Adherence in Asthma: Comparing Clinical Trials to the “Real-World”

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • June 14, 2013

Inadequate medication adherence is a widespread issue whose estimated annual cost to the health care system is between $100 billion and $289 billion in the US and €125 billion in the European Union. In asthma, rates of adherence during clinical trials are typically high and often exceed 90% with one reporting ≥96% adherence over a 52 week period. [Busse 2013] [Papi 2007] [Ringdal 2002]

In the real world, however, studies across a range of disease severities have consistently reported significant rates of non-adherence despite a direct correlation between medication intake and patient-reported symptom improvement or other negative outcomes.

In this webinar we will explore the issue of adherence to asthma medication in both clinical trials and the real world, including measurement of adherence, data interpretation, regulatory implications, and the challenges of generalizing study data to routine clinical practice. We will also examine the changing environment of ‘real world’ studies and suggest practical solutions to this challenge.

Keywords:

Speakers

Liam Heaney, Professor of Respiratory Medicine, Queens University Belfast Regional Respiratory Centre, Belfast City Hospital

Professor Liam Heaney, a world leading expert in adherence issues in asthma studies, brings 24 years clinical research experience focused in “difficult to manage asthma”. Liam has developed a research program that spans the entire spectrum from clinical assessment and management to the development of novel biomarkers and translational therapeutics. He founded and now co-ordinates the British Thoracic Society UK Severe Asthma Network and National Registry on Difficult Asthma. The Registry facilitates research into the assessment and clinical management of difficult asthma and standardizes UK specialist clinical services.

Professor Heaney’s group at Queens University has developed and validated a multi-disciplinary systematic assessment / management model in difficult asthma, which has informed best practice in National and International Asthma Guidelines

Peter Summerfield, VP, Global TAH Respiratory, Global Product Development, PPD

Peter Summerfield has more than 34 years’ experience in leadership, strategic and operational roles in the bioPharmaceutical industry. As vice president of global product development for PPD, Peter is responsible for strategic consulting in respiratory medicine. In addition, he is an expert in risk management of medicines, including acting as qualified person for pharmacovigilance for designated marketing authorization holders in Europe.

Prior to joining PPD, Dr. Summerfield worked in Boehringer Ingelheim, American Cyanamid (Lederle), GlaxoSmithKline, Roche, and Biogen. His experience spans all phases of drug development, all technologies (small and large molecules, NCE’s and generics), and all major therapeutic areas.

Dr. Summerfield graduated from Kings College Hospital Medical School, University of London. He is a Fellow of the Royal College of Anaesthetists in the UK.

Rav Seeruthun, MRCGP, MFPM, Senior Director, Global Late Stage Research, PPD

Dr. Seeruthun has more than 13 years combined physician experience in clinical practice working in the UK National Health System and in private industry. During his medical career, he worked in a wide variety of specialities including cardiology, general medicine, pediatrics, gynecology, emergency room, and psychiatry. He spent the latter part of his medical career in primary care. Since transitioning to private industry, Dr Seeruthun lead his team at Organon through the merger with Schering Plough. He has held the European lead role at Eisai Europe, heading the CNS and GI department. Dr. Seeruthun lead the newly formed clinical affairs department at Napp Pharmaceutical before joining PPD in 2012 as Senior Director in Global Late Stage Research focused on working with clients to ensure their clinical trial research programs will demonstrate their product’s full value proposition.

Dr. Seeruthun received his medical training at St. Mary’s Hospital Medical School at Imperial College London and received his bachelors honors degree in psychology from University College London.

Who Should Attend?

Companies: Large and mid-sized biopharmaceutical companies in North America and Europe involved in the development of drugs requiring late stage and post approval services

Job functions: Product development, commercialization, respiratory, medical/regulatory affairs, pharmacovigilance, clinical operations, epidemiology, commercial strategy, marketing, reimbursement

Job titles: Product team leaders / director level and above

Therapeutic area: Respiratory

Xtalks Partners

PPD

PPD is a global contract research organization (CRO) providing discovery, development and lifecycle management services. With offices in 46 countries and more than 12,500 employees worldwide, PPD has conducted clinical trials in more than 100 nations, and we have worked with all of the top 50 Pharmaceutical companies.

PPD is a leading provider of chemistry, manufacturing and controls (CMC) laboratory services for all phases of drug development and follows current Good Manufacturing Practices (cGMPs). Our cGMP laboratories provide fully integrated product and analytical development services ranging from early characterization through commercial release and stability. Our highly qualified cGMP lab staff works with large and small molecules, including active Pharmaceutical ingredients (API), drug products, inhaled products and other medical devices. With more than 200,000-square- feet of cGMP laboratory space, we have locations in Athlone, Ireland; Middleton, Wis.; and Wayne, Pa., to meet our clients’ needs.

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