Meeting the Challenges of Microbiome Directed Therapies

November 13, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

Add to Calendar 11/13/2019 8:00:00 AM 11/13/2019 10:00:00 AM Meeting the Challenges of Microbiome Directed Therapies

A high-level Google search for microbiome companies and entities working with microbiome research or services shows that there are at least 20 operating around Cambridge, MA alone, including the largest stool bank in the US supplying the majority of material for investigations of Fecal Matter Transplants (FMT) for a variety of serious diseases. There are also many international pharmaceutical and biotech companies with locations in our area who are partnered with companies working on microbiome directed therapies, in addition to our universities, research institutions, and medical communities. Discoveries of the implications of the microbiome on human health and disease are opening a whole new field with great potential to impact human health. There is much that is not known from a scientific perspective, but the field is hungry for information and involvement.

This forum will provide an opportunity for interactive discussion with our expert panel on current approaches to developing microbiome-targeted therapies, key roadblocks, technical needs, and the knowledge gaps that exist. The goal of the forum is to bring together various stakeholders in our community to build awareness of what is currently going on in the field, understand what resources are at our disposal, and to help each other overcome barriers and accelerate therapies to market for patients.

Sponsored by our Drug Discovery (DD) Forum Working Group.

 MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139
  • Eric Alm, PhD
  • Professor of Biological Engineering at MIT
  • Eric Alm is a Professor of Biological Engineering at MIT and an Institute Member of the Broad Institute. His research uses complementary computational and experimental methods to engineer the human microbiome, including data science, quantitative analysis, and novel molecular techniques. More broadly, he is interested in using technology to personalize medicine and improve public health. His laboratory has helped to start several companies and non-profit organizations dedicated to translating research findings into the real world solutions, including OpenBiome, Finch Therapeutics, Biobot Analytics, and the Global Microbiome Conservancy.
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  • Mark Bamforth
  • President & CEO, Arranta Bio
  • Mark Bamforth founded a new CDMO, Arranta Bio, in May 2019, focused on providing process development and clinical supplies to product pioneers in the microbiome space. 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.
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  • Esther Bleicher, J.D., M.P.H.
  • Regulatory and Legal Affairs at Integral Health
  • Esther W.B. Bleicher, JD, MPH, is Executive Director of Regulatory Affairs and Legal at Integral Health, Inc., a biotech venture of Flagship Pioneering, and advises other Flagship Pioneering companies on FDA regulatory issues in a broad range of product and therapeutic areas. Prior to joining the Flagship Pioneering ecosystem, Esther spent nearly 10 years at FDA. From November 2016 to May 2018, Esther was Senior Policy Advisor in the Office of the Center Director in CDRH, where she advised CDRH leadership and staff on legally complex issues and led policy development for strategic priorities. Other roles Esther held at FDA include: Deputy Chief of Staff for the Commissioner, where she facilitated resolution of key issues within the agency and the Administration; Chief Implementation Manager of the FDA Food Safety Modernization Act, where she led FDA’s rulemakings and guidance development to modernize FDA’s food safety oversight; and attorney in FDA’s Office of the Chief Counsel, where she provided legal advice to FDA on new regulatory programs, policies, and enforcement actions.
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  • Carolyn Edelstein
  • Executive Director of OpenBiome
  • Carolyn is the Executive Director of OpenBiome. She was a member of the founding team and previously served as Director of Outreach and Public Affairs, where she oversaw OpenBiome's efforts to expand the availability of FMT across 1,000 hospitals and clinics, present its work to the public, and contribute to the discourse on the regulation of fecal microbiota. Previously, Carolyn worked at the US Agency for International Development, where she helped launch the Global Innovation Fund, a $200 million institution backed by foreign aid agencies from the US, UK, Canada, Australia, Sweden, and South Africa to test and support low-cost, high-impact interventions to improve global health and prosperity. She holds an MPA and a BA from Princeton University's Woodrow Wilson School of Public and International Affairs, where she was awarded the Scholars in the Nation's Service Initiative (SINSI) Fellowship, a four-year program to support outstanding individuals to launch careers in public service.
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  • Scott Jackson
  • Group Leader - Complex Microbial Systems, NIST
  • Scott Jackson is currently the leader of the Complex Microbial Systems Group at the National Institute of Standards and Technology (NIST) in Gaithersburg, MD. In this current role, Scott is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies, developing reference materials and reference methods, and developing in vitro tools that allow us to better understand microbial community resilience and evolution. Prior to joining NIST in 2014, Scott spent 11 years as a principal investigator with the FDA. At FDA, his research focused on characterizing the global genomic diversity of enteric pathogens, with applications for food safety, bioforensics and public health. Scott performed his PhD research in biochemistry and biophysics at The University of Maryland and Johns Hopkins University, respectfully, where he focused on the biophysical properties of catalytic RNA (ribozymes) and the evolution of mobile genetic elements. Scott performed his undergraduate studies in Chemistry and Geology at the University of South Carolina.
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  • Susan Stewart, J.D.
  • Senior Vice President Regulatory Affairs & Quality, Kaleido Biosciences
  • Susan Stewart has served as Kaleido's Senior Vice President, Regulatory Affairs & Quality since April 2018. Ms. Stewart has worked for more than 25 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, regulatory affairs at Transmolecular. She also spent more than 10 years at Genzyme Corporation in regulatory and compliance roles, including serving as vice president, regulatory affairs. She received her J.D. from Concord Law School at Purdue University Global and her B.A. from the University of Massachusetts.
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  • Sonia Timberlake, Ph.D.
  • Vice President Research, Finch Therapeutics
  • 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 infrastucture 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. from MIT.
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