Scientific Advisory Board

Graham is a pharmacist with an MSc in Clinical Pharmacology and a PhD from the Universities of Glasgow and Manchester respectively. Graham’s career has focused upon the investigation of the clinical pharmacology of new drugs and novel formulations.  At AstraZeneca, he was involved in the transition of several novel molecules from discovery into humans.  He is experienced in a number of PK methodologies and has used these across the drug development spectrum.

Graham is a strategic thinker and an advocate of creative and efficient clinical study design.  He has applied these principles to many global drug development projects in several therapeutic areas.  His skills have involved him in various patent cases where he has acted as an expert witness in several jurisdictions

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 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.

Dr Kirsty Wydenbach is Head of Regulatory Strategy at Weatherden. With over 13 years’ experience as an Expert Medical Assessor at MHRA within the Clinical Trials Unit (CTU), 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.

Kirsty’s 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

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.

Sarah trained as a doctor in London before undertaking her Medical Oncology specialist training in Cambridge and the Royal Marsden Hospital. In 2003 she completed a PhD at Cambridge University in fruit fly genetics followed by a Clinical Fellowship at the Institute of Cancer Research’s Drug Development Unit.

From 2006-2015, Sarah was a Senior Lecturer at Imperial College London and led their Early Cancer Trials Unit. In 2015 she moved to the University of Oxford where she is now Professor of Medical Oncology, Director of Oncology Clinical Trials Office (OCTO), lead for Oxford Early Cancer Medicine Centre (ECMC) and runs a molecular biology laboratory exploring protein synthesis in cancer.

Sarah has been chief or principal investigator for a number of national and international cancer studies. She has worked with the MHRA/NICE to develop guidance for their new pathways to approval and advises biotechnology and pharmaceutical companies on cancer drug development.

Dr Fung has over 25 years of oncology practice as well as global Pharma and biotech experience across Hematology, Immunology, Gastroenterology and Nephrology. He has extensive experience in Translational Medicine, including the seamless transition of product candidates from preclinical research into early phase development until Proof-of-Concept (Phase IIb), biomarker expertise, the implementation of clinical operations plans and clinical development strategy.

Dr Fung has experience in EU markets, particularly Germany (AMNOG), and Orphan Drugs.

Dr Awada is Head of the Oncology Medicine Department at Jules Bordet Cancer Institute Brussels, Belgium, where he has worked extensively in the study of solid tumours and breast cancer. Experienced in the clinical drug development of cytotoxics, molecular-targeted therapies, and immunotherapy, Dr Awada has over 25 years’ experience in oncology clinical development.

Dr Awada also holds the position of Head of the Oncodistinct Network, which works to develop innovative strategies for clinical studies and accelerate the development of anti-cancer drugs in solid tumors, especially in areas of high unmet medical need.

Dr. Carlos Camozzi is an experienced chief executive and corporate governance in the biopharmaceuticals and health technology with over 30 years c-level expertise/experience of the orphan drugs, gene- and cell-therapy, biopharma and medical devices industry.

Carlos has generated innovative solutions to the evaluation, design and the execution of non-clinical, translational, and clinical development projects for several orphan drugs, paediatric and oncology clinical trials. He successfully led several clinical development programs, regulatory interactions, consultations, submissions and approvals of orphan drug applications (ODA), paediatric investigational plans (PIP) and marketing authorisations applications (MAA) by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

As Chair of our Oncology SAB, Alain Thibault is a leading oncologist with over 25 years of oncology drug development experience across phase I-IV clinical studies, including small molecules and biologics; cytotoxics, targeted therapy and monoclonal antibodies, including regulatory submissions; translational medicine and biomarker discovery.

Alain’s previous experience includes positions as Chief Medical Officer, (arGEN-X BVBA), Vice President Clinical Services, Oncology, (Regeneron Pharmaceuticals), Senior Director, Oncology, (Gemin-X Biotechnologies), Senior Director, Oncology, (Johnson & Johnson Pharmaceutical Research & Development), Director, Clinical Services, (Hoffman La-Roche Laboratories)