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Case Study

Medical Affairs: FSP Consulting Support – Communications, Clinical Trial Support, Medical Writing

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A mid-size Southern California specialty biopharmaceutical organization with one marketed product and a late stage pipeline of small molecule compounds for Rare Diseases and CNS conditions.

Key Issues:

Our client engaged BioPoint during a reorganization in anticipation of their second product approval. The original Medical Affairs team was small due to the market size of their first product, however the pending product pipeline required a more robust function.

The client was looking for an option that would provide immediate Subject Matter Expertise to the team of 3 as they developed the Medical Affairs strategy as well as continued resource support to assist their growth initiatives. It was essential that the Functional Service Provider was able to meet evolving project deliverables, quickly assemble the necessary resources and integrate them either with their team or as stand-alone experts. It was also important to our client that they were able to maintain central oversight with real time access to BioPoint consultants.


BioPoint assigned a dedicated Engagement Manager to tailor an FSP offering that addressed our client’s need for immediate consultation and long term resources. BioPoint’s Medical Affairs SME’s were substantially experienced with the client’s target therapeutic areas which allowed them to become acutely familiar with the products and processes quickly. This allowed a more streamlined assembly and deployment of resources as projects evolved.

BioPoint coordinated a comprehensive team of 1  Executive Medical Director to work alongside the Department Head and Lead the efforts of the BioPoint team in conjunction with the client’s internal team. The supporting BioPoint team consisted of: 2  Medical Directors, 1  Medical Communication Consultant, 2  Medical Writers, 1 Clinical Study Manager and 6  Medical Science Liaisons. Working both onsite and remotely, the BioPoint team was able to effectively meet deliverables in the following areas over an 18  month period:

    • Medical Communications – Developed and Executed Publication strategy, aligned with cross-functional groups to enhance medical
      communications and processes as well as author numorous abstracts, posters, and manuscripts
    • Medical Affairs Strategy- Established product launch strategy, linked internal cross-func- tional groups with MA function, supported
      KOL engagement, represented client at therapeutically aligned conferences, identified unmet needs in therapeutic areas, evidence
      generation planning and ongoing research initiatives
    • MSL and field team – Lead the formation and growth of a regional MSL team of 6 comprised of contract resources utilized for short
      term needs and long term resources that later transitioned to permanent team members


By entering into an FSP alliance with its client, BioPoint was able to provide increased control, full transparency of project deliverables and timelines, as well as substantial operational and cost efficiencies. Our client was in a position to address critical business needs while having the ability to more strategically transition to direct internal staff. BioPoint’s consultants remained available to assist with training as new employees were assimilated into the growing Medical Affairs group.