Jan 1, 1970 - Jan 1, 1970,

3 steps to delivering personalized medicine in Japan

Andrew Tolve explores the three things Japanese pharma firms need to do to become leaders in personalized medicine

The need for tailored cancer treatment in Japan is high.

Fifty percent of Japanese citizens will be diagnosed with cancer, and one out of three of those patients dies from the disease. That amounts to more than 300,000 patients lost to cancer annually.

Personalized medicine has emerged as a promising way to address these dire statistics.

Molecular diagnostics and biomarkers can help determine the optimal medicines and treatments for particular patients and particular mutations.

Successful drugs like Glivec and Herceptin have already proved the potential of personalized medicine in oncology. (For more on personalized medicine, see Personalized medicine: Lesson for Oncology and Personalized medicine: A kick-start for innovation?; for more on biomarkers, see Biomarkers and oncology forecasting: How to hit a moving target.)

And yet personalized medicine in Japan lags behind that of other countries with similar economies.

This is in part due to the high cost of living and cost of labor and to language barriers and other factors, like the attractiveness of nearby markets in Asia.

Companies in Japan, therefore, have reached a juncture at which they must decide if the Japanese market is to become a leader in personalized medicine.

“That’s the fundamental question,” says Stephen Uden, head of Japan oncology development at Novartis.

“There’s still some hesitancy and not everyone has bought into the personalized medicine story. Japan could be and should be a major player.”

1. Committed leadership

Successfully delivering personalized medicine to Japan requires at least three steps, according to Uden and other oncology experts in the Japanese market. The first is strong, committed leadership.

The journey from research and development to clinical studies to regulatory approval to commercial launch is rife with challenges.

Analyzing the properties of tumors during a clinical trial can be exorbitantly expensive and ridden with delays, regardless of whether companies choose to outsource the process or execute it internally.

Likewise, physicians can lean away from drugs and associated diagnostics due to skepticism, cost, or delays.

Furthermore, regulatory bodies can require companies to get approval for both a drug and its concomitant biosimilar, which can create further lags and ambiguity between the regulatory process and the commercialization of a drug. (For more on biosimilars, see Forecasting the potential of the biosimilars market and Pharma forecasting: Stress-testing the business case for biosimilars.)

If leadership is not fully committed to personalized medicine, these strains can quickly derail initiatives.

“None of this is impossible,” says Uden. “The key is having the mindset that you’re going to make it work.”

2. Developmental flexibility

While determination is important, it can’t come at the cost of flexibility, says Mark Smith, president of Merck Serono Japan.

Dealing with personalized medicine means embracing scientific research that is constantly evolving in new and often unanticipated directions.

Companies must therefore be committed to the overall process but flexible as to the specific nature of the product they’re pursuing.

“Your development at any stage is based on your current level of knowledge and understanding,” says Smith.

“Translating that to clinical benefit is challenging. As the science moves, your understanding may well change, so you have to be flexible in the development.”

Having a fluid understanding of the science while simultaneously trying to create a product presents tension, of course—and delays and mounting costs.

Smith says leaders in Japan must embrace these setbacks if they want their final products to truly meet unmet medical needs and benefit Japanese cancer patients.

“It demands you do more clinical studies and get more patient data as early as possible before making a final decision,” he says.

3. Communication, communication, communication

A third key to delivering personalized medicine to Japan is communication.

No matter how steadfast companies may be or how well they accommodate the evolving science behind a drug, it won’t come to any good if a sales rep can’t convince a physician that a targeted treatment surpasses the efficacy of a traditional drug.

“The simple answer is that to be successful you need to be able to deliver the information to the prescriber in a way that he fully understands what you’re talking about,” says Smith.

“That way he can then make an informed decision for the patient.”

Prioritizing education amongst a sales force is thus important.

Indeed, ensuring cross-functional communication is critical throughout the process of bringing a personalized drug to market, says Uden.

Sales reps need to understand the science behind the drug, an understanding that should be imparted by the scientists who directed the studies. (For more sales reps, see Transform reps into KAMs, Don't write off the sales rep just yet and Medical scientific liaisons: Sales reps in disguise?.)

Likewise, R&D needs to be in communication with commercial colleagues so they can think about a number of factors, like how to position the drug, where assays should be done when the product is approved, how much investment should the company risk, and so on.

“You have to look at the entire pipeline of drugs and come up with a [cross-functional] strategy,” says Uden.

Smith agrees: “There are multiple points where a cross-functional approach will lead to a better solution. It’s implementing in the organization the mindset that we don’t work in silos; we work in a matrix. You have to understand that what you do has an impact on the guy across the floor.”

For more on personalized medicine in Japan, attend Oncology Japan 2011 on November 9-10 in Tokyo.

For exclusive business insights, download eyeforpharma's Pharma Emerging Markets Report 2011-12 and Pharma Key Account Management Report 2011-12.

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Jan 1, 1970 - Jan 1, 1970,