Integrated Human Practices

Regulatory Affairs & FDA Guidance

Dr. Jacques Guyette | FDA Regulatory Specialist

AstraZeneca | Independent Consultant

Dr. Guyette (ND '03) provided comprehensive insights into GLP-1 therapeutics and FDA regulatory pathways. His background spans academic research, pharmaceutical equity research, and business development.

Discussion:

Primary Challenge: GLP-1 is a regulated therapeutic agent; OTC dietary supplement status unlikely through traditional FDA pathways.

Key Recommendation: Pursue GRAS (Generally Recognized As Safe) approval rather than FDA therapeutic approval—more appropriate for engineered bacteria in food products, less onerous than drug approval, positions Fleur in food/supplement category.

Critical Insight: "Microdosing" below therapeutic thresholds offers regulatory advantages while providing clinical benefit through consistent daily exposure.

Target Market: Post-injectable GLP-1 patients seeking sustainable, affordable maintenance ($30/month vs $1,000/month)—valuing consistency over dramatic results with reduced side effects.

Development Priorities:

• Demonstrate functional GLP-1 with good receptor binding at microdose levels
• Show microdosing efficacy in cell culture
• Prove weight loss maintenance in post-GLP-1 therapy cohorts

Positioning: "Not competing with big pharma—this is a niche area with a unique solution."

Impact: Shaped regulatory strategy (GRAS pivot), refined clinical development (maintenance therapy focus), and defined market positioning (complement vs compete with pharmaceuticals).

Scientific Expertise & Technical Validation

Dr. David Boone | Adjunct Professor of Microbiology

Indiana University School of Medicine

Dr. Boone, a GI tract microbiology expert, evaluated Fleur's technical feasibility and found the concept "compelling and captures public imagination."

Discussion:

Scientific Validation:

• Gut microbiome health impacts stem from bacterial metabolites—validates producing therapeutic molecules in situ
• While microbiome diversity varies individually, overall function remains similar across people
• Engineered bacteria with specific functions may integrate successfully into diverse contexts

Critical Challenges & Fleur Responses:

• Safety/Control: Kill switch needed; difficult to stop effects if side effects occur
  Response: Inducible expression systems and biodegradable plasmids for transient colonization
• Absorption/Bioavailability: Ensuring GLP-1 absorption from stomach into gut lining
  Response: Engineering secretion signals, selecting strains surviving gastric passage, protective formulation matrices
• Colonization Dynamics: Uncertain if Lactobacillus colonizes; permanence could be irreversible
  Evidence: Probiotic trials show limited long-term colonization; "live cultures" often overhyped
  Response: Transient colonization as feature—provides dosing control and discontinuation option
• Regulatory/Public Perception: GMO pushback despite benefits (especially Europe's "Monsanto effect")
  Response: Transparent communication emphasizing GRAS strains, natural human GLP-1, complementary therapy

Fleur's Distinction from Traditional Probiotics: Engineering specific therapeutic output (GLP-1) vs relying on general "beneficial bacteria" effects—using bacteria as transient delivery vehicles, not permanently altering microbiomes.

Advantages Over Injectable GLP-1: Natural bioidentical GLP-1, short-acting physiological kinetics, affordable, leverages established consumption behavior.

Commercial Insights: Company "Lumen" in related space; secondary market potential in companion pet obesity; preliminary patent search showed no blocking patents.

Impact: Identified critical technical challenges early. Emphasized transient colonization as feature, refined bacterial engineering. Frank probiotic trial failure assessment pushed differentiation. Validated metabolite-centric approach while highlighting absorption/bioavailability study importance.

Technical Advisory Board

Dr. Michelle Whaley | Teaching Professor of Biology

Organization: Department of Biological Sciences, University of Notre Dame

Dr. Whaley served as a core technical advisor, providing expertise in cellular and molecular biology throughout Fleur's development.

Research Expertise:

• Cellular and molecular basis of vision
• Characterization of Aedes aegypti visual genes
• Gene expression effects on mosquito behavior
• Laboratory techniques in molecular cloning and protein expression

Contributions to Fleur:

• Guidance on genetic construct design for optimal GLP-1 expression
• Troubleshooting molecular cloning strategies
• Laboratory safety protocols and training for undergraduate researchers
• Experimental design for validation assays
• Mentorship on scientific communication and presentation skills

Laboratory Access: Dr. Whaley provided access to wet lab facilities, equipment, and common laboratory consumables essential for our proof-of-concept work, enabling hands-on experimentation by undergraduate team members.

Dr. Michael McConnell | Associate Professor of Practice

Organization: Department of Biological Sciences, University of Notre Dame

Dr. McConnell served as principal technical advisor and provided entrepreneurial guidance based on extensive startup experience.

Research Expertise:

• Antibiotic resistance mechanisms
• Vaccine development
• In vivo infection models
• Target identification for therapeutics addressing antibiotic-resistant infections

Entrepreneurial Experience:

• Founder: Vaxdyn S.L., a vaccine development company
• Expertise in biotechnology commercialization
• Experience with regulatory pathways for biological therapeutics
• Industry partnerships and funding strategies

Contributions to Fleur:

• Strategic project planning and milestone development
• Guidance on transitioning from academic research to commercial product
• Connections to industry partners and potential collaborators
• Risk assessment and mitigation strategies
• Mentorship on entrepreneurial mindset for scientific innovation

Dual Perspective: Dr. McConnell's combined expertise in infectious disease biology and biotech entrepreneurship proved invaluable for balancing scientific rigor with commercial viability. His experience founding a vaccine company provided practical insights on navigating the complex intersection of biological product development, regulatory approval, and market entry.

Design & Consumer Research

James Rudolph | Assistant Professor of Design

Organization: Department of Art, Art History, and Design, University of Notre Dame

Professor Rudolph provided insights on product packaging design and consumer research, particularly in preparation for the McCloskey Competition.

Expertise Areas:

• Product design and user experience
• Consumer psychology and purchasing behavior
• Brand identity development
• Packaging design for functional foods

Key Contributions:

• Consumer perception research on probiotic products and health supplements
• Packaging design principles for standing out in competitive retail environments
• Visual communication strategies for complex scientific concepts
• Brand positioning recommendations for biotechnology-enhanced food products

Design Insights:

• Packaging must balance scientific credibility with approachable aesthetics
• "Grab-and-Go" strategy requires immediate visual impact and clear benefit communication
• Consumer trust in probiotic products relies heavily on familiar brand elements
• Transparency about engineering should be approached thoughtfully to avoid triggering GMO concerns

Impact on Fleur: Professor Rudolph's expertise helped us develop packaging concepts that communicate Fleur's sophisticated technology without alienating mainstream consumers. His insights on the visual language of health and wellness informed our brand identity development and point-of-sale strategy.

Career Development & Research Perspectives

Andrew Latham | Computational Biophysicist

Organization: NASA Ames Research Center

Andrew Latham delivered a scheduled talk on campus on October 16, 2024, discussing the PhD journey and research opportunities at NASA.

Presentation Topics:

• Career pathways in computational biology and biophysics
• Interdisciplinary research opportunities at NASA
• Transitioning from undergraduate research to graduate programs
• Applications of biological research in space exploration

Relevance to Fleur Team: As many iGEM@ND members aspire to pursue graduate studies in biological sciences, Andrew's insights on research careers and the graduate school journey provided valuable perspective on long-term career development. His interdisciplinary approach—combining biology, computation, and engineering—resonates with iGEM's synthetic biology philosophy.

Community Engagement: Synthetic Biology Night

Building Campus Awareness Through Education

Beyond individual collaborations, iGEM@ND recognized the need to broaden synthetic biology awareness across the Notre Dame campus. To address this, we organized Synthetic Biology Night—a campus-wide event introducing students to the interdisciplinary world of synthetic biology and its intersections with research, entrepreneurship, and real-world impact.

Mission: Increase awareness of synthetic biology, connect students with faculty and graduate researchers, and inspire engagement in hands-on interdisciplinary problem-solving.

Event Structure

Keynote Address (20-30 minutes)
Introduction to core synthetic biology concepts and applications in health, biotechnology, and innovation, demonstrating how engineered biological systems address real-world challenges.

Panel Discussion (30 minutes)
Faculty, graduate students, and innovation partners share experiences and advice on:
Research methodologies and experimental design
Ethics of bioengineering and responsible innovation
Commercialization and translational research pathways
Interdisciplinary collaboration strategies

Networking Session (30 minutes)
Informal connection opportunities with speakers, student leaders, and potential mentors for career guidance and research collaboration discussions.

Community Engagement: iGEM Idea Pitch Night

Our launching event: “iGEM Idea Pitch Night” - an opportunity to share our current projects and encourage development of other project ideas.

Community Engagement: Storm the Dome Event

An event to develop collaboration and brainstorming for innovative solutions for our iGEM.

“Let's come together, share diverse perspectives, and generate groundbreaking ideas that can make a real impact!”

Community Engagement: Instagram Page

Big Lessons Learned

Our collaboration experience taught us valuable lessons about developing responsible, impactful biotechnology:

• Early Engagement is Critical: Consulting regulatory experts before extensive development work saves significant time and resources by focusing our approach on the most viable pathway.
• Diverse Perspectives Strengthen Innovation: Input from scientists, business professionals, designers, and regulatory specialists created a more robust, comprehensive solution than any single perspective could provide.
• Scientific Rigor and Commercial Viability Must Coexist: Success in biotechnology requires balancing technical excellence with market realities, regulatory constraints, and consumer acceptance.
• Transparent Communication Builds Trust: Open dialogue about challenges, limitations, and uncertainties strengthens rather than weakens project credibility.
• Flexibility Enables Progress: Willingness to pivot strategy based on expert feedback (i.e. regulatory pathway, market positioning) transformed potential obstacles into opportunities.

Outreach Acknowledgments

The Fleur team extends sincere gratitude to all collaborators who generously shared their time, expertise, and insights. Your contributions have been instrumental in transforming an ambitious concept into a scientifically sound, commercially viable, and responsibly developed solution.

Special thanks to our technical advisors, Dr. Michelle Whaley and Dr. Michael McConnell, whose unwavering support, laboratory access, and mentorship made this project possible. Your guidance extends beyond technical expertise to inspire our commitment to rigorous science in service of the common good.

We also acknowledge the University of Notre Dame for fostering an environment that encourages interdisciplinary collaboration, entrepreneurial thinking, and ambitious student-led research initiatives. The resources, facilities, and networks provided through various university programs have been essential to Fleur's development.

"What would you fight for? We fight for accessible, natural, and effective solutions to metabolic disease—developed collaboratively, validated rigorously, and deployed responsibly."