Well-Versed Sharkey Ready to Take GeoVax from Buyer to Seller
11 Jul 2022
AntibodyVaccinemRNA
GeoVax VP of Business Development/Courtesy of GeoVax
Partnering is an important way to grow a business and John Sharkey, Ph.D., newly-hired VP of business development for GeoVax, is well-positioned to identify strong partners. He not only has decades of experience in the U.S. and abroad with large multinational pharmaceutical companies, but he also enjoys relationships with small- and mid-sized companies with diverse technologies. And, as a former consultant to GeoVax, he has hit the ground running.
“There are two sources of opportunities, those that are developed internally and those that are available externally,” Sharkey told BioSpace. As VP of business development, he focuses on external opportunities around the world that can be brought in to expand the company’s portfolio relative to its mission. “Our long-term plan is to commercialize in the U.S., yet we have global rights to almost all of our assets,” he said.
Sharkey’s biotech career began at Sandoz Pharmaceuticals, a predecessor company to Novartis. He was head of drug delivery in the U.S. at Sandoz and shared, “When the reorganization was occurring to form Novartis, I had the opportunity to go to Europe and work for the organization in business development.
“I was fortunate that during those years at Sandoz/Novartis, I worked in a lot of therapeutic areas, including oncology, cardiovascular and ophthalmology. This is unusual for business development,” he said, “and helps in the type of work I do now because I have at least a fundamental understanding of the key issues in those therapeutic areas.”
Seeing the Whole Board
A glance at Sharkey’s resume shows multinational experience with Novartis and Shionogi Pharmaceuticals as well as positions with small- and mid-sized companies. “I’ve always enjoyed the opportunity to work with colleagues from across multiple cultures and in different parts of the world, doing transactions and meeting people,” he said. “That’s the great part of working for a large, multinational corporation. If you’re in the right position, you get broad exposure to a lot of great people.”
When Sharkey considers his career, two triumphs stand out and speak to his perseverance and innovative thinking. Early on, he was head of the technical development team for a particular product, he recalled. “A third-party partner went bankrupt after we had submitted our new drug application. We were able to work with colleagues in Europe to put together a team to work with the [FDA] to allow us to build a brand-new manufacturing facility in Austria to manufacture this product when it was approved.” It was an intense experience, he noted. “I learned a lot of things.”
Later, at Novartis, he worked with Genentech to get the ex-U.S. rights for Lucentis, “which turned out to be a very successful product for Novartis’ ophthalmic business,” he said. The challenge was that Genentech viewed Novartis as a competitor. Sharkey, however, succeeded in presenting his company’s product as synergistic.
Eventually, he forged his own path, forming his own consultancy, Cogas Consulting, in 2010, where he called on his expertise to help small and mid-sized companies. As a consultant, he was able “to look at a lot of different technologies and therapeutic areas, and help companies early on with their partnering and strategy.”
It was as a consultant that he began working with GeoVax. “I bring skillsets that my colleagues may not have,” Sharkey said. For example, “I lived through the development side of the business and have seen products go from development to market. Not a lot of people can say that. That’s not my core competency, but I understand what’s involved. Also, part of my business involved regulatory consulting. I don’t consider myself a regulatory expert, but I probably have a better understanding of the regulatory environment than most and how to engage with it. Hopefully, this (along with my business development expertise) will help GeoVax get to where it wants to be.
“We’re a small, smart team and people have to wear a lot of hats,” Sharkey pointed out.
In practice, that also entails understanding how regulations vary across the world and identifying partners early on, thereby sharing the workload and minimizing duplicative efforts. “That’s less expensive for everybody and allows a more accelerated timeline,” he said.
Taking GeoVax to the Next Level
Sharkey noted that one of GeoVax’s objectives in hiring him was to help it become a Phase II company. “That doesn’t simply mean finding Phase II assets and bringing them in,” he pointed out. It requires ensuring those assets advance the company’s goals. Recently, that meant identifying assets that complemented its modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform.
To that end, GeoVax acquired a COVID-19 vaccineCOVID-19 vaccine, CMO4S1, for immunocompromised patients and as a booster to mRNA vaccines. It encodes for both the spike (S) and the nucleocapsid (N) proteins of the virus. Therefore, CMO4S1 elicits an early antibody response and also addresses the highly conserved N portion of the protein, which is good at stimulating the generation of T cells and supporting immune system memory. Consequently, this appears to be an effective way to address viral variants. Both programs for this asset are in Phase II.
The company also has immuno-oncology products in Phase I/II and IND-enabling studies, and studies underway for infectious diseases including Ebola and the Zika virus.
“We’re transitioning from being a buyer to being a seller, so my focus now is on trying to find (development) partners,” Sharkey reiterated. Attending partnering meetings, including the recent BIO International Convention, “to let people know what we have and what we’re thinking of doing” is a big part of his strategy. “It’s a long process,” he said, and deals tend to be done between people who know each other…who’ve been talking to each other for a while and are aware of the company, its goals and its ability to meet its targets. “Walking up to a booth and talking to a person is what starts a discussion that eventually may lead to a transaction.” Sharkey seems well-equipped to get the conversation started.
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