Increasing the Odds – Regulatory as a Strategic Business Partner

A Conversation with Daniela Drago, Chief Regulatory Officer

“People have infinite capacity for learning,” declares Daniela Drago, midway through our interview. “So the goal is to find ways to inspire and challenge them to do so.” 

It’s an apt description of her own career trajectory. Daniela has challenged herself in numerous (and diverse) educational and professional settings, starting with her completion of a PhD program in chemistry at the prestigious Swiss Federal Institute of Technology (ETH), then pursuing a career that spans industry (Biogen, Roche, Vifor Pharma, Bausch & Lomb), consulting (NDA Partners), and academia (George Washington University’s School of Medicine and Health Sciences). 

Aurion Biotech is her latest challenge. “What’s exciting is that the cell therapy space is really flourishing,” Daniela says. “In recent years, we have witnessed incredible advances. However, periods of rapid growth and progress are often accompanied by challenges created by gains in scientific knowledge and evolving regulatory frameworks. These changes can have the greatest impact on first-movers.” It’s why she serves on the Regulatory Affairs Committee of the American Society of Gene and Cell Therapy (ASGCT). “We all benefit by sharing knowledge as this field grows so quickly.” 

What kind of skill and expertise is needed in the regulatory role? It’s a seemingly impossible-to-find combination of deep scientific knowledge, a nuanced understanding of the unique complexities of each regulatory authority throughout the world, endless patience, a lawyer-like ability to consume and digest reams of complex compliance documentation, and effective communication. Daniela credits her scientific background as the foundation for her own accomplishments. “I believe it might be easier to teach law to a scientist than science to a lawyer!” From our perspective, both seem daunting.

In conversation, Daniela is at once spontaneous and quick to laugh, but also thoughtful and deliberate in choosing her words. And word choice, communication in general, is one of her “superpowers” – in multiple languages. She speaks Italian (her native language), German (her husband’s native language, and what is spoken at home with their son), and English (the language of her country of residence). Daniela is continuously (and literally) translating ideas into the right words.  

Communication is an essential component of success in regulatory affairs. “At Biogen, I was used to explaining things to people on my team who were other subject matter experts. Here at Aurion Biotech, I enjoy the challenge of learning how to communicate differently, because not everyone is familiar with regulatory jargon.” 

That same “translation” skill is essential to effective interactions with colleagues and regulators. “As Sarah Michael said recently, the goal is always getting someone from ‘no’ to ‘know,’” Daniela says. As chief regulatory officer, what does this mean? It’s about helping others understand the context – of a policy, a regulatory application, or a regulator’s feedback – in order to move forward with knowledge and confidence.  

Why did Daniela decide to join Aurion Biotech? “I love the company’s mission. From my previous experiences in ophthalmology, I know how inspiring and rewarding it is to work on projects that help people to regain their vision.”

What about the challenges Daniela faces at Aurion Biotech? She laughs. “I love getting into the trenches and building something from the ground up,” she says. “We have a lot of work to do, but long ago I realized that to succeed, a company needs three things – great science, great people, and great investors.” 

Fortunately for Aurion Biotech, we have all three ingredients for success.