Biotechnology Project Management, January - March 2019
This six-evening seminar examines critical aspects of project management, including an overview of the drug development process and regulatory agencies. Participants gain practical experience with project management tools, such as Product Development Plans, Responsibility Assignment Matrices, Communication Plans, and Work Breakdown Structures. Participants learn to use tools and strategies for working in a team environment to analyze risk, allocate resources, track projects, resolve conflicts, make decisions, and manage management. Most importantly, participants increase their ability to deliver project results.
In this practical hands-on learning environment, participants gain understanding and skills in the responsibilities, activities, and competencies required of a successful Project Manager in the biotechnology industry. Experiential learning labs, class participation, and real life examples are used to maximize educational learning.
"Biotechnology Project Management" helps executives, researchers, technicians, and managers understand the role of project management and how their job fits into the overall drug development process.
*Participants who complete the course will receive 21 Professional Development Units (PDUs) from the Project Management Institute (PMI) MassBioEd is an approved, registered provider of continuing education credits under PMI. This course does not qualify for PMP certification, nor does it prepare the participant for the PMP exam.
- Tuesday, January 29 - 5:30 to 9 pm
- Tuesday, February 5 - 5:30 to 9 pm
- Tuesday, February 12 - 5:30 to 9 pm
- Tuesday, February 19 - 5:30 to 9 pm
- Tuesday, February 26 - 5:30 to 9 pm
- Thursday, March 7 - 5:30 to 9 pm
Course Topics Include:
- Overview of Product Development
- Understanding the Regulatory Environment
- Project Management Organizational Structures
- Working in a Matrix
- Internal Governance Bodies
- Project Initiation, Planning & Scheduling, Control and Close.
- Working in an Alliance
This course is co-taught by several professionals actively involved within the biotech industry, including:
- Lydia Harris, Course Director: Lydia A. Harris, C.P.M., PMP has worked in the Biotechnology/Pharmaceutical Industry for over 25 years. Prior to starting her own consulting services, she worked at Millennium, Genzyme, and Whitehead Institute.
- Susan G. Macdonald, PhD: Susan has over 15 years of experience in the biotechnology industry, in capacities ranging from discovery science to development project management, portfolio management and alliance management. She is currently Vice President of Research and Development at Aldeyra Therapeutics. Previously, she held positions at Alexion Pharmaceuticals, NKT Therapeutics, Archemix Corp., ArQule, TEI Biosciences and Onyx Pharmaceuticals.
- Haroon Hashmi, PhD: Haroon is currently Vice President, Regulatory Affairs, Ziopharm Oncology. Prior, he served as Senior Director of Regulatory Affairs at Alynlam Pharmaceuticals, Senior Director of Strategic Initiatives followed by Senior Director of Clinical Development at Biogen IDEC and worked in regulatory affairs and alliance management previously at Biogen. He worked in regulatory affairs and analytical development at Biomira.
- Barbara Rosengren, MBA: Barbara most recently was the VP of Strategic Product Development at Momenta Pharmaceuticals. She was previously Vice President & Development Project Leader at Millennium Pharmaceuticals. She held the position at Vice President of New Product Commercialization at Novartis Pharmaceuticals and worked at Sandoz Pharmaceuticals prior.
- Pamela Gustafson, MPH, PMP: Pamela has over 25 years of biopharmaceutical experience and is currently the Vice President of Clinical Research at Proteon Therapeutics, Inc. Prior she worked at AAI International, Parexel, Alkermes, and Seragen.