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: Michael Federman – 11 years of project management and biopharmaceutical experience, 8 years at AstraZeneca in Chemistry Manufacturing and Controls (CMC) Project Management. DMV native, attended University of Maryland for undergrad (Biochemistry) and attended Johns Hopkins University for grad school (MS Biotechnology / MBA). I have held project management positions in life sciences/diagnostics, biodefence, and pharmaceuticals.
