Clinical Research (Virtual) Forum - 230309

"BioPharma PMO: How to Scale Up for A Growing Organization in the Clinical Research Industry" by NoriYah Yisrael, MSM-PM, AgilePgM, PMP, CSM, SSM, CIPM, FAAPM and Program Manager at Advanced Clinical

The Clinical Research Forum provides value to the PMI Atlanta community by regularly discussing the various aspects of clinical trial projects with special focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner for clinical trials in the pharmaceutical industry.

Presentation

The Clinical Research industry is one of the most highly regulated industries in the healthcare marketplace. The safety and effectiveness of medicinal drugs, devices, and combination products is of the utmost concern and importance to regulating bodies like the Food & Drug Administration, European Medicines Agency, and Ministries of Health whose primary remit it is to ensure the welfare and safety of the general public’s health. As a result of this high level of regulation, and other contributing factors, the research and development (R&D) projects/programs for medicinal products at biopharmaceutical companies move from the lab (i.e., discovery) to the real world (i.e., post commercial launch) under extremely cost-sensitive, time-sensitive, and compliance-driven environments.

These collective projects/programs (aka clinical trials) are on average very expensive, nowadays topping well over the estimated $2B USD mark, while the length of time it takes to get to the “profit line” (i.e., to market) is 10 years or more with less and less varying years of exclusivity. Throughout the lifecycle of a newly discovered product that may or may not make it to market, there are an innumerable amount of well-educated professionals who are involved in the R&D projects/programs that are traditionally run using a traditional waterfall (sequential) project management methodology. While biopharmaceutical companies have seen great success using this methodology, they are starting to think “outside the box” and look at new ways of working that may decrease cost, reduce time, and recognize greater efficiencies. The organization’s success (whether perceived or actual) can waiver in accordance with how attuned the PMO is with the vision, needs, and future of the organization. Knowing how to scale up a PMO at just the right time, with just the right service model takes maturity assessments, agility, and a strong aptitude for change.

Biography 

Mrs. Yisrael has 35 years of experience in the healthcare industry managing various facets of patient care from prevention and wellness to disease diagnosis and treatment. For over 24 years, NoriYah has worked in the Clinical Research industry providing best-in-class program and project management services for the strategic development, execution, regulatory submission/approval, and commercialization of biopharmaceutical drugs, devices, and combination products. Across the span of her career, she has worked for dozens of biopharmaceutical companies and clinical research organizations leading cross-functional program/project teams in many therapeutic areas of medicine to include, but not limited to, Oncology, Aesthetics Medicine, Cardiovascular and Metabolic Disease, Neurology, Orthopedics, Pain Management, Rare Disease, Vaccines, and Ophthalmology.

NoriYah has been a Certified Project Management Professional (PMP) with the Project Management Institute (PMI) since 2009, where she currently provides volunteer program management services for the PMI Atlanta Chapter. She is also a Certified Agile Program Manager (AgilePgM), Scrum Master (CSM), SAFe Scrum Master (SSM), International Project Manager (CIPM) and a designated Fellow of the American Academy of Project Management (FAAPM).

When

Thursday, March 9, 2023, 6:00 PM - 7:15 PM

Where

Webinar

You will receive an email from the PMI Atlanta Chapter with the webinar link 24 hours before the event start time.

Fees

Due to coronavirus concerns, we will be hosting this event through webinar. Because of this change, member rate is now $8 and non-member rate is $10.

Meeting content, presenter, and location are subject to change. Refunds will not be made for changes in meeting content, presenters, or locations.

PDUs

Earn 1 PDU
Talent Triangle Category: Ways of Working

PDUs can be claimed here.
For detailed instructions, please visit the CCRS User Guide.