Oral Presentations & e-posters session (North & South America, West Africa & Western Europe)
Maria Polydorou, PharmD, MSc Clinical Pharmacy, Director of Pfizer’s Pharmacovigilance Departments for Southeastern Europe (Cluster Safety Lead for SEEU)
Eleonora Sarikou, BSc Biology, MBA, Local Delivery Lead Clinical Operations, Medical Department GlaxoSmithKline Greece
H.G. Osmo1,2, E.F. Motti3, C. Schmidt4, M.V. Lima1,5, S.M. Dainesi1
1Brazilian Association of Pharmaceutical Medicine – SBMF
2IFAPP - International Federation of Associations of Pharmaceutical Physicians
3Trials & Training Consult
The Covid-19 Pandemic in 2020 and 2021 mobilized the society and caused a sudden change in the common life from a social, economic and political point of view. The topic became a major subject in discussions involving politicians, journalists and other professionals. Long reports occupied space in the media. A great gap in knowledge about the development of vaccines and drugs in general, from the preclinical phases to access, was observed. The misinformation and preconceptions about the role of the Pharmaceutical Industry in society became a theme that needed to be urgently clarified. Based on that, SBMF organized a course “Connection with the Parliament for Development”, with the support of Interfarma (Association of Brazilian Research Based Industries) and the Brazil - US Business Council. This initiative was tailored for politicians elected and present in the Parliament. Five virtual sessions were planned, every 15 days: 1) From the discovery of new molecules to the regulatory approval; 2) Ethics and regulatory environment; 3) Innovation and intellectual property; 4) Regulatory rigor and safety; 5) Access to medicines in Brazil.
The general population had little knowledge about the main steps needed before authorization to commercialize medicines: the importance of good manufacturing practices in the quality of medicines, the quality of clinical research, from ethical procedures to analysis of results. International and national laws on research ethics and the involvement of regulatory agencies were exposed. The accelerated process of vaccine approval in the exceptional case of COVID-19 pandemic was also addressed. The process of incorporation of drugs into the Brazilian Health System (SUS), the pricing definition, budget impact analysis, and general concepts of access and regulation were explained.
This initiative led by SBMF and Interfarma contributed to increase the transparency of the way medicines and vaccines are developed. Other courses like this were recommended, aimed mainly for journalists and lay public, for elucidation of several little-explored aspects in the development of medicines.
2. Results of the first edition of a Medical Information in the Pharmaceutical Industry University Expert Course in Spain
Lo Re Daniele
Medical Affairs Chiesi Spain
The MI Working Group (MIWG) of AMIFE (Spanish Association of Medicine of Pharmaceutical Industry) and the University San Pablo-CEU (Madrid) implemented the first postgraduate course on medical information (MI) in pharmaceutical companies (PC) in Spain to close the training gap identified among the MI professionals [1,2] and as an option for graduates with health sciences profile interested in the MI area in PC.
The course, organized into 9 modules, finished in May 2022, and consisted of 100 hours of formal classes, 3 days a week from 5:30pm-8:30pm, both online and face to face, taught by members of the MIWG-AMIFE (n=14) and other prestigious professionals (n=13) in the fields of searching, communicating and analyzing scientific/medical data. Students could apply for 3 months of optional internship in MI areas of PC. Members of MIWG-AMIFE had the option to choose to attend only selected modules.
In total, 20 people from 3 different countries registered and attended the entire course (15 professionals in PC, 1 documentalist and 4 health science graduates). Additionally, 11 MI professionals chose to attend 3 specific modules. All students attended at least 80% of required classes [media (range)]: 93% [80%-100%], and 100% responded the questionnaires submitted to evaluate them. Participants rated 5 (highest score): content structure [media (range)]: 62% [50%-79%], usefulness of training material: 59% [45%-71%], lesson utility: 61% [48%-79%] and teachers’ communication skills: 67% [57%-83%]. Five students applied for internships. As positive aspects of the course, participants highlighted: confidence, motivation, and knowledge; they suggested to increase practical work vs. theory classes.
The success of the course encourages to MIWG-AMIFE to plan new editions in which to implement the suggestions proposed by the participants in this first edition.
- Flores A, et al. DIA Congress 2015 Nov 10-11; London, UK.
- Flores A, et al. EPI 2021;30(3). https://doi.org/10.3145/epi.2021.may.10.
3. The Importance of Latin America in Global Clinical Trials: Expanding Clinical Research Beyond Borders
Marlene Teresa Llópiz Avilés
Global Oversight Director for PPD
The dramatic increase in globalization―especially into conducting more trials in Latin America (LATAM)―may be attributed to greater competition in the USA and European markets; costs, patient recruitment, as well as looking for specific therapeutic indications and the demand for qualified clinical research professionals. The rapid economic growth and improved regulatory processes in emerging and growing regions, partly driven by wider adoption of ICH guidelines and principles are important factors considered.
LATAM has again come into the limelight for pharmaceutical, biotechnological and device studies. Biopharmaceutical and especially biotechnological companies have uncovered new opportunities in Central American, Caribbean, and South American countries.
The current population of Latin America and the Caribbean is 665,407,471, based on the latest United Nations estimates. LATAM and the Caribbean population is equivalent to 8.42% of the total world population. LATAM provides a large drug-naïve patient population with common and specific disease profiles, rapid compliant patient recruitment, motivated and experienced investigators, and USA and EC-equivalent medical standards, as well as highly trained monitoring and project management teams on GCP and ICH guidelines.
Partnering contract research organizations, regulatory businesses, patient recruitment companies and participating NGOs have contributed to conducting international global trials in LATAM. Conducting studies in LATAM provides sponsors with an array of countries for testing drugs, reduced costs for strategic multicenter studies, credible and objective submittals, and highly professional staff members at CROs who are bilingual, graduated in allied health and medical fields, often trained in the USA and Europe.
Large, urban populations in LATAM enable faster enrollment and easier patient follow-up. These populations often see clinical trials as viable healthcare options for gaining access to free medication and closely supervised and specific health care, which leads to high patient retention rates. Quality of data collected is comparable to that from any other country. LATAM is a viable and convenient option for global clinical trial conduction from the “get go”.
Regulatory Science, Regulatory Affairs, Ethical, Legal, Social related issues
Sonia Mansoldo Dainesi
Brazilian Association of Pharmaceutical Medicine – SBMF
The first request in Brazil for a post-trial access to an investigational medicine was received in 2005 from National Ethics Committee, who required that a new insulin just evaluated in a multicentric international trial should be made available for the patients who still needed the treatment after the end of the study. It appears obvious that if the patient has benefit with the new drug, the treatment should continue. However, how to safely continue the treatment outside of a clinical research environment? How can you be sure the risk does not outweigh the benefit? For how long should the drug be provided? Who would be responsible for monitoring the patients if the trial was closed? Would off-label use be encouraged with this procedure?
The first publications regarding drug access after clinical studies were related to HIV trials conducted in Africa. Vulnerability of study participants was the big concern. The clinical research participation of Brazil sites in multinational trials was growing and this made the issue gain relevance in the country, becoming a valuable case study. Many international and national legislations mentioned the theme but without clarity, leaving room for misinterpretation. Since then, post-trial access has been discussed in some international panels by all clinical research stakeholders (investigators, sponsors, ethics committees, regulatory agencies, and patients). Continued access to experimental medications is indeed one way in which subjects may benefit from research participation but only furnish the drug is not enough. Medical care and follow-up are necessary, creating an additional burden to investigators and institutions, and more important, a confusion between research and clinical care. The evolution of this debate helped us to clarify that, before starting a trial, arrangements should be agreed, in order to plan a responsible transition to clinical care at the end of the research and, in some specific cases, access to the drug must be ensured if no treatment alternatives exist. The debate is still open.
Patient Centricity in Research & Development and Health Technology Assessment
- Margetis1, C. Kani1, A. Chantzaras1, V. Koutsiouris2, F. Bacopoulou1
1Health Technology Assessment and Reimbursement Committee, Ministry of Health, Athens, Greece
2Ministry of Health, Athens, Greece
Background: Access to treatment plays a major role in the provision of quality healthcare. The purpose of the present study was to examine the proportion of applications of medicinal products with pediatric/adolescent vs. adult indications, for inclusion in the Positive Reimbursement List in Greece, during a 4-year period, from 2018 to 2021.
Methods: Data were collected from the European Medicines Agency (EMA) and the Greek Ministry of Health websites, as well as from the Greek Health Technology Assessment (HTA) Committee’s database. The dataset included all the medicinal products which received marketing authorization/extension of indication during the study period. Percentages of products with pediatric/adolescent indications were calculated according to their marketing authorization date, their submission to the Greek HTA Committee and their inclusion in the Positive Reimbursement List.
Results: Among 598 centrally authorized medicinal products/or extended indication products by EMA, 35.6% (n=213) included a pediatric/adolescent indication and 64.4% (n=385) were indicated for adults. Only 20.2% (n=43) of all centrally approved medicinal products with a pediatric/adolescent indication had been submitted to the HTA Committee by the end of the study period, from which 25.6% (n=11) have been included in the Positive Reimbursement List. In contrast, 37.9% (n=146) of all products which received marketing authorization or indication extension through the EMA for adults had been submitted to the HTA Committee by the end of the study period, from which 37% (n=54) have been included in the national Positive Reimbursement List.
Discussion: As expected, a greater proportion of medicinal products have been authorized for adults than for younger patients. Furthermore, HTA submission and reimbursement rates are lower for medicinal products authorized for children and adolescents than for adults. The needs of the pediatric/adolescent population should be taken into account in the marketing authorization procedure as well as in the overall HTA process.
Patient Centricity in Research & Development and Health Technology Assessment
Paraskevi Basdeki1, Yiota Athanassopoulou1, Georgia-Eirini Deligiannidou1, Diamanto Lazari2, Christos Kontogiorgis1, Theodoros Constantinides1
1Laboratory of Hygiene and Environmental Protection, Democritus University of Thrace, Alexandroupolis, Greece
2Department of Pharmacognosy-Pharmacology, School of Pharmacy, Faculty of Health Sciences Aristotle University of Thessaloniki, 54124, Thessaloniki, Greece
Background: Protein supplements are consumed both by amateur and professional athletes. However, amateur athletes’ knowledge, motivations, occurrence of consumption, benefits and potential health risks need to be investigated.
Objectives: This study investigates the state of protein supplements use among athletes in Greece and the sources of information, reasons of consumption and motivation and frequency of use.
Methods: The research was based on a survey. 928 people of random gender and age, of different athletic activities, from all around Greece participated. The questionnaire was shared anonymously both in person and online, mainly on gyms and other athletic fields. It consisted of 37 questions, on demographics, sources of information, regularity of use, purchasing habits, associated risk knowledge and beliefs on supplements. The data were categorized, analyzed using SPSS v15.0.
Results: Most responders were females 64.7% of mean age 27.7 years, whereas males were 35.3% of mean age 29.3 years, respectively. Mainly, they had a normal body mass index (BMI) (66.4%) and an educational level of BSc or higher (61.8%). A quarter of the participants, (24.8%) were consuming protein supplements and the majority were men. The main factor of use was the real action of this product, that means raise muscle mass (60%). In addition, users of protein supplements followed essentially Mediterranean diet (32.4%), while they also consumed other supplements such as vitamins, amino acids, carbohydrates, and creatine supplements. It was found that the most common source of information was the internet (70.4%), whereas 59.6% of consumers considered them as safe and of good quality and 47% of them preferred purchasing online due to lower costs. Regarding the form of protein supplements, powder was the first choice (90.9%). Furthermore, half of users utilized the supplements more than 2 times per week and after exercise. Finally, side effects have been observed in 6.3% of consumers.
Conclusions: Because of inappropriate information and products’ wrong labelling, the majority of youth might be led to unwanted results with the consumption of protein supplements. That is why further education of athletes and coaches for responsible purchasing and use would be necessary.
Marlene Teresa Llópiz Avilés
Global Oversight Director for PPD
On March 11th, 2020, the World Health Organization (WHO) announced the start of a pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus and disease were first identified in December 2019 in Wuhan, China – spreading rapidly worldwide.
The number of cases and deaths continued to rise rapidly in the following months, requiring countries to respond in an escalated way, as well as take action as soon as possible. Such actions were to help delay the pandemic, giving healthcare systems time to prepare and assimilate the impact. However, the virus was much faster and rampant.
Irrespective of the disease’s trajectory in each country, there were several actions that needed to be taken. There was no one-size-fits-all approach across the world. The past two years have been full of incongruities occurring at all levels of health organizations, companies, governments, people, paradoxes and absurdities. Was / is COVID-19 a common enemy? Are we still at its mercy? In some ways it is or has been, and we are somewhat still at its mercy. However, each country has approached the pandemic differently, following their own timelines; facing difficulties with previously established budgets; and tackling the problem as swiftly as possible―although they had never contemplated or experienced this emergency.
Was/is there worldwide solidarity? Were the pharmaceutical companies part of that solidarity? It is often said that confusion is often but a first step towards clarity. The world is/was/has been confused. Are we still confused? Have all our questions been answered? Far from it.
This presentation will cover the changes that were required to be made by the pharmaceutical medicine world in terms of the pandemic and how our lives have been at COVID-19’s mercy and spread. It will also include a look at returning to “normality” ―from home-based offices, family tragedies and losses, adjusting to new modalities of lifestyles and communications to hybrid conferences and meetings, companionship and new work scenarios. Included also will be pharmaceutical medicine development, vaccine strategies, worldwide collaborations, and continuous unity for a better place and life and overcoming an enemy never thought would exist.