Integrated Product Development
A UK-based biopharmaceutical company had acquired the rights to develop and commercialize a novel cancer immunotherapy product.
The chairman asked us for help and it was soon clear that the company might benefit from increased knowledge of the product development process and appropriately experienced personnel.
We were asked to oversee and manage the drug development process. One of our partners became CEO and, using our network of experts, formed a core virtual team which took on the operational management of the company.
We managed all interactions with regulatory authorities and successfully obtained US and EU orphan drug designation. We took the lead product from early stage research and completed a randomized phase II study in pancreatic cancer on budget and on schedule. We also supported the setup of a dedicated biologics manufacturing facility in France.
The clinical results were among the best seen in this difficult-to-treat cancer and gave the company a solid platform for further development, most likely in partnership with a major pharmaceutical company.