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 1986, 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.

JoAnn Dzenis is Program Director for REGISTRAT-MAPI’s Chronic Pain Management Network (CPAIN), JoAnn was formerely with Omnicare Clinical Research where she was Senior Vice-President for Global Clinical Trials Management. Starting her Clinical Research career with Parexel International as a Database Manager, JoAnn has also served as a Project Manager, Project Director, Director of Project Management, Vice President of Operations and Senior Vice-President of Project Management.

JoAnn has a Bachelor Degree in Computer Science and Economics from the University of Massachusetts at Amherst and has a Certification in Project Management (PMP).

Xavier Fournie, M.D., is Vice President, Europe for REGISTRAT-MAPI. Having practiced as a general physician for 4 years in hospitals and private practices, Xavier Fournie is aware of the realities of medical care and patient expectations. He has additional qualifications in Medical Law (Forensic Medicine), Sports and Aeronautic Medicine.

He joined the Mapi Group in 1986 and has held various posts in different companies of the group, giving him a strong knowledge of the different roles in Health evaluation and management: Market Research project management (3 years), Clinical Trials and Pharmaco-Epidemiological studies (11 years: project management, Quality Assurance and Legal Affairs development, medical direction), Central Lab (2 years, Executive General Manager).

In 1995, he created a company called Genematic, specialized in the development of e-tools for clinical research, through which he gained sound knowledge of the power of these new technologies and their acceptance in the real world.

From 2001 to the end of 2008, as a CEO, Xavier Fournie has overseen the development of this organization (renamed PROCLINICA) by extending its services to a fieldwork company specialized in direct to patient management (PRO data collection using/combining the relevant tools, patient management: information, assistance, reminders…) and logistic support in studies.

MAPI Group Corporate Medical Director since January 2008 and Vice President of REGISTRAT-MAPI Europe since 2009, Xavier Fournie is in charge of coordination and supervision of Medical and Regulatory Affairs, Quality Assurance, Safety and Communications capabilities within the MAPI Group. Xavier helps to develop and implement partnering strategy with external service providers and to integrate new companies and new services into the MAPI Group.

Specialties

Medical Doctor, Contract Research organization, Medical Affairs, Medical Law, Quality Assurance, Clinical trials and Pharmaco-Epidemiological studies, Regulatory Affairs, Direct Patient Management

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.

Dr. Luross is Director, Global Projects at REGISTRAT-MAPI. With over 12 years of experience in medical research, clinical product development and global project management, Dr. Luross provides multi-national leadership and expertise for global project teams to ensure the successful design, planning and implementation of global Late Phase services.

Prior to joining REGISTRAT-MAPI, Dr. Luross held the position of Director, Clinical Product Development at a U.S.-based biotechnology company, as well as multiple positions in global project management and clinical operations at contract research organizations (CROs) in the USA and United Kingdom. Dr. Luross earned his PhD in Cellular Immunology from the University of Bristol, U.K., and MSc and BSc degrees in Biomedical Sciences from the University of Guelph, Canada.

Juliette Longin has a Doctorate of Human Biology (endocrinology of reproduction) and certificates in Methods and Practices in Epidemiology and in Statistical Methodology applied to medicine and medical biology. She has Masters degrees of Metabolisms, Endocrinology and Nutrition and of Physiology.

She joined the MAPI Group in 2001 as Project Manager at the MAPI Research Institute where she coordinated international research projects such as the Cochrane Patient-Reported Outcomes (PRO) Working Group and trainings in the PRO field. She worked for six years as a Project Director within the Pharmaco-Epidemiological Unit of REGISTRAT-MAPI where she carries out Pharmaco-Epidemiological projects for pharmaceutical companies.

She now works as Associate Director, Scientific Expertise and Proposal Development. She is specialized in Pharmaco-Epidemiological studies requested by Health Authorities (HAS, AFSSAPS, EMEA). She developed In fine PHARMA® (French pharmacies network) in 2007. She is also involved in the scientific coordination of the Pharmaco-Epidemiological Summer Congress organized once a year by MAPI since 2004.

Dr William C. Maier, is Vice President Epidemiology, Drug Safety, and Risk Management 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. He was previously Senior Director of Epidemiology at GlaxoSmithKline and Elan Pharmaceuticals and led research groups conducting observational research using registries, databases, chart reviews and field 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 (www.ispor.org/Intl_Databases/) 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).

Trained as a general physician, Hubert Méchin practiced general medicine for 5 years and complemented his training with a Master's degree in Health Marketing from the University of Paris IV. His career in the pharmaceutical industry began in 1992 in Medical Products for MSD Laboratories where he spent 2 years. He then entered into the service performance field for the pharmaceutical industry starting as a Project Manager and later Project Director for a European CRO (FDM Pharma) where he developed a department dedicated to observational studies.

In 1998 he created his own enterprise (NAXIS) which was entirely dedicated to observational and Pharmaco-Epidemiology studies. In 2001, NAXIS joined the MAPI Group where he developed the Late Phase activity on both national and international levels. Hubert Méchin is a guest lecturer for numerous continued education courses (Master of Health Marketing at the University of Paris IV, Pharmaco-Epidemiology degree programs at the University of Lyon I, and Pharmaco-Epidemiology symposiums and conferences) and in 2004 created the Summer University of Pharmaco-Epidemiology (UPE). Additionally, Hubert Méchin is the Vice-President of the French Association of CRO's (AFCROs).

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.

Steven Shoemaker, MD serves as Medical Director for REGISTRAT-MAPI. He is board certified in Internal Medicine, with a specialty in Pulmonary Diseases. With over 20 years of experience in the biopharmaceutical industry, Dr. Shoemaker offers a variety of expertise to our clients. His drug development experience spans early phase, proof-of-concept animal studies of novel recombinant and small molecule compounds developed in start-up companies, to later phase NDA approval, commercialization, and life cycle management of drug delivery products marketed by established pharmaceutical companies.

Dr. Shoemaker’s most recent focus has been on novel small molecules for asthma and various cardiovascular applications. He also has significant experience in developing opioid compounds for approval and with risk minimization plans for these compounds. He has held a variety of positions in the pharmaceutical industry, including President of two medical strategies companies, which he founded, and Vice-President of Medical Affairs for several biotechnology companies.

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 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 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.

Mr. Webb is responsible for business and global 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.