10.09.19 -- Biotech Startup: Planning Ahead For Compliance, Outsourcing, And Skilled Labor

The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market, there are many regulatory milestones and hurdles. This article provides some tips to assist with up-front planning to prevent headaches down the road.

Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? This article explores, from a biopharma process development and drug manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.

Collaboration with a contract development and manufacturing organization (CDMO) can make it possible to bring your drug to market, but complete transparency and open communication are both critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?

A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. Waste time trouble shooting, and you may delay your time-to-market. In today’s global markets effective tech transfer is critical.

Several trends currently shaping the future of biopharma will have a direct impact on workforce development. What strategies should your company consider for recruiting, training, and retaining qualified candidates in order to remain competitive in a burgeoning biopharma market?