Modern Medicine wouldn’t be where it is today if not for the final medicinal product (tablet, pill, capsule, lotion, creams etc) that is not only stable in real world conditions but also acceptable to patients in dosage and form.
Om Shelke (PhD), our next pathbreaker, Formulation Development Scientist, develops drug products for Semisolid/Topicals/ Dermatology Formulations so that a suitable and stable dosage can be easily administered to patients.
Om talks to Shyam Krishnamurthy from The Interview Portal about working on a range of formulations to administer health products to meet different needs; and interesting challenges he faced in the development of new formats for oral care.
For students, formulations are playing an increasingly important role in the world of medicine through newer and effective ways to administer drugs. Focus on better technologies to improve drug efficacy.
Om, tell us about your background?
I was born and brought up in a big (22 people) joint family where we used to run so many businesses in our village. We used to have a monopoly in the village: whatever you wanted to buy, you could buy from us and whatever you wanted to sell, you could sell us.
I was completely involved in business activities, in fact, I wanted to be a cricketer. I used to play very good cricket and always used to lead our cricket team. In our village, we had school till 7th standard only. When I completed 7th standard, the teacher told my parents that since I was a bright student, they should send me to the district for further schooling. Actually, this is the moment which transformed my business mind to focus on other opportunities.
I completed my education till 12th Standard from the district. I moved to Pune which was completely new for me. The interesting part is, when I used to talk in Pune, people used to recognize me as being from Marathwada. I took that opportunity to learn the language of Pune so that nobody could judge where I was from.
What did you do for graduation/post-graduation?
I have completed my BPharm and MPharm from the University of Pune
I then started preparation for the GATE(GPAT) Exam which is mandatory if you want to pursue MPharm along with a stipend. My hard work and luck led me to qualify for the GATE(GPAT) Exam for which I got the 8000 Rs per month stipend throughout the MPharm programme. I was very fortunate to have good seniors in my college, they guided me very well. I would like to acknowledge two of my seniors, Kunal Sable and Rohit Shirode. They played a very important role in my academic journey, helping me and guiding me through every step.
I also did my PhD in Pharmacy, Pharmaceutical Sciences, and Administration from Pacific University, Udaipur.
What made you choose such an offbeat, unconventional and uncommon career?
I was very passionate about research in the pharmaceutical field. What attracted me to this noble profession was the ease with which medicines relieve the pain or discomfort of a person.
I was not willing to do the MPharm unless I got through the GPAT exam. If I didn’t get through, I had decided to work as a teacher in a pharmacy college, so that I would get sufficient time to study and reappear for the GPAT exam. Fortunately, I got through the exam in my first attempt only. Based on my GPAT scores, I got admitted for MPharm. During MPharm, I decided to enter into the industry.
How did you plan the steps to get into the career you wanted? Tell us about your career path
I started looking for my industrial project internship after completing my first semester in MPharm. It took a lot of effort to search for an industrial project in the second year of my MPharm. Though I had very limited contacts in the industry, I tried very hard and approached all seniors and teachers. I applied at so many places but received no responses from companies because one needed a strong reference to get an industrial project. After applying to so many places I got an industrial project in Glenmark research center through my senior Rohit Shirode. This was the breakthrough I needed to enter into the industry and I took this golden opportunity very positively. My senior colleague (Ashish Rane) always used to tell me to work hard here. I worked very hard on my project as well as company projects. Generally, trainees do not get an opportunity to work on company projects, but fortunately, I got this opportunity.
In Glenmark, I started as a project trainee for 9 months. Generally, the project needs to be finished within 6 months; but I could not finish in 6 months as I was also working on company projects which were of higher priority than my projects. The project got extended by 3 months, which was a big turning point in my career and i got a break as an employee in Glenmark as Research Associate. I worked for 3 years in Glenmark research and development Centre for the US FDA Market.
As an intern, I started working on the tablet which is used in the treatment of Cardiac Arrhythmia. It was a high priority project and almost two teams of scientists (6 scientists) were working on the project to meet the timelines. We failed 14 times to meet the bioequivalence studies on actual human volunteers but succeeded in the 15th study. Another project in which I had worked on was the antimalarial suspension.
I learned based on my experience; I would help my superiors to finish some of their work which would not only help them but was equally beneficial for me as well, as I was learning the work of my superior one level up in the organization. Similarly, my superiors helped their superiors, in this chain everybody was getting exposed to the work of one level above their position. This will help a person grow in their organization professionally and financially.
I worked with the Glenmark Research Centre for three years. I used to develop medicated products for the US market. The important aspect about myself is, I never say no to any work. If you know how to do the work, it will increase your perfection, and if you do not know, it’s a great opportunity for you to learn. This has increased my knowledge in my professional life.
I moved to Dr. Reddy’s Lab in Aug 2015 as a Formulation Scientist for the development of semisolid products for USFDA. The culture and the professional environment in Dr. Reddy’s Lab shaped my professional etiquettes and behavior. There I learned how to portray my work to higher management. Basically, everybody should know how to portray their work in a good way, presentation of work is very important in order to pass the project stages.
Actually, I wanted to enter the industry after completion of my PhD, but fortunately I got a job immediately after completion of my internship during my MPharm project. Amongst the 12 interns, I was the only one who got selected for the job after 5 rounds of interview. During my internship I worked very hard. This helped me a lot in building my practical experience and hands-on knowledge of each equipment and instrument. Then I decided to pursue a PhD while working, which requires a lot of dedication and effort. For those who want to achieve something in life, life always makes way for them. It took me 4 years to complete my Phd while working. It was not easy to finish the research work and do my thesis while working, it took lots of effort and sacrifices. I had been working more than 18 hours to complete my PhD research and thesis.
To get a PhD was my dream and I approached one of my teachers, who was a principal in a Pharmacy college. He was a very good human being. He introduced me to my PhD supervisor and we had a very good discussion about the project plan. He was registered as a supervisor at Pacific University. Generally, students choose the university first and then the supervisor, but it was reverse in my case. The university announced the test exam for PhD students in December 2014. I got through the PhD entrance test and presented my research proposal to the committee; the committee liked the research proposal. They approved the research proposal and I finally got admitted for PhD in March 2015 .
My Ph.D. thesis was based on the development of “Emulgel” (When gel and emulsion are used in the combined form, they are referred as Emulgel) product by using the concept of Quality by Design. In pharmaceutical industries, the testing is done after the product is manufactured, but the Quality by Design concept ensures that quality is built inside the product through tests to ensure the product is meeting the predefined specifications. I developed the Emulgel product which has better antifungal efficacy than the currently marketed product. I have done animal studies for antifungal efficacy on mice. It was very critical to get approval for animal studies. To perform animal study, the study protocol should be approved by the Control and Supervision of Experiments on Animals (CPCSEA) and the Institutional Animal Ethics Committee (IAEC). It took me 3 years to finish the research work and half a year to complete the thesis typing. I have presented my thesis work to my supervisors and to another professor as pre-viva. Then I submitted my thesis after the approval of my supervisors. It took 3-4 months for them to review the thesis and arrange the final viva. I successfully defended my Ph.D. viva in July 2019 and officially became Dr. Om Shelke.
In Dr. Reddy’s Lab, I had worked on 505 b2 (NDA) products. These types of products are different from what is available in the market. Though a new product could be for a new disease or same disease, the formulation will be different to meet the patient’s needs. If patients are using the drug as a tablet, the same drug can be used for some other disease in the form of cream. I have changed the route of administration of the drug which was previously used in the form of tablet into cream by developing this formulation. I was the first one in the department, who developed the product within one year and successfully completed the toxicology studies on pigs. I then transferred the project from R & D (10 Kg batch size) scale to commercial production site (500 Kg batch size). Now that product is being successfully marketed in the US market.
To support my wife’s education as she was studying in Mumbai, I switched to Abbott India. In 2017 Abbott was the top pharmaceutical company in India. It was a proud moment to work with India’s top ranked company. There I developed projects for the Indian market. The biggest difference between working for the US market and the Indian market is the satisfaction of seeing the product developed by you, helping your relatives, friends, and family to relieve their pain or discomfort. This gives immense work satisfaction because we are helping our own community. In my past career, I launched so many projects but couldn’t see the benefit of the products as they were all launched in the USA.
In Abbott, I worked on the development of differentiated formulations. Differentiated formulation means a formulation that is modified in such way that it will be very easy for the patients to apply. There was a cream product available in the market, but creams are oily and difficult to apply on the back side of the body. We developed a formulation as lotion (Liquid) from the cream (semisolid) which allows patients to apply it comfortably on all parts of the body and skin. I have developed a range of medicated shampoos for use on a daily, weekly and biweekly basis for dandruff. We have also developed an applicator to insert the gel product in the anus to make it easier for patients to apply and feel comfortable when they use the medicine.
In 2018, I got an opportunity to work with Hindustan Unilever, which is a subsidiary company of Unilever industries. Unilever is the world’s top company and is present in almost all segments. Probably, everyone starts their day with Unilever products and ends their day with Unilever products such as Pepsodent, Close-Up, Knorr, Kwality Walls, Brookbond, Lifebuoy, Fair and Lovely, Rin, Tide, Pure-it and so many other brands.
In Unilever, I worked on Oral care products such as Pepsodent and Close-Up. I was involved in the development of new formats for oral care. Traditionally, we have always used powder (ash powders) for cleaning the teeth and mouth. Since toothpaste has been invented people have been using toothpaste for maybe the last 100 years. We never thought of an alternative to toothpaste, though in Unilever, we have developed a tablet for brushing. Instead of carrying the toothpaste, you just need to carry the tablet and crush the tablet in your mouth and start brushing. Spit out the residue after brushing and rinse the mouth with water 2-3 times. Why brushing tablets? Brushing tablets are made from powdered toothpaste that’s condensed into tablets. They’re small and solid, more closely resembling a pill than a paste. They can be packaged and shipped in recyclable glass or paper containers, negating the need for tubes—which are often made from a combination of plastics and aluminum. Generally, 70 % of water is used for the manufacturing of toothpaste as well as brushing with the toothpaste and for mouth rinsing (Approximately 10-12 rinsing). However, brushing tablets are water-free and require less water for mouth rinsing (approximately 3-4 rinsing). So ultimately we are saving a large quantity of water which results in a lower carbon footprint. Since they’re solid, they’re also travel-friendly, and the tablet size ensures the optimum amount of paste with every brushing. I have worked on oral care products to make them preservative-free without impacting the microbial stability of the products. Unilever is the best place to work for those who are willing to grow three-dimensionally (Professional, financial and personal). Loop was an interesting project launched by TerraCycle based on sustainability and reducing the carbon footprint in the UK. One of the products which I developed was the part of it. Loop by TerraCycle was based on the concept of using the product, returning the containers, and reusing the containers.
How did you get your first break?
My first break was through an industrial project in Glenmark Research Center through my senior Rohit Shirode. This was the breakthrough I needed to enter the industry and I took this golden opportunity very positively. This turned into a full-time job before my PhD.
What were some of the challenges you faced? How did you address them?
Adapting to the work culture was very difficult for me; since research work does not have time limits, sometimes I had to work more than 18 hours to meet the deadlines, and fortunately or unfortunately, I was working on a high priority project. So working continuously for more than 18 hours was very difficult for me. Sometimes we ate food late and sometimes we ate no food at night. But I was willing to learn and it was a great opportunity for me to work on such a project. If you are ready to do hard work, you will be happy to do work.
Adjusting with the professional culture was another challenge for me. I was exposed to only an academic background; I knew only about academic life. But I overcame this challenge by undergoing training on Professional Etiquettes and Behaviour. This helped me in building my confidence in handling professional situations.
Where do you work now? Tell us about your role
One fine day in 2019, I received a call for an international opportunity in research and development. I have always wanted to pursue an M.S. from foreign universities, but due to lack of finances and proper guidance, I was not able to apply to foreign universities. After an interview and completing the formalities, I got recruited and received a visa for Hong Kong in 2019. Since then, I have been working in Hong Kong as a Formulation Development Scientist in Bright Future Pharmaceuticals Lab Ltd. Adjusting to the new culture in a new organization is very difficult, especially with the Chinese companies as they don’t prefer to talk in English and that’s the only language through which we can communicate with them. We need to be more proactive in planning and performing the work tasks.
What is your role as formulation development scientists?
Formulation scientists develop a drug product that may be in solid, liquid, or semisolid form such as a tablet, suspension, or cream. Basically, we convert the drug molecule into the form so that a suitable stable dosage can be easily administered to the patient to travel inside the patient’s body. The drug should be stable inside the product. We need to study the drug properties extensively to understand the drug behaviour in different chemical compositions and under different storage conditions. Based on drug molecule stability and the intended clinical action, we decide which formulation is suitable for the drug. Then we select the different chemicals called excipients or ingredients to stabilize the drug in the drug product. We study the stability of each chemical composition as per the ICH guidelines and select the stable formulation composition amongst them. The stable formulation is studied for the in-vitro models. Sometimes extensive animal studies also need to be done on actual animals such as rats, mice, rabbits, or pigs. What are the in-vitro models? In-vitro models are the tools through which we can create a similar condition like in our body, in the instrument artificially and complete testing. After doing the in-vitro studies, the study will be performed on actual human volunteers and the final formulation is selected. Then that will be transferred to the commercial production site. All the study data will be submitted to the drug regulatory agency of respective countries. After reviewing the data, if everything is okay, the regulatory authority will give the marketing authorization, and subsequently, it will be launched in the market.
The typical day will be like, coordinating project activities with cross functional teams, performing development activities in the lab, attending the project meetings, and planning future activities. Most of the time in a day will be spent in the lab with different activities. Sometimes, we also need to search literature extensively to resolve the issues associated with projects. It is always hard to coordinate with the cross functional teams and get the work done from them.
Tell us an example of a specific memorable work you did that is very close to you!
Developing products for the Indian market is closer to my heart because you can see the output of your work. I have developed one product for the Indian market and that was a transparent gel. When I was discussing with the supplier who had discovered these excipients, he told me that transparent gel with these excipients is not possible. But I made it possible with my efforts. This innovation was a bit challenging and I always like to take on challenges. I am always happy to stress myself to the extreme and achieve something which is difficult.
How does your work benefit society?
I personally feel I am in a noble profession of helping people who are suffering from pain or discomfort in life. The medicines either cure the pain or discomfort associated with the patients. Actually, medical practitioners get all the credit for their treatment but the ones who actually invented or manufactured the medicine, don’t get the right credit for the treatment from society. In Spite of this, we are bound to invent or manufacture medicine for the good of society.
Your advice to students based on your experience?
There is no alternative for hard work, of course. Though I believe in luck also, if you do the hard work, you will get the fruits one day. It might take a while, but you will definitely get it. Planning your future is the most important thing if you want to have a great future. It is better to plan everything in advance to execute in a better way. Though there may be some deviation, the goals should be fixed. Strong determination will lead to success.
I personally believe in learning; I have always wanted to learn things that will help me in building my future career. Recently, I have completed an executive MBA course through distance learning in Oct 2020. Now I got admitted for another course in Regulatory affairs, this will help increase my future opportunities for a higher position. Everybody should build their knowledge so they can grow in their career.
Forecasting is very important in the professional as well as personal life, this will lead to planning your life very well. Regarding future planning, I want to be a good leader in the pharmaceutical field. In order to achieve that vision, I have done my MBA, and now pursuing a course on Regulatory Affairs. I would also like to pursue a course in Intellectual property rights.