Exact Sciences

Federica Rebagliati

A seasoned and passionate professional with nearly two decades of experience in the healthcare industry and compliance, Federica Rebagliati, is an accomplished leader renowned for her strategic acumen and adept management of intricate projects. Her distinct skill set encompasses medical affairs, marketing, market access, compliance, and patient advocacy, showcasing a robust background. Rebagliati’s keen eye for risk assessment, creative and analytical approach, and organizational mindset, consistently deliver innovative solutions through end-to-end project management. Her perseverance in facing challenges, commitment to surpassing average expectations, and desire for continuous self-improvement further define Rebagliati’s professional character. Currently, she serves as Sr. Compliance Manager, International at Exact Sciences.

Please share with our readers your career journey.

I have a solid background of almost two decades in the healthcare sector, primarily in the pharmaceutical industry. And recently I have transitioned into the medical devices arena. Throughout this two-decade journey, I have served in various roles across different functions, including medical operations, marketing operations, patient advocacy, and market access. This diverse experience has provided me with a comprehensive understanding of the business, offering insights into the practical realities of the healthcare world. In my previous company, my varied background caught the attention of the compliance team. Recognizing my background in business as well as having a heterogeneous yet authentic understanding of the industry, I became a bridge between compliance and the business, ensuring effective communication and collaboration. This distinct background in various arenas took me to the realm of compliance.

Can you share some of the challenges you notice in the industry?

In my experience, around a decade ago, engaging with the compliance manager was often accompanied by fear – fear of judgment, and fear of making mistakes. However, the dynamics have significantly evolved since then. Compliance has transitioned into a more collaborative role, serving as a partner that fosters an increased dialogue between compliance and the business. It is no longer someone to be feared rather it is someone that helps build business. The key challenge, as I see it, arises when there is a lack of trust between the business and compliance. Without trust, meaningful dialogue becomes difficult, impeding the development of a true partnership. Building a culture of trust and compliance within the company is crucial to establishing a positive relationship.

Could you explain how you approach a new business with a new initiative?

I believe trust is a significant factor in a business and so I encourage business owners to share details about their initiatives, even in their early stages when they might be embryonic and not fully defined. We begin with understanding needs, objectives, and key performance indicators. During the discussion, we create a space for an open dialogue about the genuine needs they aim to address.

It is more of a brainstorming session where I constructively challenge the idea, not the individual. The intent is never to hinder the initiative but to guarantee that the business owner has considered all aspects. Following this, we initiate a discussion to identify potential operational, regulatory, and reputational risks associated with the initiative. Simultaneously, we engage in a cross-functional evaluation to outline a comprehensive mitigation plan. This cross-functional discussion is crucial for ensuring the business is approached in the right way.

How do you envision the future of this industry?

Compliance spans various domains, and I would delve into three key areas of focus. First, AI. Beyond the compliance perspective, the ethical implications of AI are profound and transformative in our lives.  Compliance plays a pivotal role in offering guidance on the development of AI tools. However, the crucial question at this point is which AI tools are ethically sustainable. Before delving into practical applications, it's imperative to thoroughly understand the ethical foundations of AI tools.

The second is cybersecurity which still remains a perpetual concern. Due to the ever-evolving landscape of technology, a continuous focus on it is necessary. As a result, being compliance professionals, our role is to proactively prevent data breaches, secure remote access to company systems, and safeguard data privacy and corporate security.

The third is corporate sustainability due diligence. It is our responsibility to recognize our individual and company's responsibilities both morally and legally to assess the impact we have on human rights and the environment.

What is your piece of advice to your fellow peers?

The compliance manager is the enabler that supports business in executing the right actions in the right manner. As a result, they must stay abreast of new trends, especially in the realm of digital activities. It's crucial to be consistently aligned to identify potential areas of non-compliance or ethical risks, enabling the evaluation of business operations and initiatives to assess and mitigate risks. In a nutshell, my advice to a colleague or someone entering the field of compliance is to avoid making assumptions. Instead, ask questions without preconceived judgments and listen attentively to the business needs without anticipating them. And at last, constructively challenge the ideas, but not the people.