Our client:

Cantargia AB specialises in antibody-based cancer treatments. The company focuses on two forms of cancer where there is a significant need: non-small cell lung cancer and pancreatic cancer and has just started a Phase IIa clinical trial with its main product, CAN04. The company has also started development of a new antibody designed for treatment of autoimmune and inflammatory diseases.

Cantargia, which was listed on Nasdaq Stockholm Main Market (Small Cap) in 2015, is based in Lund, Sweden. To date it has raised SEK 500m and has a strong balance sheet (SEK 250m).


The challenge:

The company had so far worked with external consultants and now wished to attract a full time RA leader with experience of RA leadership from major pharma organisations and SMEs. The incumbent needed to demonstrate experience of new organisational design and change, be an RA expert with documented track record developing value propositions, defining RA pathways, negotiated with regulators, submitted INDs, NDAs and/or BLAs.

The position ideally required expertise from the field of oncology and immunology, have presented and defended BioPharma submissions and Market Authorisation Applications (MAAs) to the FDA and EMA, assessed and managed alliances with CROs, managed solid KOL interactions and have an international regulatory network.

Key responsibilities involved advising Leadership Team members on drug development requirements to facilitate the transition of new products through the development process ultimately leading to marketing approval. The Regulatory Leader would plan, implement and have overview of clinical trial applications leading to the submission and approval of MAAs.


How our approach made a difference:

Positive clinical data published by Cantargia secured an additional fundraise and enabled the company to take on a full time VP of RA. Our search for the right candidate primarily focused on Sweden and Denmark, with a secondary priority of the rest of the EU. We mapped key companies in Medicon Valley and Ideon Science Park in our search for the perfect fit.

As a result of meticulous research and due diligence, we secured a candidate with extensive experience from Regulatory Affairs activities from LEO Pharma and Astra Zeneca, as well as experience of managing the integration of acquired projects into the commercial portfolio of LEO Pharma. In addition, this candidate also had experience from areas outside RA which made her even more suitable for a pre-commercial SME.

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