At an FDA Advisory Committee (ADCOM) meeting – one of the most important days in a product’s development – Sponsors typically have no more than 75 minutes to credibly and persuasively explain their entire development program. The stakes are high because the committee plays a key role in influencing the…
In the “old days” (aka, last year), the FDA rarely mentioned the “cost of drug development.” The line between research and development (R&D) costs and regulatory was clear and not to be breached. And when the term “price” entered the vernacular, FDA officials were consistent in their message that the…
In my last post, I discussed the role that contextual intelligence (CI) (understanding stakeholder emotions, behaviors, and beliefs) plays in the collaborative and transparent communication of a product’s value.
But how do pharmaceutical and device teams use CI to successfully communicate in an increasingly complex healthcare environment – one currently defined by a growing number of powerful, vocal, and sometimes competing stakeholders? In this post, I explore practical ways to leverage the information from CI to achieve consensus among conflicting stakeholder
For healthcare companies, talk of “being customer-centric” is all the rage – especially when it comes to placing a value on their products. In the pharmaceutical and device arenas specifically, the term “customer” refers to more than just the patient; it refers to all stakeholders – the diverse set of…
As someone who spent the last seven years working at the Center for Devices and Radiological Health (CDRH), I can tell you that the underlying relationship between your company and its review division really matters – from submission, through a potential Advisory Committee meeting and beyond to your medical device…
My first time moderating an advisory board, I had the distinct feeling of being a lion tamer in a cage without a chair or whip for protection. The panel of 15 KOLs had three who loved the sound of their own voices and assumed everyone else would as well. Some other participants may have been shy – but almost all were unwilling to compete, disagree, or offer alternative opinions. I thought there had to be a better way of managing a group like this. Through talking to others who excel at moderating, some Internet research, and my own evolving experience, I have landed on these 10 tips as particularly useful.
It might seem obvious that one person alone cannot drive successful FDA advisory committee (ADCOM) preparations. What’s less obvious is that one unchallenged thought process could also result in failure. But that’s the unfortunate outcome of company groupthink.
In our last blog, we focused on the non-transparent nature of CHMP meetings – and the challenges sponsors face in making sure that CHMP representatives understand and retain the presenters’ messages.
In this follow up article, we detail how to succeed given an often limited preparation timeline. It requires five key considerations.
The first thing you need to know about CHMP meetings is that they are not public.
Because of this, you can’t research the meeting by watching a video online or reading a transcript. At the same time, these are extremely high-stakes meetings, where companies present their data and answer questions before a panel of individuals who will likely decide – or at least heavily influence – the future of the company’s product.
Have you ever heard that “God gave us one mouth and two ears for a reason, so we ought to listen twice as much as we speak”? The old Irish proverb holds true and is now backed up by science. In Part 1 of this blog series, we talked about how effective speakers set up their presentation to help foster active listening. In this blog, we will discuss how speakers can make sure that THEY are actively listening.
Using both ears is just the beginning.