In this age of heightened regulatory and payer scrutiny, Biogen accepted the challenge with courage and stayed focused on gaining a better understanding of the benefit:risk profile for Tysabri. Now, there is a better understanding of patients at greatest risk for developing PML and a diagnostic test to help determine a patient’s risk.
Life science companies can learn a lot from how Biogen handled this situation, and here are three key learning’s…
- Face your challenges head on and with courage. Be committed to searching for answers. Consider hiring a management consulting firm to help you ask questions and develop an action plan.
- Work with strategic partners that have expertise you lack. In challenging times surround yourself with others that are more knowledgeable about a specific area than you.
- Communicate your actions and outcomes. The lives of patients are at stake. Proactively communicate with regulatory officials, physicians, patient advocacy groups, and patients and caregivers.
The need for innovation is everywhere. Whether it’s finding new uses for existing products, determining how to overcome barriers to market acceptance, or strategic pipeline planning innovation is a common theme. At Snowfish we combine our unique and highly effective methodologies with disease-state understanding, sophisticated software, and analytic capabilities to provide actionable insights into your most pressing product development challenges. Our website has more information on our services, and a section on the white papers we've published.
Give me a call at 703.759.6100 to discuss your challenges and how we can help.
You are absolutely right that Elan handled the PML situation rather well and despite all the negative news about PML, it managed to came up with a solution that seems to be beneficial for patients and the company as well. Don't get me wrong, PML is still a horrible complication to have, especially since there are no effective treatments for progressive multifocal leukoencephalopathy. At the end of the day it will be decided by patients if the risks worth taken. At least they have information to base their decisions on.
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