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Not Enough Days at the Beach

As I have commented in a previous blog, the DIA Annual Meeting this year was in San Diego. The meeting was excellent but perhaps I should have stayed over a few days to enjoy the weather at the beach.

There were several sessions that I enjoyed what I learned and perhaps you will too. As an overall comment, I noticed a considerable shift in exhibitors from the past where the floor was overwhelming with CROs. It was much more balanced this year with a variety of representatives from many vendors serving the industry. This is a positive change.

There were 13 countries who sent representatives from their agencies to the meeting. Two panel sessions focused on International Collaboration between Regulators. The key take-away for me was the direction (stated by the FDA) (confirmed by others) seeking mutual recognition across agencies, especially on drug approvals and inspections.

There are some significant issues to resolve due to ‘societal values’, where the culture of a country will cause a different perspective concerning the risks and benefits of that drug in the marketplace. Issues from inspections will take on a greater or lesser importance to an agency because of local public values.

There is an even increased difference concerning OTC products and the impact of experience on their opinions. There was agreement from the panel that they (each agency) needs to better understand themselves first. They will need to assess their own positions on risks and benefits clearly before anything concrete can be accomplished.

A trend towards extensive partnering/outsourcing with CROs is another hot topic of discussion. Pharmaceutical sponsors are finding real value in reducing costs by conducting Clinical Trials with the help of CRO partners. We have seen this trend increasing over the past 5 years.

More recently, large Pharma have been selecting premier or preferred CROs where they will direct all or most of their business. This is causing a segmentation of large Pharma with large CROs and medium Pharma with medium CROs. CROs are scrambling to closely align themselves with their preferred partners.

Based on the data shown in the session, it was shown that with large pharma, the percentage of trials outsourced increased with each stage. In contrast, medium pharma outsources more consistently across the various clinical trial stages. Therefore, it will be interesting to see how the industry will adjust and align their specific needs and capabilities with the opportunities for clinical trial outsourcing among both sponsors and CROs.

At OpenText we’ll be helping organizations create and ensure seamless regulated content management business processes across the extended enterprise regardless of organizational size.

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