Sean Ainsworth is Immusoft’s Chief Executive Officer and Chairman of the Board. He has 20 years’ experience in pharmaceuticals and biotechnology. Previously, he founded and led RetroSense Therapeutics, a gene therapy company he advanced into human clinical trials and sold to Allergan in 2016 in a deal valued at up to $555 million.
Earlier, he was deeply involved in the launch of Compendia Bioscience, Inc., and GeneVivo, LLC. At both he assisted in developing business models, licensing technologies, building management teams, and securing capital and first customers. Life Technologies acquired Compendia BioScience in 2012.
Sean founded Ainsworth BioConsulting in 2004 to provide licensing, as well as strategic and business planning services to the life science and entrepreneurial community. His clients included large pharma, small biotechs, universities, CROs, and venture investment funds. He has worked with clients at all stages of development.
His other professional experience includes research at Medical Biology Institute (now Avanir Pharmaceuticals, developers of Abreva, the leading cold sore medication) in San Diego, Calif., intellectual property at Koyama and Associates in Tokyo, and international corporate development consulting at The Mattson Jack Group in St. Louis, Mo.
Sean earned an M.B.A. in strategy and finance from Washington University in St. Louis. He holds a B.S. in Microbiology from University of California, San Diego.
R. Scott McIvor, Ph.D., Chief Development Officer at Immusoft, is Professor of Genetics, Cell Biology and Development at the University of Minnesota.
Dr. McIvor graduated with degrees in Cell and Molecular Biology, and Pathobiology from the University of Washington and obtained his Ph.D. in Microbiology from the University of Minnesota in 1982. He was a postdoctoral fellow first at the University of California, San Francisco, and then at Genentech, Inc., in South San Francisco, California, where he conducted some of the earliest work on gene transfer into animal tissues in vivo.
He has been at the University of Minnesota since 1986, where he initially was a member of the Department of Laboratory Medicine and Pathology and the University of Minnesota’s Institute of Human Genetics, where he served as Director of the Gene Therapy Program.
He is a two-time former member of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) has served extensively on NIH study sections and the Scientific Advisory Board of the NIH National Gene Vector Laboratories. He is currently a member of the Gene Therapy Resource Program Steering Committee for the National Heart, Lung and Blood Institute, and serves on the Editorial Board for Molecular Therapy. His research has been primarily in the area of human gene therapy, where he has extensive experience developing both viral and non-viral vectors for the treatment of genetic diseases and cancer.
Monika Swietlicka is Senior Vice President of Regulatory Affairs at Immusoft. She leads development and implementation of regulatory strategy and quality systems, including overseeing regulatory submissions and compliance. She is responsible for quality oversight and program management of Immusoft’s clinical pipeline.
Monika has broad knowledge of the product lifecycle from Investigational New Drug approval through the Biologics License Application process with the U.S. Food and Drug Administration and the European Medicines Agency. She brings to Immusoft extensive experience in various biotechnology settings, having specialized in discovery, pre-clinical, clinical, commercial and translational research. She is versed in all stages of cellular therapeutics and biologics drug development, and manufacturing.
Previously, Monika managed a continuous improvement program for a first in class immunotherapy product, Provenge (Sipuleucel-T), for which she also developed new processes to monitor method lifecycle. She has authored content for FDA and EMA submissions, led Contract Manufacturing Organization tech transfer activities and compliance audits.
Immusoft is Monika’s third experience with a biotech startup. Earlier, she worked on in-situ therapeutic antibody rescue technology, T-cell activation platform, and the first autologous antigen-presenting cells vaccine designed to stimulate an immune response to a variety of tumor types. She was part of early collaborative efforts with the International AIDS Vaccine Initiative to develop HIV-neutralizing antibodies and has worked on broadly neutralizing antibodies for treating pandemic influenza and severe seasonal influenza.
Monika has degrees from Seattle Pacific University, having earned an M.B.A. in International Business and a B.S. in Biochemistry and Molecular Biology. While earning her master’s, she co-authored an operations management textbook now used by the graduate business program. As an undergraduate, her senior thesis focused on studies of NKG2D and MICA on Surface and in Solution in which MICA ligands were mutated at residues that do not contact NKG2D.
Monika is a strong advocate for disruptive biotechnologies and passionately supports all regulatory activities to advance Immusoft’s strategic initiatives.
Dr. Robert Hayes is the Chief Scientific Officer at Immusoft, where he oversees Immusoft’s preclinical research and spearheads the near-term advancement of ISP-001 for the treatment of Mucopolysaccharidosis type I (MPS I) into a clinical study, and additional Immune System Programming (ISP™) candidates towards clinical development.
With nearly two decades of biologics discovery and development experience, Dr. Hayes has a proven track record for building teams around new scientific concepts and technologies, including cell therapeutics, transposon systems, cancer vaccines, and bispecific monoclonal antibodies. He also has significant experience in forming partnerships to advance the development and application of novel therapeutic platforms.
Dr. Hayes obtained his Ph.D. in Biochemistry at Imperial College London as a Royal College of Science Scholar. He was awarded a Royal Society University Fellowship for the work contained in his thesis and spent three years studying protein biochemistry at University California, Berkeley. He then joined a start-up computational biology company called Xencor located in Pasadena, California where he helped establish their “Antibodies by Design” technology. Xencor has since collaborated with many of the top pharmaceutics companies to bring improved antibodies to the clinic.
After six years at Xencor, Dr. Hayes joined Janssen
BioTherapeutics (Johnson & Johnson) where he co-founded and developed the
vision and strategy for Centyrex, a stand-alone Janssen R&D biotechnology
company that developed alternative scaffolds with applications beyond
traditional protein therapeutics. In 2014, he became Head of Biologics at
Amgen, responsible for leadership, operational and strategic management of all
aspects of biologics preclinical discovery, including bioreagent generation,
large molecule lead identification, biologics optimization, and transition into
preclinical development and manufacturing.
Robert Sikorski, M.D., Ph.D., is an experienced drug developer who currently serves as the Managing Director of Woodside Way Ventures, a firm that advances the clinical development of novel, lifesaving technologies.
Prior to his current role, Dr. Sikorski served as the Chief Medical Officer of FivePrime Therapeutics, a public biotechnology company that was acquired by Amgen. He led the development of FivePrime’s biologics pipeline that spanned preclinical discovery through proof of concept to pivotal registration trials. During his tenure at the company, FivePrime grew from a market cap of $150 MM to $1.5 B.
Previously, Dr. Sikorski led an early-stage clinical development group at Medimmune and then AstraZeneca that advanced six novel molecules into clinical trials. He played a leading role in building Medimmune’s oncology portfolio through partnering and acquisition efforts. Before joining Medimmune, he led late-stage clinical development and post marketing efforts for several commercial drugs and drug candidates at Amgen. His leadership in the development of Vectibix resulted in the drug’s global approval with a first-in-class companion diagnostic based on tumor genotype.
Dr. Sikorski began his career as a Howard Hughes Research Fellow and Visiting Scientist at the National Cancer Institute and the National Human Genome Research Institute in the laboratory of Nobel Laureate Harold Varmus. Dr. Sikorski received a combined M.D. and Ph.D. from The Johns Hopkins University School of Medicine through a Medical Scientist Training Program scholarship. He completed his residency at Massachusetts General Hospital and an Oncology fellowship at The Johns Hopkins Oncology Center and has been board certified in both Medical Oncology and Internal Medicine. He is a former editor of the journal Science and the Journal of the American Medical Association.
Dr. Sikorski resides with his wife and four children in Woodside, California.