Impact of Pandemic on Permanent Procedures

Conducting virtual audits, conducting effective virtual training, and enhancing communications with suppliers to ensure an uninterrupted supply chain are among the changes implemented to maintain operations, stay compliant, and continue manufacturing medically necessary products. The necessity for virtual audits was to allow companies and regulators to continue to evaluate the compliance stature of manufacturers while respecting stay-at-home and social distancing requirements that prevented in-person site audits. Some of these venues are free, and some require a registration fee. supply chain quality Enhanced communication with suppliers to ensure an uninterrupted supply chain has also become a priority during the pandemic.

Supplier change, market competition and enterprise innovation

PurposeThe purpose of this paper is to study enterprise innovation in the perspective of external supplier relationship. On this purpose, this paper examines the impact of supplier change on enterprise innovation with the moderating role of market competition.Design/methodology/approachUsing 2012–2020 empirical data of Chinese listed manufacturing enterprises, this paper investigates the relationship among supplier change, market competition and enterprise innovation through a two-way interaction model.FindingsThe results show that supplier change has a negative impact on enterprise innovation. And market competition intensifies the negative relationship between supplier change and enterprise innovation. Additional analyses indicate that the main effect and the moderating effect are more significant when the enterprise is non-state-owned or has lower ownership concentration.Originality/valueThis paper studies enterprise innovation from the perspective of external stakeholders. It focuses on supplier relationship in a dynamic variation view, instead of the traditional static ones. Moreover, this paper explores the contingency effect of market competition and gives practical implications for managers to adjust innovation strategy flexibly.

The Impact of COVID-19 on Supply Chain in UAE Food Sector

The COVID-19 outbreak has significantly impacted supply chains and has caused several supply chain disruptions in almost all industries worldwide. Moreover, increased transportation costs, labor shortages, and insufficient storage facilities have all led to food loss during the pandemic, and this disruption has affected the logistics in the food value chain. As a result, we examine the food supply chain, which is one of the key industries COVID-19 has detrimentally affected, impacting, indeed, on the entire business process from the supplier all the way to the customer. Retail businesses are thus facing supply issues, which affect consumer behavior by creating stress regarding the availability of food. This has a negative impact on the amount of food that is available as well as its quality, freshness, safety, access to markets, and affordability. This study examines the impact of COVID-19 on the United Arab Emirates food distribution systems and how consumer behavior changed in reaction to interruptions in the food supply chain and the food security problem. Hypothesis testing was used in the study's quantitative methodology to assess consumer behavior, and participants who were consumers were given a descriptive questionnaire to ascertain whether the availability and security of food had been impacted. The study used JASP 0.17.2 software to develop a model of food consumption behavior and to reveal pertinent connections between each construct. Results show that consumer food stress and consumption behavior are directly impacted by food access, food quality and safety, and food pricing. Furthermore, food stress has an impact on how consumers behave when it comes to consumption. Food stress, however, is not significantly influenced by food supply.

Stakeholder Analysis: Medicare Diabetes Prevention Program Awareness and Implementation

Study Design: We conducted a qualitative stakeholder analysis project with suppliers of the MDPP and health care providers. Am J Manag Care. 2023;29(6):In Press _____ Takeaway Points More than 5 years after CMS enacted coverage of the CDC-approved Medicare Diabetes Prevention Program (MDPP) in 2018, little is known about why MDPP uptake is so limited. * Findings of our stakeholder analysis with program suppliers and health care providers reinforced existing evidence on insufficient reimbursement and low awareness of the program. * Newer insights include recommendations about lagged payments, ongoing virtual delivery, and formally diagnosing prediabetes among MDPP participants. * Our findings on barriers and facilitators can inform policy to refine the MDPP and research on the MDPP, particularly within the field of implementation science. _____ Population-level strategies to prevent type 2 diabetes are urgently needed for the more than 24 million older adults with prediabetes in the United States.1 Evidence-based lifestyle interventions can prevent diabetes onset, per evidence from the landmark Diabetes Prevention Program trial.2 Thus, the CDC launched the National Diabetes Prevention Program (NDPP) in 2010.3 Significant reductions in weight and medical spending were observed among Medicare beneficiaries who participated in the NDPP,4 prompting CMS to fully cover the Medicare Diabetes Prevention Program (MDPP) starting in 2018.5 Despite unprecedented Medicare coverage for a disease prevention program, MDPP uptake is limited. Regarding awareness, national guidelines recommend referral to lifestyle intervention for adults aged 40 to 70 years with prediabetes.9 Yet less than 5% of adults eligible for a NDPP reported receiving a referral,10 which may stem from limited awareness among health care providers.11 Thus, we conducted a qualitative stakeholder analysis to learn about regional awareness of, referral to, facilitators of, and barriers to the MDPP. The 8 interviewees included 5 program directors (3 from YMCAs, 1 from a private organization, and 1 from a hospital system) and 3 health care providers (2 family physicians and 1 dietitian).

Demonstrating the Value of Collaboration

[...]of the search for effective vaccines and treatments for COVID-19 being a priority, the development and manufacture of other treatments have been delayed, he adds. Through these industry collaborations, many developers have gained benefits, such as reduced time-to-market for new products, he specifies. [...]Quick believes that there will be more companies leaning towards outsourced services in the future, for development work and commercialization phases too. Given the disruption to the global pharmaceutical supply chain that has been experienced during the pandemic, O'Sullivan predicts that there will be opportunities for API suppliers in Europe, and elsewhere, to prosper from increased local demand, so long as the capacity and flexibility to deliver the required quantities are on available. [...]we will see significant investment by European API suppliers in expanded production capacity and capabilities in 2021 in order to attract Europe-based customers on the look-out for new local partners," he says. [...]Cruz emphasizes the rise of electronic health and customer records across Europe as an exciting prospect, particularly as it can lead to companies gaining a greater insight into treatments and customer needs.

Securing the Supply Chain

According to market research, the API market is expected to experience a compound annual growth rate of 6.7% in the forecast period of 2020-2027 (1). "The low-cost benefits of manufacturing APIs and drug products within Asia has helped to turbocharge the generic drug industry and expand global access to a range of lower-cost medication options," says Meudt. "The shift has been positive for patients, allowing consumers to benefit from lower cost drugs from US Food and Drug Administration (FDA) and European Union (EU) inspected current good manufacturing practice (cGMP) facilities while still maintaining quality, innovation, and allowing efficient drug development and commercialization routes," he says. "While manufacturing cost will always be important, pharmaceutical companies are increasingly selecting their long-term CMOs based upon other factors including security of quality and supply, regulatory track record, data control, and environmental sustainability.

Supplier selection framework to evade pseudo-resilience and to achieve sustainability in supply chains

PurposeDue to increasing uncertainty in the global business scenario, research on supply chain resilience is gaining significance. The outbreak of the COVID-19 pandemic has accelerated and magnified the issues already pertaining in the supply chain thereby increasing the vulnerabilities in the network. This study attempts to build the concept of pseudo-resilience in supplier selection and evaluation for supply chain sustainability.Design/methodology/approachA combination of multi-criteria decision-making methods AHP and R is adopted, and an integrated method called Combined AHP–R method is used to identify and include the property of pseudo-resilience into supplier selection processes.FindingsThe authors identified various factors contributing to pseudo-resilience considering supplier selection process and found the most important attribute. Using the combined AHP–R method, the suppliers were evaluated, considering the attributes contributing to the pseudo-resilience of supply chains and best supplier was selected.Originality/valueTo the best of our knowledge, this is the first study addressing a supplier selection problem for sustainable supply chains, considering pseudo-resilience. Also, this is the first study to apply the AHP–R method for supplier selection in the resilience or sustainability context.

Criteria Clustering and Supplier Segmentation Based on Sustainable Shared Value Using BWM and PROMETHEE

With the advent of healthy visions, two of the trends that have become extremely important in the supply chain in recent decades are corporate social responsibility (CSR) and sustainability, which have affected the activities of buyers and suppliers. The next trend that is emerging is the vision of creating shared value (CSV), which wants to move the supply chain toward solving social problems in a completely strategic way. This research intends to develop a step-by-step framework for evaluating and segmenting suppliers based on CSV criteria in the supply chain. In the first stage, the criteria for creating sustainable shared value (CSSV) are obtained through existing activities in the field of CSR. The obtained criteria are then divided into two categories, strategic and critical, and then the weight of each criterion is obtained using the best–worst method (BWM). In the next step, based on the Kraljic model, the suppliers are divided into four clusters using the preference ranking organization method for enrichment evaluation (PROMETHEE) technique. This framework helps the buyer to conclude and select purchasing decisions and relationships with suppliers through the lenses of CSV and sustainability.

Guest editorial: Post-COVID-19 sustainable supply chain management in emerging markets

Since the early 2000s, emerging markets have become the heart of global supply chains hosting a large volume of industrial productions. The second article looked into the barriers to attaining sustainability in supply chain of the Bangladeshi pharmaceutical sector and developed a hierarchical structure of those barriers using interpretive structural modeling and MICMAC analysis. The eleventh article explored a new way to assess suppliers' suitability by considering pseudo-resilience factors to achieve SSC in the post-COVID-19 era using an analytical hierarchy process and R. It also provided a case study of three smartphone processor suppliers (Jessin et al., 2023).

Protecting the NHS from Cyber Attacks

Given that cyber security underwrites public trust in digital services and technologies, the new cyber strategy sets out a vision for reducing the cyber security risk to health and social care organizations across the Department of Health and Social Care (DHSC), National Health Service (NHS) organizations, local authorities, independent social care providers, and suppliers-which includes pharmaceutical manufacturers. [...]attacks can cause a complete loss of access to clinical and administrative information technology (IT) systems, resulting in significant disruption in day-to-day operations. According to the NCSC, ransomware attacks are increasingly seen to include data theft and extortion with a threat of data leaks (3). According to the UK government's recently published policy paper outlining the new cyber security strategy, "all these threats pose risk not just to patient and staff safety, but also to public trust in a health and social care system that can and must safeguard people's data" (2).

Drivers of digital supply chain transformation in SMEs and large enterprises – a case of COVID-19 disruption risk

PurposeDigital transformation in supply chains (SCs) has emerged as one of the most effective ways to minimize SC disruption risks. Given the unprecedented impact of the COVID-19 pandemic on global SCs, this study aims to identify and provide empirical evidence about the drivers of digital SC transformation, considering the interactivity between environmental dynamism, technology, and organizational capabilities during the pandemic era.Design/methodology/approachUsing partial least squares structural equation modeling (PLS-SEM), this study examines 923 firms in Vietnam to ascertain the drivers of digital SC transformation between small- and medium-sized enterprises (SMEs) and large enterprises, based on the technology–organization–environment (TOE) as an overarching framework.FindingsThis study finds that greater digital SC transformation adoption could be achieved under the interactivity between the TOE components of firms' technological competencies, learning capabilities, and disruptions in socioeconomic environments due to the COVID-19 pandemic. Moreover, a multigroup analysis shows that the drivers of digital SC transformation differ between SMEs and large enterprises. SMEs were found to be more motivated by the COVID-19 disruption risk when adopting digital SC models.Originality/valueThis study represents an original and novel contribution from Vietnam as an emerging market to the literature on the impact of COVID-19 on the global value chain. Apart from the unique dataset at the firm level, the analysis of interactions between external and internal drivers of digital SC transformation could provide crucial managerial implications for SMEs to survive major disruptions, such as those caused by the COVID-19 pandemic.

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).

European Pharmacopoeia Updates: EDQM Tackles Nitrosamine Impurities

Vielle (EDQM): The new chapter 'Test for bacterial endotoxins using recombinant factor C' (2.6.32) describes a bacterial endotoxins test using a recombinant factor C based on the gene sequence of the horseshoe crab and fluorimetric detection. [...]a new general chapter on 'Multivariate Statistical Process Control' (5.28) was published in Supplement 10.4. [...]the control of W-nitrosamines has been moved to the Production section, which now requires a risk assessment and, if necessary, a modification of the manufacturing process and the implementation of a control strategy.

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.

Scaling Up Fast

The added pressure of meeting accelerated deadlines during a pandemic presents additional challenges for process development, materials supply, equipment acquisition and installation, and process validation. Experience of model design and in the identification of potential critical process parameters (CPPs) are crucial to the successful scale up of new chemical entities (NCEs). Supply chains must secure sufficient supply of additional raw materials to meet expanded production. [...]it is important to accept only projects that fit the capabilities of the organization to avoid failure, especially in times of drug shortages.

Ensuring a Safe and Robust Supply of Pharma Materials

In the short term, Sebastian Tomlin, logistics manager at Charles River, a contract research and development firm, says that time and investment in supply chain management and logistics operations are needed to expedite the movement of materials during this crisis. "By far, a cradle-to-grave supply chain with local starting materials, ingredients, and excipients for essential drug production will help to support resilient supply chains by removing the reliance on imports and driving new investments in green chemistry and Pharma 4.0 efforts." Maintaining a high safety stock of critical APIs and other materials is imperative, says Vincent Colicchio, vice-president and Head-Supply Chain and External Manufacturing for North America Generics at Dr. Reddy's Laboratories. Having a stringent process for qualifying material suppliers is also important, according to Hamilton Lenox, senior vice-president, business development at LGM Pharma, an API sourcing and supply chain management company.

Is the Packaging Supply Chain Ready?

[...]SCHOTT, which operates a global validated production network with 20 plants and more than 600 production lines for pharma glass and packaging, already has delivered millions of glass vials to SARS-CoV-2 programmes including supplying three out of every four COVID-19 vaccine projects undergoing Phase I, II, and III testing (3). Since we produce the pharmaceutical glass tubing for the packaging ourselves, we are also able to adjust the capacities for glass production in advance, which also benefits packaging manufacturers who do not have their own glass production facilities." "Since our sites are already validated by the authorities and by major pharma companies, our expansion is happening at a very fast pace," reports Stöcker. Per the agreement ... with BARDA [Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response], Corning will provide priority access to designated BARDA vaccine and drug development partners."

Supply Chain Challenges Creating Hurdles to COVID-19 Vaccine Production

BioPlan Associates interviewed front-line bioprocessing decision-makers to assess and highlight the general bioprocessing, raw materials, and supply chain challenges associated with COVID-19 vaccines, together with need for approaches to moderate risks and avoid delays. From basic raw materials (e.g., buffers, resins, sodium chloride), to consumables (e.g., single-use bags, tubing, sterile filters) and fill/finish (e.g., vials, stoppers)-these all need to be available and in place for the system to function. The ad hoc approach to bioproduction of the various vaccines in development and in production has, and will continue to, lead to competition for raw materials, consumables, and supplies. Too little capacity, and life-saving medicines do not get manufactured in time. [...]measuring production capacity and capacity utilization has been important in assessing the industry's ability to balance supply and demand.

Analyzing the effects of COVID-19 pandemic on supplier performance evaluation factors via fuzzy cognitive map with a hybrid learning system

PurposeThe COVID-19 pandemic has proven that how supply chain management (SCM) can become a crucial process for sustainability of the world's production/service. The global supply chain crisis during pandemic has affected most of the sectors. Home and personal care products manufacturers are among them. In this study (1) the problems at SCM of personal and home care products manufacturers during pandemic are discussed with the help of medium-size manufacturer and (2) the factors affecting suppliers' performance for the relevant sector during COVID-19 are analyzed comprehensively.Design/methodology/approachThe importance of the factors is evaluated using fuzzy cognitive maps that can help to reveal hidden casual relationships with the help of expert knowledge. In order to eliminate subjectivity due to usage of expert knowledge, the maps are trained with a hybrid learning approach that consists of Non-linear Learning and Extended Great Deluge Algorithms to increase robustness of the analysis.FindingsThe findings of the study indicate that the factors such as general quality level of products/services, compliance to delivery time, communication skills and total production capacity of suppliers have been crucial factors during pandemic.Originality/valueWhile the implementation of the hybrid learning approach on supply chain can fill the gap in the relevant literature, the promising results of the study can prove the convenience of the methodology to model the of complex systems like supply chain processes.

Tracking API Quality During a Pandemic

With additional safety protocols required in the manufacturing environment, gatherings of large people generally prohibited, and onsite inspections limited due to restricted travel, ensuring quality throughout the supply chain from raw material to API is more challenging. Employee safety is always a priority for Thermo Fisher Scientific, and since the start of the COVID-19 pandemic the company has focused on protecting their health and safety while continuing to serve the needs of its customers, according to Vice President of Drug Substance Quality, Ben Gerlach. [...]of the support, flexibility, and discipline of our colleagues and supply chain partners, as well as the IT infrastructure available, all Thermo Fisher API manufacturing sites have remained operational since the start of the pandemic with continued GMP compliance," Gerlach remarks. Expanding our footprint and ensuring supply chain redundancy has enabled us to minimize the risk of supply chain interruptions and work with partners efficiently," he explains. Because of the circumstances connected with COVID-19, Ross also stresses that it is extremely important to frequently engage with supply chain partners to ensure that Cambrex understands the impact of the pandemic on their businesses and any potential downstream effects on Cambrex's unit operations that might ensue.