Reducing Risks in Global Comparator Sourcing



Pharma IQ
02/14/2011

One of the main challenges facing comparator professionals is ensuring a consistent supply, as well as reducing cost, and these were recently addressed by Andrea Chopek, writing for Contract Pharma.

She pointed out that comparative effectiveness studies for new drugs are not yet common and in the majority of cases clinical studies compare investigational drugs to placebos instead of pitting a drug in development against an existing treatment.

Subsequently, the pressure is mounting on many organisations to conduct comparative effectiveness trials, but in these cases it is essential that companies put in place strategies to initially select a comparator drug and then source and supply it to all trial sites in a cost-effective and uninterrupted manner.

Chopek explained: "Sourcing a comparator drug, which in all likelihood is manufactured by a competitor, can be a challenging task that exposes a company to operational, regulatory and financial risks."

She noted that it is important to combine a number of comparator sourcing and supply elements which, when included as part of a comparator sourcing strategy, can effectively reduce risk.

A strategic approach is essential, the expert said, as the process of sourcing and supplying comparator drugs for global clinical trials can contain many "pitfalls".

To help minimise the risk of delay or interruption in clinical trials and any financial consequences, she said that the strategy needs a "thorough understanding" of global regulation governing sourcing.

Another key element is proactive demand planning, as this can "rapidly accommodate" changes in the quantity of comparator drugs required as patient enrolment fluctuates or the trial itself changes unexpectedly.

Leveraging connections is also an effective way of removing the risk from the sourcing process, and sourcing directly from the comparator's manufacturer via a supply agreement is an excellent way of achieving this.

Although such a direct route can be problematic due to the anonymity requested by some trial sponsors, it may still be worthwhile, Chopek suggested.

"Trial sponsors can leverage this direct sourcing route while preserving anonymity through partnership with a sourcing specialist that maintains extensive relationships with manufacturers and can negotiate on the sponsor's behalf," the expert stated.

However, often the simplest ways of reducing risk during the comparator sourcing process is to plan early and effectively, she said, especially during the protocol design stage.

She explained that having a "head start" is essential, because comparator drugs are likely to be available from numerous sources across many regions.

Advance planning allows time to launch a comparator procurement strategy to assess the availability and limitations of sourcing the required comparator, as well as evaluating regional variations of comparators, such as dosage form, strength and concentration of active pharmaceutical ingredients.

"It also allows time to review sourcing options in terms of regulatory requirements, packaging, reformulation and re-labelling needs, establish a required volume and delivery schedule and evaluate the price and total cost of acquisition of the comparator, as well as confirming availability of the required pedigree and product documentation," the expert noted.

Finally, as the goal of comparator sourcing is ultimately to get the right drug to the study site in the necessary quantities at the correct time, the management and movement of clinical trial supplies is an essential factor in the trial's success.

She noted that having an agile global inventory and logistics management process which is supported by extensive regulatory expertise is arguably more vital than it has ever been in ensuring compliance, supply chain security and the prompt delivery of the comparators, as well as global batch traceability if a recall were to occur.

"It is critical that trial sponsors remain updated on and attentive to the constantly evolving regulations affecting the geographies in which trials are running and maintain close relationships with key regulatory bodies should sourcing-related questions arise," the expert concluded.

By bearing such recommendations in mind, industry professionals may be able to develop a secure strategy for comparator drug sourcing and stability testing to help support increasingly important global comparator trials.