Company: Eli Lilly & Co.
Liaison(s): Michele Sharp, Shelley Ford
Eli Lilly & Co. is a leading pharmaceutical company with a diverse product portfolio including small molecules, biologics, injectables, oral tablets, and medical devices. Founded in 1876, Eli Lilly continues to focus on five disease areas and is committed to their core values of integrity, excellence, and respect for people. Eli Lilly & Co.’s Global Regulatory Affairs Department (GRA) advises internal Eli Lilly teams engaged in development, clinical, manufacturing, and commercial activities, on the regulatory expectations to develop and obtain regulatory approval for the commercialization and distribution of prescription drugs and medical devices. GRA also leads the interactions between Eli Lilly and global regulators around the world. The global regulatory environment is constantly changing to match the advancements in science, medicine, and technology to address the needs and requirements of health authorities and regulators. Companies must be aware of these changes to keep up to date and comply with pharmaceutical and biotechnological industry regulations. The Eli Lilly TMP team was tasked to identify the current regulatory landscape and assess its future trajectory in order to develop long-term strategies that may help GRA to better adapt to the future regulatory environment. The team identified key findings and themes from its secondary literature research and conducted interviews with key opinion leaders and subject matter experts within Eli Lilly. The four major goals of the project were to identify global regulatory environment scenarios, assess their anticipated impact and likelihood, determine commonalities, and inform Eli Lilly of the strategies identified. By the completion of the project, Eli Lilly hopes to gain an expanded knowledge and understanding of the future regulatory space, with insights as to how to better prepare for that future.
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