The Official Blog of the Annual Translational Microbiome Conference

The official blog of the Annual Translational Microbiome Conference provides readers with information, insight and analysis regarding the microbiome.

YUN Overcomes European Regulatory Issues Surrounding the Use of Live Probiotic Bacteria for Topical Skin Application

These microbiome insights are brought to you by Dr. Ingmar Claes, Chief Scientific Officer at YUN, and Arrowhead Publishers and Conferences. Dr Claes will be presenting YUN’s work at Arrowhead’s 4th Annual Translational Microbiome Conference, 18th-20th April 2018. (www.microbiomeconference.com).

We all know that the skin is critical for our health by serving as a protective layer against external factors, but we tend to overlook the importance of the skin microbiome. The skin microbiome, acid mantle and epidermal skin barrier functions as our first layer of defense against pathogens. Use of products with live beneficial bacteria, also known as probiotics, pharmabiotics, or live biotherapeutic products (LBPs), have the potential of improving dysbosis for a multitude of skin disorders. Such restoration of the microbiome using ‘live’ probiotic bacteria to treat disorders is known as probiotherapy.

YUN is a Belgian-based biotech company with a totally new vision on health and hygiene. YUN aims to take healthcare to the next level. YUN believes in maintaining and restoring the skin microbiome; and the importance of the microbiome for human health. Working closely with leading probiotherapy experts from the University of Antwerp over the past decade, YUN has developed a world premier range of skin products including treatments for pimples (ACN and ACN+) and athlete’s foot (FNG).

World Premier ACN and ACN+ Products
YUN’s ACN and ACN+ products are the first creams (oil in water cream) in the world that contain ‘live’ probiotic bacteria in a dose that will have an impact on the skin microbiome. This major breakthrough was made possible by the development of an innovative type of microcapsule. This new microcapsule contains the ‘live’ bacteria in a core suspension, surrounded by multiple layers to protect them from the water in the cream. Furthermore, YUN strains are ‘probiotic’ which are specifically selected lactobacilli strains. These have some shared mechanisms of action with other probiotic strains, but also have some very specific properties against a selection of pathogenic or problem-causing micro-organisms such as Propionibacteriuim acnes, Trichiphyton spp, Staphylococcus spp., Malassezia spp., Candida spp.

Tough Regulatory Approval Challenges
LBP products face tough regulatory hurdles. Unlike the US in which the FDA’s Center for Biologics Evaluation and Research (CBER) has issued LBP guidelines for industry, the EU lacks regulatory framework. Regulations are lagging behind the new innovations. As in all regulations, safety is considered the most important factor. Thus, safety should always be the first concern when using LBPs.

As a completely new field of products for topical application, YUN faced tough European regulatory approval challenges. YUN has been looking from the start to market its products outside the EU, and it is clear that there are differences in regulations between the US and Europe. Indeed, regarding the FDA LPB product guidelines, it is unclear whether YUN’s topical products fall under the FDA’s definition of LBPs.

Further complicating matters is there are major differences between the safety assessment of oral medical drugs and LBPs for topical use. Specifically, for topical application, the challenges regarding safety should not be neglected. Even though our epidermal skin barrier, the acid mantle layer and the skin microbiome seem to be protective for systemic problems, carefully selected safe ‘probiotic’ strains should be selected for topical application.

As YUN’s topical skin care LBP products are safe and work by restoring or maintaining the skin’s natural defense layer, namely the skin microbiome, they fall in the EU under the cosmetic regulations. These products must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use (cfr. Regulation (EC) N° 1223/2009) and data proving the safety of the probiotic strains being used must therefore be provided.
YUN specifically substantiated for the safety of all their topical products, both at the probiotic strain level and the final product itself. YUN goes even one step further as it wants to address the issues at hand of many of the current topical products which neglect safety on the skin microbiome.

Probiotic Strain Safety Research
YUN specifically performed research for the safety of the probiotic strains both in vitro and in vivo. Indeed, Dr Claes emphasized the importance of the safety of YUN’s probiotic strains particularly during the pre-clinical in vitro screening phase of development. Consequently, all the YUN’s strains were thoroughly characterized at the strain level. Mobile antibiotic resistance elements and virulence factors were investigated and excluded. Furthermore, interactions with human cells were also investigated.

Final Product Level Safety Research
At the final product level, aseptic filling, absence of contaminant pathogenic bacteria and amount of ‘live’ probiotic bacteria had to be proven by YUN. Additionally, the products with ’live’ probiotic strains were clinically evaluated by YUN to underline their level of safety for topical application on the skin.

Quality Control Issues
YUN guarantees the viability of its probiotic bacteria through patented breakthroughs in new galenic formulation and the development of microcapsules shielding its ‘live’ probiotics from water present in creams. Keeping the bacteria in a water-free core suspension ensures a minimal viable dose for up to six months at room temperature as the bacteria’s metabolical activity is minimal in the water-free suspension.

New Regulatory Framework is Needed
Dr Claes explains that by constructing the safety documentation and quality controls in the production of YUN’s products, they could be notified to EU authorities and placed safely on the market. It is therefore clear that safety is the most important aspect for LBPs and should always be addressed correctly. The added therapeutic benefits of these products for topical skin application might be the future for addressing specific skin disorders by using carefully selected probiotic strains.

Furthermore, YUN is a member of the Pharmabiotic Research Institute (PRI) and hopes to constructively interact with the European Medicine Agency (EMA). YUN believes that for some specific applications and products a completely new regulatory framework should be proposed for these new innovative products, which in the first place should always tackle safety before efficacy.

Clearly, approval regulation is lagging behind innovation. European drug authorities must tackle regulatory challenges to produce concise guidelines for industry in the development of LBPs. YUN deserves much credit for not only developing the world’s first ‘live’ probiotic creams in a dose to maintain and restore the skin microbiome, but overcoming tough European regulatory approval challenges.

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Joint-Providership Accreditation and Designation Statement

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Office of Continuing Medical Education of the University of Virginia School of Medicine and Arrowhead Publishers. The Office of Continuing Medical Education of the University of Virginia School of Medicine is accredited by the ACCME to provide continuing medical education for physicians

The University of Virginia School of Medicine designates this live activity for a maximum of 8 AMA PRA Category 1 Credits.TM Physicians should claim only the credit commensurate with the extent of their participation in the activity. (The number of credits offered for this event is subject to change dependent upon future additions/revisions to the agenda.)

The University of Virginia School of Medicine, as accredited provider, awards 8 hours of participation (consistent with the designated number of AMA PRA Category 1 Credit(s)TM ) to a participant who successfully completes this educational activity. The University of Virginia School of Medicine maintains a record of participation for six (6) years.

Shahram Lavasani, Ph.D.

Founder, Chief Executive Officer and Chief Scientific Officer
Immune Biotech

Profile coming soon.

Scott Jackson, Ph.D.

Group Leader, Complex Microbial Systems
NIST (National Institute of Standards & Technology

Profile coming soon.

Rachel Clemens, Ph.D.

Commerical Innovation Manager, Life Science Lead
ISS US National Lab, Center for Advancement in Science in Space

Profile coming soon.

Lynne Elmore, Ph.D.

Director, Translational Cancer Research Program
American Cancer Society

Lynne Elmore, PhD, is the director of the Translational Cancer Research program in the Extramural Grants department of the American Cancer Society (ACS). She manages a research portfolio focused on cell biology, infectious disease, the microbiome, molecular genetics, and cancer drug discovery.

Garth Ehrlich, Ph.D.

Professor of Microbiology & Immunology, Professor of Otolayngology - Head & Neck Surgery
Drexel University College of Medicine

Dr Ehrlich is Professor of Microbiology and Immunology, and Otolaryngology-Head and Neck Surgery at Drexel University College of Medicine (DUCOM) in Philadelphia, PA, USA. Dr. Ehrlich is also the founder and director of three Research Centers of Excellence in the Institute for Molecular Medicine and Infectious Disease: the Center for Genomic Sciences (CGS); the Center for Advanced Microbial Processing (CAMP); and the Center for Surgical Infections and Biofilms.

He also directs Drexel University’s Core Genomics Facility and the Meta-Omics Shared Resource for the Sidney Kimmel Cancer Center – an NCI-designated Cancer Center.

Momo Vuyisich, Ph.D.

Chief Scientific Officer
Viome

Momo Vuyisich is a co-founder and Chief Science Officer at Viome, a data-driven personalized nutrition company. Momo provides scientific leadership at Viome and his vision is to revolutionize healthcare from "symptoms management" to a true preventative medicine. He leads product development, clinical test implementation, and comprehensive clinical research portfolio.

Momo is also an Adjunct Professor at the University of New Mexico and New Mexico Tech. Before co-founding Viome in 2016, Momo spent 12 years at Los Alamos National Laboratory, where he led the Applied Genomics team, which developed the core technology used by Viome today.

Nancy Caralla

Founding President, Executive Director
C Diff Foundation

Nancy C Caralla is a three-time Clostridioides difficile infection (CDI) survivor. She has accumulated over 25 years of experience in the nursing profession blended with over 30 years in international construction management. Over the past several years, Nancy, in partnership with C Diff Foundation members, has focused on raising C. difficile awareness through education and advocating for Clostridium difficile infection prevention, treatments, clinical trials, AMR, and environmental safety worldwide. The C Diff Foundation is a non-profit organization that takes great pride in its volunteers, chairpersons, and committees.

Rachel Teitelbaum, Ph.D.

Chief Executive Officer
Hervana

Profile coming soon.

Sonia Timerlake, Ph.D.

Vice President of Research
Finch Therapeutics

Dr. Sonia Timberlake is the VP of Research at Finch Therapeutics, a microbiome therapeutics company. Sonia is an expert at designing NGS-based algorithms for applications in microbial genomics, immunogenomics, and evolution. Prior to joining Finch, she built and managed AbVitro's computational algorithms and infrastructure, supporting high throughput single-cell immune phenotyping and repertoire sequencing technology. This technology platform was acquired by Juno Therapeutics, where Sonia led a multidisciplinary team to harness native adaptive immune responses for developing engineered cell therapies in oncology.

Dae-Wook Kang, Ph.D.

Assistant Professor, Department of Civil & Environmental Engineering
University of Toledo

Profile coming soon.

Sameer Sonkusale, Ph.D.

Prof. of Electrical & Computer Engineering, Prof. of Biomedical Engineering (adjunct), Director/Principal Investigator, Nano Lab
Tufts University

Profile coming soon.

Amy Feehan, Ph.D.

Research Scientist
Ochsner Health System

Dr. Feehan is an early stage investigator who received her BS and PhD in Neuroscience from The Brain Institute at Tulane University in New Orleans. She has conducted research in humans and rodents covering topics ranging from drug development of novel endomorphin analogs for pain, to sleep and circadian rhythms research and most recently the gut-brain axis and infectious disease. Her doctoral work led to two patents for a compound that reverses both acute and chronic pain with no observable risk of addiction. She currently works as a research scientist in the Infectious Disease department at Ochsner in New Orleans designing and executing investigator-initiated clinical trials.