Why Japan and why A2?

Advantages for Including Japan

	Why Japan?	Why A2 Healthcare?
Market	•Japan has 70 billion USD drug market which is the third largest in the world. •Citizens are mandatorily covered by our National Health Insurance System so Japanese patients will have easy access to be treated with innovative/expensive drugs.	•A2 is well known as a top-tier CRO in Japan and has supported NDA for 220 IPs (52 for oncology products). •We serve as to be your “professional” regional partner, providing high-quality deliverables for your product to be marketed in Japan.
Cost	•Japan is NOT an expensive country to run your trial. •Japan has rarely faced inflation in the past decades. Including Japan could be cost-effective in your global development plan.	•A2 will coordinate and select local SMOs and vendors, as well as manage site costs to minimize study budget. •Open to have a fixed price contract based on your needs (details TBD). •CRO service fees tend to be lower compared to global CROs.
Data Integrity	•Data integrity levels from Japanese sites are very high. •Japanese data are applicable for foreign submissions. (eg. FDA, EMA).	•A2 has experienced 40 site inspections by PMDA, and 1 each by FDA and EMA. •with no major/critical findings
Site / Patients	•Over 120 million in population and 84 years of average life. Possessing huge patient/subject pool for many target indication. •Patient compliance to the study is high and tends to result in a low drop-out rate compared to ROW.	•A2’s database covers accumulated 84 million patient data from 97,000 Japan sites. •Initiated nearly 9,500 sites (3,800 individual sites) in the past 8 years. •Strong connections with KOLs in various TAs including oncology KOLs.
Enrollment	•Patient enrollment is likely to be achieved as planned. •In many cases Japan will increase the original target number of patients to bring more patients for the participating global study.	•Achieving over 90% enrollment compliance within the agreed schedule on recent completed studies, which outperforms in this industry. •A2 will propose the best site selection plan to meet your enrolling timeline.
Regulatory	•PMDA usually expects 15% of the global data to be Japanese patients for them to provide Japan NDA. In some cases, it could be even lower. •Incentives to explore like Orphan Drug Application and SAKIGAKE (fast track approval).	•Well-experienced regulatory team can support the development of your best regulatory pathway. •A2 can act as your In-Country Clinical Caretaker (ICCC – Local Representative) to manage your study in Japan.

As a Summary..

Inside your global program

-Small portion of Japanese patients will open Japan market

-Japan will accelerate patient enrollment

-Adding Japan will likely not increase study budget

A2 Healthcare is a professional and quality driven CRO to support your regional development