Before you choose a CRO

– We are a small company and it is very important for us to maintain our core competence within development of novel nanomaterials, Tove Sivik Sonne, Head of Development at Spago Nanomedical says.

Lund based Spago Nanomedical is developing a new contrast agent for use in magnetic resonance imaging, MRI, of tumors and metastases. The agent, Spago Pix, is based on nanoparticles that are too large to cross over from blood into healthy tissue. However, tumors have leaky blood vessels that would enable Spago Pix to cross over the vessel wall and accumulate in the tumor (the so called EPR effect) – making it a cancer selective contrast agent.

– The contrast agents that are used today consist of small molecules that leak out into all tissues. We are hoping to improve the diagnostisation of cancer. Today, MRI leads to approximately 30 percent false positive diagnoses, says Tove Sivik Sonne, Head of Development at Spago Nanomedical who is one of the speakers at Pharma Outsourcing Dec 10th in Stockholm.

She adds that regulatory agencies have urged caregivers to be more restrictive with the use of contrast agents for MRI. The reason is that they contain gadolinium – an element which is retained in the brain and other tissues. It is not known what the effects of this may be, but it has lead to a lot of concerns regarding these contrast agents. Spago Pix does not contain gadolinium. Instead, it contains manganese.

– We consume manganese every day and the body has developed ways to maintain homeostatis. In regulatory safety studies in animals, signs of toxicity appeared only at doses several magnitudes higher than the ones used in the clinic.

The development of Spago Pix reached clinical phase in September, when a first-in-human study, Spago Pix-01, was commenced. The end results are expected in early 2020.

Large portions of the development of Spago Pix has been outsourced. For instance, the regulatory preclinical studies were performed by a French CRO. Many parts of the work with the Spago Pix-01 study are also outsourced and the trial involves a clinical CRO, a CMO, a fill and finish company, an imaging CRO, a logistics provider and a biobank. In addition, individual consultants and CROs have been used for regulatory services, to ensure the documentation required for entering clinical trials is up to scratch.

– We are a small company and it is very important for us to maintain our core competence within development of novel nanomaterials. Therefore, we have outsourced many other parts of the development. However, we have still had to work a lot with the study. For instance, the work with moving the bioanalysis from one lab to another and upscaling the production has required a lot of time. It took approximately 1 ½ years from the initial tech transfer until we had a product that is ready to use, says Tove Sivik Sonne.

Tumorad is the name of another project in Spago’s pipeline. It is based on the same nanomedical platform as Spago Pix, but is aimed at treating cancer. By loading nanoparticles with radionuclides, the company hopes to be able to destroy tumors using local radiation delivered systemically.

– Tumorad is yet in the preclinical phase and we are using smaller CROs for some development work, pharmacokinetic studies for instance. When we reach later developmental stages with Tumorad, we will contract with certified CROs that fulfill the requirements of each developmental stage.

Which are your best tips when it comes to outsourcing?

– Before you choose a CRO, talk to a lot of people to make sure that you make the right choice. When you have found one, it’s good to put a lot of effort into the planning. Also make it clear to yourselves and the CRO what the roles and responsibilities are. Make sure you feel comfortable about communication plans, and define escalation pathways early on.

– As a small company it has been good for us to work with small CROs, where you can tell that you are very important to them!

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