BeiGene

Stefano Ferrara is a seasoned and versatile professional with extensive experience in the clinical science sector. He has expertise in executing strategic clinical approaches for the global clinical development of products. He has worked with several reputed companies across Europe including Celgene Corp, Novartis Pharma, Sanofi-Aventis, and Schering.

In an exclusive interview with Pharma Tech Outlook Europe, Ferrara shared his invaluable insights regarding the future of the industry, the ensuing challenges and the possible solution.

Could you provide a brief overview of your journey as a thought leader in the clinical sciences space as well as your current roles and responsibilities?

My first major experience was at the Georgetown Cancer Centre, Washington D.C, where I completed a fellowship 20 years ago. It was during my stay there that I developed an interest in oncology, especially clinical development in oncology. After returning to Italy, I worked for several companies and later moved to Switzerland to work at Novartis.  However, I resigned Novartis to work in a smaller company since I believe that smaller organisations can make a bigger impact and operate more efficiently than big corporations. In 2010, I joined Celgene and worked there until it was acquired by BMS, and hereupon shifted to a small biotech firm. However, I realized I was not able to make any noteworthy difference through my work there, which eventually led me to move to BeiGene, where I am currently working on a phase-three study in hematology.

What valuable lessons have you gained from your experiences in both academic and industry environments?

Learning as a process should be all-encompassing, which means that you should be able to acquire knowledge from all the occurrences around you, including both good experiences and mistakes.

In this regard, my experience working with big companies has proved to be valuable. This is primarily because dealing with the people involved and gaining insight into their various functions aids you in your work in clinical development. A leader in clinical development must have a thorough knowledge of all the other necessary functions ranging from cleanups to data management and dealing with investigators. The work in clinical development is not restricted to writing protocols and collecting data but also putting together the aforementioned functions. For instance, during my time in Novartis, I had the opportunity of getting involved and understanding all the aspects and functions of drug development within the organisation. 

The knowledge acquired from big companies can be used to drive the smaller companies in the right direction by bringing the culture of collaborative function, ensuring that the team works together. It is the clinical development that ultimately leads the organisational team, since the responsibility of delivering the results of a clinical trial rests with them. This makes it necessary that the other functions willingly accept the leadership of clinical development for the smooth functioning of the processes.

Implementing a culture of working together and collaborating in a smaller company is, undeniably, difficult, as people tend to be reluctant about changing their methods of working.  However, it is solely through cooperation can desirable results be obtained, and the clinical sciences space is no exception.

What, according to you are some of the prevailing challenges in the clinical sciences space today, and how do those impact the design execution and regulatory approval of clinical trials?

The first major prevailing challenge is the cost factor. Clinical development, trials, and drugs remain too expensive for the majority of the population to afford, and no suitable measures have been taken thus far to mitigate the issue. To give a personal example, I recently came across a gene treatment that is effective enough to eradicate the disease in just one shot, but it costs around 3 million dollars. Pharmacologists tend to justify these exorbitant prices by pointing out that the cost of patient care happens to be significantly more than that of the drug. The second challenge is one concerning the great deal of time it takes for new drugs to reach the point where you have all the necessary data needed to send them to the approval stage. It takes a considerable amount of time to activate a trial and enroll the patient, and the situation has remained largely unchanged in the last 50 years.

“The research and studies on new drug development should proceed with a clinical and scientific rationale for the benefit of the patients without being solely preoccupied with commercial interests.” 

Consequently, there is a requirement to not only reduce the cost of life-saving drugs but also streamline the approval process to make them readily available. This is particularly relevant in light of the fact that as the age of the general population increases, a spike would also be observed in diseases and the number of people being affected. The research and studies on new drug development should proceed with a clinical and scientific rationale for the benefit of the patients without being solely preoccupied with commercial interests.

What according to you are some of the latest technological advancements that you find promising in the clinical sciences field?

A recent development of paramount importance would be the ability to handle big data alongside advancements made in artificial intelligence (AI). The latest research indicates that AI has the capability of finding new antibiotics in 10 minutes. Many companies are already using algorithms to treat patients through the collection of vital patient data which the AI uses to suggest the best treatment and clinical trial. The same technology can also help identify people with a higher chance of developing cancer. A possible limitation of this AI technology is that the screening of the population might lead to the identification of people who are not likely to develop critical health issues, which would then entail unnecessary costs.

This technology remains a favorable option as it removes patients’ dependency on big hospitals, with even small hospitals having the capability of suggesting the best treatment and clinical trial. Given that a proper internet connection is the only requirement in this case, it can help people in developing countries in Africa and Asia in gaining access to clinical trials.

What would be your advice to fellow peers and aspiring individuals who want to pursue a career in the clinical and oncology space?

 The first step is to ascertain your motivation for working in oncology, which is certainly not the same for everyone. The motivating factor becomes crucial as it’s not a rewarding job, due to the high mortality rate at the end of clinical trials. For me personally, a major turning point was my work in pediatric cancer, where I realised that although we cannot save everyone, there are also those whom we can. In other kinds of cancer too, like pancreatic cancer, not every patient can be saved, but the number of those who can be saved is increasing steadily.

As a result, it is important to have this kind of motivation to contribute as part of a larger system, making a difference not in one day but gradually over a period of time. Likewise, it must be remembered that in this sector it takes a considerable amount of time before reaching any results.

At the same time, one must be curious about the various related aspects of clinical development and work towards gaining knowledge in these areas.