HQ Han, Founder, President and CEO
HQ Han, MD, PhD, is an accomplished leader in drug discovery and innovation in the field of metabolic disorders and muscle wasting diseases. He founded AliveGen in 2014 and has been serving as its president and CEO. Prior to AliveGen, Dr. Han spent 17 years at Amgen, where he held positions with increasing responsibilities in R&D including scientific executive director and head of muscle unit. He spearheaded new therapeutic initiatives and R&D strategies on muscle wasting diseases at Amgen and led teams to successfully advance multiple novel clinical candidates from lab bench to clinical development. He also served as a PI for NASA life science and led multinational team efforts to explore countermeasures for spaceflight-induced muscle atrophy and bone loss. As the scientific founder, Dr. Han contributed significantly to the formation of Atara Biotherapeutics, Inc., now a publicly traded company. Prior to joining Amgen, he served on the faculty of The Rockefeller University as an assistant professor. He received his doctoral degree in molecular and cellular neuroscience under the guidance of Nobel laureate Prof. Paul Greengard at The Rockefeller University and his postdoctoral fellowship training under the supervision of Prof. Alfred Goldberg at Harvard Medical School. He is an inventor of many therapeutic patents and has published articles in Cell, Nature and Science.
Xiaolan Zhou, Co-Founder, VP, R&D Operations
Xiaolan Zhou, co-founder of AliveGen, brings deep biopharmaceutical industry experiences in therapeutic discovery and development as well as project management to the company. Most recently, she was senior scientist at Amgen, and during her 16-year tenure at Amgen, she made many important contributions to drug discoveries spanning across diverse therapeutic areas ranging from neuroendocrinology to cancer, inflammation, and metabolic diseases. As a therapeutic discovery leader, Xiaolan led her team to successfully advance several clinical candidates from lab bench to preclinical and clinical trials. Prior to joining Amgen, Xiaolan worked as a research staff in the Department of Genetics and Orthopedics at the Case Western Reserve University School of Medicine. She received her M.S. degree in Molecular Biology and Biochemistry from The University of Kansas. She is an inventor of many therapeutic patents and has published research papers in Cell, Cancer Research, and Endocrinology.
Neal Salomon, Chief Medical Officer, Medical Monitor
Neal Salomon, MD, is a general and cardiothoracic-vascular surgeon. With deep knowledge and experience in medicine and therapeutic development, Dr. Salomon has served as a consultant for many pharmaceutical and biotech companies in the fields of surgery, cardiology, oncology, and metabolic diseases. He graduated from New York University and Albert Einstein College of Medicine. After surgical training at University of Colorado and Stanford University, he served on the faculty of surgery at University of Arizona Health Sciences Center and helped establish the state’s first heart transplant program. He later served on the faculty of Johns Hopkins University Medical Center. Dr. Salomon has been a board member at Chesapeake Research Review, an internationally established institutional review board covering all elements of human subject protection in clinical trials. He has served on a number of data and safety monitoring boards and was founder and physician mentor for Johns Hopkins University’s pre-professional post-baccalaureate program and mini-medical school. He has authored numerous scientific publications.
David Essayan, Clinical Development Regulatory Officer
David M. Essayan, MD, FACP, serves as an Executive Vice President of ONCORD, Inc. Dr. Essayan previously served as an Executive Director of Regulatory Affairs at Amgen, Inc., where he held global responsibility for both pipeline and marketed products in the inflammation and general medicine therapeutic areas. Prior to Amgen, he was a Supervisory Medical Officer in the Office of Therapeutics Research and Review, CBER/FDA and a Principle Investigator in the Laboratory of Tumor Molecular Biology, CBER/FDA. He serves as a Member of Scientific Advisory Board at Biocon Limited. He served as a Member of the Clinical Advisory Board of Receptos, Inc. He completed his Residency in Internal Medicine at Temple University Hospital and his Fellowship in Allergy and Clinical Immunology at the Johns Hopkins University School of Medicine, where he held a faculty appointment for 12 years. He is Board Certified in both Internal Medicine and Allergy and Clinical Immunology. He received his BS degree in Chemistry from Yale University and his MD degree from the University of Pennsylvania.
David Browning, Clinical Operations Director
David Browning is a highly accomplished clinical operations expert with more than two decades of clinical development experience working in the pharmaceutical industry, contract research organization and academic settings. David has directly managed over 30 phase I through III clinical trials worldwide from research through drug approval. Previously, he helped build Medelis, Inc., an international oncology-focused clinical research organization and as Chief Operating Officer and Vice President of Clinical Operations, he made key contributions to the company’s growth by closing more than $50 million in research service agreements; managing worldwide clinical operations; establishing a global team of medical, regulatory, safety, and clinical oncology experts; developing a global network of highly-experienced research institutions and oncology investigators; and ensuring all clinical trials complied with ICH/GCP principles. While at the NCI-designated Comprehensive Cancer Center, Vanderbilt-Ingram Cancer Center, he oversaw the daily operations of the Clinical Trials Office which was responsible for over 175 oncology trials and 13 INDs. David also managed clinical trials in diverse therapeutic areas including clinical studies in neurology, cardiovascular diseases, ophthalmology, dental medicine and infectious diseases.
Tom Boone, CMC and Process Development Officer
Tom Boone is an internationally recognized leader in the development of protein therapeutics. He was previously Vice President and Global Head of Protein Sciences of Amgen Inc. During his 28 years of tenure at Amgen, Tom held leadership positions with increasing responsibilities and successfully led Amgen Protein Sciences to grow to an organization of over 300 researchers across five different sites while maintaining a long tradition of industry excellence. Through his deep expertise in protein engineering, production, purification and process development, Tom made significant contributions to the advancement of many novel biologics into the clinic, including several approved drugs. Tom is widely recognized for his critical role in the discovery and process development of G-CSF (Filgrastim/NEUPOGEN®), a blockbuster drug for the treatment of neutropenia. He was also the inventor and a lead scientist in the development of Nplate®, a novel treatment of thrombocytopenia.
Mary Ellen Cosenza, Nonclinical Development Officer
Mary Ellen Cosenza, PhD, DABT, ATS, RAC is a regulatory and toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. Most recently, Mary Ellen served as Executive Director, U.S. Regulatory Affairs, at Amgen, Inc. During her 20-year tenure at Amgen, she led the International Emerging Markets Regulatory Department and served as Executive Director of Global Regulatory Affairs and Safety. In addition to her leadership and expertise in Regulatory Affairs, she is also recognized as an expert in preclinical biologic drug development and served as Senior Director of Toxicology at Amgen and past president of American College of Toxicology.
Linda Pullan, Business Development Officer
Linda M. Pullan, PhD, has over 20 years of drug industry experience, beginning in drug discovery at Monsanto/Searle/now Pfizer and ICI/Zeneca/now AstraZeneca. She contributed to and led teams that put the multi-billion dollar antipsychotic Seroquel and other molecules into development. Her business development experiences began with in-licensing technology and early drug candidates in all therapeutic areas at what is now AstraZeneca, and continued as head of oncology and hematology licensing for Amgen, and Kosan Biosciences as VP of Business Development. For several years, Dr. Pullan has been providing companies help in strategy, presentations and messaging, identification, evaluation, valuation, negotiation for partnering in or out. She has an extensive deal sheet ranging from company acquisitions to Phase III compounds to preclinical candidates to technologies.
Alfred L. Goldberg, Co-Chair, SAB
Alfred Goldberg, PhD, is Professor of Cell Biology at Harvard Medical School, where he has been on the faculty for his entire academic career. His important discoveries have concerned the biochemical mechanisms and physiological regulation of protein breakdown in cells and the importance of this process in human disease. His laboratory first demonstrated the non-lysosomal ATP-dependent pathway for protein breakdown, now termed the ubiquitin-proteasome pathway. They first described the roles of the 26S and 20S proteasomes in the degradation of ubiquitinated proteins and discovered the ATP-dependent proteases responsible for protein degradation in bacteria and mitochondria. In addition, their lab has elucidated their novel biochemical mechanisms and mode of regulation. Also of wide impact have been Dr. Goldberg’s studies showing that the ubiquitin-proteasome pathway is critical in the clearance of misfolded aggregation-prone proteins, in the excessive protein breakdown causing muscle atrophy in many disease states, as well as in antigen presentation to the immune system. He and his colleagues also first introduced proteasome inhibitors widely used as research tools (e.g. MG132), and he initiated the development of the proteasome inhibitor, Bortezomib/VELCADE®, now used worldwide for the treatment of multiple myeloma. Dr. Goldberg received his AB degree in Biochemistry from Harvard College and his PhD in Physiology from Harvard University, after attending Cambridge University as a Churchill Scholar and Harvard Medical School. His research accomplishments have been recognized with many honors, including the Novartis-Drew Award for Biochemical Sciences, Severo Ochoa Award (New York Univ), Knobil Prize for Medical Research (Univ Texas), the Gabbay Award for Biotechnology and Medicine (Brandeis Univ.), the Gordon Alpert Prize for Medical Research (Harvard Univ) and the Ernst Beutler Prize for Basic Research (American Hematological Society). He is a Fellow of the American Academy of Arts & Sciences and a member of the National Academy of Medicine and the National Academy of Sciences. He has also received honorary doctoral degrees from Cold Spring Harbor Laboratories (Watson Graduate School), the University of Maastricht and University of Barcelona and is among the 1% most cited authors in the life sciences.
David Lacey, Co-Chair, SAB
David Lacey, MD, received both his undergraduate and medical degrees from the University of Colorado and has his board certification in anatomic pathology. He was on faculty at Washington University, St. Louis, following the completion of his training. Dr. Lacey joined Amgen in 1994 where during the last five years of his tenure he assumed the head of Discovery Research (>1200 FTEs) for Amgen. At any given time there were over 100 actively managed preclinical projects across four therapeutic areas: hematology/oncology, inflammation, metabolic disorders, and neuroscience. Scientifically, Dr. Lacey played a fundamental role in the discovery of the OPG/RANKL/RANK pathway at Amgen which led to the development of the anti-RANKL human mAb denosumab, a blockbuster for both osteoporosis (Prolia®) and cancer-related bone diseases (XGEVA®). Denosumab has received a number of awards including the US 2011 Prix Galien award for best new biotechnology product and the 2010 Scrip award for best new drug. Following his retirement in 2011, he has continued to be active in the biopharmaceutical industry. His current activities include advising academic institutions, biotechnology companies and venture capital firms.
Willard Dere, Member, SAB
Willard Dere, MD, FACP, is Professor of Internal Medicine, Executive Director of Personalized Health, and Co-Director of the Center from Clinical and Translational Sciences at University of Utah Health Sciences Center. He received his MD degree from the University of California, Davis, and trained in internal medicine at the University of Utah, and endocrinology/ metabolism at the University of California at San Francisco. He is an internationally regarded medical researcher and leader in the biopharmaceutical industry where he worked for 25 years. He started working at Eli Lilly in 1989, and held a number of different global roles in clinical pharmacology, regulatory affairs, and both early-stage translational, and late-stage clinical research. He led the development of Evista® and Forteo®. He joined Amgen in 2003 where he held increasing responsibilities including the head of global development and the corporate and international chief medical officer. At Amgen, he led clinical development for Prolia® and many other therapeutic programs. He returned to his academic position with University of Utah after retirement from Amgen at the end of October 2014. Dr. Dere has published numerous medical articles, wrote and co-edited a primary care textbook, and was the recipient of the 2008 UC Davis transformational leadership award. He is a fellow in the American College of Physicians.
Se-Jin Lee, Member, SAB
Se-Jin Lee, MD, PhD, is Professor at Johns Hopkins University School of Medicine. He is a leading expert in molecular genetics and TGF-beta family biology. He obtained his A.B. summa cum laude in Biochemical Sciences from Harvard College in 1981. He then entered the Medical Scientist Training Program at Johns Hopkins University School of Medicine, where he pursued his graduate studies with Nobel laureate Dr. Daniel Nathans in the Department of Molecular Biology and Genetics. After obtaining his MD and PhD degrees in 1989, Dr. Lee joined the Carnegie Institution of Washington’s Department of Embryology as a Staff Associate, where he initiated his studies investigating the role of secreted proteins in regulating embryonic development and adult tissue homeostasis. Dr. Lee returned to the Department of Molecular Biology and Genetics at Johns Hopkins as a faculty member in 1991 and achieved the rank of Professor in 2001. In 2013, Dr. Lee was named as the inaugural recipient of the Michael and Ann Hankin and Partners of Brown Advisory Professorship in Scientific Innovation. In 2017, Dr. Lee moved his research program to Connecticut, where he holds a joint appointment as Presidential Distinguished Professor at University of Connecticut and Professor at The Jackson Laboratory. Dr. Lee is best known for his discovery of myostatin as a master regulator of skeletal muscle mass. In recognition of this work, Dr. Lee was elected to the U.S. National Academy of Sciences in 2012 and was awarded the Rolf Luft Award and the Ho-Am Prize in Medicine in 2013. Dr. Lee was elected as Fellow of the National Academy of Inventors in 2015.