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: Group Director, Head of Submissions Project Management, Clinical and Quantitative Pharmacology (CPQP), Biopharmaceutical R&D, AstraZeneca. She has 18 plus years of experience and leadership from early development to commercialization managing programs in biologics, device combination products and small molecules ranging from start-up to large pharmaceutical companies.
