Registration & Morning Coffee

Chairperson’s Opening Remarks

Overcoming Regulatory Challenges & Understanding the IP Landscape
to Move Microbial-Based Products Towards the Market Place

Session Purpose:
Although regulatory agencies, particularly in the US, have been proactive in putting regulation in place for microbial-based products, the definitions for various product types remain unclear. Additionally, regulatory constraints heavily define the IP landscape that we must navigate. This theme provides an opportunity to discuss the regulatory hurdles being overcome and how to build a strong IP portfolio of both therapeutic and cosmetic products harnessing the skin microbiome.


Regulatory Considerations for Topical OTC MicrobialDerived Drug Products for the Skin

• Understanding the product regulatory status - under the FDA laws a product’s regulatory status is determined by the product claims
• How will microbiome products affect the skin? Are products affecting the microbiome having bodily functions or structure been altered?
• Will products that affect microbiome create health or safety issues? Can affecting the microbiome create a safety concern?

Sharon Blinkoff
Senior Counsel
Locke Lord & Independent Cosmetic Manufacturers and Distributors (ICMAD)


IP & Patent Strategies for the Microbiome Dermatology Company

• Importance of freedom to operate analyses to potential investors and partners
• Key aspects of developing patent life cycle strategies to protect your microbiome-based product or service
• Effective patent prosecution strategies to obtain patents quickly in a cost effective manner

Matthew Bresnahan
Partner – Intellectual Property
Wilson Sonsini
Goodrich & Rosati


Understanding How Regulatory Bodies Currently Review Microbiome Candidates for Therapeutic & Cosmetic Development

• How does product modality impact regulatory thinking e.g. live biotherapeutic products vs. microbiome-derived small molecules vs. engineered strains vs.
bacterial lysates?
• How does testing to prove or disprove the activity of the microbiome and how it interacts with the skin and products used on the skin fit into the regulatory dialog?
• How important is it to understand the critical regulatory hurdles in order to develop the best product strategy and maximize chances of market success with different IP claims?
• What are the commonalities/differences in regulatory strategy for the US vs EU? What is being done to align regulatory thinking on microbiome based therapeutics and cosmetics globally?

Sharon Blinkof
Senior Counse
Locke Lord & Independent Cosmetic Manufacturers and Distributors (ICMAD)

Matthew Bresnahan
Partner – Intellectual
Wilson Sonsini
Goodrich & Rosati

Travis Whitfill
Azitra Inc.


Networking & Morning Refreshments

Understanding Clinical Study Design Considerations for Skin Microbiome Research

Session Purpose:
It is vital to understand how to progress your microbial candidates from the pre-clinical to clinical stages of
product development. The purpose of this theme will be to review clinical study design considerations for
the skin microbiome R&D community that will lead to breakthrough product development.


Discussing Clinical Trial Considerations – An Example from a Live Biotherapeutic Product in Cancer TherapyAssociated Rash

• Outlining how the role of the microbiome in skin disease must be factored into the clinical trial design (Correlation or causation Prevention or treatment?)
• Understanding why biomarker selection is key in early clinical trials
• Realizing that patient population exclusion and inclusion criteria are also important

Travis Whitfill
Azitra Inc.

Therapeutic Interventions Targeting the Skin Microbiome to Restore Balance & Treat or Reduce Risk of Disease

Session Purpose:
This theme will explore emerging products aiming to gain therapeutic regulatory approval and work to treat and reverse dysbiosis that is causing disease in the skin microbiome.


MatriSys Bioscience – Clinical Update & New Developments

• Understanding the range of therapeutic opportunities
• Regulatory strategy for microbiome
• Better understanding the commercial aspects of new microbiome science

Mark Wilson
Co-Founder & CEO
MatriSys Bioscience


Exploring the Role of Microbial Biofilms & the Functional Microbiome

• Understanding the importance of microbial biofilms
• Defining what the functional microbiome is
• Identifying clinically relevant microbial data

Nicholas Monsul
CEO, Principal & CoFounder
Quorum Innovations


Digging in the Dirt for Our Missing Microbiome

• Understanding how environmental microbes can influence the immune system
• Developing ammonia oxidizing bacteria to treat skin disease
• Reflecting on how treating bacteria as a therapeutic continues to pose challenges

Alex Goddard
VP, Research & Development


Lunch & Networking

Cosmetic Products Harnessing the Skin Microbiome for Improved Skin Health

Session Purpose:
Having explored the different types of therapeutic products harnessing the skin microbiome to treat disease, this theme will reveal the diversity of cosmetic products using the skin microbiome to improve skin health and wellness.


Focusing on the Disequilibrium of Microbiota - Is There a Link with Skin Symptoms After Aggression of Daily Life?

• Recapping how skin microbiota play a fundamental role in skin protection, skin regulation/rebalance and skin recovery after alteration
• Revealing how daily life aggressions are able to alter the skin microbiome and how these modulations might be correlate with skin symptoms
• Evaluating whether there are possibilities to help the skin to recover after aggression and what are the skin benefits

Audrey Gueniche
Senior Clinical Expert, Advanced Research
L’Oréal Research & Innovation


A Comparative Study on the Effect of Microbial-Derived L. Reuteri Probiotics & Lysates on Human Skin

• Discussing photoprotection: Both live and the lysate form are anti inflammatory in UV-R induced inflammation model
• Strengthening the skin barrier: Demonstrating the complementary effect on selected key barrier gene expression from both live and the lysate form
• Demonstrating anti-microbial activity: Only live probiotics target skin pathogens

Ia Khmaladze
Principal Scientist Skin Health
Oriflame Cosm etics AB, Skin Research Institute


Harnessing the Jekyll & Hyde Skin Microbiome for Healthy Beauty

• Like Jekyll and Hyde, we know that our skin microbes can also take on dual personalities, transforming from ‘good’ bugs to ‘evil’ pathogens
• The transformation involves quorum sensing, biofilm formation, and a plethora of metabolic changes that ultimately results in acute and chronic skin inflammation
• Preventing, inhibiting or even reversing the pathways involved in this transformation is an attractive new therapeutic strategy for both dermatology and cosmetic science

Greg Hillebrand
Senior Principal Research Scientist

Addressing Patentability & Market Entry Strategies for Microbial-Based Products Targeting the Skin Microbiome

Session Purpose:
The diversity of microbial-based product types being developed as cosmetics or therapeutics has led to a plethora of market entry options. The conference will wrap up over a conversation on how to build a robust IP portfolio, how cross industry-collaborations can move the science forward and what the challenges and opportunities are in gaining market entry for your product.


Discussing Future Horizons for Microbial-Based Therapeutic & Cosmetic Products for the Skin

• If we weren’t cost-limited, in what ways could microbial-based therapeutic and cosmetic product development be improved?
• How can mechanism of action be effectively communicated to consumers and physicians to increase use of microbial-based therapeutics and cosmetics?
• What are the different routes to market for products with different claims?
• How can we ensure that products are used in the right settings?
• What will developers need to do if they are seeking to get insurance reimbursement for e.g. therapeutic over-the-counter products?

Matthew Bresnahan
Partner – Intellectual
Wilson Sonsini
Goodrich & Rosati

Mark Wilson
Co-Founder & CEO
MatriSys Bioscience




Chairperson’s Closing Remarks

End of Conference Day One