8:00 am Check-In & Light Breakfast
8:45 am Chair’s Opening Remarks
Looking Beyond HMOs: Progression of Other Bioactive Components & Ingredients
9:00 am Does Protein Matter? The Functional Significance of Alpha-Lactalbumin in Infant Formula
Synopsis
- Protein in infant formula is important for providing essential amino acids, but too much protein can lead to an increased risk of metabolic dysfunction
- alpha-Lactalbumin has higher tryptophan content than other milk proteins, and therefore increased levels in infant formula can reduce the protein levels
- alpha-Lactalbumin digestion has positive impacts on host health that is important for the developing neonate
- This session will explore the pre-clinical and clinical evidence for using alpha-lactalbumin in infant formula
9:30 am Sharing The Role of sn-2 Palmitate in Enhancing Human Milk Fat Composition & Structure
Synopsis
- Human milk fat comprises 25% of dry human milk and provides 50% of the energy infants require for healthy growth and development
- Human milk has a typical fatty acid composition, with high levels of palmitic acid, oleic acid, and linoleic acid, as well as a unique stereospecific triglyceride structure called sn-2 palmitate
- A fat ingredient was developed to mimic the sn-2 palmitate structure of human milk; numerous clinical studies carried out over the past 30 years suggest that this unique structure supports fat and calcium absorption by reducing calcium soap formation, benefiting infants during their first months
- The session will illustrate the clinical evidence behind sn-2 palmitate fat blends developed for infant formula
10:00 am Transitioning from Initial to Further Clinical Studies to Identify MFGMs’ Mechanisms of Actions
Synopsis
- Leveraging historical data to inform clinical trial strategies
- Extending study timelines and building follow-on studies to better understand mechanisms of actions of bioactive ingredients
- Exploring innovative trial designs that balance ethical considerations with robust and effective data collection
Accelerating Cost-Effective Clinical Trials to Support Regulatory Approval
10:30 am Roundtable Discussion: Harmonizing Between Regulatory & R&D Functions to Support Efficient & Cost-Effective Decision-Making
Synopsis
- Balancing the volume of innovation with being a good business partner through strategic ingredient selection and development
- Creating a general consensus about efficient workflows to accelerate the implementation of beneficial ingredients into infant formulas
- Lessons learned from how cross-functional teams work to overcome shared challenges
11:15 am Morning Break & Networking Poster Session
12:15 pm Optimizing Trial Participant Selection & Recruitment to Overcome Enrollment Challenges & Generate High-Quality Data
Synopsis
- Standardizing the timelines and methodologies for clinical trials with correct parameters to avoid approval delays or ineffective results
- Improving clinical trial recruitment within a protected population to meet trial criteria and examining the rise of decentralized clinical trials
- Effectively demonstrating equivalency or superiority to existing formulas
12:45 pm Roundtable Discussion: Incorporating Cognition Biomarkers in Clinical Studies for Bioactive Ingredients to Move Beyond Anthropomorphic Measures
Synopsis
- Elucidating the specific, measurable effects on infant development
- Developing effective measurement strategies in a trial setting
- Enabling isolated testing of different criteria to effectively quantify the effects of ingredients given their complex and diverse function
1:15 pm Networking Lunch
Blue Sky Thinking & Advancing Industry Collaboration to Transform Infant Formula
2:15 pm Showcasing Next-Generation Bioactive Ingredient Innovation to Support Horizon Scanning: The Science Behind Animal-Free Lactoferrin
Synopsis
- Using advances in precision fermentation to produce high-quality lactoferrin
- Discussing the potential of lactoferrin to support infant immunological development
- Preclinical and clinical development data that demonstrate the safety and tolerability of animal-free lactoferrin
2:45 pm Mind the Gap: Bringing the Content & Forms of Nutrients in Infant Formula Closer to Human Milk
Synopsis
- Considering why nutrients in infant formula differ from human milk and if there are implications for infant nutrition
- Highlighting vitamin K and folate as examples
- Targeting discovery through metabolomics: 1-carbon metabolites
3:15 pm Fireside Chat: Updates from the Human Milk Science Workshop
Synopsis
- Exploring ways to further advance human milk science and the steps that can be taken to identify knowledge gaps and define research needs
- Identifying core priorities for 2025 and beyond to advance towards innovations in infant formula that close the nutritional and functional gap with human milk