Xin Ke, PhD
Xin Ke, PhD is the CEO and Co‐Founder of FMD K&L.
Dr. Ke has over 20 years of experience in the pharmaceutical industry, with a focus on data management and statistical programming.
Since 1992, he has worked in several global pharmaceutical companies including Novartis, Johnson & Johnson, and Merck as a Senior Statistical Analyst. In 1995, he founded K&L Consulting Services, Inc. (K&L), and has been managing K&L to provide niche contract research organization (CRO) services to global pharmaceutical and biotech companies in the areas of data management, statistics, statistical programming, CDISC / SDTM / ADaM standardization and conversion, and medical writing. In 2014, K&L merged with Fountain Medical Development, LTD. (FMD), to become FMD K&L. Dr. Ke serves as President for US operations post‐merger.
Since founding K&L, Dr. Ke has acted as a project team lead for several pharmaceutical companies supporting 15 US NDA filings. The filings were well accepted by the FDA and 11 have been approved for marketing.
Dr. Ke received his PhD from Rutgers University in the US and his Bachelor of Science degree in Applied Mathematics from Tsinghua University in China.
Tim Seitter, MBA
President of the Americas
Tim Seitter is the President of the Americas at FMD K&L as well as a member of the executive leadership team. Mr. Seitter is responsible for managing Business Development, Marketing, Client Engagement, HR/Operations, Finance, Global QA, Global IT, and Europe operations.
With over 25 years of well-versed experience, he possesses a wealth of knowledge in clinical trials, regulatory and safety, sales and marketing, and accounting.Prior to joining FMD K&L, Tim was the Vice President and Head of the Oral Care Strategic Business Unit for Church & Dwight, Inc., the General Manager for the Hefty EZ Foil Division at the Pactiv Corporation (Hefty Consumer Products Group), the Vice President of Marketing for the Golf Division at Spalding Sports Worldwide, and the Senior Brand Manager at Jell-O Ready-to-Eat Snacks at Kraft Foods, Inc.
Mr. Seitter received his Master of Business Administration in Marketing and Finance from the University of Florida, his BS in Commerce with a Concentration in Accounting from the University of Virginia, and is a Certified Public Accountant.
Tiepu Liu, MD, PhD
President of Global Biometrics
Tiepu Liu, MD, PhD, is the President of Global Biometrics as well as a member of the executive leadership team.
With training in medicine and quantitative methodology, Dr. Liu has extensive clinical research experience in various therapeutic areas. He served as a Biostatistician and Epidemiologist at the UAB Comprehensive Cancer Center and directed a Biostatistics and Epidemiology group at the University of Cincinnati. Over the last 15+ years of his industry career, Dr. Liu has served as Director of Biostatistics at PPD, Executive Director of Statistics and Data Management at UBC, and a Senior Director of Biostatistics at Graceway Pharmaceuticals and The Medicines Company, before joining FMD K&L to lead the Biostatistics and Data Management functions.
Dr. Liu has published over 90 scientific papers and more than 100 abstracts and presentations. He has served on working committees of several professional societies, on numerous scientific review committees and panels for the National Institute of Health (NIH) and other government agencies and independent organizations, and as a statistical and methodological reviewer for multiple biomedical journals. He was the Lead Biostatistician for the NIH AIDS Malignancy Consortium from 1995 to 1996, Chief Biostatistician for the Emergency Cardiac Research and Education Group from 1996 to 1999, and PI and Director of the Data Coordinating Center for the NIH Immune Tolerance Network from 2002 to 2006.
In the pharmaceutical industry, Dr. Liu has led numerous clinical development projects in oncology, diabetes, cardiovascular, anti‐viral and anti‐infective, immunology, respiratory, gastrointestinal, CNS, dental, and devices, as well as other therapeutic areas. As a statistician core team member, he participated in multiple full development (IND to NDA) and post-marketing programs, leading to successful, global approval and commercialization of Arestin (minocycline), Zyclara (imiquimod), and Kengreal/Kengrexal (cangrelor). Dr. Liu has served as a statistician interacting with various regulatory agencies, including presenting at multiple advisory committee meetings. He has worked with Data Monitoring Committees in various capacities, including serving as a voting independent statistician member and coordinating and presenting frequently to DMCs.
Dr. Liu received his PhD in Biostatistics and Epidemiology at the University of Alabama at Birmingham School of Public Health in the US and received his Doctor of Medicine and Master of Public Health from Tongji Medical University in China.
President, APAC Region
Mahesh Mudnur is the President of the APAC region as well as a member of the executive leadership team.
Prior to this role, he was the co-founder of iMEDGlobal, which has since merged with FMD K&L. Mahesh has more than 23 years of industry experience including 14 years of designing and implementing global software solutions in the healthcare and pharmaceutical domains. His most recent experience includes tenures as Global Head, Product Development at ArisGlobal, India, and Engineering Manager at WYSE, India. As a consultant, Mahesh helped DSA develop its IT service offering for the life sciences industry and worked on the Triage XML Intake system. He also has experience developing a proposal for a triage intake system for Zensar, and then executing the proposal after it was accepted.
Mr. Mudnur received his Bachelor’s Degree in Instrumentation Engineering from Bangalore University, India.
Yuguang Zhao, MS
Senior Vice President of Programming and Development
Yuguang Zhao is the Senior Vice President of Programming and Development at FMD K&L and serves as a member of the executive leadership team. Mr. Zhao is responsible for providing strategic planning and corporate direction for continued growth of the company, providing scientific leadership and resource planning for statistical support on all projects, and ensuring the teams provide high quality statistical programming support for Phase I, II, III, and IV clinical trials in the pharmaceutical industry.
He has over 19 years of experience in the pharmaceutical industry. Prior to joining FMD K&L, Mr. Zhao held a position at Eisai as Director of Global Statistical Analysis and served as Programming Therapeutic Area Head for Oncology at Sanofi. In these roles, he led different teams and worked on many regulatory submissions such as NDAs / sNDAs.
Mr. Zhao has been very active in industry working groups. He has co‐led the CDISC / FDA data integration pilot as well as being a key contributor in the industry standardization efforts through his participation in CDISC SDS and ADaM working groups.
Mr. Zhao earned his Master of Science degree from the University of Nevada in the US and his Bachelor of Science degree from Inner Mongolia National University in China.
Vice President, Business Development
Ken Smith serves as the Vice President of Business Development for FMD K&L and is a member of the executive leadership team. He is responsible for leading Business Development activities including direct sales to new clients, continued relationship building with key accounts, and maintaining strategic partnerships.
Mr. Smith has over 30 years of technical sales experience and for the last 12 years has focused on clinical and regulatory solutions centered around biostatistical analysis and design of clinical studies, data standardization and conversions, electronic submissions to the FDA, and selling business process outsourcing services to pharmaceutical, biotechnology, and medical device sponsors globally.
In his previous role, Mr. Smith was responsible for providing direct sales expertise for global accounts and pioneered sales strategies for new business in clinical and regulatory development within the clinical data standards and electronic submission segment of the pharmaceutical market.
Mr. Smith earned his Bachelor of Science degree in Chemistry‐Biology from West Chester University of Pennsylvania.