Patient Safety Physician, Metabolism

Looking Beyond Market Approval: 7 Questions with Catherine Alonzo

Catherine Alonzo, Patient Safety Physician, Metabolism, tells us about the importance of drug surveillance/monitoring after a drug has received marketing approval, and ensuring treatments are as safe as possible when they are ‘out in the wild’. 

How long have you been at Boehringer Ingelheim and what was your journey here?

I’ve been at Boehringer Ingelheim for six months – so I’m still quite new. Before working in Patient Safety, I worked as a urologist for 12 years. I loved helping patients, and I felt the change would allow me to keep making an impact, but in a broader way and completely new setting.

What do you do in your role?

I focus on products in Post Marketing. Essentially, my concentration is on medications that have already been approved for use by the respective regulatory bodies – such as the FDA in the US or EMA in the EU - and are on the market. Some of these drugs are involved in additional clinical trials to assess their use for new indications, to potentially expand treatment to include additional diseases and illnesses. A typical day for me includes analyzing data and gaining understanding of how people are responding to treatments in a real-world setting. This is following thorough investigation in the clinic for both efficacy and safety before market authorization is obtained. Essentially, we need to reinforce their safety and efficacy profiles and make sure they continue to be valuable tools in patient care.

Why is Post Marketing so important?

Post Marketing allows us to observe the safety of treatments in a larger population. While clinical trials in early development provide crucial safety data, they inevitably involve a smaller number of patients compared to the number of people using the drug after FDA approval. Post Marketing surveillance helps identify any previously unknown adverse events – usually rare side effects – and ensures that the benefits of the medication outweigh the risks for the broader population.

What is the biggest challenge you face in Post Marketing? 

The challenge lies in the scale of patients involved, as Post Marketing requires monitoring medications used by hundreds of thousands or even millions of people. This means we need to be incredibly vigilant in analyzing data and detecting any new adverse events that may not have been evident in smaller clinical trials. The reward is knowing that my work has a significant impact on further ensuring patient safety and wellbeing on a broader scale.

What do you enjoy most about your role as a safety physician? 

One of the things I really love about my role is that I’m constantly learning. I come across a different challenge every day, so I really get to put my medical knowledge to great use – all in the name of making an impact on patients’ lives. I also think the culture at Boehringer Ingelheim is great. There is so much respect and support between different colleagues from different fields, which is something I really appreciate.

Is there a lot of collaboration in your role?

Definitely. And one of the nice things about Boehringer Ingelheim is our global perspective. I have colleagues from all across the world and with broad professional backgrounds, and they all bring their own knowledge and ideas. Furthermore, different populations have different health profiles, so being mindful of specific market challenges is something we need to consider and work together on.

What’s next for Patient Safety?

As I’m new at Boehringer Ingelheim, my ‘what’s next’ is continuing to learn as much as I can. I’m looking forward to continuing my journey, taking on new challenges, and using all my medical knowledge to make sure treatments continue to be safe.