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Bringing Biosimilars to Market

January 5, 2017

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Pfenex is a leading-edge biologics company driven by the desire to provide access to safe, effective, affordable products to market. CEO Bert Liang opens up about how he has transformed the company and become an award winning CEO.

Pfenex Inc. is a biologics company, focusing on biosimilars to increase access for patients who require these types of biologic medications. Biosimilars are biologic medications that have no meaningful differences from the originator reference product upon which they are based. Located in San Diego, California, USA, and evolved from a fee-for-service offering, creating biologics for other biopharma companies, to creating our own products and pipeline.

They spun out from the Dow Chemical Company, and entered into the public equity markets with an IPO in July 2014. At the moment, the firm has 12 programs, in various stages of development including those in pivotal clinical studies.

The biosimilar industry is fledgling in the United States, while it is well-established in Europe. Bert Liang, CEO of Pfenex Inc., explains more about the company and how they are maintaining their success in a period of economic uncertainty.

“Our focus on biosimilars reflects the cutting-edge technology that allows us to produce these types of molecules with the highest quality, short time frame and lower cost, which creates a very competitive offering. Regulatory bodies require high levels of quality based on sophisticated testing, of which Pfenex has significant expertise, and the marketplace is competitive and requires competitive pricing, which we anticipate can be offered based on our efficient innovative technology.

“Our ability to compete is, and will continue to be based on, our ability to innovate with our technology of producing these types of medications efficiently, and creating appropriate value-adding partnerships on both a local and global basis. Further, as a newer industry in the US, there has been a significant amount of education and advocacy required with stakeholders, from physicians and patients to policymakers and payers. As the Chairman of the Biosimilars Council, a trade group part of the Generic Pharmaceutical Association, I’ve taken on a role that leads such communication. Hence, our strategy is not only to advance as a company with respect to our technology and pipeline, but also to ensure appropriate stakeholders understand the relevance of these efforts.”

Bert has had a profound effect on Pfenex Inc. is. He noticed potential in the company and decided to alter the firm’s mission which has contributed to its renewed success as he explains.

“Fundamentally, when I was brought on to spin the company out of the mother ship, there was a fairly uninspiring vision to be a service provider of last resort. What I saw was the potential for the company to become much more that that – given the efficiency and expertise of the technology and personnel, the burgeoning of this new field of biosimilars, and a global environment faced with resource pressures. We thus changed the mission of the company to ‘innovative solutions for global health’. This required a reset of the organizational principles and concepts under which the company operated, and constant education upon how we, as an organization, could have significant influence on the lives of patients.

“By being stalwart in our mission, persistent in our goals, we were able to transition into a product company, creating value with programs that entered into the clinic quickly, and becoming a leader in the field. Part of the success equation related to a strong and passionate management team who totally bought into the change, as well as a company that truly got behind our mission, and the associated values of positivity, passion, diversity, and accountability.”

The biosimilars industry is a new one in the US, but is derived from the biotechnology industry in the past. It is the natural consequence of the life cycle of biologic products going off patent, and continues to garner momentum domestically, with the hope of catching up to the leader, Europe. Bert outlines his thoughts on the current state of the industry and how they will be affected by any issues.

“There has been significant momentum in the biosimilar space within the US recently, with the approval of a total of four drugs in this space, continuing clarification of the regulatory pathway, and uptake by the reimbursement community, as well as investment by both large cap companies and blue-chip investors. We will continue to be affected by those legal challenges, federal policies, and legislative efforts around any new industry. However, the impetus is clear, that these types of medicines are a reality in the US, and the hope is that we will be able to approach the success Europe has experienced in the very near future.”

Technology, particularly in the areas of bioanalytics and manufacturing, are key to compete in this industry. “Our very business was based on the development of our proprietary technology which took a decade to hone, and manifests as a high quality, low COGS, efficient system; this was and is accompanied by bioanalytical expertise built to the highest of standards,” says Bert. “Our dedication to the continued innovation in our space is a testament to our belief in the importance of technology.”

Becoming a CEO is not without its challenges, both internally and externally. Bert tells us about what challenges he has had to overcome in order to be a successful CEO.

“When dealing with a new industry, there is the requirement of tireless education to everything from the investment community to regulators. But the nature of education is the creation of messages needed to be understood by the audience to whom one speaks, and it required me to go back to my days as a professor and physician in order to speak in the appropriate parlance.

“Internally, it was a different kind of education, that of understanding our potential as a company, what our leadership and management style should be, and what we should expect of ourselves.” In fact, this approach was articulated in a book, ‘Managing and Leading for Science Professionals: (What I Wish I’d Known while Moving Up the Management Ladder)’, which was written during this time of transition. “Both these duties are ongoing, but the commitment to motivation and our mission is unwavering.”
Bert believes that successful leaders are both good listeners and sensitive organizational observers, saying, “It is, at best, difficult to succeed without working with others, and as companies move from a small group of entrepreneurs to corporate groups with functional areas and a human resource department, the need to have skills in both is paramount. Further, within this context, having managerial courage to express a considered opinion, and being able to engage in disagreement without being disagreeable is also a derivative of both of these traits. These are areas I try not only to emphasize in myself, but in the organization as a whole.”

Bert has helped to change the fortunes of Pfenex. He tells us what keeps him motivated to carry on in tackling any challenges in the industry.

“Every day I start by identifying the things I am grateful for, and the people I am grateful to. I compare what Pfenex was, to what it is today, and what our promise is for tomorrow. That is an exercise that makes me understand that the glass is always half-full (or more) rather than the reverse, and that it is a privilege to be able to guide such a capable ship an on such an exciting journey for such a relevant mission.”

Today, Pfenex are a development stage company, with a number of partnerships with large cap companies in their space, both locally and global. “We have a robust pipeline, and development expertise in the biosimilar industry and are a leader within this group,” says Bert. “We continue to invest in our capabilities and develop our products, with the aim of commercializing these compounds for patients who harbour conditions that require them, increasing global access to biologic medicines.” The relevance of their mission is unquestioned, getting affordable biologic medicines to patients remains their key objective, to which their current and future goals are aligned.

Company: Pfenex Inc.
Name: Bertrand C. Liang
Web Address: www.pfenex.com
Address: 10790 Roselle Street, San Diego,
California, USA
Telephone: 1 858 352-4400

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