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.