Lung Imaging in Inhaled Product Development. Lea Ann Dailey, PhD DDL 05 December 2012

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1 Lung Imaging in Inhaled Product Development Lea Ann Dailey, PhD DDL 05 December 2012

2 The Drugs in the Lung Consortium Network Data Sharing Research King s College London GSK Pfizer Novartis Astra Zeneca Boehringer Ingelheim An Agenda for Open Innovation

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6 Advances in Imaging Science and their Application to Oral Inhaled Product Development

7 Advances in Imaging Science and their Application to Oral Inhaled Product Development Understanding & monitoring lung disease Biomarker development Measuring and modelling lung deposition Monitoring effects of therapeutic intervention Challenges Clinical Imaging Pre-clinical Imaging New Techniques

8 Advances in Clinical Imaging Science - Biomarker Development Dr. Phil Murphy, GSK Examples 18 FDG-PET -Neutrophil infiltration -COPD HRCT - Airway dimensions -COPD MRI -Regional air trapping -Asthma fmri -Dyspnea

9 Advances in Clinical Imaging Science - Measuring and Monitoring Deposition Dr. Omar Usmani, NHLI Efforts to harmonise 2D-γ scintigraphy image analysis for clinical use Biddiscombe et al (2011)

10 Advances in Clinical Imaging Science - Measuring and Monitoring Deposition Dr. Deborah Bickmann, Boehringer Ingelheim In vitro deposition Anatomical throat piece + NGI IVIVC Published γ- scintigraphy studies

11 Advances in Pre-Clinical Imaging Science - Model & Biomarker Development Dr. Sally Sharpe, UK HPA

12 Advances in Pre-Clinical Imaging Science - Model & Biomarker Development Dr. Anna Morgan, Novartis Babin AL et al., J Magn Reson Imaging 2011; 33:

13 Advances in Pre-Clinical Imaging Science - Biomarker Development & Deposition Studies Dr. Kumar Changani, GSK Animal model refinement through non-invasive imaging

14 Advances in Pre-Clinical Imaging Science - Biomarker Development & Deposition Studies Dr. Kumar Changani, GSK Preclinical and clinical disease How do they manifest themselves differently? Can clinical imaging inform pre-clinical model development? How does delivery correlate with efficacy / retention / absorption? What are the effects of formulation on deposition and efficacy? How does preclinical delivery correlate with clinical reality? Does disease type and severity have implications on delivery to the site of action?

15 Advances in Ex-Vivo Imaging Science - Biomarker development using FTIR imaging Dr. Christoph Krafft, Institute of Photonics, Jena, Germany

16 Advances in Ex-Vivo Imaging Science - Deposition studies using MS imaging Prof. Per Andren, University of Uppsala

17 Advances in Imaging Science and their Application to Oral Inhaled Product Development Advantages Help to bridge the gap between clinical and pre-clinical studies Evaluate normal tissue state, diseased state, and effect of therapeutic intervention Non-invasive Allows longitudinal studies Refinement of animal usage Limitations Use of radiolabels in some techniques Costly and restricted accessibility Much work to be done comparing preclinical models of delivery with clinical reality

18 Advances in Imaging Science and their Application to Oral Inhaled Product Development Lea Ann Dailey 1*, Per Andren 2, Anna Morgan 3, Nicolau Beckmann 3, Deborah Bickmann 4, Kumar Changani 5, Lena Gustavsson 6, Christoph Krafft 7, Ruth Lock 8, Janet Maas 8, Phil Murphy 5, Gary Pitcairn 9, Sally Sharpe 10, Omar Usmani 11, Ben Forbes 1 1 King s College London, Institute of Pharmaceutical Science, UK 2 University of Uppsala, Sweden 3 Novartis Basel, Switzerland 4 Boehringer Ingelheim Pharma, Ingelheim, Germany 5 GlaxoSmithKline R & D, UK 6 University of Lund, Sweden 7 Institute of Photonic Technology, Germany, 8 Novartis Horsham Research Centre, UK 9 Pfizer R & D, UK 10 Health Protection Agency, Porton Down, UK 11 National Heart and Lung Institute, Imperial College, London, UK

19 Advances in Imaging Science and their Application to Oral Inhaled Product Development Understanding & monitoring lung disease Biomarker development Measuring and modelling lung deposition Monitoring effects of therapeutic intervention Challenges Clinical Imaging Pre-clinical Imaging New Techniques

20 Acknowledgements Speakers: Per Andren Nicolau Beckmann Deborah Bickmann Kumar Changani Christoph Krafft Anna Morgan Phil Murphy Sally Sharpe Omar Usmani Chairs and organisers: Ben Forbes Lena Gustavsson Ruth Lock Janet Maas Gary Pitcairn Organisations: Drugs in the Lungs APSGB Novartis DDL