ROLE IN THE PROJECT
The general objective is to design an oral formulation of siRNA nanotherapeutics, able to locally deliver the JAK3 siRNA to the inflamed colon.
Commissariat a l’Energie Atomique et aux Energies Alternatives (CEA) is a French research-and- technology organization with activities in energy, IT, healthcare, defence and security.
The Laboratoire d’Electronique et de Technologie de l’Information (Leti) is focused on creating value and innovation through technology transfer to its industrial partners. It specializes in nanotechnologies and their applications, from wireless devices and systems, to biology, healthcare and photonics. NEMS and MEMS are at the core of its activities. An anchor of the MINATEC campus, CEA-Leti operates 8,000-m² of state-of-the-art clean room space on 200mm and 300mm wafer platforms. It employs 1,800 scientists and engineers including 250 Ph.D. students and 200 assignees from partner companies. CEA-Leti owns more than 2,800 patent families.
The Microtechnologies for Biology and Healthcare Division focuses on the development of micro- nanotechnologies for applications in the fields of medical imaging, security, in vitro diagnostic, nanomedicine, medical devices and environment monitoring. These activities cover the design, integration and qualification of systems comprising sensors (radiation, biochemical, neural activity, and motion detection), actuators, analog front end electronics, acquisition system, signal processing algorithms, data management and control software.
Within CEA, the CEA-BIG Institute has placed the study of the proteins at the heart of its interests. The aim is to examine biological processes on a molecular scale and to contribute finalizing work carried out in Biotechnologies and in Technologies for life sciences and health, with a large range of platforms [molecular & cell imaging, proteomics, automated screening of collections of molecules (including siRNAs), nanotechnology, modeling and laboratory animals]. The CEA-BIG Biomics is more particularly interested in large-scale gain and/or loss-of-function genetic screens. We developed microtechnologies to study genetic and microenvironmental controls of early carcinogenesis. Our team performs on routine basis RNAi (siRNA, miRNA)-based high throughput and high content cell-based assays.
Since 2012, he is currently principal investigator in collaborative projects dealing with the targeted delivery of bio-macromolecules, such as proteins, peptides and/or nucleic acids for applications ranging from the RNAi transfection to vaccine formulations. Since 2016, he is leading a laboratory of 16 permanent research scientists, engineers and technicians, dealing with the design and validation of new diagnostic tools or therapeutics strategies by using micro-and nano-technologies. Skills: Engineered nanoparticles, non-viral vectors, RNAi delivery, vaccine formulations, drug delivery, in vivo imaging, Cellular and animal models.
He got a tenure position at INRA France, and then served as Associate Director of R&D at Xenometrix Inc., a spin-off start-up from Harvard University, where he got interested in global approaches and genomics. He then joined in 2000 the newly created Functional Genomics Laboratory at France’s Atomic Energy Commission (CEA) in Paris and managed it until 2008. This laboratory focused on large scale functional genomics approaches to analyze proliferation/differentiation balance in oncology. In 2009, he was appointed director of a new laboratory, “Biomics” at CEA in Grenoble, to use microsystems for cell biology, where he focuses on large scale RNAi-based functional screening and 3D organoids oncology. Since 2015 he manages both the Biomics Laboratory and the “Large Scale Biology Unit” at CEA Grenoble. Xavier Gidrol authored or co-authored more than 110 publications.
ROLE IN THE PROJECT
ERS provides administrative support, helps to implement risk assessment, internal monitoring and common standard procedures, all in order to safeguard outcomes within time, budget and EU guidelines.
The European Research Services GmbH is a public-private-partnership that supports researchers in planning and managing EU-projects. ERS provides technical and administrative support, adapting project-management to the size and complexity of each specific project. ERS helps to implement risk assessment, internal monitoring and common standard procedures, safeguarding outcomes within time, budget, and EU guidelines.
In particular ERS
Oliver Panzer is stockholder and Managing Director of ERS. He holds a Diploma in physics, and worked 5 years as a postgraduate researcher in the area of nano-analytics. Next to experience in industry and in managing the office of a national network of excellence, he worked at the European Commission as a Seconded National Expert. His background will make sure that the management structure & procedures meet the needs of the European Commission.
ROLE IN THE PROJECT
In this project the HZI will contribute with its expert’s knowledge on advanced coculture models of the intestinal barrier and expertise in siRNA delivery.
The Helmholtz Centre for Infection Research is a research organization and part of the Helmholtz Association of German Research Centres. The focus of our work is the investigation of medically relevant pathogens. This spans from host-pathogen interactions, to immune responses and interventions and include the search for new anti-infectives.
The Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) is the first permanently installed extra-university institution in Germany explicitly dedicated to Pharmaceutical Research; and is a branch of the Helmholtz Centre for Infection Research (HZI) in Braunschweig. The Department of Drug Delivery aims to improve the efficacy and safety of anti-infectives by means of carrier technologies.
Moreover, we develop and provide advanced cell and tissue based in vitro systems to study cellular and molecular effects as tool for drug and carrier development.
Claus-Michael Lehr received his PhD from Leiden University. In 1991/92, he was a PostDoc in the lab of Prof. Vincent H. L. Lee, University of Southern California, USA, before he became 1992/93 a Research Associate at the Drug Research in Leiden, NL. In 1993, he was appointed full Professor for Pharmaceutical Technology at Philipps-University Marburg. Since 1995, he is full Professor and Head of Department Biopharmaceutics and Pharmaceutical Technology at Saarland University.
As one of the co-founders of the Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS), Claus-Michael Lehr is head of the department “Drug Delivery” at the HIPS. He is also cofounder of Across Barriers GmbH and PharmBioTec GmbH, providing R&D services to the pharmaceutical industry.
ROLE IN THE PROJECT
NIT as WP5 leader will lead the “in vitro” and “in vivo” safety evaluation. Main contribution will be to study the safety and biocompatibility of the the products generated in the consortium.
Nanoimmunotech (NIT), founded in 2009 and recognized as EIBT (Technology-Based Innovative Companies), is a Spanish SME in the Nanobiotechnology sector. NIT has a vast experience in the design, synthesis and functionalization of nanometric materials for applications in molecular diagnostics, drug delivery and the study of biomolecular interactions, including the functionalization of nano- and microstructured materials with peptides involved in cellular internalization or adhesion, antibodies, enzymes, dyes, drugs, among others. NIT has highly qualified and internationally recognized human resources, and a renowned scientific advisory board with wide experience in Biotechonology, Health and Nanotechnology.
The NIT team combines over 20 years of experience in synthesis, functionalization and characterization of nanomaterials (www.nitbiosafe.com ), and NIT team is also involved in the field of Nanotoxicity, being members of National Platform of Nanomedicine (Nanomed Spain) and European Platform (ETP Nanomedicine), participating in several projects and networks related to nanosafety, and collaborating with groups in this field. Covering areas as toxicity, sterility, biocompatibility, immunogenicity or biodistribution,
NIT members have large experience in toxicological and immunological studies that contribute to risk assessment of the nanomaterials. These particles should lack immunogenicity, and be hemo- and cytocompatible. To accomplish this task, the Company has standardized protocols and experimental environments to ensure a good laboratory practice, implementing USA recommendations and all EU regulation regarding nanosafety. Finally, NIT has the know-how to perform proper supervision, advice and validation of different nanosystems, as a first step to the previous use of nanoparticles in biotechnological and biomedical applications.
Received his Ph.D in Biology from the University of Vigo, Spain. Associate professor of the University of Vigo, joins Nanoimmunotech as an expert in monoclonal antibodies development, as part of the technical department in 2012. Few years after, he becomes the manager of the Nitbiosafe department, being principal investigator of FP7 and H2020 projects. He is now the new Chief Innovation Officer at Nanoimmunotech. Senior researcher holds over 13 years of experience: in vitro and in vivo assays. His research activity is focused in the nano-biocompatibility, nanotoxicity, sterility and immunotoxicity evaluation.
ROLE IN THE PROJECT
IDIBAPS main goal is to translate basic discoveries into the clinics. To do so it brings together scientists with some of the top leaders in the world on diseases such as cancer, inflammation, immune mediated diseases, diabetes, infectious disease and neurological disorders, among others. As such IDIBAPS structure and purpose is aligned with the objectives of this proposal and provides the environment and infrastructure needed to perform in vivo studies and to potentially translate this into future clinical trials.
The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS) is a public research centre dedicated to translational research in the field of biomedicine. Its mission is to integrate state of the art basic research and quality clinical research. Founded in 1996, IDIBAPS is formed by the Government of Catalonia, the University of Barcelona's Faculty of Medicine (UB), the Hospital Clínic de Barcelona (HCB) and the Institut d'Investigacions Biomèdiques de Barcelona of the Spanish Council for Scientific Research (IIBB-CSIC)..
IDIBAPS has a high scientific productivity with more than 1.000 indexed original articles per year and a yearly progression of up to 10%. Of these publications, 69% are in the first quartile of impact in their field during 2014. The progression of the yearly Impact Factor figures show a growing trend, achieving 5,5 Impact Factor points in 2014. Moreover, IDIBAPS ranks first in scientific productivity and quality among the Certified Health Research Institutes of Spain. Moreover, IDIBAPS has a strong track record working in European projects and has a dedicated European Projects Office (OPE) and the Knowledge and Technology Transfer Office (KTT). The OPE is currently managing 31 projects in H2020 (2 as coordinators).
Dr. Salas has been devoted to biomedical science and in particular to the study of inflammatory mechanisms for over 20 years. She spent 5 years as a postdoctoral fellow at Harvard Medical School working on molecular mechanisms of integrin activation and mucosal immunology. Since November 2004 she has been an investigator at IDIBAPS, Hospital Clinic in Barcelona. She has served as an Associate Professor of Immunology at the University of Barcelona since September 2009.
ROLE IN THE PROJECT
Coordination of WP2 and WP3 tasks of ProDigest. This includes the implementation of a SHIME technology platform under IBD conditions and the use of the Host-Microbe-Interaction (HMI) module to analyse the impact of the gut environment on epithelial cells and mucus penetration.
ProDigest BVBA is a spin-off company from the Laboratory of Microbial Ecology and Technology (LabMET), Ghent University, focused on the development of technology platforms for the study of food and health interactions and the bioavailability and targeted release of active ingredients in foods and pharmaceuticals. ProDigest BVBA was founded in September 2008 based on the development of an extensive technology platform for the study of the gastrointestinal transit, bioavailability, and functional fate of bioactives.
ProDigest’s specific interest and expertise relates to gut-mediated health effects in which intestinal (microbial) processing of active (pharmaceutical) ingredients affects human health, and the development of biotherapeutics to treat diseases involving gut microbiota. Using its technology platform and expertise ProDigest aims both at customized service-type research work for key players in the food and pharmaceutical industry and at the in- house development of innovative intervention strategies to improve host health through host- microbe interactions.
In addition to this, ProDigest is continuously improving its available platforms and is actively investigating potentially interesting add-ons to its preclinical models in order to maximize its service and product development capacities. Therefore, ProDigest is eager to participate in this project and deploy its ample expertise in in vitro gut modelling in health and disease to evaluate how the novel siRNA-loaded nanotherapeutics are able to cross the intestinal barrier at their target site.
Dr. ir. Pieter Van den Abbeele performed his PhD between 2007 and 2011 at the Laboratory of Microbial Ecology and Technology (LabMET, Ghent University), studying the effects of prebiotic compounds on the human gut microbiota with a focus on the investigation of mucosal gut microbes as potential guardians for human health. During this PhD research, unique in vitro models were developed and validated in order to allow the study of this largely unknown community of gut wall-associated microbes with high potential to affect health.
After performing postdoctoral research at Ghent University between 2011 and 2013, dr. Van den Abbeele joined ProDigest bvba, which is a spin-off company that commercialized the various in vitro models developed at LabMET. After working as a senior scientist on a European project of which ProDigest was the coordinator, dr. Van den Abbeele was appointed as ‘contract research and technology director’.
ROLE IN THE PROJECT
Amatsigroup will be responsible for the formulation of the nanoparticles and will provide a solution for colon delivery of the nanoparticles.
AmatsiSEPS, part of the Amatsigroup, is a privately held pharmaceutical company engaged in drug delivery and development. AmatsiSEPS provides advanced drug product development services to the leading pharmaceutical and biotechnology companies and is dedicated to the development of innovative drug delivery systems serving solutions to enhance bioavailability and control drug release.
George Dakwar (1987) studied for the degree of “Bachelor of Science” in Chemistry and Life Sciences at the Hebrew University of Jerusalem (Israel). He then continued for a degree of “Master of Medical Sciences” specializing in Pharmacology at Ben-Gurion University of the Negev (Israel), where he graduated with cum laude. In July 2012, he received an award for his excellent achievements in Biomedical Research at the Ben-Gurion University of the Negev. In October 2012, he joined the Ghent Research Group on Nanomedicines (Ghent University, Belgium) and started a Ph.D. project under the supervision Prof. Katrien Remaut and Prof. Stefaan De Smedt. During his doctoral thesis, he focused on the development of lipid nanoparticles for siRNA delivery for intraperitoneal therapy of peritoneal carcinomatosis. In December 2016, he joined AmatsiGroup as a senior scientist at the department of biopharmaceuticals.
ROLE IN THE PROJECT
Our activities range from creating a visual identity for a project, creating the right communication materials – cleverly targeted to reach the designated audiences – designing and regularly updating the project’s website, handling press relations, developing a social media strategy to best suit the project needs and measuring research outcomes impact.
Sparks & Co is a science communication agency specialized in European projects. Our team of experienced communicators make research accessible to all audiences and give projects the widest visibility. Horizon 2020 research projects deserve the best communication strategy and that is why we have entered the NEW DEAL proposal as Communication and Dissemination partner.
Ms. Caroline Estephan is Work Package leader for communication and dissemination activities, managing her team, partners and contractors to provide the project the best communication strategy as well as a smooth implementation for maximum project impact.
She is educated in marketing and communications (Novancia Business School Paris) with a strong interest in research and innovation. She has gained experience in various specialties ranging from marketing, internal communications, business development in both small start-ups or banking companies (Société Générale). She has joined Sparks & Co in 2015 to become Project Manager and is now WP leader of three Horizon 2020 projects in health research.
ROLE IN THE PROJECT
Staff members, specialists in immunology, inflammatory diseases or in therapy based on kinase inhibitors, will contribute to works of this project. Their expertise in the monitoring of the immune and inflammatory responses to evaluate the efficacy of the anti- inflammatory nano formulations produced by partners.
INSERM is the French National Institute dedicated to Health and Medical Research and operates with 318 Research Units, which mostly set up in Universities or Hospitals. Analytic Immunology of Chronic Diseases team, headed by P Marche, is located in the Research Unit U1209 supported by the INSERM and the University of Grenoble (UGA). Its main activity resides in the analysis of the immune system and its digressions in chronic diseases associated to inflammations. The team studies the effects of nanomaterials on the immune system to assess safety/toxicity and/or to develop new tools modulating immune responses.
ROLE IN THE PROJECT
The main objective of Mayoly is to establish the future Clinical Development Plan of new siRNA-based nanotherapeutics. The aim is to ensure that sufficient information and evidence is generated to support the regulatory approval and initiation of a Phase 1 Clinical Study using the identified candidate from the programme for the treatment of IBD.
Laboratoires Mayoly Spindler is a French independent and family owned international pharmaceutical company, which is involved mainly in gastroenterology. Mayoly is active in development, manufacturing, registration and marketing of pharmaceuticals in more than 70 countries. It has also a division in dermo-cosmetics. The company aims to become a global reference in gastroenterology and is currently the marketing authorization holder of medicines developed for various pathologies such as Irritable Bowel Syndrome, Inflammatory Bowel Disease and pancreas disease.
Mayoly Spindler is involved in drug co-development programs with several partners. Recently, an agreement with AzurRx BioPharma, USA, for the clinical development of a recombinant protein coming from Mayoly’s research department and developed for exocrine pancreatic insufficiency. This new compound has already successfully completed a Phase I/IIa human clinical trial for the treatment of chronic pancreatitis, and the phase IIb study is planned to complete by 2016. In addition, Mayoly has established several partnerships with scientific organisations renowned in gastroenterology such as the UEG (United European Gastroenterology) the SNFGE (Société Nationale Française de Gastro-entérologie),and the AGA (the American Gastroenterology Association).
Chantal BURELOUT was initially trained as a pharmacist (Paris XI university- School of Pharmacy) and then obtained a master’s degreein Biochemistry (Faculty of Sciences at Orsay, Paris XI University). She was involved in immunopharmacology of inflammation and basophil cellular biology (Inserm U200, Paris) and was then employed as a pharmacist and a medical biologist in coprology and immunochemistry (Hôpital Pitié-Salpêtrière, Paris).
She later graduated as a PhD in Immunology—Microbiology (Laval University School of Medicine in Québec, Canada) where she worked on neutrophil intracellular signaling during the inflammatory reaction (chemoattractant and PGE2 signaling pathways, urate crystals signaling). As a post-doctoral fellow at the CEA (Atomic Energy Commission in Fontenay-aux-Roses, France), she managed a research project on the humoral response during the HIV /SIV primo-infection in men and macaque monkeys, and more particularly on the role of the cytokine BAFF in the B cell dyfunctions observed during the early phase of HIV/SIV infection. She joined Mayoly Spindler as a Drug Safety Officer in Jan. 2012.
ROLE IN THE PROJECT
Creation of a Clinical Development Plan for the product, co-ordinating the contact with the European Medicines Agency in the EU and the Food and Drug Administration in the USA in order to arrange a Scientific Advice Meeting and Pre-IND Meeting respectively with them, drafting the documentation to facilitate these meetings, responding to the feedback from these meetings and amending the development plans accordingly.
Boyd Consultants Ltd provide a range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Our aim is to help organisations translate their research ideas into medicinal products, which will benefit patients. This is done by providing a team of people who are experienced in medical product development to these organisations and companies to help them achieve their aims.
We work across a wide range of pharmaceutical medicine & therapeutic disciplines and we have specific expertise in the development of biological based products, particularly those related to DNA and RNA technologies. We work by getting involved as early as possible in the translational programme to create a target product profile that defines the overall clinical product development plan and to ensure that the client has all the information needed to make the best, informed decisions as to how to proceed with the development plan and progress to clinical trial approval and eventually market authorisation.
Professor Alan Boyd began his 30 years’ pharmaceutical career with Glaxo Group Research Ltd. From 1988 he led ICI’s cardiovascular medical research team, later assuming the role of Director of Clinical and Medical Affairs at ICI Pharma, Canada. In 1999, after four years as Head of Medical Research for Zeneca Pharmaceuticals, he became Director of Research and Development for Ark Therapeutics Ltd where he was responsible for delivering the majority of key development milestones that have shaped the company.
In April 2005, he left to set up Boyd Consultants. The focus of which is to aid and support early stage life-science based companies of the sort of which Ark had its origins. His clients now include many companies in Europe, North America and Japan who are devoted to the development of medical drug products, devices and in vitro devices.