Designing A Global Drug Development Program To Secure FDA Approval

As biotech companies navigate the current instability and reduced funding available within the public and private markets, there is an increased movement to take clinical trials to global contract research organizations in the Asia-Pacific region. Global partnerships have proven to utilize capital and increase asset valuation efficiently, particularly in Australia and China. However, building a global program takes careful planning to ensure that the necessary regulatory approvals are granted, providing patients access to innovative new medicines. The earlier a global drug development strategy is planned and defined, the sooner biotech companies can begin to reap the benefits, including the fast-tracking of high-quality clinical data collection.

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