Leveraging big data to create transparency, mitigate risks and operate in real-time is critical

With the innovation boom in Asia and many early-stage assets emerging, the time is ripe for Asian economies to establish cross-border business relationships by systematically tapping potential markets for successful market penetration.

- Hithaishi C Bhaskar

Edwin Ng, Senior Vice President, General Manager (Asia-Pacific), Medidata Solutions

Regulatory compliance and patient protection are simultaneously enhanced by increasing investments in technology to meet quality and efficacy which are paramount in the pharma/biopharma and clinical trial space. Yet, with the rapidly changing regulatory expectations, certain regions in APAC experience regulatory inertia which can hinder development and bilateral trade. Despite the challenges, Asian economies are adopting evolving policies and regulations supporting operations. However, can regulatory reforms bring down the cost and time required to bring a product to market? Edwin Ng, Senior Vice President General Manager (Asia-Pacific) at Medidata Solutions shares more insights with Biospectrum Asia. Edited excerpts;

What are the most challenging market access issues pharma and biopharma companies are facing across the APAC region?

One of the biggest challenges in market access of life science and healthcare solutions are regulatory hurdles in clinical trials. Only 10 per cent of drugs that complete Phase I trials ever reach patients this low success rate is largely a result of a highly inefficient clinical trial process. The risks presented by regulatory non-compliance, and the associated significant delays, have a substantial impact on any company's business and outputs. Sponsors that preempt regulatory obstacles can gain an advantage by reducing time-to-market, creating significant shareholder value, and getting their drug to patients faster. The ability to use big data to create transparency, mitigate risks and operate in real-time is critical for life science leaders.