Leading the Way with Lifesaving Innovation

“They tried to kill me, and instead, they put me on the map — all of a sudden, everyone knew about this woman who stood up to the pharmaceutical industry.”

— Dr. Manon Cox, president and CEO, Protein Sciences Corp.

IN AN INDUSTRY dominated by formidable corporations and well-established manufacturing protocols, a small Connecticut-based company has begun quietly claiming the spotlight. In early 2013, Protein Sciences Corp. made headlines when its much-anticipated Flublok influenza vaccine became the first U.S. Food and Drug Administration (FDA)-approved recombinant influenza vaccine. Bringing the product to market has been a labor of love decades in the making, and strategically positioned on the frontline of this effort is the company’s visionary and tenacious leader, Dr. Manon Cox.

Dr. Cox joined Protein Sciences in 1998 as director of business development, became chief operating officer in 2000 and CEO in 2010. Her passion for innovation and desire to make a difference within an industry bogged down by dated technology has been a driving force behind the company’s remarkable success. “We basically asked ourselves why today’s vaccines should be made using technology from the 1940s,” says Cox. “We saw an opportunity to make a real difference in the influenza field and solve the problems associated with the traditional egg-based technology used to make flu vaccines. And, we did.”

Pioneering DNA Technology

As a company, Protein Sciences has been transforming the biopharmaceutical landscape through the application of its patented Baculovirus Expression Vector System (BEVS) technology. BEVS is currently being used to develop new, innovative products that can save lives and improve health around the world.

Thirty years ago, scientists at Protein Sciences developed and patented BEVS, which has the ability to harness the power of cell culture, programming cells to produce large quantities of specified proteins. Since the active ingredients in vaccines are proteins, the company can use BEVS to make just the active ingredients of vaccines, without growing pathogens.

The advantage of developing BEVS-generated influenza vaccines is that vaccines can be produced in a mere two months; are not limited by strain origin; do not require biocontainment; and are 100 percent egg-free. In addition, the active ingredient in the BEVS influenza vaccine matches the circulating influenza virus since it is made using DNA technology rather than propagating the influenza virus in eggs.

“Our vision was to create a vaccine using a streamlined manufacturing process where highly pure vaccines could be made by design, using modern DNA technology and cell culture in a sterile, well-controlled environment,” says Cox. “Flublok is our first-of-its-kind influenza vaccine containing no egg protein, influenza virus, preservatives, antibiotics, gelatin or latex — it’s an accomplishment we are extremely proud of.”

The Path to Approval

Anyone who has ever brought a vaccine to market knows it is no small feat. But, for a company with fewer than 50 employees at the time, navigating the approval process was very much a David versus Goliath undertaking, wrought with setbacks, detours and even hostile takeover attempts. “We are a young innovative company, and we are going up against the status quo,” says Cox. “At one point, the National Institutes of Health asked us to do an additional study for our proposed vaccine, at a cost of over $20 million. We hired a banker to help raise funds, and during the process, our entire company was almost sold out from under us.”

Cox explains that when shareholders rejected the offer to buy the company, they faced a series of lawsuits, including some filed against her personally: “It was a very difficult time, but some say what does not kill you makes you stronger. They tried to kill me, and instead, they put me on the map —all of a sudden, everyone knew about this woman who stood up to the pharmaceutical industry.”

Making a Difference One Vaccine at a Time

As a biology student, Cox recalls taking a trip to Africa and witnessing the devastation of entire villages following the first wave of the HIV epidemic. Through her studies, Cox had become fascinated by the efficacy of vaccines and their power to eradicate disease, and wondered idealistically if she could one day make a significant contribution within this lifesaving industry. “I began learning about the ins and outs of vaccine development and what dealing with the FDA entails, so I wisely decided to start with something less challenging than a vaccine for HIV,” she says. “I devoted my energy to a new influenza vaccine, but ultimately my desire is to create vaccines for diseases that, like HIV, are killing people in developing countries.”

Cox says her immediate goal is to expand the delivery systems for Flublok and introduce new vaccines into the company portfolio using the BEVS technology platform. Innovations in the pipeline include a vaccine for rabies and an infused therapy for spinal cord injuries. “This technology has tremendous potential in so many different arenas, and is already being used for the development of a wide range of vaccines and therapeutics,” adds Cox. In addition to Flublok, two other BEVS-generated products have progressed through Phase II clinical development, including a therapeutic vaccine for type I diabetes and a gene therapy for lipoprotein lipase deficiency.

Passionate about her company’s mission, Cox says as a leader she strives to inspire and motivate her team to collectively accomplish things they might never achieve individually. She encourages team work and advises young employees to go the distance in their careers in favor of bouncing from job to job. While maintaining a “can do” attitude in the face of opposition can be challenging at times, Cox says it’s easier when the company’s primary product has lifesaving potential: “In a way, it’s easy to stay motivated when you do something as important as what we do in our company. It’s one thing to treat people who are sick, but vaccines are the only way to eradicate disease. We don’t have polio anymore because of vaccines. We’re developing vaccines that save lives. It’s an exciting time to be a part of such a vibrant, growing industry.”