Conference Day Two
Friday, July 12 2024

8:20 am Chair’s Opening Remarks

De-Risking Routes to Market Through Robust Clinical Pipelines & Portfolio Management

8:30 am Pioneering a New Class of Microbial Immunotherapies for Women’s Health

Synopsis

  • Our journey from idea to topline positive clinical readouts
  • Expanding the horizon of microbiome therapeutics to reproductive health
  • Strategy to leverage the growing movement of both the microbiome and women’s health spaces to accelerate new therapies for patients

9:00 am Panel Discussion: Defining Innovative Clinical Strategies Conserving Spend

Synopsis

Join panelists to address securing funding strategies and perspectives on:

  • What adaptive trial methodologies or other innovative approaches can biopharma look to incorporate for cost-efficiency which also guarantee rigor?
  • What are the benefits and drawbacks of strategic partnerships as an approach to expertise sharing and accelerated progress in microbiome drug development?
  • What criteria and benchmarks capture investor attention and how can developers strategically position their projects to align?

9:45 am Morning Networking Break & Tech Slam

Synopsis

An opportunity to network, discuss and collaborate with like-minded leaders alongside demonstrations of the latest novel technology advancements, showing expanded capabilities across sequencing, metabolomics, multi-omics analysis and biomarker discovery. Leverage this session to remain up-to-speed with technology advancements applicable to your pipeline, and make comparisons for assessing your future partnerships.

Novel R&D & Translation to the Clinic

Preclinical Planning Ahead: Novel Stratification, Efficacy & Predictive Testing to Ensure Clinical Robustness

10:30 am Advancing Translational Relevance through Humanized Mouse Models

  • Katy Patras Assistant Professor, Baylor College of Medicine

Synopsis

  • Explore the utilization of humanized mouse models which better mimic human microbiota to bridge the gap between preclinical research and clinical outcomes
  • Dive into novel approaches leveraging dynamic mouse models allowing tests for treatment efficacy as well as remission and flare-ups, better recapitulating the dynamic nature of clinical responses
  • Learn expert approaches on the potential of novel models to inform clinical design and stratification, providing valuable insights into how candidates will perform in human populations

11:00 am Unveiling the Power of Microbial Signatures in Disease Diagnosis, Monitoring & Treatment

Synopsis

  • To better diagnose, understand and treat diseases that includes a microbial compound, an accurate picture of the microbial signature associated with the disease is required
  • To analyze microbial cell free DNA in liquid biopsy samples a novel approach was developed that targets “genus-level” bacterial markers, enabling universal sequencing and analysis of bacteria at higher sensitivity and lower cost than deep sequencing of cell free DNA
  • This approach was successfully validated in a retrospective study on blood plasma samples of IBD patients and allowed to predict clinical events where the fecal calprotectin levels and disease indexes (Mayo-6, SCDAI) failed

Manufacturing Microbiome-Altering Modalities

Scaling Up Manufacture Capacity Amidst Increasing Demand

10:30 am Interactive Working Group Roundtable Session – Meeting Rising Demand with Collective Approaches to Increase Manufacturing Capacity in Microbiome Drug Development

Synopsis

Join this interactive working session designed to bring perspectives from biopharma and CMOs to light, on today’s state of play for microbiome drug manufacture capacity. Facing capacity challenges for developers looking to up-scale, this session brings all the opportunity to discuss current strategies in the short and long-term to navigate the current manufacture landscape.

Hear and contribute actionable takeaways in a room of influential leaders in the microbiome drug development sphere to address:

  • How can a better understanding of the manufacture capacity landscape support industryforward planning and scale-up speed?
  • How can industry better adopt automation, process optimization, and novel manufacturing technologies to meet the rising demand for microbiome-based therapeutic interventions?
  • What risk, resource optimization and scalability considerations will be crucial in the coming 12 months to support resilient and responsive approaches to manufacture capacity requirements?

11:30 am Presentation Reserved for Wacker Chemie AG

12:00 pm Networking Lunch

Leveraging Standardization & Industry-Wide Collaboration: Quality Data Generation from the Discovery Setting & Beyond

1:45 pm Development of AX-5006, a Small Molecule Inhibitor of CsgA Aggregation as a Symptomatic & Disease-Modifying Treatment for Parkinson’s Disease

  • Becca Senter Vice President, Head of Preclinical R&D, Axial Therapeutics, Inc.

Synopsis

  • Understanding the role of the microbiome in Parkinson’s Disease
  • Outlining the rationale for targeting CsgA as a therapeutic for Parkinson’s Disease
  • Revealing the preclinical efficacy and development profile of AX-5006

2:15 pm Fireside Chat: Collectively Unifying Data Generation in Drug Discovery for Accelerated R&D Progress

  • Jun Terauchi Chief Scientific Officer, Metagen Therapeutics
  • Paul Miller Chief Scientific Officer, Piton Therapeutics

Synopsis

  • Where is progress being seen to establish industry-wide standards for creating unified frameworks enabling benchmarking and cross-comparison of early R&D?
  • What challenges are currently posed by diverse methodologies and enrichments for advancing R&D?
  • How can collaborative standardization initiatives mean more efficient regulatory review process and expedite the translation of microbiome research into viable therapeutic solutions?

Scaling Up Manufacture Capacity Amidst Increasing Demand

1:45 pm Advances and Challenges of Fecal Microbiota Transplantation Starting from Japan

  • Hiroto Tamura Director of Business Management Division, Metagen Therapeutics

Synopsis

  • Advancements in the development of FMT products for Ulcerative Colitis in collaboration with Juntendo University
  • Manufacturing Challenges of FMT from donor recruitments to drug supply in Japan
  • Expansion of FMT platform for multiple diseases in partnership with top medical institutions

2:15 pm CMC Strategy for LBPs

Synopsis

  • Analytical methods for LBPs
  • Manufacturing operations for LBPs
  • PK/PD strategy

2:45 pm Afternoon Networking Break

Clinical Development & Commercial Viability in Microbiome Drug Trials

3:15 pm Using Lactobacillus for Drug Delivery, Clinical & Development Update

Synopsis

  • Local-acting immunotherapies
  • Update on clinical- and development programs
  • Derisking

3:45 pm Efforts in Translating Microbiome Insights into Clinical Applications

  • Nadim Ajami Executive Director, Scientific Research, Platform for Innovative Microbiome & Translational Research (PRIME-TR), MD Anderson Cancer Center

Synopsis

  • Developing a portfolio of translational microbiome research projects at MDACC
  • Resourcing and advancing translational microbiome research projects at MDACC
  • From clinical observations to interventional trials

4:15 pm Chair’s Closing Remarks & Close of the 9th Microbiome Movement Drug Development Summit!