September 23, 2011

Risk Management of Drug Safety: Pre-Approval Planning and Research will Ensure Success

Risk Management of Drug Safety: Pre-Approval Planning and Research will Ensure Success

The last decade has witnessed an increase in the power of national regulatory authorities to require explicit programmes to control and mitigate risks related to the use of new and existing drugs. The impact on the pharmaceutical industry is substantial because these new laws and regulatory powers will require a significant change in the way drugs are developed and supporting research is done prior to the filing of new drugs.

National regulatory agencies in the US and Europe have adopted similar approaches to enacting risk control programmes. In the US, the FDA has developed the concept of Risk Evaluation and Mitigation Strategies (REMS). The European approach requires that a formal risk control plan (called an EU-RMP) be submitted with each new drug approval application at both a pan-European and national level.

This new era of risk control and accountability requires that companies obtain evidence of the likely effectiveness of their proposed risk control programmes prior to the submission of an application for drug marketing. Failure to provide this information is likely to lead to either longer approval times or increased failures during the drug approval process. However, the information on programme effectiveness is relatively easy and inexpensive to obtain prior to submission of a marketing application. As a result, companies can ensure the success of their new medications by conducting this research.

This webinar will discuss the new US REMS guidance and EU-RMP legislation, and what companies need to do in order to prepare for submissions. This will include the design and evaluation of the appropriateness of different risk management programmes and assessment of the feasibility of different types of post-marketing commitments.

Medical directors, medical affairs, drug safety, epidemiologists, individuals involved in the commercialisation and/or marketing of new drugs

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) 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).

Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi  

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.

Dr. Paula Thompson, Senior Epidemiologist,  Registrat-Mapi 

Dr. Paula L. Thompson, PhD, MSc, Senior Epidemiologist, joined REGISTRAT-MAPI in October 2010. Her previous career includes working as a Project Leader at i3 Innovus, an Epidemiologist at Boehringer Ingelheim and an Information Officer at the Health Protection Agency.

Paula gained her Doctorate in Pharmacoepidemiology from The School of Pharmacy, University of London and her Masters in Epidemiology from the London School of Hygiene and Tropical Medicine, for which she was awarded a competitive MRC Studentship. She holds a First Class BSc Honours in Biomedical Science, during which she undertook a twelve-month placement at the Paediatric Epidemiology Group, University of Leeds.

Whilst at university, Paula was elected Co-Chair of the International Society for Pharmacoepidemiology Student Council. She also sat on the Paediatric Subgroup of the Department of Health’s Specialist Advisory Committee on Antimicrobial Resistance (SACAR) and was a member of the Improving Children’s Antimicrobial Prescribing (ICAP) group, which is a formally constituted UK Research Network of the British Society for Antimicrobial Chemotherapy and the Royal College of Paediatrics and Child Health. Paula is a current member of the EMA’s European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Paula has published her research in several high-impact journals, has presented at numerous international scientific conferences and has acted as a peer-reviewer for the Archives of Disease in Childhood and the International Conference for Pharmacoepidemiology and Therapeutic Risk Management.

REGISTRAT-MAPI provides strategic and operational solutions for our clients in the design and implementation of Late Phase studies. We are the pharmaceutical industry’s largest global CRO dedicated exclusively to real world clinical research. With more than 250 experienced professionals, we have served the biopharmaceutical and medical device industries for more than 20 years.

REGISTRAT-MAPI is an established leader in navigating the complex and evolving landscape of global Late Phase research. With offices in Europe, North America, and Asia, we guide our clients through strategic and practical issues from project conceptualization and design, to global execution in the real world.

REGISTRAT-MAPI experts are your direct link to the latest views and solutions associated with Late Phase research. Most importantly, our expertise is honed from hands-on involvement in the practical challenges of designing and managing Late Phase research.