Dr. Julia Dreisbach, a veterinary doctor, led the preclinical development of BTZ-043 and now acts as clinical project manager in the BTZ-043 Multiple Ascending Dose Study in Patients.
She coordinates in parallel all non-clinical activities like for example long term toxicity studies in animals, cold- and radiolabeled ADME studies in animals and the development of a suitable drug formulation for BTZ-043
Larissa completed her studies in nutritional science in 2009 and graduated with majors in nutritional medicine. Thereafter, she started her career in the field of clinical trials as a study coordinator for regulated clinical trials in an in-patient clinical setting. After several years she took up a position as a clinical operations manager in a biopharmaceutical start-up company gearing towards the development of immune evasion vaccines and later joined Hipp GmbH & Co. KG as a clinical project manager for the management of clinical studies on infant formulas. During those years she completed several trainings in ICH-GCP, study management and medical writing. In 2018, Larissa joined the Division of Infectious Diseases and Tropical Medicine at the LMU Munich and acts as a clinical project manager for PanACEA TB trials in the office in Munich and in the field.
The first formal meeting of SimpliciTB General Assembly (GA) took place on the 25th of July. We had an excellent representation of the collaborating groups with 20 attendees from 9 countries. The Executive Group (EG) has been established with colleagues from South Africa, Tanzania, and our new partners from Uganda, Mozambique, Malawi and Gabon joining the group. A number of membership proposals were received for the Scientific Advisory Board and the Ethics Advisory Board, up and coming African scientists will form both of these groups. Contractual developments, finance and budgets for the clinical trial were discussed. We are also pleased to inform you that significant progress was made in operationalizing the capacity development and community engagement components of the work.
On the 1st of July the PanACEA General Assembly met by teleconference for its quarterly gathering. The program of the project is progressing as the preparations for the next trials are ongoing and the Operational Teams are meeting on a regular basis. The Expertise Cores are involved as well, rolling out the MBL assay, building infrastructure for data management, training monitors and so forth.
SimpliciTB is a multi-centre phase 3 clinical trial evaluating a new shorter drug regimen (all-oral BPaMZ) in drug susceptible and resistant pulmonary tuberculosis across 4 continents led by TB Alliance. The trial started in 2018 and the European and Developing Countries Clinical Trials Partnership (EDCTP) has recently awarded 12 million euro for the execution of the trial in sub-Saharan Africa. It also includes capacity building funding that will enhance clinical research in these settings. The University of St Andrews will coordinate the grant and lead medical monitoring, and the TB Alliance will work with PanACEA clinical research sites of PanACEA to deliver the trial.
We are excited that a significant component of the grant is dedicated to building clinical trials capacity in PanACEA sites in line with PanACEA’s objective to support the consortium to deliver improved treatments for patients with tuberculosis.
On 19 and 20 March 2019 hosting partner Instituto Nacional de Saúde welcomed the General Assembly to Maputo, Mozambique, for the second PanACEA II Annual Meeting. Highlights of the second year of the PanACEA II programme were the completion of the HR1 trial, start of the postgraduate programme, site assessment visits and capacity development activities (e.g. MBLA implementation) and the SimpliciTB collaboration. For the third year, the WP2 trials and SimpliciTB kick-off within PanACEA are planned. During the meeting each site presented ongoing scientific studies to exchange knowledge and experience.
In the quarterly teleconference on 10 December 2018 the PanACEA partners assembled to discuss the progress of the projects program. We looked back to 2018 as a year in which we ended our first trial. We are ready to start 2019, when our other trials are scheduled to start. The General Assembly meets again, face to face, at the second Annual Meeting in Maputo, Mozambique.
The Union World Conference served as a good occasion several PanACEA get togethers. On the 25th of October the Executive Group came together to discuss the completion of the HR1 trial and the preparations for the upcoming trials.
The TBA was also invited to prepare for the SimpliciTB trial for which EDCTP favourably evaluated a grant application by PanACEA and the TB Alliance. SimpliciTB is a global phase III trial to evaluate the efficacy, safety and tolerability of a novel and potentially shorter drug regimen of Bedaquiline, Pretomanid, Moxifloxacin and Pyrazinamide (BPaMZ).
One of the yearly highlights in TB research is the Union World Conference. The 49th edition was hosted by the city of The Hague and the KNCV Tuberculosis Foundation from 24th until 27th of October 2018. This gathering of clinicians, public health workers, policy makers, researchers and advocates serves as an unique platform for a global public health response to TB and lung pollution with a special focus on resource-limited settings. The message this year was: “Declaring our rights: social and political solutions’
PanACEA consortium members Martin Boeree, Stephen Gillespie, Michael Hoelscher, Rob Aarnoutse, Peter Donald, Andreas Diacon, Gerry Davies, Elin Svensson, Celso Khosa, Lindsey te Brake, Issa Sabi, Carlijn Litjens, Nyanda Ntingingya, Patrick Phillips, Derek Sloan, Stellah Mpagama, Norbert Heinrich, Blandina Mmbaga, Celso Khosa, Christina Manyama and many more contributed to the message with presentations and active participation.
The 11th International Workshop on Pharmacology on Tuberculosis Drugs was held in The Hague on 23rd of October 2018 during the week of the Union World Conference. At this premier TB pharmacology meeting leading experts presented and discussed the latest findings in the TB research.
PanACEA was well represented by a delegation existing of Rob Aarnoutse (Radboudumc), Elin Svensson (Radboudumc, Uppsala University), Lindsey te Brake (Radboudumc), Carlijn Litjens (Radboudumc) and Patrick Phillips (UCSF).
