Ex-Novartis AG Exec to Lead Moderna’s Manufacturing and Operations Scale-Up

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna Therapeutics, a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that Juan Andres, former Global Head Technical Operations (Manufacturing and Supply) at Novartis, has joined the company as Senior Vice President of Late Stage Technical Development and Manufacturing (beyond human proof of concept, or hPOC). Mr. Andres will be responsible for the scale-up of Moderna’s manufacturing and quality efforts as it continues to advance its growing pipeline of mRNA medicines and prepares to bring its state-of-the-art Good Manufacturing Practice (GMP) mRNA clinical manufacturing facility online in 2018. In addition, he will lead efforts aimed at preparing Moderna for Phase 3 development and commercialization. Mr. Andres will work closely with Moderna President Stephen Hoge, who will continue to lead Early Stage Technical Development (pre-hPOC), to ensure successful transition between early and late development activities. Mr. Andres will be a member of Moderna’s Executive Committee and report to the company’s Chief Executive Officer Stéphane Bancel.

“Having had the privilege to work with Juan while we were at Lilly together, I know first-hand his abilities and effectiveness leading a complex global pharma development and manufacturing organization,” said Stéphane Bancel, Chief Executive Officer at Moderna. “Juan would be a hugely valuable addition to any number of biopharma companies’ executive committees around the globe. So, I feel truly honored that he chose to join Moderna. With the pace of our progress and the scale of our ambitions, ensuring we can deliver consistently high quality GMP mRNA is a critical enabler of Moderna’s long-term vision. With Juan as part of our team, we have now significantly enhanced our ability to execute our vision and deliver on our mission. I look forward to working with him again.”

“I’ve spent a great deal of time with Stéphane and the Moderna team in recent months, and I have gotten an ‘under the hood’ look at the science, technology platform, advancing R&D programs, and the sophisticated infrastructure that is being built to accelerate Moderna’s mRNA research efforts and drive its early development programs,” said Juan Andres, Moderna’s incoming Senior Vice President of Late Stage Technical Development and Manufacturing. “I look forward to leveraging the expertise and skill set I’ve accumulated working at established large pharma organizations to help Moderna build its drug development organization. The novelty of what Moderna has set out to accomplish, coupled with the fact that I know and trust Stéphane’s leadership instincts and abilities, convinced me that I could not pass up this tremendous opportunity.”

Mr. Andres was previously the Global Head of Technical Operations (Manufacturing and Supply Chain) for over 25,000 Novartis employees across all of its divisions. In this role, he had responsibility for all of Novartis’ manufacturing sites, and related support functions and technologies worldwide, overseeing small molecules drug substance and drug product, as well as biologics drug substance, drug product and technical development. Mr. Andres’ previous roles at Novartis included Group Novartis Quality Head, Global Head of Technical Research and Development, and Global Pharmaceutical Operations Head. Prior to Novartis, Mr. Andres worked at Eli Lilly & Co. for 18 years in a variety of manufacturing, production and quality roles in the United States, Puerto Rico, UK and Spain, most recently serving as Vice President, Pharmaceutical Manufacturing. He holds an undergraduate degree in pharmacy from Alcala de Henares University in Madrid and completed an advanced development program at the London Business School.

Steve Harbin, who previously served as Senior Vice President of Manufacturing and Operations at Moderna, is transitioning to new roles as Chief of Staff and Chief Sustainability Officer.

“I have worked with Steve for the past 17 years at three different companies now. In each role he has held, because of his broad expertise, his strong leadership skills, and his ability to successfully tackle any project, he has proven to be an invaluable asset to the respective companies and an incredible partner to me,” said Mr. Bancel. “Steve has been leading our corporate sustainability efforts to date and will now be able to focus more intently on these initiatives as they continue to expand and permeate across our organization. As Chief of Staff, he’ll continue to work closely with me on critical projects related to our scale-up and advancement as a development stage company.”

Moderna announced its first 12 mRNA development programs in January 2017, including eight prophylactic vaccines, a personalized cancer vaccine, two immuno-oncology therapeutics, and a therapeutic for cardiometabolic diseases. Five of these programs are in clinical study in the United States, Europe and Australia, and the remaining seven programs are advancing toward the clinic.

To support and manage the breadth of simultaneous clinical studies Moderna foresees in the coming months and years, the company is building a 200,000-square-foot GMP mRNA clinical manufacturing facility in Norwood, Mass. The fully integrated facility will enable the manufacture, quality, control and supply of clinical grade mRNA therapies and vaccines for Good Laboratory Practices (GLP) toxicology studies as well as Phase 1 and Phase 2 clinical studies. At the site, Moderna will carry out all manufacturing activities—from raw material production to active pharmaceutical ingredients (APIs), formulation, filling and finish. Moderna plans to open the facility in 2018.

About Moderna Therapeutics

Moderna is a clinical stage pioneer of messenger RNA (mRNA) therapeutics and vaccines, an entirely new drug technology that directs the body’s cells to produce intracellular or secreted proteins. With its breakthrough platform, Moderna is developing mRNA vaccines and therapeutics as a new class of medicines for a wide range of diseases and conditions, in many cases by addressing currently undruggable targets. Moderna is developing its innovative mRNA medicines for infectious diseases, cancer (immuno-oncology), rare diseases, cardiovascular disease and pulmonary disease, through proprietary development and collaborations with strategic partners.

Headquartered in Cambridge, Mass., privately held Moderna currently has strategic agreements with AstraZeneca, Merck and Vertex Pharmaceuticals, as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS); and the Bill & Melinda Gates Foundation. To learn more, visit www.modernatx.com.