Women in STEM: Early Phase Drug Development

Dr. Maria de Miguel, MD, PhD, MBA, an oncologist and Director, Clinical Research for START Rioja, offers her perspective on the evolving landscape of early phase oncology drug development. With a decade of experience spanning phase 1 clinical trials, her expertise covers a broad spectrum of novel therapies, including immunotherapies, antibody drug conjugates (ADCs), and targeted therapies.

Regarding the industry's talent pipeline, Dr. de Miguel highlights the importance of education programs in the fields of science, technology, engineering, and mathematics (STEM) in building the confidence and critical thinking skills necessary to manage the uncertainties of scientific research.

According to Dr. de Miguel, although women constitute nearly half of the biomedical workforce, they occupy only 20–30% of leadership roles. She attributes part of this gap to a “natural pipeline effect” as more women have entered these fields relatively recently, but she stresses that STEM initiatives are vital for ensuring women progress into positions where their expertise and judgment can shape high-impact decisions.

In the specialized sectors of rare disease treatment and early drug development, Dr. de Miguel stresses that the contributions of women are essential. Because these areas often involve limited data and high ethical stakes, they require a blend of scientific rigor and clinical reality. Women in the field frequently bring a collaborative, patient-centered perspective that is indispensable when evidence is scarce and every decision is important.

Technological “revolutions” are impacting the pharmaceutical sector. Dr. de Miguel expresses significant enthusiasm for precision medicine and advanced biologics, specifically bispecific antibodies and ADCs. These clinical advancements are being matched by the implementation of more adaptive and clever trial designs that allow for better-informed decisions earlier in the development cycle, improving efficiency and reducing uncertainty to ensure meaningful therapies reach the market more rapidly.

About the speaker

Dr. Maria de Miguel is an oncologist and Director, Clinical Research at START Rioja. Dr. de Miguel is focused on establishing START Rioja as a regional hub for oncology research in northern Spain and expanding patient access to innovative treatments. Inspired by the collaborative efforts between specialized pharma teams, CROs, and clinical investigators, she emphasizes that thoughtful clinical decision-making remains the most powerful tool for impacting the trajectory of new treatment development.

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Hello, I'm Dr. Maria de Miguel. Thank you very much for having me today.

I am a medical oncologist specialized in early phase oncology drug development. Over the last decade, I have worked in phase one, first in human clinical trials, covering all novel cancer therapies, including immunotherapies, antibody drug conjugates, and targeted therapies.

I currently direct START Rioja, an early phase clinical trial unit within the public healthcare system in northern Spain. I'm very passionate of my work, which is beautiful at the intersection of clinical care, translational science, and execution of complex trials.

What are some of the benefits of STEM programs for girls in school? How do these programs translate to women building careers in the pharmaceutical industry?

STEM programs are about building skills and confidence. They help all the students to learn how to think critically, solve problems, and work with uncertainty, which are abilities that are essential in science.

In biomedical and health science, women represent close to half of the workforce. However, we only account for 20–30% of leadership roles, and these rates drop significantly when we talk about other STEM fields.

Part of this reflects, in my opinion, a natural pipeline effect, as large numbers of women have entered these fields relatively recently, thanks to these kind of programs, among other factors, and some might relate also to differences in career interests.

So, to me, what really matters is that STEM programs give girls the tools and confidence not only to enter scientific careers, but also to progress into positions where their expertise and judgment shape high-impact decisions, including my field, early phase, drug development.

How do women working in STEM fields uniquely contribute to areas such as rare disease treatment development?

So, in rare diseases and early drug development, decisions are often made by limited data and a high responsibility toward patients. What matters most in this context is careful judgment, collaboration, and a strong patient-centred perspective.

So many women bring a way of working that integrates scientific rigor with clinical reality, which is particularly valuable when evidence is scarce and every decision carries an ethical weight. In this setting, the role of women is essential.

What exciting innovations do you see on the horizon for the pharmaceutical industry?

Nowadays, we are very excited to see many different revolutions in cancer therapy, from precision medicine to advanced biologics, such as bispecific antibodies and antibody drug conjugates, and this is coming all along to more adaptive and clever trial designs.

These advances allow us to make better-informed decisions earlier in development, improving efficiency while deepening biological understanding. The goal is not only to move faster, but to develop smarter by reducing uncertainty and increasing the likelihood that meaningful therapies reach patients.

All of these have translated into significant achievements in cancer treatment during the last years and many, many drug approvals throughout my career.

Who are you inspired by in the pharmaceutical industry?

I have been very lucky to work alongside a wide range of professionals who are deeply committed to advancing oncology research. This includes very early career oncologists asking sharp, relevant scientific questions, as well as internationally recognized leaders, men and women, in the field whose experience has really shaped the way we think about cancer today.

But I'm also inspired by progress driven by the pharmaceutical industry and CROs, where highly specialized teams can translate very complex science into viable clinical development programs. And I think that we all have in common the love for science and belief in having fruitful discussions to push the field forward for our patients.

What are you currently working on that you are passionate about?

I'm currently focused on consolidating START Rioja as a regional hub for oncology research, expanding access to innovative therapies for patients across all the north part of Spain.

Of course, I remain deeply involved in early drug development as a principal investigator because I really think that thoughtful clinical decision-making can have a real impact on how new treatments are developed.