As Vice President for Regulatory Affairs, I lead a global team responsible for the regulatory activities relating to our respiratory and immunology treatments. My team works with colleagues across R&D – from early discovery science through to late-stage development, including supporting clinical trials – to ensure that our medicines have the highest quality evidence required to gain approval by international regulatory bodies. 

It is our responsibility to apply innovative regulatory strategies to our respiratory & immunology pipeline, so that life-changing medicines can reach patients as quickly as possible. 

I joined AstraZeneca in 2020, and since then I have been very impressed by our exciting pipeline: from vaccine development to our longstanding leadership in asthma and COPD research, and more recently our ambition to apply our strengths in respiratory research to the treatment of a wide range of immunology diseases. 

Before this role, I spent 10 years at GSK as Medicine Development Leader for respiratory medicines. I initially trained as a pharmacist and did a Ph.D. in Pharmaceutical Sciences  before beginning my career at GSK. Before my Medicine Development Leader role, I took on numerous and diverse Regulatory Affairs roles. I love roles where you can work with everyone across R&D – scientists discovering the molecules and development scientists producing the medicine, but also commercial colleagues who enable patients to gain access to our life changing medicines.

Late-stage Respiratory and Immunology R&D is such a fantastic place to work in regulatory affairs. We follow the science and challenge each other to think creatively when it comes to finding solutions – all working together to develop treatments that address the huge unmet needs facing patients today.

Christine Elaine Jones Vice President, Regulatory Affairs, Late Respiratory & Immunology R&D, AstraZeneca

CURRENT ROLE

Vice President, Regulatory Affairs, Late Respiratory & Immunology R&D, AstraZeneca

Joined AstraZeneca in 2020

Joined AstraZeneca, heading up Respiratory and Immunology Regulatory Affairs – it was an incredible privilege to work on once-in-a-lifetime development programs underway at the time.

Appointed as a GSK Medicine Development Leader in 2009

Strategically led optimal global medicine development programs from phase 2 to market and managed life cycle development.

Senior regulatory leadership role in 2004

Appointed as Vice President Regulatory Affairs for Respiratory, Allergy & Dermatology franchises for GSK.

Appointed to the first of many and diverse roles in Regulatory Affairs in 1992.

First in the global labeling group. Followed by regulatory strategic roles in the UK and the USA and US advertising and labeling regulatory policy.

Joined Glaxo Pharmaceuticals in 1989

As a Medical Representative – the start of the most rewarding career.

Scientific Publications

Once-Daily Single Inhaler Triple Versus Dual Therapy in Patients with COPD

David A. Lipson, Frank Barnhart, Noushin Brealey, Jean Brooks, Gerard Criner, Nicola Day, Mark Dransfield, David Halpin, Meilan Han, C Elaine Jones, Sally Kilbride, Peter Lange, David Lomas, Fernando J. Martinez, David Singh, Maggie Tabberer, Bob Wise, Steven J. Pascoe                     
New England Journal of Medicine (May 2018)

DOI: 10.1056/NEJMoa1713901

http://www.nejm.org/doi/full/10.1056/NEJMoa1713901

The Effect of ICS Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study: A Randomized, Double-blind Multicenter Trial

MeiLan K. Han, Gerard J. Criner, Mark T. Dransfield, David M.G. Halpin, C. Elaine Jones, Sally Kilbride, Peter Lange, Sally Lettis, David Lipson, David Lomas, Neil Martin, Robert Wise, Dave Singh, Fernando Martinez                        
American Journal of Respiratory and Critical Care Medicine (June 2020)

DOI: 10.1164/rccm.201912-2478OC

http://pubmed.ncbi.nlm.nih.gov/32584168/

Single-inhaler triple therapy fluticasone furoate/umeclidinium/ vilanterol versus fluticasone furoate/vilanterol and umeclidinium/ vilanterol in patients with COPD: Results on cardiovascular safety from the IMPACT trial

Nicola C. Day, Subramanya Kumar, Gerard J. Criner, Mark T. Dransfield, David M.G. Halpin, MeiLan K. Han, C. Elaine Jones, Morrys C. Kaisermann, Sally Kilbride, Peter Lange, David A. Lomas, Neil Martin, Fernando J. Martinez, Dave Singh, Robert Wise, David A. Lipson
Respiratory Research (June 2020)

DOI: 10.1186/s12931-020-01398-w

http://pubmed.ncbi.nlm.nih.gov/32503599/

Reduction in all-cause mortality with fluticasone furoate/umeclidinium/vilanterol in COPD patients

David A. Lipson, Courtney Crim, Gerard J. Criner, Nicola C. Day, Mark T. Dransfield, David M.G. Halpin, Meilan K. Han, C. Elaine Jones, Sally Kilbride, Peter Lange, David A. Lomas, Sally Lettis, Pamela Manchester, Neil Martin, Dawn Midwinter, Andrea Morris, Steven J. Pascoe, Dave Singh, Robert A. Wise, Fernando J. Martinez                   
American Journal of Respiratory and Critical Care Medicine (June 2020)

doi: 10.1164/rccm.201911-2207OC

http://pubmed.ncbi.nlm.nih.gov/32162970/

Comparison of LAMA/LABA vs ICS/LABA in high risk COPD patients: Pre-specified analysis on lung function and health status from the IMPACT trial

David A Lipson, Frank Barnhart, Isabelle Boucot, Courtney Crim, Noushin Brealey, Gerard J Criner, Mark Dransfield, David M.G Halpin, Sally Kilbride, Meilan K Han, Peter Lange, David A Lomas, Fernando J Martinez, Dave Singh, Ian Naya Naya, Christine Elaine Jones, Robert Wise. European Respiratory Journal 52 (November 2019)

doi.org/10.1183/13993003.congress-2018.PA4385

http://erj.ersjournals.com/content/52/suppl_62/PA4385.article-info