SIFI

Laura Bonino

From Biotechnology Student to Clinical Development Leader

My background is in medical and molecular biotechnology, and my dream as a student was to work in a pharmaceutical company, helping patients struggling with incurable diseases. My first experience was in a preclinical lab at a dynamic startup in Milan, which focused on oncology studies. As soon as I was introduced to clinical research, I fell in love with the field and transitioned into clinical operations, working in oncology, respiratory diseases and now ophthalmology. I have worked in various roles in clinical research: first, as a Clinical Research Associate, then I began dealing with Clinical Trial Supplies, ensuring they matched the clinical study design, clinical operations needs and CMC constraints. Later, I took on the role of Clinical Project Manager, where I managed clinical studies and projects at different levels.

Understanding preclinical studies and CMC (Chemistry, Manufacturing, and Controls) activities, combined with strong experience in Clinical Operations, has enabled me to manage the Clinical Development department at SIFI SpA. The department is responsible for generating and disseminating clinical data and evidence with the aim of commercializing medical drugs and medical devices. We ensure that all studies and investigations are in compliance with GCP, applicable laws, high-quality standards and the company’s clinical strategy.

Maintaining Flexibility and Agility in Clinical Development

As a relatively small team, we strive to stay very flexible. We manage multiple clinical development programs, assigning priorities based on the company’s strategy. With smooth and linear company processes and agile resources, we can quickly assess and adjust priorities. Additionally, the Clinical Development department is transitioning to digital tools to streamline activities and enable faster priority shifts.

Navigating Regulatory Changes Across Regions

Ongoing training is crucial for our team. We continuously review and update guidelines to ensure our work remains compliant. We are also supported by Clinical Research Organizations (CROs) for the execution of each clinical study. Their knowledge of local guidelines helps us stay compliant with regulatory requirements, and we perform in-depth feasibility studies before starting any clinical trial.

Ensuring Compliance and Timelines

Compliance with regulations and quality is paramount for us, and it takes priority over project timelines. However, it’s equally important to adhere to study timelines. We typically analyze compliance requirements for each clinical study in advance and plan accordingly. Careful planning and feasibility are essential to avoid surprises during the trial. Unexpected events can jeopardize the study, so monitoring and preventing compliance issues is critical. This is achieved by creating a risk management plan for each study in collaboration with the CRO and sharing it with clinical sites, which are our partners in this process.

Moreover, we believe that training all resources on study procedures and compliance requirements is key to maintaining high-quality standards and enabling the team to identify compliance issues early. This is particularly important at SIFI, as our research spans pharmaceutical development—including rare diseases—and medical devices, where regulatory requirements can differ. Regular updates and collaboration with the CRO and colleagues are vital to ensuring compliance and quality.

Fostering Collaboration across Teams and Partners

Interdisciplinarity is essential in clinical development to ensure the successful execution of clinical studies. Stakeholders bring different perspectives valuable in setting proper endpoints, identifying the right clinical sites, ensuring data quality and protecting patient rights. Our internal stakeholders include preclinical, regulatory, pharmacovigilance and medical marketing teams, while external stakeholders include CROs, patients and investigators.

We ensure interdisciplinarity through regular meetings and continuous alignment with stakeholders, which allows for collaborative study design. This alignment must continue throughout the study to ensure the team remains focused on objectives and identifies solutions to any issues, such as compliance problems, slow enrollment or poor data quality.

For example, when conducting clinical investigations with implantable medical devices like intraocular lenses, one of the most critical aspects is identifying appropriate clinical sites. These investigations are time-intensive for investigators and patients, requiring extensive clinical assessments and long follow-up periods for long-term clinical evidence. Clinical sites must be prepared for these additional demands, with appropriate staff and equipment, and be committed to ensuring that patients remain in the study for over a year.

Training for medical device implantation is also an important part of the clinical investigation and usually requires multiple training sessions and hands-on coaching in the operating room. Each surgeon has a learning curve, which must be completed before starting the clinical investigation. In this regard, collaboration with the marketing department, clinical application specialists and the clinical CRO is crucial to ensuring the study's success.

The Role of Digital Health Technologies in Clinical Trials

Digital health technologies are increasingly becoming integral to clinical research, particularly with the growing use of artificial intelligence (AI) in research software. In the coming years, clinical trials will benefit from these technologies in several ways, such as enabling remote data capture, supporting decentralized trials and reducing patient burden. Secondary data usage is another area where digital technologies will have a significant impact. However, patient consent and the appropriate use of collected data must be carefully managed. The European Union is already working on European Data Spaces, with the first focused on health.

SIFI is also exploring digital health technologies, including a companion app for patients with Acanthamoeba and Fungal Keratitis. Additionally, SIFI has developed an AI-powered digital calculator to assist surgeons in selecting the correct intraocular lens power before cataract surgery.

Advice for Aspiring Clinical Development Professionals

The future of clinical development lies in collaboration between pharmaceutical companies, patients and health authorities to ensure data collection aligns with patients' real needs and focuses on the parameters that genuinely impact their health and well-being. Aspiring clinical research professionals will need to become familiar with AI and its applications, as well as the principles of risk-based evaluations.

I recommend continuing education, sharing ideas with preclinical departments to stay informed about emerging innovations and engaging with patients to ensure that new technologies and approaches address their real-world needs. Clinical research professionals must also remain flexible, combining the gold standard of randomized clinical trials with real-world data from healthcare providers and patients. This approach will provide evidence that is both rigorous and more representative of everyday experiences.