Waiving intellectual property rights: Boom or bust for medical innovation?

Proposals to waive intellectual property rights (IPRs) on coronavirus 2019 (COVID-19)-related developments have gained considerable support among politicians, including from US President Biden, academics, nongovernmental organizations (NGOs), the media, and the general public. However, there are surprisingly few reflections about the short- and long-term consequences for medical innovation, particularly the development of new drugs and vaccines. In this feature, I reflect on the consequences for innovative entrepreneurial companies, the incentives to innovate, and consequences for international knowledge flows to low- and middle-income countries. I conclude that waiving IPRs reduces opportunities for entrepreneurial companies to attract sufficient funding for developing medical innovations. Low- and middle-income countries might suffer reduced knowledge inflows in the absence of IPRs that undermine their ability to develop medical innovations.

European countries in the race to attract successful biopharma investment: Winners and laggers.

The post-coronavirus era will open myriad opportunities for the biopharma industry. However, the extent to which each country will take advantage of this promising new scenario will largely depend on its position in a few key areas. Here, we offer an overview of the European countries that are winning and those that are lagging behind in the race to attract the greatest investment in this industry and to attain the highest rate of successful new ventures. Our results highlight the vital importance of a sound, active funding base, especially in terms of venture capital. Our findings also suggests that general scientific foundations are not enough to secure an advantage in new venture formation.

Build a Sustainable Vaccines Industry with Synthetic Biology.

The vaccines industry has not changed appreciably in decades regarding technology, and has struggled to remain viable, with large companies withdrawing from production. Meanwhile, there has been no let-up in outbreaks of viral disease, at a time when the biopharmaceuticals industry is discussing downsizing. The distributed manufacturing model aligns well with this, and the advent of synthetic biology promises much in terms of vaccine design. Biofoundries separate design from manufacturing, a hallmark of modern engineering. Once designed in a biofoundry, digital code can be transferred to a small-scale manufacturing facility close to the point of care, rather than physically transferring cold-chain-dependent vaccine. Thus, biofoundries and distributed manufacturing have the potential to open up a new era of biomanufacturing, one based on digital biology and information systems. This seems a better model for tackling future outbreaks and pandemics.

Preparing for the Next Normal: Transformation in the Role of Medical Affairs Following the COVID-19 Pandemic.

The medical affairs function represents one of the scientific interfaces in a pharmaceutical organization. Over the last two decades, medical affairs has evolved from being a support function to a strategic pillar within organizational business units. The COVID-19 pandemic has given rise to unforeseen circumstances resulting in a dramatic change in external stakeholder engagements, catapulting the medical affairs function into leading the way on scientific engagements and patient-centric endeavors. The changes in stakeholder interactions and behavior as a result of the pandemic last year are likely to persist in the foreseeable future for which medical affairs professionals need to enhance existing skill sets and acquire expertise in newer domains. In this paper, the transformation of the medical affairs team to a key strategic partner and the skills required to strengthen this transition, in the next normal of a post-COVID world, is explored.

Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor's Perspective.

INTRODUCTION: Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce. OBJECTIVE: This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment. METHODS: This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA®) Preferred Terms and subsequent clinical review were used to characterize COVID-19 cases. RESULTS: Over 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented. CONCLUSIONS: This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.

Viral pandemic preparedness: A pluripotent stem cell-based machine-learning platform for simulating SARS-CoV-2 infection to enable drug discovery and repurposing.

Infection with the SARS-CoV-2 virus has rapidly become a global pandemic for which we were not prepared. Several clinical trials using previously approved drugs and drug combinations are urgently under way to improve the current situation. A vaccine option has only recently become available, but worldwide distribution is still a challenge. It is imperative that, for future viral pandemic preparedness, we have a rapid screening technology for drug discovery and repurposing. The primary purpose of this research project was to evaluate the DeepNEU stem-cell based platform by creating and validating computer simulations of artificial lung cells infected with SARS-CoV-2 to enable the rapid identification of antiviral therapeutic targets and drug repurposing. The data generated from this project indicate that (a) human alveolar type lung cells can be simulated by DeepNEU (v5.0), (b) these simulated cells can then be infected with simulated SARS-CoV-2 virus, (c) the unsupervised learning system performed well in all simulations based on available published wet lab data, and (d) the platform identified potentially effective anti-SARS-CoV2 combinations of known drugs for urgent clinical study. The data also suggest that DeepNEU can identify potential therapeutic targets for expedited vaccine development. We conclude that based on published data plus current DeepNEU results, continued development of the DeepNEU platform will improve our preparedness for and response to future viral outbreaks. This can be achieved through rapid identification of potential therapeutic options for clinical testing as soon as the viral genome has been confirmed.

Drug development post COVID-19 pandemic: toward a better system to meet current and future global health challenges.

Introduction: Despite advances in drug research and development, our knowledge of the underlying molecular mechanisms of many diseases remains inadequate. This have led to limited effective medicines for several diseases. To address these challenges, efficient strategies, novel technologies, and policies are urgently needed. The main obstacles in drug discovery and development are the mounting cost, risk, and time frame needed to develop new medicines. Fair pricing and accessibility is another unmet global challenge.Areas covered: Here, the authors cover the pace, risks, cost, and challenges facing drug development processes. Additionally, they introduce disease-associated data which demand global attention and propose solutions to overcome these challenges.Expert opinion: The massive challenges encountered during drug development urgently call for a serious global rethinking of the way this process is done. A partial solution might be if many consortiums of multi-nations, academic institutions, clinicians, pharma companies, and funding agencies gather at different fronts to crowdsource resources, share knowledge and risks. Such an ecosystem can rapidly generate first-in-class molecules that are safe, effective, and affordable. We think that this article represents a wake-up call for the scientific community to immediately reassess the current drug discovery and development procedures.

Short and long term impacts of COVID-19 on the pharmaceutical sector.

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) was characterized as a global pandemic by the WHO on March 11th, 2020. This pandemic had major effects on the health market, the pharmaceutical sector, and was associated with considerable impacts; which may appear in short and long-term time-horizon and need identification and appropriate planning to reduce their socio-economic burden. OBJECTIVES: Current short communication study assessed pharmaceutical market crisis during the COVID-19 era; discussing short- and long-term impacts of the pandemic on the pharmaceutical sector. RESULTS: Short-term impacts of COVID-19 pandemic includes demand changes, regulation revisions, research and development process changes and the shift towards tele-communication and tele-medicine. In addition, industry growth slow-down, approval delays, moving towards self-sufficiency in pharm-production supply chain and trend changes in consumption of health-market products along with ethical dilemma could be anticipated as long-term impacts of COVID-19 pandemic on pharmaceutical sector in both global and local levels. CONCLUSION: The pandemic of COVID-19 poses considerable crisis on the health markets, including the pharmaceutical sector; and identification of these effects, may guide policy-makers towards more evidence-informed planning to overcome accompanying challenges. Graphical abstract .