The Evolution of a Biotech Start-Up

A biotech start-up transitions from research and development to commercial manufacturing.

Results at a Glance:

  • Established operational meetings to improve cross-functional communication.
  • Enhanced team alignment.
  • Facilitated Biologics License Application (BLA) submission and approval.
  • Moved to full-scale commercial production.
  • Developed resource allocation optimization and supply chain best practices in the pre-clinical operations group.

 

Background:

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.

Challenge:

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:

  • Develop and help manage manufacturing timelines.
  • Collaborate with internal partners and external contract manufacturers.
  • Support the implementation of an inventory management system, along with other supply chain initiatives.
  • Manage facilities and equipment validation during a lab expansion project.
  • Develop a yearly manufacturing plant shutdown plan.
  • Support preclinical and early portfolio initiatives.
  • Manage timelines, capacity, and resource allocation.
  • Develop a clear and actionable information-sharing plan.

Results:

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:

  • Implementation of project management and supply chain best practices for improved communication and organization
  • Better transparency to stakeholders
  • Improved transparency to resource capacity
  • Excellent management of details like maintaining issue logs and putting risk management plans into place
  • A more cohesive team unit where individuals are aligned with the overall plan and their role within it

 

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

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