Day Two

Thursday, August 8, 2024

8:00 am Registration & Morning Refreshments

8:50 am Chair’s Opening Remarks

Tapping into Ingredient Availability & Regulatory Approval to Promote Effective Application for Infant Formula Products

9:00 am Case-Study: Outlining Safety Packages for Specific Bioactive Ingredients to Lay Down a Regulatory Framework & Product Timeline Horizons

  • Manki Ho Principal Regulatory Affairs Specialist, Novonesis


  • Discussing how to curate a robust safety package from pre-clinic and clinic to regulators to streamline ingredient approval
  • Understanding what a bioactive compound from a regulatory perspective is to speak to and diffuse objections
  • Setting up a framework for approval as an ingredient provider to assess and eradicate risk ahead of time when working with unapproved bioactives 

9:30 am Panel Discussion: Discussing the Regulatory Framework & Market Access Approach for Ingredient Providers & Formula Manufacturer Dynamic to Streamline Approval


  • Unpicking market access strategy including data packages and ingredient characterization to pin-point potential challenges and solutions
  • Enhancing robustness of market access strategies ahead of regulatory and partner collaboration to promote stakeholder engagement
  • Exploring experiment optimization strategies to present evidentiary data to help influence partnership decisions

10:15 am Morning Break

Propelling Forth Novel & Innovative Bioactives to Discover Unexplored Opportunity & Direct Products of the Future

11:00 am Discussing the Evolution of Technology for Cellular and Precision Fermentation-Derived Ingredients as a Gateway to Sustainability & Economic Feasibility


  • Tapping into the changing world of infant formula HMOs vs traditional production to fill in market gaps
  • Outlining differences between cell-based and fermentation approaches to pin-point areas of opportunity
  • Developing on proof of concept for cell-based and exosome technologies to pinpoint and exploit major successes for application

11:30 am Panel Discussion: Keeping Up with the Latest & Greatest in Discussing Opinions & Future Movements on Novel Technologies


  • Pin-pointing novel bioactive sources and technologies with the most translational promise and consumer benefit
  • Understanding best prioritize bioactives within the portfolio according to current demand
  • Discussing the extent of potential for cutting-edge cell-based and novel fermentation technologies reach new horizons for infant formula

12:15 pm Networking Lunch

Streamlining from Proof of Concept to Technical Implementation for Novel Formulae

1:15 pm Case Study: Building a Mammary Biomanufacturing Platform to Explore Novel Avenues For Ingredient Production


  • Looking into BIOMILQ’s biomanufacturing platform that utilizes the unique potential of human mammary cells to produce human milk ingredients for the betterment of human health
  • Communicating the rationale behind using bioactive approaches to encourage innovation and shape the future of early life nutrition
  • Demonstrating proof of concept for cell-based technologies to support collaboration and streamline investments

1:45 pm Case Study: Building Trust Surrounding Precision Fermentation Approaches to Shift Traditional Mindsets & Explore Novel Avenues for Ingredient Production


  • Displaying novel approaches and innovative technologies to showcase future horizons for formula applications
  • Communicating the rationale behind using non-standard and non-approved bioactive approaches to encourage innovation
  • Demonstrating proof of concept for humanization of formula ingredients to engage support for experimental trials and regulatory plans

2:15 pm Afternoon Break

Leveraging Research Insights to Inform Efficacy Demonstrations Fit for Proof of Product Claims

2:45 pm Securing Industry & Academic Collaboration to Effectively Transition from Concept to Proof of Viability

  • Douglas Burrin Senior Research Scientist, Children's Nutrition Research Center, Baylor College of Medicine, USDA-ARS


  • Learning how to promote your technologies to academia and speak to desired interests to promote engagement
  • Examining what’s desired regarding IP discussions and publications to uncover what good looks like from an academic perspective
  • Tackling translational science from preclinical trials to infant physiology to exploit key benefits through data displays and market delivery

3:15 pm Enhancing Preclinical Efficacy for Bioactive Data Demonstration & Displaying Rationale Behind Decisions

  • Sharon Donovan Director of Personalized Nutrition Initiative, University of Illinois at Urbana-Champaign


  • Addressing critical growth parameters and models to support translational science and efficacy
  • Discussing the concept of human milk as a biological system (BEGIN project): assessing bioactive ingredients in conjunction vs singular analysis
  • Exploring examples of outcomes with single vs. combined ingredients (probiotics/ HMO or HMO/HMO) to observe combinatorial effects in preclinical trials 

3:45 pm Chair’s Closing Remarks & End of Summit