Head of Regulatory Strategy, Weatherden
Dr Kirsty Wydenbach has recently been appointed as Head of Regulatory Strategy at Weatherden, a consultancy experienced in supporting preclinical and clinical stage biotech companies to de-risk drug development.
Prior to joining Weatherden she has over 13 years experience as an Expert Medical Assessor at MHRA within the Clinical Trials Unit. She has been involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and many first-in-man studies. Kirsty has also been involved in European discussions aiming to establish an EU harmonised approach to clinical trials and was an EMA expert for the update of the First-in-Human guideline.
Other work has included collaboration with external industry groups and regulators regarding adaptive and novel trial designs, including several publications. She led the MHRA work on novel trial design for the Life Sciences Industrial Strategy as well as through the new MHRA Innovative Licensing and Access Pathway (ILAP), leading the novel methodologies tool. Kirsty also oversaw the clinical trials work for COVID-19 and provided regulatory expertise on vaccines both within MHRA but also as part of the Government Vaccine Taskforce.