Medpace Expands Medical Leadership Team in Asia Pacific

Medpace is pleased to announce the addition of four experienced medical experts, Dr. Shinichi Asabe, Dr. Morihiro Watanabe, Dr. Kiyoshi Hashigami, and Dr. Jisin Yang to the medical leadership team in Asia Pacific.

As a leading global CRO, Medpace has been operating in Asia Pacific for over 20 years, with expert in-house teams and strong local experience and resources to accelerate your clinical study programs. In this blog, our medical experts share an overview of their professional backgrounds and discuss many hot topics such as trends in clinical development for rare cancers, the potential of next generation biotherapeutics, and considerations for clinical development in Asia Pacific.

Meet Our Experts

Tell us about your background. How does your prior experience contribute to your work at Medpace?

I worked at AbbVie GK (Japan) Clinical Development and was involved in several projects such as phase 2 and 3 programs of dermatology, rheumatology, and gastroenterology and early phase programs of oncology. That was an exciting and challenging period that highly motivated me for new field of tasks for patients in addition to clinical work and basic research. Then I moved to Medical Affairs and focused on launches of new assets in IBD that taught me the importance of medical and scientific knowledge for driving proper strategy for the marketing and commercialization of medicines. After successful launches, I hoped to find a new challenge in the pharmaceutical industry and widen my experience in clinical development. Then I had the opportunity to join Medpace.

How does your prior experience contribute to your work at Medpace?

Various experiences in clinical development are readily useful for CRO work. My clinical experience in gastroenterology and hepatology directly contributes to the current work at Medpace. For Example, I did clinical research of MASH, obesity, and diabetes (also oncology) at the university hospital and am acquainted with many KOLs in the field. I hope I can leverage those connections in future work.

For nearly a decade, Japan has grappled with the problem of "lagging drug approvals." Drugs already approved in the United States and Europe may take longer to reach the Japanese market due to Japanese clinical trial regulations. It was recently reported that Japan's Ministry of Health, Labour and Welfare may relax the rule that new drugs must complete early clinical trials in Japan before they can be marketed in Japan, meaning that sponsors can use Phase I clinical data collected in the United States, Europe, China and South Korea to file applications in Japan. If this change is realized, what opportunities or risks could it present?

It means Japan's Ministry of Health, Labour and Welfare announced to relax the regulation that made it mandatory to execute Phase I study for Japanese subjects before doing later phase studies. Most pharmaceutical companies want to minimize the cost of Phase I study before PoC study, so they are reluctant to add a Japanese cohort. However, if planning Phase I study of Japanese cohort after getting PoC, it would delay the participation of Japanese subjects in multi-regional clinical trials and in some cases, regulatory approval in Japan would be largely delayed. Although Phase I studies of Japanese subjects are still strongly recommended and PK/PD data of Japanese subjects are necessary for submission, it would lower the barrier and accelerate entry of Japanese subjects in studies, resulting in earlier and more certain regulatory approval in Japan. I also want to emphasize that Japanese subjects' entry in pivotal studies is still important except some rare disease and pediatric disease cases.

What do you think of Japan's attractiveness as a country for conducting clinical trials and on the other hand, what do you think about the drag lag and drug loss issue of Japan?

One of the largest factors that makes conducting clinical trials in Japan attractive is the size and health insurance system of Japanese market. Although the Japanese population is decreasing, the increasing proportion of elder people will demand more medical services in the coming decades. The oncology area is expanding rapidly, and a westernized lifestyle leads to the rising number of patients of metabolic disease and immunological disease such as obesity, MASH, rheumatoid arthritis, ulcerative colitis, and Crohn's disease. And the insurance system allows patients to receive the latest treatment with relatively low copayment. For example, in many European countries, newly approved advanced therapy is limited to patients who are refractory to the existing therapy, mostly due to financial reasons. In Japan, this regulation is much less stringent and once scientifically approved, the new drug can be widely used, and this makes the Japan market attractive for the originator pharma.

On the other hand, Japanese regulator, PMDA (Japan's Ministry of Health, Labour and Welfare) has been keeping original regulatory policies for years since it has been safety conscious and tended to value the safety data of the Japanese population. These policies could contribute to higher cost and a longer period of clinical trials in Japan. It may result in drug lag and loss. The Japanese government recognizes the issue and is trying to change some regulations in coordination with ICH revisions. The phase 1 study of Japanese subjects before the pivotal studies is not mandatory anymore and the required number of Japanese subjects in pivotal studies are negotiable in more flexible way. But still, I'd like to emphasize that enrolling Japanese patients in pivotal (Phase II or III) studies is versatile for timely regulatory approval for Japanese market.

Please share your perspective on what sets Medpace apart from other global CROs.

My image of CROs is that they are passive supporters of clients: The sponsor makes the decision, the CRO follows, and if there are any questions, the CRO confirms with the sponsor. On the contrary, I have found that we support sponsors much more autonomously and take ownership throughout clinical trials than I expected. This may be because many of our clients are early-stage biotech companies that need our experience, relations with study sites or regulatory agencies and other stakeholders. What makes my work exciting and motivating is this unique relationship with sponsors.

A growing number of oncology pipelines are focusing on rare cancers. What are the unique challenges of clinical development for rare cancers compared to non-rare cancers? What special factors should be considered during the design and execution of trials for rare cancers?

One of the biggest challenges is the recruitment of eligible patients for clinical trials. The other challenge is establishing a high level of evidence due to limited sample size. To address these challenges, the patient registry is very helpful. SCRUM-Japan, for example, is a nationwide cancer genome screening initiative involving more than 200 medical centers networked across Asia. Screening identifies multiple targeted gene mutations for biomarker-driven studies, including rare gene mutations. The other example is the MASTER KEY project. It's a rare disease patient registry and biomarker analysis project. Both are joint efforts between industry and academia and have supported many successful clinical trials leading to new drug approvals. Patient registries are also very important to understand the outcomes of rare diseases because randomized controlled trials are difficult to conduct. In many cases the data from the patient registry for a rare disease is used to evaluate the result from uncontrolled clinical trials for rare disease and part of the dossier for drug registration. Therefore, ensuring this support is critical to the success of the trial for rare cancers.

From a clinical development standpoint, what innovations in solid tumors and hematologic cancers are you most excited about?

Emerging innovations such as antibody-drug conjugates (ADCs), bi- or tri-specific antibodies, and cell and gene therapy have unique approaches. And all demonstrated efficacy in oncology trials, often achieving high efficacy. However, there is still room for improvement in most cases. The results of the recent urothelial cancer trial using ADC in combination with immunotherapy were quite impressive. Our goal in cancer treatment is cure. To achieve this goal, we need to maximize efficacy and improve the safety profile of future treatments. I will be most excited to see efforts to explore the combination of these modalities together with the conventional treatment for the best outcome.

What drew you to Medpace?

It was the tenure of the colleagues with whom I interviewed, which spoke volumes about Medpace as a great place to work. Everyone I spoke to was (and is) a serious professional who could have any choice of jobs, and they had happily chosen to work here at Medpace for extended tenures. All spoke about the collegial and productive Medpace culture as to why they chose Medpace, and why they stay. In the six weeks since joining, this impression has only been confirmed. The no-nonsense, get-things-done-as-a-priority attitude permeates the day-to-day, and established processes effectively transform this philosophy into action. Medpace colleagues appear productive and content as a result. I am excited to be here and to become a productive member of the Medpace team!

According to a recent study, next-generation biotherapeutics are increasingly under investigation for hematological cancers, with more than five times more trials started globally in 2023 compared to decade ago, accounting for 25% of the hematological-oncology pipeline. What risks and opportunities are specific to next generation biotherapeutics from a clinical research and development perspective?

"Next-generation oncology therapies" is a broad category, so a comment specifically for current CAR-T (Chimeric Antigen Receptor T-cells) development: These therapies have shown remarkable clinical benefit in hematologic cancers with generally dismal outcomes, thereby opening new frontiers in cancer care. At present, much of CAR-T development is focused on hematologic malignancies and rare diseases, but there is much hope that this therapeutic class can be applied to more common solid tumors. This is likely a matter of "when," not "if," as CAR-T technology and knowledge of antitumor immunity advance in parallel. Hence the opportunities for oncology CAR-T therapy are clear, but there are risks and challenges to their realization.

A recognized major challenge in CAR-T therapeutics is their high (often prohibitive) cost. Invariably costing hundreds of thousands of dollars per treatment course, CAR-T therapy is available only in countries and health care systems that can afford them. Realistically, patients outside of these geographies have zero access, and this has created a new area of treatment disparities. These disparities are glaring in Asia Pac, which is characterized by wide diversity of populations and health care systems. Left un-addressed, these cost issues will be worsened when CAR-T applications are realized in common tumors.

To address these challenges and ensure equitable access to CAR-T therapies, there is a clear need for effective strategies to reduce costs and increase scalability of cell engineering processes. This will require advancements in manufacturing and regulatory streamlining. As with other innovative therapeutics, collaboration between industry, regulatory bodies, and healthcare providers will also be a prerequisite to provide equitable access to innovative cancer treatments like CAR-T. With such concerted efforts, I am hopeful that the potential of CAR-T technology in cancer can be fully realized to transform cancer care for the better.

What challenges, considerations, or risks are specific to Hematology & Oncology clinical development in Asia Pac compared with that in the US or EU?

The Asia Pac region is home to about 4 billion people of varying backgrounds and cultures. Many of these countries are plagued with rapidly aging populations, and this shift in population demographics has led to marked increases in regional cancer incidence. This is a sizeable market opportunity for oncology companies worldwide, but only the largest of global pharma companies successfully address this market today. Even these mega-pharmas have limited their development to the most advanced of Asia Pac markets, like Japan, South Korea, and China. This leaves much of Southeast Asia with sparse access to innovative clinical trials and new treatments. This gap can be attributed, at least in part, to the wide diversity of the Asia Pac region. Variations in ethnic biology, socioeconomics, drug development regulations and overall medical infrastructure must all be considered in the regional development of new drugs.

Navigation of these complexities can be done via early proactive engagement of local stakeholders (i.e., regulatory bodies, academic groups, investigators), but this is a costly proposition that only the deepest of development pockets can afford. This leaves much of Asia Pac without the active development of new cancer medicines, to the detriment of patients. Medpace, with our robust regional presence, is well positioned to help address to this development / access gap. Enabling a wider swath of the global biopharmaceutical industry to achieve its Asia Pac ambitions is a win-win scenario, one that would grow the regional cancer therapeutics sector for the ultimate benefit to patients.

How does your prior experience translate into the work you do at Medpace? For a global headquartered sponsor that aims to conduct a multi-reginal trial within Asia Pacific, what special considerations should be taken into account?

I was previously at another CRO after 10 years at several pharmaceutical companies and covered diversified indications such as diabetes, infectious disease, hemophilia, and immunology. Together with my clinical practice in internal medicine, I am sure I can provide appropriate medical input/insight in various therapeutic indications. In addition, prior experiences give me perspectives from the sponsor side as well and that can help make communications with clients smoother.

For a global headquartered sponsor that aims to conduct a multi-reginal trial within Asia Pacific, what special considerations should be taken into account?

For a global headquartered sponsor aiming to conduct a multi-regional trial within the Asia Pacific region, several key considerations come into play.

There seems to be several key factors for consideration - such as Regulatory Compliance, Cultural Sensitivity including language considerations, Logistics and Infrastructure in the region, and the medical perspective. Although standards of care in APAC region have become similar or identical to those of developed countries, there remain some distinct differences in day-to-day practice, and these are often influenced by regional historical background. Cultural nuances can significantly impact trial conduct and participant engagement. Tailoring communication and recruitment strategies to resonate with diverse cultural backgrounds is essential for trial success. Consultation from a CRO with APAC expertise can bring appropriate advice to project strategies based on a wealth of experience & expertise in the region.

For the other type of sponsor - one that is headquartered in Asia Pacific and aim to conduct a global trial across the US, EU, Asia Pacific, with an intention to internationalize its drugs, what special considerations should be taken into account?

When an Asia-Pacific headquartered sponsor aims to conduct a global trial spanning the US, EU, and Asia-Pacific regions, additional complexities emerge: Regulatory Harmonization across the regions (e.g., FDA, EMEA, PMDA) is essential. And we often experience cultural and socioeconomic variability: Recognizing and addressing differences in healthcare systems, socioeconomic factors, and cultural norms across regions is essential for optimal participant recruitment and retention.

It is recommended to have early engagement with regulatory agencies in each region to understand their requirements, seek alignment on trial protocols, and address potential concerns, which can facilitate smoother regulatory approvals. This leads to development of trial protocols that accommodate the regulatory requirements of each region while maintaining scientific rigor and ethical standards, which can reduce administrative burden and expedite regulatory approvals. Another important factor is to provide training and education to trial investigators and site staff on cross-regional regulatory requirements, Good Clinical Practice (GCP) guidelines, and trial-specific procedures, which enhances compliance and quality of trial conduct. Especially for sponsors with limited experience of multi-regional clinical trials, it is essential to proceed with the guidance of an experienced supporting organization like Medpace. As a global CRO with a record of successfully supporting small-to-midsize biotech companies under a full-service model, Medpace can take several specific actions to navigate cross-regional regulatory harmonization with its regulatory expertise, local presence, and global network on investigators.

In summary, both scenarios present unique challenges related to regulatory compliance and cultural sensitivity. Tailoring trial strategies to address the specific requirements of each scenario is essential for successful trial execution and ultimately advancing drug development efforts on a global scale.

Asia Pacific Drug Development Services

As a global CRO with an operational footprint across 42 countries with 5800 employees, Medpace has broad experience designing and conducting Phase I-IV clinical trials around the world. Our medical, regulatory, and operational experts have the resources to advance your medical therapeutic on a global scale. Since establishing our Asia Pacific presence in 2004, our medical and operational specialists have country-specific expertise, which allows them to integrate local language, culture, and requirements into study conduct, to deliver faster enrollment, and obtain access to country-specific patient populations. Our regulatory experts can plan and coordinate each aspect of regulatory strategy and engagement - locally and globally.

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