“Wherever the art of Medicine is loved, there is also a love of Humanity.”
– Hippocrates
I cannot think of this quote from Hippocrates, the father of medicine, without also thinking of my Certara colleague, Dr. Mayumi Hasegawa, Senior Director, Integrated Drug Development. She has over 15 years of drug development experience focused on the areas of clinical pharmacology and pharmacometrics. Mayumi specializes in supporting clients in the Asia Pacific regions (APAC; Japan-Korea-Taiwan). So, her love for helping develop innovative medicines that benefit patients is evident. But in talking to Mayumi, I was also struck by her boundless optimism and passion for helping create a workplace culture of accountability and empowerment. Like Hippocrates, her love for humanity clearly shines. Please enjoy the highlights from our conversation.
pictured: Mayumi Hasegawa, Senior Director, Integrated Drug Development
Suzanne Minton: How have you found the transition from a senior operational role in pharma to a consulting role in a global consultancy practice?
Mayumi Hasegawa: At Certara, I support clients who are working on Asian-related development programs or submissions to APAC region health authorities. I deliver a wide range of Certara’s Model-Informed Drug Development (MIDD) capabilities to Asian customers. I often act like a bridge between regulatory agencies and clients or between Japanese subsidiaries and global headquarters within the client company. Like my previous roles in pharma, my clients expect me to digest scientific data and utilize it for their benefit. My motivation is to convey the benefits of using MIDD approaches both inside and outside of pharma companies.
When I worked in pharma, senior management expected us to educate other departments on the benefits of including pharmacometric strategies in development programs. In addition, I developed strategies for incorporating multiple quantitative solutions that integrate knowledge and inform decisions. In both my roles in pharma and at Certara, I really enjoy making a difference by providing tailor-made solutions to each project. The key value of MIDD is integrating data from multiple sources to provide a solution that can enhance the efficiency of drug development, both decreasing timelines and cost. In the context of the regulatory approval process, MIDD can enhance the rationale for key development decisions.
In my previous roles at pharma companies, team members made decisions collectively. Whereas as a Certara consultant, I make my recommendations by incorporating public and internal data and the advice of subject matter experts (SMEs) to provide on-time deliverables to clients. Thus at Certara, I keep in mind that my advice to clients should always be professional and well considered because I function like their “drug development concierge.”
SM: You have worked in both American (BMS) and Japanese (Takeda) drug development companies. Are there any notable differences in the approach to drug development between American and Japanese companies?
MH: While Takeda is a Japanese company, they have been supporting global drug development programs since the late 1970s. Both companies have been focusing on the US, EU, and Japan as major markets in which to pursue regulatory approvals.
However, my time spent working in the American business environment at BMS gave me some unique insights. American and Japanese business cultures are very different. In the United States, there are many examples of working mothers that hold senior professional leadership roles and share their domestic responsibilities with their partners. During my time working at the BMS Princeton location, I was inspired by their culture of individual ownership of roles where staff works independently while respecting others. After I became the Clin Pharm development head in BMS Japan, I held regular professional development workshops for my team to help empower them to become leaders in their own fields.
SM: What are some major regulatory trends coming out of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)?
MH: In recent years, the PMDA’s review process has become as fast the FDA’s. Their SAKIGAKE Designation System (introduced in 2015) and Conditional/Time-limited Marketing Authorization System by the Ministry of Health Labour and Welfare (MHLW) are notable because these systems identify innovative drugs that are initially developed in Japan that show effectiveness against serious and life-threatening diseases. The objective of these systems is to make such drugs available to patients in Japan ahead of the rest of the world. Drugs receive these designations at a comparatively early stage of development and get priority for clinical trial consultation and review.
SM: What do foreign companies get wrong most frequently when seeking marketing authorization for a drug in Japan and vice versa?
MH: I have been involved in numerous interactions with the PMDA, and it is becoming more receptive to innovative approaches by sponsors.
However, the PMDA maintains that it would like sponsors to include Japanese patients in clinical trials before submitting their new drug applications (NDAs). Even though the PMDA accepts model-based approaches, especially in rare disease areas and pediatric indications, it always focuses on a drug’s efficacy/safety/pharmacokinetic (PK) profile in Japanese patients. Therefore, if foreign companies ignore this point, their interactions with the PMDA will be negatively affected.
SM: The PMDA sees the next key development in drug development science as “Rational Medicine,” which means employing evidence-based medicine to deliver personalized medicines to patients. How can Certara help Japanese companies to realize this important objective?
MH: Since Certara has the ability to use MIDD in every phase of drug development with pre-clinical experts, pharmacometricians, clinical pharmacologists, and regulatory writers, we are already providing cutting-edge solutions to clients and supporting the approval of innovative medicines. Modeling approaches such as physiologically-based pharmacokinetic modeling (PBPK), population pharmacokinetics, exposure-response modeling, quantitative systems pharmacology (QSP), and model-based meta-analysis (MBMA) are all powerful approaches Certara is implementing for clients’ projects.
In addition, we often need to use large complex datasets and data beyond what clinical trials can provide to understand drug and disease mechanisms. With this in mind, Certara’s diverse team also includes real world data (RWD) and scientific informatics experts. Having a team with these varied skill sets gives clients more options to solve unprecedented drug development challenges.
SM: Can you compare the adoption of model-informed drug development technology in the US vs Japan?
MH: The PMDA has recently embraced modeling and simulation approaches. Sometimes, individual guidances in Japan are tricky, and we must pay attention to them in addition to global guidances such as the International Conference on Harmonization (ICH) guidance. And, there are small differences between the FDA and PMDA which need to be accounted for when submitting an application. For example, in study design optimization, MIDD is used to justify a single-dose study in small or difficult-to-recruit patient populations and to inform label recommendations on the optimal dosing regimen. In silico models can also help bridge clinical data to new populations (pediatric, elderly, etc.) and inform label expansions accordingly.
SM: What made you choose to come work at Certara?
MH: I’m passionate about pushing the regulatory science forward. When I worked in the Expert Working Group for ICH E11A (Pediatric extrapolation), I learned a lot from extensive discussions with global regulators and industry SMEs to harmonize the global guidance. Certara was an attractive opportunity because it offered the ability to help pharma clients who struggle with the methodologies and strategies required to employ MIDD. I really like working with Certara’s talented consultants, and I’m excited to bring their skills into drug development programs in Japan.
SM: What advice would you give to a clinical pharmacologist or pharmacometrician just starting out in her career?
MH: Because clinical pharmacology and pharmacometrics (CP&P) are very broad disciplines, the journey to become an expert looks super-long and challenging. But, these subjects are worth your passion! Where there is a will, there is a way. Enjoy all the aspects of clinical pharmacology and pharmacometrics: modeling and simulation, data handling, clinical study design, and negotiation with regulators. I’m happy to go the extra mile in my work because CP&P has so many challenges to solve. The bigger the challenges I face in a project, the more invaluable experience I will gain from it.
SM: Is there anything else that you’d like us to know about you?
MH: On a personal note, I’m a mother, and I want my children to grow up in a world where they can see the impossible as achievable.
I’m passionate about helping drug developers tackle some of medicine’s biggest challenges with hope and optimism. I am working towards a future where innovation leads to cures to our most intractable disease challenges, and where life-threatening diseases are treatable. Scientists tend to regard their research as “just research” and not as a driver for real social change. However, we must change this mindset and encourage scientists to communicate more proactively with external stakeholders, potential collaborators, and non-scientists.
In addition, young entrepreneurs using interdisciplinary approaches will be instrumental in solving our major global health issues. I hope to contribute to more interdisciplinary as well as international drug development collaborations. Cooperation between different scientific communities in various countries is critical to support large-scale research. Scientific diplomacy should include the active participation of not only diplomats, but also researchers, engineers, and business leaders to produce cross-border solutions that will ultimately benefit patients.
— To see the Japanese translation, click here —
It was great to talk to Mayumi, and I agree wholeheartedly with her points about how interdisciplinary approaches are needed to support modern drug development. To learn more about MIDD uses quantitative methods to demonstrate safety and efficacy, please read this article.