MaxCyte Minutes Focus On…

MaxCyte Puts A Focus On: Gene Zhu, VP Regulatory

Please join me in welcoming Gene Zhu to the MaxCyte team as Vice President, Regulatory Affairs. Gene comes most recently from Atara Biotherapeutics, where he led a team to prepare and submit marketing authorization application (MAA) and biologics license application (BLA) for Tabcel, an allogeneic T cell therapy to treat PTLD.

Gene has more than 15 years of regulatory experience supporting regulatory affairs following more than 17 years of experience in chemistry, manufacturing and control (CMC) with a range of expertise supporting enabling technologies and cell and gene therapies. Gene has vast experience helping organizations draft and submit IND, DMF and BLA filings for Actemra, Krystexxa, Dupixant, Enhertu, as well as working with the FDA to bring these products to market. Gene will be critical to our growth as we support our partners through clinical development and their commercial success, as well as ensure we can continue expanding the reach of our long-standing Drug Master File (DMF).

What drew you to become a regulatory professional? What drew you to work at MaxCyte?

Throughout my career as a CMC developer for biopharmaceuticals, I have focused on developing manufacturing processes for therapeutic antibodies and recombinant proteins, as well as analytical tests. Having achieved as much as possible in this area, I wanted to broaden my knowledge and expertise to other areas of CMC, including regulatory affairs.

There were two main reasons why I was interested in working at MaxCyte. Foremost was the Company’s supportive and inspiring culture, as well as the competency and expertise of the team members. Secondly was the opportunity to explore something new, to be able to work for a product and service provider in the biopharmaceutical industry for the first time.

What is your “why” or your passion — why do you come to work each day?

As a regulatory scientist, I am passionate about new and innovative ways to solve a problem or make something better, faster, safer, and more cost-effective and efficient. This is the underlying motivation that drives me to work every day for a highly innovative technology and service developer and provider like MaxCyte. I am very happy to be part of MaxCyte and its culture to provide positive impacts on my colleagues, the company, our customers, and ultimately, the patients we serve.

Describe the scope of work for this position.

New scientific discoveries and innovations drive the biopharmaceutical industry to develop novel treatments for patients. To ensure safety, efficacy and quality, the industry is highly regulated by the government regulatory authorities.

In my role, I work with my team to provide latest regulatory guidance, intelligence and strategies to MaxCyte and its customers, to support company’s products and services by keeping MaxCyte‘s drug master files (DMFs) current and compliant to the appropriate regulations, as well as to interact with the worldwide regulators to address their concerns, if any, and to align their understandings.

In what ways does regulatory help to solve challenges faced by MaxCyte’s customers?

Due to the proprietary nature of MaxCyte’s electroporation system, our customers cannot access critical confidential information and describe it in their regulatory filings. To solve this challenge, we created a regulatory filing like DMF which contains this confidential information to be accessed only by the regulators like the FDA. We then provide a letter of authorization (LOA) to our customers to reference the DMF in their regulatory filings (IND, MAA and BLA), allowing regulators to access this information and speed up regulatory approvals.

What is the biggest priority for the regulatory team? How does this fit into the Company’s mission?

The biggest priority for my team is to ensure our DMFs are robust enough to not only support our customers’ regulatory filings for clinical studies but for commercialization and to address any regulatory challenges associated with our electroporation system in a timely manner without causing approval delays for their applications. We are the only company in the industry to have such a long standing DMF embedded into our instruments and continually make updates to keep it current, making it a powerful tool for our customers. We look forward to this next chapter in MaxCyte’s story – transitioning from a clinical to a commercial equipment provider – and continuing to build long-term relationships with our customers.