Company: Eli Lilly & Co.
Liaison(s): Marija Popovic, Shanthi Sethuraman
Eli Lilly & Co. is an Indianapolis- based company founded in 1876 with a vision to make medicines that help people live longer, healthier, and more active lives. The company continues to be committed to making a significant contribution to humanity by improving global health in the 21st century. Lilly has developed a diverse portfolio in several therapeutic areas, i.e. bone muscle joint, cardiovascular, diabetes, men’s health, neuroscience and oncology. Lilly was the first company to mass-produce penicillin, the Salk polio vaccine and insulin. Lilly has locations in 18 countries and their products are sold in 125 countries. The drug development process in the U.S. is highly regulated by the Food and Drug Administration (FDA), and it assesses safety and efficacy of the drug products to be used by the patients. Since it takes 9-12 years to bring a drug to the market, pharmaceutical companies diligently look for ways to improve the overall drug development paradigm, minimize the time to the product launch, provide timely valued medicines to patients and to decrease the duration of drug development and total cost. The conversations that take place between the Sponsor and the FDA during the development of a drug product appear to be instrumental in the drug’s successful preclinical and clinical assessment and ultimate launch. Presently, it is unclear which types of interactions between the Sponsor and the FDA may be the most impactful to the successful development of a product. Therefore, it would be ideal to understand optimal interaction strategies between the Sponsor and the FDA and proactive approaches the Sponsor could undertake to improve the robustness of their internal portfolio development. The Lilly Regulatory Affairs (Lilly-RA) Team Master’s Project (TMP) team was asked to investigate the impact of formal and informal interactions, in the pharmaceutical industry, between the Sponsors and the FDA from 2009-2014 (last 5 years) by focusing on successful submissions of the New Drug Applications (NDAs) and new Biologics License Applications (nBLAs). To accomplish this objective, the Lilly-RA team: performed literature research on current FDA guidance’s; devised and launched an industry-wide survey; interviewed experienced industry experts in the field of US-regulatory affairs; and, gathered publicly available documents. Upon consolidating the data from this research, the team assessed the industry’s best practices. Ultimately, the team made recommendations to Lilly which describe the optimal interactions between the Sponsor and the FDA as well as the timing of these interactions to improve successful drug development.