Home Archives for james.runkle@drummondst.com

Author: james.runkle@drummondst.com

Microbiome – An Overview

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

The microbiome research has been expanded over the last decade with extensive research published in many fields – including dermatology, oncology, neurology – where some light has being shed on how the microbiome could be beneficial for our health rather than just being detrimental as long believed (1–3).

The microbiome represents the genome of microbiota or microorganisms such as bacteria, yeast, fungi, viruses, mites… that live within us. A recent evaluation estimated the total number of bacteria inhabiting the human body being close to 40 trillion for 30 trillion of human cells, which at the skin level represents 55 billion of bacteria per square meter (4). With these numbers, it is quite hard to imagine that it took us so long to get interested in these little organisms!

But why is the fascination just starting now?

Microbiome research got a kick start about 10 years ago, when the NIH funded a large program aiming to characterize the human microbiome and to understand how it could influence human health. While long being investigated for environment-related applications, the Human Microbiome Project (HMP) helped unravel fundamental characteristics of the microbiome in several organs including the skin (5).

While defining the microbial landscape of our skin, mouth, lungs or intestine, researches highlighted that the microorganisms that live within us are quite unique to one individual even if they can be generally defined as communities found in all human beings (6). What makes everyone’s microbiota so special comes from one’s history: from the way we were born, to the very first exposures to environmental factors, the lifestyle, the medical history. A baby born by natural delivery will have a much richer skin microbiota than a baby born by C-section, who will not be exposed to its mother vaginal microbiota (7). It is even suggested now that microbiota develops in utero (8). Early exposure to antibiotics will have devastating effects on the microbiota community richness and favor what is called scientifically “dysbiosis”, meaning a disequilibrium in the microorganism population with generally one group of microorganisms overpopulating the others. The lifestyle including diet, sleep, smoke habits will favor some microorganisms over others by providing their preferred food source or creating physicochemical conditions that would favor their growth. In addition to these external factors, the host’s genetical background will influence the microorganisms it welcomes, by the physical and chemical environment it provides (9).

The skin microbiome will develop and organize itself as we grow and become site specific with oily, dry and moist areas bearing their own set of microorganisms (10). The same way the host influences the composition of its microbiome, it has been shown that the microbiome influences the host’s well-being. During development, skin commensals (bacteria naturally living on our skin) will instruct our immune system to develop tolerance toward them, while fighting foreign bacteria or pathogens (11–13). The skin microbiota has also been linked to a stronger skin barrier function, with studies showing that skin lacking a microbiome was weaker and could not respond to external assaults as well as a microorganism-populated skin, because it missed some essential structural components (14,15).

When looking at the relationship between the microbiome and diseases of the skin, studies have shown how a dysregulated microbiome can impact and contribute to conditions such as eczema or acne (9). In both pathologies, it appears that one specific specie becomes pathogenic and overcomes all the other microorganisms, starting to trigger skin damage, including uncontrolled inflammation. How such an event can happen is still unclear, but some argue that bacteria can either acquire virulent features by serial mutations or horizontal gene transfer (thanks to an inactive CRISPR/Cas locus) or express virulent toxins and enzymes by the activation of the quorum sensing (a system regulated by population density and enabling bacteria to sense and communicate with their environment through signal molecules) (13,16).

Because of the control the microbiome can have over skin integrity and health, new therapies are emerging to try restoring a lost balance in the microbiome. Different strategies have been proposed with some already being used in clinical trials in the dermatology field. Some researchers are using either commensal bacteria able to inhibit or kill the pathogen (and using what is called quorum quenching – inhibition of the quorum sensing); or bacteriophages (viruses that infect and can kill bacteria) (17,18). Some therapies are also trying to replace the lost bacterial communities by transferring the skin microbiota of healthy individuals (microbiota transplants) (19,20).

But the enthusiasm about skin microbiome research has not been only restricted to the dermatology field, it has also gained traction in the personal care industry, which aims to improve or maintain one’s microbiome as a part of a healthy skin routine. That said, even if health benefits of the microbiome are becoming quite striking, it is still hard to materialize this thought at the consumer level. However, the personal care industry is working its way through by notably taking advantage of all the work that has been done by the food industry. Nowadays, more and more brands (from indie to well established brands) provide products containing food sources for health associated bacteria such as prebiotics and bacteria lysates or ferment extracts – as we can assume that the metabolism of commensal bacteria provides molecules contributing to skin health (21). Unfortunately, the latter two are often improperly labeled as “probiotics” to help the consumer understand the product. Beyond the technical challenges that represent working with real probiotics, i.e. live microorganisms, we have to keep in mind that the consumer might simply not be ready yet to apply consciously live microorganisms on its skin.

Nevertheless, it is with joint effort and by promoting clear information and education, that this paradigm will change. We are fortunate enough to live in this new exciting technological era enabling us to dive even deeper in our understanding of the microbiome and in the development of appropriate microbiome-related products.

 

References:

  1. Chen J, Douglass J, Prasath V, Neace M, Atrchian S, Manjili MH, et al. The microbiome and breast cancer: a review. Breast Cancer Res Treat. 2019 Dec;178(3):493–6.
  2. Mohajeri MH, Brummer RJM, Rastall RA, Weersma RK, Harmsen HJM, Faas M, et al. The role of the microbiome for human health: from basic science to clinical applications. Eur J Nutr. 2018 May;57(Suppl 1):1–14.
  3. Byrd AL, Belkaid Y, Segre JA. The human skin microbiome. Nat Rev Microbiol. 2018;16(3):143–55.
  4. Sender R, Fuchs S, Milo R. Revised Estimates for the Number of Human and Bacteria Cells in the Body. PLoS Biol. 2016 Aug;14(8).
  5. Human Microbiome Project – Overview. Available from: https://commonfund.nih.gov/hmp/overview
  6. Lloyd-Price J, Abu-Ali G, Huttenhower C. The healthy human microbiome. Genome Med. 2016 27;8(1):51.
  7. Dominguez-Bello MG, De Jesus-Laboy KM, Shen N, Cox LM, Amir A, Gonzalez A, et al. Partial restoration of the microbiota of cesarean-born infants via vaginal microbial transfer. Nat Med. 2016 Mar;22(3):250–3.
  8. Walker RW, Clemente JC, Peter I, Loos RJF. The prenatal gut microbiome: are we colonized with bacteria in utero? Pediatr Obes. 2017;12 Suppl 1:3–17.
  9. Dréno B, Araviiskaia E, Berardesca E, Gontijo G, Sanchez Viera M, Xiang LF, et al. Microbiome in healthy skin, update for dermatologists. J Eur Acad Dermatol Venereol JEADV. 2016 Dec;30(12):2038–47.
  10. Kong HH. Skin microbiome: genomics-based insights into the diversity and role of skin microbes. Trends Mol Med. 2011 Jun;17(6):320–8.
  11. Naik S, Bouladoux N, Wilhelm C, Molloy MJ, Salcedo R, Kastenmuller W, et al. Compartmentalized control of skin immunity by resident commensals. Science. 2012 Aug 31;337(6098):1115–9.
  12. Naik S, Bouladoux N, Linehan JL, Han S-J, Harrison OJ, Wilhelm C, et al. Commensal–dendritic-cell interaction specifies a unique protective skin immune signature. Nature. 2015 Apr 2;520(7545):104–8.
  13. Parlet CP, Brown MM, Horswill AR. Commensal Staphylococci Influence Staphylococcus aureus Skin Colonization and Disease. Trends Microbiol. 2019 Jun;27(6):497–507.
  14. Meisel JS, Sfyroera G, Bartow-McKenney C, Gimblet C, Bugayev J, Horwinski J, et al. Commensal microbiota modulate gene expression in the skin. Microbiome. 2018 30;6(1):20.
  15. Chen YE, Fischbach MA, Belkaid Y. Skin microbiota-host interactions. Nature. 2018 24;553(7689):427–36.
  16. Horvath P, Barrangou R. CRISPR/Cas, the immune system of bacteria and archaea. Science. 2010 Jan 8;327(5962):167–70.
  17. Williams MR, Costa SK, Zaramela LS, Khalil S, Todd DA, Winter HL, et al. Quorum sensing between bacterial species on the skin protects against epidermal injury in atopic dermatitis. Sci Transl Med. 2019 May 1;11(490).
  18. Castillo DE, Nanda S, Keri JE. Propionibacterium (Cutibacterium) acnes Bacteriophage Therapy in Acne: Current Evidence and Future Perspectives. Dermatol Ther. 2019 Mar;9(1):19–31.
  19. Perin B, Addetia A, Qin X. Transfer of skin microbiota between two dissimilar autologous microenvironments: A pilot study. PloS One. 2019;14(12):e0226857.
  20. Hendricks AJ, Mills BW, Shi VY. Skin bacterial transplant in atopic dermatitis: Knowns, unknowns and emerging trends. J Dermatol Sci. 2019 Aug;95(2):56–61.
  21. 35 Microbiome Skincare Products. TrendHunter.com. Available from: https://www.trendhunter.com/slideshow/microbiome-skincare

Mini-biography:

Dr. Carine Mainzer joined Silab in 2016 as a Scientific Support Manager. Before joining Silab, Dr. Carine Mainzer was a postdoctoral scholar in the Department of Dermatology at University of California San Francisco under the supervision of Dr. Peter Elias and Dr. Yoshikazu Uchida, where her work focused on the communication between inflammatory cells and cutaneous cells under bacterial challenges. She obtained her Ph.D. from the University of Lyon (France) in 2014 with work focused on the involvement of the Insulin-like growth factor (IGF)-1 on epidermal differentiation and aging. Dr. Carine Mainzer has been within the cosmetic industry since several years now, working notably with Johnson & Johnson Consumer France, Natura and Silab. Her current position offers her the opportunity to continue applying her scientific expertise to the research problematics of the cosmetic industry in various domain around skin.

The facts you need to know: new FDA proposed Sunscreen Regulation

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Sunscreen Innovation Act

The Sunscreen Innovation Act sponsored by Jack Reed was introduced to the Senate Committee Health, Education, Labor and Pensions on March 13, 2014.  It amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.

FDA Proposes New Safety Testing for Selected Sun Filters

On February 26, 2019 the FDA published a proposed rule that would put into effect a final monograph for non-prescription OTC sunscreen drug products.  It establishes conditions under which certain OTC drugs may be marketed without approved new drug applications, indicating these products would be Generally Recognized as Safe and Effective (GRASE).  The sun care industry was hopeful that data previously submitted to the FDA would lead to the approval of additional sun filters currently used in Europe, under the FDA time and extent rule (TEA) policy.

Significance of the Proposed Safety Testing Protocol

To establish safety in use of sunscreen products, the FDA is proposing a Maximal Usage Trial study (MUsT). This is a human pharmacokinetic test that measures the amount of absorption of a drug into the body.  This study is new to the cosmetics industry and is more commonly used to study absorption of prescription drugs into the body.  The FDA believes this study will help to determine the potential effect of long-term use of an active ingredient.

 


Bio for Howard Epstein, Ph.D.

Howard Epstein is Director of Technical Services for EMD Performance Materials Corporation, Philadelphia, PA., an affiliate of Merck KGaA, Darmstadt, Germany. He was a scholar in residence at the University of Cincinnati department of dermatology and received his Ph.D. in Pharmacognasy from the Union Institute & University in Cincinnati, Ohio during that time. He has been in the cosmetics industry for many years since he began his career formulating cosmetics for Estee Lauder, Maybelline, Max Factor, Bausch & Lomb and Kao Brands. In addition to his interest in botanicals Howard previously served as editor of the Journal of the Society of Cosmetic Science and is a member of the International Academy of Dermatology. He is on the editorial board of the dermatological journals Clinics in
Dermatology and SKINmed representing the cosmetics industry to dermatologists.

Howard has authored chapters in various cosmetic technology textbooks including various chapters in Harry’s Cosmeticology, and holds eight patents and two patent applications.

Clinical Study Dos and Don’ts: Designing Safety & Claim Support Studies

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Clinical Study Dos and Don’ts:  Designing Safety & Claim Support Studies

Nothing makes an R&D director happier than providing a validated sound scientific dossier to his/her marketing team on a technology or formulation that has gone through months, if not years, of development.  From inception to market, there are endless meetings about progress, budgets, resource allocation and most of all, data generation.   When you think about all of the time and energy you have spent on this one aspect of your pipeline, validating your work becomes paramount so that it is universally accepted by not only the market place but by your management and investors as well. Ironically, this is the most crucial and usually the most expensive point of the project as a whole.  What can you do to ensure that you are efficient in your success?

In order to properly validate your mechanism of action and support your claims, an outside lab is usually brought into the fray for good reason: you want an objective 3rd party verification of all you have done to this point.   This will entail having all of your project management skills ready to go. This is akin to getting to the championship game in your favorite sport.  The whole season now rides on how well you do in the next game or series.  How do you position yourself for success?  Below you will find some do’s and don’ts that I have been faced with, both as a client and as a provider of clinical testing for personal care and cosmetic products.

Are you Ready to Test?

From the service side of the industry, I find that many clients come to the table thinking they are ready to test with a 3rd party laboratory. However, after the first meeting is over, they are usually going home with a to-do list longer than the questions they had for me.  So, ask yourself, are we ready to test?  No matter your title or level of responsibility, you must build a team to answer this question.  Having a team in place that represents all facets of the project, including where you have been and where you are going is the first step.  Understanding how you landed on the functional claims, category and target consumer/customer are going to lay the foundation of what type of 3rd party lab you will need and what type of study design is warranted, as not all testing labs are created equal.  All of your team members must bring their information and needs to the table to answer that question before you pick up the phone and ask for 3rd party commitment.  Have a timeline built and map out the approval process commensurate with your company’s policies.  There are some companies that inherently have more red tape than others.  Know and understand your internal process before bringing in outside counsel.  This will certainly convey confidence and keep you in the driver’s seat.

Represent your Stake Holders

Having a good mix of representation on your team of R&D, marketing, operations, regulatory and sales personnel, especially in the initial meetings with a 3rd party laboratory, will ensure that everyone’s needs are accounted for and visible.  This will also make for a much smoother utilization of data when it comes time to launch.  Some of the best launches are the result of this synergy alone.

Communication

Gathering, moving and analyzing information is the norm in today’s market place and is critical for success.  It is imperative that the team you build have an open channel of communication within its team members and the lab when necessary.  As the team leader/project champion, you must know who your go-to people are.   There are often cases of misplaced assumptions regarding who knows what, and who is responsible for deliverables and decisions.  Many times I work with a project team looking to perform validation studies only to find that delays are imposed from executing as planned because the test materials are not available or not delivered on time to the testing facility.  There are many reasons for this.  Some examples include delays in release from QA, test materials that have not passed physical or chemical stability, last minute changes to the formulation design and for our international clients, test materials getting stuck in customs at the border.  All of these issues can be mitigated with proper channels of information being open.  If one person is the gate keeper of all the information, that person needs to have access to all facets of the project and to includes information that the team members possess.  Establishing portals for information sharing especially when collaborations exist over multiple time zones is something to also consider. At the end of the day, proper, concise and efficient communication is paramount to keeping all stakeholders informed and abreast of the status of your project.

Understand your Goals

Have a holistic view of the expectations and goals.  I always say to prospective clients, “work your project backwards”.  Assuming that you get the best data possible, what will you say about it?  Understanding the end game allows everyone to see the goal in the detail that is needed.  Having a vague undefined goal is grounds for confusion, uncertainty and delays to market.  Having the goal in mind is also crucial for developing the protocol to get you to the desired objective.  One of the most common delays and unpredicted expenses companies incur are due to last minute protocol changes.  These cause delays in final approvals, delays in recruiting the required subjects, and ultimately delays in study execution at the 3rd party lab. There is a high risk for decisions being made before final protocols are signed by not having your team review the protocols early on. This can lead to re-works, delays and loss of access to resources, equipment and personnel needed to perform the study.

Know your Financial Limitations

Budget, budget, budget, how many times have we all heard, “we can’t do that, it’s too expensive”?  Have a deliberate budget in mind when you are ready to validate claims.  You can start off shooting for the stars but inevitably, you land back on earth holding your budget in hand saying, “we need a new plan”.  Match your needs within your budget.  So many clients come to me with a beautiful study design only to realize that it is light years beyond what they budgeted for.  Factors that drive price in any clinical study are of course the time and resources allocated by the lab; however, there are study design oversights that drive up study costs significantly.  Having time points that can be managed Monday through Friday and within a regular work day reduces overtime commitment by the lab.  Choosing technicians (or expert graders) to perform evaluations other rather than MD’s (where appropriate) is another way to save money.  IRB cost, interim data requests, expedited reports and last minute changes to the schedule once protocols are signed are huge drivers of cost, and many of these can be avoided with proper planning and good team building.

Focus on what you want to Achieve

Validation of claims or target mechanism of action is in the eyes of the beholder.  Keep in mind, in the personal care industry, consumer perception trumps all.  If your technology/finished product does not deliver on consumer perceivable results, you most likely will not get a return customer and the market will quickly lose interest in your product.  The good news is, consumer use studies are not that expensive.  Know your consumer base, ask the right questions and provide the best use instructions possible.  Many clients like to marry consumer use data with objective instrumental measures and/or expert grading.  This is the trifecta of clinical study success.  If you can show agreement with consumer perception, instrumental measures and expert assessment, you have a solid foundation for a bullet proof marketing campaign.

Understand your Consumer

Consider the consumer experience when designing your study.  Have you prepared use instructions that best represent how the product will be used?  Do you have a mechanism in place to understand off indication used of your product?  Factoring in these questions is critical to reduce the variation in consumer generated data.  People in general are variable in their recollection of experiences.  Having a way to reduce this through easy to read, easy to understand, and simple use instructions makes for a happy experience.  Consumers/subjects evaluating a product will, when asked, provide valuable negative feedback as well.  Ask for it, don’t wait for it.  It’s better to understand the short comings of using your product before it hits the market.  Is your product providing comfort and ease of use?  If so, it will be viewed in a better light.  Ask for diary comments, proof of use, have a hot line into the testing company for adverse event reporting.  All of these provide subjects on your study with a positive experience which will ultimately be reflected in your data on product performance.

Translate your Science and Check Regulatory Requirements

Marketing should play an integral role as a co-champion of the validation process.  They should be able to translate the science to consumer language which in turn should be converted to questions used for consumer perception studies.  Marketing should also understand what the competition in their particular category is saying about similar products.  3rd party labs do not make marketing claims; they provide data to support them.  Your marketing team should also have a hot line to a regulatory expert in the geographic regions of where you plan to sell your product.  So much for world harmonization, the individual regulatory requirements worldwide are ever growing further apart and complex.  Don’t spend your valuable time and resources developing a technology only to find out you can’t sell it in your target region because of regulatory hurdles, restrictions on trade, and/or miss alignment with what is culturally acceptable.

Know your Data

Finally, what to do with your data?  Chances are, you may be in charge of getting a 3rd party laboratory to perform some validation or claim support studies but you don’t remember the first thing about statistics.  Your report comes back from the lab with P values and Z scores.  Paragraphs about significant and non-significant data along with ANOVA analysis….YIKES!, what does all of this mean?

Did you set up the study to have the data be understandable or are you counting on one of your science team members to make sense of it all?  Is the data audited?  So many times as a client, I have asked for the raw data to review and “crunch” myself to better understand the relationships.  On the flip side, as a testing lab, I have had clients spend significant time and money on a study and not know what their data means or how to apply it back to the original objective of the study.

Final Remarks

No matter how you get to your goal, always keep in mind the fundamentals.  They are so easy to take for granted and in retrospect, the lack of attention to the fundamentals is the very reason why projects don’t go as planned.  So, build an effective and comprehensive team, know your budget limitation upfront, manage information in and out of the team efficiently, understand the expectations and stick to the plan. Understand the needs of your customers and translate the data in a way they understand.  Last but not least, know your market and consumer front to back and translate data so that they both understand it to the point at which they come back for more.

 

Author’s Biography:

Michael Anthonavage is the current VP of Operations and Technology at Eurofins CRL Cosmetic Testing. Michael has 20+ years of experience in personal care product development and a career spanning background in skin biology and models and methods development. He specializes in R&D to marketing translation and claims validation, both in vitro and in vivo. Michael is an engaging public speaker and product technology advocate with an ability to marry complex ideas and concepts to various consumer needs; he is also an educator in the area of herbal studies, instructing students in the study of plant chemistry and their impact on human physiology.  Michael has a number publications and patents to his name and continues to be an influential speaker in personal care, bioinstrumentation and skin testing.

 

 

New York Society of Cosmetic Chemists (NYSCC) Announces 2020 Executive Board

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Leaders Representing Prominent Brands, Suppliers & Manufacturers will Chart the Future Course!

 

(New York, NY, November 2019) – The announcement was made by Sonia Dawson, Chair, NYSCC and Regional Marketing Manager -DSM Personal Care North America, that the Executive Board has been confirmed for 2020 with some current board members assuming new roles, and newly elected members joining in roles that will carry through to 2021.  The 2020 Executive Board includes:

Giorgino “Gino” Macalino, Chair
Manager, Makeup Innovation, The Estée Lauder Companies

Sonia Dawson, Advisor/Past-Chair
Regional Marketing Manager, DSM Personal Care North America

Susanna Fernandes, Chair-Elect
Lead E-Sales Executive, TRI-K

Stephen Carter, Treasurer
Business Manager, Jarchem Innovative Ingredients

Mohamed Abdulla, Treasurer-Elect
Account Manager, SEPPIC

Leor Fay Tal, Secretary
Technical Marketing Leader, Gattefossé USA

“I am excited to get down to business and keep building on what my predecessors have done over these past few years,” said Gino Macalino. “Our educational programs anchored by Suppliers’ Day in NYC continue to dominate the landscape of North America.  We are eager to keep the SCC brand flourishing across our region, North America and across the globe!”

With the support of the newly-elected board, 2020 programming is already in place and will embody the  theme of “Revolutionary Disruptors.”  Programs will focus on elements and sectors of cosmetic/personal care product development that are literally changing the traditional landscape.  In addition, NYSCC Show Management has implemented strategies, programs and partnerships for Suppliers’ Day taking place May 5-6, 2020 at the Jacob K. Javits Convention Center.  NYSCC and Suppliers’ Day will continue to have a presence at SCC and industry events across the nation and around the world with the aim of continuing to strengthen the NYC event’s position as the dominant North American tradeshow.

NYSCC Suppliers’ Day 2020 Announces Show Theme & New Programs

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Revolutionary Disruptors Frame the Leading Trade Show & Conference for Innovations in Beauty and Personal Care Ingredients, Raw Materials and Formulations  

(New York, NY, November 2019)—North America’s main event for beauty ingredients, formulations, and delivery innovations, New York Society of Cosmetic Chemists (NYSCC) Suppliers’ Day, recently held a press and friends reception in New York City at Casellula to announce its show theme and new educational programming.  The 41st Annual Suppliers’ Day will take place May 5-6, 2020, at the Jacob K. Javits Convention Center in New York, NY.

At the reception, Giorgino “Gino” Macalino, NYSCC Chair Elect, announced the  theme for Suppliers’ Day 2020: Revolutionary Disruptors”.   Macalino stated, “New educational programs, returning popular content as well as show floor experiences will illustrate how revolutionary disruptors are impacting the traditional way of sourcing and the entire product development cycle.  These disruptors impact what consumers want, as well the companies that manufacturer them.”

Suppliers Day 2020 will also have a full day conference program on one of the beauty industry’s trendiest disruptors, Cannabis, featuring speakers covering sourcing, formulating, testing, branding and distributing as well as legal and regulatory updates.       The latest innovations in the Indie market will be featured in a targeted program featuring an experiential component that will include many of the supplier accelerators on the show floor.

Another trend that Is disrupting product development Mindfulness/Wellness, will be explored in a session highlighting why this is driving consumer purchasing.  Mindfulness/Wellness will also be evident in show floor activations and showcased in the Suppliers’ Day 2020 INNOVATIONS HUB.

Disruptors will be highlighted in Suppliers’ Day core programs, including Digital Age of Beauty, World of Chemistry, Discover Sustainability as well as included in new tracks focusing on color cosmetics, hair care, and healthy aging.

NYSCC Suppliers’ Day also announced it will continue working with other industry-empowering organizations that are committed to helping the beauty and personal care industry innovate and grow including ICMAD, IFSCC, PCPC, and market analyst firms such as Kline, Spate and Mintel.

NYSCC will again partner with CEW on its Supplier’s Award: Ingredients and Formulation, recognizing the role of formulation and ingredients in creating standout products for consumers. The winner will be announced at Suppliers’ Day and then celebrated at the prestigious CEW Beauty Awards luncheon the following week.

The Future Chemists Workshop will be back at Suppliers’ Day 2020.  This “live lab” experience on the exhibit floor is popular with students and will include a wider net  of participating schools, as well as a challenge that will allow winning students to be rewarded; details to be announced shortly.

“Revolutionary Disruptors will take Suppliers’ Day to the next level and provide attendees with relevant content and immersive experiences that will advance their product development and formulations,” said Macalino.

Sunscreen Monograph Proposed New Rules and its Impact on Formulations-Part II

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

In my recent blog published in August, changes to the current sunscreen tentative monograph were proposed.  These changes are probably the most drastic changes to the sunscreen monograph since its inception.  In this section, I would like to tackle two key areas related to the changes requested by the FDA.  The first one is the human pharmacokinetics Maximal Usage Trial (MUsT) for sunscreens conducted by the FDA and published in the Journal of the American Medical Association in May 2019.  The second is the response from the Personal Care Product Council (PCPC) to the requests from the FDA for additional safety data.

The FDA conducted a MUsT trial on 4 sunscreen formulations.  The products consisted of 2 sprays, one lotion and one cream. A detailed description of the products used in the study and the sunscreens concentrations used is displayed in Table I below.

Table I

Concentrations of sunscreens in all treatments

Treatment Percent sunscreen contents per label
Avobenzone Oxybenzone Octocrylene Ecamsule
Spray 1 3.00 6.00 2.35 0.00
Spray 2 3.00 5.00 10.00 0.00
Lotion 3.00 4.00 6.00 0.00
Cream 2.00 0.00 10.00 2.00

Twenty-four subjects were enrolled in the study and were randomized into 4 groups.  Each treatment was studied on 6 individuals. All subjects finished the study except one.  Products were applied at a rate of 2 mg/cm2 on 75% of the body area.  Products were applied by a trained expert and were re-applied every 2 hours four times a day.  The study ran for 4 days and panelists were kept indoors.  Thirty blood samples were collected from each panelist over a period of 7 days and were analyzed for their concentration of sunscreens using a validated HPLC method.

Mean maximum plasma concentrations for all sunscreens were calculated for the four treatments and are displayed in Table II.

Table II

Geometric mean maximum plasma concentration for all treatments

Treatment Geometric Mean Maximum plasma concentration, ng/mL (%CV)
Avobenzone Oxybenzone Octocrylene Ecamsule
Spray 1 4.0 (60.9) 209.6 (66.8) 2.9 (102) Not applicable
Spray 2 3.4 (77.3) 194.9 (52.4) 7.8 (113.3) Not applicable
Lotion 4.3 (46.1) 169.3 (44.5) 5.7 (66.3) Not applicable
Cream 1.8 (32.1) Not applicable 5.7 (47.1) 1.5 (166.1)

As seen from the table, all sunscreens tested had higher blood levels than the FDA proposed threshold of 0.5 ng/mL.  These levels were also achieved on the first day of treatment.  The levels obtained triggered the FDA to request safety data not only on the sunscreens studied but also on the 12 sunscreens listed in the monograph.  In addition, the FDA requested MUsT studies to be conducted by the manufacturers on several dosage forms to establish proper guidelines for usage based on safety and efficacy.  Regardless of the results obtained, the FDA insisted on the fact that individuals should not refrain from using sunscreens.

In response to the request from the FDA, the PCPC sent a letter to describe the protocols and studies suggested by the council as well as a timeline.  The PCPC suggested to conduct, in addition to MUsT studies, several surveys on usage of sunscreen products to guide the council in designing the MUsT studies.  The timeline extends till 2023 which should give the industry some breathing room in terms of formulations.  Once the studies are received and completed, an additional timeline delineating the safety of the selected molecules will be proposed.  In the council’s response, two sunscreens were not considered for MUsT studies.  These are Cinoxate and Dioxybenzone.  The fate of these two sunscreens is not determined at this stage yet.

The sunscreen monograph has been evolving for the past 35 years to keep up with the advancement in science.  Formulators, and companies in the field of sun care will have to adjust one more time to the changes.  These changes bring a lot of new challenges and opportunities to innovate and lead.


 

Biography

Dr. Fares started his career in personal care studying the effect of solvents on sunscreen chemicals.  His interest in skin drug delivery especially from polymeric matrices grew during his graduate work at Rutgers, where he completed his Ph. D. in Pharmaceutics.

Dr. Fares worked at Block Drug and GlaxoSmithKline where he held positions in research and development in the areas of skincare and oral care.  After that, he joined L’Oreal where he held several positions of increasing responsibility leading to AVP of skincare.  He is currently the Senior Director of skincare and oral care at Ashland Specialty Ingredients.  Dr. Fares is the author of many publications, and patents and made many presentations in national and international meetings in the areas of suncare, skincare, and oral care.

 

Natural and Clean Cosmetics – The Science Behind the Ingredients

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

In recent years we have seen in the cosmetic market an increase of simplified products with fewer ingredients.

The marketing message of these products is often linked to the ingredients sourcing, functionality, and safety (including the absence of the so called no-no ingredients). Labeled as clean beauty products, they often rely on natural ingredients that, due to the identification of natural with recognized by the human body, biodegradable, and often used in traditional medicine, they easily fit into the concept of safety (and carry a nice story on sourcing). But what about efficacy? Is it possible today to develop clean beauty products, carrying the purest and most ethical sourced natural ingredients, and prove their efficacy with Science? Technology and science is available today for both developing the natural extracts and for testing them, therefore increasing their safety and efficacy while maintaining their positive image of clean, pure, eco-friendly, safe and sustainably sourced. Technologies derived from the pharma and the imaging industries are available at affordable cost and flexibility. Genomics, proteomics and metabolomics analysis are now offered to the cosmetic scientist1 as well as machines able to qualify and quantify skin characteristics in a non-invasive way. In other words, it is finally possible to verify the scientific edge and efficacy of any natural and natural derived ingredient.

Raw materials – Minimal Processing

Raw materials sourcing from sustainable supply chain are often linked to:

– Biological agriculture

– Sustainable harvesting form the wild

These raw materials seem to emerge in the food supply chain first. Initial markets are in the country of origin on a micro-scale (local green markets), following a macro-scale and industrialization step (larger distribution in retail space). Often commercialized at a continent level, they are eventually “discovered” in other continents and growing according to their commercial and marketing appeal.

Example – Pomegranate Seed Oil

Pomegranate is sourced through a sustainable model and cold pressed oil is produced. Due to its unique and elevated level of omega-5 (conjugated linolenic acid, punicic acid) (Table 1),  the oil is a strong anti-oxidant, showing protection from UV-induced protein oxidation (carbonylation) and DNA damage.2


Table 1. Omegas Fatty Acids and Vitamin E Composition of Pomegranate Seed Oil

Further research highlighted the oil’s soothing properties such as inhibition of inflammatory mediator lipoxygenase;3 but also its regenerating characteristics, like the stimulation of keratinocytes growth.4

Raw Material – Extraction and Transformation in an Active Ingredient

Raw materials are often transformed into active ingredients for personal care applications. Specific extraction by using biodegradable and natural solvents produces ingredients with specific physical-chemical characteristics and solubility for different cosmetic applications. Once ingredients are validated based on stability assays and scaled up, they can be tested for safety and efficacy in different models (in vitro, ex vivo, and clinical – non animal).

Example – Fucoidan from Seaweed

Seaweeds are rich in phenols derivatives and polysaccharides with protecting activity.5,6 Brown seaweeds also contain a compound called fucoidan that assists with protection from marine pathogens.  Fucoidan is a fucose-rich polysaccharide with anti -viral, immune modulating and matrix metalloprotease inhibiting properties.7 By isolating fucoidan from seaweeds, the formulator can use smaller concentrations of the extract. These lower levels reduce the risk of incompatibilities and material setting, color issues and scent, improving overall stability.8 Recent research highlighted the scientific added value of fucoidan as skin soothing and skin regenerating agent (reduction of Trans Epidermal Water Loss, decreased wrinkle’s depth, increase elasticity, reduction of proteases) (Figure 1).9

Figure 1. Seaweed Extract rich in Fucoidan inhibits proteases and tyrosinase (from Fitton JH et al.9)

Conclusion

Natural and Clean Beauty Products contain natural ingredients communicated through ethical sourcing and safety. Scientific tools allow to analyze and test these ingredients for efficacy, therefore helping to select the right ingredient concentration to add to the finished product for optimal functionality. Natural and Clean Beauty Brands need to start validate their ingredients efficacy through real scientific testing and/or select their suppliers based on how scientific is their ingredient offer. Natural ingredients can step up for efficacy once good science is performed to validate their benefits for cosmetic applications. There is a clear need in the market for more science and more credible claims and we can provide them both helping consumers properly chose the cosmetics they need.

References

  1. Rai A, Saito K, Yamazaki M. Integrated omics analysis of specialized metabolism in medicinal plants. Plant J 90(4):764-787, 2017
  2. Afaq F, Zaid MA, Khan N, Dreher M, Mukhtar H. Protective effect of pomegranate-derived products on UVB-mediated damage in human reconstituted skin. Exp Dermatol 18(6):553-561, 2009
  3. Schubert SY, Lansky EP, Neeman I. Antioxidant and eicosanoid enzyme inhibition properties of pomegranate seed oil and fermented juice flavonoids. J Ethnopharmacol 66(1):11-17, 1999
  4. Aslam MN, Lansky EP, Varani J. Pomegranate as a cosmeceutical source: pomegranate fractions promote proliferation and procollagen synthesis and inhibit matrix metalloproteinase-1 production in human skin cells. J Ethnopharmacol 103(3):311-318, 2006
  5. Fernando IP, Kim M, Son KT, Jeong Y, Jeon YJ. Antioxidant activity of marine algal polyphenolic compounds: a mechanistic approach. J Med Food 19(7):615-628, 2016
  6. de Jesus Raposo MF, de Morais AM, de Morais RM. Marine polysaccharides from algae with potential biomedical applications. Mar Drugs 13(5):2967-3028, 2015
  7. Fitton JH, Stringer DN, Karpiniec SS. Therapies from fucoidan: an update. Mar Drugs 13(9):5920-5946, 2015
  8. Dell’Acqua G. Sustainable ingredient science: brown algae. Cosmet Toil 128(4): 226-229, 2013
  9. Fitton JH, Dell’Acqua G, Gardiner VA, Karpiniec SK, Stringer DN, Davis E. Topical benefits of two Fucoidan-rich extracts from marine macroalgae. Cosmetics 2(2): 66-81, 2015

 

Giorgio Dell’Acqua, PhD, is a cosmetic scientist and a consultant for the personal care industry. A graduate from the University of Rome, Italy, Dr Dell’Acqua worked for 15 years as an investigator in applied medical research in different Research Institutes and Universities, including Mount Sinai Medical School in New York and Harvard Medical School in Boston. Moving to the private sector in 2000, he has spent the last 20 years as an executive and cosmetic scientist in the personal care industry. He is specialized in skin and hair care ingredients, finished product development and technical marketing. He has helped bring more than 200 successful active ingredients and finished products to market and has authored more than 70 publications in medicine and cosmetic science. From last 10 years he has been writing and lecturing on natural cosmetic ingredients, sustainable supply chain, and helped sourcing, developing and bringing to market many natural ingredients. He is an award winning speaker on natural ingredients and a regular writer on sustainability and cosmetic science. He is also the chair of the Scientific Committee for the New York Society of Cosmetic Chemists and its scientific blogger.

 

 

 

NYSCC Suppliers’ Day Showcases Evolution & Innovation

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Record-breaking Attendance, Enhanced Programming, & Expanded Exhibit Floor Highlighted 40th Anniversary Celebration

(New York, NY, June 2019)—The New York Society of Cosmetic Chemists (NYSCC)  40th Annual Suppliers’ Day came to a successful conclusion last week, May 7-8, at the Jacob K. Javits Convention Center in New York. Showcasing thousands of ingredients and raw materials on an expanded expo floor that housed nearly 100,000 net square feet of exhibits while attracting 9,981 registrants, representing 64 countries, Suppliers’ Day 2019 enjoyed a 5% increase in overall attendance – more than 25% increase since its move to NYC in 2017.

“Nearly three dozen education, association, and media partnerships continue to fuel our buyer expansion at Suppliers’ Day. Our enhanced and innovative programs with CEW, ICMAD, PCPC, ASP, and IKW provided us with a strong voice into every element of product development and resonated with attendees” said Sonia Dawson, Chair of NYSCC.

The increase in attendance and new programs at Suppliers’ Day was also praised by exhibitors. “Participating in Suppliers’ Day gives Dupont great exposure in the US market. Beauty is a full experience with the consumer always in the forefront of our developers’ minds and we are proud to be part of  “The Evolution of Beauty!” said Pierra Pericu, Market Leader, Dupont.

In addition to an exhibit floor that featured nearly 550 exhibiting companies including 107 new exhibitors, Suppliers’ Day also boasted standing-room only Presentation Theater sessions that included tracks focused on sustainability and sub-zero waste (Discover Sustainability) and the global beauty marketplace (The World of Chemistry).  Kicking off the show was a ribbon-cutting ceremony that featured past chairs, present committee members and industry partners that have been integral in the 40 years of Suppliers’ Days and are key contributors to the evolution of beauty.

The Future Chemists Workshop hosted dozens of college students from Rutgers, Fairleigh Dickinson University, Kean University, Long Island University, University of Miami Health Systems, Montclair State University, Fashion Institute of Technology,  and  The University of Toledo, who competed in mini-challenges for the best formulation.  The NYSCC Mentoring Program was also launched during Suppliers’ Day with members connecting and collaborating with mentees looking to enhanced their professional development and career in cosmetic chemistry.

The Digital Age of Beauty returned with presentations on trends, blockchain and big data; and featured a presentation by Ariane La Port, Insights Manager, Google.  New programs included Microbiome: Inside Out Beauty; Fragrance: The Invisible Art; as well as Innovation & Compliance brought to the event as a collaboration between PCPC and IKW.  ICMAD’s FDA Regulatory Workshop closed out the week on Thursday with nearly 150 registrants returning to the Javits for this content rich, must-attend conference.

The NYSCC Awards Night event took place on Tuesday, May 7h at Stage 48 and showcased the finalists of the CEW Supplier Award: Ingredients and Formulation, as well as the Judges who represented iconic brands such as Chanel, L’Oreal, bareMinerals, eos Products, and Edgewell Personal Care. KOBO Products, Inc.’s  4 in 1 Multi-Purpose Sunscreen Cream was revealed as the winner and was recognized again at the CEW Beauty Awards Luncheon on Friday, May 17th.

Evolution and the latest product development advancement were the underlying themes of the 2019 event.  The Innovation Hub & Solutions Center sponsored by SPATE, included products making their North American debut at Suppliers’ Day, as well as the CEW Supplier Award finalists.  The Hub was supplemented by an Innovation Theater that not only showcased presentations from the Hub participants, but also hot-button topics such as Beauty/Wellness Trends, CBD, Indie Beauty, and Claims Substantiation.

Plans are already underway for the 2020 NYSCC Suppliers’ Day taking place May 5-6, again at the Javits Center, with 85% of exhibitors already resigned.  “The show floor for Suppliers’ Day 2020 will include the expanded area used for new activations in 2019. NYSCC will also strengthen its industry partnerships and continue to work closely with its members and the SCC to create the best global ingredients event for the industry, by the industry,” said Giorgino Macalino, Chair-Elect, NYSCC. “We are going from evolution to revolution!”

NYSCC Suppliers’ Day Supporting the Next Generation of Chemists

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Future Chemists Workshop and Mentorship Launch at Leading Beauty & Personal Care Trade Show

(New York, NY, May 2019)— New York Society of Cosmetic Chemists (NYSCC) is committed to educating and supporting the workforce of the future and will launch a new Mentorship program and continue its popular Future Chemists Workshop at Suppliers’ Day its flagship event.  Taking place May 7-8, 2019 at the Jacob K. Javits Convention Center in New York, Suppliers’ Day is the largest trade show and conference in North America for innovations in beauty and personal care ingredients, formulations and raw materials.

The NYSCC Mentoring Program, spearheaded by NYSCC’s Eileen Kim, Principal Research Scientist, R&D, at CHANEL will launch on May 8th and is designed to bring seasoned formulation professionals together with students, grad students and junior members of the NYSCC to mentor, offer advice, discuss career paths and more.  At Suppliers’ Day, mentors and invited mentees will meet for a program that includes a coaching session, panel discussion on “Evolution of the Cosmetic Chemist,” a networking lunch for mentors and mentees as well as a framework of the mentorship program moving forward.

In its 3rd year, the popular Future Chemists Workshop (FCW) will, once again, be managed by John Carola, Sales Manager with Protameen, and have its largest and most diverse range of participants with students from sister SCC chapters.  FCW is designed for student innovators and leaders of tomorrow and provides real-time insight on how to be a Cosmetic Chemist through a tutorial and practical workshop which is then turned into a mini-challenge.  FCW is led by Team Captain, Christina Ladouceur-Bishop, Senior Manager for Hair Color Product Development, Coty, Inc., and will take place on May 7th in Hall D –“The Chemists’ Classroom.  Participating colleges and universities include:  Fairleigh Dickinson University, FIT, Kean University, Long Island University, Montclair State University, Rutgers, The University of Toledo, and University of Miami Health System.

Past participants of FCW are now working for leading brands and suppliers in the beauty and personal care industry.

“My favorite part about the SCC Suppliers’ Day was being able to formulate on-site! It seemed like a lot of effort went into setting up all of the equipment for this educational session. Not only did we make a cream, but also had a speaker to teach us emulsion formulation basics.  This event was a great way to build connections with suppliers and I enjoyed learning more about the new, innovative raw materials, said Margaret Gorz, Associate Scientist, The Estée Lauder Companies.

“As a student, I was thankful that the SCC gave me the opportunity to attend and that they place a focus on nurturing young talent within the cosmetic science industry,” she added.

Elizabeth Aquirre, a Chemist at L’Oréal, and past FCW participant said,

“I have learned how to network within the industry and how to communicate more effectively attending events such as the Future Chemist Workshop. It was through these experiences that have helped me gain the confidence I needed to engage in conversations which lead to the employment at my current company, L’Oréal. I am truly thankful to have been a part of the Future Chemist Workshop as it was a place that helped me learn and grow.”

Celebrating its 40th Anniversary, NYSCC Suppliers’ Day will also have educational sessions on “Fragrance: The Invisible Art;” “Microbiome: Inside Out Beauty;” “Innovation & Compliance;” “Discover Sustainability;” “The World of Chemistry;” and “Digital Age of Beauty;” along with the pre-show SCC CEP Courses and the ICMAD FDA Cosmetics Regulation Workshop on Thursday, May 9th.

Specialty areas on the expanded exhibit floor include the Innovation Hub & Theater with the CEW Supplier’s Award finalists speaking and showcasing their nominated ingredients and formulations, Presentation Stage,  a 40 Year Retrospective of “The Evolutions of Beauty,” as well as the Future Chemists Workshop in The Chemists Classroom.

NYSCC Suppliers’ Day Offers New Educational Programming on Fragrance Development and the Microbiome Role in Product Creations

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Leading Global Ingredient Trade Show & Conference for Beauty & Personal Care Takes Place May 7-8 at the Javits Center in NY

(New York, NY, May 2019)—Providing relevant education to chemists and product development teams is the hallmark of the NYSCC Suppliers’ DayFragrance: The Invisible Art and Microbiome: Inside Out Beauty are two new educational programs added to Suppliers’ Day, May 7-8, at the Jacob Javits Convention Center in New York.

Sponsored by the American Society of Perfumers, Fragrance: The Invisible Art will take place on Tuesday, May 7, from 10 am – 3 pm.   Attendees will get an inside journey of the fragrance development process and hear from the various “artists” who create this art composition which is often not seen and only understood by the developers.

Speaking in this program will be the customers who develop a new concept that involves a scent.  The perfumer, who then must translate this concept into fragrance, and uses their knowledge of combining various fragrance materials to develop a target scent.  This also requires working with the trained evaluators, also known as the noses, who will perfect the juice with the perfumer.

The marketer’s contribution to the story will also be discussed as they will be responsible for speaking about the overall appeal of the fragrance composition.  Once the fragrance is determined the technician will work in the lab to stabilize coloring and packaging.  The final result – a masterpiece of art – which may be a back drop to the product or the centerpiece that drives the sale.

Fragrance: The Invisible Art panelists include Shana Finkelstein and Ana Nouel, Brand Product Management Fragrance Development, Maesa as the customers;

Kari Arienti, Founder, Aroma Knowledge and Vincent Kuczinski, Vice President Senior Perfumer, MANE Fragrance, as the perfumers; Pamela Vaile, Founder, Pam Vaile Associates as the evaluator; Jenine Guerriero, Director of Marketing, Givaudan as the marketer; and David O’Halloran, Vice President Fragrance and Cosmetic Technology, Arcade Beauty as the technician and Christopher Diienno, Chairman, American Society of Perfumers as the overall conference instructor.

Top of FormMicrobiome: Inside Out Beauty, an exciting new area of research, will take place on Wednesday, May 8, from 9:15 am -1:15 pm.  This new program, moderated by Tom Branna, VP/Editorial Director, HAPPI, will dive deep into microbiome and biogenetic technologies and how formulating cosmetics and personal care products includes living, tailor-made solutions.

The stage will be set for the program with a co-panel presentation of “Top Trending Ingredients…Microbiome is One of Them!” by Yarden Horowitz, Co-Founder, Spate; followed by” What Does This Mean for Product Development?” presented by  Karen Young, CEO, The Young Group.

The program then takes a deep dive into Microbiome with: “Development of a 3D Skin Model Colonized with an Uncultured Skin Microbiota,” presented by Valérie Cenizo, Skin Biology Lab Manager, L’Occitane; “Skin Microbiome-based Ingredients for Innovative Cosmetic Formulations:  Key Considerations and Evaluation Methods,” taught by Dr. Pascal Yvon, President/Founder, Biosciences Expansion; and “Claim Support for Microbiome Skin Care,” with Christiane Uhl, Sales Manager, Courage + Khazaka electronic, GmbH.

            There will also be an expert Microbiome panel discussion on this emerging trend with Daniel Winn, President, Acetera; Dr. Marielle Le Maire, Global Head of BU Activities, Symrise; Ferderica Carlomagno, R&D Manager Roehlm; and Simon Grundy, Business Development Manager, proDerm.

NYSCC Suppliers’ Day will also have educational sessions on Innovation & Compliance, Discover Sustainability, The World of Chemistry, and Digital Age of Beauty, along with the pre-show SCC CEP Courses and the ICMAD FDA Cosmetics Regulation Workshop on Thursday, May 9th.

Specialty areas on the expanded exhibit floor include the Future Chemists Workshop, Innovation Hub & Theater with the CEW Supplier’s Award finalists speaking and showcasing their nominated ingredients and formulations, Presentation Theater as well as a 40 Year Retrospective from NYSCC past chairs, members, brands, and suppliers.

X