Life Science Innovation Research Articles

Stem Cell Patentability: Legal Challenges

Stem cells are versatile cells capable of self-renewal and differentiation into different specialized cell types. Their immense potential has led to a surge in research and practical applications medicine. Patentability of the stem cells has been a subject of controversy, with concerns that restrictions on access to crucial technologies could hinder the translation of research into practical medical applications. It is a promising field that's rapidly advancing and has the potential to revolutionize modern medicine. The patentability of stem cells faces several legal challenges, including ethical, moral, and religious concerns, as well as difficulties in obtaining a patent license. Patent protection is crucial for driving innovation and commercial success in regenerative medicine and life sciences. This article examines the patentability restrictions and specific challenges associated with human stem cell patents in Europe and the United States.

Collaboration for new therapies: maximizing health and innovation.

Innovative medicines and vaccines can provide direct health benefits to patients and populations by preventing, treating and curing diseases, and also drive wider socioeconomic and productivity gains. However, researching and developing them is complex and risky. Funding for life sciences R&D has different sources: public, charitable/NGO, and private sector. We believe there is consensus that all are required, although there is less understanding about their respective roles, synergies, and funding priorities. The purpose of this paper is to provide an overview of the current life sciences innovation ecosystem in Europe, highlighting challenges for funding and innovation of new therapies and our proposed options to address these. The basis of this paper stems from the reflections made by the co-authors during a webinar with title "Collaboration for new therapies: maximising funding and innovation," in March 2023, with further targeted literature reviews. We identify eight challenges in the European life sciences ecosystem, some closely related, and nine options that we think might be helpful to address them. Each option on its own can have different levels of 'impact', but collectively will provide synergies among them, and thus maximize their impact. It is critical to ascertain how the strengths of each actor can be leveraged to bring new medicines/treatments to market, quicker and more efficiently. We need a trusted environment, with strategic collaborations between the public and private sectors, and policy initiatives and incentives should be targeted to strengthen the infrastructure with the aim of fostering such optimal alliances.

The evolving role of technology transfer offices in the entrepreneurial university: Go-betweens or playmakers?

AbstractTechnology transfer offices (TTOs) play an increasingly important role in universities, supporting researchers in translating science knowledge into commercially and socially valuable outcomes. However, the literature is limited regarding how TTOs support the technology transfer process. This study contributes deeper insight into the role of TTOs in facilitating knowledge transfer outcomes. A case study of life science commercialization in Australasian universities drew on depth interviews with senior TTO managers and industry experts, on longitudinal participant observation within a life science intermediary business to inform about supply side elements, and on secondary data. The findings emphasise the effects of wider institutional change on quintuple helix (5H) stakeholders, i.e., the environment, society, government, universities, and industry. Financialization and competition places growing demands on universities for commercializable intellectual property (IP) production. In response, TTOs have built competencies in translational engagement (trust and reputation building and boundary spanning) and value co-creation (service quality management and de-risking). Those competencies translate to a five-stage process of technology transfer facilitation: (1) Identifying, (2) assessing, (3) protecting, (4) promoting and (5) profiting. In the complex context of life science innovation, innovation networks benefit from investment in university outreach, stakeholder relationship building, tax credits, and fund matching with transnational corporations. To ensure optimal social and commercial outcomes independent oversight of the process should be maintained, by representatives from all 5H stakeholders.

Liquid-Metal Molecular Scissors.

Molecules are the smallest units of matter that can exist independently, relatively stable, maintaining their physical and chemical activities. The key factors that dominate the structures and properties of molecules include atomic species, alignment commands, and chemical bonds. Herein, we reported a generalized effect in which liquid metals can directly cut off oxygen-containing groups in molecular matter at room temperature, allowing the remaining groups to recombine to form functional materials. Thus, we propose basic liquid-metal scissors for molecular directional clipping and functional transformations. As a proof of concept, we demonstrate the capabilities of liquid-metal scissors and reveal that the gallium on the surface of liquid metals directly extracts oxygen atoms from H2O or CH3OH molecules to form oxides. After clipping, the remaining hydrogen atoms from the H2O molecules recombine to form H2, while the remaining fragments of CH3OH produce H2, carbon materials, and carboxylates. This finding refreshes our basic understanding of chemistry and should lead to the development of straightforward molecular weaving techniques, which can help to overcome the limitations of molecular substances with single purposes. It also opens a universal route for realizing future innovations in molecular chemical engineering, life sciences, energy and environment research, and biomedicine.

Life Science Incubation at LabCentral/BioLabs with Partners Extending from the USA to Europe.

This chapter provides a blueprint for accelerating biotech and life sciences innovation using public-private partnerships to create innovation infrastructure that become a platform for scientific breakthroughs and economic growth. Examples are provided on creating standalone co-working labs as well as through partnerships with academic and healthcare system partners both in the United States and Europe. Risks and challenges are addressed as well as the overall benefits to the broader public of investing public funds in biotech and life science infrastructure versus individual companies based on the potential impact to global public health from new treatments, therapies, devices, and diagnostics.

Revolutionizing Biological Science: The Synergy of Genomics in Health, Bioinformatics, Agriculture, and Artificial Intelligence.

With climate emergency, COVID-19, and the rise of planetary health scholarship, the binary of human and ecosystem health has been deeply challenged. The interdependence of human and nonhuman animal health is increasingly acknowledged and paving the way for new frontiers in integrative biology. The convergence of genomics in health, bioinformatics, agriculture, and artificial intelligence (AI) has ushered in a new era of possibilities and applications. However, the sheer volume of genomic/multiomics big data generated also presents formidable sociotechnical challenges in extracting meaningful biological, planetary health and ecological insights. Over the past few years, AI-guided bioinformatics has emerged as a powerful tool for managing, analyzing, and interpreting complex biological datasets. The advances in AI, particularly in machine learning and deep learning, have been transforming the fields of genomics, planetary health, and agriculture. This article aims to unpack and explore the formidable range of possibilities and challenges that result from such transdisciplinary integration, and emphasizes its radically transformative potential for human and ecosystem health. The integration of these disciplines is also driving significant advancements in precision medicine and personalized health care. This presents an unprecedented opportunity to deepen our understanding of complex biological systems and advance the well-being of all life in planetary ecosystems. Notwithstanding in mind its sociotechnical, ethical, and critical policy challenges, the integration of genomics, multiomics, planetary health, and agriculture with AI-guided bioinformatics opens up vast opportunities for transnational collaborative efforts, data sharing, analysis, valorization, and interdisciplinary innovations in life sciences and integrative biology.

Uncovering new families and folds in the natural protein universe

We are now entering a new era in protein sequence and structure annotation, with hundreds of millions of predicted protein structures made available through the AlphaFold database1. These models cover nearly all proteins that are known, including those challenging to annotate for function or putative biological role using standard homology-based approaches. In this study, we examine the extent to which the AlphaFold database has structurally illuminated this ‘dark matter’ of the natural protein universe at high predicted accuracy. We further describe the protein diversity that these models cover as an annotated interactive sequence similarity network, accessible at https://uniprot3d.org/atlas/AFDB90v4. By searching for novelties from sequence, structure and semantic perspectives, we uncovered the β-flower fold, added several protein families to Pfam database2 and experimentally demonstrated that one of these belongs to a new superfamily of translation-targeting toxin–antitoxin systems, TumE–TumA. This work underscores the value of large-scale efforts in identifying, annotating and prioritizing new protein families. By leveraging the recent deep learning revolution in protein bioinformatics, we can now shed light into uncharted areas of the protein universe at an unprecedented scale, paving the way to innovations in life sciences and biotechnology.

Moving Research-Based Learning in Life Sciences Upstream, and Beyond Borders: An International Group Research Project for High School Youth.

International cooperation beyond borders, institutions, and intergenerationally is an important aspect of science and research-based learning. Timing of learning also matters. Early exposure to group research-based learning can potentially have lasting positive impacts on youth and their careers in life sciences. Here, we report our work on the International Group Project (IGP), which builds on the International Biology Olympiad (IBO) organized in Yerevan, Armenia, in 2022. The IBO is an annual international competition for high school students held since 1990 around the world. We envisioned the IGP as a novel opportunity for life sciences research-based education among youth. We formed diverse IGP research teams 2 months before the IBO, and comprised high school students from 32 countries, communicating in a digital environment via videoconferencing. Each team formulated a research question in an IGP theme from five domains of life sciences: "Biomedicine," "Molecular and cell biology," "Bioinformatics and Artificial Intelligence," "Bionics and Biomimicry," "Across Species." Subsequently, team members collectively solved their research question by applying life sciences methodologies under supervision from a facilitator scientist. Each team created a poster based on their research and presented in-person to the public at a satellite activity at the IBO. A special subcommittee of the IBO International Jury graded posters and allocated prizes based on scientific ingenuity and presentation quality. This experience from the IGP lends evidence to the feasibility of research-based learning in life sciences for high school youth beyond borders. Moving research-based learning upstream and internationally is well poised to advance 21st century life sciences from both interdisciplinary and intergenerational standpoints. The historic impact of the COVID-19 pandemic suggests that youth engagement in research-based learning and innovation in life sciences is timely.

Introducing 'Open Innovation in Life Sciences'

Introducing 'Open Innovation in Life Sciences'

Seeking Life Science Inno-vation Opportunities and Beyond: The Art of Blending Science, Medicine, and Business

This update on life science innovation extends Boni's 2018 works1,2 to include industry stakeholder expert opinion. This paper’s focus is to address three research questions relevant to innovation within the biopharmaceutical industry concerning 1) its current state, 2) challenges, opportunities, and frameworks, and 3) existing examples in the extant literature and practice relevant to progress and challenges. It utilizes mixed methods involving a 1) narrative review to establish a current understanding of the extant literature and frameworks and 2) qualitative interviews to coalesce themes around the core research questions. The first section summarizes current industry challenges, successes, and best practices that support sustained and disruptive innovation in the biopharma industry. It charts a brief overview of proven models for innovation, entrepreneurial thinking, and for development of open innovation as applied to this complex, challenging, continuously evolving industry. This initial discussion advocates the pursuit of commercialization that 1) incorporates a phased, interdisciplinary, collaborative approach and 2) blends the principles of business, science, and technology through diverse, collaborative teams, networks, and alliances. The paper transitions to a second section. This effort builds on these concepts and provides insights and alternative perspectives from a cohort of leading experts within the biomedical investment, development, and commercialization space. It also illustrates and leverages collective intelligence through interdisciplinary perspectives across the life science landscape and reinforces trends for pursuing innovation.

PSY6-4 Regulatory aspect of regional collaboration for medical products development in Asia

It's been a while since access to medicines and other essential medical products was recognized as one of the important agenda in global health. COVID-19 pandemic has been affecting every parts of the world and never before has international concord to facilitate development and to achieve access to new medical products been requested to tackle this ongoing threat regardless of development stage of each country. Regulatory authorities play a key role to assure quality, safety and efficacy of medical products. ICH and IMDRF composing of regulatory authorities including US FDA, EMA and MHLW/PMDA have long been leading global harmonization activities that minimize regulatory deviation among regulatory authorities and enable to develop medical products on a common ground. APEC's Regulatory Harmonization Steering Committee under the Life Sciences Innovation Forum further promotes it in Asia pacific region, making full use of deliverables of those initiatives. In addition to PMDA's participation in those global and regional initiatives, PMDA has been contributing to implementation of regulatory harmonization and reliance principle by providing training programs to regulators through Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) established in 2016. Moreover, with a recognition that access to medical products particularly in Asian region is essential for the realization of Universal Health Coverage (UHC), which is regarded as an integral part of Japan's contribution in global health, the Headquarters for the Healthcare Policy of Japan approved the Grand Design for Asian Pharmaceutical and Medical Devices Regulatory Harmonization in 2019 aiming at concretizing regulatory harmonization to contribute to the health of people in Asia. In accordance with the Grand Design, PMDA reorganized Office of International Programs and further contributes to regulatory harmonization in Asian region through multi- and bilateral cooperation.

COVID-19 Is a Crisis in Planetary Health and Politics of Expertise: Time to Think Critically and Innovate Both.

This expert review offers an analysis of the global governance of the COVID-19 pandemic. The pandemic is not only a health crisis but also a crisis of global governance. For example, the nation states in dealing with the crises of the pandemic have turned inwards, toward native and national solutions, and therefore away from the much-needed global cooperation to respond to the pandemic. This is an important concern for systems medicine and integrative biology in both normative and instrumental sense. Moreover, if we are to "pandemic-proof" the planet and the life science innovation ecosystem, new ways of understanding global governance are called for. This article examines the ways in which national governments have reacted to the crises triggered and embodied by the COVID-19 pandemic, surfaces the different approaches and conflicts between scientific experts and policy makers, and reveals the failure of science and politics. I analyze the uneven and disjointed way Western democratic governments have responded to the crisis and the way unchecked normative values and ideas have influenced the pandemic policy and prevented effective measures to contain the pandemic. Finally, the complex relationships between politics, knowledge, science, and governments are explored and clarified, and the way the COVID-19 crisis highlighted the long-standing tensions between technocracy and democracy. In conclusion, it is time to think critically and reflexively for all knowledge actors in systems science and innovate both planetary health and its global governance.

Measuring Progress of Regulatory Convergence and Cooperation Among Asia\u2013Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic

PurposeRegulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes—which can be achieved in part through regulatory convergence and cooperation—both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19.MethodsThe Asia–Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC’s 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence.ResultsThis paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation.ConclusionsConvergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19.

Creating Communities of Life Science Innovation in the US: History of Critical Factors That Helped the BioHealth Capital Region Emerge

Advancements in biotechnology are recognized as one of the most important scientific achievements of the 20th Century. The emergence of biotechnology profoundly impacted the health of the world, and the economic vitality of regions where bio clusters and bioresearch parks grew. This article explores some of the historical and policy implications undergirding this development in the United States and the importance of alignment of life science research activity, public policies, and leadership to build place-based communities of biotechnology innovation.

The COVID-19 crisis as an opportunity to strengthen global regulatory coordination for sustained enhanced access to diagnostics and therapeutics.

The coronavirus disease 2019 (COVID-19) pandemic presents an unparalleled opportunity for regulators globally to strengthen coordination, advance alignment initiatives, and exercise regulatory agility to facilitate access to the surge in diagnostics, therapies and vaccines without compromising public safety. We describe international collaborative initiatives, summarise key experiences, and urge the global regulatory community to apply lessons from the current pandemic to strengthen and sustain cooperation for future public health emergencies and enhanced health products access.

Sentiment Analysis of the News Media on Artificial Intelligence Does Not Support Claims of Negative Bias Against Artificial Intelligence.

Artificial intelligence (AI) is a hot topic in digital health, as automated systems are being adopted throughout the health care system. Because they are still flexible, emerging technologies can be shaped significantly by media representations as well as public engagement with science. In this context, we examine the belief that negative news media coverage of AI-and specifically, the alleged use of imagery from the movie Terminator-is to blame for public concerns about AI. This belief is identified as a potential barrier to meaningful engagement of AI scientists and technology developers with journalists and the broader public. We name this climate of risk perception the "Terminator Syndrome"-not because of its origins in the movie of the same name per se, but because such unchecked beliefs can terminate broad public engagement on AI before they even begin. Using both quantitative and qualitative approaches, this study examined the hypothesis that the news media coverage of AI is negative. We conducted a sentiment analysis of news data spanning over six decades, from 1956 to 2018, using the Google Cloud Natural Language API Sentiment Analysis tool. Contrary to the alleged negative sentiment in news media coverage of AI, we found that the available evidence does not support this claim. We conclude with an innovation policy-relevant discussion on the current state of AI risk perceptions, and what critical social sciences offer for responsible AI innovation in digital health, life sciences, and society.

Branding and place identity of scientific innovation in life sciences

Branding and place identity of scientific innovation in life sciences

Stage-gate process for life sciences and medical innovation investment

Life science innovation has led to significant improvements in clinical outcomes and has been a source of financial growth for individuals and institutions capable of performing appropriate investments in this sector. Several groups have developed methodologies to assist medical technology innovators in the design and development activities. Unfortunately, these tools have not aided the general investment community to profit from these enterprises. This situation has contributed to a general reduction in risk capital directed towards life sciences compared to other industries. We review the current investment practices in the life science sector and present a comprehensive stage-gate model that aims to captures this investment process. An analysis of best practices and in-depth interviews with 68 life sciences investors and entrepreneurs worldwide are used to support such model. A single case-control study comparing life science investment execution within two similar investment firms was conducted to evaluate feasibility in the implementation of these practices. The stage-gate model includes (I) General vision and investment strategy definition; (II) Venture search, screening and rapid pre-evaluation; (III) Due diligence and negotiation of terms; (IV) Portfolio management, evaluation, and exit. The difference in execution of investment and results from a post-performance Root Cause Analysis were consistent with a reduction in perceived risk from the case company trained with the proposed model compared to the control. This suggests that our developed model and process may be useful in encouraging life sciences investment via evidence-based evaluations.

Recent lab‐on‐chip developments for novel drug discovery

Microelectromechanical systems (MEMS) and micro total analysis systems (μTAS) revolutionized the biochemical and electronic industries, and this miniaturization process became a key driver for many markets. Now, it is a driving force for innovations in life sciences, diagnostics, analytical sciences, and chemistry, which are called 'lab-on-a-chip, (LOC)' devices. The use of these devices allows the development of fast, portable, and easy-to-use systems with a high level of functional integration for applications such as point-of-care diagnostics, forensics, the analysis of biomolecules, environmental or food analysis, and drug development. In this review, we report on the latest developments in fabrication methods and production methodologies to tailor LOC devices. A brief overview of scale-up strategies is also presented together with their potential applications in drug delivery and discovery. The impact of LOC devices on drug development and discovery has been extensively reviewed in the past. The current research focuses on fast and accurate detection of genomics, cell mutations and analysis, drug delivery, and discovery. The current research also differentiates the LOC devices into new terminology of microengineering, like organ-on-a-chip, stem cells-on-a-chip, human-on-a-chip, and body-on-a-chip. Key challenges will be the transfer of fabricated LOC devices from lab-scale to industrial large-scale production. Moreover, extensive toxicological studies are needed to justify the use of microfabricated drug delivery vehicles in biological systems. It will also be challenging to transfer the in vitro findings to suitable and promising in vivo models. WIREs Syst Biol Med 2017, 9:e1381. doi: 10.1002/wsbm.1381 For further resources related to this article, please visit the WIREs website.

Unified economic ideas and their hybrid policies: the case of Swedish life science innovation work

ABSTRACT Institutional theory describes organisations as being open to external influences, including policy-making. Policy-making is in turn based on normative ideas that inform how markets and economies unfold. Policies may include wide-ranging concerns and trade-offs (as in science and industry policy) or may be detailed and specific (as in the case of, e.g. procurement policies in the medical technologies sector), but they tend to play a role in shaping markets. A study of the Swedish life science innovation field suggests that the policy shift in life sciences governance to what Berman [2008. ‘Why Did Universities Start Patenting? Institution-building and the Road to the Bayh-Dole Act.’ Social Studies of Science 38: 835–871] names a market logic. In the present case, the market logic is not sufficiently supported by favourable market conditions, leading to a ‘hybrid logic’ enforcing an enterprising ethos but otherwise remains couched within a bureaucratic innovation system not providing critical resources conducive to life science innovation – venture capital funds and commercial human resources. The outcome is arguably case of ‘over-entrepreneurialisation’.