RESULTS OF FAILED-RESEARCH

Reads: 118  | Likes: 0  | Shelves: 0  | Comments: 0

  • Facebook
  • Twitter
  • Reddit
  • Pinterest
  • Invite

More Details
Status: In Progress  |  Genre: Other  |  House: Booksie Classic

Submitted: June 27, 2019

A A A | A A A

Submitted: June 27, 2019

A A A

A A A


This article was my speech delivered at Bangalore in April 2018. Now, that speech is renewed into this article for readers’ read-through. 

SPEECH:

The global pharmaceuticals market will reach $1170 billion by 2021 with a growth rate at 5.8%.

Do Pharmaceutical business and its sales so huge and characteristically real?

Or

Is there any manipulation somewhere in between multilayers?

Pharmaceutical companies in India whether big or small cannot survive in near-future unless they have strong R & D department. Research and Development department can produce many downstream benefits, though it does not produce original research products.  In this speech, we shall analyse the importance of R & D, and hidden multi-layered conniving promotional activities of pharmaceutical product-mix in India.

At the outset, every new medicine’s embryonic gestation before mark it to market can take around 9 to 13 years depending on researchers’ intellect, teamwork, R & D capabilities and selection of candidate molecule based on diseases prevailing and in anticipation. Even then, there is no guarantee for new molecule’s therapeutic success in the process-making as thousands of candidate-drugs are in inventory and pipeline squadron. The eventual fate of these candidate molecules can either be in the retail front-ends if gone through a precise ordeal or fell by in junk-pill disposal kiosks.

Above all, research in Pharmaceutical Industry is altogether different from that of other fields. Research in pharmaceutics is arduous and challenging as different units of related sciences have to coalesce for an eventual result. The very process starts with spanning the entire spectrum of drug discovery, development, evaluation, and regulatory approval.

The concept of proposed research may be abstract comprising any one of either small drug molecules, or biotechnology products including genes, peptides, proteins, vaccines, and genetically engineered cells. As the research entity is in progress, there is a great deal of emphasis on the areas of pre-formulation studies to describe physical and chemical properties of a drug molecule in order to develop safe, effective and stable dosage form, drug delivery and targeting. On par with this process, the researchers have to prepare formulation design, engineering, and processing.  In the pre-final stage to evaluate its fate in animals and human clinical trial, the researchers have to study pharmacokinetics, pharmacodynamics, pharmacogenomics, molecular bio-pharmaceutics, drug disposition; and computational bio-pharmaceutics, among others. After this entire ordeal, the final candidate-molecule will be in the hands of drug approving authorities.

The Process of the Research is the mother of other beings like inventions, innovations, discoveries of therapy-related services such as non-surgical invasive techniques or implants. Occasionally unproductive experiments in research development can also upshot fissiparous disruptive processes for other therapeutic by-products.  This is where Western and European countries are far ahead and Indian companies are lagging behind. There is no wastage from Research and the failed Researcher has a bright future.

For instance, In 2010 the FDA's Centre for Drug Evaluation and Research (CDER) approved 21 novel new drugs known as New Molecular Entities (NMEs).

If we go back into the Government drug approvals in western and European countries, they had approved maximum 6 molecules NMEs up to 1930 (depending on different countries bio-standards norms) such as sulpha, morphine, apiol and aspirin etc. for confirmed indications. But many denied or kept-in-abeyance candidate drugs were promoted by the then pharmaceutical or medico-marketing outfits based on assumptions or physicians’ empirical considerations for non-confirmed indications as therapeutic alternatives, not as a front-line choice. Some denied-drugs were fallen in category to alleviate symptoms. From then on, it became a practice of the day to promote ethically non-approved products on assumption-basis notwithstanding the outcome of clinical trials.

As on today, if we subtract implant devices and invasive therapeutic techniques, the Total Number of Small Molecule Drugs globally is 10256 (Government approved). Small molecule products mean having a simple molecular structure such as aspirin, Acetaminophen etc.

Biotech Drugs number is 1670. Biotech drugs are different from pharmaceutical drugs as biotech use biotechnology as a means for manufacturing, which involves the manipulation of microorganisms, such as bacteria, or biological substances, like enzymes, to perform a specific process.

It is estimated that the financial amount spent on research and developments for biotech drugs is roughly $26 billion up to 2012 and claimed over 40 per cent of the world’s share of filed biotechnology patents between 2010 and 2012.  And Biotech drugs registered $76 billion in sales in 2018. As we read this article on R & D and mark-to-market molecule approach, the number of new drugs FDA approved each year has remained relatively steady over time.

Think for while the quantum jump from the 1930s 6 drugs to 11926 till date approved drugs globally. It is an amazing achievement.

If the world is going in that direction, what are Indian Pharmaceutical and its R & D contributions either to India or to the world?

In countries like America, Japan, U.K and Australia journey of a molecule’s ideation and initiation starts from university’s lab but not from Pharmaceutical in-house R & D. The alma mater is the shelter for the Professors, Scientists, and Researchers, better equipped with state-of-art Labs facilities, accrued with a huge library for ready references. Adding to this flourishing milieu, Universities are also provided with grants from the Govt. and Private exploration bodies or the pharmaceutical industry to navigate towards new drug destinations.

The interested pharmaceutical companies can either invest or take the extent of research from Universities by compensating royalty to that effect. The companies can start from then-on at their R & D units in a more novel way to understand in-depth, mechanism-based, hypothesis-driven, and addresses significant issues in drug discovery development as per regulatory guidelines.

It is a perfect environment with a link-pattern to undertake basic research by understanding the processes behind a disease, often at a cellular or molecular level.  As we are in the pharmaceutics and medico-marketing, we know that in earlier years, researchers extracted candidate molecules from natural compounds, plants, bacteria, fungi or marine animals to offer us for therapeutic benefits.

In 2012, I had visited more than 16 renowned Indian universities and spent more than 6 months to study the feasibilities of research infrastructure in Indian universities I visited.  I had discussed at length with Professors of Molecular biology, Biochemistry, Microbiology, Pharmacology, Medical biology and chemistry, Branches of Medicine, Associates of Medical research and Neuroscientists.  They had given me one simple reply, “do not have advanced labs, funds and paucity of students’ interests on new entity exploratory fields such as bioengineering, application of nanotechnology, robotic intervention and genome etc.”

Also, I had gotten into varied discussions with Jr. Researchers to know their kind of understanding and defining disease processes, pathways to target for new treatments recognized.

And by far, with a stretch of 6 months continuous interaction with high-end Professors and Post-doctorate distinguished personalities, I became familiar to give a knowledgeable pitch on any subjective material in this regard. That was a blessing in a disguise to me.

From 2014 onwards, in India, there had been an escalation and upward mobility, that had led us to new level playing fields. It was the introduction to supercomputers and computer-generated animation in pharmaceutic process, in-body disease manifestation, genome-disease identification, correction, and also animation on in-vivo and vitro biochemical reactions etc. So, scientists gained not only access to humongous data but also the virtual reality on genetics and proteins to create new molecules theoretically to interfere with the disease process.  

So it has become easier to identify, target and hunts for molecules or compounds faster than never before. The invention of molecules must also go hand-in-hand with the discovery of new diagnostic tool and disease prognosis, which are the most quintessential to Medical profession lest the importance of candidate-drug goes awry.

From 2008 through 2016, the FDA had pushed through the door on average about 31 novel drugs per year. The US Food and Drug Administration permitted 46 new drugs in 2017. This approval was the highest number in 21 years and more than twice the number approved in 2016. The drugs launched up to 2017, are good for promotion but it is too soon to know their success. The FDA approved a record 59 drugs in 2018, but the commercial potential of these drugs is lacklustre.

The R & D has been not only concentrating on synthetic small molecules and bio-similar drugs but also on certain nutraceutical substances naturally available. The nutraceutical is also called as bioceutical.  This branch of medicinal science is a pharmaceutical alternative claiming physiological benefits when the ingredients are given at an appropriate potency either in isolation or together with. But largely this branch is unregulated; because the ingredients of bioceuticals exist in the same category of dietary supplements and food additives. This is gaining good patronage from the medical profession due to their lack of iatrogenic properties and reduced tachyphylaxis in the long run. If we look at statistics from the 1990s onwards, the growth of nutraceutical studies. The Total Number of Nutraceutical preparations had gone from 0 to 129.

From this article beginning to here, we have chronologically perceived layers in global medicinal inventions, innovations, research, discovery and promotion.  While some are lifesaving drugs, few drugs are for symptomatic relief and others are as supplementary etc.

There are layers in the selection of medicines from mandatory, therapeutic, symptomatic relief, sub-therapeutic, prophylactic, and sub-prophylactic etc.

I am coming to conclusion, not closing, but with an opening-out into the new horizon as far as India is concerned. What is happening in this multi-layered promotional strategy?  Countries like China, Japan, Korea, and certain European countries are not encouraging this multi-layer pharmaceutical promotion. In the U.S.A, Canada and U.K, the medical professional does not prescribe sub-therapeutic, prophylactic and sub-prophylactic multi-vitamin preparations.

Their choice is simply a diagnostic tool, disease identification, quarantine without medicine, prognosis, treatment and last option surgical intervention. The treatment is disease-centred, patient-affordable and early-recovery.

But in India, the promotional strategy is business-centric ignoring R & D.

We have got a lot of R & D divisions in many of top Indian companies.

What these Indian companies’ R & Ds have achieved so far?

Have they achieved inventions or innovations or Original research molecules, be they either small molecules or bio-similar drugs or Nutraceutics substances or ingredients?

If we take up words like invention or innovation or research or discovery, there is a difference in their true sense.

In the Pharmaceutical Industry, exclude medico-marketing, Invention is the creation of a product or introduction of a process for the first time.

Innovation happens when someone improves the technically stable combination of two or more existing molecules without ingredients’ interaction or nullification to make a significant contribution to something which is hitherto not existed.  

Research is the process with a series of attempts and variable repeated actions for the Original class.

Discovery is the result. Discover something because of research, invention, innovation and discovery is the product or service or process for Marketing.

I reason that it is momentous to debate this detail as to what influences western and European countries achieve so much and what lags Indians left so far behind except to copycat or co-market MNCs products?

I think human beings have a significant reason to research or discover or invent or innovate to be successful. To start with, human nature is as such, we may claim that creativeness is the objective. Methinks convincingly, creativity is totally not objective when we have too many questions to be answered and find no answers at all to those questions. 

Let us presume that research not only happens in the Company’s or at University labs but research can also be done elsewhere when candidates have the curiosity to pursue research. And research never starts with a great many questions or theoretical pile-up.  Every research also starts with simple questions. Of course, infrastructure is mandatory.

To start with, let us take a case study of a researcher. A researcher has to mark about what to create, what are the intended outcomes?  

How one will conduct research?

Who will pay for their creativity, and how one will present one’s research conclusions to others?

What and how one will define one's work of research and methodical theory presentations?

And of all, the important question is what do I want to accomplish with research personally and how I can change the world?

If readers of this article ask these questions themselves and find answers, they can become a successful researcher in a good team.

Even if you fail in research, you don’t have to worry as you tried your level best. When you are bored with research, you can come out from the project, you can become a research-guide, thought-leader, mentor for start-ups in disrupt-technology or consultant or expert in the research-led field or can become a professor.

Meaningful research is an outcome of demanding efforts of teamwork. You may not invent but you can at least innovate or disrupt to transform the community and you can change the world in a better way.

I have a few words to write before I close this article. Independent-consultancy is not a great profession in India. Through writing this spiel, I am trying to democratising independent-consultancy, for which I have great respect. If ever the readers of this article come across valued or respectable consultants regardless of age just accost them and respect them. Do not think “a consultant is an outsider; the consultant is a professional like any other professional.”


© Copyright 2020 thai prasad. All rights reserved.

  • Facebook
  • Twitter
  • Reddit
  • Pinterest
  • Invite

Add Your Comments: