I am Vice President and Clinical Portfolio Leader in the Pfizer Inflammation and Immunology Research Unit in Cambridge, Massachusetts. I joined Pfizer in 1995 to lead the Gastrointestinal Discovery Biology group at the Sandwich site in the UK and then joined the Experimental Medicine group in 2002. Prior to this I worked for Glaxo as a Research Leader in the Gastrointestinal Pharmacology Group. Since joining the clinical world I have led early clinical development and translational medicine activities from first-into-human to clinical proof-of-concept across a range of diverse diseases in gastroenterology and hepatology. Since 2008, I have been leading clinical development activities across several areas of internal medicine, including nephrology, as either RPL or Clinical Lead. I currently have responsibility for early clinical development activities in Inflammatory Bowel Disease.

RESEARCH AREA(S)

My research focuses on the early clinical development of novel medicines, primarily in the field of gastroenterology, but also nephrology, skin scarring, complications of diabetes and women’s health. The scope of my research is Phase 1 to Phase 2b and includes biomarker-based and translational medicine-based approaches to decision making.

PUBLICATIONS

1. Scheele W, Diamond S, Gale J, Clerin V, Tamimi N, Le V, Walley R, Grover-Páez F, Perros-Huguet C, Rolph T and El Nahas M (2016) Selective inhibition of phosphodiesterase type 5 reduces albuminuria in subjects with type 2 diabetes and overt nephropathy. J Am Soc Nephrol 27(11):3459-3468. https://www.ncbi.nlm.nih.gov/pubmed/27113485
2. Walley R.J, Birch C.L, Gale J.D and Woodward P (2015) Advantages of a wholly Bayesian approach to assessing efficacy in early drug development: a case study. Pharm Stat 14: 205-215. https://www.ncbi.nlm.nih.gov/pubmed/25865949
3. Manousou P, Burroughs A.K, Tsochatzis E, Isgro G, Hall A, Green A, Calvaruso V, Ma G.L, Gale J, Burgess G, O'Beirne J, Patch D, Thorburn D, Leandro G, and Dhillon A.P. (2013) Digital image analysis of collagen assessment of progression of fibrosis in recurrent HCV after liver transplantation. J Hepatol 58(5): 962-8. https://www.ncbi.nlm.nih.gov/pubmed/23262247
4. Gale, J.D and Houghton L.A (2011) Alpha2delta (2) ligands, gabapentin and pregabalin: What’s the evidence for potential use of these ligands in irritable bowel syndrome. Frontiers Gastrointestinal Pharmacology 2:1-9 https://www.ncbi.nlm.nih.gov/pubmed/21713059
5. Ferens D.M, Yin L, Ohashi-Doi K, Habgood M, Bron R, Gale J.D. and Furness J.B (2010) Evidence for functional ghrelin receptors on parasympathetic preganglionic neurons of micturition control pathways in the rat. Clin Exp Pharmacol Physiol 37: 926-932. https://www.ncbi.nlm.nih.gov/pubmed/20497419
6. Neubert H, Gale J, Muirhead D (2010) Quantitative Protein Bioanalysis by Online High Flow Peptide Immunoaffinity Enrichment and Nanoflow LC-MS/MS: Assay Development for Measuring Total Salivary Pepsin/Pepsinogen. Clin Chem 56: 1413-1423.https://www.ncbi.nlm.nih.gov/pubmed/20472821/

EDUCATION

European Confederation of the Upper Rhine Universities, Basel, Freiburg & Strasbourg, Diploma and University Professional of Advanced Studies in Pharmaceutical Medicine, European Center of Pharmaceutical Medicine, 2015
University of Warwick, 2011
University of London, Royal Free Hospital School of Medicine, Ph.D: “Morphological and pharmacological studies of 5-HT in sympathetic nerve fibres,” 1988
Sunderland Polytechnic, Sunderland, Pharmacology, Class II (i), B.S. (Honors), 1985

AWARDS & HONORS

Honorary Professorship, University of Liverpool, 2015 – 2018
Postgraduate Award in Management of Chronic Kidney Disease (Obtained a 67% overall), University of Warwick, 2011
Graduated in top 25% of class in 4/5 modules, European Confederation of the Upper Rhine Universities, Basel, Freiburg & Strasbourg, 2003-2005