This year, our annual Microbiome: Recent Developments, Regulatory, Quality, and Commercialization Summit will take place ONLINE on Zoom. We are very excited to bring you an event dedicated to the best practices and inside views of the future of microbiome-based products concerning the quality, safety, and efficiency.
What are the recommendations for driving efficient strategies within the microbiome landscape? Do you want to know more about the CMC, QA/QC technical perspectives of the microbiome?Read more
The Summit will shed light on current challenges, best practices, and inside views of the future of microbiome-based products in relation to the quality, safety, and efficiency.
We will discuss key findings, critical insights, and recommendations for driving efficient strategies within the microbiome landscape.
It is an honor and privilege to invite you to participate virtually in this Summit.
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, and Managers specializing in:
Bone Marrow Transplantation
High Throughput Screening
Live Cell Therapeutics
Mergers & Acquisition
Ross has spent over 30 years inventing products, technologies, and processes for various industries and holds over 75 patents worldwide. He is driven to innovate by a focus on what is better, faster, and less expensive. Ross' recent major innovations include an R&D 100 Award for collaboration on biopolymer technologies. In 2009, Biosortia was awarded a $6 million ARPA-E (U.S. Dept. of Energy R&D) grant for its algal harvesting technology, which helped lead to the development of Biosortia's drug discovery platform.
In 1998, Ross was awarded the Ernst & Young Ohio Entrepreneur of the Year award. Additionally, the U.S. Small Business Administration honored him as their national "Business Person of the Year" in a presentation made by Vice President Al Gore.
Manfred Ruthsatz leads an international consulting company providing regulatory vision and integrated solutions. He shares expertise and passion at Nutrition+HealthCARE to improve people's lives, making consumer and patient CARE (connecting people, advocacy, regulation and empathy) personal and sustainable.
His past roles focussed on building and strengthening relations between multiple stakeholders, like regulators, policymakers, manufacturers, academia, healthcare professionals and patient NGOs. He led advocacy, regulatory, safety and quality, reimbursement, and health economics functions in nutrition and healthcare industries (Nestlé Health Science, L’Oréal-innéov, Abbott, Roche), providing him with strategic experience in nutrition, botanicals, biotech, drugs, devices and cosmetics. A prior NIH Visiting Fellow (cancer virology; molecular biology), he served as a reviewing pharmacologist and US-FDA (CDER).
He maintains a long-standing recognition as faculty and on governing, scientific and editorial boards (ISDI, VP; RAPS; ERNA; MIRRI; European Botanical Forum, presidency) and leads global/regional medical nutrition/dietary/food supplements association working groups.
Manfred has published articles and presents frequently to governments, associations and at global nutrition and healthcare conferences in Europe, the Americas and Asia on healthcare and safety topics, including personalised nutrition, healthy ageing, disease-related malnutrition, microbiome, food-drug borderline, global convergence, multi-stakeholder engagement and policymaking.
He upholds board certifications in pharmacy, toxicology (DABT), regulatory affairs (RAC) and he received the rare distinction as a Regulatory Affairs Professionals Society (RAPS) Fellow and as Competent Communicator (CC) from Toastmasters International.
Dr. Ger Rijkers is a medical immunologist and senior scientist at the Laboratory of Medical Microbiology and Immunology of the St Elizabeth Hospital in Tilburg, The Netherlands. As an academic and researcher, Ger’s specialization is in the interaction between the human immune system and micro-organisms of the respiratory and gastrointestinal tract, in immunoregulation, vaccination, and healthy aging.
He has published over 350 papers in peer-reviewed scientific journals, as well as a textbook on Immunology. He is Co-Editor in Chief of Pneumonia and Section Editor of Beneficial Microbes and a scientific advisor of IPA.
Dr. Sin-Hyeog Im has investigated to identify probiotic bacteria that enhance anti-inflammatory or anti-tumor immunity immune responses, then identifying the effector molecules and their action mechanisms. Recently he published an article in Science Immunology 3 (28), eaat6975 (Cell surface polysaccharides of Bifidobacterium bifidum induce the generation of Foxp3+ regulatory T cells). The paper was highly cited and well recognised on the point of microbiome therapeutics.
Jessica Parsons O'Connell is a partner in Covington's food and drug regulatory practice group, where she provides strategic advice to a broad range of companies and trade associations in engaging with food and drug regulatory bodies and Congress. In particular, she assists clients in complying with U.S. regulatory requirements for the manufacture and sale of foods, dietary supplements, cosmetics, OTC drugs, animal products, and the import and export of FDA-regulated products.
Michal Daniely, PhD, is the director of research and development for Merck KGaA, Darmstadt, Germany, at the Jerusalem and Rehovot locations in Israel.
Michal is responsible for developing technologies and products for a wide range of research applications, using core technologies such as: microbial fermentation, recombinant proteins design and expression, next-generation sequencing (NGS), mass spectrometry (MS) and antibodies development.
Over the past three years, Michal has been involved in shaping the company’s strategy within the microbiome research field, aiming to develop products and technologies to support the growing need in this market.
Michal earned her master’s and PhD in human genetics from the Sackler Medical School, Tel Aviv University, Israel. Prior to joining Merck KGaA, Darmstadt, Germany, she held various roles with medical device and pharma companies, where she managed the research and development activities.
Before joining J&J, Colette Shortt was science director at Yakult (the Japanese probiotic company) and held a research nutrition position at SmithKline Beecham Consumer Healthcare. Colette has been active in the development of product-related standards and health claim substantiation throughout her career and coordinated one of the most successful disease risk reduction health claim regulatory submissions in Europe while at J&J’s McNeil Nutritionals Ltd. Colette is a registered nutritionist, Fellow of the Association for Nutrition, Fellow of the Royal Society of Medicine and a visiting professor at Ulster University. She is active on the board of the Pharmabiotic Institute and International Life Science Institute. She is a graduate of the National University of Ireland, with post-graduate qualifications in nutrition (MSc, PhD) and business (MBA) from the University of Surrey, UK.
Formerly a researcher at Institut Pasteur, Georges Rawadi was vice president of business development and intellectual property and a member of the management team at Celyad.
Previously, he successfully held various business development positions at Cellectis, Galapagos, ProStrakan and Sanofi-Aventis, and led strategic alliance development consulting assignments. He holds a PhD in microbiology from Pierre and Marie Curie University (France) and a master’s degree in management and strategy in the health industry from ESSEC Business School.
Todd Krueger is the chief executive officer, president and a director of the company. He is primarily responsible for the overall management, corporate development and strategic planning of the company and has been with the company since 2015. At Northwestern University (US), Todd graduated with a bachelor’s degree with highest distinction in economics and earned his MBA from Northwestern’s Kellogg School of Management.
Prior to joining OpenBiome, Todd had over 20 years of experience in healthcare strategy, business development, operations and finance. He started his career as a consultant for Bain and Company, a management consulting firm, from 1990-93, responsible for providing strategic analysis and solution implementation to Fortune 500 clients. In 1999, he co-founded Fluidigm Corporation, which is principally engaged in the design, manufacture and sale of biological research equipment and is currently listed on NASDAQ (stock symbol FLDM), where he served as its chief financial officer and the vice president of business development from 1999-02, responsible for strategy development, finance, business development and operations. From 2006-13, he held various senior business development and strategy roles at Applied Biosystems Inc., and later Life Technologies Corporation (which was formed as a result of the merger between Applied Biosystems Inc. and Invitrogen Corporation in 2008), where his last role was head of business development for molecular medicine. From 2013-14, he was chief financial officer of Claritas Genomics, Inc., a genetic diagnostics laboratory based in the United States, and from 2014-15, he was the director of strategy and operations for the Broad Institute, a biomedical and genomic research centre based in the United States. He was responsible for overseeing the commercialisation of the genetics platform.
Todd also currently serves as a director of General Automation Laboratory Technologies, Inc. (GALT), a microbiome tools company based in the United States.
T. Jonathan Tanaka is a Scientific & Regulatory Affairs, Snr. Project Manager at Morinaga Nutritional Foods, Inc. (the US subsidiary of Morinaga Milk Industry Co., Ltd.), one of the pioneers in Bifidobacterium research. Jonathan is responsible for regulatory, quality, scientific, & technical matters for the North and South American market. He is active in several trade association related regulatory/probiotics matters such as the International Probiotics Association. To date, he has over 10+ years in combined experiences with 5+ years in the probiotics industry alone; he has also written GRAS dossiers and a deep understanding of the US-FDA's GRAS notification structure. Jonathan earned his BS in Biology/BA in Cognitive Psychology from University of California San Diego (UCSD), MS in Biological Sciences from California State University Fullerton, have completed post-graduate work on neuro-cognitive imaging at UC Irvine School of Medicine, and holds several certifications in quality matters. He is also currently pursuing a Ph.D. in the Clinical Sciences.
Carlo Romano Settanni completed his fellowship training in Gastroenterology at Università Politecnica delle Marche (Ancona, Italy) in 2018. Currently, he is working as a consultant physician and he is pursuing a Ph.D. degree at the Università Cattolica del Sacro Cuore (Rome, Italy). His research field is the role and the modulation of gut microbiota in intestinal and extra-intestinal diseases, with a focus on faecal microbiota transplantation.
Romain Daillère completed his PhD in 2015 in the laboratory of Professor Laurence Zitvogel at the Gustave Roussy Cancer Campus (GRCC), Villejuif-Grand Paris, France. His research focusses on the complex interplay between gut microbiota and the efficacy of anticancer regimens. He previously graduated as a biotechnology engineer at the Ecole Supérieure de Biotechnology de Strasbourg (Trinational School of Strasbourg), and worked at the Ragon Institute of MIT, MGH and Harvard in Boston. He’s the co-founder of EverImmune, co-inventor of EverImmune Technology and he has acted as head of the preclinical research of EverImmune since 2018.
Dr. David Pepperl is a pharmacologist-toxicologist and currently senior consultant and nonclinical group leader at Biologics Consulting, based in the Washington DC metro area. With a background in both nonclinical development and molecular biology, he assists early to mid-stage biopharma companies with product development and regulatory strategy. At Biologics Consulting, David oversees nonclinical development programs for a variety of product types, including cell and gene therapies, vaccines, blood products, monoclonal antibodies and protein therapeutics as well as small molecules. He routinely consults on regulatory submissions, reviews nonclinical sections of pre-INDs, INDs and CTDs, and oversees nonclinical studies and programs on behalf of his clients. David received his BS in biochemistry from Michigan State University and his PhD in pharmacology and toxicology from the University of Arizona in 1994. He is actively involved with both the American College of Toxicology (ACT) and Drug Information Association (DIA), and he currently resides with his family in Maryland.
Silvia leads Anagram's Team to deliver best-in-class clinical research services. Twenty years of Clinical Research experience from phases I to IV, including drug and medical devices. Extensive experience as Project Director and Project Manager, coordinating full scope international trials across all functional areas. Global program management experience in > 25 countries in multiple therapeutic areas, Silvia is highly expert in planning efficient and cost-effective strategies to ensure clinical trial success. PharmaTimes International Clinical Researcher of the Year, 2015 PM Gold Award.
With a Law degree by the University of Deusto, Bilbao, Spain and a Master’s degree in European Community Law and Comparative Law by the University of Maastricht, The Netherlands, David has over 15 years of experience providing strategic and regulatory advice to companies, trade associations and government bodies in the food, nutrition and health arena at national, regional and international level in Asia, Europe, Latin America and the Caribbean and the United States. This also includes his expertise in regulatory harmonisation processes in international organisations such as the Codex Alimentarius Commission, in the notification processes of regulations to the World Trade Organisation and in the development of international policies on health and nutrition such as the World Health Organisation and the Panamerican Health Organisation. David has vast expertise leading regulatory projects consisting of the analysis of regulations applying to foods, beverages and other nutritional products, advising in regulatory harmonisation processes, creating, expanding and consolidating international and regional trade associations, and developing, coordinating and implementing strategic plans contributing to the removal of trade barriers and the access of products and ingredients to markets worldwide. David has organised, participated and spoken in events, conferences and training workshops for industry, academia and government bodies representatives in the foods, beverages, food supplements and medicines areas across the globe. Moreover, David has written articles and publications and given interviews for media magazines, newsletters and blogs internationally on trending topics on food, beverage and food supplement regulations and market entry.
Craig is one of the founding members of the HGF-IP microbiome team. He has considerable experience in providing pragmatic, commercially focused advice to a wide range of clients and in relation to biotechnological and pharmaceutical inventions. As well as patent drafting and prosecution, Craig advises on the development of company-wide IP strategies, preparing for or carrying out funding/acquisition due diligence, and advising on aggressive/defensive strategies in relation to third party IP. After having worked on matters in the field for more than 15 years, Craig’s practice's particular focus relates to therapeutic microbiome innovations. Craig has worked on projects in relation to OTC products, faecal transplant therapies, bacterial and bacteriophage therapies (single strain and consortia), formulation technologies, bioinformatics analysis of microbiome, production and purification processes, synthetic biology, and a wide range of diagnostics (for example, those for detecting or quantifying bacterial infection and those that use bacteriophage). Having worked closely with multi-national corporations, Craig is aware of the particular challenges of efficiently prosecuting large multi-national patent portfolios, whilst keeping them relevant to the business. Craig has also found this experience of value when advising SMEs on collaborations with such large entities. Craig is a European, UK, and Irish patent attorney. Prior to qualifying in London as a patent attorney, he was a Patent Examiner at the UKIPO.
Eline Klaassens is BaseClear's expert in human microbiome analysis and its link with human health and disease. She holds a PhD degree from Wageningen University in Microbial Eco-physiology of the Human Intestinal Tract. She has a background in using multiple omics tools for profiling diversity as well as the functionality of the human microbiome.
Adalberto Costessi is BaseClear's expert on the application of whole-genome sequencing technologies to regulatory affairs. Adalberto graduated in Medical Biotechnology at the University of Trieste, and he specialized in molecular biology and next-generation sequencing during his PhD at the Radboud University in Nijmegen.
Alain M. Sourabié, PhD Hons is Procelys (a Lesaffre Group Business Unit) Global Science, Technology and Innovation Director after being the Head of Bio Springer Biotech Applications Labs. He graduated with a PhD. (Hons) in Industrial Microbiology / BioChemical Engineering from the Life Sciences Institute AgroParisTech and holds a MBA certificate from ENPC ParisTech (Paris, France). Before joining Lesaffre group, Dr. Sourabié has held different post-doctoral and Research Scientist positions across North-America and Europe.
In his current role with Procelys, Dr. Sourabié oversees the BU strategy for new development projects as well as coordinating the effort towards products and concept innovation for fermentation industries. He has in-depth industry experience in Fermentation Sciences and Technologies, BioProcess Engineering, as well as for the industrial production of various molecules and biomass. He is leading or involved in various Research and Innovation projects including both academia and industry, and has extensive experience in supervising post graduate and graduate projects related to Bioprocess engineering and Applied Biotechnology. Dr. Sourabié is a member of the Standing Committees of many professional organizations such as the Federation of European Microbiology Societies (FEMS), US Society of Industrial Microbiology and Biotechnology (SIMB), and recently the Lactic Acid Bacteria Industrial Platform (LABIP) and International Probiotics Association (IPA). He is a reviewer of renown international scientific journals and has published more than 50+ research papers, book chapters, and conference abstracts.
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“Thank you for a well-organized and good meeting in Berlin.”
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Yakult Nederland B.V.
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Oct 17, 2019
3rd Annual Microbiome: Regulatory, Quality Developments and Commercialization Summit