Posts
Moderator: Mark Roseman, Vice President, Account Manager, PPD, INCWorkshop Faculity: Simon Britton, Vice President, Account Management, PPD, Inc
Mitchell Katz, Vice President, Business and Clinical Operations, Eisai Global Clinical Development
Jorge G. Guerra, Senior VP, Global Clinical Operations, Biogen Idec
Jose Eduardo Neves, Medical Director, Astrazeneca
Earlier today at this panel, members of the CROs industry discussed the best ways to conduct clinical trials in nontraditional countries.
What are the issues facing in the pharma and biotech industry today? The panelists stated that cost was an issue in addition to understanding the regulatory climate outside the US. Keeping on top of the ever-changing environment also presents a challenge. It’s also important to recognize that going into new markets and keeping the costs down while ensuring the quality. It is also difficult to address the concerns of the people about the safety of the trials.
When looking to expand to other areas, the majority of the panel members agreed that Europe and North America have similar standards. For Japan, they’re looking to expand past Japan, to Korea, China and even India. Large pharma have offices in Japan, and they’re trying to force Japan to be part of the global studies.
The panelists were asked whether companies expanding or relying on CROs? The panelists responded: Astrazenica uses CROs are in terms of individual programs. Mitchell Katz states that Eisai Global Clinical Development has affiliates in offices across the globe. Experience in the country will come from the service provider. PPD states that it’s understanding what’s in the country. Some companies are trying to grow in global needs, others are trying to grow in terms of registration studies. Many of the CROs were already running studies, so Astrazenica saw the opportunity to be in that country. PPD, Inc says pharma growing commercial groups and taking research out. Mitchell Katz of Eisai Global states that it’s not where to go, based on the practice of medicine. Their protocols depend collaboratively on CROs who already have experience with that particular country.
When conducting Mitchell: It’s not about cost savings, it’s about the right countries and people to focus your studies on. Planning on the front end, do global trials (regulatory issues), but not practical in competitive to be able to do all trials in US.Jorge: Ideal to attract all patients in US. But all in US, you could gain a lot of time if you could guarantee acceleration.
Two-thirds of trials are still being conducted in regional market. Will this change soon? Astrazeneca provided the example in terms of the current state of China. If China wants to become world power, it must reform some institutions. Same to clinical, we’ll still see growth, but in nontraditional markets, they have to adapt to the system as well. Mitchell- will be balanced. Traditional drug development was all domestic at one point. Most small and medium sized companies didn’t have structure. But now we’ll see that the industry has allowed us to go global. This is a very approved approach for drugs being approved. Can’t afford to do that, and will be more balanced in terms of globalization.
Regulatory challenges are real because of the constantly changing climates. For regulatory approval process, there needs to be planning. But is this reality? No. Patient population is opportunity in China, it’ll be a realistic place to plan a study. We depend on CROs to guide us through these countries. Critical to stay on changes, some countries are getting better and some are getting worse, and CROs can guide small companies in these matters.
