Paidion Research, Inc.
Devon Kuehn, MD is a board-certified pediatrician and neonatologist with more than 15 years of clinical trial experience with 5 years dedicated to of managing clinical research operations, regulatory compliance, fiscal performance, and strategic development for a neonatal and pediatric clinical trials portfolio at an academic site. Dr. Kuehn also collaborates on a variety of PI-initiated clinical trials with specific interest in fetal and neonatal exposures and impact on infant and child development and growth. Dr. Kuehn completed medical school at the Uniformed Services University of the Health Sciences and her pediatric residency and neonatal fellowship at Walter Reed Army Medical Center and National Military Medical Center. Devon also completed post-graduate education in epidemiology at NICHD, statistics at NIH, and principles of clinical research at Duke University.
|Darrel has more than 25 years of successful consumer and medical product development within large enterprises and start-up ventures. He led consumer health device product development efforts with in Braun Ag and has successfully founded, financed and commercialized numerous start-up ventures in the Digital Health market. He also is a mentor to a number of start-up ventures in the consumer health and healthcare markets.|
Director of Clinical Sciences
Nestle North America (Gerber)
Brian Kineman, PhD, has > 10 years experience in the infant nutrition industry providing strategic leadership in the development of product innovations, consumer and healthcare professional educational materials, regulatory strategy and preclinical and preclinical and clinical study support. Brian is currently the Director and Clinical Sciences Lead for the U.S. Nestlé Nutrition business where he oversees the scientific translation of new publications, development of scientific reviews of the body of evidence on current and prospective nutrition topics, design and conduct of clinical trials and evidence development for pediatric nutritional products.
Professor & Director Mucosal Immunology & Biology Research Center
Massachusetts General Hospital
Alessio Fasano, MD, is the W. Allan Walker Chair and Chief of the Division of Pediatric Gastroenterology and Nutrition at MassGeneral Hospital for Children (MGHfC) in Boston, Mass. A Professor of Pediatrics at Harvard Medical School, Dr. Fasano founded the Center for Celiac Research and Treatment in 1996, where he treats adults and children for gluten-related disorders. His visionary research, which established the rate of celiac disease at one in 133 people, led to the awareness of celiac disease as a growing public health problem in the United States. Dr. Fasano is widely sought after as an expert in celiac disease, autoimmune disorders, intestinal permeability and the role of the gut microbiome in disease and health. He has been featured in media outlets around the world, including National Public Radio, The Wall Street Journal, The New York Times, The Washington Post, The Daily Mail, Elle, TIME and other online and media outlets. He recently authored Gluten Freedom and is prinicpal investigator for a five-year, prospective study on the development of celiac disease in at-risk infants, the Celiac Disease Genomic, Environmental,Microbiome and Metabolomic Study (www.cdgemm.org).
International Business Development
Aurélien Baudot is handling the worldwide business development at ProDigest, translating research questions of the food, feed and pharma industries in tangible gastro-intestinal simulation projects. Originating from a biomolecular and artificial intelligence background, he is fascinated by the interplay between in vitro testing and the real-life outcome. ProDigest crosses this bridge with its state-of-the-art simulation technology (SHIME®). Already for 3 years one the fastest-growing life science company in Belgium, ProDigest is constantly broadening the scope of digestion and microbiome research. Infant, obesity, IBD, pathogen models and many more simulations meet the increasing number of strategies aiming at regenerating or improving gastro-intestinal health. Aurélien collaborates strongly with the scientific team within ProDigest to accommodate the most complex demands, aiming to maximise the scientific value of the preclinical projects for his customers.
NC State University
Dr. Benjamin Callahan joined NC State in January 2017 as a Chancellor’s Faculty Excellence Program cluster hire in Microbiomes and Complex Microbial Communities. As an Assistant Professor in the Department of Population Health and Pathobiology and a member of the Bioinformatics Research Center, Dr. Callahan’s research focuses on “microbiomes” — the complex microbial communities which inhabit and interact with almost every part of the world around us. He develops new statistical and bioinformatic methods to better characterize microbial communities from high-throughput biological data, and uses those methods to study important problems, such as the relationship between the maternal microbiome and preterm birth. Dr. Callahan received a B.S. in Physics and Math from Iowa State University, and began to work on problems in quantitative biology while obtaining a Ph.D. in Physics from the University of California, Santa Barbara. After graduation, Dr. Callahan worked as a postdoc in the Applied Physics and Statistics departments at Stanford University, where he studied adaptation in large populations through modeling, comparative genomics and experimental evolution.
Director, Immunology & Diagnostic
Bethany is an immunologist with extensive experience investigating maternal and infant immunity as well as a decade of experience designing, optimizing and bringing to market rapid point-of-care diagnostics focused on improving the lives of individuals globally. In addition to her position at Evolve Biosystems, Bethany also serves as an Adjunct Assistant Professor in the Food Science and Technology Department at the University of Nebraska Lincoln.
1:00 pm | Exploring Immune Education of the Gut During Early Life
Bunning Food Allergy Professor
University of Chicago
Dr. Nagler is the Bunning Food Allergy Professor and Professor of Pathology, Medicine, Pediatrics, and the College at the University of Chicago. Dr. Nagler graduated with honors from Barnard College, Columbia University, obtained her Ph.D. from N.Y.U. School of Medicine and did a postdoctoral fellowship at M.I.T. She was Associate Professor of Pediatrics (Immunology) at Harvard Medical School before joining the University of Chicago in 2009. Dr. Nagler has participated in numerous review panels for the Crohn’s and Colitis Foundation of America, NIDDK and NIAID, including the Food Allergy Expert Panel and has served the American Association of Immunologists as Deputy Editor for the Journal of Immunology, Instructor (Mucosal Immunology) for the Introduction to Immunology course and as member of the Program, Clinical Immunology, Publications and Awards Committees. Dr. Nagler’s research interests encompass the mechanisms governing tolerance to dietary antigens and the ability of intestinal bacteria to regulate susceptibility to allergic responses to food.
Director of Operations
John W. Colson, PhD, is currently Director of Operations at ClostraBio, Inc., where he is responsible for all company operations and finances and manages the scientific development ClostraBio’s drug candidates. Prior to joining ClostraBio, Dr. Colson was a Postdoctoral Scholar at the University of Chicago at the Institute for Molecular Engineering as well as an Associate at the University’s Innovation Fund, where he led a number of commercially focused projects originating at the University of Chicago. In this role, he developed operational plans and led teams through proof of concept studies to enable initial financing. Dr. Colson was a National Science Foundation Graduate Research Fellow at Cornell University and earned his PhD in Chemistry in 2014. For his doctoral dissertation, Dr. Colson received the Henkel Award for Outstanding Graduate Research in Polymer Chemistry, a national award given by the American Chemical Society for outstanding PhD research in polymers. His multidisciplinary scientific expertise includes organic and polymer chemistry; his work has focused on the noncovalent interactions that dictate the assembly of polymers in bulk and at interfaces and leveraging these interactions to prepare novel morphologies using established chemistries with wide-ranging applications from energy storage to drug delivery.
Executive Chairman & CSO
Dr. Kyle, Chairman and CSO of Evolve Biosystems Inc, is a 35-year veteran of nutritional biotech, having co-founded a range of successful biotech companies in the fields of infant nutrition and health including Martek Biosciences and Evolve BioSystems Inc. David combines a distinguished scientific background with significant commercial acumen, has published over 70 scientific articles, edited two books, is the named inventor on over 250 patents, and was inducted into the US Space Technology Hall of Fame in 2009, for his contributions to Science and Industry.
Associate Adjunct Professor
Friedman School of Nutrition Science & Policy - Tufts University
Deshanie Rai, PhD, FACN is an accomplished scientist with > 15 year of industry and academic experience focused on developing, translating, communicating, and commercializing science in the health and wellness category. She has led the design, implementation and translation of preclinical and clinical studies across multiple therapeutic areas including gastrointestinal health and the microbiome. Her research has been published in peer-reviewed journals and presented at national and international meetings. She has supported the development of science-based products and the launch of differentiated claims and messaging initiatives focused on probiotics and targeted towards adults, children and infants. Deshanie has led Advisory Board meetings and moderated scientific panel discussions on a variety of health benefit areas including sleep, mental energy, functional nutrients, and gastrointestinal health. She has implemented education and awareness programs targeted towards health care professionals and consumers. She has been the recipient of several academic and industry awards including from Mead Johnson Nutrition, DSM and Bayer Health Care. Deshanie is currently an Associate Adjunct Professor with the Friedman School of Nutrition and Policy, Tufts University and a Scientific and Regulatory Affairs Consultant in the over the counter (OTC), dietary supplement and probiotic and prebiotic categories. She is also the Co-Chair of the Women in Science Chapter in the NY, NJ and CT areas where she co-led events focused on personalized medicine and tissue-agnostic oncology.
Division of Vaccines & Related Product Applications, OVRR/CBER/FDA
Dr. Jeff Roberts is an Associate Director in the Office of Vaccines Research and Review (OVRR). He joined the FDA in 2008, and has served as a Medical Officer, Team Leader, and Clinical Branch Chief before assuming the Associate Director role in 2018. During that time, Dr. Roberts acquired experience with review of a broad array of biologics, including vaccines, allergenics, and live biotherapeutics. He also developed expertise in multiple regulatory policy issues, such as maternal immunization.
Dr. Petrosino is Founder and Chief Scientific Officer for Diversigen, Inc. He is also the Cullen Foundation endowed interim-chairman of the Department of Molecular Virology and Microbiology at Baylor College of Medicine (BCM). Dr. Petrosino has over 18 years of expertise in microbial genomics and 12 years in metagenomics and, together with his leadership role in the NIH Roadmap Human Microbiome Project, led him launch the Alkek Center for Metagenomics and Microbiome Research (CMMR) at BCM in 2011. The CMMR has received over $18M in institutional support and has engaged in more than 400 diverse projects with over 200 collaborating groups from around the world leading to authored contributions in more than 130 manuscripts. Translating these academic activities to the commercial arena, Dr. Petrosino Founded and became the Chief Scientific Officer for Diversigen, Inc., a microbiome services company launched by BCM Technologies that offers microbiome sequencing, analytics and consulting services to small and large biotechnology and pharmaceutical companies. Dr. Petrosino serves on a number of proposal review panels involving microbiome studies, including those from NIH, JDRF, and Diabetes UK. He reviews manuscripts for several of the Nature journals as well as Genome Research, PLoS One, PNAS, and BMC journals, among others. Dr. Petrosino is also on the editorial board for the journal ‘Microbiome’ and was an American Society for Microbiology Distinguished Lecturer from 2014-2016.
Postdoctoral Fellow, Dominguez-Bello Lab
Following receipt of his bachelor’s degree in biology from Mount Vernon Nazarene University Keith completed a 2 year post-bac in Joan Slonczewski’s lab at Kenyon College where he studied pH homeostasis in E. coli. In November of 2018 Keith completed my PhD at NYU School of Medicine’s Sackler Institute in Maria Gloria Dominguez-Bello’s lab where he began studying the effects of C-section on mouse development. Keith is now continuing this research as a Postdoctoral Fellow in Dominguez-Bello’s lab at Rutgers University.
I received a Ph.D. in 1978 from Louisiana State University School of Medicine with concentration in Physiology. I trained in neuroendocrinology during the next 4 years as a postdoctoral fellow at the Indiana University School of Medicine and then returned to New Orleans to work with Dr. Andrew Schally (Nobel Laureate for defining Neuroendocrinology) at Tulane University School of Medicine where I co-invented the drug Lanreotide (Therapeutic Somatostatin Analogs WO/8601516, 1986), which is used to treat pituitary adenomas. Because of my expertise in the study of growth hormone secretion, I was recruited to Eli Lilly Research Labs in 1987. Lilly initiated a research effort to discover drugs to treat individuals with obesity in 1994 and I accepted a role to develop a core metabolic physiology lab for the group. My lab was the first to demonstrate that leptin regulates energy balance by inhibiting neuropeptide-Y synthesis (Nature 377:530-532, 1995). My lab also developed the first validated RIA to measure leptin in humans and demonstrated the well know positive correlation of leptin levels with adipocity (N. Engl. J. Med. 334:292-295, 1996). The assay still serves as a gold standard as well as assays to measure leptin in canine and rodent species. More recently, my lab was the first to demonstrate that ghrelin stimulates a positive energy balance (Nature 407: 908-913, 2000). My research success awarded me with promotions to Research Fellow and I spent my final few years at Lilly as the Chief Scientific Officer (CSO) of Obesity Research. In 2014, I was awarded Fellow status in The Obesity Society for my research contributions to advance the science of obesity. I retired from Lilly in 2009 and cofounded MicroBiome Therapeutics. As the CSO and Vice President of Research at Microbiome Therapeutics, I discovered a gastrointestinal microbiome modulator to manage glucose intolerance in individuals with prediabetes and type 2 diabetes (J Diabetes Complications 29(8): 1272-1276, 2015, J Diab Sci Tech 9(4):808-814, 2015). I currently spend the majority of my time as the CSO of Scioto Biosciences committed to discovering solutions for Necrotizing Enterocolitis by modulating the neonatal GI microbiome. In my role as CSO, I established a research lab to study functional biomarkers of the GI microbiome. My vast experiences in large pharma directs the lab to fill needs for translational and Phase 1 enabling preclinical studies.
Assistant Professor, Pediatrics and Child Health
University of Manitoba
Dr. Meghan Azad is an Assistant Professor of Pediatrics and Child Health at the University of Manitoba. She holds a Canada Research Chair in Developmental Origins of Chronic Disease. Her award-winning research program (www.azadlab.ca) is focused on the role of infant nutrition and gut microbiota in the development of asthma, allergies and obesity. Dr. Azad co-leads the Manitoba site of the Canadian Healthy Infant Longitudinal Development (CHILD) Study (www.childstudy.ca), a national pregnancy cohort following 3500 children to understand how early life experiences shape lifelong health. She directs multiple projects related to lactation and infant feeding practices in the CHILD cohort, including integrated studies linking human milk composition and gut microbiota with epigenetic profiles and clinical phenotypes. Dr. Azad also co-leads the Population Health Pillar for the Manitoba Developmental Origins of Chronic Disease Network (DEVOTION), and the Maternal, Fetal and Child Health Working Group for the new Canadian Urban Environmental Health Research Consortium (CANUE). In 2018, Dr. Azad was awarded the University of London 150th Anniversary Prize and the International Society for Research in Human Milk and Lactation (ISRHML) Ehrlich-Koldovsky Award recognizing early-career investigators making outstanding contributions to the study of human milk and lactation. Her research is funded by the Heart and Stroke Foundation of Canada, the Canadian Lung Association, and the Canadian Institutes of Health Research. Dr. Azad serves on the ISRHML Executive Council and the Breastfeeding Committee of Canada.
Harvard Medical School
Dr. Jain received a Ph.D. in Biomedical Sciences from the University of Massachusetts Medical School with specific training and expertise in cellular and molecular Immunology. She currently heads a research laboratory at the Massachusetts General Hospital in Boston where her main goal is to understand how the immune system develops and operates in early-life and in identifying environmental and host factors that dictate malleability in neonatal immune responses. At birth, the immune system of newborns is faced with the monumental task of classifying the newly flourishing intestinal microbiota as benign, commensal or pathogen. The trillions of bacteria that collectively outnumber host cells by almost ten-fold are not simple bystanders, and the continuous cross talk between bacteria and host cells is crucial for several physiological and developmental processes. Dr. Jain’s research is focused on understanding whether and how maternal and microbial influences regulate the development of lymphocytes and their function.
Noah has been personally and professionally involved in the microbiome, genomic and personalized health space for the past five years. Recently, leading strategic, product development, regulatory and R&D engagements with Fortune 100 to emerging growth start-ups. In the microbiome space, projects have ranged from advising Fortune-level biotechs on microbiome investment/pipeline/industry trends in support of recent acquisitions, developing R&D strategy for emerging a microbiome CPG beverage to collaborating with one of the leading global probiotic brands on disease indication expansion options. Genomic and personalized health sector engagements have focused on industry intelligence, sales channel positioning, product development and scientific due diligence for DTC genetic or microbiome-based tests with clients ranging from Fortune 100 to venture-backed start-ups. Previously, Noah was Business Development Manager at Ritter Pharmaceuticals, a late-stage microbiome Rx/GI company developing potentially the first FDA approved treatment for moderate-to-severe lactose intolerance. Noah's microbiome expertise reaches beyond therapeutics and nutraceuticals to diagnostics and sample collection technology in a business development role with Metabiomics. Metabiomics is an early-stage microbiome Dx company with multiple patents in IBD and CRC diagnostic development.
Post-Doctoral Associate, Aagaard Lab
Baylor College of Medicine
Dr. Ryan M. Pace is a NIH IRACDA Postdoctoral Fellow at Baylor College of Medicine. His research aims to use highly multidimensional human microbiome data to probe at the complex ecology of microbial strains in the perinatal period to address the mode of transmission from mother to child and origin of microbes, how microbial communities are structured, and how they function to affect health from infancy to adulthood. In addition, as part of a large consortium, Dr. Pace has previously worked on a highly relevant non-human primate model (Macaca fuscata, Japanese macaque) of maternal obesity to examine how dietary exposures during pregnancy and nursing, specifically western style diet, modulate the acquisition and maturation of the gut microbiome, and in turn better understand the effects of the interplay between the environment and microbial contributions to complex disorders such as obesity, diabetes, and anxiety-like behavior.
Infant Bacterial Therapeutics
Staffan is currently the CEO of Infant Bacterial Therapeutics and has over 20 years of experience in the pharmaceutical industry. Besides his role as Head of Medical Devices at the Swedish Medical Products Agency, he has also been Vice President of Nicox France, and had management positions at AstraZeneca. Staffan has particularly had experience in the development of orphan drugs as Head of R&D of Swedish Orphan.
Tuval Ben-Yehezkel, PhD is a scientist-entrepreneur focused on applied genomics and synthetic biology. He has authored key patents, publications and book chapters in synthetic biology and genomics. Tuval has also founded and secured $15.3M in funding for two biotech start-up companies (Loop Genomics & SynVaccine Ltd).
Janssen Pharmaceutical Companies of Johnson & Johnson
Richard Insel, M.D. is the Global Head, Healthy Baby Initiative, World Without Disease Accelerator, Global External Innovation, Johnson & Johnson. The Healthy Baby Initiative is focused on prevention and interception of non-communicable diseases of early childhood, including food allergy. Prior to working with Janssen, he spent 13 years at the Juvenile Diabetes Research Foundation (JDRF) where he held titles of Executive Vice President of Research and Chief Scientific Officer. From 1977 to 2003, Dr. Insel was affiliated with the University of Rochester Medical Center where he held several positions including Professor of Pediatrics and Microbiology/Immunology, founding Director of the Center for Human Genetics and Molecular Pediatric Disease, and Director of the Strong Children’s Research Center.
President, CSO & Co-Founder
Dr. Nikole Kimes is President and Chief Scientific Officer of Siolta Therapeutics, a San Francisco-based biotech company developing novel microbiome-focused strategies for the prevention and treatment of inflammatory diseases. As a founder and the lead executive driving Siolta’s early-stage development, Dr. Kimes heads a talented team of scientists, blending microbiology, immunology, and bioinformatics expertise to leverage microbiome data and research for the improvement of patient stratification and development of precision microbial therapeutics. Dr. Kimes has over a decade of experience in microbial ecology and host/microbe interactions, and her research in Dr. Susan Lynch’s lab at UCSF provided the foundation for the company’s translational research program.