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. 

Media contact

About Novotech Novotech-CRO.com 

노보텍은 글로벌 full-service CRO이자 임상 과학 자문 기업으로서 모든 임상 단계에서 바이오텍 및 제약회사의 신뢰받는 파트너로 자리매김하고 있습니다.  

아시아 태평양, 북미, 유럽 전역에 걸쳐 30개 이상의 지사와 5,000개 이상의 임상시험기관 파트너십을 보유하고 있으며, 다양한 환자 집단에 대한 최적의 접근성을 바탕으로 삶을 변화시키는 치료제의 성공적인 시장 진입을 지원하고 있습니다.  

고객 중심 서비스 모델을 통해 노보텍은 인재, 프로세스, 기술을 유기적으로 통합하여 혁신적인 치료제를 보다 신속하게 시장에 도입하는 데 기여하고 있습니다. 또한, 진정한 파트너십 접근 방식을 바탕으로 고객의 성공, 혁신 역량 강화 그리고 전 세계 의료 발전을 향한 노보텍의 확고한 의지를 실천하고 있습니다.  

노보텍은 19년 연속 Frost & Sullivan의 ‘Global Biotech CRO Award’를 비롯한 다수의 글로벌 어워드를 수상하며, 임상시험 운영 및 혁신 역량의 우수성을 공식적으로 인정받고 있습니다. 심층적인 치료 및 규제 전문성, 현지 시장에 대한 인사이트를 바탕으로 노보텍은 임상시험의 전반적인 효율성을 향상, 데이터 분석의 최적화 그리고 정밀한 환자 모집 전략 수립을 통해 고품질의 임상시험 운영을 실현하고 있습니다. 

노보텍은 과학적 진보를 바탕으로, 글로벌 건강을 개선하는 혁신 치료제 개발을 실현하는 것을 사명으로 삼고 있으며, 앞으로도 바이오텍 및 제약회사의 성공적인 임상 개발 여정을 함께할 것입니다. 

자세한 정보를 확인하거나 전문가와 상담하려면 www.Novotech-CRO.com을 방문하세요.

기타 관련 콘텐츠