Executive Group meets face-to-face again

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.

Prof. Rob Aarnoutse PharmD

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.

Dr. Francis Mhimbira

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.

 

Dr. Elin Svensson

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.