Dear Clinical Trials Capacity Group, I am a Regulatory Affairs professional with a background in molecular biology/microbiology/cell biology, and with broad and up to date experience in drug/biologics/diagnostic Regulatory Affairs in the US and the EU (and good knowledge about the ROW). I have been working with a group of experienced people to spin out/start a company to develop new and improved TB drugs. The group is well connected with government members and clinical institutions in Africa, and has the means to do very efficient R&D and preclinical work, and has funding in place. My task has been to develop a regulatory strategy for the clinical development and marketing application of new TB drugs that this group is working on, both preferably with local (African) clinical centers and Medicinal Regulatory Authorities. Through my work with them I have gained a very good understanding of the current situation regarding existing TB treatment and the need to develop better and faster-acting medicines. From a regulatory standpoint, I think it is important to develop a process where new and improved treatments and treatment combinations can get to the clinic in a fast and efficient way, where clinical trials can be improved regarding the time to conclusive results, and where local Regulatory Authorities can be assisted in developing a safe process for an independent review and registration process for new drugs. It is my strong desire to help push this development forward and to get involved in existing initiatives where I feel my experience could be useful, such as the Clinical Trials Capacity Group. In addition to my experience in the clinical and regulatory field, I am very energetic and efficient, and able to motivate people and move things along. An example of that is my prior engagement with the CIMT RRG (Cancer Immunotherapy Regulatory Research Group) where I helped draft a new regulatory concept for the development of personalized cancer medicines and a respective submission-ready concept paper, and organized an Innovative Task Force (ITF) Meeting with the EMA. Please don't hesitate to contact me, I would be very happy to hear from you soon. Sincerely, Michaela Nielsen