Building better biologics and a stronger future for women in STEM

With nearly three decades of hands-on experience in biopharma, Dr Lidia Serina knows what it takes to turn an idea into an injectable therapy ready for the clinic. As Head of Development Services at Simtra BioPharma Solutions, she oversees the early development and process-building work that underpins sterile injectables and next-generation modalities like antibody-drug conjugates (ADCs). From analytical strategy to process design and the delivery of Process Performance Qualification batches, her remit is to ensure every programme is built for clinical progress and long-term manufacturability.

Beyond the science, Serina is committed to creating environments that support and retain women in STEM. Her own path started with a self-driven internship at the Pasteur Institute and progressed through leadership roles across major pharmaceutical and biotech companies. It’s a journey that highlights both her technical depth and the determination required to rise in a field where women remain under-represented at senior levels.

Serina brings a clear view of what the sector needs: tighter development frameworks and workplaces where more scientists, including women, can thrive.

From early research training to industry leadership

Serina’s scientific motivation began early. “From a young age, I believed that biological science – understanding how the body works, what causes disease and innovating meaningful therapies – offered me a path toward making a difference in the world and improving people’s lives.”

Her decision to pursue a PhD at the Pasteur Institute was driven by that same motivation, but she recognised the challenge of entry into one of the world’s most competitive research centres. Rather than waiting for an opportunity, she created one. “I sent a letter to every unit within the organisation offering to volunteer as an intern the year prior to my doctoral work. I received only one positive response, but it was all I needed to embark on the journey I wanted to take.”

That experience set the tone for a career built on determination and proactive steps. It taught her self-reliance, resilience and the importance of cultivating strong networks. These lessons guided her through roles at GSK, Sanofi Pasteur, Lonza and emerging biotech companies before joining Simtra.

“I’ve spent nearly 30 years in the biopharmaceutical industry and have had the opportunity to work with large pharmaceutical companies, as well as smaller biotechnology companies. These experiences enable me to provide value to our clients, as I have first-hand knowledge of their needs, concerns and priorities.”

The expanding opportunity of ADCs

One area Serina finds especially compelling is the rapid advance of ADC science. “I find it remarkable that science continues to provide new insights into how the human body functions. These insights are the foundation for transformative therapies, such as ADCs, that leverage the specificity of the adaptive immune system to enable therapies that mimic immune function but improve safety, efficacy and outcomes.”

What makes ADCs so powerful also makes them complex. They combine biologic and small-molecule components that behave differently and require careful optimisation. “The biggest challenge is the complexity of ADC molecules,” Serina explains. “ADCs comprise a biologic component (the antibody) and a small molecule component (the drug), and these components have different properties that need to be considered and balanced to develop an optimised formulation and manufacturing process.”

Each ADC is essentially its own unique entity. Antibodies may be mono-specific, bi-specific or tri-specific. Payloads are often cytotoxic and require specialised handling. Approximately 90 percent of ADCs are produced as lyophilised powders, adding significant process considerations related to energy use, stability and cost.

“I believe that Simtra is uniquely positioned to address these challenges because we have expertise in lyophilised formulations and process development science as well as in the underlying biology of ADCs.”

Why early formulation strategy matters

In the rush toward first-in-human studies, early development steps can sometimes be under-resourced. Serina argues that this is a mistake, especially for complex biologics. “The simple answer is that there are no shortcuts in ADC development. Early investment in optimising formulation and process development can reduce time and cost to reach the market. Plus, this can also enable final product attributes that position the ADC for commercial success.”

Changing formulation or process design once a product is already in the clinic is costly and disruptive. Simtra’s approach is to work backward from the desired product profile. “Whether the client wants a liquid or lyophilised product, starting with the end goal in mind allows a streamlined process that will support early development, late-stage trials and commercial success.”

For emerging biopharma companies, the stakes are particularly high. Early choices influence regulatory readiness, manufacturability, pricing and long-term viability. The advice is invest early, plan strategically and build a foundation that supports clinical and commercial success.

Creating environments where women can thrive in STEM

While Serina’s technical leadership is central to her role, she is equally committed to championing women in science and engineering. Her perspective is shaped by years spent in male-dominated rooms. “Unfortunately, we are still in an environment in which the higher you move up the corporate ladder, the fewer women you are likely to encounter. I’ve spent many years being the only woman or one of only two women in a room full of men.”

These experiences shaped her understanding of the challenges women face. “I’ve also been told on many occasions that this is not about emotions – it is about facts, data and business. You need to be tougher. Even today, the business world tends to put women in the category of not knowing enough and being too emotional.”

Her response has been to cultivate confidence without compromising values. “The bigger challenge is finding the path to your goal that allows you to arrive there with humanity intact and, hopefully, allows others to follow in your footsteps.”

At Simtra, Serina emphasises authenticity, safety and mentorship. “Fostering an environment that empowers women to thrive in STEM comes down to creating spaces where women are comfortable being their authentic selves and have the confidence to ask questions without having to worry that seeking knowledge will be viewed as a sign of ignorance.”

Simtra also supports structural initiatives, including women’s affinity groups and a programme where high-school students shadow women scientists in the company’s Bloomington labs. “We believe that empowering women to thrive in STEM means encouraging and supporting the next generation of women scientists.”

Advice for the next generation of women scientists

Serina’s message for young women entering STEM is clear and practical. “Learning is a continuous process. Be curious and ask questions. If there’s a skill you want or need to acquire to advance to the next level, be proactive about learning it. Don’t wait for things to happen – make a plan to reach your goals.”

She also stresses the importance of choosing environments that align with personal values, seeing failures as lessons and cultivating a strong support network. Her advice is rooted in experience: “Every time you walk into a room with the belief that you have earned the right to be there, your self-confidence will increase.”

On the industry level, she would like to see a shift away from rewarding self-promotion over competence. “Too often, it’s the loudest voice that gets heard while the person who is quietly executing on her responsibilities is overlooked.”

Better recognition, she argues, benefits both individuals and the industry as a whole. “Managers need to do a better job of understanding the contributions that each individual makes and reward people based on those contributions rather than rhetoric.”

A career defined by purpose

Across her work in ADC development, process innovation and scientific leadership, Lidia Serina’s focus remains consistent: making a meaningful difference in patients’ lives and creating opportunities for others to do the same.

“This was, is, and will continue to be my credo.”