7:30 am
Networking Coffee & Registration

Divulging & Assessing the Latest Clinical Updates of IPF Drug Development

8:30 am Chair’s Opening Remarks

8:40 am Analyzing the Latest from Phase III IPF Clinical Trials

  • Larry Tsai Global Head of Respiratory & Rheumatology Product Development, Genentech
  • Mark Eisner Chief Medical Officer, FibroGen

Synopsis

  • Understanding the likely next therapies to hit the market
  • Accentuating the lessons learned from the trials and what to consider for the future
  • Considering how mechanism of action may translate into efficacy
  • Understanding the clinical trial endpoints used

9:10 am Uncovering the TETON Phase III Clinical Trial of Inhaled Treprostinil in the Treatment of Idiopathic Pulmonary Fibrosis

  • Peter Smith Vice President – Product Development, United Therapeutics

Synopsis

  • Reviewing the background on inhaled treprostinil development and potential for treatment in IPF
  • Exploring key study design and attributes of the TETON phase III clinical program

9:40 am Divulging the Clinical Development of LTI-03 in IPF

Synopsis

  • Assessing the “dual threat” of LTI-03: inhibition of the profibrotic process and lung regenerative effects
  • Uncovering how biomarkers could be used to reveal these properties

10:10 am
Morning Break & Networking

11:00 am Panel Discussion: Reflecting on the Progress & Lessons Learned in IPF Clinical Drug Development – Where Will the IPF Road Lead us Next?

  • Peter Smith Vice President – Product Development, United Therapeutics
  • Brian Windsor Chief Executive Officer, Lung Therapeutics
  • Eric White Senior Clinical Program Lead, Boehringer Ingelheim

11:30 am Roundtable Interactive Discussions: Actioning the Lessons Learned from Latest Updates of IPF Drug Development

Synopsis

This session will facilitate in-depth discussion between participants in an informal environment to absorb, consolidate, and implement the lessons learned from the morning sessions; and discuss what this means for the next 5 years of IPF drug development

12:00 pm
Lunch & Networking

Basic Science & Early Translational Track

Late Translational & Clinical Track

Navigating Pathophysiology and Pathobiology to Explore Approaches for Novel Target Identification - Drivers of the Disease

Supercharging Effective Therapeutics to IPF Patients: Illuminating Clinical Trial Design & Endpoints

1.00 Transforming IPF Targets: Turning Towards Epithelial Cells

  • Examining the biology of basal cells and their role in lung regeneration
  • Discussing basal cells as the commander of fibroblasts – where do fibroblasts get their commands from?
  • Evaluating whether this is also relevant to other ILDs

Naftali Kaminski, Professor, Yale School of Medicine

1.00 Navigating Regulatory Expectations Using Knowledge From the Journey of IPF Therapeutics to Propel Your Therapeutic Candidates to Patients

  • Understanding the lessons learned to develop new and effective therapeutics that will satisfy regulatory requirements
  • Supercharging through early stages of development and minimizing the length of time to obtain regulatory approval
  • Presenting a regulatory perspective on the clinical trial designs and endpoints that need to be considered for IPF therapeutic development

Galecto Lydia Gilbert-McClain, Principal, LVM Pharmaceuticals Consulting LLC (Former Regulatory Body Director)

1.30 Going Beyond Fibroblasts to Other Pathologic Cell Populations to Expand the IPF Target Horizon

  • Revealing novel cell types that have been identified to pursue for IPF drug development
  • Characterizing alternatively activated macrophages and developing strategies to prevent activation and promote reprogramming

Kjetil Ask, Associate Professor, McMaster University

1.30 What can we Learn from Recent Placebo-Controlled Trials: Can we Leverage Synthetic Control Arms?

  • Exploring innovative IPF clinical trials
  • Discussing whether to look at recent historical data with patients with IPF
    and no treatments
  • Will this be considered valid from an agency perspective to compare to clinical trial interventions?

Toby Maher, Professor, University of Southern California

2.00 Using Artificial Intelligence to Identify Novel Fibrosis Targets & Drug Candidates

  • Reimagining the IPF target landscape to identify novel targets
  • Opening up the realm of possibility for IPF therapeutic approaches

Michelle Chen, Chief Business Officer, Insilico Medicine

2.00 Incorporating the Patient Perspective into Developing Clinical Endpoints & Clinical Trial Design

  • Rethinking clinical trial design and patient focused drug development with the patient perspective in mind
  • What are patient experiences and how do we utilize this knowledge when developing new endpoints and designing clinical trials?

Representative to be Confirmed, Pulmonary Fibrosis Foundation

2.30 Panel Discussion: What to Consider When Exploring Approaches to Novel Target
Identification?

Naftali Kaminski, Professor, Yale School of Medicine
Kjetil Ask, Associate Professor, McMaster University
Lisa Hazelwood, Senior Principal Scientist, AbbVie
Michelle Chen, Chief Business Officer, Insilico Medicine
Marilyn Glassberg, Professor, Loyola University

2.30 Implementing a Novel Trial Design for IPF

  • Discussing a planned novel IPF clinical trial design
  • Navigating designing a novel clinical trial
  • Understanding the potential benefits to sponsor, sites and patients

Majd Mouded, Executive Director, Novartis

3:00 pm
Afternoon Break

Reflecting on IPF Clinical Trial Design & Endpoints: Looking to the Future of IPF Drug Development

3:30 pm Discovering the Latest from the Blade Therapeutics Phase II Trial

Synopsis

  • Navigating translatability challenges from preclinical models to entering the clinic
  • Designing clinical trials that capture the IPF patient population
  • Uncovering how biomarkers were used effectively as endpoints in the trial
  • Illuminating patient recruitment in a phase II trial

4:00 pm Discussion Panel: Reflecting on the Elements of Clinical Trial Design that Need to be Improved

Synopsis

  • What Should the Focus be for the Next Year of IPF Research be?
  • Composite Endpoints vs. Single Endpoints – Which Should we Use?

4:30 pm Summarizing the Summit for Future Direction – Roundtable Interactive Discussions

Synopsis

This roundtable session is the opportunity for post-doctorate and graduates to collaborate on a an IPF Summit Report. This can then be harnessed as a tool and a benchmark for the next 12 months of IPF research.
Email info@hansonwade.com for more information

5:30 pm Chair’s Closing Remarks