Day Two

Thursday, August 8, 2024

8:00 am Registration & Morning Refreshments

8:45 am Chair’s Opening Remarks

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

9:00 am Case Study: Building the Safety Package for Bioactive Ingredients, Taking into Consideration the Current Regulatory Framework & Product Timeline Horizons

  • Manki Ho Principal Regulatory Affairs Specialist, Novonesis

Synopsis

  • Discussing the current regulatory challenges surrounding bioactive ingredients that are intended for use in infant formula
  • Using case example(s) to highlight the robust safety packages (preclinical & clinical data) that have been gathered to successfully gain regulatory approvals
  • Exploring considerations for ingredient providers when setting up regulatory strategies for the approval of bioactive ingredients

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

Synopsis

  • 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 & Refreshments

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

Synopsis

  • 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

Synopsis

  • 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

Synopsis

  • 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: Discussing a Randomized, Double-Blind, Controlled Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Safety

Synopsis

  • 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 – Energize & Engage!

Synopsis

Network with your peers aside our beneficial light therapy lamps to rejuvenate before the last few sessions.

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 Research Physiologist & Professor - Pediatrics, Baylor College of Medicine, USDA-ARS

Synopsis

  • 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

Synopsis

  • 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