world’s second-highest number of coronavirus infections, behind only the United States, reported Reuters on December 01, 2020.

Fathoming seriousness of rapidly unfolding Covid induced all round disruptions across the nation, on October 17, 2020, the Indian Prime Minister issued a clarion call. He called for full preparedness of the country to ensure speedy access to Covid vaccines for every citizen.

However, the above view was subsequently changed. On December 02, 2020, quoting Union Health Ministry of India, it was reported, ‘the Government has never spoken about vaccinating the entire country.’ The Director General of the Indian Council of Medical Research (ICMR) said, “the Indian government is of the opinion that vaccination against the deadly pandemic may be needed only to the extent of ‘breaking the chain.’ If we’re able to vaccinate a critical mass of people and break virus transmission, then we may not have to vaccinate the entire population.”

Why the PM said ‘Covid vaccines for every citizen’ at that time?

In my view, what the PM said made perfect sense at that time. This is also vindicated by a fact-based interesting discussion in The Wire on July 16, 2020, carrying a title – ‘How Effective Does a Vaccine Need to Be to Stop the Pandemic? It quoted an in-depth study concluding, “a vaccine with an efficacy as low as 60% could still stop the pandemic and allow society to return to normal. However, most, if not all of the population would have to be vaccinated.”

This research article, titled ‘Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Intervention,’ was published in The American Journal of Preventive Medicine (AJPM) on July 15, 2020. The study found that the vaccine has to have an efficacy of at least 70% to prevent an epidemic and of at least 80% to largely extinguish an epidemic without any other measures (e.g., social distancing).

The PM’s observation will make even better sense, while taking into account the draft ‘Regulatory Guidelines for Development of Vaccines with Special Consideration for Covid-19 vaccine in India. This guidance document for vaccine developers was issued by the Central Drugs Standard Control Organization (CDSCO), and was reported by the media on September 23, 2020. It also says, among other specifics, a COVID-19 vaccine candidate should show at least 50 per cent efficacy during phase III of clinical trials for it to be widely deployed.”

Why health ministry’s current plan of not vaccinating all, also makes sense:

Indian Health Ministry’s latest assessment that vaccination against the deadly pandemic may be needed only to the extent of ‘breaking the chain,’ also makes sense in the rapidly emerging contemporary scenario.

It makes sense, considering, even the World Health Organization (WHO) experts have, reportedlypointed to a 65%-70% vaccine coverage rate as sufficient to reach population immunity, based on scientific reasons. This raises the subsequent question of who in India will get priority for vaccination.

The priority group for Covid vaccination in India:

As reported on November 26, 2020, according to the Principal Scientific Advisor of India, about 300 million people will be part of the first ‘wave’ to receive Covid vaccines in India. This number includes, health care workers, totaling 30 million, police personnel and those above 50 and those younger with underlying illnesses that make them vulnerable. However, everything in this area doesn’t seem to be as clear or straight forward as is widely expected. India’s Covid vaccination plan still seems to be a work in progress.

India’s Covid vaccine plan is still a work in progress:

This is evident from many reports, such as one of December 01, 2020. This report says, experts still believe that the government should spell out whether the vaccination should be confined to only uninfected individuals or encompass everyone. These reports may vindicate the murmur in the corridors of power that many details of Covid vaccination in India are yet to crystallize.

Let me quote the Indian Prime Minister in this regard, as he is not only the head of the current Government, but is also the national voice on all contemporary issues in the external world.

Interestingly, on November 24, the Prime Minister himself acknowledged: ‘Will go by scientific advice on Covid vaccine, don’t have many answers yet.’ He made it clear that he did not yet have answers to:

• Vaccine dosage
• Pricing or sourcing

Although, his Government has been in touch with local and global vaccine developers, nations and multilateral institutions to ensure vaccine procurement, the PM added.

Curiously, unlike what the Principal Scientific Advisor of India, ... continue reading of...'India Not To Vaccinate All For Covid Control: Upsides And Unknowns' at https://bit.ly/3gjMaWb

Combating Covid Pandemic: When ‘Something Is Better Than Nothing’

Combating Covid Pandemic: When ‘Something Is Better Than Nothing’ 

As the new Coronavirus overwhelms the world, since its global outbreak, up until November 29, 2020, over 1,458,305 people have died from this pandemic. Understandably, the Governments in all countries are frantically searching for some robust remedial measures to prevent these unfortunate deaths, besides protecting livelihoods of a vast majority of people.

For this purpose, experts considered effective preventive measures, such as vaccines could help taming this menace, alongside existing personal prevention measures. Accordingly, scientists around the world, have are hard to accelerate development and manufacturing of safe and effective Covod-19 vaccines, within the prescribed guidelines. Equally important is the fact these vaccines must be safe with predictable effectiveness- for all age groups.

The good news is, vaccines are now a distinct possibility in the near future, with the positive interim Phase III clinical trial reports pouring in. It gets reflected in the remark of the Director General of the World Health Organization (WHO), on November 23, 2020, at the media briefing on Covid-19. He said: There is now real hope that vaccines – in combination with other tried and tested public health measures – will help to end the pandemic.

Interestingly, amid these reports, a lurking fear of many experts also surfaces – on the impact of possible side effects, that Covid vaccine may cause, besides their medium to long term efficacy in human subjects. But, with the mounting number of deaths, near collapse of the global economy, including India, there isn’t any more time to watch and wait.

Apparently, all governments now want some scientifically relevant vaccines, instead of nothing. This article will deliberate on the one hand – an unprecedented achievement, alongside some critical concerns – voiced even by the Indian Prime Minister. Let me begin with the apprehensions, as expressed by some domain experts on some rough edges, as it were, in the process of its development.

Queries on vaccine dosing, efficacy, safety and testing:

On November 23, 2020, AstraZeneca and Oxford reported interim results of their vaccine with the average efficacy of 70% prevention. This sounded good to many, as it falls within the expectations of above a 50% standard that the FDA had set for Covid vaccines. However, the puzzling part in this result was – bigger (standard) doses of the vaccines were less efficacious. The vaccine was only 62% effective in a group that got two full doses spaced about a month apart. But among about 2,700 people who got a half-dose followed by a full, the number rose to 90%, the report highlighted. This incident prompted several questions about the most effective dose of AstraZeneca and Oxford vaccine, including its safety record and the approach to testing. Consequently, apprehensions surfaced whether the Drug regulators will clear it, based on the currently available data.

It now appears, AstraZeneca ‘s Covid-19 vaccine is ‘headed for an additional global trial as the drug maker tries to clear up the uncertainty and confusion surrounding favorable results in its current study.’ Incidentally, in India - AstraZeneca and Oxford vaccine will be manufactured by Pune-based Serum Institute of India (SII) under a collaborative arrangement. Let me now dwell on a broader as aspect in this space.

Could current Covid vaccines become useless in the future?

There isn’t an iota of doubt that developing Covid vaccine in ten months, which otherwise takes around ten years – is an unprecedented achievement. However, there are several other important areas in this space, where pundits have expressed uneasiness through various articles.

One such paper is titled, .... continue reading at Combating Covid Pandemic: When ‘Something Is Better Than Nothing’ http://www.tapanray.in/combating-covid-pandemic-when-something-is-better-than-nothing/

Create Greater Patient–Value To Excel With Repurposed Covid Brands

Create Greater Patient–Value To Excel With Repurposed Covid Brands 

Regular introduction of new molecules, line extensions or a Novel Drug delivery System (NDDS) has remained the life blood for pharma to rejuvenate a company’s product portfolio for driving organizational growth. But, Covid’s unprecedented and devastating assault on human lives and livelihoods, has pushed many of these initiatives off track. Covid infection was declared pandemic by the World health organization (WHO) on March 11, 2020, compelling the industry to primarily focus on finding solutions for survival, especially in the product development areas.

As the fight against time, the need for survival became so intense, there was no time for pharma companies going back to primary research, to discover new effective Covid specific drug molecules. Vaccines – at the initial stage of the pandemic, were considered by experts could be the only ‘magic bullet’, to get the humanity back again on its feet, after a fierce knockout blow by the virus. As on date, although vaccines seem to be nearer the finishing line of creating adequate initial immunity against Covid, still there are no scientifically proven drugs to predictably cure this infection.

Meanwhile, the focus of all concerned is on the existing drugs, to examine their effectiveness against Covid-19. Accordingly, right from hydroxychloroquine, dexamethasone to a number of already existing antiviral agents were repurposed for Covid treatment, under emergency approval by country regulators, pending detailed clinical trials.

For various critical reasons, experts now feel that the use various NDDS technologies in repurposing existing drugs, would create greater value for patients in Covid treatment. At the same time, this will help pharma companies to create a cutting-edge differentiator for their repurposed brands – being more patient centric. In this article, I shall dwell in this area, starting with the current status and issues with repurposed Covid drugs, as of date.

Current status and issues with repurposed Covid drugs:

According to recent reports, such as one titled ‘Formulation and delivery strategies for COVId-19 drugs,’ published by the AIchE in June 2020, more than 40 different drugs are currently being explored for efficacy against COVID-19. Unfortunately, side effects of many of these repurposed drugs limit their use in most severe cases, besides preventing their use as prophylactics.

A large proportion of repurposed Covid drugs are small-molecule medications, antivirals, and immune-modulating antibodies. These are already approved for other indications (like hydroxychloroquine, ribavirin, favipiravir), or under clinical trials, but not yet approved by the U.S. Food and Drug Administration, FDA (like, remdesivir, galidesivir, leronlimab).

If proven effective, these drugs would offer several advantages from a rapid- response perspective, such as the availability of safety data. In addition, several of these drugs offer broad-spectrum activity that makes it more likely they will remain functional even if the SARS-CoV-2 virus mutates. However, there are also exists some critical issues with repurposed Covid drugs.

Some critical issues with repurposed Covid drugs:

Let me cite below two examples, just to drive home the point of some critical medical issues, now existing with these repurposed Covid drugs:

• Hydroxychloroquine – the malaria drug, when used as directed, commonly produces nausea, diarrhea, vomiting, besides muscle weakness. Importantly, at higher concentrations – only two to three times the daily dose, it can cause potentially fatal acute cardiovascular toxicity. Thus, the possibility of severe side effects makes the drug unattractive as a preventive measure. Drug formulation and delivery strategies, such as controlled release and targeted delivery could expand the use of such existing drugs, the report recommends.

• The HIV drug combination lopinavir and ritonavir, which is under evaluation as a COVID-19 treatment, has side effects that include diarrhea, nausea, and liver damage. With a half-life of about 4–6 hours, the systemic concentrations can vary by a factor of eight between peak and trough. Developing a controlled-release formulation that maintains the minimum effective drug concentration, could mitigate side effects by reducing the steady-state drug concentration by as much as eightfold and reducing the burden on the liver by 81%, the above study, published by the AIchE in June 2020, highlighted.

At this point, for greater clarity, let me recapitulate what NDDS really means.

NDDS – clinical and marketing relevance:

Novel Drug Delivers Systems or NDDS generally ‘refers to the approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects.’...continue reading at https://bit.ly/35UmDiq

Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard

Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard 

here isn’t even a shade of doubt today that Covid-vaccines are coming. However, some critical questions in this area continue to hang in the air, and are expected to remain so for some more time. Thus, every news on the development of Covid vaccines, particularly in their late stages of clinical trials, fuels billions of hopes and excitement, across the world.

The same thing happened, when Pfizer and BioNTech announced on November 09, 2020, some key details on their vaccine candidate. These include, ‘vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis’ from Phase 3 studies. The release also highlighted, ‘Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.’

Amid these new developments, it is also now beyond doubt that the pandemic will be brought under control, eventually. Interestingly, none possibly knows when it will happen. There doesn’t seem to be any clearly charted – time-bound pathway in place for the same, either – not just yet. That said, from the overall developments in this area for the past 10 months, especially in India, – two other crucial questions also remain elusive, as follows:

• Has the country started preparing itself against any Covid-like future biological threats? If so, in what manner?
• As India conducts the world’s largest  Universal Immunization Program (UIP), how robust is the country’s vaccine supply chain to effectively inoculate every Indian with Covid-vaccine?

I have already deliberated on several aspects of the former question in one of my previous articles, in this write-up. Therefore, this write-up will focus on the second query, with a specific reference to the continued relevance of abidance of the defined health norms for some more time, especially for my pharma industry readers. Accordingly, all astute pharma professionals in India, need to accept this new reality, and rewrite their brand demand generation strategies for the new normal. Let me start with how the cold-chain logistics for vaccines, in general, work in the country.

The cold-chain logistics for vaccines:

A paper published by the BBC News, on November 11, 2020, captured how the cold-chain logistics for vaccines, in general, work almost in all countries, including India. The article is titled, ‘Coronavirus: How soon can we expect a working vaccine?’ The steps involved in this exercise are as follows:

1. Vaccines transported to destination countries (imported varieties).
2. Refrigerated trucks for transportation to designated cold rooms.
3. Distribution in portable and appropriate ice boxes to regional centers.
4. Stored in electric fridges between 2 degree to 10 degree Celsius (for most of the existing vaccines.)
5. Carried in portable and appropriate ice boxes to local venues for vaccination to individuals.

Associated challenges:

As the above paper highlighted, some important associated challenges in this space, which are mostly faced by the developing countries, like India, are as follows:

• Adding a new vaccine to the existing mix could pose huge logistical problems for those already facing a difficult environment.

• According to prescribed norms, all Vaccines in India requires a storage temperature in the range of +2 degree to +8 degree Celsius, except for Oral Polio Vaccine which need to be stored in the frozen state (-25 degree – 15 degree Celsius) at all stores except PHC/ CHC/Health post. The new vaccine ROTAVAC (116E rotavirus) by Bharat Biotech is being recommended to be stored at (-15 to -25 degree Celsius) till the intermediate stores and to be stored in the range of +2 degree to +8 degree Celsius at the last storage points like PHC/ CHC/Health posts. This has not posed much of a challenge. However, expanding it to cover the entire population of the country can be an “immense task.”

• It is worth noting, although, AstraZeneca vaccine would need the regular cold chain between 2C and 8C, the Pfizer and BioNTech vaccine would need ultra-cold chain – storage at around minus 70C to 80C.

• ‘Maintaining vaccines under cold chain is already one of the biggest challenges’ that countries face, and this will be exacerbated with the introduction of a new Covid vaccine.

• Thus, more cold chain equipment will require to be added, making sure that fuel is always available (to run the freezer and refrigerators in absence of electricity) and repair/replace them when they break and transport them wherever you need them.

Curiously, India’s cold-chain logistics that cater to one of the world’s largest immunization programs for children and mothers, may not be enough for Covid-19 vaccination of the country’s 1.3 billion population.

Why India’s cold-chain logistics may not be enough for Covid vaccination:

Before coming to the above question, it is important to note that India is not just the pharmacy of the world, contributing over 20 per cent by value to the global generics market, and over 40 per cent (by volume) of US drugs. According to a recent report of Bernstein Research, Indian vaccine producers, such as, Serum Institute of India supply the bulk – over 40% of the global capacity of 5.7 billion doses annually. Home to some of the world’s biggest vaccine makers, India produces 2.3 billion doses of vaccines yearly, with 74% for export, said...continue reading of Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard https://bit.ly/2Iv2S8z