Dr Georgina Meneses-Lorente, clinical pharmacologist, Roche Products Ltd
What do you do? and what is a typical week for you?
I am a clinical pharmacologist at Roche, UK and work in the oncology ClinPharm group. I lead the ClinPharm strategy for various projects for both early and late phase products.
I am currently working on the filing for new indications for an approved product. This involves various filing and health authority meetings. I lead the ClinPharm subteam for the different projects I am responsible for, working together with pharmacometricians and disease modelers. This enables a balanced quantitative pharmacology strategy on these projects.
A typical week involves a range of activities from presenting at team meetings, analysing data, writing/reviewing briefing packages, updating Investigator’s Brochures (IBs) and working closely with the modelers to ensure the modelling and simulation (M&S) aspects of the projects are delivered on schedule.
What qualifications and experience do you have?
A clinical pharmacology MSc and then PhD. I have multiple peer reviewed publications and more than 20 years’ experience in the pharmaceutical industry. Experience includes clinical protocol design, writing and implementation, contributions to key documents including regulatory submissions and assessment of project results and liaison with project leaders and scientists from multi-disciplinary teams. I worked for nine years in the drug metabolism and pharmacokinetics department at Merck & Co, UK, before joining Roche.
Extensive knowledge of drug metabolism and pharmacokinetics concepts in drug discovery and clinical development and extensive knowledge of monoclonal antibodies. Experience also includes filing activities including attending health authority meetings both USA and European meetings in the filing of obinutuzumab in CD20 malignancies.
What’s the most interesting aspect of your job?
I am always eager to see emerging data from the various oncology trials I work on. Understanding the exposure/efficacy/safety variability to ensure that patients would be properly dosed to ensure maximum benefit and minimum risk. In the past years I have really enjoyed the implementation of systems biology on the different projects I work on. While empirical models are extremely useful to understand the variability observed across patients, disease modeling is becoming another important piece of the puzzle. Such approaches would help to tease out differences among diseases, even when expressing the same target.
I enjoy interacting with teams and the different functions to fully implement the strategic component of drug development and how that fits with ClinPharm aspects. I like working on the various documents for filing purposes since this is the time when a comprehensive assessment of all the data takes place. In addition, it gives the opportunity to be on the shoes of the regulators and start thinking about potential questions that would need to be addressed.
I like being involved in multiple projects at different stages of drug development as this gives me a wider perspective of the process.
What are your research interests?
I have worked in oncology for the last ten years so this has become my specialist topic, but all disease areas are of interest to me.
My role allows me to work on the profiles of a drug as a result of its mechanism [variability] for the diseases. This is the key to deliver better treatments and optimised dosing/regimens to specific patient populations.
What one piece of advice would you give to someone seeking a career in clinical pharmacology?
Clinical pharmacology is a complex subject as we need to understand a wide range of disciplines, from basic science to what makes a medicine marketable. We interact with functions such as discovery; toxicology; DMPK; technical; science; safety; modeling; stats; regulatory to ensure we deliver a comprehensive labelling package when a NME [new molecule entity] becomes a medicine.
My advice is to remember that ClinPharm is an evolving subject.
My suggestion is to get a PhD in either clinical pharmacology or quantitative pharmacology since it is an important component for clinical pharmacology.