CONFERENCE DAY TWO
FRIDAY, MAY 24 2019

8.00 Registration & Morning Coffee

8.50 Chairperson Opening Remarks

Mobilizing Regulatory Guidance to Move Solutions Towards Approval & the Market Place

Introduction and Purpose:
Given the active engagement of US regulators with regards to live biotherapeutics in recent years, significant progress has been made in understanding the regulatory pathway and requirements for these products. This theme will provide a regulatory overview of considerations for microbiome-based products for pregnant women and in the pediatric setting.

9.00 

Development of Live Biotherapeutic Products for use in Pregnant Women & Infants: U.S. Regulatory Perspective

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Jeff Roberts
Division of Vaccines and Related Product Applications
FDA

Therapeutic Interventions Targeting the Infant Microbiome to Restore Balance & Treat or Reduce Risk of Disease

Introduction and Purpose:
Whilst nutritional and preventative measures have been explored in the context of the adult human microbiome before, therapeutics targeting the infant microbiome are newcomers to the field. The purpose of this theme is to explore emerging products aiming to gain therapeutic regulatory approval and work to reverse dysbiosis in the infant gut microbiome.

9.30 

Spontaneous Weaning of Rat Pups is Stimulated by SB-121 –mediated Gut Development

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Mark Heiman
CSO
Scioto Biosciences

10.00 

Microbiota-Derived Metabolites to Treat Food Allergy and Prevent Food Allergen Sensitivity

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John Colson
Director of Operations
ClostraBio

10.30 Morning Refreshments & Networking

11.30 

Preventing Necrotizing Enterocolitis (NEC) in Premature Infants with IBT’s Drug Candidate IBP-9414

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Staffan Stromberg
CEO
Infant Bacterial Therapeutics

Addressing the Public Health, Economic & Educational Considerations for Commercializing Microbiome-Based Products for Infants & Mothers

Introduction and Purpose:
The economic burden of chronic diseases that develop over the life course is costing healthcare systems billions of US dollars. Additionally, as the public makes more choices with regards to health and wellness, it is to communicate the science, risks and benefits of microbiome-based products to consumers, including physicians and mothers. This theme will allow reflection on the opportunity that lies in being at this early stage in understanding the maternal-infant microbiome, in shaping, influence and defining the future of product development.

12.00 

Re-defining the Gold Standard… A Highly Functioning Infant Microbiome

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David Kyle
Executive Chairman & CSO
Evolve BioSystems

12.30 Lunch & Networking

13.30 

Panel Discussion: How Will the Future Horizons of Delivering Microbiome-Based Products into the Hands of Physicians and Mothers Change?

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Panelists:

Deshanie Rai
Associate Adjunct Professor
Friedman School of Nutrition
Science & Policy - Tufts University

Noah Voreades
Consultant
GenBiome Consulting

David Kyle
Executive Chairman & CSO
Evolve BioSystems

14.00 

Bridging the Gaps in Developing, Communicating and Commercializing the Scientific Relevance of the Microbiome in Early Life: Opportunities and Challenges

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Deshanie Rai
Associate Adjunct Professor
Friedman School of Nutrition Science & Policy - Tufts University

14.30 

14.50 Chair’s Closing Remarks

15.00 End of Summit