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Virtual Biotech Product Development: Managing a Three Ring Circus

The role of a seasoned project manager

When developing novel biotherapeutics, it’s all about getting your molecule into the clinic. For virtual biotechs, the pressures from competitors, reaching benchmark product development goals, and meeting financial milestones are among the anxiety producers. Drug development is no easy task even when you have a full complement of internal resources available. The degree of difficulty increases significantly for virtual companies because of their dependence on outside vendors like a CRO or CDMO to get the work done on time and budget.

Product development begins with the end in mind and relies on the best input from multiple disciplines. The path seems straightforward. You have a completed Gantt chart in hand, money is available, and expectations are high, all you need to do is execute, right?  Hopefully yes, but consider adding a seasoned project manager to the mix to hedge your bet. Why? – because an experienced project manager will apply the following four key strategic principles to keep your program on track by aligning interfaces and obsessing over the gaps that will inevitably occur when working with teams of outside contractors.

 

  1. Improving alignment and handoffs

Often this is stated as simply communication, communication, communication. While obviously true, underneath this mantra is the need to streamline transitions within internal and external teams, since team members come and go, by:

  • Assuring that new members are “up to speed”.
  • Appointing experienced persons to be responsible for timely sub-team outputs where their work impacts other sub-teams.
  • Assigning rotating reporting assignments to the overall project team to involve new members.
  • Monitoring and reducing the time needed for critical path activities:
    • predicting where sub-teams will converge.
    • making everyone aware of an approaching project intersection.
    • keeping sub-teams focused on spotting important new activity tasks on the critical path.

 

  1. Accelerating development activities

Looking for opportunities to generate phase appropriate, technical information faster should always be a goal during development, by:

  • Applying Design of Experiment (DoE) methods to reduce experimental load while capturing the necessary design space information.
  • Using shared knowledge from other programs or SMEs can also shorten the path to obtaining essential insights and characteristics of your molecule.
  • Ordering product development activities under the highest priority time constraints.
  • Knowing when to stop or start specific development activities.

 

  1. Scheduling parallel activities

Taking multiple approaches simultaneously can have a payoff, but requires intense attention to the details and very active management, by:.

  • Scheduling non-critical path activities to avoid resource overloading.
    • Drafting sections of the Common Technical Document (CTD) as an ongoing activity.
    • Setting up required stability studies.

 

  1. Minimizing rework

Addressing issues in a timely, phase appropriate manner to avoid costly project delays, by:

  • Focusing on developing analytical methods early.
  • Ongoing capture of process and analytical data.
  • Minimizing clinical impact on development.
  • Translating activities into process knowledge.
  • Obtaining manufacturing alignment.

Along with proper planning and using the most knowledgeable SMEs available, an experienced project manager will actively manage the interplay between many moving parts, instead of focusing on details of a specific area.  Where people are involved, promoting a culture of shared ownership (blameless autopsy) goes far. A seasoned project manager is key to running a functioning three-ring circus while keeping chaos caged.

Blog article by: Denis Boyle

The following BioProcessBlogs by my colleagues address other issues related to project management.

Speed Can Kill: In Biotech Too!

Your Biologics CMO: Choose Wisely, Then Negotiate

Quality Agreements: The Devil is in the Details!

Keys to faster development pathways