Presentation: Managing Change in BioPharma – A Tough Pill to Swallow
Abstract: Managing the development of a drug molecule from research through commercialization is a long and arduous journey. Along that journey are many speed bumps and triumphs, process optimization, clinical trials, and manufacturing validations. Through each phase of development, toxicology, and clinical trials, lies a variety of key inputs and decisions which generate any number of required changes and risks. The approach a project team takes to change management can impact timelines, budgets, and resources and ultimately define the success of the program and take the team to the next level. Understanding why the change is being made, who are the stakeholders involved, what the key objectives are, and how the change will be managed are all vital on the road to meeting goals and delivering medicines to patients.
PMI Talent Triangle: Ways of Working
Biography: Michele is the Senior Director and Team Leader, Global Portfolio and Project Management and her pharma experience spans nearly 20 years, with almost 14 years at AstraZeneca. After several analytical chemistry roles she moved into CMC project management, and eventually led a team of CMC PMs. She joined Global Portfolio and Project Management in 2019 and now serves as Global Project Manager for a leading Respiratory Franchise, responsible for advancing brand strategy and the life cycle management program, including the development of several respiratory and immunology programs. She is influential within the organization, providing project management leadership and guidance, and leading a team of Global Project Managers in Respiratory and Immunology.
