A Biotech CTO on the Outsourcing Dilemma: “The Stakes Are Extremely High”

A CRO may deliver excellent quality. A CDMO may provide exactly the expertise a company needs. But drug development rarely follows a perfectly predictable path – especially in smaller biotech companies, where changing priorities and financing can quickly reshape development plans.

How do you balance flexibility, speed and control in such an environment?

Pernille Hemmingsen has extensive experience in pharmaceutical development, manufacturing and quality. As CTO at Danish biotech company Adcendo and returning moderator of Pharma Outsourcing – Find the Right Partner, she brings a practical perspective to the challenges of external collaboration.

Small biotech companies increasingly rely on external partners. Are we approaching a point where some companies outsource too much?

“Especially in small biotech companies, the stakes are extremely high. Often, it is business-critical for the company that activities are completed on time and to the required quality standards.

Accordingly, the classic outsourcing dilemma of control versus flexibility is even more relevant in the biotech space.”

Where do you see the greatest tension between speed, cost and control when working with external development partners?

“Maybe the theme is flexibility.

Many CDMOs and CROs are extremely reliable and deliver outstanding quality. And with the business model leaning more and more towards outsourcing over the last decade, the scale of outsourcing has helped create a fairly effective market in terms of cost and pricing.

So the remaining question becomes: how does the outsourcing model accommodate the rapid shifts in priorities and financing that are an everlasting reality of biotech?”

From your experience in CMC, manufacturing and quality, what do biotech companies tend to underestimate when entering external partnerships?

“While speed is often what is needed most, accelerating timelines usually comes with a 'technical debt' that needs to be taken care of at a later time point.

That debt is often underestimated and even forgotten.”

Looking at this year's Pharma Outsourcing programme, which questions or challenges are you particularly interested in seeing the speakers address?

“In the last couple of years, the financial challenges that biotech faces have moved from early preclinical development to early clinical.

This is obviously good news, as it allows innovation to mature a bit more before hitting a financing cliff. But it does leave the question of how to make the most of the resources at hand.

Pharma Outsourcing is an excellent opportunity to explore, learn and establish new partnerships enabling optimal development.”

Where Drug Development Meets the Right Partners

These challenges are at the heart of Pharma Outsourcing – Find the Right Partner, returning to Life City in Stockholm on 2 December for its 12th annual edition.

The conference brings together biotech and pharmaceutical companies, CROs, CDMOs, investors and other drug development specialists to explore outsourcing strategies, external collaborations and the decisions that shape successful drug development.

Through real-life cases and practical experiences, speakers will address everything from maintaining control over externally executed clinical development to preparing drug candidates for global partnerships and navigating the transition into more advanced clinical stages.

But Pharma Outsourcing is more than a conference – it is a matchmaking event at its core. Designed to connect drug developers with the expertise, services, investment and partnerships they need, the event combines a focused seminar programme with partnering meetings, an exhibition and dedicated networking opportunities throughout the day.

For participants, it is a chance not only to learn from others' experiences, but also to meet the people who could help move their own projects forward.