Getting the Most From FSP Model

Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas The COVID-19 pandemic has shown that there's a lot more flexibility in clinical trial systems than what was realized in the past. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.3 Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model include: * Clinical monitoring (CM) * Clinical data management (CDM) * Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC) * Medical writing (MW) * Pharmacovigilance/drug safety (PV) * Regulatory affairs (RA) Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. * Combination of CDM, BS&P, and data conversions * Extension of the CDM, BS&P, and MW into a "clinical data services' package * Combination of clinical monitoring, CDM, BS&P, and medical monitoring into a "centralized monitoring team" (potential future services) * Combination of PV and regulatory activities due to regional synergies and submission/compliance requirements (potential future services) To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices ahead (and summarized in Figure 1 above) that can be leveraged and further customized as needed by sponsors: 1.Functional sourcing strategy: Sponsors must include specific criteria as part of their evaluation of service providers for the FSP sourcing plan (some of these are also typically done during a full-service CRO outsourcing process): Size and geography focus of provider that needs to be aligned with the strategic plans of the sponsor (e.g., where they plan to conduct trials to meet their regulatory needs or the size of stud ies). Team strength, capacity, and experience with both FTE and unit/deliverables-based pricing models of delivery. * Commitment to deliver year-over-year productivity gains using automation, digital/AI/ML technologies, and other approaches. * Partnership approach to play a critical role in initiating, driving/participating in innovation, and transformation initiatives of the sponsor. * Past client and employee turnover (attrition) that should be on par or below benchmark for the same function and similar type of service. * Executive commitment to participate actively in joint-governance discussions that ensures proactive monitoring and tracking of the program milestones and drive mitigatory actions, should milestones not be delivered on time, quality, and cost. 4.RFI/RFP process, joint solution development, and rigorous scoring of proposals and solutions:

Outsourcing's, Race Toward Novelty

According to Jeetendra Vaghjiani, senior director of clinical development and strategic marketing at Lonza, emerging biotech companies are reliant on contract development and manufacturing organizations (CDMOs) because of their development and manufacturing capacity, expertise, and flexibility. Because of the high attrition rate associated with drug development, the better your preclinical programme, the stronger the position you can establish in terms of programme design and patient identification (2). [...]because of the relative scarcity of approvals over the past decade, companies looking to capitalize on this new market are likely to require specialized knowledge to get through the approvals process.

Addressing the Key Pitfalls Hindering Technology Transfer Success

The key challenges that are commonly faced by companies undertaking a tech transfer include: * Client expectations and initial project scope definition: the initial assumptions of the drug developer or marketing authorization holder (MHA) based on their initial information relating to the product can be a significant challenge. Typical examples include product stability issues (typically on legacy products) being evidenced due to a change to more compliant analytical methods;change to product brought about by compliance-related requirements on legacy products, such as nitrosamines, and elemental impurities guidelines, etc.;and regulatory requirements being misjudged at the onset of the project, among other factors. * Product knowledge management: particularly when undertaking tech transfers of legacy products or products in the initial discovery phase, there may be a lack of technical knowledge on the product itself to make a comprehensive and robust tech transfer process. All this may contribute to slowing down the transfer of knowledge, with implications for tech transfer timelines. * Standardization at receiving site: another challenge typically faced by receiving sites of CDMOs is a lack of standardization of their internal processes and or documentation brought about by multiple tech transfers with varying types of clients with multiple requirements. The originating site-particularly if it belongs to a small start-up-may not have team members with specialist experience in handling a transfer, so may need additional support in collating the required information to hand over to the receiving site.

The Burden and Autonomy of Women in the IT-BPO Industry in Metropolitan Manila: Under the COVID-19 Pandemic

The purpose of this chapter is to discuss how the COVID-19 pandemic affects the lives and household responsibilities of women in the IT-BPO industry in the Philippines. The growth of the industry has created possibilities for university-educated women in adversity to upgrade their lives, enhance their autonomy, and achieve upward mobility. Through online interviews with female workers/former workers in IT-BPOs in Metropolitan Manila, the author explores their gendered contribution and responsibility in households both prepandemic and during the pandemic, while paying attention to differences in both according to life stage. This study suggests the possibility that young female IT-BPO workers from low-income households, who tend to be economically responsible for their families, are more vulnerable to the pandemic. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2023.

Trends Affecting Biopharmaceutical Manufacturing

The landscape for bioprocessing continues to evolve, driven by many externally imposed trends that have been combined with ongoing technological changes and internal progress in bioprocessing. [...]most ongoing bioprocessing-related trends are not new and are reported after they become evident or familiar, making it difficult to cite when a specific trend starts and ends. The Top 1000+ Global Biopharmaceutical Facilities Index currently tracks over 1900 facilities worldwide with total estimated bioreactor capacity now over 17.3 million litres, including >720 facilities with an >2000 L capacity (2). * More biosimilars, biobetters, and biogenerics, with continued expansion in developed markets and capturing growing market shares in developing countries, due to an increase in prices of the originals. * Single-use bioprocessing systems will continue to rapidly displace commercialscale stainless steel-based manufacturing, both at commercial manufacturing and clinical scales. * Expansion of second-source bioprocessing facilities to combat supply chain issues due to the COVID-19 pandemic. * Flexible manufacturing facilities, including modulation, further aided by the increased adoption of single-use bioprocessing systems. [...]of this build-up and investment, non-pandemic projects continue to be shifted out to contract manufacturing organizations (CMOs).

Supporting the Industry During a Pandemic

Among the lessons learned from the pandemic response are changed perceptions within the industry regarding flex capacity, risk management, supply chain, and inventory control, according to Eric Langer, managing partner at BioPlan Associates. [...]infectious disease drugs have already overtaken perpetual leader oncology as the year's top therapy area for contract manufacturing service agreements, since many of these vaccine-developer companies are small and lack manufacturing capabilities. The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products using spray-drying, hot-melt extrusion, and melt-spray-congeal processing and CGMP suites for early-phase CGMP manufacturing featuring added storage, gowning, and a customer in-plant viewing corridor (4).

Balancing Pressing Priorities

Reevaluating the supply chain and timelines The pandemic highlighted a variety of issues related to the biopharmaceutical supply chain, and supply chain risk mitigation, especially for APIs, has become increasingly important, says Gene Nakagawa, EVP business development at LGM Pharma. Joe Sinclair, vice president, corporate strategy and business development at Vibalogics, agrees the pandemic caused a global trade disruption, and supply chain management is crucial. "Video conferencing and remote communications dominate the way we perform internal and external communications. Since there is no way to visit facilities for an audit, at least in India for the time being, CMOs who have good track record will continue to get recommendations from fellow clients," says Davuluri. "COVID-19 has made everyone in the industry revisit their sourcing strategies and risk management;even companies with stable in-house facilities have reassessed their risk profiles and vulnerabilities in supply chain, and sought after CDMO partnerships," says James Choi, chief information and marketing officer at Samsung Biologies.

The Rise of FSP Outsourcing in Drug Development

Simultaneously, advances in mobile technology, data aggregation and analysis tools, and risk management methodologies are changing how clinical trial data are collected and monitored, influencing how companies outsource core clinical research tasks. The established full-service model, in which biopharmaceutical companies retain a preferred contract research organization (CRO) to perform the full range of clinical trial activities, has been increasingly complemented by an functional service provider (FSP) approach, which allows companies to engage discrete expert services- such as medical writing, biostatistics, or clinical monitoring-when and where they need them. [...]it cultivates continuity because FSP relationships tend to be long-term. [...]companies that need to bolster a specific type of expertise or fill a geographic gap are using FSP to do so in a highly targeted fashion. [...]data aggregation, AI, and machine learning were steadily gaining traction pre-pandemic. Because the value of a CRA rises rapidly with experience and a solid track record-and they move up quickly-we are facing a potential shortage of Level 1 or entry-level CRAs. [...]Parexel enhanced its recruitment and training efforts in parts of the world where supply and demand for CRAs is not as tight.

Incentivizing at‐risk production capacity building for COVID‐19 vaccines

Our study analyzes capacity management for promising vaccine candidates before regulatory approval (i.e., at‐risk capacity building) in the presence of production outsourcing and different operational challenges: misaligned interests, possible ex post negotiations, asymmetric information between developers and manufacturers, and government involvement. We develop analytical models to compare two vaccine production modes: (1) the integrated mode (a single company determines the at‐risk capacity and produces in‐house) and (2) the outsourcing mode (a manufacturer determines the at‐risk capacity and a developer determines a funding level to share the capacity‐building cost). Our study reveals that outsourcing can achieve a higher at‐risk capacity only if it can achieve sufficient cost savings compared to the integrated mode. Our research also proves that both vaccine production modes tend to underinvest in the at‐risk capacity. Following this, we suggest measures to improve the at‐risk capacity building in both vaccine production modes. Our signaling game model reveals that a developer with high competence cannot always send credible signals of its true competence level to the manufacturer. Our incomplete contract model verifies that the relative performance of the two vaccine production modes is robust when ex post negotiation occurs under the outsourcing mode;however, the two parties may show incompatible preferences for the ex post negotiation. Our study also analyzes the optimal allocation of government financial support to development funding and capacity funding to incentivize at‐risk capacity building. We present comprehensive guidelines for the different stakeholders to collectively contribute to ramping up the at‐risk capacity of promising vaccines.

Profit-Sharing Contract of the Fresh Agricultural Products Supply Chain under Community Group Purchase Mode Considering Freshness Preservation Efforts

This article constructed a four-level fresh agricultural product (FAP) supply chain with a two-stage pricing strategy under a "community group purchase (CGP) platform + direct procurement from the FAP supplier” sales model. We investigate the influence of the CGP agency's participation in the control strategy of FAP freshness preservation efforts on the profits of supply chain stakeholders. This article discusses the effects of the FAP supplier profit-sharing ratio, the CGP agency profit-sharing ratio, and consumers' sensitivity to FAP freshness on the supply chain stakeholders' freshness preservation efforts. Moreover, based on the fairness preference theory, this article designed a profit-sharing contract that involves the Nash bargaining game between the FAP supplier and the CGP agency as the supply chain coordination mechanism. Modeling results revealed that: (1) The CGP agency's freshness preservation efforts increased total supply chain profits. (2) The FAP supplier profit-sharing ratio, CGP agency profit-sharing ratio, and consumers' sensitivity to FAP freshness have a positive correlation to the profits of the FAP supply chain and promote the coordination of the supply chain. (3) Considering fairness preferences, with the increase in FAP suppliers' business negotiating ability, their freshness preservation efforts and fairness utility both increased gradually, while the fairness utility of the CGP agency gradually decreased.

PTI: Coping with the COVID-19 crisis from a resource-based view

Small and medium-sized enterprises (SMEs) are suffering heavily from the Covid-19 pandemic. Pincode Telenet International (PTI) is a small company providing software solutions to the utility sector in the Netherlands. Its revenue depends entirely on outsourcing contracts given by utility providers. When the market environment is disrupted by the Covid-19 outbreak and its lasting impact, PTI is confronted with a 35% drop in revenue and many uncertainties. This case illustrates how PTI copes with uncertainties by focusing on one certainty: the available resources. The resource-based coping strategy presented in this case engages students to reflect on how different resources can be used to strengthen collaborations and expand a customer base. It thus advances our understanding of opportunity recognition and entrepreneurial behaviour in times of crisis.

Outsourcing or reshoring? A manufacturer?s sourcing strategy in the presence of government subsidy

Multinational firms can outsource to contract manufacturers in low-labor-cost regions. However, in recent years, several developed countries and regions have subsidized their local manufacturers (LM[s], she) to encourage reshoring for external benefit (e.g., creating more domestic jobs or improving industrial struc-ture), especially after the COVID-19 pandemic started. This paper investigates the sourcing problem of an LM with brand premium in the presence of government subsidy and differences in labor costs. An LM faces three options: producing in-house, outsourcing to an original brand manufacturer (OBM, he), which sells competitive substitutes without brand premium, or outsourcing to a non-competing contract manu-facturer (NCM). We find that, first, the LM chooses reshoring if the external benefit or brand premium is sufficiently high. Second, if the LM decides to outsource, she chooses the OBM (NCM) if her brand pre-mium is high (low). Third, the government prefers to subsidize LM reshoring or outsourcing to an NCM. If the government intends to induce LM to reshore, the subsidy should be at a moderate level. Interestingly, when the LM has a low brand premium but chooses outsourcing, the government still subsidizes her to improve her competitiveness.(c) 2022 Elsevier B.V. All rights reserved.

Towards Secure and Privacy-Preserving Data Sharing for COVID-19 Medical Records: A Blockchain-Empowered Approach

COVID-19 is currently a major global public health challenge. In the battle against the outbreak of COVID-19, how to manage and share the COVID-19 Electric Medical Records (CEMRs) safely and effectively in the world, prevent malicious users from tampering with CEMRs, and protect the privacy of patients are very worthy of attention. In particular, the semi-trusted medical cloud platform has become the primary means of hospital medical data management and information services. Security and privacy issues in the medical cloud platform are more prominent and should be addressed with priority. To address these issues, on the basis of ciphertext policy attribute-based encryption, we propose a blockchain-empowered security and privacy protection scheme with traceable and direct revocation for COVID-19 medical records. In this scheme, we perform the blockchain for uniform identity authentication and all public keys, revocation lists, etc are stored on a blockchain. The system manager server is responsible for generating the system parameters and publishes the private keys for the COVID-19 medical practitioners and users. The cloud service provider (CSP) stores the CEMRs and generates the intermediate decryption parameters using policy matching. The user can calculate the decryption key if the user has private keys and intermediate decrypt parameters. Only when attributes are satisfied access policy and the user's identity is out of the revocation list, the user can get the intermediate parameters by CSP. The malicious users may track according to the tracking list and can be directly revoked. The security analysis demonstrates that the proposed scheme is indicated to be safe under the Decision Bilinear Diffie-Hellman (DBDH) assumption and can resist many attacks. The simulation experiment demonstrates that the communication and storage overhead is less than other schemes in the public-private key generation, CEMRs encryption, and decryption stages. Besides, we also verify that the proposed scheme works well in the blockchain in terms of both throughput and delay.

The Impact of Perceived Benefits on Blockchain Adoption in Supply Chain Management

Globalization has prompted enterprises worldwide to increasingly seek the optimal supply chain configuration. However, outsourcing, shortened product life cycles, and a reduced supply base severely weaken supply chain risk tolerance. With the emergence of blockchain, enterprises see an opportunity to mitigate supply chain risks. The purpose of our research is to explore supply chain managers' intention to adopt blockchain technology from the perspective of supply chain risk management. Using a survey sample of 203 managers in China and the USA, we explored the impact of four perceived benefits of blockchain technology on supply chain risk resistance by extending the technology acceptance model. The results show that the traceability, transparency, information sharing, and decentralization of blockchain can enhance the perceived usefulness of blockchain in supply chain resilience and responsiveness, and the ability to withstand disruption risks and supply and demand coordination risks encountered in the supply chain, thus promoting the adoption of the technology. In addition, the relationships between supply chain resilience and blockchain technology adoption and between supply chain responsiveness and blockchain technology adoption are more salient for managers with high levels of uncertainty avoidance.

From lucem aspicio to the neoliberal shadow: cleaning services outsourcing at the University of Costa Rica.

Introduction: Changing universities into for profit corporations has taken them to outsourcing as a way to reduce expending. Objectives: This article tries to understand the way in which outsourcing, as a «third space»or «middle space» is built by workers hired by Servicio de Limpieza a su Medida S.A (SELIME), at the University of Costa Rica (UCR). It also describes how these persons experience precarious labor, which is established by contracts, norms and practices between private and public spheres. Method and technique: Our research is based on participant observation, analysis of five minutes of sessions from the Consejo Universitario, nine in depth interviews with cleaning workers, and an interview with the personnel from the Oficina de Servicios Contratados. The interviews focus on the categories working conditions and labor environment. Another interview with the working team from the Vicerrectoría de Administración that is analyzing outsourcing at UCR focused on outsourcing policies and bidding processes at the University. Results: We analyze the way in which a bicephalous and ambiguous structure of precarious forms creates hierarches and affect the bodies of people dedicated to cleaning work as they occupy the bottom step of a normed but arbitrary and hostile organization, especially in the context of the Covid-19 pandemic. Conclusions: It is evident the fragmentation of the labor sector in this structure, with which labor control is facilitated. Despite all these, and in contradiction with the humanistic vision at the University, the public institution sustains and even increases outsourcing. (English) [ FROM AUTHOR] Introducción: La transformación de las universidades en corporaciones para el lucro ha llevado a que se utilice la tercerización como un medio para reducir costos. Objetivos: Este artículo busca conocer la forma en que se construye la tercerización, entendida como un «tercer espacio» o «espacio en medio», por las personas trabajadoras contratadas por la empresa Servicio de Limpieza a su Medida S.A (SELIME) para brindar servicios de limpieza en la Universidad de Costa Rica (UCR). Asimismo, intenta describir cómo estas personas viven la precariedad laboral establecida mediante contratos, normativas y prácticas entre lo privado y lo público. Método y técnica: La investigación se basa en observación participante, revisión de cinco actas del Consejo Universitario, en nueve entrevistas en profundidad con personas trabajadoras de limpieza, una entrevista con el personal de la Oficina de Servicios Contratados que giran alrededor de las categorías condiciones laborales y ambiente laboral;y otra con el equipo de trabajo formado por la Vicerrectoría de Administración, a cargo de analizar las políticas sobre tercerización en la UCR, la forma en que estas se han implementado y el procedimiento para aprobar las licitaciones. Resultados: Se determina la manera en que una gestión bicéfala y ambigua estructura formas de precariedad que jerarquizan y vulneran los cuerpos de las personas que deben dedicarse a tareas de limpieza, esto al ocupar el escalón más bajo de una estructura normada pero arbitraria y hostil, especialmente en el contexto de la pandemia del Covid-19. Conclusión: En esa estructura se genera la fragmentación del sector trabajador, con lo cual se facilita su control. A pesar de esto, y en contradicción con la visión humanista de la universidad, la institución pública sostiene y aumenta esta forma de contratación. (Spanish) [ FROM AUTHOR] Copyright of Revista Reflexiones is the property of Universidad de Costa Rica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Risk, Responsibilisation and the Political Economy of the Pandemic in the UK

In this chapter, I argue that there are two significant aspects to the British government's response to the Covid virus. One was a focus on individuals rather than infrastructure or state capacity. The second was a technocratic legitimation of policy as ‘science led' with no alternatives possible. I will argue that although the Covid response was unprecedented in British history as a way of dealing with a public health problem, the British government's policy response to Covid is one that can be understood as a continuation of the way in which British policy has developed over the course of several decades. I will situate British Covid responses in a context of a post-Cold War shift in the way in which the state exercises power. In essence, I will argue that over the course of the post-Cold War period there has been a turn away from directly governing and enacting policy and a shift to justifying policy choices by claiming authority that derives from above and beyond the citizens. This, I suggest, can help to explain the trajectory of British Covid responses. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.

A Secure Blockchain-Assisted Access Control Scheme for Smart Healthcare System in Fog Computing

IoT-based smart healthcare system allows doctors to monitor and diagnose patients remotely, which can greatly ease overcrowding in the hospitals and disequilibrium of medical resources, especially during the rage of COVID-19. However, the smart healthcare system generates enormous data which contains sensitive personal information. To protect patients’privacy, we propose a secure blockchain-assisted access control scheme for smart healthcare system in fog computing. All the operations of users are recorded on the blockchain by smart contract in order to ensure transparency and reliability of the system. We present a blockchain-assisted Multi-Authority Attribute-Based Encryption (MA-ABE) scheme with keyword search to ensure the confidentiality of the data, avoid single point of failure and implement fine-grained access control of the system. IoT devices are limited in resources, therefore it is not practical to apply the blockchain-assisted MA-ABE scheme directly. To reduce the burdens of IoT devices, We outsource most of the computational tasks to fog nodes. Finally, the security and performance analysis demonstrate that the proposed system is reliable, practical, and efficient. IEEE

An exploratory study of organisational and industry drivers for the implementation of emerging technologies in logistics

Purpose: Emerging technologies have the capacity to transform industries offering substantial benefits to users. Given the increasing demand for advanced logistics services, third-party logistic service providers (LSPs) face greater pressure to deploy and realise these technologies, especially given the demands and operational challenges created during the COVID-19 crisis. Drawing upon the diffusion of innovation (DOI) theory and technology–organisation–environment (TOE) framework, this paper goes beyond just identifying drivers and barriers to technology adoption to understanding how LSPs and industry experts perceive these drivers and barriers and simultaneously confront and undertake actions to implement them. Design/methodology/approach: An exploratory study was conducted in three phases: (1) in-depth interviews with twelve stakeholders in the Australian logistics industry;(2) five in-depth interviews conducted with stakeholders during the COVID-19 crisis and (3) a focus group discussion session. All interviews were analysed using content analysis and revealed several drivers for the deployment of emerging technologies, including internal organisational factors that drive supply chain (SC) network optimisation. Findings: The analysis of the three phases identified several drivers for the deployment of emerging technologies in logistics, including internal organisational factors that drive SC network optimisation. Also identified were external drivers including the impact of the COVID-19 crisis, along with barriers and specific actions that were considered and implemented by LSPs for sustainable operations, particularly in a post-COVID-19 environment. Originality/value: This study explores organisational and industry drivers for the implementation of emerging technologies. Explicitly, it extends the extant research by highlighting organisational and industry drivers and enablers that influence adoption and deployment of emerging technologies. Second, it advances the existing perspectives on LSPs in the Australian context on the development and implementation of technology strategies. The paper offers insights around implementation of technologies, directly obtained from industrial application for managers and practitioners. © 2023, Emerald Publishing Limited.

SYSTEMIC APPROACH TO COPING WITH SUPPLY CHAIN DISRUPTIONS: A CASE FOR CORPORATE GOVERNANCE

Global disruption of supply chains caused by the Covid-19 pandemic had led to reassessment of how logistic functions are integrated into operations and management goals. This paper is based on semi-structured interviews of stakeholders engaged in freight transportation, carried out in the post-Covid period. It also includes a case study of a leading pharma company that illustrates how the top management has successfully dealt with today's disruption-prone business environment. This paper contends that Supply Chain Management (SCM) and distribution logistics are too critical to be relegated to the background even when an organisation chooses to outsource them. It highlights the ongoing debates on mitigative measures and recommends that corporate governance needs to accommodate logistics functions under its fold so as to establish a systemic approach to cope with future disruptions.