From start-up to staple: meet the co-founder of Assurea

Written by RegMedNet

To celebrate International Women’s Day (8 March) and acknowledge the often challenging career path taken by women in science we spoke to Tanya Sharma, co-founder of Assurea LLC (NC, USA) about  her inspirations as a woman in science, the resources and mentors she draws upon to support her career development andd how learning from her mentors helped Assurea find and fill an unmet need in the market.


Tanya Sharma
Co-founder of Assurea LLC (NC, USA)

Assurea is a boutique quality compliance consulting firm that serves as a quality and computer system validation delivery partner for fast-growing biotech and pharmaceutical clients. Tanya’s expertise is in digital transformation and computer system validation for emerging technologies platforms and novel technologies. She is one of the contributing authors for the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) and is active in the blockchain special interest group. She is a former steering committee member for ISPE Women in Pharma and continues to be involved in empowering women in biotech by leading efforts for Assurea’s campaign, #rootingforyou.

What are you most proud of in your career?
I’m most proud of being a minority woman entrepreneur in STEM and building my company, Assurea, which supports biotech and emerging technologies in quality, IT and computer system validation services. It’s a great feeling to be able to make an impact in such a meaningful way and to grow Assurea and our team. I could not have imagined any of this at all and it makes me very proud that, along with many others, we are setting an example for the next generation of Women in STEM!
What resources/networks have you found useful in your career, particularly as a woman in science?
I started Assurea with my co-founder, Krisha Patel. Being in our late 20s with a few years of work experience and having limited exposure to decision-makers in the biotech industry were some of the elements that were challenging to navigate at the beginning of our journey. Through our involvement in the International Society of Pharmaceutical Engineering (IPSE) and the Advanced Therapies Conferences run by Phacilitate (London, UK), we gained confidence, mentorship and a support system that truly continues to empower and inspire us as we navigate the journey of being a startup. There were many conversations and shared perspectives that were key turning points for our growth as individuals and leaders, and for building our brand.

A few communities that I found useful as a woman in science and would like to share are the following:
1. ISPE Women in Pharma
2. Women in Advanced Therapies by Phacilitate
3. The CGT Circle LinkedIn Group
4. Rootingforyou Campaign by Assurea

Do you have any advice for young women in science, technology, engineering and mathematics (STEM)?
I encourage women in science to bring forward their ideas, self-promote and promote others around them. It is very important for women to be in a positive space where they can share their viewpoints and be heard. If you want to explore a new field or an area, I would encourage joining a community of practice. I was always curious about use cases for blockchain technology within healthcare, therefore I joined the Blockchain Special Interest Group in ISPE to learn more. Being part of this group and learning from my mentors, Jamey Canterbury and James Gannon, Assurea was able to find an unmet need in the market – validation of blockchain platforms. Through many months of learning, sharing our idea with blockchain leaders in the industry and combining it with our existing knowledge about validation, we were able to add blockchain validation services to our portfolio. Fast forward to now, we are the Quality unit of a leading blockchain platform, Hataali by ATMPS Ltd (London, UK), and a member of the PharmaLedger consortium.
What are you most excited about in the years to come, especially around women in science?
I’m excited about a future (and I think that we are on our way) where we create an inclusive community that is rooting for women in STEM and where everyone is part of the conversation, not just women. By spreading awareness, being an ally and promoting women, we can shape a movement that encourages the important conversations we need to be having, such as increasing the percentage of women in STEM fields, fair maternity and paternity leave policies, lack of funding of women entrepreneurs and how to increase the number of women in the C-suite.
What inspires you as a woman in science?
My mom is a biology teacher and I’m really inspired by the STEM outreach programs that she has launched for her students. I have seen firsthand how impactful these educational programs have been for her students to learn more about the biotech and pharmaceutical industry. The students led a research study given by scientists in the field and just after 3 weeks, presented their results to their peers and the sponsors of the project. This experience motivated them to learn more about the life of a scientist and their educational backgrounds which helped them visualize what their life could be like as a scientist. I’m sharing this story because I think this type of atmosphere is what we need to encourage interest in STEM.

I also truly believe that being in STEM is now a cool thing and we can really see that with the peaked interest in science after the Covid-19 pandemic, the ‘steminist’ movement and Alie Hazelwood’s fiction romcom books based on STEM! We have encouraged more women through these mainstream engagements. Let’s continue to inspire young girls all over the world! The world is their oyster!