Dr. Morinello completed his PhD in the Curriculum in Toxicology in 2001. He conducted his dissertation research at UNC under Dr. James Swenberg, where he studied vinyl chloride-induced DNA adducts using high-resolution mass spectroscopy. After UNC, Dr. Morinello joined Southern Research Institute, a toxicology contract research organization. He later joined ChemRisk Inc., a scientific consulting firm. Dr. Morinello is now a Senior Scientific Manager of Product Quality/Occupational Toxicology at Genentech, a subsidiary of F. Hoffmann-La Roche Ltd.
How did you first become interested in the field of Toxicology?
I always had an interest in the life sciences but began to specifically consider toxicology after my uncle, a senior organic chemist in the agricultural division of a large chemical company, told me while I was in high school that they “couldn’t hire enough toxicologists.” In addition to the possibility of finding a job, I was attracted to the interdisciplinary nature of the field. Those factors, along with my undergraduate training in biochemistry, made a Toxicology PhD program seem like a great fit.
So what was your first job after graduate school?
My first job was at Southern Research Institute, at which I was responsible for the oversight and reporting of studies conducted for the National Toxicology Program, National Cancer Institute, and commercial clients. This provided me with first-hand experience with in vivo study designs and animal models that proved invaluable in my later career. It was also interesting to observe how the results of those toxicology studies were subsequently used to inform drug development or public health decision making.
How did you find your way to Genentech?
After my time at Southern Research Institute, I relocated to San Francisco to work at ChemRisk, a human health risk assessment consulting firm where my work focused on issues related to environmental or occupational chemical exposures. I had a few colleagues from the Curriculum who were in the Safety Assessment department at Genentech, a biopharmaceutical company headquartered nearby. Although it seemed like a longshot, they eventually convinced me to apply for a role in their group. At Genentech, I was initially a project team representative responsible for toxicology aspects of investigational and marketed drug programs. During that time, I was fortunate to be assigned to a molecule that was eventually approved as a first-in-class treatment for certain cancers in humans. That is a once-in-a-lifetime experience for many pharmaceutical scientists. I also acted as a pharmacology team leader with additional responsibility for other nonclinical aspects of development programs, which was another valuable experience.
That sounds really interesting! So what do you do now?
My official title is Senior Scientific Manager in the Product Quality/Occupational Toxicology group. Our group generates various safety assessments that are required to support manufacturing activities.
Much of our work is related to potential impurities in our drugs, which is an area of great interest to FDA and global health authorities. For example, toxicology assessments are required to address trace-level genotoxic impurities that may be present in small-molecule drugs. It is also necessary to evaluate the health effects of leachable substances derived from materials used in the manufacturing of biologic products or from components of delivery devices. Another area of concern is potential carryover of one product into the next product manufactured in the same equipment.
Our group also generates hazard assessments used to ensure that the workers manufacturing the products are adequately protected from the substances they are handling. Pharmaceuticals differ from most other manufactured chemicals in that they are designed to cause effects in humans at relatively low doses. This is desirable in patients but also means exposure to workers during manufacturing must be carefully controlled. Our assessments play a major role in informing industrial hygiene practices across the global Roche organization. It’s a very interesting role because I have the opportunity to apply my experience in drug safety in a different context.
What is your typical day like at Genentech?
That’s a tough question to answer, since no two days are exactly the same. In my role as a development team representative, a significant portion of my time was spent in project team meetings with representatives from other functions such as Metabolism/Pharmacokinetics, Clinical, Pharmacovigilance, etc. Each toxicologist was responsible for multiple projects at different stages of development, so I was always busy. Another big part of my job was integrating our findings into health authority submissions. In my current role, most of my time is spent preparing or reviewing hazard assessments or providing guidance to project teams. I also participate on several cross-functional teams and an industry consortium focused on leachable substances. These occasionally require international travel or conference calls at odd hours. When on campus, there are terrific employee facilities such as the cafeterias and gym, and Genentech provides plenty of forums to gather to catch up with colleagues or blow off some steam.
When you aren’t working, what are your biggest hobbies?
My wife also works full-time, and we have three children under 6, so most of my hobbies are currently on hold. However, we love getting outside with the kids as often as possible!