Full-Scale, Customized Library/Information Services
Challenge:
Late-phase company preparing to submit NDAs for antibiotics designed to combat resistance among community-acquired bacterial pneumonia and acute urinary tract infection pathogens, respectively. Several areas of the company need ongoing information science support.
Solution:
Working through Medical Affairs, Maxwell Research:
Secured a Copyright License Agreement
Trained employees on basic copyright compliance
Created a Virtual Library and imported previously-purchased documents
Trained employees on use of the Virtual Library
Uploaded proprietary scientific posters to the Virtual Library for easy, corporate-wide access
Created subject-specific, shared bibliographies in the Virtual Library for quick access to literature about particular topics
Created RSS feeds to the Virtual Library to facilitate monitoring of the literature for specific disease areas
Ongoing, we perform:
DSUR and Annual Report literature searches each year
Ad hoc literature research in support of Medical Affairs, Clinical Development, Regulatory, Pharmacovigilance, etc.
Periodic training for new employees on copyright and use of the Virtual Library
Results:
Company is able to scale library/information science support based on current needs.
Competitor Awareness
Challenge:
Company was in launch mode after having recently received approval for a novel drug/device to deliver a topical corticosteroid deeply into the sinuses to treat chronic rhinosinusitis. They needed to keep abreast of the competitive environment on all levels.
Solution:
Developed and early warning system in the form of a weekly email alert to the Management Team and other stakeholders. It included:
New medical and scientific literature
Clinical trial updates
News/press releases
Summaries of competitors' quarterly conference calls
Summaries of pertinent SEC filings
Results:
Management Team is kept abreast of competitors' progress and activities, enabling them to strategize/maneuver in real-time.
Sharing Literature within the company Compliantly
Challenge:
Company was preparing to file their first NDA for a potential treatment for narcolepsy. To facilitate interactions with physicians, the Medical Science Liaison team needs to have a command of the narcolepsy literature, while economizing on the costs for literature procurement, and remaining copyright compliant.
Solution:
Maxwell Research facilitated:
Purchase of a Copyright License Agreement
Training of the team on basic copyright laws
Creation of a copyright-compliant central repository (i.e. Virtual Library) to house all literature purchased
Real-time literature alerts by setting up feeds from literature databases to alert MSLs to relevant new literature
Results:
The Company MSL team is sharing important literature in a copyright compliant way and has virtually eliminated unnecessary duplicate document purchases. They are now continuously abreast of the latest literature and better prepared for scientific discussions with physicians.
