Speakers

Speakers

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Libusha Kelly
Associate Professor
Albert Einstein College of Medicine

Our basic research program develops new experimental and computational technologies to biologically organize and describe the dynamics of the tremendous genetic diversity in microbial communities. Microbes and viruses are first responders to alterations in the environment. Microbial responses to environmental changes include transcriptional, proliferative, and genomic changes little is known about how viruses respond to environmental perturbations in the context of interactions with their hosts. Furthermore, microbes and viruses exist in tight-knit networks that compete for, produce, and share resources. Microbial community structure/function relationships are poorly understood, which inhibits our ability to support or prevent particular functions. We develop new computational methods to 1) quantify genomic differences and interactions in microbial and viral populations and 2) characterize novel viruses. We recently reported in Nature a novel family of tailless viruses that are major unrecognized killers of marine viruses with the Polz lab at MIT (Kauffman, et al. 2017). These mysterious viruses are also found in the human microbiome, and we are in the process of characterizing their effects on microbial communities in the human body. If we understand how communities are organized and how they change over time under particular conditions, such as inflammation, we can better target microbes and genes to alter that condition.

Our translational research program provides patients and their doctors with actionable information about their microbiomes to improve health and treatment plans. For example, we recently discovered that microbiomes of different individuals have different capacities to activate irinotecan, an anti-cancer drug (Guthrie, et al, 2017). We linked this differential metabolism to specific microbial carbohydrate active enzymes. In mouse models, gut metabolism of irinotecan leads to adverse events, including severe diarrhea. We hypothesize that the life- threatening diarrhea that afflicts up to a quarter of metastatic colorectal cancer patients who take this drug might also be caused by microbial turnover, and are working with oncologists at Einstein/Montefiore to recruit and track patients receiving regimens that include irinotecan. Our goal is to provide patients with early warnings that they are likely high irinotecan metabolizers, thereby enabling prophylactic diarrheal treatment and closer monitoring by their treatment team. A tantalizing possibility here is to use a dietary carbon source to saturate the drug- interacting carbohydrate active enzymes before patients are given the drug, thereby reducing the number of patients who suspend treatment due to severe adverse events.

Jackie Papkoff
Chief Scientific Officer
Assembly Biosciences

Dr. Papkoff has worked in both pharma and biotech for over 20 years and has broad scientific strategy, executive leadership and business experience. She has deep expertise in cell biology and molecular mechanisms of disease, which she has applied to therapeutic and biomarker preclinical discovery & development in oncology, inflammation and autoimmunity. Prior to joining Assembly Biosciences, Dr. Papkoff was Senior Vice President Research at Evelo Biosciences, where she led the preclinical scientific team to discover, validate and nominate microbial therapeutics for clinical development in oncology indications. Prior to Evelo, Dr. Papkoff was a founding member of the J&J California Innovation Center, where she served as Vice President of Immunology Scientific Innovation for the Janssen Immunology Therapeutic Area focused on inflammatory and autoimmune diseases. Previously, she was CSO of CFD Therapeutics, a cancer-immunology focused antibody therapeutics company she co-founded, and held R&D leadership positions at diaDexus and Aventis pharma. Dr. Papkoff has a BA in Biology from University of California Santa Cruz, a PhD in Biology from University of California San Diego & the Salk Institute, and was a postdoctoral fellow at Stanford and University of California San Francisco.

Sara Ferrando Martinez
Research Scientist
AstraZeneca

David Donabedian
CEO
Axial Therapeutics

Dr. Donabedian is an accomplished business development and strategy executive with extensive leadership experience. Dr. Donabedian has a track record of building companies, most recently as a Venture Partner at Longwood Fund. Prior to joining Longwood, Dr. Donabedian has held various leadership roles at biopharmaceutical companies including AbbVie and GSK. At AbbVie, Dr. Donabedian served as Vice President & Global Head of Ventures and Early Stage Collaborations where he led a global team that completed significant transactions across multiple therapeutic areas and stages of development. Prior to AbbVie, Dr. Donabedian served as Vice President Global New Deal Strategy and Development at GlaxoSmithKline, and Senior Manager at Accenture’s Strategic Services Consulting Group. He holds a BA in Chemistry from St. Anselm College, a Ph.D. in Polymer Chemistry from the University of Massachusetts Lowell, and an MBA from the University of North Carolina. He currently serves on the Board of Alcyone Life Sciences, a privately held CNS company which he co-founded.

Stacy Kahn
MD, Attending Physician
Boston Children’s Hospital

Dr. Stacy Kahn completed her undergraduate degree in history at Washington University in St. Louis, and her post-baccalaureate premedical training at Bryn Mawr College in Pennsylvania. She attended New York University School of Medicine and then went on to complete her pediatric residency and pediatric gastroenterology fellowship at the University of Chicago. While at the University of Chicago, she also completed an ethics fellowship at the Maclean Center for Clinical Medical Ethics. Clinically, Dr. Kahn’s interests have focused on the care of children with IBD, in particular she is interested in the care and management of teens and young adults with Crohn’s and colitis. While on the faculty at the University of Chicago, she founded and was the Director for the Transitional IBD Clinic. Dr. Kahn's other primary clinical focus is recurrent and refractory Clostridium difficile infection. She is a national expert and leader in the field of fecal microbiota transplantation (FMT) and performed the first colonoscopic FMT in a child. Dr. Kahn's research interests include FMT for Clostridium difficile, FMT for inflammatory bowel disease, transition of care and self-management in IBD and research ethics. She is the director of the FMT research program at Boston Children’s Hospital and has led the development of the first national pediatric FMT registry.

Jessica Allegretti
MD, Director Clinical Trials
Brigham & Women’s Hospital

Dr. Jessica Allegretti graduated from Cornell University in Ithaca New York, and The Miller School of Medicine at the University of Miami in Miami, Florida. She was trained in internal medicine at Massachusetts’s General Hospital and completed her gastroenterology fellowship training at Brigham and Women’s Hospital. She later went on to receive a Master of Public Health degree from the Harvard School of Public Health. Currently she is an attending gastroenterologist at the Brigham and Women’s Hospital Crohn’s and Colitis Center, where she also serves as the center’s Director of Clinical Trials. In addition to her clinical responsibilities and caring for patients with IBD, Dr. Allegretti is the director of the fecal microbiota transplant program at Brigham and Women’s Hospital. She is currently leading several clinical trials investigating the use of fecal transplantation in several chronic diseases such as inflammatory bowel disease, primary sclerosis cholangitis and obesity. Additionally, Dr. Allegretti’s research focuses on investigating the mechanisms of recurrent clostridium difficile infections.

Gerard Honig
Associate Director, Research Innovation
Crohn’s & Colitis Foundation

Aaron Del Duca
VP Microbiome Platform
DayTwo

Sonia Timberlake
VP Research
Finch Therapeutics

Dr. Sonia Timberlake is the VP of Research at Finch Therapeutics, a microbiome therapeutics company. Sonia is an expert at designing NGS-based algorithms for applications in microbial genomics, immunogenomics, and evolution. Prior to joining Finch, she built and managed AbVitro's computational algorithms and infrastructure, supporting high throughput single-cell immune phenotyping and repertoire sequencing technology. This technology platform was acquired by Juno Therapeutics, where Sonia led a multidisciplinary team to harness native adaptive immune responses for developing engineered cell therapies in oncology. Sonia graduated from Caltech with a B.Sc in Molecular Biology and received her Ph.D. in Biological Engineering from MIT.

Cynthia Sears
MD, Professor of Medicine
John Hopkins Medicine

An expert in foodborne and intestinal infections, Cynthia Sears is a professor of medicine and oncology at the Johns Hopkins University School of Medicine as well as a professor of molecular microbiology and immunology at the Bloomberg School of Public Health. She is the microbiome program leader of the Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins and is director of the Johns Hopkins Germ-free Murine Facility. She is an infectious diseases expert who has focused on gut infections including diarrhea, foodborne illnesses Clostridium difficile (C. diff) and Helicobacter pylori during her career. In the laboratory and in clinical settings, she has studied the pathogenesis of enterotoxigenic Bacteroides fragilis (ETBF) over the past 25 years. The current focus of the Sears laboratory is to determine how the microbiota and specific bacteria contribute to colon carcinogenesis. The Sears laboratory integrates studies in humans and mouse models, employing microbiology, bioinformatics and immunologic methods. Dr. Sears has worked abroad in Thailand, Brazil, Haiti, Bangladesh and Malaysia. Dr. Sears received her medical degree from Thomas Jefferson Medical College followed by training in internal medicine at The New York Hospital (Cornell Medical School) in New York City. She trained in infectious diseases at the Memorial Sloan Kettering Cancer Institute and the University of Virginia. Dr. Sears joined the faculty at the Johns Hopkins University School of Medicine in 1988.

Alison Lawton
CEO
Kaleido Biosciences

Alison Lawton has served as Kaleido’s Chief Executive Officer, President and as a member of the Board of Directors since August 2018, after initially joining the company as President and Chief Operating Officer in December 2017. Ms. Lawton has more than 30 years of experience in a range of executive and operating roles in the biopharmaceutical industry. Prior to joining Kaleido, she was COO at Aura Biosciences, and previously held the same role at X4 Pharmaceuticals and OvaScience. Ms. Lawton spent more than 20 years at Genzyme Corporation and subsequently at Sanofi following its acquisition of Genzyme. She served as Senior Vice President and General Manager of Sanofi Biosurgery, a $750 million business that included surgical, orthopedics, and cell therapy and regenerative medicine franchises. Earlier, as SVP of Global Market Access for Genzyme, Ms. Lawton led global functional organizations, including regulatory affairs and quality systems, public policy, health outcomes and strategic pricing, product safety and risk management. Additionally, Ms. Lawton worked for seven years in the U.K. at Warner-Lambert/Parke-Davis. She previously served two terms as the industry representative on the Food & Drug Administration’s Cell & Gene Therapy Advisory Committee and as Chairman of the Board of the Regulatory Affairs Professional Society (RAPS). She is currently an independent Director of ProQR Therapeutics and Verastem, Inc., and was previously a director on the boards of Cubist Pharmaceuticals, CoLucid Pharmaceuticals, and Magenta Therapeutics. Ms. Lawton earned her Bachelor of Science degree in Pharmacology from King’s College London.

Day One

Thursday 13th December 2018

8:30 am | Microbiome Leaders Panel Discussion

Sahil Khanna
MD, Associate Professor of Medicine & Consultant
Mayo Clinic

The research program of Sahil Khanna, M.B.B.S., focuses on the epidemiology, risk factors and treatment of Clostridium difficile infection (CDI). As the most common infection in hospitals, CDI is an urgent public health threat with high mortality and recurrence rates. With an epidemic of this infection seen in the community, there is an emergent need to study the epidemiology and novel risk factors. Dr. Khanna leads Mayo Clinic's clinical and research program involving fecal microbiota transplantation for CDI, performs clinical trials for treatment of CDI, and studies the role of the gut microbiome in the management and outcomes of CDI.

Geoffrey Hannigan
Associate Principal Scientist
Merck Exploratory Science Center

Nathan Crook
Assistant Professor – Chemical & Biomolecular Engineering
NC State

Dr. Crook received his PhD in Chemical Engineering at the University of Texas at Austin in 2014 under the guidance of Hal Alper, where he focused on developing novel genetic engineering techniques for Saccharomyces cerevisiae.  He then undertook postdoctoral studies at Washington University in Saint Louis in the laboratory of Gautam Dantas, where he studied the evolutionary trajectories of probiotic bacteria in the mammalian gut.  The Crook Lab develops new high-throughput experimental and computational genetic engineering techniques. In doing so, his lab hopes to uncover novel biological phenomena and accelerate applied research and development in the broad areas of metabolic engineering, synthetic biology, and microbial ecology.

Wes Whitaker
Chief Scientific Officer
Novome Biotechnologies

Majdi Osman
MD, Clinical Program Director
OpenBiome

Majdi is the Clinical Program Director at OpenBiome. He is an Internal Medicine physician who trained at University College London. He previously worked at the World Health Organization and completed his Master's in Public Health at the Harvard T.H.Chan School of Public Health on a Frank Knox Fellowship.  He was trained in tropical medicine and infectious diseases at the London School of Hygiene and Tropical Medicine (LSHTM) and has taught and practiced medicine throughout Africa.  He co-founded YBank, a non-profit dedicated to adolescent health. His research focuses on infectious diseases, quality improvement and clinical safety.  He is excited to be part of OpenBiome in its mission to deliver safe access to FMT

Theresa LaVallee
VP Translational Medicine & Regulatory Affairs
Parker Institute for Cancer Immunotherapy

Theresa LaVallee, Ph.D., is the Vice President of Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy. She has more than 25 years of research and industry experience, with broad knowledge of drug discovery and development. Previously, Dr. LaVallee served as Senior Vice President of Regulatory and Precision Medicine at Celldex Therapeutics and Senior Vice President of Translational Medicine and Product Development at Kolltan Pharmaceuticals. Prior to those roles, she was Senior Director Translational Medicine at MedImmune and EntreMed. In these positions, she advanced drugs in oncology, immunology and inflammation from discovery through late stage development. Dr. LaVallee has a depth of expertise in translational medicine to enable science-driven development decisions and to implement effective use of biomarker assays in clinical studies. She is author or co-author of more than 50 publications and abstracts with a focus on translational medicine approaches in clinical development. She received her doctoral degree in microbiology and molecular genetics from the University of California, Los Angeles and her bachelor’s degree in biochemistry and molecular biology from the University of California, Santa Barbara. Dr. LaVallee completed her postdoctoral research at the American Red Cross Holland Laboratory.

Colleen Cutcliffe
Co-founder & CEO
Pendulum Therapeutics

Colleen Cutcliffe is the CEO and Co-Founder of Pendulum. She has over 15 years of experience leading and managing biology teams in academia, pharmaceuticals and biotechnology. Prior to starting Pendulum, Colleen was the Senior Manager of Biology at Pacific Biosciences and a Scientist at Elan Pharmaceuticals. Colleen received her Ph.D. in Biochemistry and Molecular Biology from Johns Hopkins University and her B.A. in Biochemistry from Wellesley College.

Barbara McGovern
MD, VP Medical Affairs
Seres Therapeutics

Barbara McGovern is VP of Medical Affairs at Seres. Dr. McGovern has over 25 years of experience in infectious diseases. Prior to joining Seres, she served as Medical Director in the Medical Affairs Division at AbbVie and helped to launch Viekera Pak for treatment of hepatitis C virus (HCV) infection. At AbbVie, Dr. McGovern was recipient of the “2015 President’s Award” in recognition of successful execution of 7 major publications in the New England Journal of Medicine, Lancet and JAMA. She also authored more than 50 journal articles, editorials, and textbook chapters on HIV and HCV and was an Associate Editor of Clinical Infectious Diseases. Dr. McGovern has also served as a member of the Antiviral Advisory Committee for FDA and as a panel guideline member for the Department of Health and Human Services. She earned her undergraduate degree from Queens College, CUNY, her M.D. at Albert Einstein College of Medicine and completed her internship, residency and infectious disease fellowship at Tufts Medical Center.

Matthew Henn
CSO
Seres Therapeutics

Matthew Henn is the Executive Vice President and Chief Scientific Officer of Seres. He has more than 16 years of combined research experience in microbial ecology, genomics, and bioinformatics that spans both environmental and infectious disease applications. Dr. Henn's research has focused on the development, implementation, and application of genomic technologies in the area of microbial populations and their metabolic functions. Prior to joining Seres, he was the Director of Viral Genomics and Assistant Director of the Genome Sequencing Center for Infectious Diseases at the Broad Institute of MIT and Harvard. He has authored over 60 peer-reviewed publications in microbiology and bioinformatics, and has led multiple large-scale international genomic projects. He has served as a consultant for the WHO’s Grand Challenges in Genomics for Public Health in Developing Countries, as a scientific advisor for the National Institutes of Health’s Viral Pathogen Bioinformatics Resource Center, and as an ad-hoc reviewer and editor of many peer-reviewed journals. Dr. Henn earned his Ph.D. in ecosystem sciences from the University of California at Berkeley, where he was a NASA Earth Systems Sciences Fellow, and trained as a NSF Postdoctoral Fellow in microbiology at Duke University.

Bruce Roberts
Chief Scientific Officer
Vedanta Biosciences

Dr. Roberts has 30 years of experience in biotechnology and pharmaceutical drug discovery and development. He most recently served as Head of Neuro-Immunology and Immune-Mediated Disease Research at Sanofi Genzyme where he directed pre-clinical efforts resulting in the introduction of therapeutic antibodies, gene therapies, cell therapies and small molecules into multiple clinical trials for the treatment of cancer, multiple sclerosis and autoimmunity. He also directed research efforts in support of several approved products including lemtrada, aubagio, thymoglobulin, Mozobil, alemtuzumab, leukine, chlofarabine and fludarabine and contributed to the generation of ecallantide. Dr. Roberts has authored more than 50 peer-reviewed publications and contributed to several issued patents and patent applications. He received his PhD. in Biochemistry from the University of Ottawa, Canada.

Marcus Rauch
Chief Scientific Officer
AlphaBiomics

Marcus is a microbiologist with 18+ years of experience in academia and pharma. He focused his research interest on microbiome sciences while a staff scientist at the University of California, San Francisco. More recently, as a Principal Scientist at Janssen and Head of a microbiome lab, he led a cross-disciplinary team and successfully built and managed internal & external collaborations. He co-founded AlphaBiomics in 2018 and serves as the company’s CSO.

Mark Bamforth
President & CEO
Arranta Bio

Mark Bamforth founded a new CDMO, Arranta Bio, in May 2019. Previously, Mark founded Brammer Bio in 2015, a best-in-class viral vector contract development and manufacturing organization (CDMO) supporting cell and gene therapies. Brammer’s team grew from 110 in 2016 with the addition of 100 from the acquisition of two Biogen commercial facilities, to over 600 at the time of its acquisition by Thermo Fisher Scientific in April 2019. In 2010, Mark founded a biologics CDMO, Gallus BioPharmaceuticals, and acquired a world-class facility and team of 160 from J&J with a commercial supply agreement. Gallus tripled through organic growth and merging with Laureate Biopharma. Gallus was sold to DPx Holdings B.V. in Sept. 2014. Mark previously spent 22 years in the UK and USA running a global manufacturing operation and a pharmaceutical CMO business for Genzyme and served as a corporate officer for 9 years. He began his career as a petroleum engineer exploring for North Sea oil with Britoil, then as a chemical engineer in the whisky industry with Whitbread. Mark serves on the boards of Avid Bioservices, MassBio, Wentworth Institute of Technology, and Entrepreneurial Scotland. He has a BS in Chemical Engineering from Strathclyde University and an MBA from Henley Management College.

Day Two

Thursday 13th December 2018

10:00 am | Meeting the Supply Needs of the Microbiome Sector

Jackie Papkoff
Chief Scientific Officer
Assembly Biosciences

She has deep expertise in cell biology and molecular mechanisms of disease, which she has applied to therapeutic and biomarker preclinical discovery & development in oncology, inflammation and autoimmunity. Prior to joining Assembly Biosciences, Dr. Papkoff was Senior Vice President Research at Evelo Biosciences, where she led the preclinical scientific team to discover, validate and nominate microbial therapeutics for clinical development in oncology indications. Prior to Evelo, Dr. Papkoff was a founding member of the J&J California Innovation Center, where she served as Vice President of Immunology Scientific Innovation for the Janssen Immunology Therapeutic Area focused on inflammatory and autoimmune diseases. Previously, she was CSO of CFD Therapeutics, a cancer-immunology focused antibody therapeutics company she co-founded, and held R&D leadership positions at diaDexus and Aventis pharma. Dr. Papkoff has a BA in Biology from University of California Santa Cruz, a PhD in Biology from University of California San Diego & the Salk Institute, and was a postdoctoral fellow at Stanford and University of California San Francisco. He holds a BA in Chemistry from St. Anselm College, a Ph.D. in Polymer Chemistry from the University of Massachusetts Lowell, and an MBA from the University of North Carolina. He currently serves on the Board of Alcyone Life Sciences, a privately held CNS company which he co-founded.

Assaf Oron
Chief Business Officer
BiomX

Assaf Oron has served as chief business officer since January 2017. Prior to this position, he served for over a decade at Evogene (NYSE:EVGN), an agriculture biotechnology company which utilizes a proprietary integrated technology infrastructure to enhance seed traits underlying crop productivity. At Evogene, he worked in various roles such as executive vice president of corporate development and executive vice president of strategy and business development. From 2004 to 2006, Mr. Oron served as CEO of ChondroSite Ltd., a biotechnology company that develops engineered tissue products in the field of orthopedics. From 1999 to 2003, Mr. Oron was a senior project manager and strategic consultant at POC Ltd., a leading Israeli management consulting company. Mr. Oron holds an M.Sc. in Biology (bioinformatics) and a B.Sc. in Chemistry and Economics, both from Tel Aviv University.

Adrien Nivoliez
CEO
Biose Industrie

Dr. Adrien NIVOLIEZ is the Chief Executive Officer at Biose industrie (Drug GMP for Live Biotheraputic Products) and develops R&D activities for the group Biose. Prior to this position, he has worked for several years at Probionov and Lyocentre. Adrien has completed his studies at the Université Paris-Sud, his PhD in Medical Microbiology and bacteriology at the University Blaise Pascal and had also gained an MBA from the European Institute of Technology (EPITECH). A major part of its research has been focused on the manufacturing impact on Live Biotherapeutic Product potenties, especially for vaginal application.

Chris Reyes
Co-Founder & CEO
Bloom Science

Dr. Reyes is a biophysicist and entrepreneur with a passion for creating solutions to improve our health, environment and economic sustainability. He has founded two companies focused on developing therapeutics to address serious medical needs as well as a tech company focused on connecting people to socially conscious commerce solutions. Dr. Reyes has a Ph.D. in Biophysics at the University of California, San Francisco and B.A. in Molecular and Cell Biology, Biophysics from the University of California, Berkeley.

Jeffrey Heiser
Director Microbiology
Boston Analytical

Day One

Thursday 13th December 2018

9:30 am | Gut Microbiome Endgame: Ramping up cGMP Program Design to Ensure Regulatory Preparedness for Microbiome Products

Luc Sterkman
CEO
Caelus Health

Luc Sterkman, MD (CEO) obtained his medical degree (MD) in 1988 at the Free University in Amsterdam. He has broad experience in the fields of general management, business development and R&D. From 1992-2002 he was COO and later CEO of U-Gene Research, that was successfully sold to Kendle USA (NASDAQ –KNDL). From 2002 to 2004, he worked as a Board member of the biotech company OctoPlus and from 2005 to 2010 he was General manager at the pharmaceutical company Disphar International BV (part of the Nordic Group). From 2011-2016 he worked as a COO at Newtricious, which company is focusing on innovative nutrition and functional foods. As the CEO at Caelus Health, he is since January 2016 overall responsible for building and directing the company in the next phase of growth and further expanding its pipeline of new microbiota-based products in the field of cardio-metabolic diseases.

Stephen Conafay
Principal & Founder
Conafay Group

Steve Conafay has 35 years of leadership and management experience in government relations, public policy and communications. As the sole principal at The Conafay Group, he oversees all client servicing. While leader of the bio-life science practice at Fabiani & Company, he oversaw more than $810 million in non-dilutive financing awarded to the team’s clients. For 12 years, Mr. Conafay was vice president of government relations for Pfizer, where he was elected as a corporate officer in 1984. He served as senior vice president of corporate affairs for Glaxo Inc., where he was also a member of the Board of Directors. After heading the legislative practice for Jones, Day, Reavis and Pogue, the world’s second largest law firm, he was tapped by the Pharmaceutical Research and Manufacturers of America (PhRMA) to assume the No. 2 position of executive vice president of strategic and legislative affairs. He also served as an executive fellow at the American Enterprise Institute, the leading free market think tank in the U.S. After moving to the New York area, Mr. Conafay joined Shandwick, where he assumed several positions of increasing responsibility, culminating with his appointment as chief executive officer for The Americas-East in 2000. Mr. Conafay is a lawyer and a decorated Vietnam veteran. He served as an infantry platoon leader and was awarded the Silver Star, Bronze Star with Oak Leaf Cluster, the Air Medal and the Army Commendation Medal, among others. He is also an avid golfer and has been a member of Congressional Country Club for more than 30 years. Mr. Conafay is a lifelong fan of the New York and San Francisco Giants. In his 60s, he ran and completed four Army 10-miler races, and plans to continue competing in his 70s.

Day Two

Thursday 13th December 2018

9:30 am | Updates from the Microbiome Therapeutics Innovation Group (MTIG) – Building a Collective Voice to Enhance the Regulatory, Investment and Commercial Success of Microbiome-Based Therapeutics

Dan Knights
CEO
Corebiome

Dan Knights is a computer scientist, computational biologist, and globally recognized expert in microbiome informatics who has developed some of the leading methods for analyzing microbiome data. He directs informatics & software development at CoreBiome, and was educated at Middlebury, University of Colorado, and Harvard Medical School.

Day Two

Thursday 13th December 2018

10:30 am | A Trifecta in Microbiome Advancements: Expectations from the Partnership of Diversigen, Corebiome and DNA Genotek

Arne Materna
Vice President Product
CosmosID

Day One

Thursday 13th December 2018

10:00 am | Shotgun Sequencing & Strain-Level Analysis: Study Design for Pre-Clinical & Clinical Development

Christophe Bonny
CSO
Enterome

Christophe Bonny has served as our Chief Scientific Officer since 2016. Dr. Bonny has approximately 20 years’ experience in the field of molecular biology and signaling pathways and 15 years in the field of hit identification to candidate selection. Before joining us, Dr. Bonny served as the Chief Scientific Officer at Bicycle Therapeutics Limited from 2013 to 2016. From 2006 to 2012, Dr. Bonny served as the Chief Scientific Officer of Xigen SA and also served as its President from 2011 to 2012. In 2005, Dr. Bonny received the Pfizer Research Prize. Mr. Bonny holds a Ph.D. in biochemistry and molecular biology from Neuchâtel University.

Daniel van der Lelie
Chief Scientific Officer
Gusto Global

Daniel van der Lelie is the Chief Scientific Officer and Co-Founder of Gusto Global, a leading microbiome drug discovery and development company focused on the rational design of live biotherapeutics that modulate the immune system. Dr. van der Lelie has worked in senior management roles in biotechnology, agriculture, environmental sciences and on the interface between biological sciences and nanotechnology throughout his career. Dr. van der Lelie’s research has resulted in more than 150 publications in peer reviewed journals, including PLoS ONE, PLoS Genetics, Nature, Nature Chemistry, Nature Nanotechnology and Nature Biotechnology, and 27 patents / patent applications.

Dirk Gevers
Global Head
Janssen Human Microbiome Institute

Johan van Hylckama Vlieg
Chief Scientific Officer
Kaleido Biosciences

Dr. van Hylckama Vlieg has served as Kaleido's Chief Scientific Officer since July 2019. Dr. van Hylckama Vlieg has 25 years of experience leading teams and R&D programs in gut microbiology, probiotics and live biotherapeutics, and industrial biotechnology in industry and academia. Most recently, he served as Vice President for Microbiome and Human Health Innovation at Chr. Hansen in Denmark, responsible for new strain development for probiotic and therapeutic application, spanning discovery to clinical development and novel technology platforms. Previously, Dr. van Hylckama Vlieg worked at Danone Research and in several roles at NIZO Food Research. He completed his Ph.D. and post-doc in biochemistry at the University of Groningen in the Netherlands.

Paul Peter Tak
President & CEO
Kintai Therapeutics

Paul-Peter Tak is President, Chief Executive Officer and Board Member of Kintai Therapeutics and a Venture Partner at Flagship Pioneering (both in Cambridge, MA). Dr. Tak is also a Professor of Medicine at the Amsterdam University Medical Centre (AMC), Honorary Professor of Rheumatology at Ghent University and Honorary Senior Visiting Fellow at the University of Cambridge. He received his medical degree cum laude from the Free University in Amsterdam and was trained as an internist, rheumatologist and immunologist at Leiden University Medical Center, where he also received his Ph.D. He later worked as a scientist at the University of California San Diego for two years. He served as Professor of Medicine and founding Chair of the Department of Clinical Immunology and Rheumatology at the Academic Medical Centre/University of Amsterdam (AMC) for 12 years, where he was also the Program Director for the Rheumatology fellowship. His scientific work in academia has focused on the discovery of the cholinergic anti-inflammatory pathway in rheumatoid arthritis (RA), synovial tissue analysis in different stages of arthritis and in response to various targeted treatments, the development of gene therapy for autoimmune diseases, and studies on the earliest stages of RA. Dr. Tak has published extensively in peer-reviewed journals (560 publications; H factor 121 [Google Scholar]), and served on numerous editorial boards, including as Co-Editor of Arthritis & Rheumatism. He received the Medal of Honour from the Netherlands Society for Rheumatology, was elected ‘Toparts Reumatologie’ (Elected by peers as ‘Best Rheumatologist’ in the Netherlands based on his clinical work), was awarded Honorary Membership by the European League Against Rheumatism and has been elected Fellow of the Academy of Medical Sciences in the U.K. At GlaxoSmithKline (GSK) he served as Senior Vice President, Chief Immunology Officer, Global Development Leader, and co-chair of the Scientific Review Board. He oversaw the creation of a portfolio of drug candidates for immune-mediated inflammatory diseases and pain, including anti-OSM antibody, anti-LAG3 antibody, RIP1 kinase inhibitor, ESM-BET inhibitor, anti-GM-CSF antibody, anti-CCL17 antibody and Benlysta sc. Later, he also led the Oncology and Infectious Disease Therapy Area Units and oversaw research in immuno-oncology, cell and gene therapy and epigenetics. He is the founder of GSK’s Immunology Network, a collaboration between GSK and leading academics, which provides the latter with privileged access to the latest research and facilities GSK has to offer. He was a board member of Galvani Bioelectronics and ViiV Healthcare. In addition to his work in academia and big pharma, he established a biotech company developing intra-articular gene therapy (Arthrogen b.v., Amsterdam), was Chief Executive Officer of Tempero Pharmaceuticals (Cambridge, MA), is one of the founders and board directors of Sitryx Therapeutics (Oxford), and serves on the board of directors of Levicept (London) and Omega Therapeutics (Cambridge, MA).

Day One

Thursday 13th December 2018

8:30 am | Microbiome Leaders Panel Discussion

Stacy Burns-Guydish
VP Biotherapeutics Development & Manufacturing
List Laboratories

Tuval Ben-Yehezkel
CEO
Loop Genomics

Jason Ryan
Head of Upstream
Luina Bio

Gunjan Singh Thakur
Senior Scientist Computational Biology
Merck Exploratory Science Center

Xue Liang
Microbiome Scientist
Merck Exploratory Science Center

Will DeLoache
Co-Founder & CSO
Novome Biotechnologies

Dr. DeLoache is Co-Founder and Chief Scientific Officer of Novome Biotechnologies, a biotechnology company based in South San Francisco that is engineering bacterial therapeutics for chronic diseases. Until 2019, he served as President and CEO of the company, helping to raise a combined $40M in financing. Prior to Novome, he worked as a Scientist at Zymergen, where he led the development the company’s next-generation sequencing pipeline. Dr. DeLoache earned his Ph.D. in Bioengineering at the University of California, Berkeley, studying synthetic biology and metabolic engineering in the laboratory of John Dueber. He received his B.S. with Honors in Biology from Davidson College.

Mohan Iyer
Chief Operating Officer
Pendulum Therapeutics

Tomas de Wouters
Co-Founder & CEO
PharmaBiome

Keri Donaldson
CEO
Prescient Metabiomics

Massimo Marzorati
CEO
ProDigest

Ryan Wilson
Head of Live-Bioprogrammes
Quay Pharma

Julius Goepp
Founder & CEO
Scaled Microbiomics

Dr. Goepp trained in Pediatrics, Emergency Medicine, and Infectious Disease at Harvard and Johns Hopkins before entering the microbiome therapeutics field. After 23 years in academic and clinical medicine, he became fascinated by discoveries relating human health to microbiome composition and dynamics. His previous work with anti-bacterial vaccines prepared him for the pursuit of immunotherapeutics as applied to microbiome composition and dynamics. He founded Scaled Microbiomics in 2016 with a vision for a platform technology capable of rapid, cost-effective discovery of therapeutics and diagnostics leveraging our growing understanding of cell-cell signaling pathways in microbiome-associated disease causation. Today, he leads the company’s development of a series of targeted formulations capable of intercepting disease-promoting event cascades within a microbiome, aiming at conditions as diverse as Travelers’ Diarrhea, colorectal cancer, and responsiveness to levodopa therapy in Parkinson's disease

Stacy Townsend
Director of Pre-Clinical Development
SciBac

Stacy has almost 20 years’ experience in antibacterial and anti-inflammatory therapeutics research and development in the biopharmaceutical industry with proven ability to progress antibacterial efforts from target identification to clinical trials. She has led the life science research and development groups with responsibility for in vitro assays relating to antibacterial, anti-inflammatory, and wound healing programs. In addition, she lead several early stage programs, from target identification to lead optimization, and a chronic lung infection program that delivered a therapeutic in Phase I clinical trials. During the last two years she has focused on preclinical development of live biotherapeutics for the treatment of chronic lung infections. At SciBac, Stacy coordinates the team’s activities and works with the relevant CROs to progress all preclinical studies.

Ken Blount
CSO
Rebiotix

Ken Blount, PhD, is a seasoned director of collaborative research programs in biotech, pharma, clinical, and academic research settings, and his scientific expertise includes antibiotics discovery and development, fecal microbiome analysis, translational medical oncology, and RNA-targeting therapeutics. Prior to joining Rebiotix, Dr. Blount coordinated translational urologic oncology research for the Yale Cancer Center. Previously, he was a cofounder and the Director of Biology at BioRelix, a venture-backed Connecticut biotech that developed new antibiotics to target structured bacterial messenger RNAs. At BioRelix, Dr. Blount led a combined force of internal scientists and external resources that delivered development candidates for treating Clostridium difficile infections. Dr. Blount received his undergraduate degree in biochemistry from the University of Arkansas and earned a PhD in biochemistry from the University of Colorado Boulder, after which he completed an NIH post-doctoral fellowship at the University of California San Diego.

Day Two

Thursday 13th December 2018

9:30 am | Updates from the Microbiome Therapeutics Innovation Group (MTIG) – Building a Collective Voice to Enhance the Regulatory, Investment and Commercial Success of Microbiome-Based Therapeutics

Barbara McGovern
MD, VP Medical Affairs
Seres Therapeutics

Barbara McGovern is VP of Medical Affairs at Seres. Dr. McGovern has over 25 years of experience in infectious diseases. Prior to joining Seres, she served as Medical Director in the Medical Affairs Division at AbbVie and helped to launch Viekera Pak for treatment of hepatitis C virus (HCV) infection. At AbbVie, Dr. McGovern was recipient of the “2015 President’s Award” in recognition of successful execution of 7 major publications in the New England Journal of Medicine, Lancet and JAMA. She also authored more than 50 journal articles, editorials, and textbook chapters on HIV and HCV and was an Associate Editor of Clinical Infectious Diseases. Dr. McGovern has also served as a member of the Antiviral Advisory Committee for FDA and as a panel guideline member for the Department of Health and Human Services. She earned her undergraduate degree from Queens College, CUNY, her M.D. at Albert Einstein College of Medicine and completed her internship, residency and infectious disease fellowship at Tufts Medical Center.

Matthew Henn
CSO
Seres Therapeutics

Matthew Henn is the Executive Vice President and Chief Scientific Officer of Seres. He has more than 16 years of combined research experience in microbial ecology, genomics, and bioinformatics that spans both environmental and infectious disease applications. Dr. Henn's research has focused on the development, implementation, and application of genomic technologies in the area of microbial populations and their metabolic functions. Prior to joining Seres, he was the Director of Viral Genomics and Assistant Director of the Genome Sequencing Center for Infectious Diseases at the Broad Institute of MIT and Harvard. He has authored over 60 peer-reviewed publications in microbiology and bioinformatics, and has led multiple large-scale international genomic projects. He has served as a consultant for the WHO’s Grand Challenges in Genomics for Public Health in Developing Countries, as a scientific advisor for the National Institutes of Health’s Viral Pathogen Bioinformatics Resource Center, and as an ad-hoc reviewer and editor of many peer-reviewed journals. Dr. Henn earned his Ph.D. in ecosystem sciences from the University of California at Berkeley, where he was a NASA Earth Systems Sciences Fellow, and trained as a NSF Postdoctoral Fellow in microbiology at Duke University.

Eric Shaff
CEO
Seres Therapeutics

Eric Shaff is the President and Chief Executive Officer of Seres. Mr. Shaff was previously the Executive Vice President, Chief Operating and Financial Officer of Seres. He has more than 15 years of experience working in leadership roles in biotechnology finance, corporate development, and capital markets. Prior to joining Seres, he was Vice President, Corporate Finance, at Momenta Pharmaceuticals, where he helped manage Momenta’s accounting, finance, planning, and procurement functions, as well as contributing to Momenta’s investor relations efforts. Prior to joining Momenta, Mr. Shaff was Vice President, Finance, of Genzyme’s Rare Genetic Disease Division, responsible for a global portfolio of products. Mr. Shaff held several positions at Genzyme in business unit finance, corporate finance, and corporate development. Prior to Genzyme, Mr. Shaff worked in corporate finance at Pfizer and worked in investment banking for Broadview International (now Jefferies LLC). Mr. Shaff earned his B.A. from the University of Pennsylvania in political science and economics and his M.B.A. with a concentration in finance from the Johnson Graduate School of Management at Cornell University.

Day One

Thursday 13th December 2018

8:30 am | Microbiome Leaders Panel Discussion

John Aunins
Chief Technology Officer
Seres Therapeutics

John Aunins is the Executive Vice President of Bioprocess & Manufacturing and the Chief Technology Officer of Seres. He has more than 26 years of experience in the biotechnology industry, with a focus in bioprocess development, manufacturing support, and project leadership. Prior to joining Seres, he led process and product development teams at Merck Research Laboratories for Vaqta®, Varivax®, Zostavax®, ProQuad®, Rotateq®, and Gardasil®. The Vaqta and Gardasil process teams were awarded with ACS Industrial Biotechnology Awards for innovation, contribution to bioengineering, and societal impact. He is a Fellow of the American Institute for Medical and Biological Engineering, and an adjunct Full Professor at the Instituto de Tecnologia Química e Biológica (ITQB) in Oeiras, Portugal. He has authored over 50 articles and book chapters, and has chaired five international conferences in vaccines and bioprocess technology. Dr. Aunins earned his Ph.D. in chemical engineering from MIT in 1989 under Institute Professor Daniel I.C. Wang.

Nikole Kimes
Co-founder and CSO
Siolta Therapeutics

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.

Ricardo Valladares
VP Research & Development
Siolta Therapeutics

Ricardo studied as a graduate NSF Fellow at the University of Florida where he focused on identifying molecular mediators of probiotic Lactobacillus-host interactions in type 1 diabetes. He later joined the laboratory of Dr. Susan Lynch at the University of California San Francisco as a NIH Research Fellow investigating microbial community dynamics during allergy and asthma development. Prior to joining Siolta Therapeutics in 2017, Ricardo served as Director of Research and Development at Medical Neurogenetics Laboratories where he developed Next Gen Sequencing-based diagnostic tests for rare genetic disorders. As Vice President of R&D at Siolta, Ricardo leads an interdisciplinary team in the development of live biotherapeutic products for the treatment and prevention of inflammatory diseases.

Eric Van der Helm
Head of Synthetic Biology & Bioinformatics
SNIPR Biome

Gerardo Toledo
Co-Founder & CEO
Solarea Bio

Jeffrey Hymes
Scientist
Symberix

Jeff Hymes is passionate about the microbiome and its potential as an untapped source of novel drug targets. In 2016, he joined Symberix, a startup company pioneering a completely new class of small molecule drugs that selectively block harmful bacterial activity without disturbing the gut microbiota. As a scientist at Symberix, Jeff has expanded Symberix’s drug discovery platform, identified novel microbiome drug targets, and managed a research collaboration with the National Center for Advancing Translational Sciences (NCATS). Jeff has published multiple articles related to human-associated bacteria and the microbiome.

Yogesh Mudaliar
Research Investigator Drug Product Development
Takeda Pharmaceuticals

Yogesh Mudaliar is currently a Research Investigator at Takeda Pharmaceuticals, where he supports the lyophilization development of live microbiomes, monoclonal antibodies and antibody drug conjugates. After obtaining his Pharmacy degree, Mr. Mudaliar gained valuable professional experience in various pharmaceutical departments such as a science executive, in marketing, advertising etc. However, Mr. Mudaliar’s passion for R&D drove him back into grad school where he obtained his M.S. in Biological Sciences from University of Massachusetts. After graduation, Mr. Mudaliar obtained a position at Merck Millipore as a Bioanalytical Scientist, where he developed chromatography methods and performed characterization studies for biologics. He subsequently joined AstraZeneca as a Formulation Scientist gaining experience in formulation, process development and large scale manufacturing of lyophilized and liquid biological products from early through late stage development. His work on particle formation due post-lyophilization stability issues in monoclonal antibodies won him the Thomas Jennings award at the ISLFD 2016. Concurrently, during his time at AstraZeneca he also completed a professional learning course on Biotherapeutic Formulations from MIT. In 2018, Mr. Mudaliar joined Takeda Pharmaceuticals as a Research Investigator, to provide technical leadership for formulation development and lyophilization of LBP, antibodies, ADCs and fusion proteins. Currently, Mr. Mudaliar also serves on the company’s millennial advisory board to the CEO.

Gregory Lambert
CEO and VP R&D
TargEDys

A Pharmacist, with a PhD in pharmaceutical technology, Gregory’s career has been split between Biotech and Pharma as Chief Scientific Officer and Chief Executive Officer in companies such as Novagali Pharma, Septodont and currently TargEDys. Gregory has led the development of several products from the laboratory to the market. In 2014, Gregory joined the scientific founders of TargEDys as CEO. Having completed preclinical development and produced industrial batches, TargEDys now concentrates on human clinical trials and commercial launch activities.

Benjamin Lelouvier
Chief Scientific Officer
Vaiomer

Dr Lelouvier received his Ph.D in Cellular and Molecular Neurobiology from the University Pierre et Marie Curie, Paris VI, France, in 2007. After a postdoctoral fellowship at the National Institutes of Health (USA), he joined Vaiomer in 2012. As cellular and molecular biology group leader and head of biomarkers discovery, he developed with his group the molecular tools (16S qPCR and 16S metagenomics sequencing) to study specifically the blood and tissue microbiomes, before becoming Chief Scientific Officer of Vaiomer in 2016. The study of tissue and blood microbiota allows Vaiomer to link intestinal dysbiosis and tissular inflammation for the development of biomarkers and therapeutics in the fields of cardiometabolic diseases, neurodegenerative disorders and chronic infection.

Bernat Olle
CEO
Vedanta Biosciences

Dr. Olle is a co-founder and Chief Executive Officer of Vedanta Biosciences. He has been a member of the founding teams of several companies of the PureTech portfolio and served as a member of the Board of Directors of Vedanta Biosciences and Follica Biosciences. In 2013 Dr. Olle was named "Innovator of the Year" in MIT Technology Review Spain's "Innovators under 35" awards. He completed his doctoral work at the Chemical Engineering Department at MIT, where he developed a novel method for large-scale bacterial culture. During his graduate work, Dr. Olle was awarded the "la Caixa" fellowship. Dr. Olle received his B.S. in Chemical Engineering from Universitat Rovira i Virgili, in the Republic of Catalonia, his M.S. and PhD. in Chemical Engineering Practice from MIT, and his M.B.A. from the MIT Sloan School of Management. He has published his work in journals including Nature and Nature Biotechnology.

Day One

Thursday 13th December 2018

8:30 am | Microbiome Leaders Panel Discussion

Ryan Toma
Research Scientist
Viome

Ryan is a Research Scientist at Viome, the leader in data-driven personalized nutrition. He focuses on designing and implementing clinical studies with the aim of harnessing Viome's personalized nutrition program to combat chronic diseases. Ryan is also a member of the R&D team at Viome and is involved in product development. Prior to joining Viome, Ryan was a key member of the Applied Genomics team at Los Alamos National Lab that developed the core technologies that Viome uses today. Viome's systems biology platform enables precise modulation of microbial functions and supplementation of missing human functions via nutritional interventions.

Matthew Meyerson
Professor and Principal Investigator
Dana-Farber Cancer Institute

Dr. Meyerson received his MD in 1993 and PhD in 1994 from Harvard University. After a residency in clinical pathology at Massachusetts General Hospital and a research fellowship with Dr. Robert Weinberg at the Whitehead Institute, he joined DFCI in 1998. Dr. Meyerson has concentrated on using genomic approaches to understand the biology and genetics of human lung carcinomas. More broadly, his laboratory is focused on cancer genome discovery and pathogen discovery in human disease. Dr. Meyerson serves as Professor of Pathology at Dana-Farber Cancer Institute and Harvard Medical School, as Director of the Center for Cancer Genome Discovery at DFCI (with Dr. William Hahn), and as Senior Associate Member of the Broad Institute.

Alexander Kostic
Assistant Professor
Harvard Medical School

Yang-Yu Liu
Assistant Professor of Medicine
Harvard Medical School

Yangcong Zhang
Postodoctoral Fellow Huttenhower Lab
Harvard T.H. Chan School of Public Health

Cynthia Sears
MD, Professor of Medicine
John Hopkins Medicine

An expert in foodborne and intestinal infections, Cynthia Sears is a professor of medicine and oncology at the Johns Hopkins University School of Medicine as well as a professor of molecular microbiology and immunology at the Bloomberg School of Public Health. She is the microbiome program leader of the Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins and is director of the Johns Hopkins Germ-free Murine Facility. She is an infectious diseases expert who has focused on gut infections including diarrhea, foodborne illnesses Clostridium difficile (C. diff) and Helicobacter pylori during her career. In the laboratory and in clinical settings, she has studied the pathogenesis of enterotoxigenic Bacteroides fragilis (ETBF) over the past 25 years. The current focus of the Sears laboratory is to determine how the microbiota and specific bacteria contribute to colon carcinogenesis. The Sears laboratory integrates studies in humans and mouse models, employing microbiology, bioinformatics and immunologic methods. Dr. Sears has worked abroad in Thailand, Brazil, Haiti, Bangladesh and Malaysia. Dr. Sears received her medical degree from Thomas Jefferson Medical College followed by training in internal medicine at The New York Hospital (Cornell Medical School) in New York City. She trained in infectious diseases at the Memorial Sloan Kettering Cancer Institute and the University of Virginia. Dr. Sears joined the faculty at the Johns Hopkins University School of Medicine in 1988.

Christine Pierce
Assistant Member – Department of Cancer Epidemiology
Moffit Cancer Center & Research Institute

Dr. Pierce Campbell’s research is focused on understanding the complex interactions between the human microbiome (bacterial, fungal, and viral communities that exist throughout the human body) and immune system within the context of cancer development, tumor progression, and the response to cancer therapy. Through the use of integrative molecular epidemiological techniques, Dr. Pierce Campbell’s research aims to assist in the development of molecular biomarkers for cancer diagnosis, prognosis, and therapeutic outcomes. The human body harbors several diverse and complex microbial communities, each occupying a unique ecological niche. An estimated 500-1,000 bacterial species live in the gut and over 600 live in the oral cavity. These commensal microbes (i.e., microbiota) have co-evolved with human hosts and play a critical role in maintaining our physiology and metabolism, and modulating our immune and inflammatory responses. Microbiota also influence the host’s ability to mount a successful anti-tumor immune response. Dr. Pierce Campbell’s research aims to understand how a patient’s microbiota may influence the effectiveness of cancer therapies, particularly immunotherapy. Her studies have largely concentrated on cancers of the head and neck, lung, breast, and colon. These studies will improve our understanding of the role of the microbiome in cancer treatment and may aid in the development of personalized microbiota-based interventions to optimize anticancer therapies (e.g., prebiotics, probiotics, and fecal microbiome transplants).

Jonathan Peled
MD, Medical Oncologist
Memorial Sloan Kettering Cancer Center

After his medical residency at Massachusetts General Hospital in Boston and heme/onc fellowship at Memorial Sloan Kettering Cancer Center, Jonathan joined the Adult Bone Marrow Transplantation Service of MSKCC where he serves as an Assistant Attending. He studies how the intestinal microbiota interact with the host immune system as it relates to hematopoietic stem-cell transplantation, with a particular interest in graft-vs-tumor activity and graft-vs-host disease. Nathan Crook, Assistant Professor – Chemical & Biomolecular Engineering, NC State Dr. Crook received his PhD in Chemical Engineering at the University of Texas at Austin in 2014 under the guidance of Hal Alper, where he focused on developing novel genetic engineering techniques for Saccharomyces cerevisiae. He then undertook postdoctoral studies at Washington University in Saint Louis in the laboratory of Gautam Dantas, where he studied the evolutionary trajectories of probiotic bacteria in the mammalian gut. The Crook Lab develops new high-throughput experimental and computational genetic engineering techniques. In doing so, his lab hopes to uncover novel biological phenomena and accelerate applied research and development in the broad areas of metabolic engineering, synthetic biology, and microbial ecology.

Aida Habtezion
MD, Principal Investigator
Stanford University

Dr. Habtezion is a physician scientist, appointed as the endowed Ballinger-Swindells Scholar, Tenured Associate Professor in the Department of Medicine, Division of Gastroenterology & Hepatology and Institute for Immunity, Transplantation and Infection, and Associate Dean for Academic Affairs at Stanford School of Medicine. She is a fellow of the Stanford ChEM-H (Chemistry, Engineering & Medicine for Human Health), member of the Stanford Neuroscience Institute, Stanford Cancer Institute, Stanford Pancreas Cancer Research Group, and Stanford Diabetes Research Center. Her research supported by the NIH, Department of Defense, and foundation grants aims to understand immune signaling and pathways in diseases affecting the pancreas and the intestine with hopes of finding therapeutic targets that can be translated to clinical care. In 2011-2012 she was named digestive disease investigator and in 2012-2015 she received the Robert Wood Johnson Harold Amos Medical Faculty Development Award. In 2013 she received the Division of Gastroenterology & Hepatology Teaching Award and in 2016 the Immunology Faculty Mentor of the Year. In 2017, she received Synergy Award from the Kenneth Rainin Foundation for her research in inflammatory bowel disease (IBD), she was elected into the American Society for Clinical Investigation and also into the American Pancreas Association Council.

Betty Theriault
DVM, Assistant Professor
University of Chicago

Dr. Betty Theriault is Director of the University of Chicago Gnotobiotic Research Animal Facility. She holds a faculty appointment as Professor in the Department of Surgery and Clinical Veterinarian within the Animal Resources Center at The University of Chicago. She is a veterinarian with over thirty years of experience working with animals in a variety of settings and across a broad spectrum of species. Her work focuses on assisting researchers develop animal models of human disease and adapting technologies to unique applications. She has been primary or co-author to publications spanning a diverse range of models and species including but not limited to animal models of transplantation, ovarian cancer metastasis, food allergy, circadian rhythm and obesity. She is past President of the recently revitalized Association for Gnotobiotics, and current President of the International Association for Gnotobiology. Dr. Theriault has presented lectures on topics of gnotobiology at scientific meetings locally, nationally and internationally and has led gnotobioticfocused workshops annually at national American Association for Laboratory Animal Science (AALAS) meetings for the past several years. She received her Doctorate in Veterinary Medicine from the University of California at Davis. She is a Diplomate of the American College of Laboratory Animal Medicine.

Nikki Klatt
Associate Professor Pediatrics
University of Miami

Dr. Nikki Klatt is the Vice Chair of Research, Adrienne Arsht Endowed Chair in Pediatric clinical research, Associate Professor at the University of Miami. She received her Ph.D from Emory University. In her short time as a P.I., Nikki Klatt has accomplished many great things including being the director of the mucosal immunology core and microbiome core at the University of Washington. The focus of Klatt Lab is to understand the microbiome relative to drug metabolism, mucosal immunology and host processes in HIV infection.

Stephan Patrick Rosshart
Principal Investigator & Group Leader Translational Microbiome Research
University Medical Center Freiburg

Dr. Rosshart studied biology and medicine at the Albert-Ludwigs-University Freiburg, Germany. In February 2010 he obtained his doctorate degree in basic immunological research with "summa cum laude" from the University of Freiburg. After his postgraduate training in clinical internal medicine at the University Medical Center Freiburg, he joined the National Institutes of Health in Bethesda, USA for a 6 year postdoctoral fellowship in basic immunological research. During this time he conceived the "natural microbiota theory" which he published as corresponding author in the journals Cell (2017) and Science (2019). In July 2019 he took his new position as academic physician scientist, group leader of the translational microbiome research laboratory and head of the gnotobiotic mouse facility at the Department of Medicine II, University Medical Center Freiburg. His work focuses on mammalian microbiota and their impact on health and disease. He utilizes natural microbiota- and pathogen-based mouse models and a bench-to-bedside approach to identify new treatment strategies for human diseases.

Hariom Yadav
Assistant Professor, Molecular Medicine
Wake Forest School of Medicine

The central research goal of my lab is to improve the understanding about mechanism(s) involved in gut microbiome-mediated pathology of metabolic diseases like diabetes, obesity and aging, and to develop treatment options to prevent and/or cure these health ailments. To achieve this goal, my research program focuses on three major interconnected themes: 1. Define contribution of gut microbiome/virome on microbiome-gut-brain axis to regulate energy metabolism via modulating enteroneuroendocrine-immune axis 2. Development of human-origin probiotics 3. Study microbiome-drug interactions to modulate drug efficacy To accomplish the goals of our research projects, we use a combination of transgenic mice models of human disease, germ-free mice models, next generation sequencing, bioinformatics analyses in conjunction with bacteriological, biochemical, functional genomics, and ex-vivo and in-vitro models.

Speaker TBC
CBER
FDA

Day Two

Thursday 13th December 2018

9:00 am | Regulatory and Clinical Considerations for LBPs