Pharmaceutical Sciences Beyond 2020

The International Pharmaceutical Federation (FIP) held the 5^th Pharmaceutical Science World Congress (PSWC) in Melbourne for 2014. Co-sponsored by many of the world’s leading pharmaceutical science and educational organisations, the PSWC brought together the leading scientists from around the world in a discussion of cutting edge research. This discussion centred on the congress theme of the direction of ‘Pharmaceutical Science Beyond 2020’.

The FIP was founded in 1912 and represents more than three million pharmacists and pharmaceutical scientists worldwide. The global federation is a visible advocate for pharmacists as their roles change in the provision of healthcare, whilst still maintaining their grounding in the pharmaceutical sciences. The event attracts the best and most enthusiastic scientists in an interactive program designed to stimulate thought and transformation.

The congress provided a platform to shape the future direction of pharmaceutical science and draw knowledge from the research of international colleagues. The event offered the opportunity to listen to leading international authorities across multiple disciplines, including, but not limited to pharmaceutical science, pharmacoepidemiology, biochemistry and industry. Although a number of the presentations and poster exhibitions were very technical or departmental, many subjects readily applied to the practical aspects of pharmacy.

The simplistic definitions of ‘clinical pharmacist’ and ‘pharmaceutical scientist’ characterise practitioners according to whether they operate in pre-clinical or clinical domains. However, through a common interest in drug development, safety, and efficacy there is considerable overlap of effort; which may be considered as an opportunity to improve available drug regimens, and to implement adaptive strategies which improve health outcomes.

The need to focus knowledge from both professions is exemplified particularly in the areas of translational research and personalised medicine. The concept of personalised medicine has developed from the paradigm shift in the therapeutic relationship between health professionals and patients to patient-centred care. That is, the delivery of healthcare congruent to the patient’s needs and preferences, where personalised medicine stems from the definition to tailor therapeutics to the individual.

Pharmacists and pharmaceutical scientists are currently key players in promoting personalised medicines and it is this collaboration between practice and science in the expanding healthcare industry that can promote the integration of emerging scientific developments. ‘Translating’ the findings from basic science into useful applications that can enhance pharmacy practice and produce meaningful health outcomes is an urgent need.

One of the most important approaches towards more personalised medical care is the study of pharmacogenomics. This emerging science has had a significant effect in drug research as the basis for selecting the right drug for each patient. Molecular markers are used to select individuals with a differential benefit to specific therapies. In the case of high cost treatments, such as anti-EGFR antibodies, a predictive biomarker represents an opportunity to limit therapy to the subgroup of patients most likely to benefit.

Other examples include the testing of the HER-2 gene for breast and gastric cancer, the BRAF gene for melanoma, and the EGFR gene mutation for lung cancer; all of which demonstrate that the optimal clinical and economic performance of a proposed test and drug are interdependent.

However, personalised medicine faces some challenges in practice, such as the method reliability, the clinical research, the cost-benefit, and the ethics against its widespread uptake in society.

Themes elaborated upon during the congress included the heterogeneity of effect in pharmacogenetics, modifiers of genomic marker effects, association versus clinical utility, and economic drivers.

Although pharmacogenomics has had minimal impact in clinical practice to date, personalised prediction of a patient’s response to medical treatment illustrates this global goal in healthcare.

As drug therapy experts, pharmacists are in a unique position to explore the frontiers of pharmacogenetics in both the research and clinical practice environments. Specific roles for pharmacists are likely to fall within three major areas:

• Developing research methodologies and setting research directions
• Establishing the value of genetic testing in clinical practice, and
• Participating in education and infrastructure development that moves pharmacogenetic technologies toward implementation.

Studies of pharmacogenetic variability will require the evaluation of comprehensive repositories of clinical data during and after a clinical trial. Randomised controlled trials can be underpowered, or not designed, to assess the full range of adverse events applicable to the general heterogeneous population that the trial medicine is intended for.

In addition, the increased availability of large datasets for pharmacoepidemiological research from post-marketing surveillance represents an important opportunity for investigating exposure to multiple medications and optimisation of treatment regimens, further enhancing the potential for personalised medicine.

For example, adverse effects considered important to older people; including impaired cognition, hospitalisation and institutionalisation are not quantifiable from initial trial data owing to common exclusion criteria including age, polypharmacy and comorbidities. Most trials have a drug-specific focus without considering the whole drug regimen, including medication burden or multiple medical conditions.

Contributions by pharmacists to pharmacosurveillance systems are not limited to reporting episodic adverse drug reactions, but include as well the collection of data that complement longitudinal pharmacoepidemiological studies.

As greater emphasis is placed on the value of these databases, pharmacists will be increasingly called upon to conduct epidemiologic studies. Formalised training in the principles of epidemiology and biostatistics will allow pharmacists to expand their role in this important area of research.

The 5^th FIP Pharmaceutical Science World Congress gave an insight into the future direction of pharmacy practice and opportunities for direct engagement with global pharmaceutical science leaders. Both internal and external forces are steering the course of modern healthcare, and practitioners must consider their role in the progression of the industry.

The question is, in 2020 when we review our progress, will implemented new approaches keep up with the changing face of healthcare, and will these approaches lead to faster evaluation and more successful processes important in drug development?