8:30 am Registration & Coffee Networking
8:55 am Chair’s Opening Remarks
Discovering Better Biomarkers for Clinical Monitoring to Effectively Manage & Treat Patients in Need
9:00 am How Can Biomarkers be Used to Objectively Monitor Patient Drug Response?
- Kenneth Hung Senior Director, Inflammatory Bowel Disease Gastroenterology Therapeutic Area Lead, Pfizer
- Examining the Efforts to Identify Novel Biomarkers to Predict Response to an Investigational Drug
- Techniques for integrating biomarkers into clinical practice to reduce the reliance on subjective assessments
- Approaching a standardized criteria for incorporating objective biomarkers into IBD monitoring to improve the accuracy and reliability of patient assessments
9:30 am Using Biomarkers to Change our Approach to Early Clinical Development
- Frederic Baribaud Senior Lead - Translational Early Program, Bristol Myers Squibb
- Proof of concept studies (POC) today are time consuming, costly and deliver undifferentiated therapeutic options for patients mainly because current clinical endpoints lack dynamic range and carry imprecisions
- Defining complementary molecularly based clinical endpoints with high dynamic ranges and very low intra- and inter-assessor variability would beneficially impact the duration of POC studies
- Defining complementary molecular-based clinical endpoints would also allow a thorough comparison of existing and upcoming therapeutics in a disease area
10:00 am Morning Break & Poster Session
Enhancing Safety & Efficacy to Accelerate Patient Access to Personalized Drugs
11:00 am Achieving the Selectivity Required for the Elusive Trifecta of Safety, Efficacy, & Convenience in IBD Drug Development
- Jamie Wong Senior Director, Immunology, Morphic Therapeutics
- Driving high selectivity of integrin-targeted medicines with Morphic’s MInT Platform
- Leveraging understanding of integrin structure and function to develop novel molecules designed to achieve the potency, high selectivity, and pharmaceutical properties required for oral administration
- Employing innovative end points to accelerate decision making for POC studies in IBD
11:30 am Harnessing Biomarker Signatures for Phenotypic Stratification in IBD: Leveraging a Precision Medicine approach to maximize the mechanistic potential of ESN-X
- Kiana West Manager, Enveda Biosciences
- Deep molecular phenotyping addresses the complexities of the underlying biology in IBD.
- Multi-omics and machine learning enable identification of patients most likely to benefit from specific drugs.
11:40 am Roundtable Discussion: Companion Diagnostics, Data Handling, & Effective Drug Development – The Future Steps
- Brihad Abhyankar Senior Vice President - Global Clinical Development, Morphic Therapeutic
- Handling real-world data to evaluate the long-term efficacy and safety of IBD treatments.
- Leveraging companion diagnostics to facilitate personalized treatment approaches for IBD
- How can companion diagnostics predict the efficacy of combination therapies?
- What is the most effective source of data for achieving accurate and reliable companion diagnostics?
- What steps should we be taking to collect, store, and handle data to inform better decisions regarding the right drug, to the right patient, at the right time?
12:40 pm Lunch and Networking Break
Delving into Novel Approaches to Deliver Best-In-Class IBD Drugs to Patients in Need
1:40 pm Panel Discussion: Exploring the Fusion of Novel Approaches to Comprehensively Tackle IBD
- Matt Staron PI, AbbVie
- Paul Kayne Vice President, Palatin Technologies
- Alexander Lukyanov Senior Director, Data Science, Merck & Co
- Can research into the microbiome work in unison with other new approaches to provide a deeper understanding of IBD?
- Which therapeutic avenues remain underexplored and should be focused on?
- How will developments in cutting-edge drug delivery technologies enhance treatment precision?
- The holistic understanding – combining our knowledge, old and new, to pave the steps for future research into IBD
2:10 pm Future Outlooks into IBD Research
- Valerie Pivorunas Scientific Director, Precision Medicine Immunology; Head of Gastroenterology, Abbvie
- Overview of current approaches for precision medicine in IBD
- Application of biomarkers in clinical trials: What success have we had to date and where can we improve and evolve?
- How are we changing the way we think about IBD as a disease and treatment for patients to drive novel approaches for precision medicine in IBD?
2:40 pm Unconventional Players in IBD Pathogenesis & Precision Therapies
- Jesse Hall Chief Medical Officer, AltruBio
- An in-depth exploration for the capacity of emerging approaches regarding non-immune cells to revolutionize our understanding of IBD
- Exploring the capacity for precision medicine strategies target these unconventional players to open new avenues for IBD treatment innovation
3:10 pm Harnessing the Bodies Natural Defence to Reverse IBD
- Paul Kayne Vice President, Palatin Technologies
- Biasing tissue and immune cells towards resolving inflammation
- Unprecedented safety by employing the natural mode of resolution removes efficacy/ toxicity balance considerations
- Exploring the need for and type of patient stratification biomarkers