Utilizing an Agile Framework When Implementing ATMPs

April 11, 2019

Who says you can’t teach an old dog a new trick? Having spent the last 25+ years in small molecule, large molecule, medical devices, I have spent a lot of time planning and executing everything from changing an SOP to building a multistory facility for the launch of the next blockbuster drug. The last 2 years have been spent on ATMP’s, specifically CAR T treatment for Leukemia & Lymphoma.

The variables of personalized medicine for individual treatments have strained traditional organizations who need to move more quickly than usual. The rapid changes needed to address different stress factors and achieve the expected outcomes are not feasible with the typical structured waterfall approach, forcing adoption of a new quick-paced Agile approach.

The way to implement Agile is:

  1. Identify the specific patient need as a shopping list
  2. Develop proof of concept to meet those specific needs
  3. Plan a sequence of sprints to implement the change

Next, form teams of 5-12 team members with different skill sets and utilize a coach (sometimes referred to as a SCRUM master) to help focus the team.  Leadership’s role is to identify the specific outcome needed. The outcome can be as simple as achieving 70% viable cell for a treatment or modifying a key ingredient due to a specific factor.  The team reviews the variables and identifies multiple proof of concept changes. The team includes regulatory affairs personnel with an in-depth knowledge of the filing, production personnel who specialize in the CAR T process, analytical experts to identify specific testing capabilities, an immunology expert, quality assurance expert and a technical writer.

The team is given a short window of time (2 days in some cases) to develop the process, maintain change control, modify documents, and fast track the treatment through the regulatory system.  The key activities are running the process, testing the outcome, updating the process, testing the outcome, repeat, repeat, repeat, repeat to confirm the change is effective and document what has changed.  This testing style is called “sprints” because that is what we are doing.  We are taking what was typically a 6 – 9 month process and crushing it to 2 – 8 weeks.

The challenge with personalized medicine is that it has a face, it has a family, and it has a expedited need.  Agile methodology could be the difference between life and death with very little time between the two.  Agile methodology presents a solution to that challenge, by providing actionable results in a fraction of the time a traditional process would require. This is a new approach for many organizations, but it is what I would use if it was my family, or my friend who was looking for hope where none existed.


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