Market development strategy and process performance of knowledge-intensive SMEs in the epidemic era: a process-oriented perspective

PurposeThis study analyzes in-depth how knowledge-intensive small and medium-sized enterprises (SMEs) can achieve higher new product development (NPD) process performance in the epidemic era and examine the internal development mechanism of knowledge-intensive SMEs in the process of continuous digital transformation.Design/methodology/approachThis issue is tested with partial least squares on data collected via a survey conducted from November 2021 to February 2022. The sample comprises 487 knowledge-intensive SMEs operating in China.FindingsThe results indicate that one form of cross-functional ambidexterity, market development strategy (MDS), plays an important role in process performance from an inside-out financial perspective and an outside-in customer perspective. Simultaneously, product innovation efficiency (PIE) mediates the relationship between MDS and the above results. Big data analytics capabilities (BDACs) positively regulate the relationship between MDS and PIE.Research limitations/implicationsThe authors do not consider other contingency factors. Future research should introduce influential factors such as leadership and competitive intensity to further distinguish the effects of MDS on NPD process performance.Practical implicationsThe study findings offer suggestions to help knowledge-intensive SME managers better manage their NPD process by making better use of their limited resources in developing countries such as China.Originality/valueThis study is one of only a few to adopt a process-oriented perspective to specifically examine how one form of cross-functional ambidexterity, MDS, impacts knowledge-intensive SME process performance in the epidemic era. This study also extends the theoretical framework of cross-functional ambidexterity to BDAC research.

Opening Up Opportunities in 2023

"The ongoing journey to standardization on more aspects of submission and data exchange will continue to have an impact," he notes. lan Crone, business unit director Europe-fme Life Sciences, which provides business and technology services, points out that the web-based human variations electronic application form (eAF) for centrally authorized products (CAPs) has been available for use since 4 Nov. 2022 on the European Medicines Agency's (EMA's) new product lifecycle management (PLM) portal. Renato Rjavec, Amplexor Life Sciences "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/software as a service environment platform that brings foundational benefit to individual functions," states Steve Gens managing partner. Internal productivity and external regulatory requirements are both driving this data connectivity within industry, he adds, which "requires a clear cross functional digitization strategy and focus on cross-functional data governance, master data management, and ensuring all data from these various authoritative systems [are] at the same high level. " "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/ software as a service environment platform that brings foundational benefit to individual functions." -

Getting Proactive with Pharma Packaging

According to market research, the pharmaceutical packaging sector is expected to grow at a compound annual rate of 7.4% between 2022 and 2031, reaching an estimated USS178.8 billion (€171.8 billion) by the end of the forecast period (1). "Pharmaceutical waste continues to be a huge problem, so to eliminate non-biodegradable and single-use plastics from the supply chain, more research is taking place around bio-based PET [polyethylene terephthalate]. "By designing a product's primary and secondary packaging well from the outset (including investing ample resources into the process), manufacturers can reduce the amount of materials used and wasted, test new eco materials, ensure safety compliance and efficacy, and benefit from cheaper transportation costs," Quelch surmises. [...]pharma companies can benefit from a packaging supplier with a true global footprint," he says.

Taking an Alternative Approach to Drug Delivery

Increased awareness of the carbon footprint associated with pharmaceutical products and the replacement of high global warming potential (GWP) constituents used in the final product, or within the manufacturing process, may drive further diversification of formulation approaches in the future. [...]the nose offers an opportunity to deliver drugs directly to the brain or central nervous system (CNS) via the olfactory pathway. Two relatively recent commercializations for intranasal delivery are naloxone nasal spray to treat suspected opioid overdose emergencies and diazepam nasal spray for short term rescue treatment of seizure clusters. [...]in cystic fibrosis, the overproduction of mucus and alteration of mucus properties, represents a challenge for effective drug delivery by inhalation alone.

Overcoming Vaccine Development Challenges

According to recent market research, the vaccines market is expected to grow at a compound annual rate of 14.7% for the forecast period of 2020-2026 (1), the growth of which has been accelerated by the recent COVID-19 pandemic. Durability of glass vials at very low temperatures and permeability of plastic vials has complicated the packaging decisions as well." Since the beginning of the pandemic, the bio/pharma industry has been under pressure to produce stable formulations for effective vaccines in accelerated timescales, Blouet asserts. [...]the drive for a COVID-19 vaccine has occurred during a period of increased basic scientific understanding, such as in genomics and structural biology, supporting a new wave of vaccine development and production, she says. According to Phadnis, in addition to single-use technologies, automation for high throughput and robust analytical assays are necessary for rapid turnover during development and manufacturing of vaccines.

Q&A

In this interview, Sujay Jadhav, global vice president, study start-up, Oracle Health Sciences, touches on how COVID has affected study start-up and what new perspectives it has forced the industry to have on its own challenges. [...]assessing site ability to leverage telehealth will be a factor in site selection. Andy Studna is an Assistant Editor for Applied Clinical Trials Sujay Jadhav Global Vice President, Study Start-Up, Oracle Health Sciences Problems with startup, more than any other phase of a clinical trial, have the greatest potential to increase timelines and budgets.

Clinical Flexibility Breaks Through Drug Development Barriers

With J&J's vaccine, cell-line optimization was also crucial, not only for speeding the vaccine's development but for optimizing its manufacturability and stability, as Paul Stoffels, executive vice president and chief scientific officer told attendees at the 2020 Galien Forum (3). [...]more bio/pharma companies have been using data analytics, including artificial intelligence/machine learning (AIML), which can be applied to real-world data from such diverse data sources as electronic health records, lab test results, and insurance claims, to ensure that trial design and patient recruitment reflect actual conditions. Closer collaboration For bio/pharma companies, one fundamental change that is speeding drug development has been increased collaboration and cross-learning through partnerships, says Lance Minor, national co-leader of life sciences practice for the management consultant, BDO USA LLP. The new pilot would cover new, nontraditional methods of data collection or analysis methods;technologies such as tissue chips that serve as micromodels of specific organ systems for safety tests;and use of artificial intelligence and wearable sensors, which could be used during clinical trials.

New Sample Prep Products and Accessories for 2023

[...]instrument-based sample preparation technologies are presented. [...]attention is turned to other sample preparation accessories and supporting technologies. First is the Swift HLB-DPX tips. First is the Thermo Scientific AccelerOme sample preparation platform automating sample preparation for liquid chroma-tography-mass spectrometry (LC-MS) proteomics.

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.

EUROPE SEEKING CLARITY IN ADVANCED TRIALS

EU officials acknowledge that the trial landscape in response to the pandemic has been fragmented, with a multitude of small, national trials, struggling to generate robust and actionable clinical data, with great duplication of efforts and direct competition for shared resources and participant populations. The European drug industry worked on complex clinical trials in 2020 with researchers in the European Organization for Research into Treatments for Cancer and specialists in the Association of Clinical Research Organizations, as well as with the European Union's Clinical Trial Expert Group, composed of national health ministry officials. [...]the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is developing guidelines on Adaptive Clinical Trials with a timeline of 2023, and on Good Clinical Practice Renovation to address the increasing diversity of clinical trial designs and data sources.

EMA: A CHANGE IN CHARACTER AS WELL AS POWERS?

[...]the latest development crosses a new frontier: "Pharma companies need to focus more on R&D for innovative medicines against infections," it tweeted in mid-November. "Pharma companies need to boost research and development." EHU, as a brand, has yet to achieve enthusiastic endorsement from member states, who are suspicious of a stealthy power grab.

EU REPORT

[...]in March it created the COVID-19 pandemic task force, to manage and coordinate discussions on relevant product development, authorization and surveillance, and to conduct post-authorization follow-up of relevant authorized products. In particular, it is helping to meet the new challenges of the current health threat in the complexity of the disease, the variety of potential or repurposed medicinal products for prophylaxis or treatment, and the need for rapid clinical trials across Europe. "EMA will be flexible and pragmatic during the assessment of affected clinical trial data submitted as part of marketing authorization applications", it adds, encouragingly.

Sharpening the Focus on Patient-Centricity as Pandemic Continues

The foundation is rooted in strategic partnerships with contract research organizations (CROs), vendors, and associations who share collective wisdom to develop best practices or apply knowledge acquired from clinical care to the clinical trial realm. A recent analysis suggests that the global market for DCTs is expected to reach $10 billion by 2026, rising at a 6.5% compound annual growth rate between 2020-2026.2 As evidence of this growth, the SCRS/Medidata survey found that televisits, already used in the past two years by 45.1% of the 204 respondents, are likely to be adopted by an additional 39.2% of respondents in the next two years.1 The survey also reported that only 15.5% of respondents participated in decentralized or completely virtual trials in the past two years. Melissa Nezos, Vice President of Clinical Operations at Firma Clinical Research, a provider of in-home health services, comments on the ongoing shift toward DCTs. Regarding the use of more home-based visits, Rasmus Hogreffe, Vice President of Decentralized Clinical Trial Innovation at Medable, a provider of a DCT platform, says, "We are seeing rising decentralized trial adoption in the industry on a daily basis, including home visits.

Early-Stage Considerations for the Manufacture and Delivery of Vaccines

Vials are versatile;in addition to liquids, they can be used to package lyophilized and cryogenic products, as well as those in powder form. If there are stability issues, reformulation will be required;this decision will be influenced by the nature of the vaccine, preferred shipping methods, and the container options. In-house manufacture may require investment in new capacity for a dedicated line for mass production of a single product or a flexible filling operation that can handle multiple products and different size vials. Depending on the future global needs for vaccinations, prefilled syringes may gain a significant market share.

Manufacturing Materials for Clinical Trials

CDMOs need to gauge their internal capacity of temperature storage units, form strategic partnerships with logistics companies, and potentially offer validated temperature storage of clinical trial material. Through the use of secure document sharing platforms, remote viewing systems, and virtual site tours, clients can be assured they will be able to perform a thorough review of facilities and quality systems and have connections with the subject matter experts and remote access to live action activities to meet their programme requirements and quality standards. To ensure projects continue to run to time, it is vital that upper management and business development have the ability to check in constantly. Hoerner (Purisys): Modelling and simulation tools have been extremely valuable to reduce the amount of work required for scale-up;for example, engineering technologies such as Scale-up Systems' Dynochem can model solvent swaps, drying, distillation, off-gassing, and many other fundamental elements of synthetic and chemical processes.

Integration of RFID strategic value attributes mechanism decision in apparel supply chain: fuzzy AHP-TOPSIS approach

PurposeThe purpose of this paper is to identify the radio frequency identification (RFID) strategic value attributes (RFIDSVAs) mechanism selections preferences and also integration of RFID tags with technology coordination tools (IRTWTCTs) alternatives ranking performance decisions in supply chain management (SCM). RFID-enabled techno-economic feasibility decisions are enhancing the SC visibility in apparel supply chains (ASCs). The RFIDSVAs mechanism selections have performed significant agility to strategic competitive advantages, namely, inventory visibility, multi-tags ownership transfer within trusted third party, etc.Design/methodology/approachFuzzy analytical hierarchy process (FAHP) and FAHP-fuzzy Technique for Order of Preference by Similarity to Ideal Solution (FTOPSIS) approaches have been used to evaluate the quantitative assessment of RFIDSVA mechanisms selection decision based on weight priority orders and IRTWTCTs alternatives selection in ASC networks. The comparison of FAHP and FAHP-FTOPSIS approaches to evaluate the integrated framework develop in RFIDSVAs mechanisms and IRTWTCTs alternatives selection decisions in Indian multi-tier ASC networks.FindingsThe result found that the FAHP-FTOPSIS approaches have used to prioritizing the RFIDSVA mechanism selection weights and also identify the IRTWTCTs alternatives ranking preferences order in apparel SCM. The comparison between the FAHP and FAHP-FTOPSIS approach to quantitative assessments from RFIDSVA mechanisms and IRTWTCTs alternatives selection decisions, which enable them SC agility potential across multi-tier visibility in ASC networks. ASC stakeholders can be benefited by techno-economic feasibility decisions, RFID-enabled shop floor activities, multi-tags ownerships transfer in SCs and knowledge-based cryptography tags/items separation in SCs.Research limitations/implicationsThe research work has considered only five RFIDSVA mechanisms and also three integration of RFIDTWTCTs alternatives in multi-tier ASC. The strategic competitive advantages are achieved by RFID-enabled break-even tags price decisions and also techno-economic feasibility decision by contractual design multi-tier SC stakeholder's involvements.Practical implicationsThe pilot project study explores that the quantitative assessment decision has based on RFID-enable techno-economic feasibility in ASCs. Stakeholders can be benefited by inventory control of the financial losses, reducing the inventory inaccuracies and multi-tags ownership transfer within trusted third-party traceability in ASC networks.Originality/valueThis study explores the RFID-enabled apparel SC process and activities visibility (natural fibre's fibre producer, fibre dyeing producer, yarn spinning producer, knitting and finishing producer).

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).

Meeting unanenges i. Solid-Dose Packaging

[...]PCI Pharma Services offers a range of packaging options so drawbacks and benefits can be assessed for each material. Paperboard and paper stock for labelling have been in particularly short supply. [...]he says, "when we look at the private-label market, we are seeing that companies are holding their supply-chain inventory extremely tight, and packaging operators are seeing more line changeovers to accommodate smaller and shorter packaging runs." Recently granted patents in both the US and Europe, the Holo-Blister technology enables conventional heat-seal blister packaging equipment to cost-effectively apply custom holograms to the back of blister packs. [...]

Five Tips to Help Research Sites Implement Decentralized Clinical Trials

Carefully evaluate which components of each study can be decentralized, such as using remote monitoring devices to collect vitals such as weight and blood pressure without an in-person visit." DCTs benefit sites by providing3: * Expanded trial access and diversity of participants * Improved data accuracy' and robustness * Improved patient engagement and retention * Expedited patient identification and cost reduction * Increased capacity for additional studies As sites become more comfortable with DCTs, they may realize that DCTs can actually enable a closer patient-physician/site relationship than a traditional, randomized clinical trial can. [...]the solution must be HIPAA compliant." With any new process, understanding the why's and how each person benefits helps to ensure success. Since coordinators will be a source of tech support for patients, establish a "super user" at each location. Real-time information also means real-time responsibility. [...]structures need to be in place for responding to data collected through the technology and it may require new decision-support processes-experienced DCT technology providers can help map this out.

The Many Paths of Diversity in Clinical Trials

"Certain compounds affect certain populations," said Diana Foster, PhD, vice president, Strategy and Special Projects, Society for Clinical Research Sites (SCRS). A 2013 study of 167 new-molecule-based therapies showed that one in five of them acted differently in minority groups, in different races and ethnicities.4 "Diversity certainly has a higher profile now, but pharma began funding [our Diversity Site Assessment Tool project] four years ago," said Foster. COVID-19 was not the irnpetus for pharma's current focus on diversity in its trials, said Marie-Pierre Hellio Le Graverand, MD, DSc, PhD, senior vice president and Pfizer's Clinical Development & Operations, Global Product Development lead. In 1932, J.M. Adams wrote about the differences in blood pressure levels between a "group of white and [African American] workmen" in the American Journal of Medical Sciences.7 Researchers then started reporting that different types of people react differently to medical therapies.