Streamlining the Comparator Sourcing Process
As the number of comparator trials continues to increase, there is a growing need for fast, effective sourcing of high-quality comparator products.
For many firms, it has become a necessity, with companies focusing on developing a secure strategy for comparator drug sourcing and stability testing to support global comparator trials.
However, this process can often be a difficult one so it is essential that firms take the right steps to ensure it is handled in the best possible way to minimise disruption.
This was recently highlighted by Lekishia White, vice-president at MultiPharma, who told GEN that most of the time, comparator sourcing is done for best in class, and usually done during Phase II or III studies.
However, she added that there are risks involved with these studies, as most companies do not want another firm knowing that they are comparing their drug to another.
"This is why drug development is so expensive. There is such a small percentage that makes it through the entire cycle. You could get through trials with a working therapy, but it may not be best in class so the company decides not to develop it," White explained.
She noted that some of the challenges involved in comparator outsourcing include obtaining all the appropriate paperwork and tackling the import and export of materials.
In addition, companies have to obtain a certificate of analysis and/or an equivalency statement as well as approval to use the materials.
For example, the expert said that there may be a drug registered and available in Europe, but not in the US, which would require an equivalency statement that ensures it is the same formulation.
She noted that comparator sourcing providers are specialised in terms of areas they service the most, though some have better relationships with the innovator companies than others.
It is all about relationship building, she said, adding that the best way for a company in the industry to know which provider to use is to attend industry meetings and ask colleagues.
White said it is a "growing field", with the number of providers doubling in the last two to three years.
"The clinical trial circle of influence is quite small - word gets around quickly who is reliable and who is best. There are at least ten comparative-sourcing providers and for such a small niche market, that's a lot," she explained.
For companies looking to outsource these procedures to contract research organisations (CROs), there are no written guidelines outlining the best way to choose them, so companies have to develop their own strategies, according to John Fry, senior director of clinical operations at Facet Biotech.
"You have to define your organisation in terms of what skills you want to retain and consider essential, and that only your organisation can carry out," he suggested.
He explained that a strict set of criteria is employed by his organisation when choosing a CRO - something many firms adapt to ensure the suitability of a firm to carry out comparator sourcing and other procedures.
"We go through a process where we start with about ten companies, reduce that down, and send a request for proposal out to about three. We then go through a rigorous selection process that can take several months," he explained.
There is little doubt that CROs will continue to play a key role in the future of drug development, while the majority of pharma and biotech companies will continue to maximise their research and development efforts.
Data from the Association of Clinical Research Organisations shows that biopharma companies currently outsource at least 30 per cent of all clinical processes, including comparator sourcing, and the trend looks set to continue in the months and years ahead.