Ron Niesen is an experienced project leader who helps pharmaceutical companies execute major transformation projects in R&D and product commercialization. After a career that spanned firms like Accenture, Deloitte, and CSC Index, Ron launched an independent consulting practice that’s focused on translating challenging market objectives into executable programs—and managing them to on-time, on-budget completion.
In our latest Expert Q&A, Ron talks about pharma product launch best practices, from coordinating across functional areas to facilitating fast decisions.
You’re currently helping a pharmaceutical company launch a portfolio of digital asthma inhalers—the first of which received FDA approval in December—that help patients track not just usage but the quality of the inhalation. What’s your role?
I’m the launch leader, so my responsibility is to coordinate the functional work streams that are involved in the product’s launch, such as product design, development, regulatory approval, manufacturing, and commercialization.
Typically, pharma products are launched one at a time, but this one is being released as a suite, with new versions coming out every six months.
Most pharma products are launched for one or two indications and tracked by the launch team for six months to a year afterwards. Then the team moves on to another product. On this project, we are launching a suite of products, where each product will be upgraded to new versions within six to eight months. While this is the norm for technology companies, it is not for the highly regulated pharma industry that by necessity is organized for a different, more methodical approach.
I imagine that’s made the task of launch management a much longer and more complex process.
It has. But decision-making is always a challenge when you’re working across multiple functions, especially in an environment that’s as dynamic as the pharma market is today. The pace at which decisions need to be made is accelerating every day. The risks are also much higher. Twenty years ago, there was an expectation that a discovery factory could churn out blockbuster molecules that would be dramatically differentiated from other products on the market. As we learned, it was impractical to make that discovery factory deliver returns, because science moved into more complex arenas like biologics and immunosuppressants, where one molecule was not the answer. Consequently, more fine-tuning must be done to optimize all the levers involved to turn a discovery into a profitable product.
Market acceptance is more complex, too.
There’s no sure thing anymore—the more complex your product is, the more complex it is to sell. You’ve got to convince the medical community and, most critically, the payer community that the product is worthwhile. This adds complexity and time, which increases risks that force companies to constantly hunt for better information on which to base their decisions. As Launch Lead, it’s my role to facilitate the activities that support this decision making. It takes assembling the right people, information, and motivation to attack a well-framed problem. I also need to be savvy about how I tee-up the questions I ask to decision-makers to focus our limited time on the issues of highest priority.
What do you mean?
In an earlier era, you could make the business case for most products on the back of an envelope: X number of millions of units sold at Y price will get you Z net sales. Now, since products typically have to be profitable with many fewer patients using them, it’s more complicated to build a solid business case that is fair to the public and still allows for more research to be done. You’ve got to put more effort into collecting data and framing the questions that will matter most to the marketplace—then answer them with the best information you can get.
What are some of the structural ways you facilitate all the decisions that need to be made and work that needs to get done on an engagement?
I try to create a comprehensive meeting structure that speeds up work, rather than slowing it down. There’s two levels to that. There’s a week-to-week and month-to-month structure I put in place to facilitate collaboration. A product launch can have nearly 120 people involved in different locations around the world. Some will be full-time, while for others, it’s maybe 20% to 30% of their job—or even less. So a large part of my role is to develop an effective means of coordinating their input so that the right people hear the right information and act on it. The time people spend on a call is time they could also spend doing something else. It’s all about balancing participation so that people find their discussions more useful than just sending emails.
The other aspect of meeting structure is organizing the team to align when we need to go to senior upper management for resources or decisions. The facts need to be clear, and everybody on the team needs the same understanding of the problem and decision to be made.
Are there certain tools or technologies you like to use to keep the work aligned?
I have my favorites, but what it boils down to, in my experience, is that it’s not so much about the technology as it is about the process that you put around the technology—and getting people to abide by the process. I can suggest, but they have to do it for it to work. Let’s use this. Let’s keep the information up-to-date. Let’s regularly review it so that it’s of value to us. And let’s adapt the process over time if it isn’t delivering the value we need.
What can clients do to get the most out of your work as an independent consultant and project manager?
Engage consultants fully as team members. Often, clients are overly concerned with the information that they share with consultants. In reality, there’s very little important information that an active consultant won’t be aware of, but delaying access to it makes them less able to provide assistance and recommend options to consider. Do I need to understand the business strategy or the marketing plan or the production schedule in order to manage the project? Yes, because understanding these elements puts the work we’re doing in context. The more I’m able to get in front of issues, put them into context, and provide options to address them, the more value I am to the team.
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