The PanACEA Annual Meeting was followed by a day of seminars, which was open to all PanACEA participants.
The PanACEA Consortium Coordination and Finance Expertise Core organized a Financial Workshop where Rutger Spoor, Wendy Simons and Jaco Swart trained the participants in several components of Financial Management en Financial Reporting. Main subjects were managing en reporting finances for EDCTP projects and budgeting for trials
The PanACEA Clinical Pharmacology Expertise Core held a Clinical Pharmacology Workshop at Stellenbosch University Tygerberg Campus. After a series of informative lectures on how to perform sound pharmacological studies and analyses, sites were given the opportunity to present their own work.
TASK Academy provided a one day accredited GCP refresher course. Karen Cloete and Louise Thomas led the interactive discussions on challenging topics and shared the latest news on the revised edition of good clinical practice to ensure everybody’s knowledge is current and up to date. Candidates that successfully completed the post course assessment were rewarded with a GCP certificate from TASK Academy.
The General Assembly of PanACEA gathered in Cape Town, South Africa, on the 28th of February and the 1st of March 2018 for the second Annual Meeting of PanACEA II.
Over 80 delegates from Tanzania, South Africa, Germany, Gabon, The Netherlands, UK, Malawi, Switzerland, Mozambique and Uganda were present, together representing all PanACEA institutions. Special guests were Monique Rijks-Surette from the EDCTP, Helen McIlleron who represented the Scientific Advisory Board of PanACEA, and Fareed Abdullah from the South African MRC.
On the first day of the Annual Meeting the consortium discussed the ongoing trial, the planned studies, and the study proposals being prepared for the latest EDCTP calls.
The second day was the highlight of the Annual Meeting, as the expertise cores revealed their final plans for capacity development at the trial sites and passionately debated how to prioritize these plans so as to make the most out of the available resources.
We look back on a successful meeting that proved a good opportunity for the consortium to exchange ideas and opinions. We look forward to the next year with great anticipation and thank all of our partners for their commitment and dedication.
Thursday 22nd and Friday 23rd of February the Instituto Nacional de Saude (INS) welcomed a delegation existing of Martin Boeree, Lindsey te Brake, Rutger Spoor (Radboudumc), Lavinia Rodney, Robert Hunt (UCL) and Sarah Konsten (LMU), for the very first PanACEA II site visit.
Overall the feedback of the delegation was very positive and the site members directly addressed all feedback by coming up with ways to further improve their site. The members are also actively contributing to the development of their site through participation in the PanACEA’s expertise cores, e.g. the microbiology core, clinical pharmacology core, and sponsor responsibility and trial management core.
The PanACEA consortium assembled for their quarterly meeting 11th of December. As last time, the main agenda item was the progress of the Core Expertise Teams.
The Core Teams are assigned to different areas of expertise related to trial conduct: Sponsor Responsibility and Trial Management, Drug Management, Clinical Pharmacology, Trial design and Statistics, Microbiology Lab, Biomarkers, Consortium Finance and Administration, Data Management and Genetics.
The Expertise Core’s goals, objectives and action plans are starting to take shape. The Cores plan to use a variety of opportunities to share expertise. The Cores intend to organize and support educational activities, exchange resources and experts, support sub-studies to facilitate the learning process, write protocols, manuals and templates, invest in software programs and/or platforms, and invest in development of methods and techniques.
The final plans of the Cores will be presented at the next General Assembly meeting that takes place in Cape Town on the 28th of February and 1st of March. This gathering is also an opportunity for the Cores to meet and organize workshops.
The global news network Euronews Television has made a 12-minute documentary about the PanACEA mission and the fight against TB. The documentary will be broadcasted on the Euronews channel, website and social networks.
The Euronews team beautifully portrayed the PanACEA project, the partner institutions in Malawi and Tanzania, and the researchers and patients involved. The documentary makes visible to the world the precarious situation of the pandemic of tuberculosis.
We thank Euronews for bringing to the attention the urgency of the fight against TB and the contribution of the PanACEA project. PanACEA is mainly funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) and receives additional funding from the governments of Germany and Switzerland. EDCTP 2 is supported by the European Union.
Documentary: Euronews Television, European Commission
The General Assembly’s quarterly meeting took place 25th of September. PanACEA assembled with representatives from the vast majority of the consortium partners. On behalf of the Executive Group the coordinator informed the General Assembly on PanACEA’s progress.
This meeting particularly covered the start-up of the Core Expertise Teams. The Cores will serve as operational support for all studies to maximize efficacy and uniformity across trials, and provide high-level oversight. International established research leaders will be paired with local investigators in order to assure quality whilst helping to develop leadership skills and enable the transfer of clinical trial expertise from European investigators to African investigators. The Core Teams will lie at the heart of PanACEA’s Capacity Development plans.
During the meeting the Expertise Cores informed each other of their start-up, plans and timelines. They will report back on their finalized goals, objectives and action plans at the next General Assembly meeting on the 11th of December. The Expertise Cores will present their final plans at the annual General Assembly meeting in Cape Town in the first quarter of 2018.
The PanACEA Executive group has returned to Amsterdam on the 26th of September to meet with representatives from South Africa, Tanzania, the UK, Germany and the Netherlands. PanACEA II has started its first trial, HIGHRIF, and is moving towards the phase IIA study; an excellent moment to discuss the latest developments in a face-to-face meeting.
In September HIGHRIF continued recruitment in Cape Town, South Africa. Previously we evaluated doses up to 40 mg/kg, and currently we are assessing the safety and efficacy profile of a 50 mg/kg dosage. First results can be expected early next year.
Furthermore, we talked extensively about the set-up and conduct of our upcoming trials. More specifically, we discussed what kind of efficacy, safety, and pharmacokinetic data from a phase IIa study could best feed the dose selection and study design of PanACEA’s STEP IIc trial, omitting the need of an intermediate phase IIb trial.
Rob Aarnoutse, PharmD PhD, is Associate Professor, hospital pharmacist and clinical pharmacologist, working at the Department of Pharmacy and with the Radboud Institute for Health Sciences at Radboudumc.
His research is focused on drug treatment of tuberculosis (TB), HIV and TB/HIV co-infection, the leading infectious disease killers worldwide. The central concept in his work is that efficacy and toxicity of drugs are dependent on drug concentrations achieved either systemically or locally. His research portfolio reaches from molecular pharmacological research to murine pharmacological studies, to pharmacokinetic studies in humans and clinical trials. In this way he develops a comprehensive translational research line that allows for quick application of relevant findings in the clinical setting. Typical topics of interest are adherence, pharmacokinetics, pharmacodynamics, safety/tolerability and effectiveness of TB drugs, antiretrovirals, other anti-infective drugs and immunosuppressants. His research is performed in The Netherlands, Indonesia, Tanzania, South Africa and other countries.
Rob Aarnoutse headed the Pharmacokinetic & Therapeutic Drug Monitoring Laboratory at Radboudumc for several years, is deputy director of education in hospital pharmacy for Radboudumc and is member of the Ethical Review Board Arnhem/Nijmegen. He has been active in various national boards for the Dutch Society of Hospital Pharmacists (NVZA) and for SKML. He is member of the Coordinating and Executive Group of the Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA), is the chairman of the annual International Workshop on Clinical Pharmacology of Tuberculosis Drugs, and is otherwise well embedded in national and international gremia relevant to translational pharmacological research in the field of infectious diseases.
Swiss Tropical and Public Health Institute
Chief investigator: A/Prof Sebastièn Gagneux, Dr. Klaus Reither
Contact: A/Prof Sebastièn Gagneux, Dr. Klaus Reither
Phone: +41 61 284 81 11
Ifakara Health Institute
Bagamoyo Research and Training Center (BRTC)
PO Box 74
Bagamoyo, Coast Region
Project Leader: Dr. Francis Mhimbara
Principal Investigator: Dr. Lilian Tina Minja
Contact: Dr. Francis Mhimbara and Dr. Lilian Tina Minja
Phone: +255 754 291657 / +255 713 254563