Relationship Takes Priority Over Cost for 66.7% of Firms Using CROs for BE/BA Studies

Pharma IQ

The value of teamwork has been increasingly recognised by pharmaceutical companies in recent times. Research has shown that around two thirds now outsource their bioequivalence and bioavailability (BE/BA) studies, suggesting that this is an area in which quality partnerships carry particular significance. Interestingly, only one third of firms using CROs for this part of the process believe cost to be the most important factor, showing that drugmakers are prepared to pay a premium for a partnership that works.

The growing importance of BE/BA studies

Bioequivalence studies have an especially crucial role to play in ensuring generic drugs are up to standard, enabling a smoother, more efficient and cost-effective journey to market. Around two-thirds of global clinical studies are involved with determining bioequivalence and it is widely accepted across the pharmaceutical community that such endeavours should take priority as early in the development process as possible.

Pharma IQ recently conducted a survey among industry professionals ahead of the 2nd Annual Bioequivalence and Bioavailability Studies conference in September. Representatives of both innovator and generic companies took part, as well delegates from CROs. When questioned as to the extent of their involvement in BE/BA research, 100 per cent of respondents said that at least five studies had been conducted by their company in the past two years.

An increasing trend in recent years has been for pharmaceutical companies to use third-party research organisations when carrying out their BE/BA studies. The survey was conducted among firms using CROs for varied proportions of their work in this area. One in three respondents claimed to be outsourcing at least 75 per cent of BE/BA studies, while 33.3 per cent cited a figure between 50 and 75 per cent. The remaining third used a CRO in less than 25 per cent of their investigations.

Challenges in BE/BA research

Most would agree that the list of issues affecting success rates in BE/BA studies is long and needs to be fully understood if products are to hit the market in a timely manner and within budget. Among the biggest challenges is compliance, whether that is in terms of satisfying the EMA guidelines or meeting the standards of the US Food and Drug Administration or other regulatory body. There are also difficulties pertaining to the actual BE/BA investigation itself.


Understanding how to successfully secure a biowaiver is one of the key concerns, as is validating in-vitro in-vivo correlation (IVIVC). Issues may also arise during efforts to increase bioavailability, while proving bioequivalence for modified release products can also present difficulties. The Pharma IQ study quizzed delegates on what represents their biggest challenge in BE/BA research – the results were spread evenly between two key issues.

While 33.3 per cent cited the ability to secure biowaivers as their main concern, another third said it was validating IVIVC. Interestingly, none of the participants singled out complying with guidelines as an area in which they face particular difficulty, though it is important and can present challenges for many organisations.

Regulatory compliance

General guidance on BE/BA studies has been available to the pharmaceutical industry for some years now, with two key developments having made an especially notable impact. In 2007, the FDA issued Critical Path Opportunities for Generic Drugs, in a bid to help streamline the process for getting products to market. In Europe, the EMA provided guidelines relating to bioequivalence investigations in late January 2009.

In an interview with Pharma IQ, Dr Ole Osterberg, clinical research scientist at NeuroSearch, discussed how the industry had adapted following the EMA guidelines' introduction. "I think they have had a huge impact. Obviously, when you as a pharmaceutical company conduct BE/BA trials, it is [crucial] to get regulatory approval. So whatever the regulatory bodies say in their guidelines, we will follow very carefully."

Benefits of outsourcing BE/BA studies

Mark Hammond, chief executive officer at Melbourn Scientific, recently outlined the benefits that a partnership can offer to pharmaceutical companies at this stage of product development. "An experienced partner will ensure that the formulation and testing procedures reflect the adequate requirements for a pre-clinical or first-in-man trial whilst making certain that sufficient data is collated for regulatory purposes at each stage," he explained.

"This will help the product get to clinic in a cost-effective and time-efficient manner," Mr Hammond went on to say, which of course are among the main reasons why BE/BA studies are so important in the first place. But in order to access the potential advantages of outsourced BE/BA studies, pharmaceutical companies must first identify the most suitable CRO with which to partner on investigations.

Choosing the best service provider

According to NeuroSearch's Dr. Osterberg, there are several key things for pharma firms to consider when choosing a CRO. "Well my first tip would be to look less at the price tag on the provider, and more on the quality you would receive. If there were to be any issues regarding your bioanalytical services, authorities might question, and you could end up with a failed trial that you have to repeat. So, number one, look at the quality not at the price tag."

It is a sentiment with which most of the pharmaceutical community seems to agree. Pharma IQ asked respondents to its BE/BA survey what they believed to be the most important factor when choosing a service provider. Two-thirds said that the potential for a strong working relationship – most likely resulting in a higher quality of service – was their most sought-after criterion. Only a third of companies were more concerned by the upfront cost, while a CRO's reputation alone would not be enough to sway any of the participants.

Dr. Osterberg stressed the importance, however, of selecting an experienced CRO for bioanalytical studies. "Often you will see new or emerging service providers. What you have to do is reassure yourself that they have experienced people behind any cost estimate for an analytical solution." Pharma IQ's survey quizzed respondents on whether they were happy with their current CRO. While 66.7 per cent of companies would not rush to change service provider, the remaining third claimed to be not entirely pleased with their partner's offering – suggesting Dr. Osterberg's tips could be of use to some in the future.