This year I was struck by a new vibe at ISPOR –the ‘must attend” conference for health economics outcomes research. ISPOR aspired to — and succeeded at — broadening its reach by replacing its usual highly technical agenda, with one that was extremely relevant for these times. For the first…
This summer’s dramatic rescue of 12 young soccer players and their coach from a flooded cave more than a mile deep into the earth is a lesson not only in the power of the human spirit but one that also can be applied to everyday business. On a personal level,…
Whether you are a CEO trying to strike a deal with an important client in a foreign country, or a team member trying to get something accomplished in your own office, cultural differences in communication often present major challenges.
There are many stakeholder groups that ultimately define the benefit-risk assessment of a medical device. These include payers, patient groups, providers, policy-makers, regulators, and many more. Benefit-risk messages touch on multiple points in the product life cycle and sponsors must constantly assess if the benefits outweigh the risks. The framework…
In our last blog we discussed five rules to help companies prepare for their interactions and meetings with FDA. But preparation doesn’t stop once you analyze your audience. In fact, it’s only after the analysis that the real work begins. In this blog, we’ll talk about the next five rules…
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…
