The benefit of running clinical trials in Asia- Pacific for biotech companies
Running clinical studies in Asia-Pacific from early to late-stage trials – why biotech companies are increasingly heading to the region.
Asia: Preferred Destination for Clinical Trials
Asia is the fastest-growing medicines market globally, with China currently the world’s second-largest market after the US, with medicines spending of $137 billion in 2018, up $40 billion from a decade earlier.
Australia: Preferred Destination for Early Phase Clinical Trials
The clinical trials process is complex. It requires substantial investment and skilled human re-sources, and involves risks, not least, the navigation of complex regulatory processes. To over-come these challenges, small biotechnology companies outsource their early phase clinical studies to contract research organizations (CROs). This white paper highlights research on why Australia continues to be a hub for early phase clinical trials.
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Regulatory requirements for clinical trials in Australia
With a streamlined regulatory environment, including no requirement for an IND, and the supportive R&D Government refund of up to 43.5% on clinical research spend, Australia has become a preferred destination for early phase clinical trials.
Accelerating Genetic Therapy Clinical Trials in Asia-Pacific
A growing number of biotechnology companies, both in the West and in Asia, are specializing in gene therapies and other regenerative treatments boosted by the approval of the first genetic therapy agent (tisagenlecleusel) by the FDA in 2017.
Accelerating Immunotherapy Clinical Trials in Asia-Pacific
Over 600 sites across Asia-Pacific have been involved in the clinical development of now approved IO drugs, and hundreds more are experienced in managing clinical trials with immunotherapies for both monotherapy and combination therapies.
Orphan drug trials accelerating in Asia Pacific
We have observed an unprecedented effort in the clinical development of Orphan drugs in the recent years. In fact, in 2018, the majority of new drugs approved by the FDA and EMA were Orphan medicines.
The objective of this report is to describe the Orphan drug development landscape and explain how the positioning of the Asia region has been evolving in the global picture.
Overview of Lung cancer landscape in Asia
Lung cancer is one of the most common malignancies in the world, representing about 1.6 million cases annually and over 10% of all new cancers. The most well-known risk factor for lung cancer is cigarette smoking which has become endemic in Asia.
Renal and Bladder cancer landscape in Asia
The incidence of urological cancer has increased consistently in the recent years globally. Bladder cancer has become the ninth most common cancer worldwide, with over 400,000 new cases diagnosed each year. A majority of all bladder cancer cases occur in men in the less developed regions of the world due to environmental factors and smoking habits.
Asia Pacific, a hub for clinical trials in NAFLD
Non-alcoholic fatty liver diseases (NAFLD) are one of the most common liver disorder in developed countries and are particularly prevalent in Asian countries, especially in South Korea and Taiwan. Over a third of all industry-sponsored clinical studies initiated during the period (2015-2017) involved sites located in a country in which Novotech operates.
Hepatitis B landscape in Asia
It is estimated that at least 2 billion people or one third of the world’s population have been infected with HBV. Approximately 240 million people or 6% of the world’s population are chronically infected and the Asia Pacific region represents three quarters of chronic HBV patients worldwide.