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From spin-off to phase II

”The people there will basically become your new colleagues” – Carina Schmidt, former CEO of Athera, about working with different contractors.

Carina Schmidt has been the CEO of Athera for nearly 13 years. In October, it was announced that she would leave her role there and hand over the chair to James Hall. At Pharma Outsourcing, she will give an insight into her experiences from her time at Athera – a semi-virtual company with offices in Stockholm and Gothenburg.

The company is developing the antibody based drug candidate ATH3G10. The aim is to prevent cardiovascular diseases by treating the underlying inflammation. ATH3G10 is currently undergoing a clinical phase IIa trial and the results are expected next year.

Athera has worked with a lot of CROs, in all parts of its development.

– When I started working at Athera I had been working as a consultant in my own company for seven years. I don’t see a big difference in the ambition levels in employees and consultants, and I have never hesitated to outsource different services to CROs, to get access to their expertise, says Carina Schmidt.

– During my time at Athera we have gone from being a spin-off company from an academic project at Karolinska Institutet to having a candidate drug in clinical phase II studies, and we have outsourced our preclinical development, clinical studies and production.

The company’s longest outsourcing project was with Lonza. It started in 2011 and focused on the development and subsequent production of the antibody.

– We have worked with multiple CROs during our preclinical development and now we have clinical studies run by CROs in the countries where our phase II trial is performed – Sweden, Denmark, and soon a third country will be announced. Most CROs that we have worked with are European. One exception was a Boston based one that helped us with our preclinical development. They had a technology that was crucial for our project at the time.

She adds that she thinks it’s important to meet each other face to face once in a while when you are working together on a project. For instance, Athera has weekly web based meetings with their current clinical CRO but they also meet face-to-face two to four times per year.

Carina Schmidt stepped down from her role as CEO of Athera in the middle of October. However, she is still a part of the management team, as a Senior Business Advisor of the company. Except for this, she is also a member of a few company boards as well as on the Center Board of a Vinnova funded competence centre at KTH, Adbiopro.

What is your advice for a company that wants to start outsourcing?

– Talk to other people from the industry and ask about their recent experiences. The greatest asset of any company is the people working there and they move around sometimes. That means that a CRO that was good five years ago might not be as good today.

– When something goes bad in an outsourced project the problem is often miscommunication. Be very clear early on with what you expect from them and how you want your communication to work. Speak regularly.

– Remember that even though the CRO is a different company, you will have to work closely together. The people there will basically become your new colleagues, so before you sign a contract, make sure that you get to meet the people that you will work most closely with at the CRO, that your personalities match and that you can communicate well.

During the event Pharma Outsourcing December 10th in Stockholm Carina Schmidt is one of the speakers. For full program and registration follow link.

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