Pre-Conference Discussions Day

Monday, March 7, 2022

Our entire pre-conference discussions day morning is dedicated to analyzing and scrutinizing the latest progress in inhaled drug delivery followed by a quick lunch break to refuel and network with fellow ILD drug developers via our custom-built virtual event platform.

After lunch, you can continue diving deeper into inhaled drug delivery or choose to attend our dedicated “Exploring Biomarkers for ILD Clinical Trials” afternoon workshop. The choice is yours! Take a look at our Pre-Conference Day agenda at a glance to view the full format.

Agenda at a Glance

at a glance

Investigating Inhaled Drug Delivery for Interstitial Lung Disease

9:00 am Registration & Networking

10:00 am Deep Diving into Delivery Mechanisms: Comparing & Contrasting Inhaled vs Systemic Drug Delivery in the Context of ILD Treatment

  • Peter Fernandes Vice President & Chief Regulatory, Quality & Safety Officer, Bellerophon Therapeutics

Synopsis

  • Evaluating the choice of treatment for ILD based on specific ILD
    diagnosis, – including both systemically delivered agents and inhaled
    delivered agents.
  • Recently approved for ILD is an inhaled pulmonary arterial vasodilator
    that is also available as systemic delivered doses to treat PAH.
  • Discussing the pros and cons of inhaled vs. systemic administration agents
    for ILD aimed at targeting the MOA, V/Q matching, ILD diagnosis and the
    recent clinical experience on these delivery options to date

10:30 am Considerations for Inhaled Drug Delivery

Synopsis

  • Basic considerations for inhaled drug delivery
  • Inhaled drug delivery challenges and how to overcome
  • Inhaled drug delivery for ILD specifically

11:00 am Integrating Inhaled Therapeutics with ILD Mechanisms to Streamline Your Drug Delivery

  • Peter Fernandes Vice President & Chief Regulatory, Quality & Safety Officer, Bellerophon Therapeutics
  • Carsten Ehrhardt Professor of Pharmacy, Trinity College Dublin

Synopsis

  • Panel Discussion and Q&A with Preceding Speakers:

11:30 am Morning Break & Networking

12:00 pm Exploring the Patient Perspective on Inhaled Drug Delivery

Synopsis

• Reviewing the advantages and disadvantages from a
patient perspective
• How do patients perceive risks and benefits of inhaled drug delivery?
• Understanding the patient experience for inhaled drug delivery

12:30 pm Lunch & Networking

Investigating Inhaled Drug Delivery for Interstitial Lung Disease Afternoon

1:30 pm Audience Discussion: Utilizing Lessons Learned from Inhaled Pirfenidone for IPF to Strategize & Enhance Effective Inhaled Drug Delivery for Interstitial Lung Disease

Synopsis

Over the past few years, significant strides have been
made in the delivery of inhaled pirfenidone for IPF,
however this has not been without it’s fair share of
setbacks. What can the ILD drug development community
learn from this? Join this interactive audience discussion
to deep dive into the success, failures and challenges
of delivering inhaled pirfenidone to treat IPF and leave
with the knowledge you need to strategically inform and
optimize your inhaled drug delivery approach.

2:00 pm Moderated Discussion: Analyzing Biologics, Small Molecules & Antibodies for the Treatment of ILD to Determine Which One is Most Easily Inhaled, Nebulized & Absorbed by the Alveoli

  • Shane Olwill Senior Vice President & Chief Development Officer, Pieris Pharmaceuticals
  • Carsten Ehrhardt Professor of Pharmacy, Trinity College Dublin

Synopsis

  • Discussing and debating the benefits and drawbacks
    of biologics, small molecules and antibodies for inhaled
    drug delivery
  • Understanding what characteristics give rise to more
    easily inhaled molecules
  • Exploring challenges associated with alveolar uptake
    of inhaled therapies in interstitial lung disease and
    understanding how to overcome them

2:30 pm Harnessing the Therapeutic Power of Secretomes to Treat IPF & the Challenges of Optimizing Inhaled Drug Delivery

Synopsis

• Exploring the potential of Activated Remedy cell
Secretome (ARcS)
• Investigating the utility of the Secretome in murine
bleomycin models
• Analyzing the outcome of Secretome experiments in
PCLS explants from end stage IPF patients

Exploring Biomarkers for ILD Clinical Trials Afternoon

1:30 pm Utilizing Biomarkers to Identify Patient Populations Which are More Receptive to Your ILD Therapeutic in Order to Design and Conduct Faster Trials in a Shorter Time Frame

Synopsis

  • Review the evolution of molecular and imaging
    biomarkers in ILD
  • Discuss an overview of application of these biomarkers
    in personalizing ILD clinical trial designs and potentially,
    shorten trial time
  • Understand the challenges in clinic utility of these
    molecular and imaging biomarkers

2:00 pm Learning how to Use Biomarkers to Distinguish Patients with Fibrotic vs Inflammatory ILD in Order to Strategically Stratify Trial Populations & Maximize Trial Efficiency

Synopsis

  • Lessons learned from SSc-ILD
  • Molecularly profiling across multiple interstitial lung diseases
  • Combining ILD biomarker knowledge and clinical utility –
    where is the field at and where do we need to go next?

2:30 pm Considerations for Clinical Trial Biomarker Selection

Synopsis

• Panel Discussion and Q&A

3:00 pm Afternoon Break & Networking

3:30 pm Advantages & Disadvantages of Different Molecule Types for Inhaled Drug Delivery

  • Carsten Ehrhardt Professor of Pharmacy, Trinity College Dublin
  • Shane Olwill Senior Vice President & Chief Development Officer, Pieris Pharmaceuticals
  • Jason Laufer Chief Executive Officer, Remedy Cell

Synopsis

• Panel Discussion and Q&A

4:00 pm Practical Experience of Delivering Inhaled Drugs in Fibrotic Lung Disease

  • Toby Maher Director, Interstitial Lung Disease Program, USC

Synopsis

  • Considerations when developing inhaled drugs for
    fibrotic ILD
  • Discussing experience from the topical IPF study
  • Assessing effectiveness of inhaled drug delivery

3:30 pm Audience Discussion: Systematically Identifying & Validating New Biomarkers for ILD: How to Select and Assess the Viability of Novel Biomarkers for More Effective ILD Drug Development

Synopsis

The difference between a successful and unsuccessful
clinical trial can come down to what biomarker you choose
to measure the efficacy of your therapeutic which is why
it’s critical to play close attention to how you incorporate
them into you clinical trial design and execution. Join
this structured audience discussion to debate how to
strategically select your next ILD biomarker with fellow ILD
experts and optimize your approach to tackling common
challenges associated with utilizing biomarkers in ILD
clinical trials

4:00 pm Enrichment Strategies on SSc-ILD Clinical Trials

  • Shervin Assassi Director of the Division of Rheumatology, The University of Texas

Synopsis

  • Impact of Background Treatment on SSc-ILD Trial Design
  • Role of pneumoproteitns for enrichment
  • Role of inflammatory cytokines for enrichment

4:30 pm End of Day