With steadily increasing drug development costs and timelines and the desire to access global patient populations, conducting clinical trials in Asian countries has rapidly become an appealing option for many pharmaceutical companies. However, conducting studies in these countries requires very careful planning to succeed. Accessing global patient populations in emerging markets requires a firm understanding of how to approach differences in culture, language, business practices and regulatory frameworks. Furthermore, recent trends in population dynamics and diseases and their impact on healthcare have been shaping the future of clinical trials in Asia and particularly in China.
In this webinar, an overview of the market environment along with the key operational, logistical, and regulatory aspects of conducting clinical trials in China and other Asian countries will be discussed by Dr. Patrice Hugo, Chief Scientist for Scientific Affairs at LabCorp Clinical Trials, and Dr. Li Yan, Executive Director of Clinical Development for Infectious Diseases, Oncology, Respiratory & Immunology, and Vaccines in Emerging Markets at Merck.
Key highlights:
- Why Asia and China are good opportunities for clinical trials?
- Advantages and challenges of conducting trials in the region
- Recent trends in emerging diseases and their impact on healthcare in China
- Opportunities around unmet medical needs
- Leveraging regulatory and clinical trial networks to expedite drug development by focusing on locally relevant diseases
- Private-public partnerships
- Evolving hurdles and opportunities – including regulatory, pharmacodynamics/biomarkers, clinical/medical challenges, and inherited genetic differences in patient population
- Lessons learned from conducting clinical trials in China, a central laboratory’s perspectiv
Speakers
Li Yan, MD, PhD, Executive Director of Clinical Development for Infectious Diseases, Oncology, Respiratory & Immunology, and Vaccines in Emerging Markets, Merck
Dr. Yan is Executive Director at Merck leading the clinical development in Infectious Disease, Respiratory & Immunology, Oncology, and Vaccines products in the emerging markets. He leads cross-functional teams to execute late phase clinical trials and support registrations in key EM countries.
Dr. Li Yan joined Merck in 2007 and has been responsible for global development of targeted anti-cancer drugs including AKT, PARP, and PLK inhibitors as well as anti-IGF1R antibody. His innovative approaches and critical contributions to early drug development earned him Merck Research Laboratory (MRL) Shining Star Award, MRL Innovation Award for Biomarker Roadmap, and MRL Team Award. He made critical contributions to the collaboration with Astra Zeneca to combine two early phase investigational drugs (AKT and MEK inhibitors), and is now leading the ground-breaking clinical trial. He and the team received MRL Award – External Scientific Affairs, and the Script Award – Best Alliance. Dr. Yan is a certified Six Sigma Green Belt in R&D process optimization, together with his team set new records for clinical trial timelines and received MRL Key R&D Early Development Award.
Message Presenter
Patrice Hugo, PhD, Chief Scientist, LabCorp Clinical Trials
Dr. Patrice Hugo, Chief Scientist at LabCorp Clinical Trials, has 20 years of biomarker experience. He obtained his Ph.D. at McGill University and completed 5 years of post-doctoral fellowship at the Walter Elisa Hall Institute in Australia, and Howard Hughes Medical Institute in Denver, Colorado. He was Principal Investigator at the Montreal Clinical Research Institute and worked in biotechs EVP R&D and Chief Scientific Officer. Dr. Hugo joined the Central lab industry as CSO of Clearstone Central Lab before its acquisition by LabCorp. He is author or co-author of over 80 scientific manuscripts.
Message PresenterWho Should Attend?
Senior Executives, Vice Presidents, Directors of:
- Clinical R&D
- Clinical Operations
- Regulatory Affairs
- Medical Affairs
Within pharmaceutical and biotechnology companies
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LabCorp
LabCorp Clinical Trials, a division of LabCorp, combines standardized international laboratory capabilities with sophisticated diagnostic technologies to provide a broad portfolio of services and clinical assays to support drug and diagnostic clinical studies.
- Full-service central laboratory support for Phase 1 through Phase IV studies
- Dedicated clinical trials laboratories in Belgium, China, Singapore and the United States
- Participation in more than 7300 clinical trials, including more than 1200 with international sites
- Scientific leadership and innovation across major therapeutic areas
- Comprehensive portfolio of clinical assays and laboratory services for accelerated drug development
- Dedicated research and development services to assist in assay development and validation, and new assay implementation
- Standardized test platforms and global reference intervals for real-time combined data
- Global proficiency testing and quality control programs
- Global courier and logistics solutions
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