February 12, 2016

It’s Never Too Early to Assess Risk

Before taking on a product stewardship role, Melissa Joerger worked in research and development for half of her 26 years at DuPont. More than most, she sees the benefit of bringing the two functions together. “It’s never too early in the product development stage to practice product stewardship,” she says. “The earlier, the better — the more solid the product stewardship foundation will be for that product.”

Without product stewardship at the R&D level, companies risk wasting time and resources. One scenario is that a product is ready for commercialization, and marketing managers plan for it to be introduced in six-to-twelve months, only for a regulatory specialist to find out it contains a substance with significant regulatory hurdles. “Now they need to file the regulatory dossier, and it might take two to three years for review and approval by the regulators, significantly delaying commercialization, because no risk mitigation and planning had been done,” says Joerger. “That’s one of the primary reasons why it’s so important to work with R&D teams before things get locked down.”

At Stewardship 2016, Joerger will talk about how to form productive relationships with R&D organizations during her presentation, From Discovery to Candidate Development…and Everything in Between: Front-End Innovation Pipeline Product Stewardship Tips.

For one thing, working with an R&D organization requires a shift in thinking. “When you have a commercial product, the formulation is fixed, the manufacturing process is fixed,” says Joerger. “In R&D, they’re still in the experimentation phase and trying a lot of different options. You may have multiple scenarios to evaluate for risk.”

On the flip side, fluidity is also an opportunity and the reason to connect with R&D early on. When red flags appear, there’s still time to mitigate risk. For instance, if new regulations are about to be implemented or if NGOs have targeted particular substances, R&D teams may not know about them. By getting involved early, product stewards can share valuable information about risks. “You can work with the research team to understand if it’s the only thing that is technically feasible or if there are other options,” says Joerger. “You can often change a step of the process and therefore mitigate the risk by essentially eliminating or substituting a substance.”

In Joerger’s experience, gaining trust of the R&D organization isn’t an overnight experience. It can take years and requires patience, understanding and flexibility. “The most important thing is the practice of product stewardship and assessments, actually implementing them and having researchers participate.”


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