Dr. Dan Zhang
Dr. Dan Zhang
Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational Corp., a member of Quintiles Executive Operation Committee, and was also the Chairman of the Board for Quintiles Medical Development (Shanghai) Company Ltd. Before joining Quintiles, Dr. Zhang provided consulting services to many pharmaceutical, medical device, and health insurance companies, such as Eli Lilly and Company, Pharmacia & Upjohn, Inc., Medtronic, Inc., and CIGNA Health Care.
Over the last 15 years, Dr. Zhang has provided services for the government and academic institutions in China. He is a member of the grant review committee for the National Key Drug Development Fund, jointly managed by the Ministry of Science & Technology (MOST), and the National Health and Family Planning Commission of China (NHFPC). He chaired the BayHelix CFDA working committee and works with the agency on development of technical guidelines. He was a member of the Overseas Expert Committee on New Drug R&D from MOST. He is senior consultant to the Chinese Academy of Medical Sciences and Peking Union Medical College. He was also a visiting professor at the Harbin Medical University of China, Nankai University, and Science and Technology University of South China. He is currently a senior consultant to the Chinese Academy of Medical Sciences and Peking Union Medical College. Dr. Zhang was an Executive Director of Sino-American Professional Pharmaceutical Society (SAPA), President (2006–2007) of the Chinese Biopharmaceutical Association-USA (CBA), a Board Director of BayHelix, and is currently Secretary General of the Thousand Talents Program.
He received his pre-med training from Peking University and MD from Peking Union Medical College in China. He continued his study at the Harvard School of Public Health in the US and received an MPH in Health Policy and Management. He then continued his training at the Wharton School of the University of Pennsylvania, where he obtained his MBA in Health Care Management in 1998 and is working on his PhD dissertation in the field of health economics and finance.
John D. Balian, MD
John D. Balian, MD
John D. Balian, MD, is the Chief Executive Officer of FMD K&L. In February 2016, he founded the consulting firm MediVista, focusing on development of healthcare and IT companies and transformative technologies. Previously, he was a senior executive at Johnson & Johnson, where he served as Chief Medical Officer of the Johnson & Johnson Family of Consumer Companies, leading Medical, Clinical, Regulatory, Medical Safety, Toxicology, and related functions. In April 2014, Regional R&D was added to his remit and his title became Chief R&D Operations Officer.
Dr. Balian joined Johnson & Johnson from Pfizer Inc, where he was Senior Vice President, Worldwide Safety & Regulatory Operations. He led efforts to capitalize on the immense data streams Pfizer collects to gain new insights into patient needs and find new opportunities to serve them better. He launched and successfully executed a complete transformation of the organization’s structure, practices and strategies to address performance and regulatory challenges facing the company.
In 10 years at Pfizer, Dr. Balian held numerous leadership positions, originally joining as an Associate Director in Drug Safety before soon becoming Vice President and Global Head for Clinical Safety and Risk Management. In 2003, he was appointed VP in Development Operations, leading a multi-functional organization responsible for Pfizer’s sourcing strategies, capacity planning, clinical trials conduct and allocation, patient recruitment, performance measures and business/operational support for all clinical trials.
He also served at Bristol-Myers Squibb, leading the Global Pharmacovigilance & Epidemiology group and a Medical Affairs group focusing on mature brands. Among the many innovative methodologies he introduced was a BMS global operations center for pharmacovigilance in Chennai, India, an industry first.
Previously, Dr. Balian worked for the U.S. Food & Drug Administration, first as a Medical Reviewer for neuropharmacology products, and then as an Associate Director in the Office of Clinical Pharmacology and Biopharmaceutics. Widely published in scientific journals, he is also a published novelist. He earned his B.A. degree from Columbia University and his M.D. degree from Tufts University School of Medicine.
Dr. Xin Ke
Dr. Xin Ke
Xin Ke, PhD, is the Chairman 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 for 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), which provides niche contract research organization (CRO) services to global pharmaceutical and biotech companies in the areas of data management, biostatistics, biostatistical programming, CDISC/SDTM/ADaM standardization and conversion, and medical writing. In 2014, K&L merged with Fountain Medical Development, Ltd. (FMD, China), to become FMD K&L. In 2016, FMD K&L merged with iMEDGlobal, further expanding services and global geographic presence.
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 FDA and 11 have been approved for marketing.
Dr. Ke received his PhD from Rutgers University and BS in Applied Mathematics from Tsinghua University, China.
Dr. Tiepu Liu
President - Global Biometrics
Dr. Tiepu Liu
President - Global Biometrics
Tiepu Liu, MD, PhD, is the President of Global Biometrics and a member of the executive leadership team at FMD K&L. With training in medicine and quantitative methodology, Dr. Liu has extensive clinical research and development experience in therapeutic areas such as oncology, diabetes, cardiovascular, antiviral and anti‐infective, immunology, respiratory, gastrointestinal, CNS, dental, and devices.
He served as a biostatistician and epidemiologist at the University of Alabama at Birmingham Comprehensive Cancer Center and led a biostatistics and epidemiology group at the University of Cincinnati. During the last 15+ years, Dr. Liu served as Director of Biostatistics at PPD, Executive Director of Statistics and Data Management at UBC, and Senior Director of Biostatistics at Graceway Pharmaceuticals and The Medicines Company before joining FMD K&L.
He has published more than 100 scientific papers and over 100 abstracts and presentations. He has served on working committees of several professional societies, 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 lead biostatistician for the NIH AIDS Malignancy Consortium in 1995–1996, chief biostatistician for the Emergency Cardiac Research and Education Group from 1996 through 1999, and Principal Investigator and Director of the Data Coordinating Center for the NIH Immune Tolerance Network from 2002 through 2006.
Dr. Liu has led numerous clinical development projects in more than a dozen therapeutic areas. As a statistician core team member, he has participated in multiple full development (IND to NDA) and post-marketing programs, leading to the successful global approval and commercialization of Arestin (minocycline), Zyclara (imiquimod), and Kengreal/Kengrexal (cangrelor). As a statistician, he has interacted with various regulatory agencies, including US FDA, EMA, and CFDA, presenting at advisory committee meetings. He has worked with numerous data monitoring committees (DMCs) in various capacities, serving as a voting independent statistician member and coordinating and presenting frequently to DMCs.
He received his PhD in Biostatistics and Epidemiology at the University of Alabama at Birmingham School of Public Health and received his Doctor of Medicine and Master of Public Health from Tongji Medical University, China.
President - Americas
President - Americas
Tim Seitter is the President of Americas at FMD K&L and a member of the executive leadership team. Mr. Seitter is responsible for managing business development, marketing, client engagement, HR/operations, global QA, global IT, and European operations.
Prior to joining FMD K&L, he was Vice President and Head of the Oral Care Strategic Business Unit for Church & Dwight, Inc. (C&D) and was responsible for the global direction of the Oral Care Business Unit. In this role, he consistently led the growth of his division, helping C&D to quadruple total market capitalization. He also served as General Manager for the Hefty EZ Foil Division at the Pactiv Corporation (Hefty Consumer Products Group), where he was fully responsible for the wholly-owned subsidiary, leading an aggressive turnaround of the North American business unit which resulted in >35% profit growth in 2005. As Vice President of Marketing for the Golf Division at Spalding Sports Worldwide, he provided overall brand leadership of Top-Flite, Ben Hogan, and Strata Golf Brands, leading a business team of 20 professionals in all aspects of brand development, strategic direction, new product introductions, marketing plan development, profitability, and volume delivery. With more than 25 years of well-versed experience, Mr. Seitter possesses a wealth of knowledge and expertise in sales, marketing, and business operations, which position him well to lead FMD K&L’s continuing growth and profitability.
He received his MBA in Marketing and Finance from the University of Florida, a BS in Commerce with a concentration in accounting from the University of Virginia, and is a Certified Public Accountant.
President - Asia Pacific
A co-founder of iMEDGlobal (an FMD K&L company), Mahesh has more than 27 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 CEO iMEDGlobal Inc – a KPO company providing services in the life sciences space. He was instrumental in taking the company from inception to a 500+ member strong company. He was also the Global Head, Product Development at ArisGlobal, India, and Engineering Manager at WYSE, India. He has also worked as a consultant, with DSA to help develop its IT service offering for the life sciences industry and worked on the Triage XML Intake system. Prior to the Life Sciences space, Mahesh has worked extensively in the Banking and Enterprise domain designing and developing solutions. Mahesh has a Bachelor’s Degree in Instrumentation Engineering from Bangalore University, India