Modern Approaches to Therapeutic Validation Recommendation
TOTAL SCORE: 9
Score
A1 (Feasibility increased by continuance of pandemic): 0
A2 (Necessity increased by covid pandemic): +1
A3 (political viability): +1
B1 (Relevance to the specific goal of increasing HALE by 5 years by 2035): +1
B2 (Relevance to general goal of biomedical healthy life extension): +1
C1 (Market readiness applicability): 0
C2 (Project readiness): 0
C3 (Move to market readiness): +1
D1 (Actionability): 0
D2 (Degree of measurability): 0
D3 (Degree of leveraging cross-sector inputs): +1
D4 (Awareness of international context): 0
D5 (Resourcefulness): +1
D6 (Reorganisation): +1
E (Disruptiveness): +1
F (Dividends - does the recommendation aid in social activity and inclusivity?): 0
Point of comparison: Aging Analytics Agency agrees with the Committee, about fast-tracking human clinical translation, but has much more to add on the specifics of incentives and methods.
RECOMMENDATION SUMMARY
Aging Analytics Agency recommends that the government create incentives for groups (companies, labs, etc.) that can demonstrate human efficacy in some form.
Progress in aging research has accelerated rapidly in recent decades, from the age of invertebrate testing in the 90s to the age of mouse testing in the early 00s. Now, as we prepare for an age of human clinical trials however, we find that aging research faces a unique difficulty: that unlike mice and invertebrates, aging takes decades to unfold in humans.
Fortunately, this same period has produced a range of more modern forms of human therapeutic validation, including the use of biomarkers of Longevity, in silico human modeling, in vitro tests using human cells and tissues, human-animal chimeras (e.g., human-mouse chimeras) for safety, toxicity and efficacy testing, and in vitro application of subtherapeutic doses using microfluidic chips (“chip-on-skin” technology). A specific task-force should be created, involving experts and industry stakeholders from both industry and academia, to roadmap and validate safe and effective approaches for human validation prior to the stage of clinical trials.
Score
A1 (Feasibility increased by continuance of pandemic): 0
A2 (Necessity increased by covid pandemic): +1
A3 (political viability): +1
B1 (Relevance to the specific goal of increasing HALE by 5 years by 2035): +1
B2 (Relevance to general goal of biomedical healthy life extension): +1
C1 (Market readiness applicability): 0
C2 (Project readiness): 0
C3 (Move to market readiness): +1
D1 (Actionability): 0
D2 (Degree of measurability): 0
D3 (Degree of leveraging cross-sector inputs): +1
D4 (Awareness of international context): 0
D5 (Resourcefulness): +1
D6 (Reorganisation): +1
E (Disruptiveness): +1
F (Dividends - does the recommendation aid in social activity and inclusivity?): 0
Point of comparison: Aging Analytics Agency agrees with the Committee, about fast-tracking human clinical translation, but has much more to add on the specifics of incentives and methods.
RECOMMENDATION SUMMARY
Aging Analytics Agency recommends that the government create incentives for groups (companies, labs, etc.) that can demonstrate human efficacy in some form.
Progress in aging research has accelerated rapidly in recent decades, from the age of invertebrate testing in the 90s to the age of mouse testing in the early 00s. Now, as we prepare for an age of human clinical trials however, we find that aging research faces a unique difficulty: that unlike mice and invertebrates, aging takes decades to unfold in humans.
Fortunately, this same period has produced a range of more modern forms of human therapeutic validation, including the use of biomarkers of Longevity, in silico human modeling, in vitro tests using human cells and tissues, human-animal chimeras (e.g., human-mouse chimeras) for safety, toxicity and efficacy testing, and in vitro application of subtherapeutic doses using microfluidic chips (“chip-on-skin” technology). A specific task-force should be created, involving experts and industry stakeholders from both industry and academia, to roadmap and validate safe and effective approaches for human validation prior to the stage of clinical trials.