Lisa is a Medical Advisor, with extensive experience in the scientific and regulatory requirements of clinical drug development in the EU and UK. Her expertise covers all therapy areas and all trial phases, but with specific expertise in first-in-human trials, rare diseases and novel trial designs (platform trials and decentralised trials).
Key Areas Of Expertise
- Comprehensive knowledge of regulatory requirements and procedures (scientific advice / protocol assistance; clinical trial applications, paediatric drug development; risk assessment and management activities), with a focus on UK, and for various kinds of medicinal products (including new chemical entities, biologics and advanced therapeutic products) in various therapeutic areas
- Broad experience in supporting early to late-stage (global) clinical development
- Provision of scientific advice to external stakeholders in over 300 meetings, including scientific advice, regulatory advice, broad scope meetings, Innovation Office meetings
- Analysis and evaluation of clinical development programmes, clinical dossiers, (clinical pharmacology / efficacy / safety databases) for clinical–regulatory purposes, covering a wide range of products and therapeutic areas and comprising pre-, peri- and post-approval stages
- Drug safety evaluation and pharmacovigilance activities on the basis of clinical trial data
- Knowledge of the use of Patient Reported Outcomes during clinical drug development
Specialist Interests
- ATMPs, Gene Therapies, Rare Diseases
- Paediatrics
- Novel Trial designs
- Patient engagement strategies and Patient Reported Outcomes
Before NDA
Before joining NDA, Lisa worked for the MHRA (2013-2022) where she was a Senior Medical Assessor in the Clinical Trials Unit. At the MHRA Lisa held the following leadership roles:
- Regulatory medical lead for developing and implementing the combined ways of working (CWoW) process and implementing the new regulation, with the Health Research Authority (HRA).
- Assessor lead for the MHRA CTU response to COVID-19, implementing a pre-assessment service, collaborating with the NIHR and HRA, assessing COVID trials (presenting to the Expert Advisory Group and the Commission of Human Medicines) as well as representing the UK regulator in global regulatory forums for COVID-19.
- Co-chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) 'Public Health Emergency Clinical Trials Working Group’ to collaborate, based on existing experience, on the development of a template protocol for platform trials.
- MHRA regulatory clinical trials lead on the Shared Commitment to Public Involvement with the HRA developing a joint guidance document on ‘Diversity and Inclusivity in clinical trials’.
- Representing the MHRA as part of the Association of the British Pharmaceutical Industry (ABPI) Maternal Health Project, promoting the inclusion of pregnant and breast-feeding women in clinical drug trials.
Prior to working for the MHRA Lisa worked for 12 years as a practicing medical Doctor in the UK, her specialty training was in Obstetrics and Gynaecology. In addition to her basic medical training she holds a MD in the area of Diabetes in Pregnancy, awarded by the University of Wales, Cardiff.
Lisa also worked as a medical advisor for Alliance Pharmaceuticals in the clinical area of induction of labour.
Recent Publications
Cruz Rivera, Samantha, Olalekan Lee Aiyegbusi, Jonathan Ives, Heather Draper, Rebecca Mercieca-Bebber, Carolyn Ells, Amanda Hunn, Jane A Scott, Conrad V Fernandez, Andrew P Dickens, Nicola Anderson, Vishal Bhatnagar, Andrew Bottomley, Lisa Campbell, […] Melanie J Calvert. 2022. ‘Ethical considerations for the inclusion of patient-reported outcomes in clinical research: The PRO ethics guidelines’, JAMA.
Retzer, Ameeta, Olalekan Lee Aiyegbusi, Anna Rowe, Philip N. Newsome, Jessica Douglas-Pugh, Sheeba Khan, Saloni Mittal, Roger Wilson, Daniel O’Connor, Lisa Campbell, Sandra A. Mitchell, and Melanie Calvert. 2022. 'The value of patient-reported outcomes in early-phase clinical trials', Nature Medicine, 28: 18-20.
Calvert, Melanie J., Samantha Cruz Rivera, Ameeta Retzer, Sarah E. Hughes, Lisa Campbell, Barbara Molony-Oates, Olalekan Lee Aiyegbusi, Angela M. Stover, Roger Wilson, Christel McMullan, Nicola E. Anderson, Grace M. Turner, Elin Haf Davies, Rav Verdi, Galina Velikova, Paul Kamudoni, Syed Muslim, Adrian Gheorghe, Daniel O’Connor, Xiaoxuan Liu, Albert W. Wu, and Alastair K. Denniston. 2022. 'Patient reported outcome assessment must be inclusive and equitable', Nature Medicine.
Calvert, Melanie, Madeleine King, Rebecca Mercieca-Bebber, Olalekan Aiyegbusi, Derek Kyte, Anita Slade, An-Wen Chan, Ethan Basch, Jill Bell, Antonia Bennett, […] Daniel O’Connor, Lisa Campbell […]. 2021. 'SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials', BMJ Open, 11: e045105.
Aaron M. Orkin, MD, MSc, MPH; Peter J. Gill, MD, DPhil; Davina Ghersi, MD, PhD; Lisa Campbell, MD, MBBCh, BSc;et al, June 21, 2021. Guidelines for Reporting Trial Protocols and Completed ‘Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances’ The CONSERVE 2021 Statement
Calvert, Melanie, Derek Kyte, Rebecca Mercieca-Bebber, Anita Slade, An-Wen Chan, Madeleine T. King, and the SPIRIT-PRO Group. 2018. 'Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension', JAMA, 319: 483-94.
