Raising Japan’s pharmaceutical game

By Jonathan DeHart

When Harumi Mukai, MD, PhD, worked at Tsukuba University, her day began at 7 am with preparing experiments for the day. After wrapping up her early rounds in the lab, from 8 am to 9 am she visited patients’ bedsides in the university hospital, followed by a trip to see new patients at a clinic until 2 pm or 3 pm. After that it was back to the hospital to check on patients again. At this point, her day was just beginning.

After somehow squeezing in time for lunch, she taught medical students, made another trip to the hospital to check on more patients, and rushed home to make dinner for her kids. Putting her children to bed, she then returned to the lab to tinker with experiments in progress. After that, she went home, slept and rose early to do it again the next day.

When a supervisor paid her a visit at her own hospital bed when she was recovering from giving birth to her second child to ask her when she could get back to work, that was enough. She began to look elsewhere and the pharmaceutical industry caught her eye. “It was just too much,” she recalls.

Her life returned to balance when she received an offer four years ago to work for Janssen, where she now serves as Director of Oncology, Virology and Immunology for the company’s Science Department. Compared with the endless list of obligations in her former post, her main duties today, which include reporting on safety and conducting clinical trials, feel manageable and interesting. Since the move, she hasn’t looked back. “I’m quite happy where I am now,” she says. “I really didn’t know anything about drug development before, but I was curious to learn more.”

Dr. Mukai’s choice to make the move from medicine to the pharmaceutical industry mirrors a trend in Japan. More medical doctors are moving into the pharmaceutical industry than ever before. The industry itself is likewise in a state of flux.

Around the world, there is a growing need for medical doctors with a practical understanding of pharmaceuticals, who can oversee the process of drug creation from the development stage to the point where patients are taking them. In response to this trend, Osaka University is launching a new course in pharmaceutical medicine from April 2013 that will prepare doctors and other professionals with backgrounds in science and engineering to work in the pharmaceuticals industry.

“This program builds a bridge between basic science and practical science,” says Akiyoshi Uchiyama, MD, PhD, an executive member of the Japanese Association of Pharmaceutical Medicine (JAPhMed) and President of Artage Inc., a dietary and nutritional consultancy. “It will show doctors how to register the drugs they have developed and how to take them through the clinical science phase to turn them into pharmaceutical products that benefit society.”

Addressing this process of drug development and tackling key concerns such as safety, the new program to be launched at Osaka University could become a game changer for Japan’s pharmaceutical industry.
For Yasushi Suzuki, a pharmaceutical industry recruiter who works for CMIC Best Solutions, “the greatest thing about the program is that it will open young medical doctors’ eyes to more options for their future careers.”

The global lab

Osaka University is creating this new course with good reason. While Japan ranks third globally in terms of basic scientific research, its place dips to 18th when it comes to clinical development, falling even below China. Not to mention, the nation has historically lagged when it comes to the introduction of drugs and medical devices. While the time lag in the approval process is largely due to bureaucratic barriers, its underperformance in clinical research and drug development stems from a dearth of funding.

According to Yasuhiro Kanatani, MD, PhD, Director of the Department of Health Crisis Management in the National Institute of Public Health, Japan’s slow drug review process and funds famine is mainly due to its lack of a strong centralized body that oversees the industry. “There is no real equivalent of the FDA,” Dr. Kanatani says. “There are far fewer drug reviewers in Japan than elsewhere, too.”

This picture, however, is starting to change. “In the past the timeline for drug approval in Japan was sometimes as long as ten years,” says JAPhMed Chairperson Kyoko Imamura, MD, PhD. “But now regulatory authorities are working hard to shorten approval times. This is very good news. There has not been any negative impact on safety so far with this shortened approval time.”

Since 2007 the PMDA (Pharmaceutical and Medical Device Agency) has been reviewing drugs and pharmaceutical products submitted by pharmaceutical companies in consultation with clinical and regulatory experts within twelve months. For special drugs, such as those for intractable diseases, the review process has been accelerated to within six months. Increasing the number of pharma-savvy doctors reviewing drugs will only accelerate the process further.

“The goal of the program at Osaka University will be to increase the number of doctors who are able to converse at the level needed to address all sides of the approval process,” Dr. Uchiyama says. “It is crucial that everyone involved in the approval process is able to discuss medicine at the medical and scientific levels.”

Alongside the quickening of drug reviews, in recent years the Japanese government has also stepped up funding to key universities for medical research. As Japanese researchers make key breakthroughs, most famously seen in the Nobel Prize winning adult stem cell research by Shinya Yamanaka, MD, PhD, of Kyoto University, this increased flow of funds will hopefully continue to grow.

Standard practice

Japan doesn’t really have much choice but to change. To keep pace with trends in the global pharmaceutical industry, business as usual is not really an option. Around the world, pharmaceutical developers are pursuing greater levels of safety, efficiency and efficacy than ever before in an ongoing effort to standardize the industry.

Europe and the US are at the forefront of this global push to standardize medical research and development. In a bid to streamline its program with the progressive West, Osaka University is basing the curriculum for its graduate level course in pharmaceutical medicine on similar programs in the UK, Switzerland, Germany, France and beyond.

Beginning in 1975 at Cardiff University, medical schools across Europe began developing a common syllabus for medical schools that essentially prepares doctors to work in almost part of the healthcare industry, from pharmaceutical ethics to the ins and outs of conducting clinical trials. Since 2009, the EU has been standardizing this course curriculum, and in 2014 intends to spread it worldwide.

Until the launch of Osaka University’s pharmaceutical medicine program in April 2013, Japan has had no such framework in place. With the help from JAPhMed, the program has been developed at the Center for Advanced Medical Engineering and Informatics, Osaka University, which received support from the highest levels of government, receiving funding from the Ministry of Education, Culture, Sports, Science and Technology (MEXT) to support postgraduate training; from the Ministry of Health, Labour and Welfare (MHLW) to support drug discovery; and from the Ministry of International Trade and Industry (MITI) to support translational research.
Opportunities for pharmaceutical industry leaders to get involved are ample, and include sending executives to give lectures, sending employees for further training, providing internships for students in the program and recruiting graduates.

“When I was teaching at Tsukuba University, there was no program that educated students about clinical trials or anything like that,” Dr. Mukai says. “It’s important to provide a program that fills in this gap for people who already have medical expertise so they can become involved in approval procedures and clinical trials.”

The standard course will last two years (equivalent to the EU’s PharmaTrain Masters course), with the option of a shortened one-year course (equivalent to the PharmaTrain Diploma course), and is targeted at MDs and those with backgrounds in science and engineering who are interested in translating their knowledge and experience into a practical skill set that will allow them to work in the pharmaceutical industry. Graduates will be prepared to work as leaders of R&D efforts, in medical affairs, post-marketing management, as reviewers of new drugs and as developers of investigator initiated clinical studies.

Safety first

Around the world today there is a growing emphasis on pharmacovigilance, or PV for short. This is a fancy term for catching and figuring out how to address complications and side effects that medicines may cause. The growing importance of PV will be a touchstone in the program, and could be seen as a boon for doctors who want to work in the medicine biz. “This is a good entry point for doctors who want to enter the pharmaceutical industry,” says Yoshiko Maruyama, a representative from the human resources department at Bayer’s Tokyo office.
Mujgan Ates, Vice President, Medical, at AstraZeneca in Osaka, adds that “need is increasing for the most up-to-date scientific information exchange with physicians about our products, adherence to therapy, and patient educational programs in order to link the science with the unmet need of the patients and improve patients health conditions.”

From communicating with the public about drugs and treatments to overseeing trials via quality assurance and safety studies, doctors who can bridge the gap between basic science (research) and practical science (turning the research into usable products and getting them into the market) are a hot commodity today.

Japan’s got talent
While many of Japan’s domestic pharmaceutical giants carry out much of their clinical development overseas, more expertise is being called for at home. Business may be booming, but industry recruiters still have their work cut out for them.

“Pharmaceutical companies have had a very difficult time recruiting doctors to work in the industry,” says Dr. Imamura. “Some doctors see a clear hierarchy with doctors at the top and the marketers and pharmaceutical industry at the second level.”

This perception, however, is changing. “The number of physicians who are interested in the pharmaceuticals is definitely increasing,” Suzuki says. “Usually these doctors already want to explore opportunities in the industry on their own, and then approach me.”

Viewed from the side of the pharmaceutical fence, however, credentials aren’t enough in themselves. According to Suzuki, for many doctors pride comes before the fall.

“Many of the doctors who are initially interested don’t have the right temperament or mindset to fit into the industry,” he says. “A common issue is having pride about their knowledge.”

Alongside pride, corporate culture shock is another stumbling block for those with a hankering to work in the industry. Traits like being a team player and having strong leadership skills are two facets that not all doctors possess. Further, as doctors often start in management level positions, this can produce resentment among subordinates, some of whom may have already spent a significant length of time working for the same company that their manager has only just joined.

“In a hospital the objective is very clear – to take care of patients,” Dr. Mukai says. ”But when doctors enter a company, the roles of various team members are not so clearly defined.” For some, this is the whole point: the interaction, the team. For some seeing patients or tinkering in a lab are not enough. These are the types that gravitate to the industry.

Maruyama from Bayer concludes: “For doctors who are interested in working more with people and who are good communicators and leaders, this is a great fit.”