Patrick Lucy, a member of the founding team at Pfenex, is Interim Chief Executive Officer, President, and Secretary and has served as our Chief Business Officer since 2009. Prior to joining us, Mr. Lucy held the position of Director of Business Development at DowPharma, a business within The Dow Chemical Company, a chemicals manufacturer, from 2002 to 2009. From 1999 to 2002, he held the position of Director of Business Development at Collaborative BioAlliance, Inc., a biotechnology company, which was acquired by The Dow Chemical Company. From 1996 to 1999, Mr. Lucy worked at Lonza Biologics Inc. a chemicals and biotechnology company. While at Lonza Mr. Lucy held roles spanning Quality, Operations and Capital Project Management, playing a key role in the design, construction and commissioning of large scale biologics manufacturing facilities. From 1991 to 1996, Mr. Lucy worked at Repligen Corporation, a life sciences company, in various leadership roles focused on biochemistry.
Mr. Lucy holds a Bachelor’s degree in Biology from Villanova University.
Paul Wagner joined us in April 2014 as our Chief Financial Officer. Prior to joining us, Dr. Wagner held the position of Director and Portfolio Manager/Sr. Equity Analyst with Allianz Global Investors, a diversified active investment manager where he worked from 2006 to 2014. Prior to that, Dr. Wagner was the Head of Development Licensing at PDL BioPharma, a diversified biopharmaceutical company from 2005 until 2006. Prior to PDL BioPharma, Dr. Wagner held the position of Vice President at Lehman Brothers, a global financial services firm, starting in 1999 until 2005.
Dr. Wagner received a B.S. from the University of Wisconsin and a Ph.D. in Chemistry from the California Institute of Technology. Dr. Wagner is also a CFA charterholder.
Patricia Lady has served as our Chief Accounting Officer since 2011. Prior to serving in her current role, Ms. Lady served as our Director of Finance and Corporate Controller from 2009 to 2011. From 2007 to 2009, she served as Director of Finance and Accounting at Neurocrine Biosciences, Inc., a biopharmaceutical company. From 2006 to 2007, Ms. Lady held the position of Corporate Controller of Avanir Pharmaceuticals, Inc., a pharmaceutical company. From 2001 to 2005, Ms. Lady held the position of Vice President of Finance at 3E Company, a technology company. From 2000 to 2001, she served as Vice President of Business Development of Everypath, Inc., a technology company. From 1999 to 2000, Ms. Lady held the position of Vice President of Business Development and Marketing at iOwn, Inc., a technology company. From 1997 to 1999, she served as Vice President of Business Development at Careerbuilder, a technology company. Ms. Lady is a certified public accountant, a chartered global management accountant and a certified management accountant.
Ms. Lady holds a Bachelor’s degree in Accounting from California State University, Fullerton and an M.B.A. from the University of California, Los Angeles.
Hubert Chen has served as Pfenex’s Chief Medical Officer since November 2014. Previously, Dr. Chen served as vice president of clinical development at Aileron Therapeutics, where he led the first IND filing and clinical investigation for the Stapled Peptide technology. He also oversaw the early clinical and regulatory activities for a first-in-class MDM2/MDMX dual inhibitor for malignancies expressing wild-type p53 tumor suppressor protein. Before Aileron, Dr. Chen was vice president of translational medicine at Regulus Therapeutics, where he provided preclinical and clinical strategies for microRNA-based medicines in multiple therapeutic areas, including atherosclerosis, diabetes, fibrosis, and hepatitis C infection. Before Regulus, Dr. Chen was senior director of clinical research at Amylin Pharmaceuticals, where he was responsible for the development of second-generation obesity and diabetes programs. He started his biotech career as associate director of medical sciences at Amgen.
Dr. Chen was staff research investigator at the Gladstone Institutes and assistant clinical professor of medicine at the University of California, San Francisco. He received his residency training at Massachusetts General Hospital, M.D. from Columbia University, and B.A.S. in political sciences and biological sciences from Stanford University. Dr. Chen is board certified in Internal Medicine and Endocrinology, Diabetes, and Metabolism.
Steven joined Pfenex in 2016 as our Chief of Manufacturing and Operations. He has over 25 years of commercial biopharmaceutical engineering and operations experience, specializing in commercial operations, facility design and licensure of large scale biopharmaceutical commercial manufacturing facilities. He has extensive knowledge of cGMP biopharmaceutical engineering as well as significant first-hand experience preparing for and interfacing with the FDA and other global regulatory agencies during pre-licensure and biennial inspections of commercial cGMP biopharmaceutical manufacturing facilities. Prior to joining Pfenex, Steven was a member of Amgen’s site executive management leadership team responsible for the aggressive growth at the Puerto Rico manufacturing site.
Henry Talbot has served as our Vice President of Operations since 2009. Prior to joining us, Dr. Talbot held the position of Biotechnology Site Leader at The Dow Chemical Company, a chemicals manufacturer, from 1999 to 2009. From 1994 to 1998, Dr. Talbot was Director of Fermentation and Manufacturing at Mycogen Corporation, an agricultural sciences company, prior to it being acquired by The Dow Chemical Company in 1998.
Dr. Talbot holds a Bachelor’s degree in Biology from the University of Colorado, Boulder, a Master of Science degree in Microbiology from the University of Missouri and a Ph.D. in Microbiology from Oregon State University.
Mitchell Gonzales joined the Pfenex team in 2015 as our Vice President of Manufacturing and Process Sciences. Mitchell is an Operations leader with over 22 years of progressive responsibility in the biopharmaceutical industry. Mitchell has a Mechanical Engineering Technology degree from California Polytechnic University in San Luis Obispo complemented with many years of experience and leadership skills in multiple operational disciplines: aseptic & pharmaceutical manufacturing, plant design, equipment design, production planning, product development, supply chain, and facilities. He holds certifications as a Six Sigma Green Belt and in Professional Project Management (PMP®). His diversity of experience includes 16 years at Amgen as well as roles at Amylin, Novartis, Baxter Bioscience and Merck. In his career he has completed two expatriate assignments in Puerto Rico and the United Kingdom. Previous to Pfenex, he joins us from Merck where he has contributed as a Director Sterile Technology & Commercialization for the three years supporting Quality compliance standardization, technical transfers, external manufacturing, and commercial supply across Merck’s global operation plant network.
Mayda Mercado joined Pfenex in 2016 as Vice President of Global Quality. Mayda is a Quality & Compliance leader with over 25 years of progressive leadership background in the biopharmaceutical/ pharmaceutical and health care industry, bringing a diverse and broad experience to the team that includes serving most recently as Independent Consultant in Quality & Compliance in the US and Brazil. Previously, she served as Vice President of Quality at Therapeutic Proteins Inc., Biosimilar startup Company with responsibilities for Quality and Compliance. She previously worked at Merck, as Executive Director, Global Biologics Quality Operations with responsibilities in Quality & Compliance for the Biologics network including Biologics Bulk Drug Substances, (DS) Active Product Ingredients (API’s), external contract manufacturing, contract laboratories and Sterile finished products for clinical, commercialization and commercial operations.
Mayda led the Quality/ Compliance journey and pre-approval site GMP inspection readiness for Keytruda (pembrolizumab), Merck’s antibody that was designated Breakthrough status by the FDA and subsequently approved. Previously, she worked at Pfizer (formerly Wyeth), as AVP Quality & Compliance responsible for Biopharma Global Quality Products and as a Site Quality Head responsible for Quality Operations/ Compliance and led transformation efforts while maintained high standard regulatory profile. Prior of joining Wyeth, she spent several years at Johnson & Johnson in positions including Director, Supply Chain Processes, at Global Supply Chain, LLC, Director of Compliance at, Centocor Inc., Quality Management Team SAP at Janssen Pharmaceutical Sourcing Group, QC Manager at Ortho Biologics. Mayda extensive experience will support our team in the execution of commercialization.