Changing the future of Oncology.
Functional Leadership Team
Dr. Bedard previously held leadership positions at Kineta, most recently as Chief Scientific Officer, Immuno-oncology and Senior Vice President, Discovery and formerly as Vice President of R&D and Head of Virology. She is the co-inventor of fifteen filed U.S. patent applications for novel classes of antivirals, adjuvants, immune agonists and their corresponding methods of identification. Dr. Bedard received her B.S. from Pennsylvania State University and earned her Ph.D. from University of California, Irvine.
Nicole Chieffo has over 25 years of clinical operations and development experience. Nicole joins Sutro from Janssen Pharmaceuticals where she previously held Sr. Director, Oncology Global Operations Head and Lead Oncology Clinical Scientist positions. Nicole worked directly with Janssen’s medical oncology and hematology physician team leaders in advancing the Early and Late-Stage Research and Development portfolio. In this capacity, Nicole led and supported clinical operations at Janssen, resulting in successful approvals of ZYTIGA®, SYLVANT®, YONDELIS®, IMBRUVICA®, DARZALEX®, ERLEADA®, BALVERSA™, and RYBREVANT™. Prior to Janssen, Nicole was with Cougar Biotechnology Inc. (acquired by Janssen in 2009) and established the Clinical Operational infrastructure to manage the development of Abiraterone Acetate (Zytiga). Nicole held various operational positions at IDEC Pharmaceuticals, a predecessor of Biogen Idec, and led the Global Clinical Development Teams for multiple indications (Non-Hodgkin’s and Hodgkin’s Lymphoma, multiple solid tumors, and psoriasis) of target monoclonal antibodies. Nicole has also held various clinical operations and development positions at Dura and Amylin Pharmaceuticals, Immune Response Corporation, and Oncology Pre-Clinical Research positions at University of Pennsylvania, Department of Radiation Oncology, and Adamantech Inc. Nicole holds degrees in Animal Science, a B.A. in Business Management, and a Master’s in Business Administration (MBA).
Quality & CMC Regulatory Operations
Carlos Lugo has over 25 years of combined experience in quality, compliance regulatory affairs, validation and manufacturing, and has been the Head of Quality for Sutro since 2016. Prior to joining Sutro, Carlos held the role of Global Quality Systems Director at Bayer supporting KogenateTM and KovaltryTM hematology products. Similarly, as QA Director, he was directly involved in the early phase clinical supply activities leading to the successful commercial launch of Keytruda® at Merck & Co. Carlos has also held various increased leadership positions at Hospira (acquired by Pfizer), Johnson & Johnson, Bristol-Myers Squibb and Baxter supporting large molecules, small molecules, medical devices and combination products. Mr. Lugo received his B.S. in Chemical Engineering from the University of Puerto Rico, Mayagüez Campus.
Information Technology & Facilities Operations
Steve Michel, M.B.A., VP Information Technology & Facilities Operations, joined Sutro as a consultant in 2009 and has 30 years of operations experience. Early in his career, he worked in digital photography at Sony Corporation, followed by managing life sciences IT for Arris Pharmaceuticals, AXYS Advanced Technologies and Discovery Partners International.
Previously, led the sales team at Apple, North America as their Retail Business Development Manager. Afterwards, joined Workwerks as their Transportation Commerce Software Developer and created IT consultancy Strategic Entrance, LLC.
While at Sutro, he leads IT and R&D facilities operations as well as construction management, EH&S, procurement and software development for scientific & business needs. Steve earned his M.B.A. from University of Illinois, B.F.A. from University of Southern California and maintains current PMP & PMI-ACP certifications.
Craig Berman, M.D. has over 17 years of experience in drug development and held increasing leadership positions. Most recently, as a Vice President of Clinical Development at QED Therapeutics. Dr. Berman lead the clinical development of PEGPH20 at Halozyme from 2016-2018, cabozantinib at Exelixis 2013-2015, and enzalutamide at Medivation (currently Pfizer) 2009-2013, including successful NDA and launch. Dr. Berman has worked on several immune oncology programs including, GVAX whole cell vaccine at Cell Genesys, intratumoral injection of TLR-9 agonists in combination with pembrolizumab at Dynavax, and PEGPH20 in combination with atezolizumab in collaboration with Genentech and Halozyme. Dr. Berman received a B.A. in Chemistry from Northwestern University in Evanston, an M.D. from the University of Colorado Health Sciences Center and completed a residency in urology at the University of Iowa and post-residency training in urologic oncology at the University of Colorado.
CMC & Supply Chain
Dr. Heidi Hoffmann, VP CMC and Supply Chain, has 27+ years of experience in biotechnology, specializing in process development, technology transfer, manufacturing of vaccines and biological therapeutics. After receiving her Ph.D. from the University of California, Berkeley, Heidi began her career at Aviron, where she worked on process development and production of vaccines for EBV, PIV and influenza (FluMist®). Heidi then joined Valentis, where she led the team responsible for process development, technology transfer and clinical production of plasmid DNA for gene therapy. In 2002, Heidi returned to vaccine work by joining VaxGen, Dr. Hoffmann was responsible for process development and manufacturing of anthrax vaccine. Later, Heidi transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of commercial production of Bristol-Meyer Squibb’s Orencia ® (abatacept) into the Celltrion manufacturing facility in South Korea. After completion, Heidi joined non-profit Global Solutions for Infectious Diseases (GSID) as Project Director responsible for coordinating the outsourcing of process development and manufacture of HIV vaccines. Dr. Hoffmann joined Sutro in February 2011, and currently leads CMC as well as outsourced cGMP manufacturing for protein therapeutics and ADCs produced using Sutro’s proprietary cell-free protein expression system.
Manufacturing & Plant Operations
Mr. Luhar has over 30 years of experience in biotech operations, including Manufacturing, Manufacturing Science and Technology, Engineering and Logistics. He joined Sutro in 2016 as Senior Director of Manufacturing and was promoted to Executive Director in 2018. At Sutro, Mr. Luhar has led the formation of Sutro’s manufacturing organization and GMP compliant operations and is responsible for Sutro’s cGMP manufacturing facility. Prior to joining Sutro, Mr. Luhar held senior leadership positions at Boehringer-Ingelheim, Novartis, Genzyme, and Baxter Bioscience where he worked for 12 years. Mr. Luhar received his B.A. in Biology from San Jose State University.
Werner Rubas, Ph.D., brings to Sutro 30 years of biotech and pharmaceutical industry experience. Formerly, Dr. Rubas was at Nektar Therapeutics for over nine years, most recently as Executive Director in Non-Clinical Pharmacokinetics and Pharmacodynamics. At Nektar he provided leadership support, directed the generation of data packages for regulatory submissions of NKTR-214, NKTR-358, NKTR-262 and NKTR-255, filed a patent application for an immunotherapeutic tumor treatment method, and provided scientific input on cross-functional teams from research concepts to late stage development. Prior to Nektar, Dr. Werner was at Roche in Palo Alto, where he was the Associate Director of the Drug Metabolism and Pharmacokinetics group. Additionally, he has been a SPARK advisor at Stanford University since 2010 and lectures classes on Drug Development at UC Berkeley Extension. Dr. Rubas earned his Ph.D. from ETH, Zurich and received his pharmacy license from the School of Pharmacy at ETH, Zurich.
Finance & Controller
Regina Cheng has 25 years of financial accounting experience and has managed our finance and accounting team since 2015. Prior to joining Sutro, while at Keynote Systems (acquired by Thoma Bravo, LLC), she built and led the finance team as the company’s first controller and assisted in its highly successful initial public offering and follow-on financing. Ms. Cheng has also held various corporate and divisional controllership management positions at several private and publicly held technology companies, such as CompareNetworks, Inc., TeraRecon (acquired by SymphonyAI Group), Sungard Data Systems (acquired by FIS) and Sterling Software (acquired by Computer Associates). Ms. Cheng received her B.A. from the University of California, Berkeley, and is a certified public accountant (inactive status) in California.
Diana Landa joins Sutro from Amgen where she recently held an Executive Director, Global Regulatory Affairs position. Ms. Landa provided leadership for the development and execution of global regulatory strategies for the biosimilar portfolio in the oncology and inflammation therapeutic areas. While at Amgen, Ms. Landa led numerous Health Authority interactions and marketing applications with FDA, EMA, PMDA, Health Canada and ROW. Prior to Amgen, Ms. Landa was with Teva Pharmaceuticals where she led the global regulatory filings for innovative programs in the hematology therapeutic area with leadership of cross-functional teams from IND to BLA stage.
Ms. Landa brings 20 years of Global Regulatory Affairs experience with new product development and marketed product life-cycle management with expertise in biologics and small molecules. She brings extensive experience in leading global Health Authority interactions, negotiating strategies with respect to CMC and clinical development and a successful track record of marketing applications world-wide.
Ms. Landa received her M.S. in Regulatory Affairs/ Quality Assurance from Temple University School of Pharmacy and her B.A. in Chemistry and Biochemistry from LaSalle University.
Dr. Maderna joins the Sutro team after spending the majority of his career at Pfizer in the department of oncology medicinal chemistry. As an associate research fellow, he led multiple chemistry design teams in hit to lead optimization campaigns of small molecule programs directed at various immuno-oncology, cell singling and epigenetic targets. Dr. Maderna’s expertise also includes antibody drug conjugates (ADC’s). At Pfizer, he led the payload discovery and development efforts to support Pfizer’s antibody drug conjugate portfolio. His team developed new and highly potent payloads that led to multiple ADC clinical candidates. For his contributions Dr. Maderna received the 2015 Pfizer Worldwide Research and Development Individual Achievement Award. Before joining Pfizer Dr. Maderna was the project leader of multiple oral kinase inhibitor projects at Wyeth and Valeant Pharmaceuticals. He discovered the MEK inhibitor Refametinib which has been investigated in multiple phase 1 and phase 2 studies. Dr. Maderna obtained his Ph.D. in Chemistry at the University of Heidelberg, Germany. He is the author of over thirty publications and presentations and is the co-inventor on over fifteen patents and patent applications.