Dr. Manon Cox has always been fascinated by science. Her interests in molecular biology and the baculovirus expression system eventually led her to Protein Sciences Corp., where she helped develop an innovative influenza vaccine.
Dr. Cox has been the recipient of many honors and awards recognizing her importance as a leader in innovation and influenza. In 2014 she received a Women of Innovation Award from the Connecticut Technology Council in recognition of Small Business Innovation and Leadership.
Innovation Destination Hartford: Tell us a little about your background.
COX: I graduated from the University of Nijmegen in the Netherlands in the late 1980s. Shortly afterward, I landed my first job at the University of Amsterdam exploring the usefulness of polymerase chain reaction (PCR)-based human papillomavirus (HPV) screening for early detection of cervical cancer. I found the work boring, but important, as our findings supported the hypothesis that HPV 16 and 18 were associated with early-stage cervical cancer.
Not long after, I spent six years working a research scientist in Research & Development at Gist-brocades. There, I experienced the power of working in multi-disciplinary teams. Teamwork enabled us to accomplish results I never could have imagined possible. We were able to increase production levels of a detergent enzyme more than 1,000-fold, which made the production process commercially viable and decreased the cost.
A production plant was added at one of our sites in Belgium and I entered into a fast-track management development program to first-hand witness the construction of that plant in various roles.
I never thought that 20 years later we would be applying the same genetic engineering principle to produce a temperature stable influenza vaccine.
During this time, I traveled to Africa and saw the dramatic effects of the Human Immunodeficiency Virus (HIV/AIDS) throughout small villages in East Africa. I realized a vaccine was desperately needed—it would be the only way to take control of the devastating impact of the disease caused by this virus. It wasn’t until much later that I realized I could play a role in vaccine development.
IDH: When did you become involved with Protein Sciences?
COX: I joined Protein Sciences in the late 1990s for the people, the products, and the technology.
I acted as Director of Business Development from 1998 to 2001 and then Chief Operating Officer from 2002 to 2010. I’m now the Chief Executive Officer.
IDH: Tell us about Protein Sciences and the vaccine it is developing.
COX: In the late 1990s, the company was actively involved in vaccine development and the baculovirus expression system was its technology platform. The company has since developed and patented a Baculovirus Expression Vector System (BEVS), which we use in all of our products and services.
Back when I joined Protein Sciences, we knew we needed to bring our technology to maturation by receiving approval from the Food and Drug Administration (FDA).
We thought an influenza vaccine would be the perfect target since Protein Sciences had generated preliminary human clinical data in the mid-1990s that supported the hypothesis that a recombinant hemagglutinin (rHA) protein could prevent influenza. Our technology was well suited to support the annual updates required for the influenza vaccine, as only the baculovirus would need to be modified. In addition, the 1998 H5N1 bird flu outbreak in Hong Kong clearly showed the limitations of the egg-based manufacturing process used to produce influenza vaccines.
The National Institutes of Health (NIH) told us we were the only company in the world that could develop a vaccine “in time.” We met their expectations by delivering doses in just eight weeks. However, what seemed to be a straightforward project became a 14-year trajectory that ultimately lead to FDA approval of the first recombinant influenza vaccine, named Flublok.
IDH: What were your biggest hurdles during that timeframe?
COX: The main challenges we encountered throughout the FDA approval ranged from scientific to economical.
The challenge of finding the right funding was enormous. I am grateful for the financial support we initially received from the NIH, two Biotech development companies Diamyd and Unmet Medical Needs (UNM), and a few private investors who believed in our cause and the importance of prevention of disease versus treatment. We later received support from the Biomedical Advanced Research and Development Authority (BARDA) and researchers who purchased research antigens from the Protein Sciences, which fueled our development work.
The scientific challenge of designing a universal production process for Flublok was daunting—especially the purification of different HA proteins, but we knew we could overcome that with time and a strong team effort.
There were times we considered turning to other regulatory bodies such as Australian or European regulators, but Connecticut was our home base and we had fantastic support from former regulators and several progressive FDA employees, who helped us through the regulatory approval process.
Our biologics license application for Flublok was under review for five years. The novel Flublok vaccine was finally approved for the prevention of influenza by FDA in 2013.
I am proud that I have been able to help bring a modern vaccine to market and to drive innovation in vaccine development.
IDH: In addition to developing the Flublok vaccine, what other products and services does Protein Sciences provide?
COX: Our “Plug & Play” manufacturing platform used to produce Flublok is our biggest opportunity as it can be rapidly deployed to make vaccine for all kind of infectious agents with ZIKA being the most recent example. We basically have three main business lines that utilize this technology:
- Proprietary vaccines—we develop and produce the next generation of safe and effective vaccines.
- GeneXpress product development and manufacturing services—we partner with others to create and manufacture modern vaccines, therapeutics, and gene therapies.
- Research antigens—we offer various purified antigens and antibodies to the scientific community for disease research.
IDH: What do you enjoy most about living and working in Connecticut?
COX: I like that Connecticut is bordered by the sea and we have access to many outdoors activities. The Greater Hartford region is developed and there are lots of things to do including shopping, museums, casinos, great restaurants, theater—you name it!
To learn more about Protein Sciences Corp. visit www.proteinsciences.com.