Global Health Commentary
Current Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective

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Abstract

The chairs of each of the 8 Special Interest Groups of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation have compiled opinions with regard to major challenges for the pharmaceutical sciences over the next 5-10 years. Areas covered are drug design and discovery, natural products, formulation design and pharmaceutical technology, pharmacokinetics/pharmacodynamics and systems pharmacology, translational and personalized medicine, biotechnology, analytical sciences and quality control, and regulatory science.

Introduction

The International Pharmaceutical Federation (FIP) is a global organization representing 2 million pharmacists and pharmaceutical scientists, with 137 member groups, including the American Association of Pharmaceutical Scientists. It sets standards through professional and scientific guidelines, policy statements and declarations, as well as by collaboration with other international organizations, including the World Health Organization (WHO).

In 2007, the President of FIP commissioned its Board of Pharmaceutical Sciences (BPS) to develop an article on the impact of pharmaceutical sciences, a reflection on progress over the last 50 years.1 The aim was to acquaint fellow scientists with the contributions of pharmaceutical scientists and to increase awareness of the role that they have played in improving health care. Based on this review, a concise flyer was also produced to stimulate interest in the pharmaceutical sciences as a career choice for graduates.2 Having looked back at past achievements, BPS now looks forward in an attempt to identify the main challenges across the spectrum of activities that comprises the pharmaceutical sciences.

Whereas the impact article was prepared by individuals who had witnessed the development of the pharmaceutical sciences over much of the last 50 years, the main contemporary challenges have been addressed in this article by a mostly younger generation. Accordingly, the chairs of each of the BPS Special Interest Groups (SIGs) were invited to seek the opinions of 5-10 global opinion leaders in their area as to the main issues and to use their responses to identify up to 5 key challenges. Currently, there are 8 SIGs with global outreach within FIP, namely Drug Design and Discovery, Natural Products, Formulation Design and Pharmaceutical Technology, Pharmacokinetics or Pharmacodynamics and Systems Pharmacology, Translational and Personalized Medicine, Biotechnology, Analytical Sciences and Quality Control, and Regulatory Science. It should be noted that other areas such as drug metabolism, pharmacoeconomics, pharmacovigilance, and social and behavioral sciences are not represented as SIGs. Together with the Board of Pharmaceutical Practice within FIP, BPS is currently seeking to establish joint interest groups around the last 3 areas.

Section snippets

New Anti-Infective Drugs

For several years now, the world has been confronted with the rapid evolution of bacteria and other microorganisms resistant to current antimicrobial treatment (e.g., methicillin-resistant Staphylococcus aureus and carbapenem-resistant Klebsiella pneumonia), many being unaffected by more than one compound. Once the efficacy of “reserve” antibiotics such as teicoplanin has been overcome, patients will begin to die and, indeed, are already dying from otherwise easily treatable conditions such as

Production and Evaluation of the Quality of Source Plants and Identification of Their Constituents

A systematic approach to standardization of the cultivation of plant sources for natural products and the identification of their constituents will require increasing application of modern techniques in plant biology, agricultural sciences, genomics, molecular biology, and analytical and information sciences. This should lead to improvements in the sustainability and appropriate use of limited natural resources and the discovery of compounds with new therapeutic applications. Metabolomics will

Continuous Manufacture

Conventionally, large-scale production of medicines that are compliant with Good Manufacturing Practice involves a series of single steps or reactions followed by batch-specific, downstream processes. To improve control over quality and to enhance process safety as well as to reduce costs and time to market, the pharmaceutical industry is exploring fully continuous end-to-end processing.14 This implies that active pharmaceutical ingredients (APIs) are processed together with excipients, which

Physiologically Based Pharmacokinetic Modeling

The application of physiologically based pharmacokinetic (PBPK) modeling has come of age in drug development and regulation, reflecting significant advances over the last 15 years in the predictability of key pharmacokinetic parameters from physical chemistry and human in vitro data and in the availability of dedicated software platforms and associated databases.33 However, although PBPK or PD modeling is more popular today than at any other time, significant challenges remain for its effective

The Clinical Value of Genetic Testing

A persistent challenge for the implementation of pharmacogenetic testing is the issue of its cost-benefit. Because the clinical value of such testing is affected by various medical, social, and financial factors, the cost-benefit balance varies between countries such that it is difficult to achieve international consensus.39 Tests may be divided into those that aid the selection of drug and those that aid in selecting its dosage. In general, implementation of the former has been more

New Therapeutic Advances

In the past 20 years, some of the most important therapeutic advances have involved the development of biological agents that enable the manipulation of disease pathways in a manner not possible with traditional small drug molecules. Biologics now represent 25% of new drug approvals.47 More recently, there has been a coming together of biologics and small drug molecules to exploit the advantages of each type of molecule. Because biologics can provide a highly selective capacity for drug

High-Throughput Screening

Current analytical tools such as automatic liquid handling systems are expensive to set up, run, and maintain. Therefore, a significant analytical challenge is to run screening assays with higher capacity, increased speed, and lower quantities of biological material. Further development of miniaturized systems with greater numbers of wells is anticipated, along with increased application of acoustic pipetting techniques for library transfers, microfluidics, and microarray printing.

New Analytical Methods

Improvements

The Biopharmaceutical Classification Scheme

Differences between regulatory agencies with regard to the definition of compound characteristics need to be harmonized to clarify the Biopharmaceutical Classification Scheme (BCS).53, 54, 55 Although the European Medicines Agency (EMA) defines “highly soluble” with respect to “the highest single dose” recommended in prescribers' information, the US FDA refers to the “highest dosage strength” available on the market. This discrepancy causes an issue with the classification of drugs that can

Epilogue

The challenges identified herein inevitably represent the opinions of a relatively small group of individuals, and not everyone will agree with them as priorities. Nevertheless, we submit that they are key issues for the pharmaceutical sciences to ponder and act on over the next 5 years. Predicting the future longer term is more difficult, especially as the gap between idea and implementation is often underestimated. Although further integration of the pharmaceutical sciences with

Acknowledgments

The authors are grateful to the individuals whose opinions were solicited with respect to each SIG area.

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