Integrated Solutions in Japan

More than two years ago, Syneos Health launched its Biopharmaceutical Acceleration Model (BAM) globally, demonstrating how our uniquely comprehensive array of capabilities can be used to help pharmaceutical and devices companies accelerate the development and
commercialization of therapies around the globe.

The Biopharmaceutical Acceleration Model is essentially an approach to providing service based on integrated solutions; it was designed to be flexible, scalable and purpose-built to make the most of significant changes in the markets that we operate in, whether they are driven by regulatory, technological, social, economic or disease-related factors.

In Japan, given a number of very pressing market and regulatory drivers, keen interest has been shown in the Biopharmaceutical Acceleration Model and how it can be deployed to serve a range of companies and their different needs in this market. Most often we are asked three things:

• First, what is the model in detail, and how is it adapted to the Japan context to meet particular needs?
• Second, what kinds of companies are getting the most value from BAM in Japan, and how?
• Third, what early examples of deployment of BAM in Japan can we learn from?

Few doubt that the degree of change playing out in the Japanese healthcare market at the moment is as high as many of us have seen in our working lives; as a result, we note many companies showing a greater sense of urgency in responding to change and more willingness to innovate in areas traditionally thought too challenging, such as in service delivery for physicians.

At the core of the change is a pressing need in Japan for truly innovative therapies to be brought to market faster and more cost-effectively than even recent drug lag improvements have delivered, at the same time striving for extraction of vastly increased efficiencies from more mature parts of the portfolio where drugs and devices are effective, but not differentiated from lower-cost alternatives.

Fundamentally, these needs result in two drivers of change that are relevant to the BAM model: first, the need for traditional safety and efficacy testing in clinical development to be paralleled by much more comprehensive outcomes-based research (so-called Real World Evidence), in tandem with weighing commercialization considerations much earlier in the process. Getting this driver right ensures that the truly innovative merits of the drug can be properly rewarded during reimbursement negotiations.