Pioneering microbiome-based medicines to treat life-threatening diseases and infections
Our mission is to transform the lives of patients around the world by modulating the structure and function of the gut microbiome through a new class of medicinal products.
EnteroBiotix is uniquely positioned to capitalise on the promise of the microbiome as a leading innovator in this field.
Established in March 2017 by Dr James McIlroy, EnteroBiotix is a privately held and well-financed biopharmaceutical company focussed on realising the therapeutic potential of the gut microbiome to transform the lives of patients with serious unmet medical needs.
EnteroBiotix is majority owned by a small group of hands-on and committed investors that share a common vision of building a global microbiome-focussed pharmaceutical company headquartered in Scotland. Our leadership team, Board of Directors and Expert Advisors have substantial experience and expertise in microbiome science, drug development, CMC and regulatory affairs. We are united by a desire to develop best-in-class medicinal products that will transform the lives of patients suffering from debilitating diseases and infections linked to the gut microbiome.
Our lead assets contain diverse and viable communities of microbiota collected from rigorously screened donors. These therapies represent an entirely new class of medicinal product with the potential to address multiple critical public health needs. To enable our objectives we have established powerful drug development and integrated MHRA-licensed manufacturing capabilities. We have also forged several collaborations with leading institutions and organisations that bolster our internal expertise and capabilities with highly qualified and experienced scientists, acknowledged experts and state-of-the-art research and development facilities.
Our Products & Platform
Our platform delivers viable ecosystems of multifunctional microorganisms in products that are patient-friendly
EnteroBiotix has established a fully-integrated, end-to-end, starting material to drug product development and manufacturing platform. This includes an ISO:9001/2008 donor screening and starting material collection facility, multiple FDA, MHRA and UKAS accredited analytical laboratories and multiple MHRA licensed GMP manufacturing sites.
Our products harness the therapeutic potential of collections of bacteria derived from healthy human donors. In contrast to traditional pharmaceutical products, which target singular defined physiological pathways, EnteroBiotix’s products are multifunctional and therefore have potential therapeutic utility in a variety of disease indications and patient populations.
EnteroBiotix is exploiting its platform in C.difficile infection and two undisclosed disease indications.
Dr James R. McIlroy, MBChB BMedSci (Hons)
Chief Executive Officer
Dr James McIlroy Founded EnteroBiotix after recognising the therapeutic potential of the microbiome with the vision of building one of world’s leading microbiome drug development companies.
James has over 5 years of leadership experience as a biopharmaceutical entrepreneur, Board Director and company executive, with hands on experience in creating, building and successfully leading cross-functional teams through value building milestones including facility GMP-accreditation, formal scientific advice meetings and raising multiple equity investment rounds totalling 8 figures of aggregate value from international syndicates comprised of corporate and private investors.
James is a qualified medical doctor that successfully trained within the UK National Health Service in multiple hospital service areas alongside full-time employment at EnteroBiotix. He holds a BMedSci (Hons) from the University of Edinburgh and an MBChB from the University of Aberdeen, graduating with a final year distinction (top 3% of year) and the elective prize in child health awarded in recognition of his published research on intestinal microbiome modulation in paediatric patient populations.
James is a named inventor on several microbiome related patent applications and has been published as first author in journals such as Alimentary Pharmacology & Therapeutics, Frontline Gastroenterology and Clinical Immunology.
Dawn Firmin, Ph.D.
Head of Projects and Clinical Studies
Dr Dawn Firmin is a scientific professional with over a decade of combined experience in immunology & infection, toxicology management, and the management of drug development of NCEs in various indications including oncology and anti-infectives, specifically in the area of C.difficile infection (CDI).
Dawn’s expertise lies in her knowledge and experience of managing the various phases of drug development, such as all pre-clinical phases including CMC, GLP toxicology & safety pharmacology, as well as clinical Phase I and Phase IIa clinical trials, including regulatory involvement such as scientific advice and pre-IND meetings with the MHRA and the FDA. She has over a decade of experience of working with industry partners, academic institutes and funding bodies. Dawn was lead programme manager of both a Phase I trial in CDI conducted in the UK, followed a Phase IIa trial conducted in the US and Canada, both funded by Innovate UK Biomedical Catalyst fund.
Dawn holds a PhD in Immunology and Infection at the University of Aberdeen, an MSc in Medical Diagnostics from Cranfield University, and an honour degree in Ecology from the University of Stirling. She has authored and co-authored various academic papers and medical research articles.
Dr. Margaret Courtney, Ph.D.
Head of CMC
Dr Courtney has over twenty years of experience in transitioning active substances and drug products from the research laboratory into clinical studies and commercialisation.
Margaret is a registered pharmacist with a BSc in Pharmacy from the University of Strathclyde where she subsequently completed a PhD focused on the development of a polymeric modified release system. After academia, Margaret began her industrial career at a drug delivery company, Core Technologies, before joining the Oral Healthcare research group at GlaxoSmithKline.
Subsequently, she was at Vernalis (R&D) for almost fifteen years, where she was responsible for the formulation and process development of NCEs and biologics in clinical development as well as the manufacture of commercial products.
Prior to joining EnteroBiotix, Margaret was at Lamellar Biomedical with responsibility for product development and manufacture including the oversight of contract manufacturers and management of academic collaborations.
Dr. Geoff Kitson, BMBS BMedSci (Hons)
Chief Medical Officer
Dr Geoff Kitson has over 30 years of experience in the pharmaceutical industry, and a broad-based international perspective on drug development, from phase I to phase IV, experience of pre-clinical work, and regulatory requirements. He has been involved in the preparation of INDs, CTXs/CTAs, MAAs and other regulatory documents.
Dr Kitson has experience in the development of individual clinical studies, clinical trial programmes, multinational clinical trials and developing clinical strategies. In the last few years, he has taken 9 products through to first in man studies, and progressed products through to Phase II/III.
Lynsey Howard, PhD
Head of Early Phase Development
Dr Lynsey Howard has over 10 years of experience in the strategy, design and implementation of innovative biopharmaceutical R&D along with team leadership, business development and senior management.
Lynsey originally completed her BSc (hons) in Virology from the University of Glasgow, where she subsequently completed a PhD in novel stem cell and gene therapies for cardiovascular disease within the Institute of Cardiovascular and Medical Sciences. Following this, Lynsey took up a Post-Doctoral Researcher position at the University of Bristol working in the Bristol Heart Institute.
Prior to joining EnteroBiotix, Lynsey was Head of Preclinical Research and Development at Lamellar Biomedical where she created extensive internal and external scientific capability in infection biology, antimicrobial development, respiratory disease, gene therapy, and immunology. Lynsey directed several collaborations with world-leading institutes and commercial partners, as well as led an in-house team of multidisciplinary scientists. Lynsey’s work generated valuable intellectual property for Lamellar, resulting in 5 patent submissions.
Lesley Carmody, QP
EU Qualified Person
Lesley Carmody is an EU Qualified Person that has over 30 years experience in the Pharmaceutical Industry working for large pharma, small pharma, Contract Manufacturing Organisations and virtual organisations.
Lesley has extensive experience of GMP across the supply chain from drug discovery to release of packaged supplies to the clinic, and is an experience and competent GxP Lead Auditor for all aspects of the industrial practices including Interactive Response Technology (IRT).
Lesley holds a BSc (Hons) in Pharmacy from the University of Strathclyde and obtained Qualified Person (QP) status in 2004.
Dr Gavin Matthew
Head of Quality
Gavin has over 30 years of experience in cGMP Quality and bioprocess research and development.
He has worked extensively in new product introduction, technology transfer, commercial drug substance and drug product manufacture, supplier and supply chain management.
Gavin has a BSc in Biological Sciences from Napier University and a PhD in Biochemical Engineering from University College London, where he developed online monitoring techniques for microbial bioprocesses. After academia, Gavin was part of the team that originally set up the manufacturing facilities and processes at what became Cobra Biologics.
He started his Quality career with GlaxoSmithKline and has held several senior positions in cGMP QA with Axis-Shield, Aptuit, Piramal, BBI and AstraZeneca. After joining AstraZeneca in their External Sourcing organisation, he managed the quality and compliance aspects of their oncology supply chains. He has extensive experience in managing facilities and quality systems through successful Regulatory Authority and Notified Body Inspections
Prior to joining EnteroBiotix, Gavin was the Quality Director for Johnson Matthey Scotland with responsibility for QA, QC and Compliance covering two sites manufacturing, testing and distributing controlled active substances.
Dr Michael Murray, RTTP
Interim Head of Business Development
Dr Murray commercialises intellectual assets. Since 1996 he has led and closed numerous deals in the biopharmaceuticals industry using scientific, technical, intellectual property (IP), market, and deal-making expertise to assess, build, and negotiate deals valued from the hundreds of thousands to billions of dollars.
His client base is international and spans: universities, start-ups, SMEs, mid-cap companies and multinationals. He has also held interim management roles including acting as Interim Commercial Director for a UK government-owned biotech company.
Prior to setting up his own business, Michael held a succession of director- and board- level/senior management and commercial roles in biotech companies and in an international management consultancy practice. A Registered Technology Transfer Professional (RTTP) he is also a Member of the International Technology Transfer Network (ITTN, China); sits on the Advisory Board of the International Chamber of Innovation, Commerce & Enterprise ICICE, Japan); is a Mentor at Cambridge Enterprise (University of Cambridge, UK); is a Royal Society Entrepreneur-in-Residence at the University of Sheffield (UK); a Member of the Research Strategy Board of Coeliac UK; and a Course Director (IP commercialisation. training) for PraxisAuril (UK).
He holds a PhD in molecular genetics from the University of Leicester and a first degree in microbiology from the University of Edinburgh.
Board of Directors
Mark R. Bamforth
President & CEO, Arranta Bio
Mark Bamforth founded Arranta Bio to build the best-in-class microbiome CDMO, in May 2019. Arranta has process development and early clinical manufacturing in Florida and a late-stage manufacturing facility in Massachusetts. Previously, Bamforth founded Brammer Bio, a best-in-class viral vector contract development and manufacturing organization (CDMO) for cell and gene therapies. Brammer’s team grew from 110 in 2016 to over 600 in Florida and Massachusetts, at the time of its acquisition by Thermo Fisher Scientific in April 2019.
In 2010, Bamforth founded a biologics CDMO, Gallus BioPharmaceuticals, and acquired a world-class facility and team in St. Louis, MO, with a commercial supply agreement with Janssen. Gallus tripled through organic growth and merging with Laureate Biopharma. Gallus was sold to DPx Holdings B.V. in 2014.
Bamforth previously spent 22 years in the UK and USA at Genzyme, latterly running a global manufacturing operation and a pharmaceutical CMO business and serving 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. Bamforth serves on the boards of Avid Bioservices, Continuus Pharma, Pneumagen, Enterobiotix, MassBio, and Entrepreneurial Scotland. He has a BS in Chemical Engineering from Strathclyde University. and an MBA from Henley Management College.
Principal Development Solutions
Iain Baird is the principal of Development Solutions, a pharmaceutical consultancy firm focused on helping companies in Biological Pharmaceutical Development establish their Chemistry Manufacturing and Controls (CMC) capability.
Mr. Baird has supported over 50 companies in CMC development the last 11 years as well as working with the founders/CEOs of 6 companies starting companies developing new biological pharmaceutical products and CDMO’s providing services to the sector, including OSO BioPharmaceuticals Manufacturing, CANbridge Life Sciences, Gallus Biopharmaceuticals, Brammer Bio, Mikart Inc. and Vibalogics US Inc.
Prior to that Mr. Baird worked for 20 years, in the pharmaceutical and chemical industries. He started work for ICI which later became AstraZeneca. An engineer by discipline he initially designed and project managed the building of pharmaceutical facilities before moving into operational management running multiple production facilities in the United Kingdom. Since 2002 he has worked in the USA and was part of the leadership team that established the Avecia Oligonucleotides business as a CMO, taking a small team of researchers and growing it into an FDA approved manufacturing site with 150 employees. In 2006 Mr. Baird was one of the principles that established Avecia Vaccines in which he led the CMC groups in the development of vaccines against anthrax and plague.
Since 2010 Mr. Baird has assisted clients in the development of their clinical products and has been involved in filing 16 IND’s, 3 successful BLA applications and 3 successful NDA applications as well as remediating a product placed on CMC hold by the FDA. Iain has supported clients through numerous FDA, EMA and international regulatory inspections, preparing them for the inspections, supporting them during the inspections and in their successful responses.
Mr. Baird serves as an independent director on the Board of Directors of a number of biotech companies, including Mikart Inc., Vibalogics Inc and EnteroBiotix Ltd.
Mr. Baird earned a BEng in mechanical and electrical engineering from Robert Gordons University in Aberdeen.
Dr James R. McIlroy, MBChB
Founder and CEO, EnteroBiotix Limited
Dr James McIlroy Founded EnteroBiotix after recognising the therapeutic potential of the microbiome with the vision of building one of world’s leading microbiome drug development companies. He has over 5 years of leadership experience as a biopharmaceutical entrepreneur, Board Director and company executive, with hands on experience in creating, building and successfully leading cross-functional teams within fast growing companies that have gone on to deliver significant value building milestones for shareholders.
Dr McIlroy has raised multiple rounds of equity investment from private and corporate syndicates with deal values exceeding £10m. He has also secured multiple large grant funding awards from high-profile funding bodies such as the Medical Research Council and Innovate UK.
Dr McIlroy is a qualified medical doctor that has successfully completed training within the UK National Health Service in multiple hospital service areas including: Acute Internal Medicine, General Surgery and Medical Paediatrics. He holds a BMedSci (Hons) from the University of Edinburgh and an MBChB from the University of Aberdeen, graduating with a final year distinction (top 3% of year) and the elective prize in child health awarded in recognition of his published research on intestinal microbiome modulation in paediatric patient populations.
Dr McIlroy was the first undergraduate to be awarded an Enterprise Fellowship by the Royal Society of Edinburgh and is the youngest recipient of a Visiting Research Fellowship by United European Gastroenterology. He is currently appointed as Honorary Lecturer in Healthcare Innovation at the University of Aberdeen, Advisory Board member at Innovate UK/KTN Microbiome Special Interest Group and is Co-Founder of the Intestinal Microbiome-based Medicines European Task Group (IMM-ETG).
Dr McIlroy is a named inventor on several microbiome related patent applications and has been published as first author in journals such as Alimentary Pharmacology & Therapeutics, Frontline Gastroenterology and Clinical Immunology
Founder and CEO, Pneumagen Limited
Douglas is founder and Chief Executive Officer of Pneumagen Limited. Founded in April 2016, Pneumagen is developing first-in-class products for the prevention and treatment of infectious disease.
Prior to founding Pneumagen he led the rapid growth of UK-based microbiome company GT Biologics Ltd through its transition into a UK public listing on AIM in February 2014 as part of 4D Pharma PLC (AIM: DDDD).
Previously, amongst other roles, Douglas was at vaccine R&D companies – as CEO at SingVax in Singapore, which was sold to Takeda, and Business Development Director at UK based Microscience Limited which was sold to Emergent in the US.
In the 90s, he was Managing Director of vaccine
manufacturer Malta Vaccines Limited.
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