Recognizing the value of patient insights in drug development, FDA has made great efforts to integrate patient perspectives into its benefit risk framework for a number of disease areas through the Patient-Focused Drug Development (PFDD) program, an initiative of the Prescription Drug User Fee Act (PDUFA) V of 2012. One of the common points patients shared at the PFDD workshops held over the past two years is the feeling that their “chief complaints” or needs are not being factored into drug development plans, including measures of a drug’s benefit in clinical trials. To get an inside read on why this may be occurring and what can be done to correct it, we spoke with representatives from the Obesity Action Coalition, the IBD Support Foundation, and the Arthritis Foundation, all of whom are actively engaged in giving a voice to patients in their communities and improving access to optimal care. They shared their perspectives on how the role of patients has evolved in the past decade and what can be done in the future to better factor patients’ feedback into drug development and access planning.
The debate format plays to Hillary’s strengths. Unlike large stump speeches, where she has to be heard over a roaring crowd, here she had a microphone, an attentive quiet crowd, and the floor to herself when responding to questions. She didn’t have to yell or even raise her voice. She already had years of experience, having done 25 debates to her opponents’ zero. But most importantly – and I cannot stress this enough — Hillary is a classic over-achiever, and she prepares like nobody else.
Europe clearly has its own distinct set of issues: a highly variable healthcare and payer system across countries, and now a massive influx of refugees, increasing pressure on already stressed healthcare resources. While there are differences, there are increasing similarities between Europe and the United States in terms of concern and criticism of drug prices. In side conversations at the Forum, European officials mused that the U.S. was finally asking the questions being asked in Europe for years. What is society willing to pay, or can afford to pay, when it comes to medicines?
An important component of the Advisory Committee meeting is the open public hearing (OPH), normally a one-hour session reserved for the public to share opinions about and experiences with the product. The OPH can last as long as, or longer than, the sponsor or FDA presentations during an Advisory Committee meeting, yet there is little research on any potential impact it may have on the voting. This article originally appeared in Regulatory Focus in September 2015 and discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting.
Achieving authenticity is a journey of self-discovery. Values form the basis for all leadership communication. Once those values are discovered, a leader can begin to communicate through them, not merely about them. Speaking through values inspires leaders and gives them the ability to inspire others. Audiences know authenticity when they see and hear it. These three principles can help put you on the road to authenticity.
Prescription drug pricing has become a very hot topic in the last year. To have a better and more productive policy debate about drug pricing, we need to have a better understanding of how the market landscape—and the market risks—have shifted for the branded biopharmaceutical business in recent years. What follows is a brief analysis of changes in the U.S. health care marketplace and how they may affect drug launch prices.
Technology was supposed to make our lives easier, but instead of being swamped by paper, many of us are swamped by emails. The result is the same – we can’t find important contact information, individual documents, or entire files. So how can you make sure you are managing your emails instead of having your emails manage you? Here are a few Outlook tips that can be applied to other email providers as well.
It’s widely reported that the top three stresses in life are death, divorce, and moving. But pharmaceutical or device manufacturers going for product approval might add a close fourth – preparing for high-stakes presentations and meetings like an FDA Advisory Committee meeting. During intense preparations, it’s easy to lose sight of the most important thing – keeping yourself healthy,both physically and mentally. Here are some basic reminders to help you and your team reduce team stress during the ramp-up to a big event.
An FDA Advisory Committee (ADCOM) meeting is arguably the most important day of a product’s life cycle. To prepare for a successful meeting, you’ll need to carefully coordinate many moving parts. The last thing you want, is to forget a seemingly small detail that could derail an otherwise successful FDA Advisory Committee meeting. This is our checklist of high priority (and often forgotten!) steps to make sure your “game day” runs smoothly.
One of the most challenging projects a pharmaceutical or device company ever faces is preparing for an FDA Advisory Committee meeting (ADCOM). This process is a team effort that entails a lot of long days (and nights), constant practice, and never-ending critiques. As a project lead, one of your biggest, and frequently overlooked challenges during FDA Advisory Committee preparation is keeping your team motivated and moving forward. Here are tips to help avoid the pitfall of a shortsighted and apathetic team.