Emerging Leaders Session: The Lifecycle of a Drug Product
1:00 PM – 1:45 PM | West Red Level, Suite 81
The Lifecycle of a Drug Product
This presentation will offer a high level overview of the lifecycle of a drug product, spanning from initial research and development to regulatory approval. We will examine the critical stages involved in bringing a therapy to market, including early-stage discovery, preclinical testing, the different phases of clinical trials, and the various activities required to support each stage of development. Throughout the presentation, we will highlight key milestones essential in determining the trajectory of new therapies, such as safety, efficacy, and funding. The objective is to provide students and entry-level associates and specialists new to the pharmaceutical industry with a clear understanding of the regulatory approval process.
Speaker:
Laura Packer, Research Enablement Lead, Takeda Pharmaceuticals
Georgia Quartey, Senior Manager, Regulatory Strategy , Verve Therapeutics
Biographies
Laura Packer, Research Enablement Lead, Takeda Pharmaceuticals
Laura has more than 10 years of experience working in the biopharmaceutical area, specializing in Chemistry, Manufacturing, and Controls (CMC) development, particularly at the interface with Research. Currently, Laura is a Research Enablement Lead (de facto Chief of Staff) for Oncology Drug Discovery within Research at Takeda Pharmaceuticals. In this role, she leads strategic planning, execution, and optimization of functional projects.
She obtained her PhD degree in Biophysics from Boston University and completed a postdoctoral fellowship at the University of British Columbia. Laura subsequently joined Takeda in 2013, where she spearheaded the establishment of Takeda’s in-house bioconjugation capabilities in the Pharmaceutical Sciences and Research organizations. As a member of PharmSci, Laura has served as a bio-conjugation lead for ADCs, served as the PharmSci Lead for multiple preclinical programs, and facilitated Biologics Senior Leadership meetings to align on cross-functional program strategy and prioritization. Laura also led the Viral Vector Pilot and Process Development team within PharmSci, supporting Cell Therapy. Laura is known for her collaborative nature and ability to foster constructive relationships throughout the Takeda organization.
Georgia Quartey, Senior Manager, Regulatory Strategy , Verve Therapeutics
Georgia Quartey is an experienced regulatory affairs professional with four years of hands-on experience supporting global clinical trial applications for early and late phase programs. She began her pharmaceutical career as a global patient safety and regulatory post-doctoral fellow at Ironwood Pharmaceuticals, later transitioning to her current role as a regulatory strategist at Verve Therapeutics. In this role, she supports the development and execution of global regulatory submissions across early-phase programs.
Georgia is passionate about regulatory innovation and actively contributes to cross-functional planning efforts aimed at streamlining study start-up timelines. Her strong interest in drug safety and inclusive medical practices led her to pursue a Doctor of Pharmacy degree at the Massachusetts College of Pharmacy and Health Sciences.
