CDMO Samsung Biologics Appoints New Leadership in Quality and Regulatory Affairs

Samsung Biologics, the largest contract development and manufacturing organization by capacity in the world, recently announced new appointments to its leadership team. Gail Ward will serve as executive vice president and head of the quality center, while Sojeong Lee has been named vice president and head of regulatory affairs. These appointments come amid a period of operational expansion and a ramped up focus on environmental, social, and governance policies for the company.

Focus on CDMO Quality and Regulatory Compliance

Ward has nearly four decades in quality assurance at large pharma companies and biotech startups. She previously held roles at ProKidney, Celltrion Healthcare, Diosynth RTP, and Biogen.

Lee served as the regulatory affairs director at GlaxoSmithKline in South Korea before this appointment. Her role will involve managing the company’s response to and relationship with global regulatory agencies.

The timing of these appointments suggests that Samsung Biologics is looking to stay on top of a broader industry trend of strengthening regulatory compliance and quality assurance mechanisms.

While the company has not explicitly stated the reasons for these appointments, they occur at a time when it has made a significant push to foreground sustainability. The company also has initiated legal disputes with Lotte Biologics, alleging violations of trade secrets and recruitment regulations.

Regulatory compliance and quality assurance for biologics manufacturing are critical in the CDMO industry, especially when companies are involved in the production of next-generation treatments and new technologies like biosimilars, mRNA vaccines, and antibody-drug conjugates. Samsung Biologics is involved in a variety of new ventures in these areas, and the appointments could be seen as a strategic move to navigate a complex regulatory landscape in a fast-shifting industry.

“For greater transparency in our governance, we have implemented an internal control management system and continue to build up our governance structure,” Samsung Biologics president and CEO John Rim wrote in the CDMO’s 2023 ESG report.

“In order to strengthen our sustainable operations, we strive to refine our metrics and frameworks used to measure our performance and have also implemented an enterprise-wide risk management system. Our ESG committee works closely with management to determine how we deliver on our responsibility to shareholders, including actively responding to changes in the internal and external business environment.”

Strategic Partnerships and Expansion

Samsung Biologics’ recently signed contract with Pfizer is one of several steps the company has taken to expand its operations. The deal, which will involve production at Samsung Biologics’ newly operational Plant 4, is valued at $897 million. This contract is expected to contribute to Pfizer’s total orders from Samsung Biologics, projected to reach $1.08 billion for 2023.

Regulatory and quality assurance will be key as the CDMO continues to expand its operations with new plants and sign larger contracts.

The Pfizer deal follows several other 2023 contracts with large pharmaceutical companies. In March, Samsung inked a $177 million deal with Eli Lilly, followed by a $27 million contract with GSK in February and an $11 million commitment from Roche in June.

“Our consistent delivery of quality service and operational excellence, coupled with our expanded strategic partnerships with top global pharmaceutical companies, have been pivotal in driving stable revenue growth in the second quarter,” said Rim in Samsung Biologics’ most recent earnings report. “With the full completion of Bio Campus 1 offering 604,000 liters of capacity and our Bio Campus 2 expansion with Plant 5 on track to come on line by April 2025, we are well positioned to meet the growing demands of the market.”

Intellectual Property and Legal Actions

Samsung Biologics has also been active on the legal front, particularly concerning Lotte Biologics, a fellow Korean-based biologics firm launched in 2022.

The company has filed multiple injunctions against Lotte alleging that Lotte recruited Samsung Biologics employees in order to illicitly gain proprietary trade secrets. Lotte’s CEO Richard Lee is the former head of drug development at Samsung Biologics.

Navigating the Lotte dispute and other intellectual property regulations within the industry looks to be a priority for Samsung Biologics going forward.

The Future Outlook

Samsung Biologics has disclosed plans for further expansion, including the construction of a fifth plant expected to be operational by April 2025. This new facility aims to augment the company’s production capacity as it continues to take on new business.

All of Samsung Biologics’ current facilities are compliant with the U.S. Food and Drug Administration’s current good manufacturing practices, with bioreactors of varying sizes to meet different client needs. The company is also investing in technologies such as an antibody-drug conjugates facility and a dedicated mRNA manufacturing facility. Maintaining cGMP compliance and product quality throughout this expansion process is essential to maintaining the company’s growth trajectory.

The new leadership appointments at Samsung Biologics occur at a time when the company seeks to maintain this trajectory while navigating complex challenges and opportunities, including significant contracts, the construction of several new facilities, and the ongoing injunctions against Lotte.