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European Biopharmaceutical Review

The Rise of Registries

A range of novel scientific approaches to address various disease targets have characteristics associated with ‘transformative therapies’ – namely therapeutic interventions, which shift the objective of care from management of symptoms to control of disease through a modification of disease processes. Broad catagories of scientific platforms exist under this umbrella, such as cell therapy (induced pluripotent stem cells, direct reprogramming of differentiated cells), a variety of small molecules within different chemical classes, antisense RNA interference therapy, monoclonal antibodies and gene therapy.

Transformative Therapies


Although a variety of clinical development programmes can be characterised by investigational compounds meeting transformative definitions, the higher number of potentially breakthrough products in cancer reflects the growing understanding of disease processes at the molecular level. This includes insights gained through compounds investigated for multiple cancers that have similar underlying molecular mechanisms, but which may affect different organ systems.

Correspondingly, immunological conditions also share common pathophysiological touch points in spite of discrepancies in clinical expression, so potential therapeutic agents may be effective across multiple indications. As an example, there are more than 20 therapeutic monoclonal antibodies – either approved or in various stages of clinical development – that target molecular components of the cytokine cascades mediating inflammation (see full pdf). These diverse agents may interrupt pathways essential to the pathobiology of allergic asthma, inflammatory bowel disease (see full pdf), Crohn’s disease (transmural inflammation) and ulcerative colitis (mucosal inflammation).

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Dr Paola Antonini is a Senior Vice President of Scientific Affairs and, with over 25 years of industry experience, she provides scientific and medical expertise for late-phase clinical development projects. She received her MD from the University of Rome, Italy, and she also has a PhD in Clinical Pharmacology. Prior to joining Worldwide Clinical Trials in 2008, Paola held the position of Director of Medical Affairs and of Clinical Research at the Italian Subsidiary of Merck & Co. During her career, she has covered different roles, from medical affairs and clinical research operations, to drug safety and study feasibility.

Lorna Graham has 17 years’ clinical research experience. She has worked in various roles in the pharma and CRO industries including data and site management across therapeutic areas such as cardiovascular, central nervous sytem, oncology, tropical disease and women’s health. Her latest experience spans: effectiveness evaluation studies; risk management plans, evaluations and mitigation strategies; disease registries; observational non-interventional studies; healthcare provider surveys; and contributions to a global economic dossier for a HIV compound.

Dr Michael Murphy’s professional career has spanned 25 years and his positions within the pharma industry emphasise the integration of medical and scientific acumen with operational excellence. He is board-certified in Psychiatry and has a doctorate in Pharmacology, having trained at Tulane University, Stanford University and the Mt Sinai School of Medicine, US. Michael’s supervisory responsibilities as Chief Medical and Scientific Officer at Worldwide Clinical Trials are international in scope, and include strategic programme and protocol design contributions for translational research activities, particularly for orphan disease indications.

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Dr Paola Antonini
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Lorna Graham
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Dr Michael Murphy
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