Description:
Three years ago, Almac Clinical Technologies in Souderton, PA undertook a project to rebuild its web-based clinical trials technology delivery platform taking a “green field” approach. This included the development of not only a new technology platform but a new Agile-friendly SDLC replacing Almac’s waterfall-centric approach to software development. It is important to note that Agile methods are relatively new to the highly conservative pharmaceuticals domain where patient safety and data integrity are paramount. In this session, we will discuss the scope of the project focusing on Agile team and program management and how we were able to meet the rigorous product validation standards demanded by the US Food and Drug Administration. We will also discuss our novel “delivery risk” management model for enhancing delivery predictability of multi-team Agile programs.
Presentation
Adopting Agile Scrum in a Regulated Industry.pdf
Presenters:
Gary Dampman, CSM and a Six Sigma Green Belt - Agile Program Manager at Almac Clinical Technologies
Gary has over 8 years of Program Manager experience overseeing Agile software development projects. Prior to joining Almac, Gary led the introduction of Agile practices at Praxair, a global leader in the specialty gases industry. This was a paradigm changing shift in a tightly regulated industry with a long established project waterfall approach. His leadership and innovation earned him global recognition from the CIO and significantly increased Praxair’s success in delivering impactful technology projects. In his present position, Gary and his colleagues have developed an innovative approach to improving visibility, predictability and risk management in projects using an Agile methodology where short iterations and decomposed use cases can often obscure potential risk. This delivery risk model is then used to identify, communicate and manage risk to the overall program release cycle and product strategy.
Deb Kandebo, MPM, PMI-PMP, CSM, and a Six Sigma Green Belt is an Agile Project Manager at Almac Clinical Technologies
As early as 2004, she recognized how Agile can improve the quality and speed of software development and overall collaboration. In the past few years, she has focused on better understanding how business needs drive IT and how IT can better facilitate revenue. With this understanding, she empowers her teams by coaching on the qualities of open communication, innovation, and transparency of decision making. She was recently published in the Journal for Clinical Studies.
Charlie Morris, Vice President, New Products & Services, Almac Clinical Technologies
Charlie is an accomplished Commercial Software and Infrastructure CTO that combines passionate customer and prospect-facing evangelism with a uniquely high level of sales savvy and keen focus on revenue. Charlie has led technical delivery teams in the military, medical, and financial services domains. On a more personal note, Charlie is an eclectic and early adopter of technology with a passion for new and emerging software and gadgets. He is equally at home on Windows, Mac, iOS, Android and other platforms and likes nothing more than exploring new and exciting technology. Charlie is also a writer and blogger on technology leadership and technical career development topics.
