Approval for Multi-purpose Therapies Response to Recommendation
TOTAL SCORE: 12
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): +1
C2 (Project readiness): +1
C3 (Move to market readiness): +1
D1 (Actionability): +1
D2 (Degree of measurability): +1
D3 (Degree of leveraging cross-sector inputs): +1
D4 (Awareness of international context): 0
D5 (Resourcefulness): +1
D6 (Reorganisation): 0
E (Disruptiveness): +2
F (Dividends - does the recommendation aid in social activity and inclusivity?): -1
This recommendation scores high in the Political Timing Score (A).
Aging Analytics Agency strongly supports this as an eminently feasible and necessary step to achieving the current 2035 goal or anything similar.
Furthermore the present circumstances provide a useful political climate in which to garner public support to fastrack biomedical efforts.
Having seen vast portions of the national budget directed toward shielding the nation’s economy and health from the pandemic, and having adapted their lifestyles and expectations accordingly, the public would likely be extremely welcoming of such regulatory conditions as the recommendation describes.
During and shortly after the second world war, the nation made a coordinated effort to cope with an inundation of wounded veterans. When the war was over, they refused to allow the health system to re-fragment and slump back into an “old normal” of health inequality, resulting in today’s National Health Service.
The remaining political capital which presently exists for coping with the current crisis, should likewise be repurposed and redirected toward developing preventive innovations for averting a “new normal” of repeated pandemics for which the UK remains perpetually unprepared, a long-term fear at the back of the minds of many.
RECOMMENDATION SUMMARY
“Understanding of the underlying biological processes of ageing has advanced significantly in animal models, but translation to human ageing is incomplete. The lack of accurate biomarkers for human ageing is an impediment to assessing an individual’s biological age. (Paragraph 126)
Promising advances have been made in the development of drugs that target the underlying processes of ageing. These could delay the onset of age related diseases and reduce polypharmacy. Research into repurposing drugs is particularly welcome, as such drugs have already been tested for safety, dosage and tolerability. (Paragraph 144)
The fact that clinical trials are usually approved only if they target a single indication poses a challenge to research into drugs that target underlying ageing processes. The novel design of the TAME trial in the US hopes to provide proof of concept for trials targeting the ageing process itself. (Paragraph 155)
We recommend that the Medicines and Healthcare products Regulatory Agency (MHRA) show greater willingness to approve trials which target multiple conditions. It should also explore the use of novel trial endpoints, such as using biomarkers of ageing as measures of success in treatments targeting the ageing process. (Paragraph 156)”
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): +1
C2 (Project readiness): +1
C3 (Move to market readiness): +1
D1 (Actionability): +1
D2 (Degree of measurability): +1
D3 (Degree of leveraging cross-sector inputs): +1
D4 (Awareness of international context): 0
D5 (Resourcefulness): +1
D6 (Reorganisation): 0
E (Disruptiveness): +2
F (Dividends - does the recommendation aid in social activity and inclusivity?): -1
This recommendation scores high in the Political Timing Score (A).
Aging Analytics Agency strongly supports this as an eminently feasible and necessary step to achieving the current 2035 goal or anything similar.
Furthermore the present circumstances provide a useful political climate in which to garner public support to fastrack biomedical efforts.
Having seen vast portions of the national budget directed toward shielding the nation’s economy and health from the pandemic, and having adapted their lifestyles and expectations accordingly, the public would likely be extremely welcoming of such regulatory conditions as the recommendation describes.
During and shortly after the second world war, the nation made a coordinated effort to cope with an inundation of wounded veterans. When the war was over, they refused to allow the health system to re-fragment and slump back into an “old normal” of health inequality, resulting in today’s National Health Service.
The remaining political capital which presently exists for coping with the current crisis, should likewise be repurposed and redirected toward developing preventive innovations for averting a “new normal” of repeated pandemics for which the UK remains perpetually unprepared, a long-term fear at the back of the minds of many.
RECOMMENDATION SUMMARY
“Understanding of the underlying biological processes of ageing has advanced significantly in animal models, but translation to human ageing is incomplete. The lack of accurate biomarkers for human ageing is an impediment to assessing an individual’s biological age. (Paragraph 126)
Promising advances have been made in the development of drugs that target the underlying processes of ageing. These could delay the onset of age related diseases and reduce polypharmacy. Research into repurposing drugs is particularly welcome, as such drugs have already been tested for safety, dosage and tolerability. (Paragraph 144)
The fact that clinical trials are usually approved only if they target a single indication poses a challenge to research into drugs that target underlying ageing processes. The novel design of the TAME trial in the US hopes to provide proof of concept for trials targeting the ageing process itself. (Paragraph 155)
We recommend that the Medicines and Healthcare products Regulatory Agency (MHRA) show greater willingness to approve trials which target multiple conditions. It should also explore the use of novel trial endpoints, such as using biomarkers of ageing as measures of success in treatments targeting the ageing process. (Paragraph 156)”