Day One

Wednesday, August 7, 2024

8:00 am Registration & Morning Refreshments

8:50 am Chair’s Opening Remarks

Securing Bioefficacy & Safety Data to to Streamline Preclinical Translation & Safeguard Regulatory Approval

9:00 am Demonstrating Proof of Bioefficacy to Streamline Preclinical to Clinical

Synopsis

  • Discussing the rationale behind using preclinical models and alternative design of experiment routes to optimally demonstrate bioefficacy
  • Decoding the translation from preclinical to clinical growth studies to understand how to portray growth within experimental design limitations
  • Adopting a multifactorial approach to support the business of proving bioefficacy

9:30 am Case Study: Tapping into the Chinese Market to Inspire Formula Commercialization & Regulatory Strategy

  • Sebastian Finch Senior Regulatory Affairs Specialist, Arla Foods Ingredients

Synopsis

  • Shedding light on the current demographic situation to understand market status and commercial positioning
  • Navigating the complex infant formula registration journey from trial production to commercialization to pin-point successes for business strategies within the Chinese market
  • Eradicating regulatory bottlenecks – from obstacles to approval

10:00 am Navigating Pre-Submission Meetings to Propel Product Development Plans & Future Success

  • Tricia Mischler Associate Director, Nutrition Regulatory Affairs, Reckitt

Synopsis

  • Clarifying pre-submission requirements in preparation for meetings to streamline the submission process
  • Engaging with regulators from early stages to pin-point areas of risk and mitigate accordingly
  • Building relationships with regulators via pre-submission meetings to enhance open communication and spark positive collaboration

10:30 am Speed Networking & Morning Coffee Break

Specializing Functionality via Robust Measures to Enhance Quality Profiles

11:30 am Assessing the Scope & Progress of Novel Bioactives to Move Closer Towards Human Milk & Direct Future Focuses

Synopsis

  • Discussing latest scientific updates on MFGM’s in infant formula to understand current and future opportunities
  • Delving into human milk oligosaccharides and galacto-oligosaccharides to navigate complexities
  • Providing an in-depth analysis of Bovine IgG to understand its usage in infant formula

12:00 pm Evolving Functionality to Meet Infant Formula Requirements Regarding Nutritional Profile & Structures Bridging the Gap to Human Milk

Synopsis

  • Front-loading ingredient-to-formula compatibility to ensure function is retained for desired physiological and cognitive effects
  • Analyzing and assessing functional parameters in alignment with human milk functionality to hone in on desired characteristics
  • Bridging closely towards milk-based flavours and functions to support humanization

12:30 pm Networking Lunch

Leveraging Commercial Factors to Inform Formulae Personalization & Influence Perception

1:30 pm Advocating Nutrition Education to Resonate Closely with Your Market in Light of Commercialization

Synopsis

  • Depicting language nuances and marketing strategy to closely speak to your scientifically driven market for trust-building
  • Leveraging nutrition education and market resonance to identify launch location within timeframes
  • Assessing efficacy claim allowance globally to inform launch location and business gameplan

2:00 pm Roundtable Discussion: Addressing the Future Roadmap for Bioactive Ingredient Applications to Drive Technical & Commercial Expansion

Synopsis

  • Pin-pointing commercial successes and failures beyond standard bioactives to engage consumers and external partners
  • Discussing commercial entry approaches for formula products to secure consumer attraction
  • Identifying future targets for formula ingredients to shine light on next steps for industry

Optimizing Translation & Communication to Streamline from Science to End-Users

2:45 pm Delving into Translational Science & To Effectively Communicate the Value of Your Formula & Secure Engagement

  • Ari Brown Chief Medical Advisor, Kabrita USA

Synopsis

  • Demonstrating beneficial effects and value added from formula to consumers to bridge the gap between scientific approach and understanding
  • Streamlining from the clinic to the end-user in order to effectively understand requirements and communicate efficacy
  • Understanding how to prioritize which beneficial effects to communicate in order to support nutritional value added

3:15 pm Afternoon Break

4:00 pm Translating Key Clinical Trial Findings to Support Nutritional & Safety Claims

Synopsis

  • Discussing considerations for design and analysis of a clinical trial for translation of outcomes into impactful claims
  • Utilizing clinical biomarkers and parent-reported symptoms to explore the safety, efficacy, and health impact of an infant formula
  • Understanding the value creation of infant formula trials beyond individual ingredient innovation

4:30 pm Understanding Human Milk as a Biological System to Discuss Implications for Infant Feeding & Breastmilk Ecology: Genesis of Infant Nutrition: “BEGIN”

  • Daniel Raiten Senior Nutrition Scientist, Office of Nutrition Research, National Institutes of Health

Synopsis

  • Addressing unanswered questions regarding chronobiology of human milk to understand infant implications
  • Understanding translational implications regarding infant feeding and human milk biology
  • Discussing donor milk claims and effects in relation to pre-term infants to address where current requirements lie

5:00 pm Chair’s Closing Remarks & End of Conference Day One