U.S. Food and Drug Administration (FDA) official Wellington Sun, MD has been hired by biotechnology company Moderna Therapeutics, Inc. of Cambridge, MA to head its Vaccine Strategy and Regulatory Affairs division. Dr. Sun was director of the Division of Vaccines and Related Product Applications at the FDA’s Center for Biologics Evaluation and Research (CBER) where he worked on infectious disease policy, including efforts to respond to the 2009 H1N1 influenza pandemic and the 2014-2016 Ebola and 2015-2016 Zika virus outbreaks.1 2
“I am excited to work with the team here to identify new development candidates while progressing the portfolio of existing clinical programs,” said Sun.2
Prior to his 10-year career at the FDA in which he facilitated the approvals of 28 new vaccine applications in infectious diseases and over 100 applications for new vaccine indications, Sun worked at the Centers for Disease Control and Prevention (CDC) where he led research on Dengue fever and West Nile virus. Before that, Sun was a clinician and vaccine researcher for 27 years at the U.S. Army Medical Corps.1 2
According to Moderna’s Chief Medical Officer Tal Zaks, MD, to whom Sun will report, Sun is “uniquely qualified to shape” his company’s development strategy.1
Moderna is poised to become a major player on the vaccine development front. Currently focusing on a brand new class of treatments called messenger RNA (mRNA) vaccines and therapeutics, the company is working to develop new vaccines against a wide range of diseases including cancer, influenza, Zika and Chikungunya, among others.1 2
The central molecule of all forms of life involved in almost all aspects of cell biology, mRNA has been used as a method to deliver genetic information, particularly with mRNA based cancer immunotherapies.3 Scientists have been developing synthetic mRNA that is engineered to resemble mature and processed mRNA molecules not only to create new cancer immunotherapies but also to create new infectious disease vaccines.4
Vaccines using mRNA technology differ from traditional vaccines because they act as a “set of instructions that direct the body to fight or prevent disease.” Immunotherapeutic medicines and mRNA messenger vaccines are being designed to “direct the body’s cells to produce intracellular or secreted proteins” by scientists who believe the mRNA mechanism of action can be engineered to prevent or treat infectious diseases, cancer, cardiovascular and rare diseases.2
However, no new technology comes without the potential for unknown risks, especially one that involves genetic engineering. As one group of mRNA vaccine developers pointed out, “Historically, the prospect of developing mRNA vaccines was uncertain due to concerns of mRNA instability and the feasibility of large-scale manufacturing.”5
The production of pharmaceutical products using the new mRNA technology is responsible for the Moderna’s current $7 billion valuation. The company is also in “strategic relationships” with such pharmaceutical giants as Merck, AstraZeneca and Vertex, as well as agencies under the auspices of the U.S. Department of Defense, the U.S. Department of Health and Human Services (HHS), and the Bill & Melinda Gates Foundation. Moderna recently opened a major manufacturing plant specifically for its mRNA product development programs.1 2
1 Sagonowsky E. Moderna picks up FDA vaccine official Wellington Sun. FiercePharma Sept. 6, 2018.
2 Press Release. Dr. Wellington Sun Joins Moderna as Head, Vaccine Strategy and Regulatory Affairs. Moderna Therapeutics Sept. 5, 2018.
3 Weissman D. mRNA transcript therapy. Exp Rev Vaccines 2015; 14(2): 265-281.
4 Sahm U, Kanko K, Tureci O. mRNA-based therapeutics – developing a new class of drugs. Nature Review Drug Discovery 2014; 13: 759-780.
5 Brito LA, Kommareddy S et al. Chapter Seven – Self-Amplifying mRNA Vaccines. Advances in Genetics 2015; 89: 179-233.