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.
데이빗 제임스 (David James)
노보텍은 글로벌 실행 능력을 갖춘 아시아 태평양 중심의 선도적인 바이오텍 CRO 기업으로 국제적으로 인정받고 있습니다.
노보텍은 연구소, 임상1상 시험 기관, 약물 개발 컨설팅 서비스(DDC, Drug Development Consulting) 그리고 FDA 규제 전문성을 갖춘 임상 CRO 기업으로 1상에서부터 4상까지의 임상시험과 생물학적 동등성 시험을 포함하여 5,000건 이상의 임상 프로젝트에 참여한 경험이 있습니다. 노보텍은 아시아 태평양, 미국, 유럽에서 임상시험을 수행하고자 하는 바이오텍 고객들에게 서비스를 제공할 수 있습니다. 노보텍은 전 세계적으로 3,000명 이상의 직원과 34개의 사무실을 보유하고 있습니다.
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