tufts csdd internal databases
Tufts CSDD maintains proprietary databases that provide the most detailed source of historical information available on pharmaceutical and biopharmaceutical innovation in the United States. These databases contain data on products approved from 1963 to the present.
Through regular surveys of companies doing investigational work and/or marketing new therapeutic agents, Tufts CSDD obtains data on drugs and biologics that have entered human testing worldwide for the first time, as well as those that have received approval for marketing in the U.S and abroad.
Utilizing these proprietary databases, containing information on products approved since 1963, Tufts CSDD research staff are able to compile and publish groundbreaking research on pharmaceutical and biopharmaceutical innovation.
While Tufts CSDD’s proprietary databases are not available for public viewing or use, we welcome the opportunity to work with individual or multiple sponsors to conduct specific analyses as part of custom projects. Note that only aggregate analyses are provided to the sponsor, and no drug company names or products will be identified.
- Primary and Secondary Research - including surveys, executive and opinion leader interviews, focus groups, and original and secondary data analyses.
- Facilitated Roundtable and Management Meetings - including small, and large group conference-style presentations and moderated discussions held onsite at the sponsor organization or at neutral locations (for example at Tufts CSDD’s own conference facility).
- White Papers and Custom Management Reports - including the compilation of source information, review and analyses of mission-critical issues, and R&D trends and their strategic implications. Tufts CSDD can develop a custom white paper report, or, if requested, submit a manuscript for publication in a trade or peer-review journal.
**Drug developers are willing to share their drug development data with Tufts CSDD because they are assured that their information will be aggregated with data from other firms, and that no individual company data is ever identified or disclosed.
Tufts CSDD maintains six core databases, which contain information on hundreds of pharmaceutical and biological products, approved or in development, covering a time period ranging from 1962 to the present. These core databases are maintained on an ongoing basis by the Tufts CSDD research staff. In contrast, Tufts CSDD, from time to time, creates shorter term project databases, which contain information specific to a particular research interest or area. The following are descriptions of Tufts CSDD’s six core databases:
Investigational Compounds Database
The Investigational Compounds Database includes information on pharmaceutical and biological compounds that have entered human testing as “new” entities in the U.S or abroad by drug and biotechnology companies since 1963. The information contained in the database includes development history, research activity, origin of the compound, and foreign marketing data.
Approved Products Database
This Approved Products Database includes information on all New Molecular Entities (NMEs) and New Biological Entities (NBEs) approved in the U.S. since 1963. Specific data include product origin, synthesis data, clinical phase lengths, clinical holds, development and regulatory review times, regulatory review history, and marketing history.
The Biotechnology Database contains data on over 2400 investigational and marketed biopharmaceutical therapeutics, including recombinant proteins, monoclonal and polyclonal antibodies, purified proteins, synthetic peptides, and antisense nucleotides. Data for prophylactic and therapeutic vaccines are included.
Fast Track Designation Database
The Fast Track Designation Database contains information gathered from the public domain and other sources on products that have received Fast track designations. These designations are given by the FDA to chemical and biological products, either in development or approved, that are intended to treat serious or life-threatening conditions, and to address an unmet medical need. The database is updated regularly to include the most recently designated products.
Orphan Drug Database
The Orphan Drug Database contains drug name, sponsor, dates of designation and approval, and orphan indication information on all orphan drug designations and approvals granted by the FDA from January 1983 to the present.
The EMEA Database contains information on drugs that have been approved through the EMEA’s Centralized Procedure starting in 1995 (the year of the Centralized Procedure's inception). For those approvals that have received both EMEA and FDA approval, the U.S. regulatory information is included for comparative analyses. The database includes information on approval time, regulatory designation, novelty of compound, and compound type.