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Your Consultant: Goran Westerberg, PhD, Associate Professor, MTOPRA

Over the past 38 years (and 700 clinical trials) in the Pharmaceutical Industry, I have matured a broad experience in the early clinical development domain. Starting with 10 years in the Contract Research world, I moved into Pharma in 1995 working in Sweden, the UK, Italy, Japan and the US.

My main interest and experience lies in pulling compounds out of Discovery and pushing them into Development; overall, I have taken 38 new compounds into the clinic across most therapeutic areas (CNS, metabolic & respiratory diseases, anti-infectives, oncology, haematology, ophthalmology, gynaecology/obstetrics, urology and cardiovascular). 

Specific experience of Regulatory Affairs, Clinical Pharmacology and Phase I clinical studies including First-Time-in-Human, PK/PD, Toxicology, cPoC/Phase II, Pharmaceutical Development, GxP, Orphan Designation, European Commission funding, radioactivity, imaging.

Languages - fluent:

  • English
  • Italian
  • Swedish

Specialties: 

  • Due Diligence/In-licensing evaluation
  • Early stage (Phase I-IIb) clinical studies
  • Compilation of Regulatory Dossiers
  • Regulatory Advisory Services
  • Project strategy, costing and decision-making process

Positions held

2012 -              Owner and Director, La Crocina Pharmaceutical Consultants

2004 - 2012     Head of Clinical & Regulatory Development, Siena Biotech SpA, Italy

2000 - 2004     Director, Pharmacokinetics, Pharmacia/Pfizer, Milan, Italy

1996 - 2000     Senior Research Advisor, Pharmacia & Upjohn, Stockholm, Sweden

1988 - 1996     Senior Research Scientist, Uppsala PET Centre, Uppsala, Sweden

Education, degrees

1997                 Associate Professor, Radiopharmacology, Uppsala University, Sweden

1994                 PhD, Radiopharmaceutical chemistry, Uppsala University, Sweden

1992                 MSc, Radiopharmaceutical chemistry, Uppsala University, Sweden

1988                 BSc, Organic Chemistry, Uppsala University, Sweden

Selected Invited Speaker Engagements

  • Early Precision QT Modelling Approaches, March 6, 2018
  • 7th Annual Biomarkers/CNS Biomarkers Congress, Manchester, February 21-22, 2012
  • Outsourcing in Clinical Trials, Europe, Zurich, May 10-11, 2011
  • 12th Annual Phase I Clinical Trials, London February 15-16, 2011
  • Third Annual Outsourcing Preclinical Development, Basle, December 2-3, 2009.
  • 10th Annual Phase I Clinical Trials, February 10-11, 2009
  • Second Annual Outsourcing Preclinical Development, Basle, December 2-3, 2008.

Selected Publications

 

  1. Gati, I, Bergström, M., Westerberg, G., Csoka, K., Muhr, C. and Carlsson, J. Effects of Prostaglandin and Leukotriene Inhibitors on the Growth of Human Glioma Spheroids.Eur. J. Cancer(1990), 26, 802.
  2. Daniel-Szolgay, E., Carlsson, J., Westerberg, G., Acker, H.Effects of Amiloride Analogues on Tumour Spheroids of Human Glioma and Colon Carcinoma Origin. Acta Universitatis Upsaliensis (1991). Comprehensive Summaries of Uppsala Dissertations from the Faculty of Science, No. 335:V.
  3. Westerberg, G., Lundqvist, H., Kilàr, F. and Långström, B.Beta + -Selective Radiodetector for Capillary Electrophoresis.J. Chromatogr. (1993), 645, 319.
  4. Westerberg, G. and Långström, B. Synthesis of (13C)- and [11C]Cyanogen Bromide, Useful Labelling Precursors. Acta Chem. Scand. (1993), 47, 974.
  5. Tsukada, H., Lindner, K-J., Tani, Y., Bjurling, P., Kihlberg, T., Westerberg, G., Watanabe, Y. and Långström, B. Effect of 6R-L-Erythro-5,6,7,8-tetrahydrobiopterin on in vivo L-[11C]DOPA Turnover in the Rat Striatum with Infusion of L-Tyrosine. J. Neural Transmiss. (1993), 95, 1.
  6. Tani, Y., Ishihara, T., Kanai, T., Ohno, T., Watanabe, Y., Andersson, J., Lilja, A., Hartvig, P., Westerberg, G. and Långström, B. 6R-Tetrahydrobiopterin (R-THBP, SUN 0588) Acts on the Central Muscarinic and Nicotinic Receptors as Evaluated by Positron Emission Tomography (PET) Studies in Rhesus Monkey. Adv. Exp. Med. Biol. (1993), 338, 331-4.
  7. Tani, Y., Ishihara, T., Kanai, T., Ohno, T., Onoe, H., Watanabe, Y., Andersson, J., Lilja, A., Hartvig, P., Westerberg, G. and Långström, B. Positron Emission Tomography (PET) Study: The Effects of 6R-L-Erythro-tetrahydrobiopterin (R-THBP, SUN 0588) on the Central Dopamine D1, D2 and D3 Receptors in Rhesus Monkey. Adv. Exp. Med. Biol. (1993), 338, 327-30.
  8. Westerberg, G. and Långström, B. Labelling of Proteins in High Specific Radioactivity: 11C-Albumin and 11C-Transferrin. Appl. Radiat. Isot. (1994), 45, 773.
  9. Hartvig. P., Valtysson, J., Antoni, G., Westerberg, G. Långström, B., Ratti-Moberg, E., Øye, I. Brain Kinetics of (R)- and (S)-N-[methyl-11C]ketamine in the Rhesus Monkey Studied by Positron Emission Tomography. Nucl. Med. Biol. (1994), 21, 927.
  10. Westerberg, G. and Långström. B. Synthesis of Sodium [11C]Thiocyanate Using [11C]Cyanogen bromide. J. Labelled Comp´ds. Radiopharm. (1994), 34, 545.
  11. Westerberg, G., Kärger, W., Onoe, H. and Långström, B. [11C]Cyanogen Bromide in the Synthesis of 1,3-Di(2-tolyl)-[11C]guanidine. J. Labelled Comp´ds. Radiopharm. (1994), 34, 691.
  12. Hellman, P., Ahlström, H., Bergström, M., Sundin, A., Långström, B., Westerberg, G., Juhlin, C., Åkerström, G., Rastad, J. Positron Emission Tomography with 11C -Methionine in Hyperparathyroidism Surgery (1994), 116, 974 - 981.
  13. Tani, Y., Ishihara, T., Kanai, T., Ohno, T., Andersson, J., Lilja, A., Antoni, G., Fasth, K.-J., Bjurling, P., Westerberg, G., Hartvig, P., Onoe, H., Watanabe, Y. and Långström, B. Effects of 6R-L-erythro-5,6,7,8-tetrahydrobiopterin on the Dopaminergic and Cholinergic Receptors as Evaluated by Positron Emission Tomography in the Rhesus Monkey. J. Neural Transmiss. (1995), 102, 189-208.
  14. Westerberg, G., Bergström, M., Gustafson, S., Lindqvist, U., Sundin, A. and Långström, B. Labelling of Polysaccharides Using [11C]Cyanogen bromide. In Vivo and In Vitro Evaluation of 11C-Hyaluronan. Nucl. Med. Biol. (1995), 22, 251 - 256.
  15. Kumlien, E., Bergström, M., Lilja, A., Westerberg, C.-E., Antoni, G., Westerberg, G. and Långström, B. Positron Emission Tomography with [Methyl-11C]-Deuterium-L-Deprenyl in Patients with Partial Complex Epilepsy. Epilepsia (1995), 36, 712 - 721.
  16. Hartvig, P., Valtysson, J., Lindner, K.-J., Kristenssen, J., Karlsten, R., Gustafsson, L.L., Persson, J., Svensson, J.O., Øye, I., Antoni, G., Westerberg, G. and Långström, B. CNS Effects of Subdissociative Doses of (S)-Ketamine are Related to Plasma and Brain Concentrations Measured With Positron Emission Tomography in Healthy Volunteers. Clin Pharmacol. Ther. (1995), 58, 165 - 173.
  17. Matsumura, K., Bergström, M., Onoe, H., Takechi, H., Westerberg, G., Antoni, G., Bjurling, P., Jacobson, G.B., Långström, B. and Watanabe, Y. In Vitro Positron Emission Tomography (PET): Use of Positron Emission Tracers in Functional Imaging in Living Brain Slices. Neuroscience Research(1995), 22, 219 - 229.
  18. Göller, L., Bergström, M., Nilsson, S., Westerberg, G. and Långström, B. MAO-A Enzyme Binding in Bladder Cancer Characterized with [11C]Harmine in Frozen Section Autoradiography. Oncology Reports (1995), 2, 717 - 721.
  19. Tsukada, H., Lindner, K.J., Hartvig, P., Tani, Y., Valtysson, J., Bjurling, P.,Kihlberg, T.,Westerberg, G.,Watanabe, Y. and Långström, B. Effect of 6R-L-Erythro-5,6,7,8-Tetrahydrobiopterin and Infusion of L-Tyrosine on the In Vivo L-[11C]DOPA Disposition in the Monkey Brain. Brain Res. (1996) 713, 92 - 98.
  20. Jacobson, G.B., Westerberg, G., Markides, K.E. and Långström, B. Synthesis of 11C-Labelled Guanidines in Supercritical Ammonia. J. Am. Chem. Soc. (1996) 118, 6868 - 6872.
  21. Westerberg, G., Bamford, M., Daniel, M.J., Långström, B and Sutherland, D.R. Synthesis of 5-Acetylamino-4-[11C]guanidino-2,6-anhydro-3,4,5-trideoxy-D-glycero-D-galacto-non-2-enoic acid ([11C]GG167) - An Influenza Virus Neuraminidase Inhibitor. J. Lab. Compd´s Radiopharm. (1996) 38, 585 - 589.
  22. Westerberg, G. and Långström, B. On-Line Production of [11C]Cyanogen Bromide. Appl. Radiat. Isot. (1997), 48, 459 - 461.
  23. Danfors, T., Bergström, M., Feltelius, N., Ahlström, H., Westerberg, G., Långström, B. Positron Emission Tomography with 11C-D-Deprenyl in Patients with Rheumatoid Arthritis. Evaluation of Knee Joint Before and After Intra-Articular Glucocorticoids. Scand. J. Rheum.(1997) 26, 42 - 48.
  24. Bergström, B., Westerberg, G., Greger, G., Müller-Pelzer, H., Traut, M., Safer, A., Németh, G., Gross, G., Eckernäs, S.-Å. and Långström, B. MAO-A Inhibition in Brain After Dosing of Esuprone, Moclobemide and Placebo in Healthy Volunteers - In Vivo Studies with Positron Emission Tomography. Eur. J. Clin. Pharm. (1997) 52, 121-128.
  25. Westerberg, G. and Långström, B. Synthesis of meta-iodobenzyl[11C]guanidine. J. Lab. Compd´s Radiopharm. (1997), 39, 525 - 529.
  26. Tedroff, J., Torstensson, R., Hartvig, P., Lindner, K..-J., Watanabe, Y., Bjurling, P., Westerberg, G. and Långström, B. L-DOPA Modulates Striatal Dopaminergic Function In Vivo. Evidence from PET Investigations in Non-Human Primates. Synapse (1997) 25, 56 - 61.
  27. Torstenson, R., Hartvig, P., Långström, B., Westerberg, G., and Tedroff, J.Differential Effects of Levodopa on Dopaminergic Function in Early and Advanced Parkinson´s Disease. Annals of Neurology (1997) 41, 334 - 340.
  28. Kälkner, K.-M., Nilsson, S., Bergström, M., Lindner, K.-J., Westerberg, G., Långström, B. and Westlin, J.-E. PET with Hydroxytryptophan as Tracer in Hormone-Refractory Prostatic Adenocinoma: Evaluation of DecarboxylationIn Vivo. In Vivo (1997) 11, 377 - 382.
  29. Bergström, M., Westerberg, G. and Långström, B. [11C]Harmine as a tracer for Monoamine Oxidase A (MAO-A): In Vitro and In Vivo Studies. Nucl. Med. Biol. (1997) 24, 287 - 293.
  30. Bergström, M., Westerberg, G., Kihlberg, T. and Långström, B. Synthesis of 11C-Labelled MAO-A Inhibitors. In vivo Uptake Kinetics in Rhesus Monkey Brain. Nucl. Med. Biol. (1997) 24, 381 - 388.
  31. Sihver, W., Sihver, S., Bergström, M., Murata, T., Matsumura, K., Onoe, H., Andersson, Y., Bjurling, P., Fasth, K-.J., Westerberg, G., Ögren, M., Jacobson, G., Lundqvist, H., Oreland, L., Watanabe, Y. and Långström, B. Methodological Aspects of In Vitro Characterization of Receptor Binding Using 11C-labelled Receptor Ligands: A Detailed Study with the Benzodizepine Receptor Antagonist [11C]Ro 15-1788. Nucl. Med. Biol. (1997) 24, 723 - 731.
  32. Lindner, K.-J., Hartvig, P., Bjurling, P., Fasth, K.-J., Westerberg, G. and Långström, B. Determination of 5-Hydroxy-L-[beta-11C]tryptophan and In Vivo Formed Radiolabeled Metabolites in Brain Tissue Using High Performance Liquid Chromatography. A Study Supporting Radiotracer Kinetics Measured with Positron Emission Tomography. Nucl. Med. Biol. (1997), 24, 733 - 738.
  33. Andersson, J.L.R, Onoe, H., Hetta, J., Lidström, K., Valind, S., Lilja, A., Sundin, A., Fasth, K.-J., Westerberg, G., Broman, J.-E., Watanabe, Y. and Långström, B. Brain Networks Affected by Synchronised Sleep Visualised by Positron Emission Tomography. J.Cereb. Blood Flow (1998), 18, 701 - 715.
  34. Bergström, B., Kumlien, E., Lilja, A., Tyrefors, N., Westerberg, G. and Långström, B. Temporal lobe Epilepsy Visualized with PET with 11C-L-Deuterium-Deprenyl - Analysis of Kinetic Data. Acta Neorol. Scand. (1998), 98, 224 - 231.
  35. Wiesel, F.-A., Andersson, J.R., Westerberg, G., Wieselgren, I.-M., Bjerkenstedt, L., Hagenfeldt, L. and Långström, B. Tyrosine Transport is Differently Regulated in Patients with Schizophrenia.Schizophrenia Res. (1999), 40, 37 – 42.
  36. Bergström, M., Cass, L.M.R., Valind, S., Westerberg, G., Lundberg, E.L., Gray, S., Bye, A. and Långstrom B. Deposition and Disposition of [11C]Zanamivir Following Administration as an Intranasal Spray - Evaluation with Positron Emission Tomography. Clinical Pharmacokinetics (1999), 36, 33-39.
  37. Westerberg, G., Carr, R.M., Långström, B. and Sutherland, D.R. Synthesis of (E)-3-[2-([1-11C]phenylcarbamoyl)ethenyl]-4,6-dichloroindole-2-carboxylic acid ([11C]GV150526A) - A Glycine Antagonist for the NMDA-Receptor Complex. J. Lab. Compd´s Radiopharm. (2000) 42, 339-346.
  38. Frykholm, P., Enblad, P., Valtysson, J., C:son Silander, H., Hillered, L., Persson, L., Olssson, Y., Ru Yu, W., Andersson, J., Westerberg, G., Watanabe, Y. and Långström, B. Sequential PET Studies of Temporary Middle Cerebral Artery Occlusion (MCAO) and Reperfusion in Primates. A Metabolic Threshold Discriminates Between Irreversible Ischemia and Penumbra. Eur J Clin Invest. 2000 Jul;30(7):600-7.
  39. Westerberg, G., Cheng, A.-P., Fellows, I. and Långström, B. Synthesis of a Selective COX-2 Inhibitor: 8-Acetyl-3-(4-Fluorophenyl)-2-(4-(Methylsulphonyl)Phenyl)-1-Aza-Indolizine ([11C]GR253035X). J. Lab. Compd´s Radiopharm. (2000) 42, 1161-1169.
  40. Lindqvist, U., Westerberg, G., Bergström, M., Torsteinsdottir, I., Gustafson, S., Sundin, A. and Långström, B. Liver Uptake of[11C]Hyaluronan Evaluated with Positron Emission Tomography in Patients with Alcoholic Liver Disease. Eur J Clin Invest. 2000 Jul;30(7):600-7.
  41. Westerberg G, Wiklund L. Beta-cyclodextrin reduces bioavailability of orally administered [3H]benzo[a]pyrene in the rat. J. Pharm Sci. 2005 Jan;94(1):114-9.
  42. Lamanna C, Bellini M, Padova A, Westerberg G, Maccari L. Straightforward recursive partitioning model for discarding insoluble compounds in the drug discovery process. J Med Chem. 2008 May 22;51(10):2891-7.
  43. Smith MR, Syed A, Lukacsovich T, Purcell J, Barbaro BA, Worthge SA, Wei SR, Pollio G, Magnoni L, Scali C, Massai L, Franceschini D, Camarri M, Gianfriddo M, Diodato E, Thomas R, Gokce O, Tabrizi SJ, Caricasole A, Landwehrmeyer B, Menalled L, Murphy C, Ramboz S, Luthi-Carter R, Westerberg G, Marsh JL. A potent and selective Sirtuin 1 inhibitor alleviates pathology in multiple animal and cell models of Huntington's disease. Hum. Mol. Genet. 2014; 23(11):2995-3007.
  44. Westerberg, G, Chiesa, JAL, Andersen, CA, Diamanti, D, Magnoni, L, Pollio, G, Darpo, B and Zhou, M. Safety, Pharmacokinetics, Pharmacogenomics and QT Concentration Effect Modelling of the SirT1 Inhibitor Selisistat in Healthy Volunteers. British Journal of Clinical Pharmacology, 2014; 79(3): 477-491.
  45. Süssmuth, SD, Haider, S, Landwehrmeyer, GB, Farmer, R, Frost, C, Tripepi, G, Andersen, CA, Di Bacco, M, Lamanna, C, Diodato, E, Massai, L, Diamanti, D, Mori, E, Magnoni, L, Dreyhaupt, J, Schiefele, K, Craufurd, D, Saft, C, Rudzinska, M, Ryglewicz, D, Orth, M, Brzozy, S, Baran, A, Pollio, G, Andre, R, Tabrizi, SJ, Darpo, B, Westerberg, G. An exploratory double-blind, randomized clinical trial with selisistat, a SirT1 inhibitor, in patients with Huntington's disease. British Journal of Clinical Pharmacology, 2014; 79(3): 465-476.

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