August 20 – 21, 2019

Day One
Tuesday 21 August, 2018

Day Two
Wednesday 22 August, 2018

08.20
Chair’s Opening Remarks

  • Fernando Martinez Chief, Pulmonary & Critical Care Medicine, Weill Cornell Medical College

Identifying the “Idiopathic” of IPF to Drive Curative IPF Drug Development

08.30
Translational Modeling of Profibrotic & Aberrant Regenerative Mechanisms in IPF

  • Cory Hogaboam Professor of Medicine, Ceders-Sinai Medical Center

Synopsis

  • Dissecting the pathology of IPF as a disease of enhanced fibrosis and impaired lung regeneration
  • Proving how translational modeling in humanized immunodeficient mice facilitates exploration of both mechanisms in IPF
  • Describing putative therapeutic strategies that target both fibrosis and lung regeneration

Outside of Targeting Fibroblasts: Therapeutically Promoting Regeneration

09.00
Restoring Balance in IPF: Development of a Compound Targeting Both Epithelial Cell Survival as well as Myofibroblast Destruction for Improved Therapeutic Response

Synopsis

  • Outlining a novel approach beyond inhibition of fibroblast activation
  • Demonstrating the Cav1 pathway as allowing for restoring survival signals that have become dysregulated in IPF
  • Discussing the preservation of epithelial cell survival as critical in enabling restoration of  lung function

09.30
Innovative RNA Based Therapeutics as a Modality for the Effective Treatment of Multiple Fibrotic Conditions

Synopsis

  • Understanding miRNAs as regulators of systems biology
  • Outlining miR-29 as an anti-fibrotic miRNA
  • Showing miR-29 as a therapeutic target in multiple fibrotic indications
  • Presenting the development of an inhaled oligonucleotide

10.00
Morning Break & Networking

10.30
Developmental Program Identifying siRNA HSP47 as a New Therapeutic Strategy for IPF – Comprehensive Model Validation & Therapeutic Evaluation

Synopsis

  • Highlighting new target engaged in fibrotic disease development and progress
  • Demonstrating novel lipid nanoparticle for in vivo siRNA delivery which show robust anti-fibrotic activities
  • Outlining results of efficacy tested in the fully validated bleomycin rat model in the clinically relevant scenario and treatment regimen
  • Showing results from pulmonary function assessment included in the therapeutically efficacy evaluation

11.00
Think Tank Round Table Discussions: What Does the Next Generation of Phase 3 Clinical Trials Look Like?

Synopsis

More practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around pre-assigned topic areas. A valuable chance for attendees to unite around hot topics, debate best practice and share experiences to identify solutions.

 1.

What benefits will
payers need to
see to consider a
new therapeutic &
how do we design
clinical trials to
best demonstrate
these?

  2.

Can imaging
be accepted
as a secondary
endpoint?

  3.

How do we get
predictive reads
of efficacy with
smaller sample
sets to then draw
predictions for
large sample
sizes?

4.

How do we
overcome an
adverse safety
profile from a
standard of care
when running
phase 3 trials for a
new candidate?

 

11.30
Moderator Feedback & Audience Debate

Synopsis

Moderators will be assigned to each roundtable to facilitate discussion and collate the findings.
Following the roundtables, they will present back to the entire delegation as part of information dissemination and opening up the wider audience debate.

12.00
Application of 4Dx Technology to IPF Research

Synopsis

  • Identifying IPF research priorities from the Summit
  • Sharing the 4Dx translational pipeline- from mice to men
  • Presenting the 4Dx research offer

12.30
Lunch & Networking

Navigating the Rationale, Practical & Clinical Success of Combination Therapies

13.30
Lessons Learnt from Combination Therapies with Pirfenidone

  • Joe Arron Senior Director, Immunology Research, Genentech

Synopsis

  • Outlining rationale from combinations of pirfenidone in clinical trials with two new interventions
  • Analyzing decisions made
  • Benchmarking lessons learnt

14.00
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety & Efficacy of Pamrevlumab (FG-3019) in Patients with IPF

  • Eduard Gorina Executive Director Clinical Development Fibrosis Program, FibroGen

Synopsis

  • Showcasing clinical outcomes when CTGF is the target in IPF
  • Demonstrating quantitative lung fibrosis by HRCT correlating with lung function
  • Developing better tolerated treatment options for patients with IPF

14.30
Panel Discussion: Assessing the Current Drug Landscape to Understand Combinations as Successful Treatment Options Within IPF

  • Eduard Gorina Executive Director Clinical Development Fibrosis Program, FibroGen
  • Joe Arron Senior Director, Immunology Research, Genentech
  • John Moran Chief Medical Officer, Prometic Biosciences

Synopsis

  • Beyond IPF – is there potential for combinations with candidate targeting other disease areas, such as lung cancer?
  • Addressing tolerability and dosage concerns when drugs are given in combination in the context of an IPF patient
  • What is the future of IPF in terms of product development?

15.00
Afternoon Break & Networking

Robustly & More Confidently Moving Through Clinical Development: Showcasing & Analyzing Results

15.30
Targeting the Angiotensin AT2-receptor for the Treatment of Orphan Fibrotic Diseases

Synopsis

  • Describing the biology of the angiotensin AT2-receptor
  • Understanding the anti-fibrotic mechanism of action of the AT2-receptor agonist C21
  • Detailing the clinical development of C21

16.00
UCHL1 – A Deubiquitylating Enzyme with Fundamental Roles in the Regulation of Pro-Fibrotic Signalling Pathways

  • Anne Phelan Senior Vice President & Head of Discovery Research, Mission Therapeutics

Synopsis

  • Highlighting the key role of deubiquitylating enzymes in the regulation of protein homeostasis, complex formation and turnover or degradation
  • Outlining how UCHL1 is recognized as a key modulator of components of the TGFβ, AKT and ERK pro-fibrotic signalling cascades across a range of tissue types
  • Demonstrating how the expression of UCHL1 has been shown to be upregulated in lung samples derived from patients with IPF and COPD; and that UCHL1 gain-of-function polymorphism is associated with Akt mediated lung fibrosis pathologies and PAH
  • Sharing the clinical potential of a potent and selective inhibitor of UCHL1 in the treatment of fibrotic lung diseases

16.30
Evaluation of Pentraxin-2 (PRM-151) in IPF Clinical Trial Settings

  • Rick Jack President, Chief Operations Officer & Chief Scientific Officer, Promedior

Synopsis

  • Overcoming challenges in the translational steps between discovery and phase 2 Clinical Trial
  • Linking phase 1 design and results with phase 2 design
  • Translating PRM-151 into the clinic: how non-clinical and clinical data from IPF clinical trials can guide other fibrosis therapeutic applications

17.00
Chair’s Closing Remarks

  • Fernando Martinez Chief, Pulmonary & Critical Care Medicine, Weill Cornell Medical College