Drug Information Journal - March 2009 - (Page 126) 126 MEDICAL INFORMATION Whitehead, Lomma, Tran, Miao, Pikalov Listing of Written Medical Information Services for Each Alliance Partner TABLE 2 Early Alliance Formation Medical Information Service 1. Preparation and dissemination of medical letters 2. Review of medical letters 3. Medical information review of promotional materials 4. Provide medical information upon request BMS X X —* X Otsuka — — X X‡ Middle Phase Alliance BMS X X X† X Otsuka — X X† X‡ Late Phase Alliance BMS X X X† X Otsuka — X X† X‡ BMS = Bristol Myers Squibb, Medical Information Department; Otsuka = Otsuka America Pharmaceutical, Medical Affairs Department. *Promotional review was provided by another BMS medical group in the early phase and later transferred to medical information. † Promotional review process was updated. ‡Responds to medical information requests in regions not supported by BMS. might be thorough and complete, nonexistent, or something in between. You may have to create roles based on the intent of the contract if it is not clearly described. The initial setup of the responsibilities is a necessary starting point. However, the alliance partners should recognize the dynamic nature of the relationship and understand that the division of labor or specific processes will likely change to some degree during the alliance. MAINTENANCE OF A MEDICAL I N F O R M AT I O N A L L I A N C E We are currently at nine years post–alliance formation and involved in the late-phase maintenance of our partnership. Early in the formation of our alliance, there were many changes involved with setting up the partnership and working through the responsibilities of the first indication. Approximately six years post–product launch, the division of responsibilities of medical letter writing and medical review of promotional materials for our alliance has remained the same. Our product is no longer considered newly marketed and we continue to work on providing medical information for newer FDA-approved indications. Changes that occur at this stage of our alliance are fine tuning of processes used in our medical information department, such as the promotional review process, which was updated in 2007 and 2008 for our companies (Table 3). The new process more clearly outlines the role of each team member (marketing, medical, legal, and regulatory) and the specific promotional review procedures such as how to bring the material to the team for a concept review, for a first or second live review, and how to handle different opinions within the team on coming to a decision regarding the content of the material. It also defines the process for reconsideration by upper management, in case the champion who brings the item to the team disagrees with the team decision on a review piece. These improvements were based on the experiences of working together for several years. Our companies have a joint responsibility for review and approval of all promotional and training materials. A promotional review process coordinator sends out the meeting agenda and materials to the reviewers five business days prior to the live team meeting date. The reviewers then have an opportunity to review and provide their comments during the live biweekly teleconferences. With new technology available, the reviewers from both companies are able to view the changes made to the review item concurrently via their respective computers during the live meeting. The entire review process was refined and all aspects were defined in standard operating procedures (SOPs) within both companies. It
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