Denovo Biopharma

Wen Luo, Ph.D. - Chief Executive Officer, Chief Scientific Officer

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Dr. Wen Luo has over 20 years of experience in biomedical research and industry including more than 15 years of experience in applying genomic technology in drug discovery and development. Prior to founding Denovo Biopharma, Dr. Luo managed the genomic group and provided bioinformatic support to a broad range of research projects across a number of therapeutic areas including oncology, hematology, inflammation and metabolic diseases at Ligand Pharmaceuticals. He was also responsible for developing clinical biomarkers for drugs in various stages of clinical trials. Before joining Ligand, he was a senior scientist for bioinformatics at Incyte Genomics, where he managed one of the largest proteomic databases, LifePro. He was also involved in discovering novel human genes and splice variants, and was the co-inventor of patents covering hundreds of novel genes derived from these findings. Prior to Incyte Genomics, he was a research scientist at Sugen, which had been acquired by Pharmacia, where he worked on drug target identification and validation for a number of novel kinases discovered at Sugen. Dr. Luo was a Howard Hughes Medical Institute post-doc fellow at the University of California, San Francisco, and received his Ph.D. in Molecular Biology and Biochemistry from Indiana University School of Medicine. Dr. Luo received pre-med training at Peking University and medical training at Peking Union Medical College.



Ronald L. Shazer, M.D. - Chief Medical Officer, Oncology

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Dr. Shazer has more than 10 years of clinical research experience, initially as an investigator on multiple clinical trials and subsequently leading the development of therapeutics in the biopharmaceutical industry. Dr. Shazer served as Senior Vice President and Chief Medical Officer at Inspyr Therapeutics until December 2017. Previously he served as Chief Medical Officer at Tracon Pharmaceuticals. Both Inspyr Therapeutics and Tracon Pharmaceuticals are clinical stage biopharmaceutical companies developing targeted therapies for cancer. Prior to Tracon Pharmaceuticals, he was Senior Director, Clinical Lead Oncology at Pfizer, where he led the clinical development of multiple oncology compounds including antibody drug conjugates, dual targeting T cell engaging antibodies and immuno-oncology small molecules. Prior to Pfizer, he was Director, Clinical Research Oncology at Bristol-Myers Squibb and served as the study lead on the registration trial for elotuzumab (EMPLICITI™), a therapy for multiple myeloma that subsequently received FDA approval. He also served as Head of Clinical Development at Arena Pharmaceuticals during which time the company filed a new drug application (NDA) for lorcaserin (Belviq®). Dr. Shazer previously held academic positions in the Department of Medicine at the University of California, San Diego, University of California, Los Angeles School of Medicine and Cedars-Sinai Medical Center. He received his B.A. in economics from the University of California, San Diego, M.D. from New York Medical College, and MBA. from the Anderson School of Management, University of California, Los Angeles. He completed his residency in internal medicine at Cedars-Sinai Medical Center in 2004.



Lei Zhang, M.D. - Chief Medical Officer, Hematology

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Dr. Zhang has 20+ years of experience in pharmaceutical industry and clinical research. She has extensive regulatory and clinical trial experience leading to global regulatory approval of multiple indications in US and Europe, strong expertise in designing and managing clinical trials with strong therapeutic knowledge in oncology and hematology therapeutic areas. Most recently, Dr. Zhang served as Executive Medical Director/Program Lead at Celgene Corporation until December 2018. During her 10-year tenure at Celgene, she was the Program Lead for REVLIMID® overseeing clinical and scientific activities in multiple key global registration studies in the Lymphoma/CLL Development Program, including a successful regulatory filling that led to approval in Mantle Cell Lymphoma indication. She was also the Program Lead for the REVLIMID® biomarker driven global Phase III Diffuse Large B Cell registration program. Prior to Celgene Dr. Zhang served as Clinical Indication Leader at Novartis Pharmaceuticals Corporation Oncology Global Business Unit, where she was the indication lead on the RYDAPT® and FARYDAK® development program, responsible for development activities in multiple indications including Leukemia, MDS, and Lymphoma. Prior to Novartis, Dr. Zhang was at Eli Lilly and Company, where she worked on regulatory submission of ALIMTA® Mesothelioma and Non-Small Cell Lung Cancer NDA filing and managed multiple studies in various indications in solid tumor field. Dr. Zhang received her M.D. from Capital Medical University, Beijing, China. She was trained as a Neurologist at Beijing TianTan Hospital. Dr. Zhang also earned a M.S. in Biochemistry from Medical College of Virginia, Richmond, VA, where she also worked as Research Scientist in Biochemistry and Molecular Biology lab.



Xiangming Fang, M.D., Ph.D. - Chief Operating Officer

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Dr. Fang has 20+ years of experience in biomedical research and product development. She has a strong scientific background with integrated knowledge in medicine, molecular and cell biology, immunology, genomics and proteomics. She was also involved in several startup companies where she gained experience in team building and operations. Previously as the Senior Vice President and Chief Scientific Officer at GenWay Biotech, she was responsible for new technology and product development and production, as well as customer support and partnership coordination. Prior to GenWay, Dr. Fang served at GenStar Therapeutics, initially as the Director of the Cancer Program and the Director of Preclinical Studies, then as Vice President, Hemophilia and Vector Development. Dr. Fang's earlier experience includes gene therapy product development for hemophilia at Baxter Healthcare and GeneMedicine Inc. Dr. Fang obtained her M.D. from Zhejiang University Medical School and Ph.D. in Molecular Biology from the University of Alabama. She completed her postdoctoral studies at the University of Texas, MD Anderson Cancer Center. Dr. Fang was the President (2009-2010) of Sino-American Biomedical and Pharmaceutical Professionals Association (SABPA), San Diego chapter, and currently serves as Vice Chair of Board of Directors.



Michael Haller, Ph.D. - Chief Business Officer

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Dr. Haller has broad experience in the pharmaceutical and biotechnology industries, with leadership roles in business development and alliance management, finance and accounting, and corporate and product strategy. He currently leads the Business Development and Finance and Accounting teams at Denovo Biopharma. Prior to Denovo, he was Chief Business Officer, responsible for business development, finance, and accounting at Peloton Therapeutics. As Vice President of Business Development and Alliance Management at Ligand Pharmaceuticals, Dr. Haller was responsible for out-licensing activities and managing Ligand’s numerous alliances. Prior to Ligand, he was Senior Vice President of Strategic Partnerships at Anaphore, now Bird Rock Bio. He joined Anaphore from Halozyme Therapeutics, where he directed key alliances with Roche and Baxter Healthcare from deal signing through registration submissions, which resulted in several approved drugs, including Herceptin SC®, Mabthera SC®, and HyQvia®. He also served as head of Halozyme’s drug delivery franchise, Enhanze Technology. Prior to Halozyme, Dr. Haller was a McKinsey & Company management consultant focusing on complex health care issues for a number of Fortune 500 companies. Dr. Haller has published several peer-reviewed articles, presented at numerous scientific conferences, and is co-inventor on multiple patents. Dr. Haller earned his Ph.D. in Biomedical Engineering from The Johns Hopkins University School of Medicine, his MS in Chemical Engineering from Cornell University and his B.S. in Biomedical Engineering from The Johns Hopkins University.



Xiao-Xiong Lu, Ph.D. - Chief Technical Officer

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Dr. Xiao-Xiong Lu has over 30 years of experience in the U.S. biotech and pharmaceutical industries including extensive experience in pharmaceutical CMC development, manufacturing and supply chain. He has also consulted for a number of biotech and pharmaceutical companies worldwide in the areas of CMC and business development. In February 2018, Dr. Lu joined Denovo Biopharma as Chief Technical Officer responsible for all aspects of pharmaceutical CMC development, manufacturing and supply chain. Prior to joining Denovo, he served as Vice President of Technical Operations at Balance Therapeutics with responsibility for pharmaceutical CMC development, manufacturing and supply chain. From 2003 to 2015, he was with Arena Pharmaceuticals, most recently as Associate VP of CMC Technical Operations as well as Managing Director for Greater China. At Arena, Dr. Lu led or made significant contributions to the CMC activities and functions for BELVIQ® (lorcaserin) for obesity, temanogrel for thrombosis, nelotanserin for sleep disorders, ralinepag for PAH, etrasimod for autoimmune diseases, and APD371 for pain. From 1990 to 2003, he worked at Monsanto Company and its spin-off Solutia Inc. with increasing responsibilities in R&D and manufacturing. He received his Ph.D. from University of Birmingham in the UK and BSc from University of Petroleum in China, in Chemical Engineering.



Bruce M. Wagman - Senior Vice President, Regulatory Affairs and Quality Assurance

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Mr. Wagman has held positions of increasing managerial and technical responsibility at Prometheus Laboratories, Covance Inc., Omnicare Clinical Research, Genta Inc., MDS-Pharma, Inc., Astra USA, Inc., Bristol-Myers Squibb, Inc., Corning-PACT, Inc., Philadelphia Association of Clinical Trials (PACT). He has been actively engaged in the healthcare industry for thirty-six years, with eight years of experience as a Registered Nurse (RN) managing direct patient care, and twenty-eight years as a Regulatory Affairs professional in the pharmaceutical industry. In addition, Mr. Wagman served as a Captain in the United States Air Force Nurse Corps, culminating with an overseas tour of duty during Operation Desert Storm in 1991. He trained pharmaceutical professionals and/or government officials located in Australia, Austria, Canada, China, Denmark, Germany, Israel, Jordan, Sweden and the United Kingdom. In June 2003, Mr. Wagman was awarded the Drug Information Association (DIA) Outstanding Service Award. He was on the DIA Annual Meeting Planning Committee as the Good Clinical Practices Track Chairperson for four DIA annual meetings. Mr. Wagman has been an instructor for DIA for the following courses: Regulatory Affairs I, IND Phase and Regulatory Affairs II, CTD/NDA Phase, Fundamentals of Clinical Research Monitoring and the Introduction to GCPs and Auditing. Mr. Wagman received a Bachelor of Science degree in Nursing from Syracuse University and his Master of Business Administration degree from Drexel University.



Isabel Han - Vice President, Clinical Operations & Site Head, Denovo China Office

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Isabel has more than 20 years of experience in the clinical operations of global pharmaceutical companies and Contract Research Organizations (CROs). Isabel joined Denovo in September 2016. As VP of Clinical Operations and Denovo’s China site head, Isabel is responsible for the Chinese portion of global clinical development strategy and ensuring operational implementation in China. Prior to Denovo, Isabel was Director, Head of Operations, Clinical Development Service for Covance China where she spent eight years in key leadership roles and led the creation of Covance’s clinical operations team in China. Before her tenure at Covance, Isabel worked in multiple companies including Actelion, AstraZeneca, Boehringer Ingelheim, and Kirin Pharmaceuticals. Isabel received her Bachelor’s Degree of Medical Science from Peking University Health Science Center.