A biotech start-up transitions from research and development to commercial manufacturing.
This small, emerging gene therapy biotech startup needed assistance with getting their first product to the marketplace. The company was in the research phase and in the beginning stages of transitioning into a regulated manufacturing environment, so the turning point would be launching its first commercial product.
At this company, everyone was essentially an expert in their respective fields but many did not have the industry experience in manufacturing at commercial scale and to regulatory requirements. Their groundbreaking drug therapies had many variables and complexities that would be hard to handle during a scale-up to full commercial production.
In addition, the company faced the challenge of established silos that interfered with communication. This is not just an issue for large global organizations. It can happen at small emerging start-ups as well.
FlexPro was challenged to:
One of the first and most important things FlexPro did for this client was to establish a cadence for a recurring technical operations meeting. This helped formalize communications so people were sharing information in a more organized way and on a regular basis. Impromptu and ad-hoc meetings had been common practices, so adding more structure made sure all impacted parties were aligned.
Daily stand-up meetings also gave team members a way to focus intensely on the most pressing issues each day. This gave a sense of clear priorities about what needed to be done, including which remaining issues needed resolution and who would be specifically tasked with addressing them.
A major milestone that showed the success of this project was the submission and approval of the biologics license application (BLA). FlexPro was instrumental in facilitating this process, including auditing.
FlexPro improved project management on multiple fronts, including:
This project demonstrates the importance of helping talented people break down silos in order to achieve urgent company goals. It also highlights how crucial it is to clarify roles, expectations, and accountability standards when moving to a new phase in a young biotech start-up.
FlexPro’s consultants became an invaluable part of the team, helping this company take bold strides toward commercial production. Today, the company is continuing its vision of bringing its strong pipeline of innovative therapies to patients, with more commercial launches on the way.
“We will surely miss you, but the legacy of all of the beautiful dashboards you created will live on! You really helped us as an organization to learn better ways to present/share information, especially with senior management. Thanks for all of your dedication and patience.” – Biotech Client Pre-clinical Development Lead