Table 5.
“Classical” licensing | Adaptive licensing | Compassionate use | |
---|---|---|---|
Advantages | • “Gold” Standard • Already established for antibacterial drugs • Would be suitable for phage derived products • Additional legislation being introduced to streamline procedures for antibacterial drugs |
• Limited population approvals • Iterative process which can inform future work • Can be adapted for pre and custom phage cocktails |
• Immediate clinical usage • Data could be used to inform future work • Could be utilized for all forms of phage therapy |
Disadvantages | • Recruitment for trials • Cost • Reformulation would require additional trials |
• Varying degrees of complexity • Limited population approvals |
• Limited to a single patient basis • Not actually approved for use |
Other considerations | • Likely that only highly defined products would be able to succeed, limiting success | • Approval of predefined libraries would require wholly new approvals process | • Lack of public awareness of phages |
Time to implementa | ++ | ++ or +++* | + |
Cost to implementa | $$$ | $$ or $$$* | $ |
Assumption has been made that “Classical” licensing is a baseline.
Both cost and time to implementation would be affected by the form of treatment chosen. Pre-approved libraries taking longer and costing more to achieve.