Charting a Trailblazing Path in Clinical Development

Maribelle Guloy is the Director of Clinical Development at American Regent, a company of Daiichi Sankyo. Before joining American Regent, Dr. Guloy held various full-time and consulting roles at CROs, pharmaceutical, and biotech companies, including Moderna.

Dr. Guloy is an active member of the professional community. She serves on the Advisory Board of the University of California, Irvine (UCI) Clinical Trials, Medical Device, and Drug Development program and UCI’s Beall Innovation program. She has also served on the Board of Directors for the Society of Clinical Research Associates, Inc.

Dr. Guloy earned her Doctor of Health Science in Global Health from Nova Southeastern University in Florida, her Master of Science in Health Science and Clinical Research Administration from George Washington University in Washington, DC, and her Bachelor of Science in Medical Technology from the University of Immaculate Conception in the Philippines.

From Milestones to Mastery

My journey in clinical development began in 2000 when I cofounded and managed an oncology-focused clinical research organization (CRO) for 16 years. Working in a smaller company provided me with the flexibility and opportunity to pursue my master’s and doctoral degrees, with a vision to transition into the clinical science and drug research & development space.

In 2007, I joined the University of California Irvine’s (UCI) Life Science and Engineering department as an Advisory Board member, a role that later expanded into being an Innovation Advisor within UCI’s Beall Applied Innovation program. I also served on the Board of Directors at the Society of Clinical Research Associates, Inc. My career has included leadership and consulting positions at various CROs, pharmaceutical, and biotech companies such as Moderna.

In 2022, I joined American Regent following its acquisition of HBT Labs, where I had been working. Each step in my career has built on the last, shaping my expertise and passion for advancing clinical development.

Overcoming Challenges for Sustainable Clinical Development

Clinical development is rife with challenges, including regulatory hurdles and recruitment difficulties, often leading to trial delays and increased costs. To address these obstacles, I prioritized close engagement with regulatory agencies to secure guidance and consensus on development plans. Taking clinical trials outside the U.S. with a well-structured outsourcing plan and robust quality oversight processes proved an effective strategy.

Clinical development is the backbone of translating research into treatments. By forging pathways for pipeline advancements, we contribute to transforming healthcare with innovative treatments that address unmet patient needs and enhance lives

Adapting to shifting roles posed another challenge. Portfolio gaps caused by patent expirations and stiff competition required our Clinical Development team to redefine its role. Beyond traditional functions like clinical evidence planning and trial execution, we began participating in pipeline development. This shift emphasized understanding the molecule’s science and clinical potential as a therapeutic option. Stepping out of our comfort zones, taking calculated risks, and collaborating with experts in chemistry, legal, regulatory, and commercial fields were key to navigating this evolution.

Enhancing Communication for Operational Efficiency

Effective communication is fundamental to operational success. It begins with a clear understanding of corporate goals and objectives, which are then conveyed with clarity to the Clinical Development project team. This ensures alignment, enabling project managers to plan and execute granular tasks synergistically, fostering a collaborative and efficient work environment.

Strategies for Efficient Clinical Data Management

High-quality data is essential for clinical development. It must meet protocol-specified parameters and regulatory requirements for accuracy and statistical analysis. Early partnerships with data analysts and the quantitative sciences team are critical to validate data management software, ensuring it automates data collection, validation, and analysis seamlessly. Robust training programs for data managers further ensure a thorough understanding of clinical trial processes and regulatory standards.

Ensuring Compliance Amid Regulatory Changes

Staying informed about regulatory updates is vital. I subscribe to regular alerts and attend conferences to remain abreast of developments in research and regulatory standards. Compliance requires a multidisciplinary approach, heavily involving quality, regulatory, and legal teams. Regular team training within Clinical Development ensures our practices evolve alongside regulatory changes, maintaining adherence and integrity.

Clinical development is the backbone of translating research into treatments. By forging pathways for pipeline advancements, we contribute to transforming healthcare with innovative treatments that address unmet patient needs and enhance lives.

Career Insights: Advice for Aspiring Professionals in Healthcare

The clinical development field offers a dynamic and fulfilling career for those eager to impact healthcare. My advice to young professionals is to find a niche where you can flourish and feel fulfilled. Once identified, carve a clear progression path, acquire the necessary skills, and work toward becoming an authority in your chosen area. Above all, maintain a strong moral compass, prioritizing patient safety and well-being in every decision.