Use of Artificial Intelligence in Drug Development.

This cross-sectional study investigates the scope and breadth of artificial intelligence use in drug development.

Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance.

BACKGROUND: Professional associations publish guidance advising gastroenterologists on prescribing biosimilars; however, guidelines differ between countries and change over time. This study aimed to map the presence and content of guidance from European gastroenterology associations on TNFα inhibitor biosimilar use and its development over time. RESEARCH DESIGN AND METHODS: Guidelines on biosimilar prescribing from national gastroenterology associations in the European Economic Area (EEA) partnered with the European Crohn's and Colitis Organization (ECCO) were collected. Treatment guidelines and biosimilar position papers from 2010 to 2022 were included. Data were extracted using a template. RESULTS: 26 of 30 EEA countries have an ECCO-partnered gastroenterology association, of which 14 (53.8%) had national guidelines addressing biosimilars, four (15.4%) followed ECCO's position, and three (11.6%) had treatment guidelines without mentioning biosimilars. From five countries (19.2%) no guidelines were retrieved. Among 18 countries with guidance, 14 (77.8%) associations endorsed initiating biological treatment with biosimilars, and 13 (72.2%) endorsed transitioning from originator to biosimilar. Nine associations published multiple guidelines over time addressing biosimilars; overall, their positions became more encouraging. CONCLUSIONS: The majority of gastroenterology associations endorsed biosimilar use. The lack of (up-to-date) guidelines for some associations indicates an area of improvement to support biosimilar use in clinical practice.

"Biosimilar, so it looks alike, but what does it mean?" A qualitative study of Danish patients' perceptions of biosimilars.

Biosimilars are highly similar follow-on products for biologics that can foster biologics competition. Questionnaire studies have attempted to gauge the patient perspective on biosimilars, but none have delved deeper into how patients view biologics and switching of these. Considering Denmark has one of the highest biosimilar uptakes worldwide, the aim of this study was to investigate how Danish patients with psoriasis, arthritic diseases or inflammatory bowel disease perceive biosimilars. Twelve participants were semi-structurally interviewed in either a focus group or an internet-based, individual interview between May 2019 and July 2019. Content analysis was inductively applied. Participants on originators voiced more reluctance towards using biosimilars than those already using them. Both participants using originator and biosimilar products expressed concerns about reoccurrence of disease symptoms due to differences in effectiveness and safety. Participants generally struggled with understanding biosimilarity, and they voiced a need to be well-informed about switching. They were all aware of and accepted how healthcare budget restrictions played a role in the push to use biosimilars. To improve biosimilar uptake and willingness to switch to a biosimilar, patient-centred information on efficacy and safety and explanation of the societal benefits of the savings from using biosimilars must be carefully communicated.

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.

Collaboration in times of crisis: A study on COVID-19 vaccine R&D partnerships.

Collaboration is central for initiatives and efforts in the race to fight COVID-19, with particular focus on fostering rapid development of safe and effective COVID-19 vaccines. We investigated the types of partnerships that have emerged during the pandemic to develop these products. Using the World Health Organization's list of COVID-19 vaccine developments, we found nearly one third of all vaccine candidates were developed by partnerships, which tended to use next-gen vaccine platforms more than solo efforts. These partnerships vary substantially between materials-transfer partnerships and knowledge-sharing partnerships. The difference is important: The type of sharing between partners not only shapes the collaboration, but also bears implications for knowledge and technology development in the field and more broadly. Policies promoting fair and effective collaboration and knowledge-sharing are key for public health to avoid stumbling blocks for vaccine development, deployment, and equitable access, both for COVID-19 and expected future pandemics.

Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.

BACKGROUND: A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics. OBJECTIVE: The aim was to determine the perceptions of industry and medicines agency regulators regarding the value, necessity, and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity. METHODS: Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis. RESULTS: In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician's trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs. CONCLUSION: The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.

More than meets the eye: A Foucauldian perspective on treating ADHD with medicine.

BACKGROUND: Decision-making for using medicine treatment of attention-deficit hyperactivity disorder (ADHD) is complex. OBJECTIVE: The aim of this study is to investigate decision-making about ADHD medicine and its use among young adults with ADHD by exploring and analysing their beliefs, experiences and behaviours from a Foucauldian perspective. METHODS: Participants were recruited using convenience sampling. In-depth individual interviews were conducted with 7 participants, and 4 participated in a focus group; 1 took part in both. The interviewees were aged 22-29. Data were collected in Denmark from March to August 2016. RESULTS: Deductive analysis identified the sociological, bio-psychosocial and biomedical discourses as falsified, present and dominant, respectively. In a Foucauldian perspective, ADHD medicine use seems to be a disciplinary act intended to make the individual change his/her 'undesirable' ADHD behaviour. Interviewees' descriptions show power as operating internally in the form of self-monitoring in an attempt at normalisation, as well as externally through society's subjectification of them as young adults with ADHD. Although resistance towards using medicine as ADHD treatment existed, it was sparse. CONCLUSIONS: The findings show that what may appear to be the choice of an individual on the surface can also be seen as a complex interaction of networks of power. Further, that medicine adherence also can appear to be disciplinary. Pharmacists can use these findings to improve how advice-giving about ADHD medicine may be perceived by young adults with ADHD.

Mandatory medication content in the curricula of six health care personnel types with patient contact in Denmark.

Medication use is a complex process involving different types of health care personnel. This study investigated and compared mandatory medication content in the curricula of six types of health care personnel with patient contact. Using content analysis, three independent raters analysed the mandatory medication content for physicians, pharmacists, pharmaconomists, nurses, health care assistants and support workers in the Capital Region of Denmark. Three dimensions were analysed as follows: communication with patients about medication, medication use or pharmacology and medication formulation and production. ECTS credits were totalled for courses analysed to have high or medium content, and inter-rater reliability was tested with Fleiss' kappa. The total mandatory medication content for pharmacists was 197.0 ECTS, physicians 136.0 ECTS, pharmaconomists 123.3 ECTS, nurses 52.0 ECTS, health care assistants 17.8 ECTS and support workers 0.0 ECTS. Communication with patients about medication was included to the greatest extent in the educations of pharmaconomists (112.0 ECTS), pharmacists (37.5 ECTS) and physicians (25.0 ECTS). Knowledge about medication use and pharmacology was taught primarily to pharmacists (146.5 ECTS), physicians (123.6 ECTS) and pharmaconomists (89.8 ECTS) and to a lesser extent nurses (52.0 ECTS), health care assistants (17.8 ECTS) and support workers (0.0 ECTS). Medication formulation and production were taught only to pharmacists (93.0 ECTS) and pharmaconomists (25.1 ECTS). Mapping the basic competencies about medication taught to each of the six health care personnel types can lead to a better understanding of how they can complement each other in patient care. The study points to weaknesses in medication curriculum content for health care personnel with the most patient contact.

Young Muslim Women Living with Asthma in Denmark: A Link between Religion and Self-Efficacy.

Asthma is a chronic respiratory disease that can be controlled with appropriate medicinal treatment. Adherence to pharmacological treatment is therefore critical. Self-efficacy plays a key role in adherence to medicine in chronic diseases, including asthma. Additionally, ethnic minorities have poor adherence to medicines. However, the impact of religion on self-efficacy and adherence is understudied. Therefore, the aim of this study was to explore the role of self-efficacy in adherence to asthma medicine treatment and the influence of religion on self-efficacy among young, Muslim minority women. A focus group and individual interviews with 10 Muslim minority women (14⁻24 years of age) living in Denmark were conducted. Data analysis was deductive using Bandura's theory of self-efficacy and modes of agency. Overall, religion was shown to affect self-efficacy. The women reported changes in self-perceived self-efficacy during the holy month of Ramadan. In addition, praying was used as an alternative to medicine for controlling asthma symptoms. However, the women did not perceive religion and treating asthma with medicine as mutually exclusive, but rather as coexisting for the shared goal of controlling asthma symptoms. It is important for healthcare professionals (HCPs) to be aware of the link between self-efficacy, religion and adherence to asthma medicine treatment. This awareness can aid HCPs in giving advice regarding adherence to asthma treatment, and when monitoring treatment to improve the quality of asthma care for young Muslim minority women.

Managing Complexity: Exploring Decision Making on Medication by Young Adults with ADHD.

Attention-deficit hyperactivity disorder (ADHD) causes difficulties with hyperactivity, impulsivity and inattention. Treatment of ADHD includes both medication and non-pharmacological options. Knowledge of treatment preferences by young adults with ADHD is sparse. The objective of this study was to explore the beliefs and experiences of young adults with ADHD related to their medication treatment decisions. Data were collected in Denmark in 2016 through a focus group and individual in-depth interviews. Conventional content analysis was used. Ten young adults with ADHD (22-to 29-year-old) participated. Three major themes were identified: (1) the patient’s right to choose concerning ADHD medicine; (2) the patient’s decision of whether or not to treat ADHD with medication; and (3) factors affecting the patient’s decision on whether to take ADHD medication or not. The latter theme contained 15 factors, which were distributed across three levels: individual, between-individuals, and societal. The dominant factors were increasing quality of life and improving oneself e.g., improving social skills. For counselling at the pharmacy and by prescribers, it is important to be aware of the different factors that affect young adult patients’ decisions on whether to take ADHD medication or not. This knowledge will aid to understand reasons for non-adherence and to determine appropriate treatment for the individual patient.

Shifting perspectives - Planning for the future of the pharmacy profession taking current labor market trends into consideration.

The future of the pharmacy profession and concerns about professional identity have been popular and recurring themes in professional journals and at international pharmacy conferences for more than 30 years. The aim of this paper is to contribute to realistic and viable visions for the future of the pharmacy profession via insights through labor market and work organization theories. These insights provide an understanding of contemporary work patterns and what they mean for the future role of community pharmacists. It appears that an important and influential contemporary trend in work organization today is precarious work, i.e. non-standard employment that promotes and relies on a flexible and fluid work force. Contrary to permanent employment, precarious work is often poorly paid, insecure, unprotected, and in many cases cannot support a household. The growth of precarious work among professionals, including pharmacists has been documented in many countries. In the early 21st century a major concern in the UK was the growth in the number of pharmacists who choose to be self-employed "locums" as opposed to seeking permanent employment. With the spread of precarious work a new, involuntary form of employment appeared a decade later with the spread of "zero-hour contracts" and "exclusivity agreements". Particularly affected by these flexible, precarious work conditions are the highly-educated young health professionals such as pharmacists. The profession needs to be proactive in order to stay abreast of economic/workforce and organizational trends. The way forward is a commitment to a dynamic, knowledge-based vision that includes an ongoing analysis of the outside world. The core role of pharmacists in the future includes: 1. engagement in interprofessional education with other healthcare professionals; 2. an acceptance of the contribution that lay knowledge provides to the understanding of health and medicines, and 3.keeping ajour with new and revolutionary treatments, both pharmaceutical and non-pharmacological.