COMPANY NUMBER
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Vermilion Life Sciences Ltd
Experience
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Plans to improve a late Phase development programme showed a two year reduction in development time, a reduced cost and a more competitive product profile, leapfrogging competitors.
Establishment of a new Portfolio Review tool to establish a robust unified set of criteria for evaluation of risk and prioritisation of assets and investment phasing
Planning and negotiation from a position of strength to amend regulatory agency view on availability of a product and gain substantial benefit for the MA Holder
Substantial project to globalise and unify the approach of an organisation and its structure. To improve its efficiency and effectiveness and deliver substantial headcount and cost savings. This included legal requirements for employee negotiations and a significant culture change
Design and delivery of an innovative risk based plan to reduce development times by over a year
Leadership through a product crisis played out in the public arena that included media interviews, regulatory agency interactions and internal company activities
Pharmacovigilance and Regulatory
Successful management of significant regulatory challenges to products based on emerging safety concerns. Included leading internal teams and planning for Oral Explanations at CHMP and PRAC.