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
Dr. Francis Mhimbira is an epidemiologist and a TB clinical research scientist at Ifakara Health Institute (IHI, www.ihi.or.tz). He is the head of Interventions and Clinical Trials department at IHI. He has worked at Kibong’oto National TB Hospital in Tanzania (2006-2011) where he gained clinical experience on managing TB and TB/HIV co-infected patients. He joined IHI (2012-to date) and has been working in the TB research as a clinical research coordinator and investigator in a number of clinical trials, TB diagnostic studies and epidemiological studies on TB and co-infections in particular HIV and helminth infections. He was the site investigator for HIGH-RIF, NC-002, NC-005 and STAND TB drugs clinical trials. He also works with the Tanzania National TB and Leprosy Programme as a technical advisor to the TB Operational Research and Programmatic Management of Drug Resistant Tuberculosis Technical Working Groups.
Dr. Francis received his medical degree from University of Dar es Salaam, Tanzania, a Masters’ degree in Epidemiology from University of Melbourne, Australia and a PhD in Epidemiology from University of Basel, Switzerland.
NIMR Mbeya Medical Research Centre (MMRC)
Hospital Hill Rd
P.O. Box 2410
Chief investigator: Dr. Nyanda Elias Ntinginya
Contact: Dr. Nyanda Elias Ntinginya and Dr. Issa Sabi
Phone: +255 25 250 3364
Elin Svensson is a postdoctoral researcher at Radboud university medical center, focusing on pharmacokinetic and pharmacodynamic population modeling of clinical trial data. Elin holds a MSc in chemical engineering, and a PhD in pharmacometrics, both from Uppsala University, Sweden. The topic of her doctoral thesis was modeling of drug-drug interactions and exposure-response relationships for novel anti-tuberculosis drugs, partly within the PreDiCT-TB consortium. Elin also maintains a part-time researcher position at Uppsala University, and a close collaboration with the University of Cape Town, South Africa. She is part of several study protocol teams within the IMPAACT network, and is a member of the WHO Task force on PK/PD of tuberculosis medicines. Elin’s role in PanACEA includes study design and data analysis, primarily addressing questions regarding exposure-response relationships, dose optimization and biomarkers.