Pharma
This premier B2B event provides you with an appropriate platform to engage with and discuss ideas with your fellow peers while facilitating a professional atmosphere and environment for excellent company representation and development.
Read moreThe Summit will shed light on current challenges, best practices and inside views of the future of microbiome-based products in relation to quality, safety and efficiency. We will discuss key findings, critical insights and recommendations for driving efficient strategies within the microbiome landscape. It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you in Berlin in October!
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders and Managers specialising in:
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Pharmabiotic Research Institute (PRI)
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AEProbio (Alliance for Education on Probiotics)
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Olaf Larsen (1972) studied chemistry at the VU University Amsterdam and obtained a PhD in biophysics at the same university. Following postdoctoral research in New York City and Amsterdam, he continued his career within industry. Olaf worked for ASML, TNO and as a life sciences consultant within various organisations. Since 2012 he has been heading the science department at Yakult Nederland. Since 2016, he has also been a part time assistant professor the VU University focussing on the valorisation of microbiota management.
Erik Spek is the head of legal affairs and intellectual property at Vedanta Biosciences, a microbiome company based in Cambridge, Massachusetts. Erik previously worked at Epizyme, a clinical stage biopharmaceutical company focussing on epigenetic targets. Prior to Epizyme, Erik worked at Boston-based IP law firm Wolf Greenfield. Erik obtained his JD from Suffolk Law School, has a PhD in biophysical chemistry from New York University and conducted his postdoctoral research at the Massachusetts Institute of Technology.
Pharmabiotic Research Institute (PRI)
Magali Cordaillat-Simmons earned her PhD in 2005 at Université Descartes in Paris, France, in cardiovascular pharmacology. She then worked as a research associate at the University of Virginia, USA, where she studied the influence of epigenetics on renin expression. Today, she is the scientific and regulatory affairs director at the Pharmabiotic Research Institute (PRI), located in France. The PRI is Europe’s first and only expert regulatory group dedicated to supporting its members in the development and market authorisation of microbiotic medicinal products (MMPs). As a nonprofit, pro-industry organisation, the PRI is uniquely positioned to both be a trusted point of contact for the European regulatory authorities, as well as an agile and neutral partner for the microbiome/health industries. Magali currently supervises the association’s analysis of the European pharmaceutical regulatory framework as well as the PRI’s regulatory intelligence strategy so that MMPs become a therapeutic reality for European patients.
Rana Samadfam received both an MSc and PhD in pharmacology from the Université de Sherbrooke. Following her postdoctoral training at McGill University, Rana joined Charles River, where she and her team focus on inflammation, immunology, autoimmune, IBD, respiratory, skin and joint diseases. She is the recipient of several scientific awards, author of over 105 peer-reviewed publications and editor of a bone toxicology book. Her articles have appeared in Scientific American, and her most recent peer-reviewed studies have been published in the Journal of Bone and Mineral Research. Rana is a diplomate of the American Board of Toxicology.
Adrien Nivoliez is the CEO at Biose Industrie (drug GMP for live biotherapeutic products). Prior to this position, he worked for several years at Probionov and Lyocentre with quality, production and global R&D positions. Adrien completed his studies at the Université Paris-Sud, then obtained a PhD in medical microbiology and bacteriology at the Université Blaise Pascal and also gained an MBA from the European Institute of Technology (EPITECH). A major part of his research has been focussed on the manufacturing impact on live biotherapeutic product potencies.
Mark FitzGerald represents industry and academic/nonprofit institution clients, from the US and abroad, on strategic development of patent portfolios, analyses of freedom to operate, patent validity and infringement and associated opinion preparation, transactional due diligence and associated client counseling. Mark focusses on the biotechnology arena, working with clients to secure meaningful patent protection for their own technology as well as assisting them in charting a course through the patent protection shoals of their competitors. An area of intense interest and activity in Mark’s practice is the protection of microbiome-related intellectual property, and he is the editor of the Gut Check Microbiome Patent Updates newsletter series. Mark received his PhD in molecular biology from Brown University.
Christian Roghi is the chief business officer at EnteroBiotix, a Scottish biopharmaceutical company that is harnessing the human microbiome to develop novel medicinal products that restore health and prevent disease. Previously, Christian was head of business development at the Quadram Institute (Norwich, UK), a research organisation exploring how food and the gut microbiota are linked to the promotion of health and the prevention of disease. In addition to this main role, Christian was also a director of the EIT-Food Innovation hub established in Reading. Christian holds a PhD in molecular cell biology, an executive MBA and a diploma in management consulting from the Chartered Management Institute. He spent 19 years in research laboratories in France, Germany, USA and the UK, deciphering the molecular mechanisms underlying cancer tumour progression and metastasis. He has authored 25 peer-reviewed scientific publications.
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.
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.
Saravanan Thangaraj is an industry analyst in the transformational health group at Frost & Sullivan. He has over five years of experience in management consulting and has advised biotech and clinical diagnostics clients on strategy and business. He has been continuously tracking the recent development in the areas of microbiome-driven therapeutic and diagnostic and has also authored off the shelf Frost & Sullivan reports on the topic. Before Frost & Sullivan, he worked as an IT business analyst for projects under the life sciences domain at a top multinational IT firm. He has also researched one of the top medical institution in India, The National Institute of Mental Health and Neuroscience (NIMHANS) in the department of psychopharmacology. His industry experience includes biotechnology, pharma, life sciences, IVD and health systems. Saravanan holds a bachelor’s of technology in biotechnology and an MBA from PSG College of Technology
Frederique Vieville founded 5QBD-Biotech (Quality Business Development) to secure and accelerate any drug development and manufacturing process. Prior to that she acquired a multi-disciplinary vision of drug development, from research to final regulation submission, over a period of 15 years in pharma/biotech companies. Following her graduation as a pharmacist, valuable experience was acquired in a French CDMO, producing and developing solid forms for the commercial market. She then graduated as an engineer in biotechnology and did a post as head of QA/QP deputy in a Swiss company for sterile products in clinical phases. Then, Frederique was responsible for the pharmaceutical chain as quality director in a UK startup developing LBPs. Her own foundation of 5QBD-Biotech (Quality Business Development) was the next natural step to provide reliability for and increased speed of any drug development and manufacturing process.
Dr. Peter Bak, vice president at Back Bay Life Science Advisors, has more than 10 years of experience with a broad range of research approaches – cellular, molecular and biochemical – and fields, from immunology and infection through oncology.
At Back Bay Life Science Advisors, Peter leads a diverse portfolio of projects with a focus on liquidity planning and positioning, strategic franchise building, M&A and licensing strategy and buy-side diligence. He regularly works with companies of all scales, from startup to global life science brands. His research career in immuno-oncology began at Dartmouth Medical School (PhD, microbiology and immunology), where his research uncovered novel pathways of immunosuppression in ovarian cancer, and continued at MIT, as an American Cancer Society Postdoctoral Fellow at the Koch Institute of Integrative Cancer Research. At MIT, Peter focussed on the development of immunotherapies for prostate cancer and led interdisciplinary projects with researchers from the departments of biological and chemical engineering. During his academic career, Peter published peer-reviewed articles on cancer vaccinology, the molecular mechanisms of myeloid-cell-mediated immune-suppression, costimulatory requirements for intertumoral T-cell activation, and immune editing within the tumor environment. He holds a degree in biology, magna cum laude, from The College of the Holy Cross. Peter has authored several articles on the life sciences for Back Bay Life Science Advisors, including white papers on the promise of neoantigen-based cancer immunotherapy, and the promise of the microbiome and immuno-oncology.
AEProbio (Alliance for Education on Probiotics)
Dragana Skokovic-Sunjic is a clinical pharmacist with Hamilton Family Health Team and NAMS-certified menopause practitioner. In addition to her collaborative clinical practice, she is a leader in knowledge mobilisation for probiotics in Canada and US. Translating scientific research in this field, she authored the “Clinical Guide to Probiotic Supplements Available in Canada” and “Clinical Guide to Probiotic Products Available in the US”. This practical clinical tool is independently reviewed and updated annually in order to reflect the latest evidence and include new probiotic products on the Canadian and US markets. Her project has been recognised internationally, receiving a Scientific Frontiers Award at the Probiota 2015 Conference in Amsterdam and similar recognition at Probiota Americas 2015 Conference in San Diego. The Clinical Guide to Probiotics was presented at Probiota World Congress in Barcelona in February 2018 and she was an invited speaker at the International Probiotic Conference in Budapest, June 2018. In 2003, Dragana attained certification as a menopause practitioner with North American Menopause Society (NAMS). In 2008, she received the Wyeth Apothecary Award for Specialty Practice, awarded by the Ontario Pharmacists Association to a pharmacist who has completed specialty education or training and as a result has successfully expanded his or her professional practice. She is actively involved as a board member with the Canadian Menopause Society (SIGMA). Her work in the field of women’s health and probiotic influence on microbiome has been presented at two International Menopause Society World Congress (Prague, Sep. 2016 and Vancouver, June 2018) and North American Menopause Society Annual Meeting (Orlando, Fla., Oct. 2016), and published in their respective scientific journals. Canadian version of the Clinical Guide to Probiotics can be found at www.probioticchart.ca and US version at www.usprobioticguide.com
Dr. Isaksen has extensive experience with commercial biotech, and established and run several biotech companies in Norway and in the UK. In addition, he has acted as consultant for many biotech companies over the years. He has been in involved in the microbiome field for more than a decade. His passion and field of expertise is in developing better assays for gut microbiome analysis. This led him to set up and act as the CEO of Genetic Analysis from 2008 to 2013. Based on the experience and insights from that venture, he set up and is the CEO of Bio-Me in 2016. Bio-Me offers next generation gut microbiome analysis, making it possible to analyze hundreds of fecal samples in less than a day, with high resolution and low cost.
Finn Terje Hegge is CTO and Head of Operations at Genetic Analysis AS. He has more than 15 years of experience from technology and product development within molecular biology and in vitro diagnostics. Finn Terje graduated from the University of Oslo in 2004 with a PhD in Molecular biology.
Martha Carlin is an award-winning systems thinker whose microbiome-research company, The BioCollective, is changing how we understand the link between the environment, our food and water systems, and illness. A sought-after speaker, she is the 2018 NetExplo Major Digital Talent in biotech; the APC Microbiome Hero for World Microbiome Day; 2016 White House Microbiome Initiative Speaker, and an advisor for the Microbiota Vault, among others. She believes that a siloed approach to health research misses important microbial connections, and built her company to connect the dots between human and ecological systems.
Pharmabiotic Research Institute (PRI)
AEProbio (Alliance for Education on Probiotics)
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