Do we need to achieve levels required by regulatory agencies in developed countries?
Dr. Musey said that the ultimate goal for new vaccines is market penetration through rapid approval of a licensing application at a reasonable cost. Development strategy has been to take a vaccine that is already licensed in another country, and bring it to the developing world rather than initial development solely in the emerging country.
There are new opportunities to do so. Access to new customers, increase in national prosperity, increase in middle class, increase in financial support for low-income countries and potential to gain access to both public and private markets has made developing world vaccines more attractive.
An increased number of countries are adopting international guidelines for clinical trials and manufacturing, making the process more stable and reliable. There is also increasing capacity in emerging countries to conduct clinical trials programs.
Challenges still remain. Regulatory requirements can be lengthy and inconsistent for clinical trial authorization. Some countries will require that the vaccine will be manufactured locally in order to participate in trials. There are also cultural challenges and issues with one country accepting data generated in another country. Differences may exist in vaccine regimens and adverse event reporting can vary wildly. There are a limited number of laboratories that are capable of conducting vaccine release assays. And there is also little understanding of the need to keep protocols and patient information confidential.
Even with these challenges, the quality of clinical research has improved. Key factors for success include early planning of key activities at country and site levels, selection of preferred partner (local clinical trial professional), awareness of ethical issues and cultural considerations for study volunteers and those performing study procedures.
Check back here in a couple of days for the presentation. Great presentation Luwy!