Get to Know SCB’s New Vice President, Dr. Jessica Carmen

Jessica Carmen, Ph.D., was elected to serve as SCB’s Vice President in June, joining the new Executive Committee officers who took office in March for the 2019–2021 term. She was a founding director of SCB, originally serving as Secretary, and continued to provide strategic guidance as part of the Board of Directors until taking on her new role on the Executive Committee.

Dr. Carmen has been involved in the biomedical field since 2005, when she began her career conducting research for the National Institute of Aging. She brings extensive experience identifying opportunities and growing businesses in the cell and gene therapy industry, including her time at Lonza, a contract manufacturer for cell and gene therapies, and MaxCyte, developer of enabling technologies for non-viral gene delivery.

As Vice President, Dr. Carmen will work closely with the SCB President, using her knowledge, commitment, and championship of the SCB mission to help ensure continuity of SCB’s leadership.

We sat down with Dr. Carmen to learn more about her experience and her vision for the role of SCB over the next two years.

How does your past experience translate to your role as SCB Vice President?

In my experience at Lonza, working with developers of cell and gene therapies, I quickly recognized the need for standards in the manufacture of these novel therapies. I saw firsthand how each developer was developing and validating their own assays (e.g., cell counting methods) and how this created extra work and expense, requiring developers and regulators to use more of their precious time. I was thrilled to play an integral role in the establishment of SCB and I’m even more delighted to, again, serve on the Executive Committee during this important time for the organization.

What do you see as the upcoming priorities and trends for the regenerative medicine field?

I think we are going to see a surge in gene therapy and gene-modified medicines. Relatedly, there are many aspects of gene therapy that are ripe for standards development, such as tests for replication incompetence for therapeutic viral vectors,  methods for assessing product comparability, and evaluating pre-existing immunity to viral vectors.

How can SCB best support regenerative medicine standards development over the next two years?

SCB can support regenerative medicine standards development in the near term by continuing to coordinate the activities of industry and standards development organizations. It will be crucial to ensure that standards development is aligned with the needs of the industry and that the industry is aware of the standards that are being developed.

From your perspective, what role do standards play in promoting the acceptance of regenerative medicine products?

Standards play an important role in in streamlining the manufacturing process for regenerative medicine products. As standards are developed for common manufacturing components, it allows developers to focus precious resources and time on innovation and novel product-specific attributes and not on the development of generally applicable components which are not product-specific and/or are not related to their proprietary processes.