Biogen

Giovanni Guzzo

Giovanni Guzzo is a clinical research leader, Sr. Clinical Country and Site Lead as an Associate Director at Biogen. With a PharmD, MSc and PhD in Pharmacokinetics and Bioequivalence, he brings deep scientific rigor and strategic insight to complex clinical trials. From site management to patient recruitment and regulatory strategy, Guzzo is known for delivering results that accelerate timelines, uphold compliance and enhance outcomes, driving innovation where it matters most at the patient level.

Through this interview, Guzzo highlights Brazil’s clinical research transformation through a new national law that streamlines approvals, enhances ethical oversight and expands trial access, especially for rare diseases. His work focuses on accelerating innovation, patient inclusion and global competitiveness.

Building Trust through Predictable Regulatory Timelines

Over a decade ago, I joined a collective effort to address a longstanding issue in Brazil’s clinical research landscape—the lack of regulatory predictability. Without defined timelines from the Ministry of Health or ethics committees, many promising global trials bypassed Brazil entirely. By the time protocols were approved here, recruitment had already closed elsewhere. This created a serious gap for patients in need, especially those with rare or advanced conditions who had no alternative treatment options.

Recognizing this challenge, stakeholders across the industry— pharmaceutical companies, CROs and investigators—formed a task force that laid the foundation for what would become a pivotal national law. In 2015, with the support of a visionary senator, Ana Amélia Lemos, we submitted the draft legislation. Although it took nearly nine years, the law was finally approved last year, bringing long-overdue clarity to timelines and responsibilities. Today, approval processes that took up to 12 months are expected to be completed in 4 months.

Streamlining Ethics Oversight and Enhancing National Governance

One of the most significant shifts introduced by the new law is the consolidation of ethical oversight. Previously, Brazil had two layers of ethical approval, one at the local committee level and another at the Central Ethics Committee, which often led to conflicting opinions and prolonged delays. This dual-review system made little sense in a process where ethical principles are universally defined.

The new framework eliminates the central review and empowers local ethics committees to independently oversee approvals, making the system faster and more coherent. To ensure national consistency and quality, the law established a new oversight institution responsible for training ethics committee members and ensuring their alignment with legal requirements. This single-layer model enhances efficiency and transparency, benefiting all stakeholders, especially patients.

Securing Post-Trial Access and Future Regulations

While the law introduced a five-year post-market authorization limit, the current president vetoed this provision. However, based on our ongoing conversations with members of Congress and the Senate, this veto was recently overturned, restoring the law’s original intention.

In parallel, we are working closely with the Ministry of Health to implement more than 35 supporting regulations outlined in the law. These include specifics like the composition of ethics committees, development plan requirements and documentation standards. We’ve already submitted our proposals and during the recent International Clinical Research Day in Congress, I had the opportunity to emphasize the urgency of publishing these regulations. With Brazil’s world-class professionals, diverse population and strong data quality, I truly believe we are entering a new era of clinical research—one where Brazil can be a global leader in trial innovation, patient access and scientific excellence.

Empowering Investigators and Expanding Research Access

Our updated clinical research law is visibly changing how pharmaceutical companies approach operations in Brazil. What used to be a fragmented industry is now coming together. We’re sharing knowledge, aligning efforts and strengthening our collective voice. That unity played a key role in getting this law passed and it’s now driving us toward a more competitive, collaborative and innovative research environment.

Today, Brazil contributes to only around two percent of global clinical trials, far below our potential. But in the next 24 months, I expect us to more than double that to five percent. That’s not just a statistic. It translates to roughly five billion real or about one billion U.S. dollars of investment per year in clinical research, technology and drug development within the country. And the trend is already visible.

Hiring is booming across the industry, which tells me companies are serious about building local trial capacity. New study sites emerge, and physicians proactively seek training in Good Clinical Practice to become investigators. There’s even a new national study site association mapping capability across Brazil—a clear sign of growing maturity and momentum.

But the impact goes beyond business. For many Brazilians relying on the public health system, access to care can take six months to a year for non-urgent issues. Clinical trials are starting to ease that burden by providing timely care to patients who would otherwise wait. It’s a win-win: patients receive early access to innovative treatments, and our healthcare system can reallocate capacity to those in greater need.

We’re also bringing new technologies into the country, supported by local clinical data that gives regulators and the Ministry of Health deeper insight into how Brazilian patients respond to these treatments. That builds confidence and ultimately accelerates access.

To me, this is more than regulatory reform. It’s a moment of transformation. Brazil is stepping into its rightful place in global research, and the momentum is only beginning.

Championing Rare Disease Research through Policy Partnerships

At Biogen and throughout my career in biotech, I’ve had the privilege of advancing innovation that directly improves patients’ lives. One of the most impactful efforts I’ve been part of recently is the movement to secure a stronger, clearer regulatory framework for clinical research in Brazil, especially in the area of rare diseases.

Over the past two years, I’ve worked closely with a congresswoman who leads Brazil’s parliamentary front on rare diseases. Federal Deputy Rosangela Moro’s commitment and advocacy were instrumental in building momentum for this legislation. Together with other pharma associations, we made the case for why rare disease research cannot wait and how regulatory clarity can accelerate access, innovation and global participation.

This wasn’t just policy work. It was a coordinated, cross-sector effort between industry leaders, medical communities and government allies. I’m proud that our work helped drive forward a law that now opens the door for Brazil to become a far more competitive and inclusive environment for clinical trials, especially in areas where patients are most underserved.