Day 2 :
Syte Logix, Inc., USA
Time : 10:00-10:30
Dave Anderson is the Founder, CEO and President of Syte Logix. As a healthcare analytics and security executive, he brings his extensive experience in data analytics, cyber-security, risk management, patient privacy, and connectivity to the growing challenges of the MedTech and clinical data management market. His analytic and data exploration models create new opportunities for customers and partners to significantly improve the ROI around clinical research, and get products to market in a faster and more secure manner.
The increasing volume of patient generated and 3rd party data can provide great value throughout the clinical workflow. However, as this data is increasingly unstructured, and is generated from very disparate sources in a variety of formats, it is very difficult to cost-effectively extract the value from this data into the research process. The Opportunity: The integration of patient generated and 3rd party data into the clinical research workflow can add a multitude of new dimensions into all phases of a research program, including drug discovery and development, patient recruitment, risk-based monitoring, and pharmacovigilance. Automating the ingestion, management and exploration of these data sources can help analysts gain deeper context to make better and more cost-effective clinical decisions and uncover new insights that can drive competitive advantage. In this session, we will navigate strategies to integrate and capture the value of patient generated and 3rd party data into the clinical workflow
Clinical Pharmacology Research Centre, UK
Time : 10:30-11:00
Khalid Abou Farha is medical director and clinical pharmacologist of Celeron he brings 15 years of clinical research experience to this role, spanning a wide range of therapeutic areas, with a particular focus in oncology, vaccines, cancer immunotherapy, personalized medicine and autoimmune disorders. He has extensive experience in building and managing global teams, leading the development of Clinical Research drugs and biologics
Background: Clinical trials in cystic fibrosis (CF) patients might include post-B2 agonist bronchodilator (e.g. Salbutamol) evaluation of pulmonary functions. Sinus and SVT tachycardia have known dose-related side effects of inhaled salbutamol. A relationship between inhaled beta 2 agonists and increased risk of myocardial ischemia (MI) and infarction has been reported. Under normal breathing conditions, CF patients might show mild tachycardia compared to healthy subjects. Nevertheless, the impact of B2 agonists on the CF- associated tachycardia is often an ignored safety parameter in CF clinical trials. Here, we demonstrate a case of post-salbutamol clinically significant tachycardia associated with ECG features of MI in a CF patient.
Case Report: A 21 year old CF female patient has been included in a clinical trial evaluating a new medication for the treatment of CF. Medical history, physical examination, vital signs and laboratory investigations showed no clinically relevant findings. A 12- leads ECG recording showed a sinus rhythm with a heart rate (HR) of 90 bpm. An inhalation dose of 400ug salbutamol has been administered to perform post bronchodilator (PBD) pulmonary function tests and collect spontaneously expectorated sputum. The patient’s cardiac electrical activity was monitored (by means of telemetry) before (baseline, BL) and after salbutamol administration. A pre-bronchodilator (Pre-BD) telemetric recording showed episodes of asymptomatic tachycardia with fluctuating resting heart rate between 79 to 117 bpm, without ECG signs of myocardial ischemia. At 45-60 minutes after salbutamol administration, the telemetric recordings showed sinus tachycardia with resting HR fluctuating between 97 to 141 bpm and ECG manifestation of tachycardia-induced myocardial ischemia (Figures 1 and 2). 3 to 4 hours post salbutamol the HR returned to BL, and the patient has been discharged after ensuring her safety. Thyroid function tests have been performed to verify the aetiology of the tachycardia. These demonstrated normal results. Re-challenge tests have been performed on other visit. These confirmed the salbutamol associated cardiac effect.
Discussion & Conclusion: B2 agonist should be administered with caution to tachycardic CF patients. This may imply salbutamol dose adjustment and requires monitoring with cardiac telemetry. This might avoid unwanted cardiovascular adverse effects such as MI. This line of reasoning is substantiated by the increased likelihood of CF- associated cardiac CFTR chloride channel abnormality that results in deficient CFTR- induced cardiac ischaemic preconditioning and therefore increase the risk for ischemic heart disease in CF patients, particularly in the older age group with pre-existing decreased cardiac reserve.
Veracity Clinical Research, Australia
Keynote: AWI002: Trials, tribulations and the value of persisting with non-drug related clinical trials – superfine merino wool base layer garments in atopic dermatitis
Time : 11:15-11:45
Lynda Spelman is the Principal Investigator of Veracity Clinical Research. As a graduate of the University of Queensland and Fellow of the Australasian College of Dermatologists, she has worked as a Specialist Dermatologist in Australia for more than 20 years. She has an extensive 25 year history of involvement in clinical research, having conducted studies in trials for a wide range of dermatological conditions, including atopic dermatitis/eczema, chronic plaque psoriasis, psoriatic nail disease, palmoplantar psoriasis, hidradenitis suppurativa, seborrhoeic keratosis, and superficial and nodular basal cell carcinoma
In the pursuit of finding an alternative to the three traditional means of treating Atopic Dermatitis (AD) (moisturisers, topical corticosteroids, and systemic immunosuppressants), my team undertook a study that looked at the use of Superfine Merino Wool Base Layer Garments (SMWBLG) as a therapeutic intervention in the management of atopic dermatitis in children and young adults. This was an investigator lead study which received support from Australian Wool Innovation in the form of partial investigator funding and supply of the therapeutic intervention. Because the use of wool was a foreign concept in the management of patients with AD, we had to overcome many unexpected challenges and obstacles, the main one being the urban legend that wool causes allergic contact dermatitis. This was a HREC approved, proof of concept study and the second of its kind in collaboration with AWI. After proving the significant therapeutic effect that the garments had on adults, this study aimed to confirm the same was true in children and young adults. We continued to experience a number of hurdles in both completing the study and publishing this novel concept. Our team persisted through the study investigation phase and completed it with the successful proof of concept. Our study found that overall there was a significant decrease in AD extent, severity and subjective symptoms during the garment intervention phase compared to baseline and some significant effects on intensity and subjective symptoms even after the garments were removed, revealing an extended therapeutic effect. Despite evidence based research, editors commented on the relevance and significance of the use of this reusable, sustainable, effective intervention that has no systemic implications in this young population group with a chronic disease. The process of conducting this study has shown us that we must challenge current thinking, stay true to beliefs and gut feelings that practical interventions you see working each day are worth formally exploring