The effects of the U.S. government shut down and the impact on how FDA is working is all anyone seems to be talking about. Chicken Little is clucking that there is no end in sight! For the small company, delays can be disastrous. However, product development can and should continue! Now is a great time to think strategically to achieve your next development milestone(s).
Revisit your development strategy
Given what you know today, does your current strategy still make sense? Can you accomplish your development goals initially in another country? Have you been putting off GMP manufacturing? Are there nonclinical studies that you need to plan and complete? You have time now to do some formal assessments and update your strategy as needed. Our “You Are Here” Assessment can help you get to your next milestone most effectively, including alternative ways leverage your asset and get into the clinic during the US government shutdown.
Get those R&D documents under control
Your documents are critical assets that represent a huge investment of time, money and effort. Don’t risk loss, corruption or inadvertent deletion. Add value to your asset, improve team collaboration, and shorten the time from document conception to regulatory submission by getting your documents into a Document Management System (DMS) now! We can have you get up and running in Gemstone in a matter of days.
If you are looking at new acquisitions, now is perfect time to do some market research, determine your acquisition targets and consider how the acquisition can impact your strategic plan. New assets are exciting but can bring a lot of challenges to your team if you haven’t given adequate thought to their impact on existing resources and programs. While the FDA has slowed reviews and issuance of guidances to a trickle, take a breath and invest in a solid future for your company. Our Product Development Champions can help you evaluate candidates for acquisition and divestiture. Once you decide to in-license a product, Facet can work with you to develop and execute a strategic development plan that is in line with your goals, objectives, and resources.
Though the government shut down has affected FDA interactions with industry on a broad scale, you can head into 2019 at full speed! This is an opportunity to organize, prepare and ramp up to ensure a successful year. If you need assistance, the Facet team is here to help.
Our goal is to help you meet your development goals because we know that companies depend on progress and can’t let anything stand in their way!