With our Congress in Barcelona mere days away we are glad to share another of our exclusive speaker interviews, this time with Dr Ruben Rizzi. Dr Rizzi will join us for two panels next week, so if you are going to be at the event do make sure you are attending his sessions. We are grateful for Dr Rizzi’s participation in this interview, which was conducted over email, and to his team for facilitating the conversation. 

Introducing Dr Rizzi 

Dr Rizzi joined BioNTech at the end of 2019 to start work on “investigational candidates in immuno-oncology and infectious diseases”.  

“Then the pandemic hit and for more than two years I have been fully involved as global regulatory lead for our COVID-19 vaccine jointly developed with Pfizer.”  

During this time, the regulatory team has grown, and “amazing colleagues” have taken over the “day-to-day lifecycle activities for the COVID-19 vaccine”.  

“Currently, as Vice President of Global Regulatory Affairs, I work with the regulatory teams supporting our pipeline projects and, with regards to our COVID-19 vaccine, post-approval activities and labelling.” 
“Our entire pipeline has grown and matured especially with regards to product candidates in oncology, and we are continuing to develop our organisation and our processes to ensure state-of-the-art regulatory support to our ambitious projects, to translate science into survival by developing novel immunotherapies.” 
The “future of vaccinology” 

Dr Rizzi’s first panel explores the “future of vaccinology” so we asked about the changes we can expect to see in the future, and how significant COVID-19 vaccines have been in driving them. 

“The COVID-19 vaccines have certainly been a turning point in different ways.” 

For example, Dr Rizzi highlights the “crucial experience for pandemic preparedness”, in a field where “hands-on experience is scarce and therefore valuable”.  

“Pandemic preparedness frameworks were already in place before the COVID-19 pandemic and were used to address the urgent need for medicinal products, tests, and interventions to curb the pandemic.”  

In the regulatory space, Dr Rizzi identifies “a number of tools” that were employed to “expedite the processes to develop products” without “cutting corners”. 

“The combination of these tools with newly available techniques, as well as the commitment from all stakeholders involved, have created the conditions for the unprecedented rapid development of COVID-19 vaccines.” 

For the future, Dr Rizzi suggests that “there is a lot we can learn from this experience” to “improve our pandemic preparedness frameworks”. COVID-19 vaccines “represented a turning point” in the “dawn of an innovative technology in the world of infectious disease vaccines”: mRNA. This has “proven to be well suited” because it “allows for the quick design of vaccine candidates” and “subsequent adaption” of such vaccines to emerging variants.  

“We will continue to further explore the potential of mRNA for other infectious disease indications, and beyond, for example in immuno-oncology where BioNTech initiated the first clinical trial ten years ago.”  
Regulatory expectations 

Dr Rizzi already touched on the regulatory scene during COVID-19, so we asked what expectations we might see as we move forward with other vaccines. He indicates that “we will observe the development of a more concise pandemic preparedness guidance” based on “lessons learned” during the pandemic. We will also see “new regulatory definitions”, such as around the “concept of platform technologies” to help make developments “more rapid and efficient” by “leveraging existing knowledge and avoiding repetition and redundancies”.  

WHO has already issued some “regulatory considerations” specific to the development of mRNA-based vaccines for infectious disease indications. Dr Rizzi believes that “in the coming months”, major regulators “might also issue specific guidance” to “harmonise requirements and address inconsistencies”. Finally, Dr Rizzi reflects that “we are closely monitoring the evolution of the regulatory landscape” for “in-vitro diagnostics and use of artificial intelligence and machine learning”.  

“These are areas of very active regulatory innovation with the potential to shape the future landscape for individualised therapies.”  
A post-pandemic path for mRNA 

Dr Rizzi’s second panel considers the “post-pandemic path” of mRNA vaccines, so we asked about how pandemic experience will inform non-pandemic practice, and what this “path” might look like. He states that “we will continue to advance our multiple mRNA developments in immuno-oncology and infectious diseases”.  

“Messenger RNA is a very flexible platform that can be used to express a number of antigens, and this gives it a unique potential to be used in multiple areas.” 

For Dr Rizzi, an “obvious next step” is the application of mRNA to prevent other infectious disease, especially those with “high unmet medical needs” where “preventative vaccines may not be broadly available”.  

“While all these developments are based on similar or identical platforms, they obviously represent different challenges, and I think in the next few years it will be exciting to see where mRNA will show the most encouraging results. There is real potential to revolutionise multiple therapeutic areas – it’s a privilege being part of this journey.” 
Why WVC? 

Our final question, as always, invites speakers to share their hopes for, and highlights of, the Congress. Dr Rizzi says “one thing I love” is the “opportunity to share our experience with others”. 

“In our day-to-day work we tend to focus on our specific roles within our organisations. The Congress serves as a reminder that we don’t do our work behind closed doors only but are also part of a vast community all working in the same field and sharing common goals; exchanging our results and ideas is what helps us grow and answer new questions.” 

Finally, as “relevant restrictions” wind down for many, Dr Rizzi looks forward to the “pleasure” of meeting with colleagues and friends in person! 

Thank you to Dr Rizzi and his team for working with us to bring you this content, which we hope you enjoyed. Don’t forget that it’s not too late to get your tickets for next week, but if you can’t join us do subscribe for more interviews with our experts.