Newsletter

Issue 2:

July 2021

Spotlight on our project partners

Work Package 1 – Data and Pipeline Management
The WP1 team is comprised of a blend of highly skilled small to medium sized enterprises (C-Path, grit42 and Synapse) and academic expertise (UC3M) with input and collaboration from EFPIA/AS members. The lead partner for WP1 is C-Path (Critical Path Institute, Limited).

C-Path specializes in the organization and management of consortia that address challenges in medical product development. Critical Path to TB Drug Regimens (CPTR) Initiative, a consortium within C-Path, is a trusted expert in the TB community which works to accelerate the development of novel TB drug regimens through expertise including data management validation and regulatory qualification of drug development tools and novel methodologies, as well as scientific, technical and project management of consortium-level initiatives.

The WP1 primary role is the implementation of technologies and processes to inform and support the asset progression pipeline, including the standardisation and availability of data generated within ERA4TB, and data made available from other initiatives. The key personnel for WP1 are as follows:

Patrick O’Meara, who is the European Lead for the Data Collaboration Centre at Critical Path Institute (C-Path) based in Dublin, Ireland. Prior to joining C-Path and the ERA4TB project, Patrick worked for over 15 years within the CRO industry (IQVIA and ICON plc.) working on Phase II – IV trials for various therapeutic areas including infectious diseases, oncology, and CNS. He has over 11 years of project management experience overseeing data management and biostatistical services on large complex clinical trial studies. He provides expertise in clinical data management, monitoring of data processes to ensure alignment with organizational or project policies, adherence to ICH-GCP and other relevant regional policies, and is knowledgeable in CDISC standards including overseeing/supporting various data submissions to the FDA, EMA and PMDA.

Richard Liwski, based in Tucson, Arizona, Richard is the CTO of the Critical Path Institute (C-Path) and oversees the Data Collaboration Centre within C-Path. He has over 26 years’ experience with storage product development, functional area management, program management, brand/marketing management and customer relationship management working with pharmaceutical companies and healthcare providers. He provides expertise in the definition, implementation, training, and monitoring of organizational policies, including the handling of clinical data to ensure that all applicable government regulations are met.

Carlos Díaz , based in Madrid, Spain and CEO of Synapse Research Management Partners since 2008. He has over 26 years’ experience with the management of complex distributed research projects. He provides expertise in the definition of evaluation methods, business planning and knowledge management among other strategic areas of the project management. Currently leading Project Management for numerous IMI projects: ERA4TB, EPAD, eTRANSAFE, EHDEN, NEURONET, among others.

Claus Stie Kallesøe, co-founder and CEO of grit42 based in Copenhagen. He has a background as a Medicinal Chemist followed by a software development degree and an E-MBA. Prior to founding grit42 in 2014, he was heading compound management and global research informatics (2000-2014) at Lundbeck. During that same time also worked as assistant to the Head of Research (2 years).

Prof. Jesus Carretero, who is Professor of Computer Architecture at University Carlos III of Madrid (UC3M) since 2002, where he has been involved in a wide range of real-time, embedded systems, and high-performance data management related research, ranging from computer systems (distributed and parallel storage solutions and file systems) to communications systems (wireless sensor networks routing, energy, and programming techniques). Currently, Prof. Carretero coordinates the NESUS COST action IC1305, coordinator of 2 INEA/CEF EU projects, and he is the project leader of a major Spanish Research Program on data storage and management. He has published more than 150 journal and conference papers, has edited conference proceedings, and special issues of IoT journals, has supervised 18 PhD students in several European universities, and has co-authored 19 book chapters.

Our progress to date

• Overview of ERA4TB Asset Progression Plans (APPs). At present, 5 different molecules are being progressed on the ERA4TB pipeline where in-vivo, in-vitro, preclinical development activities and First-in-Human studies are being undertaken in parallel, as shown below. 

Our dissemination activities

• Last June 9th and 10th, the third ERA4TB Consortium Meeting took place with the participation of near 150 attendees. It was an online meeting, and the main objective was to share updates and discuss key points among the Consortium to enhance the project progress.
• As part of the AMR Accelerator, Alfonso Mendoza-Losana (University Carlos III Madrid) presented on ERA4TB at a webinar: Tuberculosis, a key research area of focus within the AMR Accelerator which discussed and addressed the challenges of the TB research community.
• Our project partner TB Alliance CEO Mel Spigelman recently published an opinion piece arguing for equitable access to global health innovations. You can access it here: Global health research can solve diseases — if it reaches everyone in need | TheHill

Upcoming activities and events

• Join next Monday, July 27, the live webinar “Discovery and developing new treatments for fungal infections”, where experts of different aspects of antimicrobial resistance (AMR) will share their knowledge and opinions about the status and the future challenges of this field. Click here for more details and registrations.
• The IMI AMR Accelerator projects will be represented on August 25, in the framework of the brief and digital 5th AMR Conference, during the second day titled: “What’s new with funds, incubators and accelerators?”. Find out more about the programme here and register free of charge for three exciting days of webinars.
• Johnson & Johnson Innovation addresses the Antimicrobial Resistance challenge in a virtual event where different leaders will be sharing their views on the global situation. It will take place on September 15. Find more information and registration here.