Taking an antiviral drug from lab bench to bedside - Defining the problem statement (Chapter 1)

in StemSocial3 months ago (edited)

So what does it feel like to develop a drug for viral diseases? I would say quite exciting as a scientist. However, it is a different story and a new world outside the science lab. Good science forms the core of drug discovery. But, it takes a lot more to bring the drug out and make a real impact. And this is where science gets real. The purpose of this and the following posts will be to share my journey in this field. And I hope it will also help other aspiring entrepreneurs (both scientists and non-scientists) to learn about it.

Recap: In a previous post1, I talked about shifting gears from academia to entrepreneurship. I talked about how it was challenging coming from the world of academia to a more industry-like setting.

bench to bedside.jpg

From lab bench to bedside
Illustrated using images for lab and bedside from openclipart.org | CC0

However, during the last three months, I learned a lot more about it. I made a contract and set the deadlines and milestones for the work. I initiated the validation experiment and commenced working on preliminary safety experiments. Furthermore, we have been selected for the cohort of an accelerator program run by the Wadhwani foundation. They are teaching us about creating a pitch deck to approach investors. It includes everything ranging from setting up your problem statement to setting up your business model and sales plan. While some of the concepts are common, irrespective of your business, others seem to be more specific. Nevertheless, even the specific ones are variations of basic ideas.

Defining the problem

Let's start with the core concept - why am I doing what I am doing it?

The core of all startups and innovations is about solving a problem. If you give it some more thought, that's what you are doing in your daily life chores as well - from making your bed to even brushing your teeth - you are solving or fixing something. Startups differ from the problems in our daily life and basic science for a simple reason. It is not about your pain or your excitement anymore. Now, it becomes about addressing the pains and problems of a larger niche. Hence, when you start to innovate, you should think of the following questions and clearly define your problem statement 2.

Questions you should ask

  • What is the problem?
  • When and why does the problem occur?
  • Do people really care about the problem, how does the problem affect people emotionally?
  • What do people do now when they face this problem?
  • How can I solve it?
  • Can I solve it?
  • Why solution I have in mind will work?
  • Why will people care about my solution and pay for it?
  • Is my solution better or different than other solutions? If not is there a need in the market for yet another solution?

So what is the problem that I am trying to solve?

What is the problem?

  1. Well, every year we lose millions of lives to viral diseases each year 3. These lives include both adults and children 3. For instance, influenza alone claims about 650,000 lives 4. There are many who have to face hospitalisation and discomfort. Viruses like Ebola, Dengue, and Chikungunya pose serious health risks. And then there are viruses like hepatitis, HIV, and HPV which once they enter the body stay there for a lifetime and deteriorate the health. And even though sometimes some viral infections might seem short term they may leave a long-lasting effect on the body and can be triggers for chronic diseases such as diabetes and cancers. 3.

  2. Caretakers (doctors, nurses and loved ones) fear the risk of infection when dealing with patients suffering from infectious viral diseases.

  3. Many emerging viral diseases on the horizon pose significant risks to human health. Covid19 pandemic is what we witnessed recently. And then we saw the emergence of monkeypox. Moreover, there are many more viruses lurking in the wild, which, if unchecked, can cause the next pandemic. These include (but are not limited to) - NIPAH, numerous flu viruses, Ebola, pox viruses, and other coronaviruses 5. The question is are we prepared this time?

When does the problem occur?

  1. When someone gets infected by a pathogenic virus and have to either suffer the sickness or even fatal consequences.

  2. When caretakers - doctors, nurses and loved ones have to take care of a person suffering from infectious viral disease.

  3. When a new viral epidemic/pandemic emerges.

Why does this problem occur?

  • Limited number of antiviral drugs in the market: Limited preparedness in terms of weapons we have against viral diseases. To begin with, we are inadequately equipped to mass diagnose viral infections. We are even more crippled, when it comes to drugs we can provide to treat or prevent viral infections.

  • Limited number of antiviral drugs can target multiple viruses: There are limited broad-spectrum antiviral drugs in the market. Unlike antibacterial (antibiotics) which are designed to target a wide class of bacteria or even all of them, most antivirals have been designed against specific viruses 6 (antiretrovirals for HIV 7, Tamiiflu for influenza 8, or acyclovir against chickenpox, herpes and a few other viruses 9.

  • Need of drugs that can inhibit infection without affecting cells: Most of these antivirals are designed to act inside host human cells, rather than on the virus outside the cell. Acyclovir for instance interferes with the DNA polymerase of the virus inside the human cells. The intracellular action hence increases the chances of adverse effects on human cells.

  • Safety concerns and lack of enough prophylactic measures: Safety of many if not all antivirals are of concern. Therefore, it is always preferred to prescribe them when the benefits outweigh the risks. Hence, there are limited options for prophylactic drugs (a preventive drug you can take to avoid infection).

What do people do now to resolve the problem? What are the limitations of current solutions?

  • The ideal weapon against a viral infection is a vaccine. But vaccines are not always available. The viruses such as flu often find their way around the vaccines. Hence, new flu shots are updated every year. When a new epidemic or pandemic emerges, people often have to wait for the vaccines.

  • They take currently available synthetic drugs, and if the benefits outweigh the risk.

  • They mosty take preventive measures such as using a mask and washing hands to avoid infections. But safe prophylactic measures are not always available.

What is the emotional impact? Why do people care about this problem?

Say you get something as benign as the common cold. Don't you want it to go away? Do you want to isolate yourself? Even in case of non-fatal infections, we all want to heal faster and be close to our loved ones. And we definately don't want more serious infections to get us hospitalised or linger in our body. We don't want to see our loved ones suffer.

  • viral sickness is both physically and mentally draining

  • fear of losing your loved one or your own life (in case of fatal infections)

  • Sickness is heavy on pockets in general, and hospitalisation if needed can charge a bomb

  • Isolation, if needed, can take an emotional toll on both sick and their loved ones (we have all experienced this in Covid times be that isolation voluntary or enforced).

We all want to heal faster, and reduce the emotional, physical and financial burden of viral sickness.

What is the need of the hour?

The need of the hour is - a safe, effective, and broad-spectrum antiviral solution for therapeutic and prophylactic use to help patients and their caretakers. Something that can reduce not just mortality but also the suffering that comes with the viral sickness. Something that can be taken to reduce the chances of getting infected. I mean, would it not be nice to not wait 7 days even for a cold to resolve and not have avoided kissing your loved one?

Problem statement:

In additon to being fatal in many cases, viral diseases take a huge toll on mental and physical well being of the infected and their caretakers. Thre are novel, emerging, and re-emerging pathogens on the horizon. Only our preparedness can reduce the toll of next pandemic. But, there are limited safe broad-spectrum antiviral solutions in the market for therapeutic and prophylactic purposes. This calls for discovery and development of novel drugs that can target multiple viral disease and are safe to use even as a preventive measure.

Probem statement canvas

A Problem statement canvas10 is a great tool to understand your problem for multiple angles and put them in one table. It is an insightful exercise that you can do with your idea if you would like to try it. Here is the canvas for the problem I have described above:

Problem statement canvas.png

Given that we have defined the problem, we are using our expertise and trying to solve the problem described above. I will shed more light on how in the next post. Specifically, I will be addressing these questions -

  • How can I solve it?
  • why can I solve it?
  • Why solution I have in mind will work?
  • Why will people care about my solution and pay for it?
  • Is my solution better or different than other solutions? If not is there a need in the market for yet another solution?
  • Who will buy it?

Meanwhile, if you are thinking of solving a problem too as an entrepreneur maybe you can think of giving a structure to your problem statement. I would also love to take questions here. Especially, I would love the challenging questions which could help me improvise. I would want you to think like an investor (or maybe a potential customer) and I want to know, what it would take for you to invest in the solution for this problem (or buy it),

Signing off
@scienceblocks

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You can reach out to me on discord if you are in stemsocial discord. Or you can even send me a DM. My discord handle is the same as my hive - @scienceblocks. You can also ping me on my telegram handle: @UncertainHeisenberg. Or follow me on Twitter: @skataria and @scienceblocks1

#Refrences

  1. New life at the boundary of academia and the real world.
  2. What Is a Problem Statement: Definition, How-To and Example
  3. The Human Toll of Viral Diseases
  4. Up to 650 000 people die of respiratory diseases linked to seasonal flu each year
  5. Emerging/re-emerging viral diseases & new viruses on the Indian horizon
  6. Broad-spectrum antiviral agents
  7. FDA-Approved HIV Medicines
  8. Influenza (Flu) Antiviral Drugs and Related Information
  9. Acyclovir - Uses, Side Effects, and More
  10. https://www.acceleratedfw.org/web/toolkit/problem-statement-canvas
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Well I guess you are going to spend lots of time with the "How to solve it" question, since I know many people that didn't find the answer in the academic world. Viruses different from bacterias don't have their own metabolism, they use ours! So it is quite difficult to find a way where it doesn't affect us as well. It is interesting to think about that , bacterias are the perfect organisms to produce drugs since their metabolism is independent and totally different from us. When we switch to superior organisms like fungus and protozoa it becomes difficult again, their metabolism have lot's of similarities with our cells, so it is also challenging. And if we go down to viruses we have this problem, organisms without self-metabolism. Well I would love to see your discoveries in the future! Hopefully, they will bring new insights. I agree with you vaccines aren't perfect, we can see that in the flu vaccine and MANY others, but still, they are what we have now...

!1UP

Thanks for your comment and raising such an interesting and important question. I have found a solution to this by developing the pipeline that specifically increases the chances of screening for those kind of drugs. Though I would leave the details for my next post. Also to answer your question, we don't have to look very far away from nature when looking for those kinds of drugs. Even our body produces these small proteins called antimicrobial peptides (AMPs). Some of these which can specifically bind to viral membrane and which has specific composition and cause agglutination or reduce it's ability to bind to receptors. I have recently communicated a paper on this with a colleague on one such AMP (this AMP is different from solution I have found) and it is currently under review. I will write about it once it is published. Let me know if you have further questions.

nice! great to read about it!

I remember indeed that you mentioned shifting gears to entrepreneurship. IT was quite instructive to read how you managed the transition. I have no specific comment to this blog, except that I really enjoyed reading your story. Good luck for the future, for which you get my best wishes!

Thanks a lot for your comment and wishes.

You are welcome!

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