Scientific Expertise

Ronald Christensen, M.D., CEO, North America

Ronald Christensen

Dr. Christensen has broad-based experience in academia, clinical research, and the biopharmaceutical industry.Following his fellowship training in Pediatric Endocrinology, he was Director of Endocrinology at Phoenix Children's Hospital.As a Director in both the Marketing and Medical Affairs Departments at Genentech, Inc., he provided expertise in development of observational studies to support clinical, safety, and product commercialization efforts. He was responsible for the design, implementation, and management of several patient registries in various therapeutic areas over a 10-year period.

As Senior Director of Medical Affairs at Genentech, Dr. Christensen was responsible for the management and direction of four groups: Medical Information, Drug Safety, Epidemiology, and Post-marketing Studies. These groups provided customer and product support for commercial products and were involved in the clinical development of new molecular entities.

In 1997, Stephen Webb and Dr. Christensen founded a contract research organization (CRO) focused on conducting peri- and post-approval studies that later became REGISTRAT®, Inc. In June 2009, REGISTRAT merged with a MAPI Group company to form REGISTRAT-MAPI, a global Late Phase CRO. In addition to his role as a member of the Executive Committee, his administrative responsibilities as Co-CEO include strategic oversight of North America business and operations and direct management of the Quality Assurance, Human Resources, Information Technology, and Business Development Departments.

During his 25 years in the biopharmaceutical industry, Dr. Christensen has become an industry leader in the development and application of Late Phase studies (peri- and post-approval studies) for post-marketing safety surveillance, clinical effectiveness, outcomes research, and risk management.He has been involved in the strategic design, implementation, and management of hundreds of Late Phase studies and Risk Management Programs.

Xavier Fournie

Xavier Fournie

Dr. Fournie has practiced as a General Practitioner for four years in hospitals and private practices in France and Germany.  He has additional qualifications in Forensic Medicine, Sports and Aeronautic Medicine.

Since 1986, he has held various posts in different companies of the MAPI Group, giving him a strong knowledge of the different roles in health evaluation and management. These posts included but are not limited to: project management, clinical operations lead, general management of central lab activities, medical direction, quality assurance and regulatory affairs direction, and drug safety development.

In 1995, he created a company called Genematic, specializing in the development of e-tools for clinical research. From 2001 to the end of 2008, as CEO, Xavier has led the development of this organization (renamed PROCLINICA) by extending its services to a company dedicated to multi-country direct-to-patient management for proactive PRO data collection and patient assistance in studies.

MAPI Group Corporate Medical Director since January 2008 and Executive Vice President of REGISTRAT-MAPI Europe since 2009, he is in charge of coordination and supervision of Medical and Regulatory Affairs, and Quality Assurance within the MAPI Group. He oversees global Drug Safety and Direct-to-patient contact management services. He helps to develop and implement partnering strategy with external service providers and to integrate new companies and new services into the MAPI Group.

Beth Haury Director, Medical Writing

Beth Haury

Ms. Haury brings over 20 years of drug development experience to her position as Director of Medical Writing. In this role, she leads the REGISTRAT-MAPI team in the accurate and effective reporting of study and registry data.

Before coming to REGISTRAT-MAPI, Ms. Haury most recently served as Director of Proposal Strategy for a large global CRO with offices in 25 countries. During her tenure there, she also directed Medical Writing, Regulatory Affairs, Document Management, and Drug Safety groups. She has written and directed the writing of protocols, clinical study reports, NDAs, BLAs, manuscripts, poster presentations, patient narratives, and marketing materials. In addition, Ms. Haury has benchtop laboratory experience in microbiology and surgical research and has published in these fields. She has also served as an editor of medical books and journal articles and as director of a university writing center.

Ms. Haury earned a BA in English from Georgia State University and an MA in English from the University of Virginia.

William C. Maier, MPH, PhD.

Dr William C. Maier, is Chief Scientifc Officer at REGISTRAT-MAPI the industry's largest clinical research organization (CRO) dedicated solely to real-world clinical research.

Dr Maier has over 20 years of experience in drug development and commercialization at pharmaceutical companies in Europe and the United States. Dr. Maier has most recently served as Vice President and Head of Epidemiology for REGISTRAT-MAPI. He was previously Senior Director of Epidemiology at GlaxoSmithKline and Elan Pharmaceuticals and led research groups conducting observational research to support reimbursement, marketing and drug safety investigations of pharmaceuticals throughout the world. He has worked on over 50 observational studies in several disease areas including respiratory, neurology, psychiatry, autoimmune, cancer, endocrinology, cardiovascular, cerebrovascular, urology, opioid dependency and vaccines.

He routinely provides training seminars to pharmaceutical, biotechnology and medical products companies in Europe and the US on the use and development of real-life data for use in health technology assessment, drug safety and risk management. In July 2007 he presented the Tysabri Risk Management Plan at an FDA advisory committee meeting.

Dr Maier is editor of the quarterly PharmacoEpi and Risk Management Newsletter, (http://www.prmnewsletter.org/) which publishes articles on applications of methods, development of new tools and reflections on regulatory developments in product safety, pharmacoepidemiology and risk management.

He is also involved with the International Society of Pharmacoeconomics Research (ISPOR) project to develop a global database of real-life health care information (http://www.ispor.org/DigestOfIntDB/CountryList.aspx) and is a member of the EMEA's European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (www.encepp.eu). In addition, he is a frequent speaker at medical conferences and has academic appointments in the UK (Dundee) and the USA (North Carolina).

 

 Carl de Moor, Ph.D.

Carl de Moor

Dr. de Moor brings a wealth of Medical Research and clinical research organization (CRO) experience in the areas of epidemiology, biostatistics, & health outcomes. He collectively has 24 year of experience in consulting and research in epidemiology, biostatistics, and health outcomes including retrospective and prospective observational studies, secondary database analyses, clinical and patient reported outcomes studies, economic analysis, and design of registries. He also has extensive experience in the design of Phase I-IV clinical trials.

Beginning his career as a Research Assistant Professor at the University of Texas Health Science Center, Carl has served as Chief, Behavioral Statistics & Associate Professor of Biostatistics at the University of Texas M. D. Anderson Cancer Center; Associate Director of Design & Analysis and Associate Professor, Division of Biostatistics at the University of Texas Health Science Center at Houston, School of Public Health; Director, Data Management Core, Clinical Research Program, Children's Hospital Boston and Associate Professor, Department of Psychiatry, Harvard Medical School.

Most recently, he served as Executive Director, Epidemiology & Health Outcomes at PPD where he was responsible for pharmacoepidemiology, safety registries, health outcomes, and pharmacoeconomic consulting and studies in the late stage research. Prior to this position he was Vice President Health Outcomes and Pharmacoeconomics for Supportive Oncology Services, Inc. in Memphis, responsible for direction of all health outcomes, pharmacoeconomic, and pharmacoepidemiology post marketing observational studies.

Dr. de Moor has been published in more than 95 peer-reviewed publications in clinical, epidemiological and health outcomes studies, has served as biostatistician co-investigator and co-principal investigator on 40 funded grants and contracts, and performed article reviews for 12 industry publications. He has performed grant review committee service for the NIH, Lance Armstrong Foundation, California Tobacco Control Initiative, CDC, and American Cancer Society. He received his PhD and MS in Biostatistics from the University of Washington and a BS in Biology from San Diego State University.

Derenda Nichols

Derenda Nichols

Ms. Nichols brings more than 19 years clinical research experience to the Vice President, Global Clinical Operations position with REGISTRAT-MAPI. In this role, she provides leadership and direction to the Project Management, Monitoring and Site Management, Biometrics and External Resources groups ensuring the teams work effectively and operationally meet or exceed contracted timelines and sponsor expectations.

Ms. Nichols began her career as a Clinical Research Associate with Covance where she monitored numerous phase I-IV studies in a wide range of indications. After completing assignments in regulatory affairs and clinical writing, she moved into Project Management where she successfully lead large domestic and global teams in a broad range of clinical studies conducted in both outpatient and inpatient settings. Upon joining Kendle International, Ms. Nichols assumed corporate responsibility as Director, Clinical Services. In this role, she was responsible for operations of Phase I-IV clinical monitoring, investigator services, patient recruitment and a studies support center in the Americas. Most recently, she held the position of Vice President, Americas Project Management for Omnicare Clinical Research where she was responsible for Phase I – IIIb global, regional and domestic project management activities.

Ms. Nichols received her Bachelor of Science Degree in Business Administration from Elmhurst College in Elmhurst, IL.

Richard Stead, MD Medical and Regulatory Affairs

Richard Stead

Dr. Stead is involved in clinical and business development activities for the company. With his broad-based experience at Immunex and Amgen, Dr. Stead is well positioned to provide strategic and operational expertise to clients facing challenges in clinical development, regulatory approval, and commercialization of breakthrough therapeutics.

Dr. Stead has over 15 years experience in the development of protein therapeutics, as well as small molecules, gene therapy and devices. He played a major role in filing several INDs and 5 BLAs/NDAs, and has worked closely on clinical development and regulatory filings with corporate partners in the U.S., Europe and Japan. In addition to his contribution to successful product approvals in hematology, oncology and neurology, he has also worked in a number of other therapeutic areas including nephrology, hepatology, cardiovascular, pulmonary and infectious diseases. Dr. Stead championed successful in/out-licensing efforts and strategic alliances at both Amgen and Immunex, and lead multi-disciplinary due diligence teams across several therapeutic areas.

Prior to joining REGISTRAT-MAPI in 2002, Dr. Stead most recently served as Vice President of Clinical Research and Development at Immunex where he was responsible for clinical research and development programs for Immunex products and product candidates being developed or marketed for oncology, neurology and immunotherapy. In this role, he worked closely with Discovery Research on several new pipeline molecules as they moved into clinical development. He played a key role in the FDA approval and commercialization of Novantrone for a broad indication in multiple sclerosis. Dr. Stead also led Clinical R & D efforts to partner closely with both Sales and Marketing to enhance the commercialization efforts for Leukine and Novantrone. He worked closely with the FDA, the Specialty Therapeutics Franchise, and REGISTRAT-MAPI to develop and implement the Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis (RENEW). He was also involved in the development and successful implementation of the Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1 and 2).

Before joining Immunex, Dr. Stead was recruited to Amgen in 1988 as its first physician and served in various positions in Clinical Development over the course of more than 11 years. He played a significant role in the clinical development, FDA approval and the commercialization of Amgen's first two products, Epogen and Neupogen including the establishment of post-approval registries for both products. He was a member of the clinical development oversight group that reviewed and approved all Amgen clinical protocols and regulatory filings.

Dr. Stead graduated Phi Beta Kappa from the University of Wisconsin with a major in molecular biology. After graduating from Stanford University's School of Medicine, Dr. Stead completed his training in internal medicine and a post-doctoral fellowship in hematology at the Brigham & Women's Hospital and Harvard Medical School. Following completion of a second post-doctoral fellowship at the National Cancer Institute in the Laboratory of Molecular Biology, he joined the staff of the Fred Hutchinson Cancer Research Center in Seattle, where he conducted research in the field of gene therapy. Dr. Stead has published in the fields of hematology, cytokines and gene therapy.

Stephen Webb President, North America

Stephen Webb

Mr. Webb is responsible for business and North American operations, strategic consultation on study design and analyses, international affiliates, product commercialization, and client and business development activities for the company. Mr. Webb has been in industry since 1988 marketing biopharmaceuticals, conducting clinical and basic research, and developing numerous peri- and post-approval studies including: Phase IIIb-IV studies; disease, product, and pregnancy registries; post-marketing commitment studies; and expanded safety surveillance and risk management programs.

Mr. Webb has held previous positions at Glaxo Pharmaceuticals, Research Triangle Park, NC as a Hospital/Field Sales Representative where he marketed oral and parenteral gastro-infectious disease and neurological pharmaceuticals, and ClinTrials Research where he managed Phase II-IV clinical studies for FDA submission and approvals with a concentration in Phase IV Post-Marketing Studies.

Mr. Webb is a graduate of the University of Kentucky where he majored in Business Administration and Biology, completed his premedical curriculum, and conducted basic research at the Center for Biomedical Engineering and Department of Anatomy and Neurobiology. Mr. Webb is a Fellow of the Howard Hughes Medical Institute, has authored published abstracts and scientific papers, and presents at numerous industry conferences.