Empowering women in STEM: Navigating CMC regulatory affairs

Dr Lopa Bakrania brings over 18 years of experience in pharmaceutical process chemistry and CMC regulatory affairs. As Executive Director of CMC Regulatory Affairs at Biohaven, she leads efforts to develop innovative therapies from the clinic to market approval. Throughout her career, Bakrania has held pivotal roles at renowned companies, including Biohaven, where she contributed to the development of therapies, such as migraine treatment Nurtec^® ODT. Her expertise in regulatory strategy and process development has been instrumental in advancing important treatments.

As a woman in STEM, Bakrania is deeply committed to addressing the barriers faced by women in the field and inspiring the next generation of scientists. In addition to her industry leadership, she serves as an adjunct professor at Rowan University and is actively involved in the Regulatory Affairs Professionals Society (RAPS). In this Q&A, Bakrania reflects on her personal journey in STEM, shares insights into her work at Biohaven, and discusses the evolving landscape of drug discovery and regulatory practices.

Can you share your journey in STEM and any challenges you faced along the way?

My journey started when I was a young girl interested in science. Growing up in Tanzania, there were cultural obstacles that made it challenging for women to pursue an education. My parents supported my dream and made it easier for me to believe it. I studied hard and ultimately earned a scholarship to attend Connecticut College in the US. This was a turning point in my life. Leaving Tanzania for America felt like stepping into a whole new world – one that was both exciting and overwhelming. Communication was challenging at the time; weeks would pass before I could afford a calling card to check in with my parents and let them know I was okay. To make ends meet, I worked 30 hours a week while managing my studies, an experience that shaped my resilience and determination.

After earning my undergraduate degree from Connecticut College, followed by a PhD in organic chemistry from the University of Michigan, I landed a position as a researcher at a large biopharmaceutical company. When I joined, I was one of only five women on a team of 150 men. This was a stark reminder of the gender disparity in STEM, but I saw it as an opportunity to pave my own way.

One of the most defining moments of my career came during my first pregnancy. Determined to ensure my safety and the safety of my baby, I advocated for conducting experiments in a glove box – a sealed environment that protected me from hazardous materials. The treatment I worked on during that time is now commercially available, and having my name on the patent is something I’m incredibly proud of.

Looking back, my journey in STEM has been about more than just science – it’s been about persistence, self-advocacy and pushing boundaries. Each challenge, whether cultural, financial or professional, has strengthened my resolve to keep moving forward and to create space for others to do the same.

Can you highlight a specific project you’ve worked on and its impact in your field?

One of the most rewarding projects I’ve worked on at Biohaven was Nurtec ODT (rimegepant), our groundbreaking migraine drug that was later acquired by Pfizer. From the preclinical phase through to commercial launch, I was deeply involved in shaping its development and regulatory strategy.

What made this project especially fulfilling was witnessing the profound impact it had on people living with the debilitating effects of migraine. Hearing stories from patients who could finally reclaim their daily lives underscored the importance of our work. This experience reaffirmed my commitment to advancing therapies that transformed lives and highlighted the critical role of effective cross-functional collaborations, including with regulatory agencies, in bringing innovative medicines to market.

What future applications or innovations do you foresee from your work?

As head of CMC Regulatory, I have the privilege of working at the intersection of science, strategy and compliance, ensuring that groundbreaking therapies reach patients efficiently and safely. The future of CMC lies in embracing more agile, science-driven approaches to drug development and manufacturing.

As therapies like peptides and antibody-drug conjugates grow more complex, there is an increasing need for strategies that not only align with evolving regulatory expectations but also allow for flexibility. Establishing clear yet adaptable control strategies early in development is key to reducing delays while maintaining the highest quality standards as programmes progress.

Looking ahead, I foresee a significant shift towards fostering deeper collaborations with regulatory agencies. By engaging in open, proactive dialogue and emphasising science-driven decisions, we can shape a regulatory framework that not only supports innovation but actively encourages it. Ultimately, my focus is on creating an environment where flexibility, collaboration and innovation drive the successful delivery of cutting-edge treatments to patients, transforming lives and advancing the boundaries of medicine.

On March 8th, 2025, International Women’s Day, we celebrate the achievements of women in STEM, including leaders like Dr Lopa Bakrania, who are advancing pharmaceutical research and regulatory science.

What unique strengths do you bring to your role as a woman in STEM?

One of my greatest strengths is my passion for science and my dedication to making a meaningful impact on people’s lives through discovery and research. At Biohaven, this passion fuels everything I accomplish.

As a woman in STEM, I bring a unique perspective that allows me to understand and help address the barriers others may face in this field. I am deeply committed to empowering women and children to pursue STEM careers. For example, through my role as a career consultant for the American Chemical Society (ACS), I’ve worked to connect women in STEM with mentors who can guide them through their careers. I’ve also supported workshops that help educators recognise subconscious biases against women in engineering, creating a more inclusive environment.

In addition, I strive to ignite curiosity about STEM in the next generation. I authored a children’s book about a magical doll that performs science experiments, making science engaging and accessible. I’ve also conducted workshops in schools, teaching children how to use everyday items to explore scientific principles. These efforts aim to inspire others and broaden access to the exciting world of STEM.

What advice would you give to young women considering a career in STEM?

My advice to young women is to embrace the evolving nature of a STEM career. A career isn’t limited to what you start with or what fits within a nine-to-five day – it’s about what you choose to contribute and how you grow over time.

Throughout my journey, I’ve learned the importance of mentorship and representation. Women in STEM need role models to show them what is possible. That’s why I’m committed to paying it forward. I started mentoring through the ACS to help women find guidance and support.

For young girls, I aim to make science accessible and fun. When my daughter began kindergarten, I visited her classroom to conduct simple chemistry experiments with household items. Seeing children’s faces light up with curiosity reaffirmed my belief in the power of early exposure. Whether through my work at Biohaven, my mentoring efforts, or my outreach to inspire children, my mission is to show that science is not only a rewarding career but also a platform to make a real-world impact.

How have you seen the representation of women in STEM change, and what more needs to be done?

Over the years, I’ve seen encouraging progress in the representation of women in STEM, but more is needed to ensure equity and inclusion. My role at Biohaven has given me the opportunity to use my voice to advocate for meaningful change.

One memorable example occurred during my visit to our major supplier in India. I was disappointed, though not surprised, to see very few women represented in their workforce. I spoke with their CSO about the opportunities I’ve had at Biohaven and the importance of building pathways for women in STEM. I was thrilled to see the company take actionable steps a few months later, marking International Women’s Day by launching a referral programme to recruit more women and a volunteer initiative promoting STEM education in local middle schools. I also worked with their CEO to involve local women in encouraging their daughters to consider careers at the company.

While efforts like these are promising, more needs to be done to build a stronger foundation that makes women and girls feel comfortable, confident and empowered to thrive in STEM roles. It’s about creating supportive environments, addressing unconscious biases, and ensuring equal access to education and opportunities.

What can organisations do to create a more inclusive environment for women in STEM?

Organisations can foster inclusivity by creating an environment where all employees feel empowered to grow and contribute. Biohaven exemplifies this by encouraging employees to find their unique niche and build on the skills they are passionate about. This sense of autonomy not only helps individuals excel but also creates a culture of trust and respect.

Additionally, Biohaven’s commitment to offering opportunities beyond traditional roles has played a pivotal role in shaping me as a leader. Encouraging employees to engage in initiatives outside the office, such as mentorship programmes or community outreach, allows them to develop new perspectives, build diverse skills, and make a broader impact.

Organisations must also take proactive steps to identify and address systemic barriers, ensure equitable access to opportunities, and promote diversity in leadership roles. By doing so, they can create an environment where women in STEM can thrive, contribute meaningfully and feel supported throughout their careers.

What developments in biotechnology excite you, and how do you see yourself contributing to them?

The field of biotechnology is evolving at an extraordinary pace, and the potential for transformative breakthroughs has never been greater. What excites me most is the progress in advanced therapeutic modalities such as antibody-drug conjugates and biconjugates. These innovations are pushing the boundaries of what we can achieve in targeted treatments, offering hope for conditions that were once considered untreatable.

At Biohaven, I am fortunate to play a pivotal role in advancing these technologies through regulatory strategy and innovative problem-solving. For example, I have contributed to creating unique filing strategies for complex molecules, anticipating potential challenges, and streamlining development pathways. This ensures that life-changing therapies reach patients as quickly and safely as possible.

Looking ahead, I see myself contributing by fostering collaboration between multidisciplinary teams, leveraging my expertise to navigate regulatory landscapes, and continuing to champion innovation. Beyond my role at Biohaven, I am passionate about mentoring the next generation of scientists to help bridge the gap between discovery and application. By sharing my knowledge and experience, I hope to inspire others to embrace the possibilities biotechnology offers and to contribute to shaping a future where cutting-edge therapies are accessible to all who need them.