There are many questions that must be asked, and consecutive steps planned, in order to successfully develop and launch a dietary supplement. These questions include:
- What will the product to do?
- How safe is the product?
- Who will benefit from the product?
- How is dose determined?
- What else can be said about the product and is the evidence sufficient?
- What is needed to provide the evidence?
One of the biggest questions of all is: Where do I start?
Beginning with the end in mind: the product claim
To expedite time to market and properly allocate budget, supplement developers would benefit from taking a strategic, ‘pharmaceutical-light’ approach to product development. To do this, begin with the finished product in mind. Start by identifying how the product will ultimately be marketed and what the desired scientific, health and/or marketing claim will be.
Next, review and determine the market positioning of the product. Third, examine the jurisdictions of interest. Do you want to launch the product in the United States? Canada? The EU? In multiple countries?
Finally, assess the regulatory landscape. What steps need to be taken to get to gain access to your desired market? What gaps need to be filled in order to be compliant with the regulations? All of these questions will help you get to where you want to be - a finished product with strong science to back up its claims.
The advantages of using a product development plan
Working backwards from the product claim may sound simple, but it is a complex process requiring a great deal of strategic planning and regulatory forethought. To successfully build a solid development strategy, product development plans are key. This is an area that the pharmaceutical industry pioneered many years ago after a number of compounds failed to achieve their clinical development goals.
Sufficient time spent in the ‘aim’ phase, through the completion of a product development plan, can provide significant return on investment downstream, and avoid costly clinical work that may lead to confusing or contradictory results.
Product development plans should review possible regulatory classification(s) of the product in the jurisdiction(s) of interest, assess current information about the product, evaluate the product-specific scientific evidence or, where this is not available, assess evidence on the same ingredients contained in the product of interest. A good development plan will identify gaps, risks and benefits along the pathway from conceptualization to market.
Identifying gaps in your product development pathway
After any gaps have been identified, strategies must be developed to address deficiencies. For dietary supplements, the focus often needs to be placed on human clinical trials designed to substantiate both the marketing claims and any structure/function or health claims the Sponsor wishes to make.
Jumping straight into a clinical trial without a detailed plan or roadmap can have devastating outcomes, including evidence unable to substantiate the desired claim(s), increased cost due to the need to repeat studies, strained relationships between Sponsors and institutions conducting the research, and delays in product launch.
With such high stakes, a strategic approach to the clinical development of a product is imperative. Clinical development plans are a crucial investment for Sponsors in the dietary supplement space, as they transform the vision into distinct implementation phases and clinical studies, each with defined milestones and deliverables.
To learn more about product development for nutraceuticals and other products, download our free whitepaper.
Josh Baisley, B.Sc., is Director of Domestic Clinical Trials at Nutrasource. With nearly 15 years of experience in quality assurance, clinical, pre-clinical, and regulatory affairs for the natural health products sector, Josh has been directly involved in over 65 clinical trials accounting for more than 10% of all clinical research applications received by Health Canada. Connect with Josh on LinkedIn.