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

  • B. Taylor Thompson Professor of Medicine, Massachusetts General Hospital Harvard Medical School

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

3:25 pm Panel Discussion: Implementing Practical Phenotyping to Inform ARDS Patient Treatment Pathways for Effective Treatment & Therapeutics

3:55 pm Chair’s Closing Remarks