Doctor Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead

About: A Family Physician with special interest in Clinical Research in Tropical Diseases especially Malaria. A Fellow of WHO/TDR in Clinical Research and Development. A physician with National Hospital Abuja Nigeria. As a WHO/TDR Tropical Disease Clinical Research and Development Fellow I was involved in three main projects at various stages of development. The projects are:- 1) E1224 – A novel drug in phase 2 clinical development for the treatment of chronic indeterminate chagas disease. 2) E6446 – A novel drug to be used as an adjunct therapy for the treatment of cerebral malaria. 3) E1210 – A novel drug for the management of systemic fungal infection. I was involved in and learnt about:- i) Various stages of drug development from drug discovery processes, pre-clinical studies and the four phases of clinical trial. ii) Project planning and implementation involving various team members such as project team leader, leads in various aspects such as clinical study, clinical pharmacology, chemistry, manufacturing and control, preclinical and clinical safety, biostatistics, data management, drug metabolism and pharmacokinetics, regulatory affairs, and the project manager among others. Implementation is time bound and human and financial resources among other resources are deployed to execute the project. iii) Collaboration between industry, academic institution, contract research organizations, consultants and funding organizations including the processes and legal and financial agreements involved. iv) Study designs involved in pre-clinical, phase 1 and phase 2 clinical trials including pros and cons of traditional phase 11 trial and phase 2b/3 trials using complex adaptive designs. v) Regulatory functions of Food and Drug Administration (FDA) in drug development including pre-investigational new drug, investigational new drug and new drug applications. vi) Importance and contents of investigator’s brochure (IB) and the processes of developing, editing and up-dating IB. vii) How to develop a protocol concept sheet and a study protocol based on standard operating procedures and in accordance with ICH guidelines. viii) ICH-GCP guidelines using various study modules and the application of the guidelines in practice. ix) The essence and contents of an annual report to FDA. x) How to determine first in human dose using No Observed Adverse Effect Level (NOAEL) in the most sensitive animal specie and Minimum Achievable Biological Effect Level (MABEL) xi) Literature search and preparation of a briefing book for a pre-IND meeting with FDA. xii) Introduction to the principles and practice of clinical research – an online course provided by National Institute of Health. Apart from these, I personally a) participated in a session of teleconference type C meeting with FDA. b) did a quality control review of a briefing book. c) Participated in various face-to-face, video-conference and teleconference meetings on the three projects. d) developed a protocol concept sheet for one of our projects. e) Wrote a study protocol for one of our projects.