Team of industry experts will provide strategic guidance to leading-edge biosimilar developer in advance of product commercialization
SAN DIEGO, October 19, 2016 — Pfenex Inc., a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value, difficult to manufacture proteins, today announced the development of a Scientific Advisory Board (SAB) to provide expert guidance and insight as the company advances towards product commercialization. Members of the SAB will assist the company as it navigates process development and moves closer to product commercialization.
Inaugural members of the SAB include:
- Greg Blank, PhD, a recognized global leader in bioprocess development with over 23 years at Genentech, most recently as Director of the Late Stage Purification Department responsible for development of commercial processes, post approval changes, and process validation. He received his Ph.D. in cell biology from the University of Southern California in 1981. Following post-doctoral fellowships at Case Western University School of Medicine and Becton Dickinson Monoclonal Center he joined the Recovery Sciences Department at Genentech in 1987, becoming department director in 2000. While at Genentech, Dr. Blank has focused on monoclonal antibody process technology and has led the development and commercial scale-up of recovery processes for both full-length antibodies (including Rituxan, Herceptin, and Raptiva) from mammalian cells and antibody fragments from bacteria. The purification processes Dr. Blank developed for Herceptin and Rituxan have formed the purification platform for all of Genentech’s monoclonal antibodies. He has also helped develop Genentech’s approach to process validation including virus validation, modular validation, and Quality by Design. Since 2010 Dr. Blank has consulted organizations across the globe in the areas of purification process development, scale-up of manufacturing operations, process validation and characterization, virus validation, and regulatory filings.
- Matthew S. Croughan, PhD, an independent consultant providing expert guidance on biopharmaceutical, cell therapy, and biofuels process development and manufacturing. He serves on the Scientific Advisory Board or External Advisory Panel for several firms, ranging Pfizer to PBS Biotech, and also frequently works as an expert witness. From June 2013 to August 2014, he was Chief Technology Officer at Sapphire Energy, Inc., where he led the R & D effort, with a staff of up to 90 scientist and engineers, to invent, develop, and commercialize methods to economically produce renewable crude oil from algae. From January 2006 to August 2013, Matt was the George B. and Joy Rathmann Professor and Director of the Amgen Bioprocessing Center at Keck Graduate Institute (KGI) in Claremont, CA, and was the founding professor of the KGI bioprocessing program, with over 108 masters and two doctoral graduates as his advisees. Prior to 1998, he worked at Genentech for 10 years, in process development and manufacturing sciences, where he developed the first licensed, high density, fed batch animal cell culture process, a core technology now used for dozens of commercial products with ~$100 billion in total annual sales. Matt has two chemical engineering degrees, a Ph.D. from MIT (1988) and BS from UC Berkeley (1983).
- Dennis Fenton, PhD, an industry pioneer, has over three decades of experience in biotechnology. Dr. Fenton retired after a lengthy and distinguished career with Amgen, where he held a variety of notable roles, including Executive Vice President, Operations. Prior to Amgen, he was a senior researcher with Pfizer. Dr. Fenton most recently served on the board of directors of Hospira, Dendreon Corporation, Genzyme, Kythera Biopharmaceuticals, XenoPort, Nora Therapeutics and Amira Pharmaceuticals. He is an alumnus of Rutgers University, where he graduated with a Ph.D. in microbiology. Dr. Fenton currently serves as a member of the board of directors for Portola Pharmaceuticals, Sienna, and Modern Meadows.
“The formation of this expert group of advisors demonstrates our commitment to robust process science as we advance toward commercialization of our biosimilar products, resulting in expanding access for patients,” said Bert Liang, CEO, Pfenex Inc. “We are honored to have this elite group of industry experts providing scientific guidance as we move closer to product commercialization.”
For more information on the Pfenex SAB, please visit: http://www.pfenex.com/about-us/scientific-advisory-board/.
About Pfenex Inc.
Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. The Company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology® platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines, therapeutic equivalents to reference listed drug products, and next generation biologics.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Pfenex’s expectations, strategy, plans or intentions. Forward-looking statements in this communication include, but are not limited to, statements regarding Pfenex’s expectations that the Scientific Advisory Board will assist the company as it navigates process development and moves closer to product commercialization. Pfenex’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of the uncertainties inherent in the clinical drug development process, including, without limitation, Pfenex’s ability to successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates or may require Pfenex to conduct additional clinical trials or modify ongoing clinical trials or regulatory pathways; challenges related to commencement, patient enrollment, completion, and analysis of clinical trials; difficulties in achieving and demonstrating biosimilarity in formulations; Pfenex’s ability to manage operating expenses; Pfenex’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives; Pfenex’s dependence on third parties for development, manufacture, marketing, sales and distribution of products; unexpected expenditures; and difficulties in obtaining and maintaining intellectual property protection for its product candidates. Information on these and additional risks affecting Pfenex’s business and operating results are more fully discussed in the section entitled “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 and its other filings with the SEC. The forward-looking statements in this communication are based on information available to Pfenex as of the date hereof, and Pfenex disclaims any obligation to update any forward-looking statements, except as required by law.
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Paul Wagner, Ph.D.
Chief Financial Officer
Director, Brand Management & Marketing Communications