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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 cannot do that, it is 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 rather than MDs (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.


October 2020


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. Do not spend your valuable time and resources developing a technology only to find out you cannot sell it in your target region because of regulatory hurdles, restrictions on trade, and/or miss alignment with what is culturally acceptable.


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 use 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, do not wait for it. It is 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. Third party labs do not make marketing claims; they provide data to


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 do not 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. 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.


Conclusion 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 do not 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.


PC


This article was submitted to Personal Care magazine by the NYSCC Scientific Committee


Michael Anthonavage is VP of Operations and Technology at Eurofins CRL Cosmetic Testing, and 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.


PERSONAL CARE NORTH AMERICA


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