Global Health CommentaryCurrent Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective
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.
References (67)
- et al.
Impact of the pharmaceutical sciences on health care: a reflection over the past 50 years
J Pharm Sci
(2012) - et al.
Systems biology and systems chemistry: new directions for drug discovery
Chem Biol
(2012) - et al.
The threshold of toxicological concern (TTC) in risk assessment
Toxicol Lett
(2008) - et al.
Achieving continuous manufacturing: technologies and approaches for synthesis, workup, and isolation of drug substance. May 20-21, 2014 Continuous Manufacturing Symposium
J Pharm Sci
(2015) - et al.
Process analytical technology for continuous manufacturing of solid-dosage forms
Trac Trend Anal Chem
(2015) - et al.
The business impact of an integrated continuous biomanufacturing platform for recombinant protein production
J Biotechnol
(2015) - et al.
The future of pharmaceutical manufacturing sciences
J Pharm Sci
(2015) Continuous downstream processing of biopharmaceuticals
Trends Biotechnol
(2013)- et al.
Lopez-Berestein Preclinical and clinical development of siRNA-based therapeutics
Adv Drug Deliv Rev
(2015) - et al.
Agile delivery, of protein therapeutics to CNS
J Control Release
(2014)
Formulation design of dry powders for inhalation
J Pharm Sci
Highlights of recent developments and trends in cancer nanotechnology research–view from NC Alliance for Nanotechnology in Cancer
Biotechnol Adv
Tailored functionalization of iron oxide nanoparticles for MRI, drug delivery, magnetic separation and immobilization of biosubstances
Biotechnol Adv
Perspective: concepts of printing technologies for oral film formulations
Int J Pharm
Excipient variability and its impact on dosage form functionality
J Pharm Sci
Excipient pharmacokinetics and profiling
Int J Pharm
Current methodological issues in the economic assessment of personalized medicine
Value Health
Mapping the incidentalome: estimating incidental findings generated through clinical pharmacogenomics testing
Genet Med
The developability classification system. Applications of biopharmaceutics concepts to formulation development
J Pharm Sci
Oral biopharmaceutics tools—time for a new initiative—an introduction to the IMI project OrBiTo
Eur J Pharm Sci
Use of physiologically based pharmacokinetic models to assess the clinical relevance of current bioequivalence criteria for generic drug products containing ibuprofen
J Pharm Sci
The European Medicine's Agency's strategies to meet the challenges of Alzheimer disease
Nat Rev Drug Discov
WIREs Nanobiotechnol
Epigenetic protein families: a new frontier for drug discovery
Nat Rev Drug Discov
Organs-on-chips at the frontiers of drug discovery
Nat Rev Drug Discov
Human tissue research for drug discovery
The use of induced pluripotent stem cells in drug development
Clin Pharmacol Ther
Achieving continuous manufacturing for final dosage formation: challenges and how to meet them. May 20-21, 2014 Continuous Manufacturing Symposium
J Pharm Sci
The changing model of big pharma: impact of key trends
Drug Discov Today
Cited by (22)
Unmet Medical Need as a Driver for Pharmaceutical Sciences – A Survey Among Scientists
2022, Journal of Pharmaceutical SciencesCitation Excerpt :Surgical treatment of peptic and duodenal ulcers despite its associated risks was relatively common before the introduction of the proton pump inhibitors.5 Many more examples of how in the past, pharmaceutical scientists have been fundamental in enabling innovative therapeutic options for patients regionally and globally.6 But many of these advances started rather at the lab bench than in the clinic.
Preparation of aerogel beads and microspheres based on chitosan and cellulose for drug delivery: A review
2021, International Journal of Biological MacromoleculesCitation Excerpt :Among the polysaccharides used in aerogels, chitosan and cellulose have gained quite considerable interest for manufacturing aerogels and most of aerogels based on chitosan and cellulose are fabricated in the form of monoliths which is simply because of easy preparation on laboratory scale, however, the discussion on a novel aerogel formulation in the spherical shape for biomedical applications is constrained. More impressively, the use of these aerogels with the spherical shape combined with drugs enables a subsequent reliable therapeutic effect [34,35]. López-Iglesias et al. [36] reported that the vancomycin loaded chitosan aerogel beads were fabricated through the sol-gel approach followed by drying the gel beads with supercritical CO2 (scCO2) technology and then they were measured as a potential formulation to treat and prevent infections at the wound site.
Excipients used in oral nanocarrier-based formulations
2018, Fundamentals of Nanoparticles: Classifications, Synthesis Methods, Properties and Characterization3D printed tablets loaded with polymeric nanocapsules: An innovative approach to produce customized drug delivery systems
2017, International Journal of PharmaceuticsCitation Excerpt :Among the available techniques, FDM printing has some important advantages, such as low cost, no need for organic solvents, the feasibility of blending of drugs and polymeric materials in a prior hot-melt extrusion step (Jonathan and Karim, 2016), the ability to manufacture of multidrug devices (Goyanes et al., 2015b), the modulation of drug release profiles through shape and density (Goyanes et al., 2014), the preparation of devices from FDA GRAS (Generally Recognized as Safe) raw materials (Pietrzak et al., 2015; Melocchi et al., 2016) as well as the feasibility to produce customizable drug delivery devices for personalised medicine (Choonara et al., 2016; Tucker et al., 2016). Personalised medicine covers the individualisation of the drug therapy, dosing intervals, drug combinations and drug release rate, taking into account an individual’s differences in genome, metabolic functions, patient groups, coexisting diseases and the need of multiple drugs (Alomari et al., 2015; Tucker et al., 2016). On the other hand, nanotechnology has been an important tool for the development of novel drug delivery systems (Bobo et al., 2016) and has great potential to transform medicine, including the realisation of personalised medicines (Herrmann and Rosslein, 2016).
Innovative approach for identifying root causes of glass defects in sterile drug product manufacturing
2017, European Journal of Pharmaceutical SciencesCitation Excerpt :Despite advantages inherent to other drug product types and application routes (e.g., transdermal, which usually takes advantage of the skin as a protective layer against infections caused by unsterile products or against complications triggered by particles), sterile drug products remain the preferred choice for biopharmaceutical products. This preference arises out of the insufficient capabilities of alternative routes in bringing macromolecules to the sites of action while remaining potent (Tucker et al., 2016). The administration of sterile drug products by injection or infusion releases drug product solutions directly into the bloodstream (Jameel et al., 2015).
Orodispersible films: Towards drug delivery in special populations
2017, International Journal of PharmaceuticsCitation Excerpt :The key challenges for electrospun fibers are their poor mechanical characteristics and poor handling characteristics that can impede downstream manufacturing (filling, flow, packaging) as well as intake by patient. Establishment of dedicated facilities for development and commercial scale production of personalised ODFs requires many techno-economic considerations (Rantanen and Khinast, 2015; Tucker et al., 2016). Some of them are: i) availability of manufacturing technologies and status of in terms of readiness for the industrialisation, ii) types of equipment, scale and cleaning/maintenance and possibility of scale up and scale down, iii) (critical) process parameters, process integration, control and monitoring, iv) batch versus continuous operations, v) throughput/capacity and vi) packaging.
Geoffrey Tucker is also Chair of the Board of Pharmaceutical Sciences of FIP.