In business and in life, conversations – often the uncomfortable ones – open doors to understanding and progress.
When I first joined Roche, there was a point where I stopped telling people about my background as a good clinical practice (GCP) inspector and clinical trial assessor. You could feel colleagues tense up just hearing the words. At first, some even became cautious when talking to me before realising “Oh, she’s actually on our side.”
Yes, I was that person – a regulatory authority inspector. I can tell you, you're not the most popular person when you're in that role. But it's an important role.
After nearly two years at Roche, I can see how that experience helps me understand both sides and how to best increase the acceptance of innovative trial methods. There’s a perception in the biotech industry that regulatory authorities aren’t open to even discussing innovations. But that’s not the reality; health authorities are really open if there’s good science and rationale behind new thinking.
In my time at the regulatory authority, we were always giving people this message: come early to talk to us. Guidances are not written in stone, they can be broken if there is a scientific rationale, but first, we have to have the conversation. You have to say the “why” and we have to understand the rationale.
Especially since COVID-19, I hear over and over from teams I work with: “We never thought it would work, and the regulators accepted it!” “They helped us help them.” “We thought this would never be possible, and it got approved!” Or, “We got really good feedback from regulators on how we could make an innovative approach work.”
The point is, authorities can be really open and accepting, but teams often don’t expect that collaboration. Some even imagine they are working against them.
In fact, we are all focused on the same thing – patients – but we approach it from different perspectives.
One good example is the use of innovative technologies and how to increase patient centricity. Regulatory authorities and companies are both evaluating how they can use new technologies to become more efficient, and how they can be more patient focused. For authorities, it is about efficiency and patient focus in their decision making. And for companies, it’s about how to incorporate both in drug development.
Regulators’ jobs are to ensure patient safety, make sure drugs are made to the highest quality and have a positive benefit/risk ratio. Our job at Roche is to develop innovative molecules of those characteristics, in a safe way, and bring them to the patients as fast as possible. It’s not us vs. them. It’s: How do we work together to make sure we’re all doing what’s best for patients?
As an industry we have not been great at adopting new technologies and methodologies to improve the efficiency of how we conduct our clinical trials. But that is changing. And the pandemic is acting as a catalyst to multiply the adoption and show us the power of what is possible.
It is then up to companies to proactively reach out early to regulatory agencies to discuss the new, innovative approach. Sometimes companies push boundaries, and authorities may feel they are overdoing it. But I think for the most part, they will listen. So let's go and talk to them. Let's present our scientific rationale. Let’s have the discussion and face it on the facts. Let’s advance innovation together.
In the end, we’re not so different. We are all learning together. We all want what’s best for patients.
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