We hired ImprovementatWork to design and execute the BLA and MAA submission process for Bapineuzumab, the Alzheimer’s Disease mAB that Janssen developed jointly with Pfizer.

The program was very challenging because of the disease area and the complex organizational construct across two major players in the industry. Each of the partners in the alliance had their own processes, systems, definitions, strategic preferences and governance structures that had to be aligned in order to efficiently coordinate the enormous amount of work between the last patient visit and the actual BLA and MAA submission. The program failed unfortunately because we did not reach statistical significance in our Phase 3 trials but the program was executed flawlessly. 

Anne-Marie and Johan are true BLA/NDA/MAA submission experts. They combine their deep knowledge of Health Authority requirements with Process Excellence and Project Management best practices to create a tailor-made, comprehensive and ‘fit to needs’ approach for their clients. Their approach is holistic in the sense that they analyse and factor in the company’s culture, processes, expertise and training needs when designing their solutions. Their methodology also allows for the quick assimilation of new best practices that they develop across their client engagements.

The Improvementatwork approach is most useful for smaller companies that don’t have much experience with BLA/NDA/MAA submissions, or for programs of high complexity due to partnerships and alliances. The value they bring is in faster submission timelines, reduction of uncertainty, reduction of operational risk, and an overall more pleasant experience for the team members during the most stressful burst of activity in a drug development program.

Frederic Godderis, Global Head of R&D operations, Jazz Pharmaceuticals

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