The WHO predicts that by 2030, COPD will be the third leading cause of death globally behind cardiovascular and cerebrovascular disease. In the Asia-Pacific, the world’s most populous region, the growing exposure to tobacco smoke, dusty jobs, biomass fuel exposure and increasing outdoor air pollution means that even though the population is getting richer, their respiratory health is at significant risk. What do respiratory endpoints in clinical trials, particularly in the Asia-Pacific region, tell us about the impact and future of respiratory trials in the region? How are endpoints adjudicated and managed so that the best outcome is delivered to the sponsor and most importantly to the patient?
In this live webinar, the speakers will outline both the importance of a coherent endpoint strategy as well as the importance of leveraging scientific leadership early-on in trial design.
Leading thoracic physician researcher and Chair of the Lung Foundation of Australia, Professor Christine Jenkins will use examples from her long-term partnership as a scientific leader at George Clinical to discuss:
- The importance of defining respiratory endpoints so that they are accurate and precise;
- What can go wrong if you do not…
- Develop efficiency strategies by identifying the pros and cons of using specific endpoints in your respiratory trials;
- Clinical outcomes
- Patient reported outcomes
- The standardization of endpoints;
- The importance of trial design in assessing specific endpoints and how to maximise trial efficiencies in relation to endpoints of greatest influence
Professor Jenkins will also discuss:
- The role of Scientific Leadership in endpoint strategies
- The impact of Scientific Leadership when integrated throughout trial design and delivery
- The benefits of designing and conducting large respiratory trials in Asia
Professor Christine Jenkins, Scientific Leader, George Clinical
Christine Jenkins is Head of Respiratory Trials at The George institute for Global Health, Senior Staff Specialist in Thoracic Medicine at Concord Hospital, Sydney, and Clinical Professor and Head of Respiratory Discipline at the University of Sydney.
Christine has been Principal Investigator and has led many investigator-initiated and competitively funded clinical trials in airways disease. She is chair of the Lung Foundation of Australia and has had major roles in advocacy and leadership for lung health in Australia, chairing the National Asthma Campaign, the Federal Government’s National Asthma Advisory Group and many local and international guidelines and implementation initiatives to enhance resources, skills, capacity and clinical outcomes in airways disease. She was president of the Thoracic Society of Australia and New Zealand from 2007 – 2009.
Christine is an active clinician, and teaches and supervises medical students, advanced trainees and post graduate students.
She heads the Respiratory Discipline in the Faculty of Medicine at the University of Sydney.
Christine’s area of research interest is the clinical management of airways disease and patient reported outcomes in response to therapeutic interventions, and she is currently implementing trials in asthma and COPD management and pulmonary rehabilitation in Australia and Asia. She was a member of the FDA mandated adjudication committee for large asthma studies assessing LABA.
Christine has written two books on asthma, one for medical students and one for patients, their families and carers. In 2002 she was made a Member in the Order of Australia for recognition of service to respiratory medicine as a physician, administrator and educator, especially in the field of asthma education.
Dr. Marisa Petersen, CEO, George Clinical
Marisa completed her pharmacy degree at the University of Sydney and continued her studies with a PhD in Clinical Pharmacology and Pharmacokinetics. She has worked for over 20 years in the pharmaceutical industry, fulfilling roles in Regulatory Affairs, Clinical Research and Project Management. Prior to joining George Clinical, Marisa was the Vice President Asia Pacific for Omnicare Clinical Research, a global CRO, taking responsibility for the delivery of trials in the Asia-Pacific region and developing a network of offices across the region to effectively service customer needs. In her current role, Marisa is focussed on sustainable growth of resources in the region and delivery of regional and global studies to the highest international standards. Marisa has a strong association with ARCS in Australia and Asia and is a member of the Australian R&D Taskforce.
Who Should Attend?
Company & Function Types
- Biopharmaceutical / Biologics
- Medical Device companies
- Drug development / Clinical trials consulting
- Trial / Site management
- ‘C’ Level Executives
- Clinical monitoring / Investigative site management
- Clinical trial management
- Corporate management
- R&D / Drug Development
- Project Management
- Scientific and Medical Affairs
George Clinical is a leading independent clinical research organisation (CRO) in Asia with over 200 staff operating in 11 countries. George Clinical provides the full range of clinical trial services to pharmaceutical, medical device and biotech customers, for all trial phases, registration and post-marketing trials. George Clinical combines scientific and clinical leadership with expert trial delivery capability to create a distinctive world-class service. George Clinical’s parent organization, The George Institute for Global Health, is a leader in chronic disease research, with a global network of experts with whom George Clinical engages. George Clinical delivers an operationally supported, internationally recognized scientific leadership service, bringing together an extensive series of investigator networks that allow George Clinical to provide customizable clinical trial excellence from trial design through all aspects of delivery.