66 TESTING
Designing safety & claim support studies
nMichael Anthonavage - Eurofins CRL Cosmetic Testing, US
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 dos 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
PERSONAL CARE NORTH AMERICA
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 stakeholders 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 todays 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.
October 2020
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