What was your biggest professional highlight of the past 12 months?
Having joined Hansa about 12 months ago as CEO with the goal of recapitalizing and turning the business around to ensure that we did all we could to bring our drug to patients in the US, I was delighted to have our US Phase 3 study read out with high statistical significance (p < 0.0001), enabling us to file a BLA with FDA shortly thereafter.
What is the biggest bottleneck slowing progress in drug development – and how do we fix it?
I believe that we need to get better at running clinical trials in a timely manner. This means looking further afield for patients, improving oversight of contract research organizations, and complementing that with internal resources where possible. I also think that there is quite a lot of improvement which could be made on the regulatory side. There has been long discussion about making it easier to bring drugs to market – however, in reality, there is little advancement. Conservatism, preference for written responses and rules driven decision-making still dominate. With fewer – and arguably more junior – resources at the FDA, this is concerning. How we address this, I am not sure.
What’s one widely held belief in your field that you disagree with – and why?
That “science always wins.” Many factors contribute to making a drug successful. This is often, but not always, driven by the best science. One should not underestimate the impact of informal networks, professional connections, resources and geography.
How can the pharmaceutical industry become more resilient in an increasingly uncertain world?
By becoming more transparent and placing greater emphasis on the value medicines provide relative to the overall cost of health care. Expanding geographically – even into lower-priced markets – will also strengthen resilience.
If you could introduce one policy change to accelerate progress in drug development, what would it be – and why?
I would reduce the regulatory focus on demanding a randomized trial in Phase 1/2 in rare diseases and make greater use of real-world evidence. We have learned so much over the past 30 years; we should use this knowledge more effectively. Phase 3 would still rely on randomized controlled trials.
What will look completely different about drug development in 10 years?
I hope regulatory review times will have fallen by around 30 percent. We will also be much better at predicting drug efficacy using real-world evidence, while AI will make clinical datasets more accessible and easier to analyze. Gene therapy will be more commonplace. We will be able to prevent more diseases.
Advances in diagnostics and predictive tools will allow us to assess compounds and their potential efficacy much earlier in development. Much of early drug development may have shifted to China, while later-stage trials will be conducted across a wider range of countries. The US still remains the highest value market but is closely followed by India and China due to volume. Europe has become a generics market.
Do you think your younger self would be surprised to see the career you’ve had?
Absolutely! Having had the amazing benefit of building a career across being an investment banker, a life science investor and a CEO over three decades is something I never thought would have been possible. Also, as an (often lonely) senior woman in these positions, I was at the very forefront of change, evolution and acceptance, which taught me a lot about negotiation, unconscious bias, insight and power. I believe it has enriched my life and made me a stronger and most likely better person.
Renee Aguiar-Lucander is CEO of Hansa Biopharma
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