OVERVIEW Within the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) assesses the applicant’s quality, safety and efficacy data deciding on whether to recommend marketing authorization to the EMA. 31 members: One representative from each EU member nation (28 voting members), plus 3 non-voting members…
This month we spoke at the 2018 BIO International Convention in Boston, MA on How to Effectively Communicate with Regulators. 3D Communications has spent the last 15 years preparing companies for FDA pre-submission and advisory committee meetings. During this time, we have developed our “Top 10 Rules” to help make…
It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data…
More than 42,000 Americans died from an opioid overdose in 2016. The number of deaths each year from opioids now surpasses the number of Americans who died each year from AIDS at the height of that epidemic in the mid-1990s. While misuse and abuse of prescription opioid medications is a…
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…
The New FDA Focus: “Business as Usual” Now Includes Paying Attention to the Cost of Drug Development
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.