Leaders in innovation

Dong Yang is Head of Regulatory Affairs at Fortrea China with more than 20 years of experience in drug development and regulatory affairs, supporting IND-, NDA-, and BLA-enabling programs. A board-certified Regulatory Affairs Professional (RAC Global), he leads regulatory strategy and execution, providing scientific review, gap analysis of submission dossiers, and guidance on clinical development planning in collaboration with clients and regulatory agencies.

Dong has led more than 50 regulatory agency interactions, consultation meetings, and key opinion leader engagements across multiple therapeutic areas. His experience includes IND and NDA/BLA submissions, HGRAC filings, and CIQ applications. In addition, he leads Fortrea’s regulatory contributions to the NMPA 14th Five-Year Regulation and Guideline Update and Maintenance Program, supporting evolving regulatory frameworks in China.

Where are you located? What geographical region(s) do you cover? 
I am based in Taiyuan, Shanxi, China. Over the past five years at Fortrea, I have supported monitoring activities across clinical research sites throughout China, working with a wide range of investigators, site teams, and study stakeholders. These experiences have given me a broad perspective on clinical research operations and allowed me to build strong relationships while contributing to the successful delivery of studies across different regions. 

How long have you been working in the area of clinical research? 
I have been working in clinical research for eight years, gaining experience in monitoring, site management and study execution across a variety of therapeutic areas and research settings. 

What is the best part of your job? 
One of the things I enjoy most about being a Clinical Research Associate is seeing how a clinical trial comes together through the efforts of many different people. The role requires a combination of scientific knowledge, attention to detail, communication skills and project awareness. Understanding complex protocols, identifying key details within source documentation, and working closely with investigators, site staff, sponsors and study teams all play an important part in helping studies progress. What makes the role especially rewarding is knowing that every monitoring visit, discussion and issue resolved contributes to the development of potential new therapies for patients. 

What has been interesting about your work in clinical research? Did anything surprise you about the patient population? 
What I find most interesting about clinical research is the people behind every study. Each participant has a unique story, and I am always impressed by the dedication shown by both patients and their families. Many participants join clinical trials not only in the hope of accessing new treatment options, but also because they want to contribute to medical progress and help future patients. Their commitment is inspiring and serves as a constant reminder that behind every protocol, data point and study milestone are real people placing their trust in clinical research. 

What are you most proud of in your work? 
I am most proud of the moments when a study reaches an important milestone. Clinical trials require significant planning, coordination and collaboration over many years. Whether it is site activation, enrollment completion, database lock, or overall study completion, each achievement represents meaningful progress toward bringing innovative treatments to patients. Being part of that journey is what continues to motivate me and reinforces the importance of the work we do every day. 
I'm grateful for the opportunities I have had throughout my career and remain motivated by the chance to contribute to research that may ultimately improve patients' lives and advance the future of medicine.

Reigetsu Yoshikawa, MD, PhD, is a Senior Medical Director for Fortrea in Osaka, Japan. She contributes to the development of medical strategies and execution of clients’ clinical programs and provides medical/scientific expertise to project teams. Dr. Yoshikawa has more than 30 years of experience as a physician, medical director/advisor, and professor of medicine in Japan. 

Before joining Fortrea, she was Senior Medical Advisor for Eli Lilly and previously served as Senior Medical Lead for Dainippon Sumitomo Pharma in Japan. Dr. Yoshikawa has served on the editorial boards of several peer-reviewed journals and has authored or co-authored dozens of articles, presentations, and abstracts. She joined our company in January 2021.

Ryan Zantua, MD joined Fortrea in 2020 where currently he works as a medical lead for several respiratory studies.

Dr. Ryan Zantua is a board-certified pulmonologist and received his medical degree at Far Eastern University in the Philippines in 1995. He went on with his residency in Internal Medicine and Fellowship in Pulmonary Medicine at St. Luke’s Medical Center in the Philippines. He did additional training on Pulmonary Physiology at National Jewish Health in Denver, Colorado and was an international scholar in Pulmonary Medicine at Cleveland Clinic in Ohio.

Prior to joining the industry, he established a successful practice for 12 years at St. Luke’s Medical Center, where he headed a tertiary pulmonary laboratory for 8 years. His practice was focused on pulmonary diseases and critical care, with particular interest in COPD and Bronchial Asthma. In 2014, he joined Advance Medical/Best Doctors/Teladoc Health in Boston, Massachusetts in a Medical Director role, where he established professional relationships with key opinion leaders and experts in a variety of specialties around the globe with his main function of providing medical opinions and telemedicine to their extensive clientele. His introduction to the CRO industry was thru ICON in 2019 where he served as Medical Director for Pulmonary for more than a year, heading their respiratory studies including COVID -19. Currently, he is the study physician for several pulmonary studies, focusing on COPD, Bronchial asthma and IPF.

Kiki Zhang, is the Senior Director of Digital Strategy at Fortrea, based in Shanghai, China. Her area of expertise within Fortrea lies in Digital and Mobile Health solutions, where she specializes in exploring the feasibility, compliance, and localization of digital technologies and solutions tailored for the APAC/China region. She supports clients and CRO study teams in developing the digital health solutions that are fit-for-purpose and practical for local implementation.

Kiki has over 20 years of professional experience in the clinical research industry, with expertise spanning Data Management, Project Management, Client Success and she possesses extensive experience with electronic clinical systems, encompassing the design and maintenance of Electronic Data Capture (EDC), electronic Clinical Outcome Assessment (eCOA), Medical Imaging, Randomization and Trial Supply Management (RTSM/IRT), and Clinical Trial Management Systems (CTMS). This deep understanding of eClinical systems allows her to provide invaluable insights and guidance, ensuring that the digital health solutions developed are robust, compliant, and user-friendly.

Robin Zhang, PhD is an Associate Director of China Regulatory Submissions at Fortrea with 20 years of experience in regulatory affairs and project management within the pharmaceutical industry. He oversees a broad range of China regulatory submissions, including IND submissions and maintenance, HGRAC filings, CDE clinical trial registrations and import/export permit applications.

Robin also serves as a member of the China Regulatory Intelligence Committee, supporting regulatory monitoring and stakeholder engagements.

He has played a key role in implementing eCTD publishing in China at Fortrea, supporting tool deployment, system maintenance, and team training to strengthen in-house eCTD capabilities.

Prior to joining Fortrea in 2020, Robin was Director of a global research and development center at a major Chinese pharmaceutical company, leading regulatory affairs and global development programs. He holds both a BS and a PhD in Chemistry and Chemical Biology from Nankai University.

Where are you located? What geographical region(s) do you cover? 
I am based in Beijing, China, supporting research sites in Beijing, Shenyang, Harbin, Chifeng, Weifang and Haikou. Depending on project needs, I also collaborate with sites and study teams across other regions of China. Working with sites throughout the country allows me to experience different research environments, build strong relationships with site teams and develop a broader perspective on clinical research in China. 

How long have you been working in the area of clinical research? 
I have worked in clinical research since graduating from university in 2018. I joined Fortrea, formerly Covance, as a Study Start-Up specialist in December 2018 before transitioning into a Clinical Research Associate role in 2020. Since then, I have gained experience across different functions and contributed to a variety of clinical studies. It is rewarding to see innovative therapies progress through development and know that my work may help bring new treatment options to patients. 

What is the best part of your job? 
The best part of my role is contributing to the development of new medicines that may improve patients’ lives. Although I am not directly involved in treating patients or conducting laboratory research, I play an important role in supporting the quality, integrity and compliance of clinical studies. Every detail matters when turning scientific ideas into potential therapies. I also value the opportunity to learn continuously and collaborate with investigators, study coordinators, sponsors and colleagues across different teams. 

What has been interesting about your work in clinical research? Did anything surprise you about the patient population? 
One of my most memorable experiences took place during a Pre-Study Visit with a Principal Investigator who was also the president of a major hospital. During the visit, I saw first-hand how he balanced patient care, clinical research, hospital operations and public responsibilities while remaining fully engaged in the study. A patient attending the clinic that day was also a surgeon who had travelled from another city for his advice. Watching their interaction reminded me that clinical research is about more than protocols and data. It is about people, their dedication and their shared commitment to advancing medicine. 

What are you most proud of in your work? 
I am proud of the work I do supporting sites and study teams in delivering high-quality clinical research while keeping patient safety and data integrity at the centre of everything we do. Clinical research is a team effort, and my role gives me the opportunity to connect different stakeholders, help solve challenges and support sites throughout the study lifecycle.

Where are you located? What geographical region(s) do you cover? 
I am based in Shanghai, China, supporting clinical research sites across mainland China, with a particular focus on East, West and North China. 

How long have you been working in the area of clinical research? 
I have been working in clinical research for approximately four years, gaining experience in clinical trial operations and supporting studies from start-up through execution. 

What is the best part of your job? 
What I enjoy most about my role is the opportunity to continuously learn and challenge myself while contributing to the development of new therapies that may ultimately improve patients' lives and support the approval of innovative medicines. 

What has been interesting about your work in clinical research? Did anything surprise you about the patient population? 
One of the most fascinating aspects of clinical research is seeing how a study protocol is translated into real-world practice. No two sites operate in the same way and every patient brings a unique perspective and experience. Each study provides new insights into disease biology, regulatory requirements and the importance of effective patient communication. I have also been continually impressed by the resilience, motivation and knowledge of many clinical trial participants. Patients often arrive well informed, ask thoughtful questions about treatment options and safety, and demonstrate a genuine commitment to advancing medical research. 

What are you most proud of in your work? 
I am proud of the role I play in protecting the integrity of both science and clinical practice. Every document reviewed, every process completed and every protocol deviation prevented contributes to the quality and reliability of the research. For me, clinical research is about much more than procedures and data. It is about honouring the trust that patients place in us and helping generate evidence that may benefit future patients around the world. 
I am grateful for the opportunity to contribute to clinical research and remain motivated by the knowledge that every study is a collective effort to advance medicine and improve patient outcomes.