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Building a Biotechnology Business While Helping Women Shine

Tanya Sharma

August 17, 2023

10 Min Read



Women make up a significant percentage of the people who have established careers in the biopharmaceutical industry. However, the industry still needs to work toward creating equal representation in C-suite positions and helping women entrepreneurs start their companies. We also need to increase women’s overall representation among leading companies, with women sitting on boards of directors and making important decisions. We need to have more conversations about promoting women into leadership and positions of power.

It is hard to believe that the gender gap in science, technology, engineering, and mathematics (STEM) remains significant even in 2023, with women comprising only 28% of the STEM workforce (1). Researchers at the Massachusetts Institute of Technology (MIT) found that under 10% of 250 start-ups by MIT faculty were established by women, who make up 22% of the faculty. If men and women started companies at the same rate, then an estimated 40 more biotechnology companies would exist today (2). A separate study found that only 11% of start-ups spun out from Stanford University were started by women, who make up 25% of the faculty (3). I want to help build a movement that supports women in their efforts to broaden their opportunities and celebrate themselves along the way.

My Journey
My life has been spent adapting. I moved to the United States from India when I was only five years old. My mother made this difficult move as a single parent to pursue a better life for both of us even though it meant leaving her family, friends, and entire life as she knew it behind. She became a biology teacher, which inspired me to establish my own career in biotechnology. It is an important industry around the world. The people I’ve met in the industry, so many of whom have helped me progress, are dedicated and brilliant professionals who work hard to make the world a safer, healthier, better place. I’m grateful to be part of it.

I’ve been inspired by the STEM outreach programs that my mother has launched in her classes. I have seen firsthand how such educational programs help her students learn more about the biotechnology and pharmaceutical industries. Her students led a research study working with scientists in the field and presented their results to their peers and the sponsors of the project after just three weeks. That experience motivated participants to learn more about the lives and educational backgrounds of scientists, which helped the students imagine what their own lives could be like as scientists. That type of atmosphere is what we need to expand interest in STEM. A “STEMinist” movement has arisen to promote women in STEM based on rising interest in the industry that peaked during the COVID-19 pandemic. Let’s continue to inspire young girls all over the world.

As I grew older and more established in the life-science industry, I recognized unmet needs and decided to help provide solutions for companies. My cofounder, Krisha Patel, and I were in our late 20s when we started Assurea LLC, which now is going into its third year. I’m excited that we are growing and thriving, but it has taken hard work, time, and commitment to achieve our goals. Doing so depends on passion. Without passion, entrepreneurship is just a thought, not a dream realized. And it requires openness to learn new things continually. I feel that learning to trust my instincts was one of the most important lessons of all.

Follow Your Instincts: When we started the company, I was without a well-established network. Because we were doing something unique — and I believed strongly in the value of what we wanted to provide — we had to figure out how to do it. Through establishing the Assurea company and brand, we also had to learn how to promote ourselves — not an easy task and something that is not taught in school.

My first instinct was that the biopharmaceutical industry needed a new kind of consulting model for computer system validation (CSV) and implementing emerging technologies within fast-growing biotechnology companies. There was an unmet need to support companies moving quickly toward commercialization. In discussing our approach with potential clients, we learned that we were on the right track. They needed a long-term consulting model to help them scale up operations, and we found our niche there.

We understand the challenges that our clients face with setting up new processes and systems while moving fast. In this industry, CSV typically is a staffing concern, with digital-transformation projects contracted out to consulting firms. However, such projects are highly technical, with many dependencies and critical stage gates, necessitating a model that can deliver on holistic technical frameworks and executions while taking into account all the details and sequencing of actions.

For example, if more than 70 computerized systems need validation for a new manufacturing site in a short time frame, you need a consulting partnership that can bring the best talent, project management, and quality together. When startup companies are building their quality–compliance frameworks, they need guidance that complements their trajectory rather than complicates it. So Assurea serves as both a CSV and quality unit for fast-growing clients working on tight timelines.

In our service model, clients choose from a suite of core-plan frameworks or provide us with a scope of work for a “builder plan.” The former includes policies and procedures for quality management systems, with data-integrity training and supplier quality/audit support; the latter brings on Assurea as a CSV/quality unit to support critical validation projects and implementations. Having contributed to the development of industry guidances such as the “good automated manufacturing practice” (GAMP) guide, we understand complex regulations for new segments such as cell and gene therapy and decentralized manufacturing.

I also had to follow my instincts when people told me that I should “start small and local,” first growing the company in the United States before expanding to other countries. But I knew that our distinct business model was needed around the world, so I had to put aside those limiting opinions of what could be good for our company. We took a chance and trusted our instincts to do work in the United Kingdom for our first client. We did not define where we could and could not do business; instead, we went where our services were needed.

Celebrate Yourself: During Assurea’s first year, our three-person team would get together each Friday to discuss the proud moments we had experienced that week. Sometimes that felt like a silly exercise before we had any projects or paying clients, but we would be excited when a potential client responded to us or when we had an opportunity to present our services to someone. Even without any clients through our first six months, we celebrated every experience that was out of our comfort zone. This approach shaped our attitude of celebrating small wins, which in turn inspired our confidence about growing Assurea. The same holds true for our current team of more than 15 people. In our WhatsApp group called “The A Team,” we share accomplishments we are proud of — anything from a well-cooked dinner to a walk to work-related achievements. We have created a culture of celebration.

Becoming an entrepreneur is both scary and exciting, both challenging and rewarding. Silicon Valley’s Reid Hoffman (creator of LinkedIn) said that being an entrepreneur is like jumping off a cliff and building a plane on your way down: “Either you crash or take flight.”

Being a realist is important. Your ideas won’t be popular with everyone, and that is all right. You still have to take flight. Some people will be skeptical about your journey, and some people will be rooting for you — and you must remain open to both points of view. Use feedback from skeptics as inspiration for new ideas and new ways to see your projects; use others’ encouragement as fuel to keep going.

Helping Women Shine
Through my platform, I want to help other women broaden their beliefs about what is possible for their careers. There is still much work to be done across the biopharmaceutical industry and for women in particular. Other women can take lessons from my experience, and together we can build toolkits to help empower us all.

Important lessons that I have learned so far include the following:

• Trust your gut
• Join organizations, and find your tribe
• Don’t be afraid to scale up
• Reach out and use your network
• Practice self-promotion
• Make a folder of all the nice things people have said about you, and look through it when you need a boost of confidence
• Celebrate yourself every day by writing down something that you are proud of doing
• Stretch yourself beyond your comfort zone — e.g., by accepting speaking opportunities and joining the other women who are out there providing solutions and education to the industry
• Let such experiences foster your enthusiasm and passion toward accomplishing your dreams.

Assurea recently established a campaign called “RootingForYou” (RFY) to help support women in the industry (3). Our motto is, “We didn’t work this hard just to get this far and not celebrate.” We started this campaign early in 2023 to create a positive space for celebrating women’s accomplishments. We asked more than 100 women around the world what we could do to make a positive impact every day, and we kept hearing that we don’t celebrate ourselves enough. So our mission is to help women and underrepresented groups get credit for their innovative ideas.

Women are less likely than men to promote themselves. Through this campaign, we create a positive space for women to be celebrated and have a network of ambassadors who are rooting for them. Through RFY, we amplify stories from our ambassadors in a weekly series called “Show What’s Possible Because I’m Rooting for You.” That is part of our effort to move beyond limiting beliefs about what women can achieve. Hearing from role models about what things are possible is inspiring. We are also hosting “Celebrate Yourself” workshops, through which we share resources and tools to help participants celebrate themselves. This has become a movement and a network of women empowering each other to help shape the future of biotechnology.

Our RFY workshops focus on self-promotion, being an ally, and getting your vision out into the industry. Ambassadors are provided with tools to practice self-promotion and paired together to share encouraging messages on LinkedIn. This aspect of our campaign is unique, with real-time promotion and advocation of women and their accomplishments. Such sessions have received a great deal of positive feedback. In attending panel discussions and other events, some women might not know where to start; this campaign helps them gain comfort to promote themselves and celebrate their own accomplishments.

Along with the RFY campaign’s more than 100 ambassadors, Assurea recognizes the need to help women get what they need from themselves, their partners, and their employers. Many women ask, “Where do we go from here?” I think we need to provide space for others to promote their ideas, and that begins with each individual. Trust your gut, celebrate accomplishments both large and small, and support your friends and colleagues. Let’s work together to create a better place for us all.

1 MIT Faculty Founder Initiative. Massachusetts Institute of Technology: Cambridge, MA, 2023; https://entrepreneurship.mit.edu/faculty-founder-initiative/#:~:text=The%20MIT%20Faculty%20Founder%20Initiative,of%20MIT%20faculty%20are%20women.

2 Johnson CY. Bias in Biotech Funding Has Blocked Companies Led By Women. Washington Post 29 January 2020; https://www.washingtonpost.com/science/2020/01/29/bias-biotech-funding-has-blocked-women-led-companies.

3 Rooting For You. Assurea LLC: Raleigh, NC, 2023; https://assureallc.com/rootingforyou.

Tanya Sharma is cofounder and chief executive officer of Assurea LLC in Raleigh, NC; [email protected]; https://assureallc.com.

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