11 partners from 6 EU member states
The PneumoNP consortium consists of 11 partners, from 6 EU member states.
Research institutes and a university with a sound research background and clinicians collaborate with innovative SMEs, and one enterprise.
Each partner has a distinct role in the project and ensures that the project results will be exploited in an efficient manner.
Adenium Biotech is a Danish biopharmaceutical company spun out from Novozymes A/S in 2011. Adenium focuses on the development and commercialization of novel antibiotics for the treatment of multi drug-resistant bacterial infections. Our focus is the treatment of nosocomial infections, in particular complicated urinary tract infections and hospital or ventilator acquired pneumonia caused by multi-drug resistant Gram-negative bacteria.
Adenium is responsible for the production of the active ingredient of the nano-particles. Adenium Biotech have supplied the active ingredient for the initial testing of the nano particles in pneumonia efficacy studies.
Chief Medical Officer
Dr. Fang is a physician with 10 years of antibiotic drug development experience. Prior to joining Adenium, Dr. Fang was Director of Clinical Sciences at Trius Therapeutics where he was the clinical lead on pivotal
phase 3 skin infection studies, as well as phase 1 and 2 trials, and contributed to the NDA leading to the approval of Sivextro (tedizolid) by the FDA (Jun 2014). Previously,
Dr. Fang was Associate Director of Clinical Sciences at Cerexa, where he was the clinical lead on phase 1 and 2 studies, and contributed to the NDA leading to the
approval of Teflaro (ceftaroline) by the FDA (Oct 2010). Earlier, Dr. Fang was Editor-in-Chief at Epocrates, developing content and products for software used by physicians and other healthcare professionals. Dr. Fang earned a BA from Stanford University, and an MD from the University of California at Los Angeles, where he also completed a residency in internal medicine.
Dr. Strandh is a senior scientist and project manager with more than 15 years of biopharmaceutical drug discovery and development experience. Prior to joining Adenium, Dr. Strandh was Senior Scientist at Symphogen where he was the main scientist and manager of several therapeutic antibody discovery projects within oncology and infectious diseases, including collaborations with e.g.
Genentech. Previously, Dr. Strandh was Scientist at Trellis Bioscience, where he was instrumental in the development of their proprietary antibody screening platform and their discovery projects within infectious diseases, osteoporosis and oncology. Magnus Strandh holds a PhD in Immunotechnology from Lund University.
Chief Executive Officer
Dr. Goldenheim is trained as a pulmonary physician and is currently working as a director and consultant in the field of biotechnology, serving on the boards of directors of several companies including Neurophage, Hydra Biosciences, Acesion and RSPR. He has a long history in
pharmaceutical research, development, and management, most recently as President of TransForm Pharmaceuticals (acquired by Johnson & Johnson) and Vice-Chairman of the Board of Directors of Hypnion (acquired by Eli Lilly). Paul also serves on the board of directors of The Big Apple Circus. Dr. Goldenheim has authored numerous scientific publications and been an inventor on a number of pharmaceutical patents. He received his A.B. from Harvard College magna cum laude with highest honors in biochemical sciences and his M.D. from Harvard Medical School.
CIC biomaGUNE is a non-profit research organization created to promote scientific research and technological innovation at the highest levels in the Basque Country. Established by the Department of Industry, Technology & Innovation of the Government of the Autonomous Community of the Basque Country, CIC biomaGUNE constitutes one of the Centres of the CIC network, the largest Basque Country research network on specific strategic areas, having the mission to contribute to the economical and social development of the country through the generation of knowledge and speeding up the process that leads to technological innovation. CIC biomaGUNE is integrated by three research units: Biofunctional Nanomaterials, Biosurfaces and Molecular Imaging. Two researchers of the molecular imaging unit are involved in this project.
CIC biomaGUNE is responsible for the determination of the pharmacokinetic properties and biodistribution pattern of nanosystems (and their components) after administration to rodents by inhalation. After radiolabelling, the nanosystems will be administered and the residence time in the lungs will be assessed as a funtion of droplet size, inhalation pattern or physico-chemical properties of the nanocarriers. The ultimate goal is to achieve a short-list of candidate nanosystems before entering therapeutic studies, and provide key pharmacokinetic data to determine the optimal dose.
Jordi Llop got his PhD in Chemistry at URL (Barcelona). He worked as a post-doc researcher in Clínica Universitaria of Navarra (Spain) and Uppsala University PET Centre (Sweden). In 2003 he became the Head of the Radiochemistry Department at IAT-PRBB (Molecular Imaging Unit placed in Barcelona). In 2007 he moved to CIC biomaGUNE as the Head of Radiochemistry and Principal Investigator of the Molecular Imaging Unit. Currently, he is participating as a researcher in 3 FP7 EU Projects: SaveMe (FP7-NMP-2010-LARGE-4), Nanosolutions (FP7-NMP-2012) and RADIOMI
(FP7-PEOPLE-2012-ITN). He has more than 35 publications in scientific journals, 2 book chapters and he is currently co-editing a book on labelled NPs.
Luka Rejc got his PhD in Organic Chemistry at University of Ljubljana in 2015. His work mainly consisted of the development, synthesis, and utilization of new molecular probe candidates for the detection of protein tau deposits. During his PhD, in 2013, 2014, and 2015, he joined the research group of Prof. Dr. Jorge R. Barrio at University of California, Los Angeles, as a visiting graduate researcher, where he worked with fluorine-18. After his PhD, he got a position as a researcher at the Faculty of Pharmacy, University of Ljubljana, where he was developing drugs for the inhibition of immunoproteasome, a protein over expressed in auto-immune diseases. He joined CIC biomaGUNE in May 2016 as a post-doc researcher within the context of the PneumoNP project.
Unai Cossío is a PhD student at the University of the Basque Country (UPV/EHU). He started his research program in 2014 under the supervision of Dr. Jordi Llop lab at CIC biomaGUNE (San Sebastián, Spain) as a part of the PneumoNP project. His primary research interests are the radiolabelling of antimicrobial peptides and different types of nanoparticles as well as the study of their biodistribution using a combination of in vivo imaging modalities, including Positron Emission Tomography (PET) and Single Photon Emission Computerized Tomography (SPECT). His main focus is the assessment of regional drug deposition within the lungs using different inhalation techniques.
Fundación CIDETEC (CIDETEC) is a private R&D centre created in 1997 as a nonprofit foundation with the mission of serving the industry to enhance its competitiveness through the implementation of innovative procedures and products. CIDETEC addresses its technology mainly from an applied research point of view. Its experience and know-how cover three main areas of activity: Energy (Batteries, Fuel and other materials for Energy Cells), Surface Finishing (Metallic and Ceramic Coatings and Processes) and Materials (Biomaterials, Nanomaterials and Sensors). For the past years, the Biomaterials Unit has developed different types of polymer NPs for theranostics applications (drug-delivery and imaging). CIDETEC had an annual turnover of 10 M€ in 2013 and currently employs a highly qualified staff of 125 people (40% of PhDs) capable of conducting specialised research, development and innovation, technical assessment,technological diffusion, information sourcing and training.
CIDETEC is the coordinator of the Project. In addition, CIDETEC will apply its technology in the synthesis of single chain polymer nanoparticles, for the generation of NCs suitable for drug delivery. CIDETEC will synthesize and characterize poly(metha)acrylic and dextran based NCs that will be used for the generation of NSs (nanosystems) by the combination of those NCs with AMPs (antimicrobial peptides) or Meropenem. The research group will also optimize the synthetic route for future GMP scale-up process.
Head of Biomaterials Unit
She obtained her MChem degree in the University of the Basque Country in 1998 and she completed her education with two placements in the University of Bergen (Norway) and in the Regional Technical College Galway (Ireland), where she was a research assistant with Dr. Myles Keogh. She got her PhD in Organic Chemistry in the University of the Basque Country in 2004.Since then she is the Head of the Biomaterials Unit in CIDETEC. She focuses her research in the synthesis of biomaterials, especially polymer nanoparticles, nanogels and hydrogels. She has been part of many private and public funded research projects. She has more than 20 publications in a high impact papers and has been inventor in two patents.
Marco Marradi obtained his MChem degree in Organic Chemistry (2001) and his PhD in Chemistry Sciences (2005) at the University of Florence (Italy) working on asymmetric synthesis in the group of Prof. Andrea Goti. After a post-doc in Germany with Prof. Armin de Mejiere (Georg-August University, Göttingen), he moved to the group of Prof. Soledad Penadés in Spain (IIQ/Seville and CIC biomaGUNE/Donostia-San Sebastián) focussing on the development of biofunctional nanoparticles as antipathogenic systems and contrast agents for molecular imaging. Since April 2014, he worked at the interface of the Biosurfaces and Molecular Imaging Units at CIC biomaGUNE. He just joined the Biomaterials Unit of CIDETEC.
Erasmus MC is one of the largest medical universities in Europe with more than 10,000 employees, 150 professors and 2000 medical students in education. The organization comprises more than 100 departments and is committed to achieving a healthy population and excellence in healthcare through research and education. The commitment and dedication of its employees helps cure patients, as well as others with healthcare needs, and helps keep healthy people healthier for longer.
The main task of Erasmus MC is related to the translational animal model testing of PneumoNP nanosystems, specifically with respect to potential toxic side effects and therapeutic efficacy in rat models of pneumonia caused by Klebsiella pneumoniae strains resistant to currently used antibiotics in the clinic. Additional tasks include investigations into minimum inhibitory concentrations (MICs) and time kill kinetics (TKK) studies of PneumoNP antimicrobial peptides (AMPs) using our extensive biobank of clinically relevant bacterial pathogens, which includes multi-resistant bacterial strains.
J. Hays has a PhD in virology from the UK and a PhD in Microbiology from the Erasmus MC. He is instigator and head organizer of the international “HinMax” meetings, and is a member of the editorial board of the WJCID. Dr. Hays has been involved in several European projects including DRESP2 (antimicrobial resistance) and OMVac (otitis media vaccine). He is currently the coordinator of TEMPOtest-QC (Point-of-Care Testing), as well as investigator in a Dutch nationally funded project (ZonMW) investigating carbapenem resistance (along with Dr. W. Goessens). He has >40
publications including 6 book chapters.
Dr. Bakker-Woudenberg is a key part of the project team and an expert in the field of antibiotic pharmacodynamics and antibiotic delivery systems in infectious diseases in relation to therapeutic efficiency and the emergence of antibiotic resistance, both at the level of fundamental research as well as translational-preclinical animal models (rat and
mice) for Gram-negative, mycobacterial and fungal infections. This research has led to over 130 publications in the scientific literature.
W. Goessens has published over 70 publications relating to antimicrobial resistance, and is currently leading research into pAmpC resistance funded by a Dutch ZonMW grant. The team members have an internationally established research reputation in the fields of antimicrobial resistance and animal models of infection. In addition to the staff members involved in the project, EMC will involve in this project more clinical expertise by including an EMC internal advisory board consisting out of three clinical experts: Prof. Dr. A. Verbon a clinical infectious diseases specialist, Dr. D. Melles a medical microbiologist specialized in antimicrobial stewardship and Dr. J. de Steenwinkel a medical microbiologist with expertise in nanotherapeutics.
Founded in 2000, Eurice, with offices in Saarbrücken and Berlin, Germany, is one of the largest research and innovation management companies in Europe and has a long track record as international full-service provider for researchers, universities, institutes and the industry. Eurice ranks among the TOP 20 SME participants in the European Framework Programme and has been involved in more than 250 European collaborative projects covering all major fields of research. A dedicated team of more than 40 staff members with diverse professional expertise and scientific background supports researchers and innovative companies in obtaining the best form of funding and making their research endeavors a success. In addition to classical project management, Eurice helps to develop and implement coherent IP strategies and supports consortia through dissemination, networking, training, and capacity building activities. With our expert knowledge we contribute to EC flagship initiatives such as the European IPR Helpdesk and FitforHealth.
Eurice supports the coordinator in all aspects of project management, including administrative, legal and financial matters, to ensure a smooth project implementation. This includes project monitoring, progress management, and decision making. Eurice facilitates the project workflow in general, stimulates interaction between the different project management bodies, and together with the coordinator assumes the role of a liaison between the project consortium and the European Commission. In addition to their managerial tasks, Eurice is involved in the networking strategy and supports innovation-related activities such as dissemination and exploitation of results to maximize the project impact.
Corinna Hahn is Senior Programme Manager and has experience with EU-funded research projects since 2000.
Janine Jost is Project Officer and is experienced in the administrative management of EU funded research projects in the field of ICT, FoF and other thematic areas.
The Fraunhofer-Gesellschaft is the leading organization for applied research in Europe, undertaking contract research on behalf of industry, the service sector and the government. The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM is one of 67 research institutes of the Fraunhofer-Gesellschaft. At the institute emphasis is placed on toxicological research work and services in the areas of pharmaceutical , chemicals and also particles and fibres with the goal of environmental and health protection.
Fraunhofer ITEM is leading WP3. During this WP Fraunhofer ITEM performs in vitro cytotoxicity studies of nanoparticles in lung epithelial cell lines as the basis for the development and selection of nanocompounds for the use as combined system, in vitro efficiency testing with combined nanosystems in different Klebsiella pneumoniae strains, in vitro cytotoxicity testing of combined nanosystems in lung epithelial cell lines and genotoxicity testing of combined nanosystems. Combined nanosystems will be analysed in vitro with the P.R.I.T.® system. Adherent human lung epithelial cell lines will be exposed at the air liquid phase to selected airborne test substances.
Monika Niehof, Molecular Biologist, Project Leader Department “In vitro and Mechanistic Toxicology”, more than 10 years experience in toxicological research (in vitro toxicity studies, development of mechanistic in vitro assays). She did her PhD in 1991 and before joining Fraunhofer ITEM in 2000 she worked as a research assistant at the Max Planck Institute for Molecular Genetics in Berlin, Germany and at the Medical School, Hannover, Germany.
Dr. Christina Ziemann, Biologist, Group leader Genetic Toxicology, biologist, experience in genotoxicity assays (in vitro and in vivo) and in the development of mechanistic in vitro assays.
Dr. Jan Knebel, Biologist, Deputy Head Department “In vitro in Mechanistic Toxicology”, more than 20 years experience in toxicological research (in vitro toxicity studies, development of specific exposure techniques using air/liquid technology, evaluation/validation of in-vitro tests).
Dr. Meike Müller, Immunologist, Head of Biomarker development and infection. Highly
experienced in the development, validation and standardisation of biomarker
measurement Evaluation of antibiotic efficacy of methods and chemicals against
different bacterial or viral pathogens.
Dr. Sabine Wronski, Biologist, Group Leader "Infection, Inflammation and Allergy". Experience in preclinical pharmacology with focus on infection research (efficacy studies in bacterial and viral infection models in vitro, ex vivo and in vivo, set up of methods and assays for antibacterial efficacy testing).
Ingeniatrics was created in 2001 by a team of biotech entrepreneurs and researchers who developed their own proprietary Droplet and Microencapsulation platforms enabling novel ways to create aerosols, emulsions and microparticles with unprecedented characteristics of size control, uniformity, composition and structure. Ingeniatrics provides technically innovative products and services of superior quality and value, based on their proprietary Droplet and Microencapsulation technology platforms. Ingeniatrics holds a portfolio comprising over 70 patents and patent applications, at international level.
The main task is the production of aerosol for inhalation. To achieve this goal, Ingeniatrics has to:
– Design, develop and optimise a technology for generation of aerosols
– Generate an aerosol prototype where representative materials, geometry and functioning principle of a potential future serial device will be included.
Besides these tasks, Ingeniatrics will support all partners involved in the aerosol technology validation.
María Flores, Director of R&D of Ingeniatrics Tecnologías, is an Organic Chemistry (with a degree from UAH) and a PhD from Universidad Autónoma de Madrid (Spain). Since her PhD on "inositolphosphogycans as insulin second messengers of insulin", she has been working in Medicinal Chemistry including Chemical Synthesis, Structure
Activity Relationships and Molecules of Biological Interest. She joined PharmaMar in 2001. In 2004 she moved to Seville and joined Ingeniatrics becoming the Director of Research and Development. Ingeniatrics’ R&D Department is focused on the development of microencapsulation applications of own proprietary technologies Flow Focusing® and Flow Blurring®.
PathoFinder is a privately owned SME company, founded in 2004, which develops and commercialize molecular diagnostic kits for the detection of infectious agents and their resistance markers. PathoFinder is mainly focussed on the development of multiplex PCR technologies, enabling the differentiation of various pathogens or resistance markers in a single reaction. Multiplex PCR kits are now available for detection of various infectious pathogens such as respiratory tract infections. PathoFinder has the knowledge and laboratory equipment to develop and manufacture diagnostic assays. PathoFinder is ISO13485 certified and all products are CE-IVD compliant.
The tasks and responsibilities of PathoFinder are twofold:
1. Detection of living bacteria, which will be useful to study the efficacy/efficiency of the NSs for their antimicrobial properties. To enable detection of only viable bacteria several strategies will be investigated.
2. The second objective is the detection of resistant strains of K. pneumoniae, which is crucial for establishing the treatment for the patient affected by the bacterial infection. PathoFinder has developed a platform enabling detection and identification of many pathogens or properties simultaneously. This proprietary technology is called SmartFinder® technology, based on RT-PCR as readout system.
Guus Simons, PhD, founder and CEO of PathoFinder was educated in molecular biology at the University of Nijmegen, the Netherlands where he also received his PhD. He was involved in several EU projects (FP6: GRACE and FP7:EACCAD and was coordinator of the EUROTRANS-BIO project with the acronym CandIDazol). Currently he is also coordinator in the FP7 project PARCIVAL and partner in C4L. He has written more than 75 peer reviewed articles and 15 patent applications.
Giel Gaajetaan performed his Ph.D. at the medical microbiology department of the Maastricht University Medical Centre (MUMC), the Netherlands. He investigated the antiviral properties and molecular mechanisms of several immunomodulating agents by using several techniques including Real-Time PCR. The data are presented in international peer-reviewed journals. Since October 2012 he is employed as senior scientist at PathoFinder BV in Maastricht.
SetLance srl is a small biotechnology company founded in 2009. SetLance activities are presently concentrated on the development of the antimicrobial peptide M33 that was isolated and optimized in the last years by company’s founders. SetLance facilities are used for research activity, early stage manufacturing and preliminary pharmacological studies in vitro and in vivo.
Setlance provides M33 peptide which has already been proved for its activity with Gram-negative infections with very positive results. In the application for pulmonary delivery it is important they reach the infected areas first and then have them in sufficient quantities to destroy the infection generating bacteria. For these reasons M33 is going to be tested in combination with the nanovehicles (objective 2). Setlance is also optimizing synthesis and purification for scale-up requirements.
Alessandro Pini is presently chairman and CEO of SetLance. He has a PhD in Biotechnology and a long experience in the field of combinatorial biology with a special focus on Phage Display technology. During his formation he spent some periods at the Centre for Protein Engineering of the Medical Research Council in Cambridge, UK, and at the Federal Institute of Technology (ETH) in Zurich, Switzerland. His scientific activity is documented by many publications and several patents in the field of antibody engineering and peptides.
Luisa Bracci has a Biology degree and a PhD in Animal Biology. She possesses a prolonged experience in protein and peptide biochemistry. During her formation she spent some periods at Sclavo Research Center in Siena, at the Salk Institute for Biological Science in San Diego, USA, and at the Institute de Biologie Moleculaire et Cellulaire, CNRS, Strasburg France. From 1998 to 2000 she was member of the Executive Board of the University of Siena and in 2003 she was member of the Executive Board of Philotec Srl. From 2004 to 2009 she was member of the Executive
Board of Siena Biotech Spa. Her scientific activity is documented by many publications and several patents in the field of biotech applications of peptide molecules.
Chiara Falciani is a pharmaceutical chemist and has PhD in Chemical Sciences. She has a strong expertise in synthesis of peptides and peptide conjugates. She is project and scientific consultant of a private company. She is author of many publications in chemical and biochemical journals and among inventors of several patents.
Umaps is a science communication agency created in 2009 and located in Paris, France. Its team assist national and European laboratories, innovative SMEs, R&D departments of bigger companies, and research organisations to communicate about their research and science. The Umaps Communication team provides special services to help FP7 funded research projects to better communicate and disseminate their results by gaining visibility and understanding from the media, lay people, end-users, scientists communities, the industry and policy-makers. Umaps Communication has experience in both strategy designing and implementing communciation strategies. In 2014, Umaps created a spin-off agency called Sparks & Co to specifically address the new challenges facing European research for Horizon 2020.
Umaps Communication is work package leader for WP7 on communication, dissemination and exploitation activities, with help from Eurice and CIDETEC.
Mrs. Benedicte Huchet, holds a master degree in Science Communication (Univ. of Grenoble). Previous to her work at Umaps, she hold a position at the office of scientific cooperation at the Embassy of France in Israel, and she was communication coordinator at the European Physical Society, where she was task leader in several FP7 projects.
Mikaly Rodriguez-Ruiz, engineer in computer science and in electronics, he develops websites & online platforms for our clients. He has also developped and webdesigned the social media platform Knowtex, and Bluenod, a social media tool to manage communities.
Founded in 1636, Utrecht University (UU) has evolved into a modern and leading institution with a growing international reputation. UU offers the broadest spectrum of disciplines available in the Netherlands, innovative research and liaises with universities and research centres all over the World. The Shanghai Ranking ranks the university in the Netherlands on 1, on a 16th place in Europe and worldwide on a 57th place. UU offers 50 Bachelor’s and 169 Master’s degree programmes, many of them English-taught. The University is home to 29.755 students and 6.500 staff. Each year, more than 2000 students and researchers from abroad come to Utrecht for a short or longer time.
UU is responsible for the production of nanocarriers for pulmonary delivery of antimicrobial peptides (AMPs), more specifically using liposomes. This includes preparation and scale-up of liposomal formulations. We support the formulation and production of optimal aerosols and supply material and select nanocarriers and nanosystems according to in vitro and in vivo tests. Finally, we support dissemination and exploitation of results.
Chair in Targeted Nanomedicine. (Bio)pharmaceutical and translational research on drug targeting formulations (design, characterization, (pre)clinical evaluation).
Cornelus F. van Nostrum
Research activities include the design, synthesis and characterization of polymers for hydrogels, micelles and nanoparticles and their application as drug and gene delivery devices.
Yvonne te Welscher
Postdoctoral fellow with a solid background in drug formulation, development and delivery.
PneumoNP’s consortium at its meeting in June 2017 in PathoFinder’s facilities