During a Phase 3 trial, Medical Affairs teams usually identify journal targets and congresses to announce trial results. When the trial is complete, teams start to prepare journal articles, abstracts and posters. Actually Medical Science Liaisons get involved to market preparation in advance of the launch activities. Their first task looks simple – to listen. MSLs should listen carefully to physician needs for a particular disease area, learning where current treatments are insufficient and what physicians would like to see in a new product. This input becomes extremely valuable later on as the company creates product messages and the scientific platform for publications.
Closer to product launch, MSLs should be trained on the new drug/indication. If the new product is in a familiar therapeutic area to the company, then existing MSLs can receive additional product training. But if the product expands into a new therapeutic area, then MSL managers are left with a difficult decision — bring new MSLs on board or shift resources to properly support the new product.
Although medical communications and MSL teams start supporting products early in their lifecycle, other medical functions need to be prepared for increased workloads at product launch. Medical educational projects and investigator initiated studies have to be planned and budgeted in advance (at least preliminary).
Before the product/new indication launch, MSL teams are the only ones that are permitted to provide off-label data upon unsolicited requests from physicians and thought leaders. If an unsolicited request is coming from HCPs through other functions (sales, marketing), MSLs yet have to contact with physicians directly just updating internal partners about request resolution. Off-label requests solicited (prompted) by pharma company personnel are illegal and considered bad promotion.
Pre-launch is the most important period when MSLs are generating awareness and build relationships with thought leaders. Therefore success of MSL means ability to make the launched product a long-expected solution in their practice. Following product launch, MSL programmes continue activities relating to scientific exchange and building peer-to-peer relationship with thought leaders. This process requires good planning with individual thought leader development plan as a basic tool reflecting any activities involving the HCP. These activities may include clinically supporting educational activities, speaker training programmes, facilitating the company’s clinical study publication plans. The quality and quantity of portfolio activities can serve as metrics by describing effectiveness and productivity of the MSL team.
1. Product Launch: A Busy Time for Medical Affairs Teams. http://www.cuttingedgeinfo.com/2013/product-launch-busy-time-medical-affairs-teams/#sthash.fhSCenKp.dpuf
2. Donna Baker. The Role of the Medical Science Liaison in Industry. AORN Journal 91 (3 2010): 394-398.
3. Guidance for Industry. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. December 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf
Written by Dr. Alexander Tolmachev