Targets, Trial Design, & Clinical Updates

8.25 - 17.00 EST | 5.25 - 14.00 PST

7:55 am Chair’s Opening Remarks

  • Deborah Nguyen Vice President, Head of GI / Inflammation Drug Discovery Unit, Takeda

A New Paradigm in Antifibrotic Drug Discovery: Navigating Research into Novel Cell Types to Inform Target Identification & Validation

8:00 am Reprogramming Dysfunctional Epithelial Cells to Promote Tissue Repair in Fibrotic Disorders

  • Joe Arron Vice President & Senior Fellow, Immunology Discovery, Genentech

Synopsis

• Understanding how the loss of homeostatic regenerative capacity in functionally specialized tissues is a root cause of progressive fibrosis
• Discussing how cellular senescence has unique phenotypic characteristics across different tissues
• Learning how the developmental growth factor signaling pathways may be manipulated pharmacologically to restore regenerative capacity
• Unveiling how the key challenges are understanding mechanistic bottlenecks and maximizing therapeutic index

8:30 am Investigating COVID-19 Induced Fibrosis to Highlight Novel Mechanistic Pathways

Synopsis

• Discovering the therapeutic potential of antifibrotic drugs in treating COVID-19 and preventing long-term fibrotic consequences
• Reviewing mechanisms of COVID-19 induced fibrosis
• Could research into COVID induced fibrosis have wider applications in identifying mechanisms driving fibrosis?

9:00 am What is the Next Drug Target for Treating Fibrosis? Rethinking Approaches to Target Identification

  • Samir Ounzain Scientific Co- Founder & Chief Executive Officer, HAYA Therapeutics

Synopsis

• What can we learn from clinical trial setbacks?
• Moving beyond pleiotropic protein coding regulators
• Focusing on the environment genome interface

9:30 am Morning Break & Networking

10:30 am Fibrosis & Cancer: The Intriguing Mechanistic Overlap

Synopsis

• Exploring fibrotic disease as a general shows linkage to increased cancer incidence
• Learning which fibrosis mechanisms are linked to worse cancer prognosis
• Which are the MOAs that potentially can be used across diseases?

11:00 am New Insights into Mechanisms of Alveolar Type 2 Cell Renewal in Pulmonary Fibrosis

  • Paul Noble Chair, Department of Medicine, Cedars Sinai Medical Center

Synopsis

• Identifying invasive fibroblasts in mouse and man
• Recognizing targets to block invasion and impact on fibrosis
• Dissecting the impact of new research into invasive fibroblasts on future antifibrotic drugs

11:30 am Emerging Targets & Treatments for Liver Fibrosis

  • Bernard Allan Senior Director, Head of Liver Research & Drug Discovery, GI-DDU, Takeda

Synopsis

• Targeting liver cells with oligonucleotides
• Discussing SiRNAs in clinical development
• Identifying next-generation antifibrotic treatments through analysis of evolving research in oligonucleotides

12:00 pm Lunch & Networking

1:00 pm Biologic Targeting of eNAMPT to DAMPen Organ Inflammation & Attenuate Fibrosis

  • Joe Garcia Founder & Chief Executive Officer, Aqualung Therapeutics

Synopsis

• Elucidating eNAMPT/TLR4 contribution to human and preclinical
lung fibrosis
• Exploring eNAMPT/TLR4 targeting in preclinical liver and renal fibrosis
• Examining eNAMPT/TLR4-based precision medicine approaches in human fibrosis

1:30 pm Employing Breakthrough Antifibrotic Therapeutics Across Multiple Organs to Illuminate Pipeline Development

Synopsis

• Analyzing how to harness the power of mitochondrial-derived peptides (MDPs) to potentially target a number of fibrotic diseases
• Reviewing CohBar’s clinical candidate, CB5138-3, in development for the potential treatment of idiopathic pulmonary fibrosis (IPF), which has demonstrated positive effects including reduction of fibrosis, inflammation, and collagen deposition in animal models
• Expanding the scope of antifibrotic therapeutics: investigating opportunities for relevance across multiple organs

Navigating Novel Clinical Trial Design to Promote Patient Participation & Work Towards More Effective Treatment

2:00 pm Panel Discussion: What Does a Creative Clinical Trial Design Look Like & What are the Barriers?

  • Majd Mouded Executive Director, Novartis Institutes for BioMedical Research
  • Bertil Lindmark Chief Medical Officer, Galecto
  • Eric White Senior Clinical Program Lead, ILD, Boehringer Ingelheim

Synopsis

• Discussing potential trial design options and regulatory operational benefits and risks
• Considering the selection of patient populations and patient population enrichment
• Using biomarkers or surrogate endpoints to accelerate trial design
• Comparing feasibility of novel designs across various fibrotic indications

2:30 pm Afternoon Break & Networking

Evaluating Recent Clinical Setbacks & Clinical Updates to Influence the Next Generation of Trials & Inform Pipeline Decisions

3:15 pm Aramchol – Lessons Learned & Optimization Towards Registrational Part of Phase 3 Clinical Study

Synopsis

• Liver fibrosis – from basic pathophysiology to mechanism of action of
drug candidates
• Targeting liver fibrosis – main challenges
• Aramchol – MoA, compound optimization and resulting clinical efficacy

3:45 pm Driving Innovation to Shape Future Pipelines: Latest Updates on Clinical Trial Data

  • Pnina Fishman Chief Executive Officer & Chief Scientific Officer, Can Fite BioPharma

Synopsis

• Exploring study design for optimizing clinical outcomes
• Strategies for overcoming the translational gap: a holistic approach to analyzing clinical development
• Understanding clinical trial data and future implications

4:15 pm Targeting Metabolic Remodeling in Fibrosis with IM145

  • Dean Welsch Chief Scientific Officer, ImmunoMet Therapeutics

Synopsis

• Accelerating the translation between the bench and the bedside, leveraging strengths and addressing challenges
• Evaluating biomarkers of target engagement in healthy volunteers
• Assessing approaches to an early demonstration of clinical response

4:45 pm From Early Research to Late Development in Antifibrotic Drugs: Mind the Translational Gap

Synopsis

• Understanding and elucidation of antifibrotic mechanisms of action
• Indication selection for early clinical trials
• Preparation and regulatory insight for late-stage clinical trials

5:15 pm Chair’s Closing Remarks

  • Deborah Nguyen Vice President, Head of GI / Inflammation Drug Discovery Unit, Takeda