Respiratory Update: Interpreting Minimal Clinically Important Differences in COPD and Demonstrating Product Value with Patient-Reported Outcomes (PROs)

Clinical Trials, Life Sciences, Pharmaceutical,
  • December 04, 2013

Pharmaceutical companies face the daunting task of getting new respiratory products approved and launched in a crowded marketplace. Two main challenges in respiratory clinical trials are; interpreting minimal clinically important differences (MCID) and designing a patient reported instrument to demonstrate a compound’s value. Both are critical in the approval of your compound as well as in post marketing activities.

To compete effectively in the respiratory market, it is critical to show the value of your product over the competition. One way to do this is to examine the effect of new products on patients using Patient Reported Outcomes (PROs).

In this webinar, the presenters will examine MCIDs and different types of PROs that are available for respiratory diseases and review case studies of successful demonstrations of product value in respiratory programs.

Speakers

Dr. Chad Gwaltney , Senior Director, Consulting Services , ERT

Dr. Gwaltney is currently Senior Director, Consulting Services at ERT. He has published numerous articles and book chapters addressing pharmacotherapy and clinical outcome assessments in areas such as addictive behaviors, cardiovascular health, and dental medicine. He has served on multiple international task forces and NIH review committees. He has co-authored guidelines on the content validity of new patient-reported outcome measures and migrating clinical outcome assessments from paper to electronic platforms. Dr. Gwaltney is currently on the editorial board of Psychology of Addictive Behaviors and is an investigator on multiple NIH grants.

Dr. Kai-Michael Beeh, Founder and Medical Director, insaf Respiratory Research Institute Wiesbaden

Dr. Beeh is a board-certified Internist and Pulmonologist. He is the founder and Medical Director of the insaf Respiratory Research Institute in Wiesbaden, Germany, a privately owned clinical research facility. He is also external lecturer (“Privatdozent”) for Internal and Pulmonary Medicine at the University of Mainz. Dr. Beeh has a special interest in clinical research and drug development and has designed and conducted more than 100 trials in asthma, COPD and allergies.

In 2009, he founded AEREON Consulting, a clinical service company, located in Wiesbaden, Germany. He is an Associate Editor of “Advances in Therapy” and has published or co-authored over 60 peer-reviewed articles on pathophysiology and pharmacotherapy of chronic airway diseases, including high-ranked journals as the “New England Journal of Medicine”. He reviews scientific articles for biomedical journals such as the European Respiratory Journal, Chest, Clinical & Experimental Allergy, and others. Dr. Beeh is a member of the European Respiratory Society, German Society of Pneumology, and Association of German Allergists.

Who Should Attend?

All biopharmaceutical companies that are developing or planning to develop respiratory drugs

Professionals involved in:

  • Data Management
  • Trial Management
  • Safety
  • Regulatory Affairs
  • Clinical Operations
  • Information Technology
  • Marketing Reimbursement
  • Commercial Strategy

with Job titles that include:

  • Executive Vice Presidents
  • Vice Presidents
  • Directors
  • Managers
  • Project Managers
  • Data Managers
  • Clinical Research Coordinators

Xtalks Partners

ERT

ERT (http://www.ert.com/) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. By efficiently integrating innovative solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling and reimbursement of Pharmaceutical products.

ERT delivers the most widely deployed solutions in: Centralized Cardiac Safety, Respiratory Services, Clinical Outcome Assessments (COA) – including multi-mode, electronic patient, clinician, and observer reported outcomes solutions (ePRO, eClinRO, eObsRO), Suicidality Risk Monitoring and Scientific & Regulatory Consulting in each of these areas.

ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.

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