Medical Affairs and Innovative Medicinal Product Strategy Development.

553P Innovative medicinal products and early access provision: Challenges and opportunities to improve access to care for oncology patients

Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.

An innovative medicinal product can be a new active substance acting against or preventing a disease 14 and developed to improve the quality of patient management. 15 Thus, product novelty alone is not sufficient to characterize therapeutic innovation, as an improvement 16 of health outcomes is necessary. 17Recognizing a true innovation can accelerate the development and adoption of valuable treatment 18 options, encouraging their prioritization to make them quickly available for patients with high unmet 19 medical needs. 20This Research Topic collects updated evidence about innovation in ocular pharmacology, a field which 21 rapidly grown over the last few years, leading to the discovery of disease modifying treatments for 22 several eye disorders. 23Nevertheless, several unmet needs remain, such as retinal diseases [1][2][3], characterized by a devastating 24 impact on the quality of life but also on the healthcare system and the society.

Biosimilars, the journey has begun

Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.

Chapter 6 - Reproductive and Developmental Safety Evaluation of New Pharmaceutical Compounds

LERU Briefing Paper: How to improve the development of Advanced Therapy Medicinal Products at universities

The presented article provides a systematic review of the pharmaceutical legislation (EU Pharmaceutical Package) – the current proposal of the European Commission for a new Directive, repealing and replacing Directives and modifying Regulations of the European Parliament and of the Council, incorporating the relevant parts of the Regulation concerning medicinal products for pediatrics, Regulation for orphan drugs and others, aiming at revision of the pharmaceutical legislation in the context of antimicrobial resistance and challenges facing the introduction of innovative antimicrobial medicines in Europe. It outlines a critical analysis on the impact of the changes in the context of introduction of innovative antimicrobial medicinal products with an emphasis on unsatisfied medical demands of the European population. The revision of the pharmaceutical legislation provides an argument to consider that the proposed Pharmaceutical Package could resolve some of the issues associated with the access to novel antibiotic medicines. It is necessary to find a consensus and a balance between, on the one hand, meeting the need for antibiotics for the citizens of the European Union and, on the other hand, providing timely access to generic medicines to meet the needs of the population.

The aim of the article. In the current market conditions, the main objectives of the product policy of the enterprise are to manage the competitiveness of products, adjusting their life cycles and assortment. For this purpose, the commodity strategy of the enterprise which is directed on achievement by the enterprise of target positions in the market by means of the products should be developed. The product is the subject of many management decisions: it is created, brought to market with the support of various marketing activities, if necessary modified and, if economically feasible, withdrawn from production. The aim of the article is to form marketing strategies for industrial products on the market on the basis of the developed classification of innovative goods depending on the level of their efficiency at separate stages of the product life cycle. Analyses results. The article develops the classification of innovative industrial products depending on the level of their efficiency at the separate stages of the product life cycle. The authors formed the recommended marketing strategies based on the proposed classification of products, depending on the range of levels of efficiency in which the product is. The article also presents the practical use of the developed recommendations on the example of the life cycle of the innovative electric motor of PJSC «Electromotor», which confirms their practical significance and suitability, allowing industrial enterprises to effectively manage their range. The article also builds a graph-analytical model of comprehensive efficiency indicators of an innovative electric motor, which allows to clearly track their dynamics over the entire period of its life cycle. Conclusions and directions for further research. In market conditions, each enterprise must determine the directions of formation and implementation of marketing product policy, taking into account the characteristics of each product. Forming a marketing product policy, the company must work on updating the range and bringing new products to market, because the right strategy for product range management will provide the desired volume of sales and corresponding profits. Thus, due to the proposed classification of goods at different stages of the life cycle, depending on the level of efficiency in which the product is or will be, the company can develop specific marketing strategies and tactics, including research and development (R&D), development of production, selection of sales channels, improvement of forms and methods of advertising, price regulation, development of new ones, modernization of existing and removal of obsolete inefficient products, etc. The use of effective marketing solutions can affect the duration and course of the product life cycle and consequently to achieve maximum profits. Keywords: efficiency, innovative product, product life cycle, marketing strategy, assortment management.

The continual search for new attractive ornamentals and innovative natural medicinal products is the main focus of floricultural and pharmaceutical industries worldwide. Aiming to introduce two new Cretan endemic species in the commercial trade, Acantholimon androsaceum (Jaub. & Spach) Boiss. and Limonium chersonesum Erben & Brullo (Plumbaginaceae) have been selected in the current study. These were derived from a total of 223 local endemic species and subspecies of Crete, which constitute an exceptional wild treasure of the Mediterranean flora. Prior to any commercialization, efficient massive propagation protocols are required. Although sexual propagation using seeds collected from the wild was unsuccessful for these two taxa, the results of vegetative propagation experiments were satisfactory. Wild plant material was used for cuttings in order to develop a reasonable and homogenous number of stock mother plants for propagation trials. As a result of experiments conducted in the current research, two vegetative propagation protocols were developed, which could be used commercially for the massive production of elite clonal plants of A. androsaceum and L. chersonesum. These protocols provide 71.43% successful rooting for A. androsaceum within 40 days, using 2000 ppm IBA, and 80.95% rooting for L. chersonesum within 30 days, using 1000 ppm IBA. This study is part of a strategy and research methodology aiming at the selection of new, rare and endemic native industrial crops for the ornamental and pharmaceutical sector, exploiting sustainably the rich phytogenetic resources of Crete.

Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Pharmaceutical companies are responding to the increasing demands for RWE by developing standards and processes for each stage of the evidence generation pathway. Some conventions are already in place for assuring quality, whereas other processes are specific to the research question and data sources available. As evidence generation increasingly becomes a core role of medical affairs divisions in large pharmaceutical companies, standards of rigour will continue to evolve and improve. Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.

Micro, Small, and Medium Enterprises are one of the important pillars in a country's economy. Despite their strategic role, MSMEs often face a number of challenges, such as intensifying competition, changing consumer tastes, evolving technology, and access to a wider market. This study aims to analyse product and service innovation strategies to expand the MSME market. This research employs a qualitative research approach, more precisely, a literature review, where data will be examined and explained by drawing upon information and textual materials collected from a variety of sources. The study results show that innovation in products and services plays a key role in the growth and sustainability of micro, small and medium enterprises. MSMEs play a vital role in the economy by creating jobs and contributing to sustainable economic growth. Innovation differentiates MSMEs from their competitors in an increasingly globalised and dynamic business environment. Innovative products and services can attract customer attention, provide a competitive advantage, improve product quality, and build long-term relationships with customers.

Background: Medical affairs pharmaceutical physicians (MAPPs) have unique value to pharmaceutical companies due to their accountability for activities that benefit regulators, payors, prescribers and patients. This study assessed whether MAPPs’ specialist training and education in pharmaceutical medicine could account for this level of value by determining whether there was significant variation in education and training between MAPPs and other internal stakeholders of pharmaceutical companies.Methods: A systematic search of LinkedIn profiles from the 10 pharmaceutical companies by revenue was conducted between June and October 2021.Job title and type and year of undergraduate and postgraduate qualifications were extracted. A one-sided Mann-Whitney test assessed for differences in the total number of qualifications between MAPPs and other internal stakeholders involved in medical affairs using MAPPs as the reference group. Other internal stakeholders included medical affairs pharmacists (MAPharm), other medical affairs professionals (MAOth), and market access (MAcc), commercial (COmm) and sales professionals. Sub-group analysis determined differences in undergraduate and postgraduate education.Results: In total, 524 profiles were included. Compared to all other internal stakeholders, MAPPs had a significantly higher number of undergraduate (p < 0.001) and postgraduate (MAPharm, p = 0.003; MAOth, p = 0.004; MAcc, COmm and Sales, p < 0.001) qualifications. Additionally, MAPPs had a significantly longer time to industry than other internal stakeholders apart from MAPharm. Of those with clinical qualifications, MAPPs were almost twice as likely to have business qualifications.Conclusions: Of all internal stakeholders, MAPPs had the highest number of qualifications and the best match between expertise and the contextual demands of decision-makers in the pharmaceutical industry. Pharmaceutical companies in the UK can use these findings to clarify role boundaries and decision-making power based on the nature and level of expertise of each internal stakeholder.

Pre-clinical assessment of the Lovo device for dimethyl sulfoxide removal and cell concentration in thawed hematopoietic progenitor cell grafts

In 2023, three categories of therapeutic products obtained through the collection and subsequent engineering of hematopoietic cells exist and are valuable to patients treated for neoplastic diseases as well as a variety of nonneoplastic disorders: blood cell transfusions, stem and immune cell transplants, and cellular therapy medicinal products. The procurement and nature of various blood products and transfusion practices are described elsewhere in this handbook. In this chapter, we focus on hematopoietic cellular therapies as currently defined and managed in the FACT-JACIE International Standards for Hematopoietic Cellular Therapies (nowadays in version 8). Over the last two decades, major changes have occurred in the EU regulatory framework (as well as in other parts of the world, notably in the USA) that result in the coexistence of two categories of hematopoietic cellular therapies. Innovative and industry-manufactured somatic cell therapy or gene therapy medicinal products have entered the field at an accelerating pace since the last edition of this handbook. Some of them are distributed worldwide on a large scale, and a few of these medicinal products already complete or compete with traditional hematopoietic cell transplantation practices. We here update the description of organizational consequences of this historical transition for academic facilities and the new opportunities as well as challenges these advances are bringing to patients and healthcare practitioners, including strong needs for educational initiatives.