Intervju med Ann-Kristin Spiik, Head of CMC

1. What attracted you to Oncorena, and what excites you most about joining the company?

The company stands out through its uniquely robust scientific foundation and a team that is both dedicated and deeply experienced. What truly sets us apart, however, is the team´s humility and genuine warmth — we all understand that lasting success is built through exceptional teamwork.

2. You have more than 20 years of experience in pharmaceutical development and CMC. What have been the most valuable lessons you've learned throughout your career?

You can never have too much drug substance or drug product on hand, and you can never have too much stability data. It is essential to be prepared for unexpected issues that may arise with the drug product, as its maintained quality will inevitably be scrutinized and must be justified.

Experience has shown me that regular cross-functional discussions are indispensable, and that proactive engagement with regulatory authorities provides significant value in securing a viable and sustainable path forward.

3. CMC is often described as a critical part of successful drug development. Why is it so important, and what role does it play in bringing new medicines to patients?

CMC timelines must be thoroughly reviewed and aligned with the clinical development schedule. Without a drug substance and drug product, there is no treatment. And if you have a candidate that cannot be manufactured with high quality, through a reproducible and robust process, and delivered on time, the project faces significant and potentially overwhelming obstacles.

4. What opportunities do you see for Oncorena as the company advances its lead candidate into the next stages of development?

The product, ONC175, would ideally be evaluated as an earlier line of cancer therapy, making it available to benefit a larger number of patients at an earlier stage of their disease.

5. On a more personal note – what motivates you in your work, and what continues to inspire you after so many years in drug development?

I deeply want to contribute to something that truly matters — to help bring relief to patients who are suffering and to play a part in a solution that has the power to change lives.

Outside of work, how do you recharge and find inspiration?

Spending time with family and friends, immersing myself in live music and art, and supporting others as a counsellor — these are the moments that truly inspire me.