Simbec-Orion is delighted to share the further expansion of our Clinical Pharmacology Scientific Advisory Board (SAB), with the recent appointment of Dr Kirsty Widenbach.
Compared with traditional first-into-human studies, complex early phase studies with umbrella protocols or adaptive designs can offer critical data earlier whilst reducing cost. Such trials require a CRO that is both knowledgeable and experienced with the challenges of early phase research.
As we have seen demand for such studies increase, we wanted to ensure our clients could not only benefit from our in-house expertise, but also have access to a dedicated Clinical Pharmacology SAB who will utilise their individual areas of expertise to offer additional insights, including supporting with aspects of study design and protocol development, regulatory advice, and interpretation of emerging study data.
Kirsty Wydenbach, Regulatory & Pharmaceutical Medicine Expert
We are delighted to welcome Dr Kirsty Wydenbach to our Clinical Pharmacology Scientific Advisory Board. Recently appointed as Head of Regulatory Strategy at Weatherden, a global integrated clinical consultancy, experts in scientific strategy and clinical development, Kirsty joins fellow members of Simbec-Orion’s Scientific Advisory Board to offer our clients valuable independent insight into their clinical development plans. With over 13 years’ experience as an Expert Medical Assessor at MHRA within the Clinical Trials Unit, Kirsty 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.
You can learn more about the other experts on our Clinical Pharmacology Scientific Advisory Board below:
David Jones, Pharmaco-toxicology Expert
David is a European Registered Toxicologist and a Fellow of the British Toxicology Society as well as a Chartered Biologist and a Fellow of the Royal Society of Biology. David lectures at the University of Surrey and the University of Wales.
With a background in pharma and contract research, David then joined the MHRA (formerly the Medicines Control Agency) in 1996, where he was recently working as an Expert Nonclinical Assessor, responsible for assessing the nonclinical data for Clinical Trial Authorisation Applications and chairing over a hundred scientific advice meetings every year. With over 25 years of experience at the MHRA, David will provide invaluable insight to clients looking to progress their compound into clinical trials.
Geoff Kitson, Vaccines & Infectious Disease Expert
Geoff has over 34 years’ experience in the pharmaceutical industry, with a broad-based international perspective on drug development, from phase I to phase IV, experience of pre-clinical work, and regulatory requirements. He has been involved in the preparation of INDs, CTAs, MAAs and other regulatory documents. He has experience in the development of individual clinical studies, clinical trial programmes, multinational clinical trials and developing clinical strategies.
In the last few years he has taken 5 products including 5 vaccines through to first-in-man studies and progressed products through to Phase II/III.
John Posner, First-into-Human Pharmaceutical Medicine Expert
John brings over 40 years of industry experience into his role as First-into-Human Pharmaceutical Medicine Expert. After qualifying in pharmacology and medicine at King’s College London, John’s expansive career includes roles as Head of Clinical Pharmacology for The Wellcome Foundation and Director of Clinical Pharmacology at GlaxoWellcome. More recently, John has provided consultancy in pharmaceutical medicine to a variety of companies over the past 20 years, from multi-national to small biotech.
In addition, John teaches postgraduate clinical pharmacology at King’s College London. One of John’s key areas of expertise is in exploratory development with strategic planning, design, conduct, and reporting of studies of novel compounds from ‘First-in-Human’ to Proof of Concept, which will offer our clients valuable insight into their pivotal early clinical development plans
Contact us now to find out how we can support your clinical development journey.