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
To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.
Nestlé Institute of Health Sciences SA
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.
Nestlé Institute of Health Sciences SA
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.
Susan Stewart has served as Kaleido's senior vice president of regulatory affairs and quality since April 2018. Susan has worked for more than 28 years in biopharmaceutical regulatory affairs, with significant experience devising innovative strategies for novel therapeutics, overseeing regulatory submissions at various stages of product development and leading interactions with global health authorities.
Previously, in addition to being an independent regulatory consultant for several years, she was senior vice president of regulatory affairs, quality and compliance at Tokai Pharmaceuticals and vice president of regulatory affairs at Transmolecular. She also spent 13 years at Genzyme Corporation in regulatory and compliance roles, including serving as vice president of regulatory affairs. She received her J.D. from Concord Law School at Purdue University Global and her bachelor’s degree from the University of Massachusetts. She is a Fellow of the Regulatory Affairs Professionals Society (RAPS), a Director of the Board, and holds Regulatory Affairs Certifications (RAC) in both the US and EU.
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.
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.
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.
Nicolas Carbonnelle is counsel at law firm Bird & Bird LLP and a member of the international life sciences sector group and of the retail and consumer sector group, in which he steers the food and beverage sector group.
Nicolas advises clients on regulatory law across various sectors, including food and beverage, life sciences and the chemicals sector. Across the spectrum of these sectors, Nicolas assists on borderline products classification and on regulatory path definition and compliance strategies.
In the field of food and beverage, Nicolas has built an expertise in matters relating to general food law and labelling regulations to innovative and highly regulated forms of food products, including novel food and nutraceuticals. Furthermore, Nicolas advises clients from the life sciences sector on market access, pricing and reimbursement issues and marketing policies, both at the EU and domestic level. Nicolas also regularly advises on regulation on the use of biological material for therapeutic applications and scientific research activities.
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.
Nestlé Institute of Health Sciences SA
“Thank you for a well-organized and good meeting in Berlin.”
“Thanks for the excellent conference; I enjoyed it very much!”
Yakult Nederland B.V.
“It was a wonderful congress, where the size allowed high quality of discussions and networking.”
Thank you for your interest!
Oct 17, 2019
3rd Annual Microbiome: Regulatory, Quality Developments and Commercialization Summit