STRATEGIC OUTSOURCING
Joined up thinking
Clinical supplies and investigational drug supply chain management, historically low priority areas for pharma,
are beginning to capture the industry’s imagination as companies seek to optimise their development
approaches. Astrid Frank, general manager of Fisher Clinical Services, talks up the opportunities for the
clinical supplies sector with Caroline Richards
Q.
supply team can add value. I think there is a
How do clinical supplies fit into
great opportunity for these two stakeholders
pharma’s overall clinical budget? Do the
to integrate more fully in the future, together
same teams decide on supplies as on the
tackling the challenges facing clinical trials.
clinical programmes?
Q. Why do so many outsourced projects
Clinical supplies are usually part of the overall
clinical budget. As the length, complexity
go over budget?
and geographical distribution of clinical trials
has increased, so has the budget for clinical
I think much of this problem has to do with the
supplies, often disproportionately. No longer
reasons I referenced above. Successful clinical
is this budget just for packaging ambient drugs;
trial conduct involves far more than f_i nding a
it now involves the handling of biologicals,
patient population. It has to do with the ability
often under special conditions, and distribution
of the investigator population to support the
and logistics which are more challenging in
trials and, from our perspective, it has to do
emerging markets.
with being able to reliably deliver the right drug
I am actually surprised to observe very little
to the right site so that no patient misses a dose
involvement of clinical teams in clinical supplies
at the time expected. If you think of the role
planning and decisions. This is true even within
that logistics plays in the supply chain, and the
many sponsor organisations. However, although
unpredictable nature of drug distribution across
drug distribution does not take place until after
multiple borders and regulatory requirements, it
sites are selected and patients are enrolled,
is no wonder that such a large number of trials
much of what we have to consider would be
run into issues.
more ideally suited to the early discussions over
When these challenges are thought of after a
protocol feasibility.
problem arises, naturally the budget is impacted.
We often encounter challenges with
Another observation is that sponsors fail, in my
regulatory or customs requirements because observation, to take advantage of forecasting
countries have been selected without tools choosing instead to over-order as their
consideration of the issues that may accompany primary fall-back plan. This leads to lots of
import of the investigational drug, or because wastage that will not be feasible moving forward
the programme is going to target a patient given the rising costs of drugs, together with
population for which compliance tracking is overall awareness of the environmental impact
critical. Both are areas in which the clinical of waste.
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