7:55 am Chair’s Opening Remarks
Going for Gold in ARDS Clinical Trial Design: Learning from Past ARDS Drug Development
8:00 am Leveraging Pilot Study Data, Options for Dosage & Statistics to Achieve Optimum ARDS Clinical Trial Design
Synopsis
- Utilizing data of a pilot study to inform the design of adequate and well controlled studies
- Reviewing options for dose-ranging in ARDS studies
- Exploring the statistical implications of treatment benefit in the design of adequate and well-controlled studies
8:25 am Evaluating Previous ARDS Preclinical & Clinical Trial Designs to Assess the Optimum Path to Take for Future Studies: TLR4 Inhibitors with a Monoclonal Antibody to Treat ARDS
Synopsis
- Highlighting the mechanism of action of EB05, a TLR4 inhibitor
- Reviewing the components of preclinical study designs which allowed or inhibited progression to the clinic
- Delving into past clinical trial designs to enable the success of current and future
clinical trials
8:50 am Divulging ARDS Preclinical & Clinical Regulatory Experiences
Synopsis
- Navigating the guidance and parameters for COVID-19 ARDS in preclinical and clinical study designs
- Selecting patient populations to satisfy and meet requirements
- Delving into experiences with preclinical and clinical ARDS regulators
9:15 am Panel Discussion: Considering Early Endpoints in Clinical Trials to Benchmark ARDS Therapeutic Progress & Confidently Prove Proof of Concept
9:40 am A novel ARDS therapeutic targeting the Ang1-Tie2 pathway and development of a companion diagnostic using machine learning to improve both the diagnosis and treatment of ARDS patients
Synopsis
- Development of Ang1-C4bp: a novel therapeutic for ARDS
- The importance of Ang1-Tie2 in ARDS treatment in both COVID and non-COVID patients
- Collaboration between Mannin, DNAStack, Biosymmetrics to develop a novel companion diagnostic for ARDS utilizing machine learning
- Discussion of clinical plans and timeline
10:10 am Speed Networking
Synopsis
This session is the ideal opportunity to take advantage of face-to-face networking time, and understand who is also prioritizing and overcoming challenges within ARDS drug development.
10:55 am Morning Break
11:10 am Why Have Previous Clinical Trials Not Been Successful?
Synopsis
- Evaluating previous clinical trials to explore what needs to be implemented in future clinical trials
- Outlining patient populations, mechanisms of action, and endpoints of clinical trial design to understand the limiting factors of ARDS clinical trials
- Enlightening the possible action points for future clinical trials
11:30 am Interactive Roundtable Discussions:
Synopsis
This session will facilitate in-depth discussions among participants in an informal environment. After splitting into groups, discuss key challenges and opportunities around your chosen topic:
- Discussing the ‘Gold Standard’ for ARDS Study Design
- Reviewing the Possible Objective Endpoints for ARDS Clinical Trial Design
- Exploring Direct Lung Injury vs. Indirect Lung Injury to Inform Treatment Approaches in Clinical Trial Design
12:00 pm Networking Lunch
Bringing Phenotyping into the Spotlight for the Development of ARDS Precision Therapies
1:00 pm Multi-Level Subphenotyping Using Biological, Clinical & Radiological Data
Synopsis
- Exploring the mechanisms of action of a therapeutic modality, and which subpopulation will respond
- Understanding the characteristics of patient populations which determine which mechanism of action they will respond to
- Repurposing of drugs depending on biological and radiological phenotyping
- Combining physiological, and clinical data, and biomarkers to stratify patients into distinct subgroups with divergent clinical outcomes
1:25 pm Harnessing Predictive Enrichment Strategies for ARDS Clinical Trials; Past, Present & Future
Synopsis
- Understanding and leveraging heterogeneity within the syndrome of ARDS to prospectively identify treatment-responsive subtypes: what have we learned?
- Divulging the challenges of rapid identification of ARDS subphenotypes of interest
- Navigating matching biomarker credentials to trial design
1:50 pm Evaluating Effective Biological Responses to Therapeutic Interventions: Mediation Analysis
Synopsis
- Evaluating the effect of therapy on biological markers and resulting changes in outcomes
- Identifying biological surrogate outcomes to determine successful treatment strategy
2:15 pm Afternoon Break & Networking
Synopsis
For more information, email info@hansonwade.com
3:00 pm Selecting COVID-19 Patients for Treatment with Opaganib Based on a New Paradigm for Classification of Disease Severity
Synopsis
- Highlighting risk factors for treatment failure in SARS-CoV-2 ARDS pneumonia
- Discussing clinical data about the efficacy of opaganib in a selected population of severe COVID-19 pneumonia
- Identifying a new paradigm for disease severity in COVID-19 patients