DR. VISHAL G WARKE

What was the rationale behind your career move towards being one of the Med-tech influential leaders?

Himedia has been into the diagnostic space for almost 50 decades now. The Microbiology media are used in diverse fields such as pharmaceuticals, agriculture, dairy, veterinary, etc., but one of the most critical usages of the media are in hospitals and clinical laboratories for disease diagnostics. Hence, for us, diagnostics and med tech has been a key area, which is also the core to our expertise. It was a natural extension for us to branch out into allied areas of med tech which would necessitate the use of automation and other technology platforms for rapid diagnostics.

Since I am a medical doctor, having done my Ph.D in immunology in the United States where I had the opportunity to work on quite a few diverse immunology issues, it was always on my mind to do something useful in the field of immuno-diagnostics specifically, which is my forte. The blend of a medical background along with research expertise in immunology thus made me gravitate towards developing and making available the diagnostic products in the med tech field. Basis of my decision to join the industry comes from my parents who pioneered into the diagnostic market business at a time when India had zero presence and expertise in media manufacturing process. Looking at the passion with which my parents followed their vision of ‘Make in India’, I had the desire to follow their footsteps in contributing to India’s success and self- sufficiency within the field of BioSciences.

How has the current situation affected the need for molecular testing equipments and other products during this pandemic?

Molecular testing is very critical for detection of COVID-19 and the level of accuracy and extremely high sensitivities that are required for detecting the virus copies in the infected samples, the only way to do, is by using sensitive molecular testing equipment. These machines and kits such as RT-PCR, RNA extraction kits and the rapid LAMP assay are highly sensitive. The challenge was to ramp up production to meet the burgeoning demand for almost the entire population of the planet as billions of people were being affected. Every organization had to gear up to these demands and HiMedia too, rose to this challenge. Our Molecular Biology division is headed by Dr. Rajas Warke and Dr. Kavita Khadke. They have been very aggressively and actively working towards ramping up production capacities and these platforms were already developed by HiMedia even before the pandemic had hit. Thus, we were in an ideal position to scale-up our production and were able to make the kits available in market to meet the growing demands of diagnostic centers. HiMedia

is a prominent brand known for its sterling quality and affordable pricing. Keeping this in mind, a lot of diagnostic labs looked up to us for support during the time. Heavy investments were added to our scaled up production capacities. Our CAPEX investments in diagnostics business during the year 2020-21 were almost 10 times higher than the average yearly CAPEX investment and the highest in the past 45 years. As the landscape of molecular diagnostics evolves with time, there is also a need for newer molecular testing devices which can give highly accurate results in lesser time (few minutes) and this, would be an ideal test.

As we open up, and as people travel through airports, as people would need to take spot decisions to get admission in hospitals, and to reduce waiting times at various locations, or to check for an immunity passport to allow people to mingle and attend events or travel, we need accurate and fast testing mechanisms, and such technologies have also been developed. Apart from the molecular testing equipment, we have also made available various other products like the VTM (Virus Transport Medium) kits. Currently, we have the capacity to produce a million VTM tests per day. We have also developed and commercialized the COVID-19 IgG ELISA detection kit, ELISafe 19TM, in collaboration with Syngene International. Today, we have both qualitative and quantitative ELISA estimation kits. This kit has been approved by ICMR with 100% Sensitivity and 99% Specificity.

These unprecedented times affected the healthcare industry to its core. How the Med Tech industry is contributing to help patient care?

The med tech industry is playing a pivotal role by helping in screening rapid detection and also helping doctors take decisions in their treatment protocols.

For example – Various modalities of detecting the virus in the saliva through rapid antigen tests or through RNA extraction and PCR is another way of detecting the virus. In addition to that, we also have antibody detection, the IgG or IgM titer estimations which help to recognize if a person has already been exposed to the virus and has immunity passport. Additionally, post vaccination, the immune status of a person can be mapped by measuring the antibody titer and one can monitor the titer over a period of time after the 1st as well as the 2nd dose of the vaccine. This can also be done over a longer period of time. Furthermore, many other diagnostic tests help doctors take a decision by looking at the D- Dimer values, inflammatory markers and allied technologies.

What are your key learnings during these unprecedented times?

The Med Tech industry is playing a pivotal role by helping in screening rapid detection and also helping doctors take decisions in their treatment protocols.

Looking at the Atmanirbhar mission of Hon’ble Prime Minister, our first key takeaway during these unprecedented times is that we have to be independent or, self- dependent rather, for the raw materials that are needed for developing most of the diagnostics test kits as well as equipments. Though today we have the capability to make these kits and equipment, we are highly dependent on foreign nations for primary components. This is something which needs to change. Secondly, quality standards have to be established and implemented across the country so that a certain class or high quality manufacturers can supply dependable excellent quality products in the market. Thus, the poor quality products which have flooded the market and are misleading doctors in their diagnosis can be curtailed and controlled. There have been instances where the patient is clinically COVID-19 positive yet, the PCR test results come out to be negative. This happens particularly because of the poor quality of VTM, mRNA extractions kits, PCR kits that are rampantly been used in various places. Third key takeaway is about scale. We have to be ready to scale-up at short notice and the scale-up needs to be nimble in the manner that we should be able to scale-up the production of a certain line of products. When the demand of the market shifts, organizations should be able to modify and tweak the product to suit the upcoming demand and requirement of the market. For instance, our ELISA kit, when launched first, was specifically a qualitative ELISA test kit. Later on, since people wanted to know the titer for neutralizing antibody, we specifically worked up on the S1 and RBD quantitative IgG ELISA tests and introduced them into the market. Another key takeaway for us was that, we were able to develop and make available the media used for producing the COVID-19 vaccine from HEK 293 cells. Recently, we saw that the raw material supply for the Covishield vaccine production for Serum Institute of India wasn’t available due to the embargo put by the US government. The key bottleneck was the availability of media for production of vaccines through HEK 293 and Vero cells. HiMedia today, has the serum free media for Vero cells which is being used by key vaccine manufacturers in India. We were also able to develop and make available another medium namely the serum free medium for HEK 293 cells very swiftly, which are the work horse of COVID-19 vaccine production.

What are your future endeavours to the medical industry as a leading Med Tech innovator?

Since we have been working in the med tech field for almost 5 decades

now, we have many things to offer in the development of this industry, not only in India but also the Rest Of the World. One thing which I would like to mention is about our project on Biosimilars. We have been awarded a sizeable amount of grant under the auspices of National Biopharma Mission -BIRAC to develop chemically defined serum free media for mAbs (Monoclonal Antobodies production through CHO cells) & NonmAb protein therapeutic molecules and make this available cost- effectively by scaling up the production to millions of liters of media per annum, at extremely affordable prices. This would enable the cost of Biosimilars to be brought down significantly in our country.

As I have mentioned earlier, most of the media needed for vaccine production, for various human as well as veterinary vaccines, is something HiMedia has been working and has developed a comprehensive range of these products. We offer these products to the Indian vaccine industry in India and export to several vaccine programs all over the world too.

We have also developed media for organ storage and transportation. For ex- in collaboration with certain hospitals, we have developed heart storage and transportation medium, which can be used in case of heart transplant. We have corneal storage and transportation medium wherein the medical technicians can collect the cornea, transport as well as preserve for future use. Along with these, we also have products for skin storage and collection to name a few. Additionally, we are working on stem cell media, media that can be used for expanding and differentiating various stem cells into different organs and tissue types. This will help to boost the field of organ transplantation wherein people can work on concepts such as organ on a chip and a lab grown organ.

A brief about yourself and your organisation.

I am a Scientist and Director of Cell Culture & Immunology division at

HiMedia Laboratories Private Limited. After graduating as a Medical Doctor (M.B.B.S) from the University of Mumbai, I completed my doctoral research in Cell Biology and Molecular Genetics from the University of Maryland, USA. I have been awarded with the Medical Research Fellowship of The Walter Reed Army Institute of Research (June 2002), Silver Spring, MD, USA. As the gen-next leader of HiMedia, I have established and diversified the business into other areas of biosciences, including the Animal Tissue Culture, Plant Tissue Culture, and Hydroponics businesses, thereby broadening the portfolio of the organization. I have worked on design and development of media for biosimilar production, developed many products including Serum Free Media, Lymphocyte Separation Media, Viral Transport Media, Primary Cell Media etc. for the global market. I have been an active member of several reputed scientific bodies and a PI for many collaborative translatable projects. I have been the mentor and advisor for many Start Up Biotech Companies (Globally) and have given inputs for highly techno-savvy approach in setting up Manufacturing & R&D facilities.

I remain well connected with the prime research institutes in India as an industry expert & curriculum advisor. These include the likes of IIT, ICT, CCMB, CSMCRI etc. My expertise lies in Human T-cell Receptors, CD4 receptors and Human T-lymphocytes and I have 20+ peer reviewed publications in leading journals, such as JCB, JBC, & Blood and 4 product patents. My work in the field of systemic lupus erythematosus and chemical hypoxia has been appreciated by the International Scientific community. Currently, I am working on various national and international grants which include a BIRAC-DBT grant, a NBMfacility creation grant by BIRAC, and an international grant conferred by IndoGerman Science & Technology Centre, in collaboration with ICT and two German institutes. Earlier this year, my team received the “BIRAC Innovator Award 2020” under the therapeutics, vaccines and drug delivery towards high level “Designing of innovation research for & commercialization of affordable chemically defined serum free media and feed for high value Biosimilars manufacture”.

Apart from science and technology, I also take high interest in subjects of philosophy, history, and mythology.

About HiMedia :

HiMedia Laboratories Pvt. Ltd. is a leading Bioscience Company of Indian origin, having expertise in innovation, and manufacturing of Microbiology, Cell Culture and Plant tissue Culture media, Molecular Biology, Diagnostics, Chemicals, Laboratory Equipment, and Hydroponics Solutions. The principal mission behind the establishment of the organization, four decades ago, was to help Indian scientific fraternity by providing world class quality products at competitive prices. With presence in over 150 countries, HiMedia ranks amongst top 3 Media Manufacturers in the world. Since Research and Development is the core foundation of HiMedia, the brand invests significant amount of its profits in R&D and is driven by a strong team of scientists and experts. Himedia’s stateof-the-art manufacturing units are spread over 8 locations.