With the new, abbreviated biosimilar pathway enacted in the Affordable Healthcare Act, is now the time for your company to jump in?
The many layers of this issue are too complex for a simple answer, and you won't find them in mainstream business media. Instead, you'll want to read and understand it all in IN VIVO's exclusive new Special Report, The US Biosimilars Market: The Challenges for Pharmaceutical And Generic Drug Companies.
The Asian marketplace — home of a thousand and one complications, all of them in languages you don't speak — changes daily. And you probably don't have an Asia expert on hand to keep you up to date. But the biggest pharmas do, and their current strategies are on display in an exclusive new report from PharmAsia News.
Flexible Pricing Strategies In Asia: How To Move Beyond Short-term Bottom Lines gets you inside the boardrooms and corner offices of the biggest Asia players. And it's available only from PharmAsia News, the industry's most trusted daily source for critical business intelligence and analysis of the biopharma industry in the Pacific Rim
Now that the shouting about health care reform has died down... what exactly does it mean for you and your company in cold, hard cash?
The answer to that million-dollar question is still being calculated, but you can get a first look at some important estimates in an exclusive new Special Report, Sizing Up Medicare's Donut Hole Discounts: A First Look At How Much Manufacturers Might Owe In Discounts On Drugs In Medicare's Coverage Gap from "The Pink Sheet," the industry’s most trusted source for regulatory and commercialization analysis and intelligence.
Just $95! Get this business-critical Special Report HERE.
As FDA advisory committee meetings grow more difficult - and more political - and drug sponsors receive shorter notice to prepare, a “win” from a panel has become increasing difficult. With a huge investment on the line, learn how to put your best foot forward.
Introducing: The FDA Advisory Committee Survival Manual
A Step-by-Step Guide to Preparing for a Successful Meeting
The FDA Advisory Committee Manual is a 159-page book written by 3D Communications to help prepare and guide companies through the FDA advisory committee approval process. The publisher of BioPharma Today and "The Pink Sheet" is proud to support this initiative. Click here to order your copy today!
Getting a drug or medical device to market has never been tougher, more time-consuming, or more expensive. It’s estimated that it now costs pharmaceutical companies as much as $2 billion and more than 14 years to get a product from discovery to sales. Despite this enormous investment of time and money, the success rate for getting new drugs approved by the FDA is declining.
Increasing product withdrawals and recalls, heightened concerns about patient safety, and a maelstrom of criticism around the FDA and the pharmaceutical industry have created a climate of public fear and mistrust. As a result, the FDA is requiring companies to provide more data and often to present their data at highprofile, emotionally charged FDA advisory committee meetings — hearings that often determine whether the product will ultimately gain approval.
Preparing for an FDA advisory committee meeting is more challenging than ever. While there is no single magic key to success and clearly no substitute for good data, there are critical steps that companies should take to increase the odds that the advisory committee will agree with the sponsor that their drug or device should be approved:
More than anything else, advisory committee preparation requires that companies organize a dedicated, focused team that plans to win — but works as if it’s one step away from losing.
Click here to order your copy today.
Table of Contents
Introduction
Chapter 1. Maximizing FDA Interactions Before and During Advisory
Committee Preparation
Planning
Chapter 2. Selecting, Organizing, and Managing the Team
Chapter 3. Researching and Analyzing the Advisory Committee Members
Chapter 4. Analyzing the Environment and Leveraging Advocacy Support
Preparation
Chapter 5. Creating, Prioritizing, and Harmonizing Content
Chapter 6. Writing the Briefing Book
Chapter 7. Writing the Core Presentation
Chapter 8. Creating Slides and Visual Aids
Chapter 9. Creating, Managing, and Using Backup Slides
Practice
Chapter 10. Practicing the Core Presentation
Chapter 11. Preparing for the Q&A
Chapter 12. Organizing Mock Advisory Committee Meetings
Wrapup
Chapter 13. Working With the Media
Chapter 14. Handling Game-Day Communications and Logistics
Chapter 15. A Final Word
Appendices
Appendix I. Glossary
Appendix II. How the FDA Advisory Committee Hearing Process Works
Appendix III. Special Considerations: Rx-to-OTC Switches, Devices,
and Combination Products
Appendix IV. FDAAA Legislation and Post-Marketing Safety Commitments
The FDA Advisory Committee Manual is a 159-page book written by 3D Communications to help prepare and guide companies through the FDA Advisory Committee approval process. Click here to order your copy today.
