In order to keep abreast of developments, it is wise to ask (and re-ask, on a regular basis) a number of important questions related to your disease area:
Which companies are currently conducting clinical trials?
- What is being studied in which populations?
- When are the trials expected to complete and readout?
- Are they on track with expected timelines?
- Are they the Principle Investigators for the above companies’ trials?
- Which companies are collaborating with them for their research?
- Are the journals the prominent ones in the research area?
- According to Tufts’ Center for the Study of Drug Development (2014), only 1 in 8 drugs (or 12%) that enter clinical trials is approved, however some companies have much better track records than others. For the companies in question, how often do they receive approval letters the first time around? How often do they receive “complete response letters?” How often do they fail to get approval?
- Fast track, breakthrough therapy, accelerated approval and priority review are regulatory pathways that FDA grants for promising drugs that may represent new treatments for serious diseases with significant unmet need. These drugs may be the first available treatments for a disease, or have significant advantages over existing treatments.
- How robust are they?
- What are the companies overtly stating about their pipelines in their public statements?
- Have they announced a strategic change in their therapeutic area plans for the future (that may no longer include the TA of interest)?
- Are they collaborating with known leaders or recognized trailblazers in the disease area?
These questions represent a 35K’ approach to keeping abreast of the key players and rising stars in a disease area. To discuss an in-depth analysis of the players within your disease/therapy area, contact Maxwell Research Services.
First Published in the Life Sciences Executive Network "Biotech Bulletin" Summer 2015.