Medical Affairs Projects
Pre-launch strategy
Reviewing available data, identifying both key advantages as well as data gaps and creating a plan for further data generation.
Working closely with Marketing, Health Economics to present the launch plan to the Country President and advise on a go/no-go decision.
Portfolio integration
After the merger of two companies, leading the creation of a merged product treatment pathway.
HTA creation and submission
Working alongside Marketing and Health Economists to create HTA documents for two SMC and NICE submissions, leading to positive positions.
This included both internal collaboration on economic modelling as well as leading advisory boards for obtaining external expert input.
End of patent strategy
Working with the commercial team to devise a strategy for pricing and product placement after loss of patent exclusivity in the UK.
Patient Support Programme Development
Supporting a large patient support programme both creating training materials, reviewing and publishing the website as well as hard copy items to help reduce barriers to commencing patient and retaining patients on treatment.
Creation of LEMS meetings
Legitimate Exchange of Medical Science meetings can be a contentious area and unless undertaken with care can lead to complaints and censure.
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Working alongside the in-house Medical Affairs team we were able to create a programme that enabled the objectives to be met in a compliant manner
Complaint creation and response
We have experience in working with Pharmaceutical companies with commencing and responding to intercompany dialogue and directly with the PMCPA.