Hong Kong - Novotech, a leading biotech specialist CRO in the Asia-Pacific region this month showcases its rare diseases expertise in a new ARENA webinar titled Understanding Asia’s Success as a Rare Diseases Clinical Trial Location, and a keynote presentation at the Clinical Trials in Rare Diseases Conference 2021 (September 14, virtual).
- The Understanding Asia’s Success as a Rare Diseases Clinical Trial Location webinar is available to view here: https://novotech-cro.com/webinars/accelerating-clinical-trials-rare-disease-understanding-asias-success-rare-disease.
- Novotech’s Team Lead Client Operations Kirsten Kinsey’s presented Rare Disease Program Success in APAC at Clinical Trials in Rare Diseases Conference 2021.
There are up to 8,000 rare diseases affecting between 6% and 8% of the worldwide population in total. It is estimated there are about 25 to 30 million people affected in the US while over 45 million people may be suffering from a rare condition in Asia, with 20 million in China alone.
Despite the large number of known orphan diseases, it is estimated only about 5% of rare diseases have an approved treatment.
The webinar looks at Asia’s rare disease clinical trial landscape, and China’s increasing popularity as a clinical trial location, to understand the regional advantages on offer. The panel discusses their first-hand experiences and insights working on range of rare disease programs from a clinical trial operations perspective. They also share the challenges and critical program strategies that need to be considered to support accelerating a clinical program development in the rare disease space.
About 25% of drugs granted with an orphan designation since 2015 were concentrated on 10 major indications. For most of these indications, clinical studies involving sites from Asia-Pacific outperformed the median patient enrollment duration of rare disease trials globally.
Asian countries have been implementing legal frameworks similar to the Orphan Drug Act used in the US, encouraging clinical trials in many locations including South Korea, Taiwan, Singapore and the Philippines.
These new legal frameworks in Asia offer general criteria to accelerate the registration and approvals of drugs for the treatment of rare diseases and have established new rules concerning health insurance coverage, expedited registration, and marketing exclusivity periods for biopharma companies.
Furthermore, the Action Plan on Rare Diseases launched by the Asia-Pacific Economic Cooperation is expected to accelerate supportive actions to develop public actions, disease registries, and patient access to clinical trials, and to reduce enrollment durations.
Rare disease clinical studies require a CRO with local knowledge across the Asia-Pacific regulatory, cultural and clinical processes as well as proven networks with specialist clinical leaders and organizations.
This includes expertise in site selection and access to patient registries to accelerate patient enrolment, and global regulatory knowledge regarding the specific context of rare disease trials and orphan diseases trials.
The Asia-Pacific region is the fastest growing region in the global CRO market, offering access to vast patient populations, quality data and expedited regulatory processes.
Novotech has just been awarded the ‘2021 Frost & Sullivan Asia-Pacific CRO Company of the Year’. This is the fifth consecutive year that Novotech has been recognized with the prestigious CRO regional award.
Novotech 是國際公認具有全球執行能力、首屈一指、以亞太地區為中心的生物科技領域受託研究機構 (CRO)。Novotech 是具備實驗室、第 I 期臨床試驗設施、藥物開發諮詢服務、以及美國食品藥物管理局 (FDA) 法規專業知識的臨床 CRO，擁有超過 5,000 個臨床試驗專案的經驗，包含第 I 期到第 IV 期臨床試驗和生體相等性研究。Novotech 主要服務的客戶群是在亞太地區、美國和歐洲進行臨床試驗的生物科技公司。Novotech 在全球擁有超過 3,000 名員工和 34 個辦公室據點。