Dr. Francis Mhimbira

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Dr. Francis Mhimbira is an epidemiologist and a senior research scientist at Ifakara Health Institute (IHI, www.ihi.or.tz). He joined IHI since 2012 working with a TB research group conducting TB epidemiological, diagnostic and clinical trials (drugs and vaccines). He has experience in conducting phase II and phase III TB drug clinical trials. He is currently leading the preparation and conduct of PanACEA related studies at Ifakara Health Institute. Dr. Francis has other research interests which include implementation studies on TB case finding and diagnostic studies.

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.

First patients enrolled in BTZ043 trial

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PanACEA has enrolled the first patients in the first cohort of the BTZ043 trial. BTZ043 is a new compound with activity against tuberculosis. The trial is a phase Ib/IIa study to assess the safety and tolerability of BTZ043 and to evaluate bactericidal activity of different doses. The trial takes place at the University of Cape Town Lung Institute (UCTLI) and TASK Applied Science Clinical Research Centre in Cape Town, South Africa. Klinikum der Universität München is the study sponsor.

 

SimpliciTB General Assembly

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The quarterly SimpliciTB General Assembly (GA) met by teleconference on the 24th October. Once again there was excellent representation of the collaborating groups with 15 attendees from 7 countries. The Executive Group (EG) have met regularly and gave a report on contractual arrangements, finance, collaborations, and capacity development.  There was a further call for membership proposals to join the Scientific Advisory Board, Ethics Advisory Board and Capacity Development Committee.  It was agreed to include the addition of 4 trial sites at Wits, Johannesburg. The General Assembly will meet again, face to face in Mbeya, Tanzania in February 2020.

PanACEA General Assembly

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In the quarterly meeting of the General Assembly of PanACEA on 23rd of September an update was given on the progress of the trials and the capacity development plans. The operational teams and study teams are working hard for the final preparations of the BTZ043 trial that will start in November of 2019. This phase 1A/1B trial will assess the safety/tolerability and bactericidal activity of the novel TB drug BTZ043. Preparations for the SUDOCU study are also well under way. This phase IIB trial is scheduled to start in Q2 of 2020 and will assess the optimal dose of sutezolid for larger follow-up studies.

12th International Workshop on Clinical Pharmacology of Tuberculosis Drugs

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On Tuesday 10th of September the 12th edition of the International Workshop on Pharmacology of Tuberculosis Drugs took place in London. The annual platform brings together experts to share the latest findings in the field of TB clinical pharmacology. From this perspective, Lindsey te Brake presented the PK findings of the PanACEAII HR1 trial. Elin Svensson gave a presentation on exposures, treatment response and biomarkers, also a key theme of the PanACEAII project.

INTERTB 2019

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The yearly INTERTB symposium, organised by dr. Amina Jindani, was held in London on Monday 9th of September. Martin Boeree presented the results of the PanACEAII HR1 trial and opened the discussion on the optimal dose of rifampicin. Other speakers were, amongst others, consortium members Patrick Phillips, Timothy McHugh and Gerry Davies.

Dr. Celso Khosa

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Celso Khosa is the scientific director of Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC), Instituto Nacional de Saúde Mozambique (INS) since 2018 and he is responsible for the daily activities of PanACEA II in Mozambique.

Dr. Khosa has been a medical doctor and researcher at INS-CISPOC since 2013, leading the TB research program, implementing observational studies and clinical trials in TB therapeutics and diagnostics in adult and paediatric population. He is a last year PhD candidate in Medical Research / International Health at the University of Munich. Dr. Khosa is currently the Principal Investigator in several TB studies, including clinical trials for new drugs in TB and HIV treatment.

His main research interest includes tuberculosis, HIV and Comorbidities associated with HIV.

Dr Julia Dreisbach

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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 Hoffmann

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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.

General Assembly Teleconference September

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Every 3 months the PanACEA consortium is meeting via teleconference to update each other on the progress of the trials and the capacity development program. On September the 10th 2018 the partners assembled again.

The so-called Expertise Cores can finally carry out their plans. They have started to purchase data management systems and statistical software.

The PanACEA Postgraduate Program is facilitated by the Expertise Cores and we are excited that applications have been opened.

PanACEA is also gearing up for the upcoming Ninth EDCTP Forum and The 49th Union World Conference on Lung Health.