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New Digital Tools To Protect From Infection, Neutralize Covid-19

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There seems to be some light at the end of the dark tunnel of a serious biological threat that the world is passing through, since the nightmarish last seven months. The COVID-19 pandemic has spread to 213 countries and territories, and the number of new cases is continuously rising. According to reports, the severity of the situation has already re-shaped our society, more than ever before.

In tandem, reports are arriving from most countries, testifying the tremendous commitment of the governmental, scientific and clinical communities, to help local populations dealing with the pandemic. Scientists are still far from having a complete picture of the pathophysiology of this dangerous disease, including its long-term implications on individuals.

Amid this challenge, round the clock search for a life-saving and long-term pathway to outmatch the fast-spreading Covid-19, seems to be coming to fruition, soon. If everything materializes as expected, Covid-19 vaccines may be available by the end of this year or at the beginning of the next year. If it happens, this will be a record in the history of any vaccine development process, as the normal ‘mind to market’ period to deliver a scientifically proven, safe and effective vaccine is normally around 10 years. That said, there always exists a gap between the cup and the lip, as the saying goes.

No doubt, vaccines will be the best way to bring the new Coronavirus under a tight leash to help normalize life, restore livelihoods, and putting a nation’s economy back to the growth trajectory. The good news is, alongside this magic bullet, the power of technology is exploring other technological measures to keep the virus at bay, wherever possible. In this article, I shall focus on this interesting area.

Let me hasten to add, the value offerings of these devices can’t be compared with the long-term benefits that vaccines will offer in containing this global pandemic. Nevertheless, the questions still remain, when will a well-documented, safe, effective and affordable vaccine hit the market?

W.H.O expects to deliver 2 billion doses of vaccines by end 2021:

According to a News Release of July 15, 2020, by the World Trade Organization (W.H.O): ‘Seventy-five countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility, which aims to:

  • Accelerate the development and manufacture of COVID-19 vaccines.
  • Guarantee fair and equitable access for every country in the world.

The goal of COVAX is to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO pre-qualification, by the end of 2021. Besides W.H.O, other experts are also cautiously optimistic about the availability of Coronavirus vaccines ‘soon’. Here also the question may crop up: how soon is ‘soon’?

How soon is ‘soon’ – for sooner availability of Covid-19 vaccines?

Experts have opined, a vaccine would normally take years, if not decades, to develop. However, in this unprecedented global health crisis, researchers hope to achieve the same amount of work in only a few months, following the ‘fast track’ regulatory pathway. Let me give a sense of the prevailing buzz around the availability of some of these vaccines.

Going by what the Chief Executive Officer (CEO) of Serum Institute of India said about Oxford-AstraZeneca developed vaccine, many expect their availability by the end of the current year in India. The Company CEO, reportedly, said on July 22, 2020: “By November, we hope to launch the vaccine if the trials are positive and if the Drug Controller of India blesses it and says it is safe and effective.”

Further, on July 28, 2020, Moderna Inc. and Pfizer Inc. also launched two 30,000-subject trials of Covid-19 vaccines that could clear the way for regulatory approval and widespread use by the end of this year, as the companies announced. Notably, both vaccine candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods, but does not have an extensive track record.

According to another report of July 30, 2020, Russia said, the world’s first COVID19 vaccine to be ready by August 12, 2020. The vaccine is being developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology.

India’s indigenous experimental Coronavirus covid19 vaccine candidate, developed by Bharat Biotech, is also undergoing phase 1 and Phase 2 trials at 12 sites spanning across India. The initial results are positive. Earlier, ICMR had announced its launch on August 15, 2020. However, specialists in this area feel, ‘the August 15 timeline seems totally unrealistic, if not entirely impossible.’

Be that as it may, most experts still think a vaccine is likely to become widely available by mid-2021, about 12-18 months after the new virus, known officially as Sars-CoV-2, first emerged. Bringing to the market a Covid-19 vaccine, no doubt, will be considered as a ‘huge scientific feat,’ but ‘there are no guarantees it will work’ for all. It’s also a point to ponder that ‘Coronaviruses already circulate in human beings. They cause common cold symptoms and we don’t have vaccines for any of them’ just yet, as the report highlights.

It’s, therefore, a clear possibility that a well-documented, safe and effective Covid-19 vaccine may not be available, at least, in the next 6 months. Moreover, access to an affordable Coronavirus vaccine by the global population will also not happen in a jiffy. In that case, it is encouraging to note that other cutting-edge technological initiatives are also moving ahead with a great speed, to bring the rapid transmission of the new Coronavirus under a tight leash.

Novel, non-medical tech initiatives to contain the Covid-19 spread:

As potentially lethal Covid-19 is overwhelming the world, besides search for new drugs, faster diagnosis to fight the infection – and most effective preventive measure – vaccines, several non-medical tech initiatives are also underway. Many of these are quietly heading forward in search of user-friendly solutions, not just to ‘take the pressure off overworked health care workers’, but also ‘to stop the spread of the disease.’ These are all running parallel to offer technology driven disease treatment-options during this global health crisis.

An interesting paper from the European Parliamentary Research Sevice (EPRS), also vindicates some critical developments in this area. It focuses on technology-based solutions for various pressing pandemic-related problems. Let me illustrate this point with one example each, in the areas of ‘taking the pressure off overworked health care workers’, and in ‘stopping the spread of the disease.’

Technology to ‘take the pressure off overworked health care workers’:

Even in India, one hears quite a lot about the hardship of overworked health care workers. Various unconventional ways were also prescribed for the nation to encourage them. Some of these aren’t inexpensive, either. From this perspective, one such application is robotics technology. It can be effectively used as an intelligent solution to reduce the risk of person-to-person transmission − especially in pandemic hotspots. As the above EPRS article highlighted, many countries are now deploying robots in other areas also to ‘take the pressure off overworked health care workers,’ such as:

  • To disinfect whole hospitals,
  • Decontaminate public and private sites,
  • Handle biohazardous waste,
  • Deliver food and medication to infected patients,
  • Taking patients ‘ temperatures and act as medical assistants.

For example, an Israeli-made AI-powered robot assistant is, reportedly, being used in hundreds of hospitals, medical centers, nursing homes, and corporate buildings in Asia. This is to help minimize human-to-human contact as millions of people take precautions due to the novel Coronavirus outbreak worldwide. By the way, Israel is now a good friend of India, too.

Technology ‘to stop the spread of the disease’:

On June 01, 2020, Science Daily reported, the researchers at Penn State, the University of Minnesota and two Japanese universities, have found that a personal, handheld device emitting high-intensity ultraviolet light to disinfect areas by killing the novel Coronavirus, is now feasible.

Another report of July 10, 2020 also brought to the fore that the researchers from the University of Houston have created a new air filter that virus tests at the Galveston National Laboratory found can kill 99.8 percent of COVID-19 instantly. The filter could be useful for killing COVID-19 in public places, such as, in airports and airplanes, in office buildings, schools and cruise ships, besides other closed spaces such as schools, hospitals and health care facilities. Thus, the ability of this “catch and kill” air filter to control the spread of the virus could be very useful for society,” confirmed another report.

On July 29, 2020, an Indian business news daily wrote, ‘Bengaluru-based Organization De Scalene has received clearance from the US Food and Drug Administration (USFDA) and the European Union to license and manufacture Scalene Hypercharge Corona Canon (Shycocan).’ The device disables the virus’ capability to infect, by flooding electrons in closed areas. It is claimed that Shycocan ‘has the ability to neutralize 99.9% of the Coronavirus that might be floating in the air in closed spaces.’

Although, it is not an alternative to medicines that can cure infected people or preventive vaccines, the device can be used to keep Covid-19 at bay, at least, till vaccines arrive. Thus, going by these developments, one gets a sense of various non-medical technological activities post Covid-19 pandemic outbreak. Especially about, how today’s technological whiz kids are working alongside the medical scientists to take the sting out of Covid-19 onslaught.

Conclusion:

The Lancet article – ‘Applications of digital technology in COVID-19 pandemic planning and response,’ published on June 29, 2020, also made similar observations. It said: ‘With high transmissibility and no effective vaccine or therapy, COVID-19 is now a global pandemic.’ In this scenario, to contain the spread of a highly transmissible virus, countries that have quickly deployed digital technologies in various critical areas to contain the spread of the infection, may emerge as front-runners in managing disease burden, the paper concluded.

As of August 02, 2020 morning, the recorded Coronavirus cases in India reached a staggering 1,751,919 with 37,403 deaths. Recent Sero-surveys also show COVID-19 peaks in the country is still far away. It is very likely that a vast majority of the population will survive the Covid-19 catastrophe, even if only the existing systems are followed. But, just surviving is neither the reason nor the purpose of life. What most people want today is finding out a comprehensive way for – ‘jaan bhi and jahan bhi’ (life also, the world also).

Understandably, on July 31, 2020, W.H.O has also reiterated: “The pandemic is a once-in-a-century health crisis, the effects of which will be felt for decades to come.” Under this backdrop, unleashing the potential of new non-medical digital tools, as illustrated above, seem to be of immense benefit – not just to protect many more people from the infection, but also to neutralize Covid-19 effectively, especially in India.

By: Tapan J. Ray

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

Pharma To Facilitate Self-Managing Chronic Diseases For Better Outcomes?

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“India’s burden of non-communicable disease (NCD) is escalating, but still the country does not have sufficiently detailed data on NCDs for research and policy purposes.” This was captured in a recent study, titled “India’s escalating burden of non-communicable diseases,” published in The Lancet Global Health on October 03, 2018. Thus, many experts are pondering, how to contain this menace and lower the disease burden of NCDs, in this situation. One of the ways to address this issue is exploring some unconventional ways.

As several studies have established, improving ‘self-management’ of chronic diseases by patients, after proper diagnosis and a treatment plan being in place, is one of the pillars to lower the disease burden. One such study is titled, ‘Patients’ knowledge of their chronic disease,’ appeared on June 2013 – Vol 42 (6) issue in the journal of afp – Australian Family Physician. The paper highlights that effective tools, policies and other measures to help self-management, would facilitate the process. These arecritical not just for better outcomes, but also to reduce the overall treatment cost.

In a similar context, another recent article, titled ‘Why Apps for Managing Chronic Disease Haven’t Been Widely Used, and How to Fix It,’ published in The Harvard Business Review (HBR) on April 04, 2018 made an interesting observation. The authors wondered: “In an era where nearly, every consumer good and service — from books and groceries to babysitting and shared rides — can be purchased through an electronic transaction on a mobile device, it seems reasonable to think that more and more of our health care can also be managed using apps on mobile devices.”

This article will dwell in this area, based on several interesting and credible research findings. Nevertheless, to give a proper perspective, I shall start with a brief outline on the incidence of chronic diseases in India.

Increasing incidence of chronic diseases in India:

There are several recent reports confirming the ascending trend of non-infectious chronic diseases in India, two of which are as follows:

The National Health profile 2018, published by the Ministry of Health also records that between 1990 and 2016 the disease burden due to:

  • Communicable, maternal, neonatal, and nutritional diseases, as measured using Disability-adjusted life years (DALYs), dropped from 61 per cent to 33 per cent.
  • Noncommunicable diseases increased from 30 per cent to 55 per cent.
  • The epidemiological transition varies widely among Indian states: 48 percent to 75 percent for non-communicable diseases, 14 percent to 43 percent related to infectious and associated diseases; and 9 percent to 14 percent associated with injuries.

Alongside, the above article of The Lancet Global Health also underscores the following takeaways from its comprehensive analyses of NCDs in the Indian situation:

  • The three leading causes of mortality—cardiovascular diseases, respiratory diseases, and diabetes.
  • In absolute terms, these three diseases together kill around 4 million Indians annually (as in 2016).
  • Most of these deaths are premature, occurring among Indians aged 30–70 years, representing some of the world’s largest health losses, with enormous policy ramifications.
  • India’s Ministry of Health and Family Welfare is making efforts to establish policies and intervention strategies for prevention and control NCDs. For example, the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke, launched in 2010, and the National Program for Health Care of Elderly, launched in 2010–11, the article noted.

As none of the measures taken so far could create an appreciable impact, India needs to come up with a major intervention to tackle this escalating health issue, the article concluded. In my view, optimal use of modern technology in the self-management of such virtually lifelong diseases, can be a great enabler for patients to bring down the disease treatment and management cost, significantly. Let me hasten to add again, the question of self-management comes only after a proper medical diagnosis and a prescribed treatment plan for the same being in place.

The key benefits of self-management and the unmet need:

The key benefits of effective self-management of chronic diseases are many. However, the following four clearly stands out:

  • Improves Patients’ quality of life significantly.
  • Arrests progression of the ailment – containing associated disease related complications.
  • Substantially reduces the interval and number of follow-up visits with doctors.
  • Thus, reduces the disease burden appreciably.

Curiously, most traditional pharma companies are yet to take any major step to address, at least, the above four critical areas. They don’t seem to go beyond the conventional methods of disease related advices. Whereas, the crucial need to fetch a behavioral change in patients for participative self-management of NCDs, keeps lingering.

A number of research studies have also confirmed that ‘mobile health applications are promising tools for improving outcomes in patients suffering from various chronic conditions.’ One of these studies titled, ‘Smartphone app in self-management of chronic low back pain: a randomized controlled trial’, was published in the November 27, 2018 issue of the European Spine Journal.

Sensing an unmet need in this area, besides a large number of brilliant tech startups, many large and pure technology companies, such as Apple and Google have already entered this fray.

 A recent example:

Let me cite a recent example to drive home the above point. On December 12, 2018, CNBC featured an article carrying the headline ‘Apple now has dozens of doctors on staff, showing it’s serious about health tech.’ Some of the key points of this article are as follows:

  • The number of doctors on staff is an indication that Apple is serious about helping customers manage diseases, and not just wellness or fitness.
  • Doctors can also help Apple guide the medical community on how to use Apple’s new health technologies and to deflect criticism and also to win approval among doctors who fear liability and are already overburdened by technology.
  • Many of these doctors are also still continuing to see patients. That might also give Apple an edge by emphasizing the patient experience.

This example demonstrates how detail are the plans of these tech companies for gaining a firm foothold in the healthcare space.

‘Effectiveness’ and ‘future scope’ of self-management of diseases:

The article titled, ‘Self-Management: A Comprehensive Approach to Management of Chronic Conditions,’ featured in the August 2014 edition of the American Journal of Public Health (AJPH) reiterated some important points. It established the relevance, future scope and effectiveness of self-management of chronic diseases, as follows:

  • As chronic conditions emerge as a major public health concern, self-management will continue to grow as a crucial approach to managing these conditions, preventing illness and promoting wellness.
  • Chronic disease conditions are generally slow in their progression and long in their duration. Thus, self-management can offer those living with these conditions, a means to maintain or even improve their capacity to live well, over the course of their lives.
  • Self-management intervention programs that address specific diseases are showing success across multiple chronic conditions.
  • These programs have particular value that represents an amalgamation of the goals of the patient, family, community, and the clinician with everyone working in partnership to best manage the individual’s illness while facilitating comprehensive care.
  • Self-management reaches beyond traditional illness management by incorporating the larger concept of prevention by emphasizing the notion that those who are chronically ill still have a need for preventive interventions to promote wellness and mitigate the further deterioration of health.
  • If one considers the nature of self-management in all its elements and practical characteristics, it is not only a logical approach to health and health care, but also an optimal way to address chronic conditions as a major issue in public health.

Inducing a behavioral change in chronic disorders with health apps:

For effective self-management of chronic diseases, there is a need to neutralize the negative influence of the individual’s behavioral traits. Research studies have also established that behavior-change-focused interventions play an important role in this effort.

However, not all patients take adequate care for such changes to take place. While the treating doctor may play an important role of a coach in this area, in reality, they usually don’t find enough time to spend on each patient with NCDs. The McKinsey & Company’s publication titled, ‘Changing patient behavior: the next frontier in health care value,’ also reiterates that to address the rising cost of chronic conditions, health systems must find effective ways to get people to adopt healthier behaviors.

As I mentioned before, this space has attracted active interest of many tech players in business expansion. More evidence-based health apps are being introduced to help drive patient-behavior change for effective self-management of chronic diseases. There are reported surveys on weight management aided by health apps, where ‘ninety-six percent of respondents agreed or strongly agreed that using a diet or nutrition app helped drive positive behavior change and healthy eating habits.’

In my article, titled ‘Prescription Digital Therapy Now A Reality,’ published in this blog on May 07, 2018, I mentioned that in September 2017, the first USFDA-cleared mobile app has been made available to patients. The app has both safety and efficacy label to help treat patients with ‘Substance Use Disorder’. Studies have established that it is two-times more effective than conventional in person therapy sessions.

More recently, in September 2018, Apple’s smart-watch version 4 included a US-FDA cleared electrocardiogram (ECG), officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms. In the same context, US-FDA Commissioner Scott Gottlieb, M.D., said that digital advances, creating a new technological paradigm of health tools and health apps., are empowering consumers to take better informed decisions on their medical care and healthy living.

Conclusion:

It has been well-demonstrated by research studies that evidence-based health-apps for self-managing chronic diseases improve outcomes, remarkably. Consequently, this has triggered some critical activities by purely tech companies in the health care space, even in India. The primary driver being a strong consideration of this segment as an opportunity area to meet an unmet need, where most pharma players don’t seem to be doing enough, as on date.

Before it gets too late, there appears a need to take a serious note of this shifting paradigm. The awareness of which should then play a critical role in developing marketing strategies for brands used in NCDs. Otherwise, non-pharma tech companies will eventually dominate this segment, armed with a different genre of technological prowess that they possess.

The article titled, “Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework,” published inJan-Mar 2016 edition of the Journal of JPMIR Research Protocols, epitomizes it succinctly:

“Mobile health technology creates a shift in the paradigm of chronic disease management. It offers new possibilities to engage patients in self-management of their chronic diseases in ways that did not exist in the past. To maximize the potential of mHealth requires the integration of research and expertise from multiple disciplines including clinical, behavioral, data analytics, and technology to achieve patient engagement and health outcomes. This paradigm shift also triggers a need for new approaches to designing clinical and behavioral support for chronic disease management that can be implemented through existing health care services and programs.”

These developments send a strong signal for pharma to facilitate self-managing chronic diseases, soon enough, for better patient outcomes and, in tandem, creating a win-win situation for both.

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.

 

 

The Next Frontier: Frugal Innovation For High-Tech Drugs

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Should drug innovation models remain as expensive as what these are claimed to be now by the global pharma industry, in general?

Finding a credible, appropriately quantifiable, and generally acceptable answer to this question is critical. It won’t, then, just be a myth-buster for billions of dollar price tag, that is now being attached to drug innovation and development initiatives, by the global pharma industry, as a justification for arbitrarily fixing high new drug prices. If the upcoming and new startups with frugal models for even high-tech drug innovation succeed with flying colors, the patients and the payers would also possibly breathe a huge sigh of relief, from the increasing burden of disease and the cost of medicines.

I believe, it would eventually happen, may not be overnight, but over a period of time. I shall discuss in this article about some bright sparks, already visible in that direction.

The facade of high cost of drug innovation: 

At the very outset, to avoid any possibility of misunderstanding, let me confess up front, just as many others, I also strongly believe that drug innovation is extremely important. It needs to be encouraged, protected and rewarded reasonably.

That said, let me also give the right perspective of how the cost of ‘drug innovation’ is being often misused as a facade for keeping the drug prices high, if not exorbitant.

According to a contentious study of ‘Tufts University Center for the Study of Drug Development’, the total cost of innovation of a new drug and bringing it to market, has increased more than double from US$ 1.22 billion in 2003 to US$ 2.6 billion in 2014. 

Despite these numbers being vehemently challenged in credible journals, many global pharma majors still keep justifying the high new drug prices on the same old pretext. As a diversionary tactic, they relentlessly argue that innovation has to be adequately rewarded to keep its wheels moving in perpetuity, though no one challenges this basic fact, not even remotely.

The moot questions:

The moot questions, therefore, are: how expensive is the drug innovation and how does the global drug industry establish its relationship with high new drug prices? The answers to these queries must be clear, specific, quantifiable and credible, and not ethereal, if not airy-fairy.

In this context, my article titled, “How Expensive Is Drug Innovation?” found an echo in a globally reputed journal. An analysis published in the BMJ in May 2016 titled, “Propaganda or the cost of innovation? Challenging the high price of new drugs”, expressed deep concern on the rising prices of new medicines. It reiterated that this trend is set to overwhelm health systems around the world.

The above BMJ article also put forth similar questions: “What does it really cost to bring a new medicine to the market, and do these costs justify the high price?”

The authors pointed out that the pharmaceutical market is not actually a “free market” based on supply and demand with minimal government intervention through taxes, subsidies, or regulation. On the contrary, the pharma market is highly manipulated, and not focused on achieving the best prices, or even fair prices for essential and life saving medicines. 

No linear link between high drug price and innovation cost: 

As I discussed this subject in my previous article titled, “Arbitrary Pricing of Essential Drugs Invites State Intervention”, it has been well established by now that there is no linear, or any relationship between high drug prices and cost of drug innovation.  Since long, this argument is being misused just as a façade to keep the cost of medicines high, and making high profits even at the cost of lower sales volume.

The façade has started crumbling:

In India too, the pharma MNCs often use the same façade to keep the prices of also their branded generics much higher than the comparable formulations manufactured by larger domestic pharma manufacturers. However, the façade has started crumbling in many countries, across the world. This gradually increasing general realization is welcoming. 

The Governments in many countries, have now started acting. They are increasingly forcing the drug makers to eye for volume growth, by reducing the fat margin, and improving patients’ access to high-priced drugs.

Just to draw an example, I would quote a very recent development in this area, outside India. On May 20, 2016, the Chinese health authorities announced price cuts of up to two-thirds to three patented drugs, in their latest move to reduce the cost of healthcare for patients. It is noteworthy that this happened in the world’s second-biggest economy, after the United States.

Why is arbitrary drug pricing continuing?

It appears, the only reason for the majority of the drug players to continue keeping the new drug prices high is because they can still make huge money through a small segment of patients who can afford their brands. What about the rest? This doesn’t seem to matter to them, at all, unless compelled to, in various ways.

Need to totally demolish the façade of innovation:

Thus, there is a compelling need is to demolish the façade of innovation, decisively, for keeping medicine prices high.

To move towards this direction, some flickers of a sound possibilities, are now visible in the horizon. The ‘Frugal’ or the ‘Silicon Valley’ type startups for high-tech drug innovation models, especially in the biotech sector, have shown high potential to be a game changer in this area.                                                                

Frugal innovation models for high-tech drugs:

The quest to find a pathway towards this direction continues. Recently, Professor Atul Butte, Director of the University of California Institute of Computational Health Sciences, highlighted that like other Silicon Valley startups, almost anyone can bring a drug to market from their garage with just a computer, the internet, and freely available data. Professor Butte, students, and research staff have already explored various methods and approaches of scientifically utilizing this data in search for new medicines. 

As reported in the May 5, 2016 issue of ‘The Conversation’, Professor Butte outlined this process for an audience of local and international scientists and medics in a talk given at the Science on the Swan conference held in Perth in May 2016.

Professor Butte outlined several models of ‘Frugal Innovation’, especially for new biotech drugs or finding new indications for existing drugs.

A. The search for a new target:

There could be several approaches to the search of a new biotech drug. An example of one such, that Butte’s team is reportedly engaged in, is the construction of a map of how the genetic profiles of people with particular diseases are related to each other. The team looked for diseases with very similar genetic profiles.

Some may argue, this process of discovering other uses of drugs, conventionally termed as “drug repositioning”, is in the strictest sense is not exactly a novel one. They may attempt to establish it by drawing an example from Viagra, which was originally developed for treatment of cardiovascular conditions. However, the major difference is that Viagra’s repositioning for erectile dysfunction is an outcome triggered by its side-effects in patients taking the drug for its original cardiovascular disease treatment. 

B. Desk research and discovery:

The primary desk research can start from the freely available enormous published genetic data, based on thousands of studies on humans, mice and other animals. The publications’ websites are also highly credible, such as, National Institute of Health and the European Molecular Biology Laboratory. Thus, as a result of abundantly available high quality genetic data, the cost of genetic sequencing, using gene chip technologies, is also coming down quite rapidly.                                                                                                 

C. Animal testing:

After the potential drug discovery in the garage, there is a need to test the drugs on animals. 

As Professor Butte suggests, this process also can be made much less expensive. For this purpose, he recommends the internet and the websites, such as, Assay Depot. This site is structured like Amazon, from which a researcher can order an experiment to be carried out to test a drug on a range of animal models, as the report states.

Butte finds this Internet based process very useful for ‘choosing the experiment type the researcher wants, adding it to a shopping cart, paying by credit card and getting the experimental results mailed back in a few weeks’ time.’ Such websites also offer wide choices to the researchers, even regarding the laboratory they would like to use, including the country where the laboratory is located. 

D. Human Trial:

As ‘The Conversation’ article indicates, once a new use for a drug has been shown to work in an animal model, the next step would be to test the drug on human volunteers, get approval for the use of the drug for that condition, and then finally take the drug to market.

This purpose could involve spinning out startups with money from investors. In California, Professor Butte and his students have already followed this process after discovery of new uses for several drugs.

As Professor Butte epitomizes, none of this would be possible without sharing data. The ‘Frugal innovation’ models also highlight, how the growth of availability of open research data will be able to discover a range of uses, that would not have been foreseen, when the individual experiments were being carried out.

Would Big Pharma gobble up these startups?

If ‘Big Pharma’ starts gobbling up these startups paying exorbitant prices, the expectations of lower prices of novel drugs may possibly not come to fruition. Nevertheless, the facade of innovation for high drug prices would crumble. But, surely some other different and well-orchestrated pretext would surface, to maintain their stubbornness to continue with the same business model of very high margin and lesser volume sales, with cash register ringing, as ever.

Here is an example. ‘The Huffington Post’, in an article of May 10, 2016, reported on Big Pharma’s betting on a cancer drug startup.                                                 

The May 2016 article said, the pharmaceutical giant AbbVie acquired a startup named ‘Stemcentrx’ in a deal that values it at as high as US$10 billion.

The startup Stemcentrx has found out a unique approach, though somewhat controversial, for treating several forms of cancer. While most of today’s treatments view cancer as a result of unchecked cell growth, wherein any cell is capable of becoming cancerous, Stemcentrx believes that cancer primarily sprouts from only one cell type: cancer stem cells.

Conclusion:

Be that as it may, hopefully, the evolving models of ‘Frugal innovation’, development and commercialization of high-tech drugs, are expected to be the game changer for quickly bringing a number of new drugs, or existing drugs for new indications to the market, for many disease conditions, at very affordable cost.

Big Pharma may not allow it happen so easily, just for vested interest, but the pressure group must keep a close vigil on this development, and more importantly, must prevail.

Thus, the next frontier of pharma research and development, would possibly shift to small startups of ‘Frugal Innovation’, especially for affordable high-tech drugs, extending their access to the majority of the patients, the world over. 

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.