Non-profits play a vital role in advancing the science, education and advocacy of innovative R&D. This session unpacks how non-profits can accelerate commercialisation of products through the fast-tracking of scientific discoveries via targeted research pipelines and investment collaborative partnerships.
LBPs have become the commonplace therapeutic modality to restore health and facilitate therapeutic effect in dysbiotic microbiomes. Recently there has been an increase in small molecules, phage’s, and emerging modalities to treat these conditions. Here we discuss the advantages of varied modalities in terms of R&D, investment, and manufacturing.
Dr. Nara is currently on of the co-founders, the Chief Scientific Officer and President Business Development for Keystone Bio Inc. in St. Louis, Mo., a Systemic-Oral Health Biomedical company that is targeting precision microbiome bio-therapeutics for the elimination of a specific oral bacterial associated with systemic inflammation. He is also the former co-founder, President, Chairman and CEO (1997-2017)and now Chairman Emeritus at Biological Mimetics, Inc. and cofounder of Lantern Pharma Inc. He holds a M.Sc. in Immuno-pharmacology, a combined Doctor of Veterinary Medicine and Ph.D. (retro-virology/oncogenesis) from The Ohio State University, 4 year combined residency in Comparative Pathology and NIH post-doctoral Fellowship at the Armed Forces Institute of Pathology and a NIH respectively. Dr. Nara currently holds the Endowed Eugene Lloyd Chair, Professor in Vaccinology, founding Center Director for the Center for Advanced Host Defense, Immunobiotics, and Translational Comparative Medicine in the Department of Biomedical Sciences, in the College of Veterinary Medicine at Iowa State University and also the Chief Executive Officer, President, Chairman & co-founder of Biological Mimetics, Inc.,. He is also an distinguished Alumni of The Ohio State University College of Veterinary Medicine 2014, and an elected Fellow of the American Association for the Advancement of Science in 2011. His comparative medical research interests are to more fully understand how early and pre-determined events in the host innate and acquired immune systems are sculpted and bias the development of protective long lasting responses against infectious pathogens and cancer. More importantly he and his team are interested developing new technologies and strategies to circumvent the non-protective immune responses for the development of novel classes of immunobiotics and vaccines focused on the prevention of disease and are translating these into viably products via a new academic- private-commercial model. He has been and continues as National and International member of numerous programs at the National Academy of Science, Institutes of Medicine, National Institutes of Health, Department of Defense, and Centers for Disease Control AIDS, World Health Organization, United Nations Global AIDS Characterization program–related and infectious diseases national planning, human and animal agricultural biodefense, vaccine development & policy reporting meetings involving pathogenesis, vaccine discovery, standardization, correlates of protection committees and consults and serves on numerous scientific advisory boards of corporate, private foundations and academic initiatives in the area of national biodefense, comparative medicine and immunology, vaccine discovery and immuno-therapeutics and a recent member of the U.S. State Department Bio-Industry Initiative Program, The Civilian Research and Development Foundation (CDRF) and The International Science and Technology Center (ISTC) for non-proliferation of biological agents.
After a tumultuous couple of years, large pharma and investors alike are poised and ready to return to the heights of the biotech capital markets. How can microbiome biotechs make sure that their data captures the eye of investors? What gets pharma excited about working with a particular biotech, and are there specific traits that could convince pharma to dip their toes back into the world of microbial innovation?
Understanding what is needed from sponsors to efficiently progress through the IND submission process without delay. Landscape overview of regulatory demands at each stage of clinical progression to obtain consistency and safety.
This presentation will provide an overview of regulatory considerations for microbiome-based product development in pediatric populations. Scientific and ethical issues for microbiome product development will be discussed in the context of relevant regulatory guidances. Pediatric Research Equity Act (PREA) requirements, 21 CFR Subpart D (Additional Safeguards for Children), and informed consent for this population will be highlighted. Important resources to consider when including pediatric populations in microbiome trials will be provided.
Establishing an early-stage vision for bioprocessing developments of live biotherapeutic products from a datacentric perspective
