Each year, new medicines are launched globally but few are available to Chinese patients, in comparison to those in the US or EU. Drug developers are working to reduce this gap and expand the reach of new molecular entities (NMEs) so that they can improve healthcare to patients in need. Confronting this issue requires navigating the evolving regulatory environment in China and capitalizing on parallel development opportunities in the global market.
Bill Hanlon, PhD, vice president, head of Global Regulatory Affairs, shares some of the latest thoughts and strategies from his recent presentation at the Covance Clinical Seminar in China.
When running early development studies, sponsors must consider whether or not to provide open-label, long-term treatment at the end of their randomized, placebo-controlled trial. In the past, sponsors have been hesitant to offer open-label extensions. But with our industry’s increasing focus on patient-centric care, sponsors are now weighing their options to incorporate more patient input into early development, especially when working with promising novel treatments in rare disease studies.
When it comes to clinical trials, sample collection kits need to arrive on time, or precious samples will not be able to be tested within stability, meaning their data is irretrievably lost. Adverse weather events and other disruptions to the sample chain of transport represent a serious threat to specimen stability and data integrity.
To combat this threat, Covance has invested in a team of global logistics personnel who continually monitor shipments and potential transportation problems around the world, implementing contingency plans when necessary to maintain an extraordinary record of 99.9% on-time deliveries. Even when faced with the largest storm so far this year, Winter Storm Jonas, Covance delivered.