8:55 am Chair’s Opening Remarks
- Anthony Ting Vice President of Regenerative Medicine & Head of Cardiopulmonary Programs, Athersys
Tackling the Translational Gap by Assessing Current & Future Model Systems for ARDS
9:00 am Development of Novel Injectable and Inhaled Cannabinoid Drugs for Systemic Inflammation and ARDS
- Melanie Kelly Chief Scientific Officer, Tetra Biopharma
• Evidence supporting the Cannabinoid Type 2 receptor (CB2) as an important immunemodulatory target
• Challenges, successes and caveats in the development and positioning of Cannabinoid Therapeutics for Systemic Inflammation
• Bridging the gap between systemic and inhaled cannabinoids for ARDS
9:30 am Investigating Stem Cell-Based Modelling for Understanding COVID-19 Pathogenesis & Therapeutics
- Jessie Huang Post-Doctoral Associate, Boston University
• Understanding the advantages and disadvantages of using pluripotent stem cell-derived lung organoid platforms in disease modeling
• Investigating the molecular mechanisms involved in SARS-CoV-2 infection and COVID-19 pathogenesis
• Utilizing pluripotent stem cell-derived cell models for drug development
10:00 am Deep Diving into Modelling for ARDS: Using Human Models to Predict the Pathophysiology of ARDS in COVID-19/None COVID-19 Patients & Accelerate Drug Development
- Danny McAuley Clinical Professor, Queens University Belfast
• Examining the latest research on human models for ARDS
• Understanding how to use data collected from human models to strategize your drug development against ARDS
• Discovering the key differences in the presentation of COVID-19 vs none COVID-19 ARDS in human models
10:30 am Audience Discussion: What Models are Being Generated Specifically for COVID-19 Related ARDS?
You’ll discuss with a group of industry pioneers ideas surrounding developing models specifically for the study of COVID-19 associated ARDS. What are the key similarities and differences between COVID-19 & None COVID-19 ARDS that you must consider when selecting models for clinical study? How can you accurately compare the translational relevance of in vitro and in vivo models for ARDS? Make sure you join this audience discussion to be at the forefront of conversation on the latest research on models for COVID-19 associated ARDS.
11:00 am Speed Networking Session Two
Join this second round of virtual networking to connect with other attendees and establish new industry contacts. This is your opportunity to optimize your network, so you are able to accelerate your ARDS drug development for 2021 and beyond.
11:30 am Morning Break & Networking
Reviewing the Latest Clinical Data to Optimize the Clinical Trials for Novel ARDS Therapeutics
12:00 pm Damage-Associated Molecular Pattern (DAMPs) for ARDS by COVID-19: From the Basic Immunology to Phase 2 Clinical Trial
- Seung-Yong Seong Co-Chief Executive Officer, Shaperon
• DAMPs for inflammatory disorders
• NLRP3 inflammasome and DAMPs
• Novel NLRP3 inhibitor under phase 2 trial for ARDS by COVID19
12:30 pm Audience Discussion: Leveraging Available Data to Strategically Define Patient Populations & Select Patients for Inclusion in ARDS Clinical Trials
ARDS therapeutics development brings an array of unique challenges to the effective design and execution of a clinical trial. With the rise of the COVID-19 pandemic allowing biopharma the opportunity to study large patient populations with homogenous disease for the first time ever, strategizing meaningful patient selection and recruitment has never been more important. Join this audience discussion to discuss the various challenges of running ARDS clinical trials in a pandemic and leave with the insights you need to maximize valuable output for your drugs and achieve therapeutic benefit for patients participating in clinical trials.
1:00 pm Lunch & Networking
2:00 pm Designing & Developing ARDS Clinical Trials From Concept to Clinic: Understanding What Parameters You Must Consider to Optimize the Success of Your Therapeutic in a Clinical Setting
- Juho Jalkanen Vice President Business Development, Faron Pharmaceuticals
• Understanding classical pitfalls when designing ARDS trials
• Optimize your parameters to address the pathophysiology you are tackling and seek for regulatory alignment early
• ARDS is a conservative field of medicine. New MoA will require education of KOLs and regulatory authorities
2:30 pm Blinded by the Light: Looking Past Mortality to Negotiate Clinically Relevant and Achievable ARDS Trial Endpoints
- Eric Jenkins Senior Medical Director, Athersys
• Despite high baseline mortality, achieving significant mortality reduction in ARDS RCTs is very difficult for many reasons.
• Proximal endpoints paired to investigational therapies’ mechanisms of action appropriately assess proof of concept in early development
• Trading simplicity for success. With careful attention to design and communication, pivotal trials utilizing composite endpoints can maximize opportunity to identify outcomes that are clinically meaningful to patients, clinicians, regulators and payors.