FDA'S 'GOLD STANDARD' CRITICAL FOR BIOPHARMA R&D

Last week, eight prominent biotech industry executives publicly emphasized the importance of rigorous clinical research and complete study data to support any authorization or approval of a new covid vaccine or treatment. Hahn raises concerns These statements aim to offset fears that fda might soften its approval standards due to pressure from the White House to make available a covid vaccine in October. Continuing predictions from the White House about a vaccine being available in two months, and instructions from the Centers for Disease Control and Prevention (CDC) that state public health departments should be prepared to distribute a vaccine by the end of October, heightened concerns that political pressure will lead to some kind of authorization of a new vaccine before the Nov. 3 election.

Rebadging Gains Momentum Amidst COVID

Rebadging also reduces fixed or direct costs for clients, as well as the legal risks associated with using contractors in full-time, long-term engagements. * Employees are assured secure employment, re-assigned back to their original employer (as a vendor contractor) or via new positions within the FSP vendor. * Vendors find rebadging not only an important source of revenue, but also gain broader access to top-level talent, critical for any successful service provider. While FSP models with or without rebadging are ultimately about capacity management, the best vendors deliver wide-ranging value to help the client: * retain access to a dedicated team of full-time equivalent (FTE) staff for a broad range of services (data management, medical writing, program leadership, clinical supplies, regulatory, clinical monitoring, statistics, medical, etc.). * increase flexibility, including on-demand access to time and materials (T&M) or unit-based models that can deliver services with work volume that does not require dedicated FTEs. * access additional vendor expert staff from across the globe and shift or centralize services to increase efficiency, reduce timelines and save costs. * accelerate and optimize key HR processes, including hiring, onboarding and training. [...]in the EU and elsewhere, ARD-type regulations are in place to help ensure employers don't take advantage of their employees by offshoring their work or forcing them to rebadge with lower salaries and benefits. [...]joining a successful FSP vendor gives the employees a range of value beyond job security. Vendors The global market for outsourced clinical development services to CROs, including FSP providers, is estimated at approximately US $44.3 billion, and projected to grow to US $57.2 billion by 2024 (CAGR: 6.5%).'

Pfizer's Idea Orchard

Recognizing reality, Uwe Schoenbeck, PhD, senior vice president and chief scientific officer for Emerging Science & Innovation (ES&I) at Pfizer, has synthesized and made functional core lessons from two of the past decade's best business books: According to Schoenbeck, ESLs are highly experienced in the relevant disease area and embedded within the respective therapeutic areas, resulting in high strategic alignment of the opportunity being sourced and avoiding opportunities that are not a strategic fit (1). The ES&I team, in conjunction with colleagues working in Business Development, has stood out for bringing genuinely creative partnership ideas and innovations into an already creative and crowded environment. [...]a collaboration with Codex DNA will potentially streamline the mRNA production process by facilitating synthetic DNA assembly, another notable fruit of the team's labour to bring forth a competitive pipeline in gene therapy.

Looking Ahead to Factors Shaping Market Activity

According to EY's 23rd edition of its Global Capital Confidence Barometer, 89% of life sciences executives saw a drop in profits in 2020, with two-thirds saying they cancelled or failed to complete a planned acquisition (1). According to PwC, biotech acquisition activity in the US $2-$10 billion (€1.7-€8.5 billion) range is accelerating, and funding will continue to trend as well, with companies looking for strategic deal making and partnership opportunities (6). According to the government's impact assessment, up to 1800 transactions could be notified each year (11). [...]any transactions since 12 November 2020 could be eligible to be called for review retrospectively, so there is the possibility that a deal that has already been completed may be subject to intervention (11).

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.

Equipment Suppliers and CDMOs Advance Process Development

Rapid growth in biopharma is driving faster process development, more efficient manufacturing, and increased manufacturing capacity Process development is moving at unprecedented speed as manufacturers race to produce COVID-19 vaccines and treatments and the products needed to make them, such as viral vectors, as well as keep up with the burgeoning cell and gene therapy sector. Since 2020, EMD Millipore has been hard at work supporting developers of treatments for COVID-19. Because rapid scale up to high volumes of commercial product were needed, AstraZeneca called on multiple CMOs for production. Glover notes that, through the consortium, the CMOs worked to each use as similar a process as possible, which simplified the supply chain for equipment and raw materials.

Building Relationships Key for Smaller Sponsors

Strong collaboration critical as trial development advances Prior to the COVID-19 pandemic, biotech and emerging biopharma companies were increasingly turning to contract research organizations (CROs) to contain costs and secure therapeutic and clinical trial expertise to help meet their individual objectives. Therapeutic and clinical trial expertiseWith exploratory drug development often focused on multiple indications, a CRO with depth of tic expertise optimize clinical delivery enhancing quality and reducing timelines. Furthermore, years of therapeutic expertise and interaction with investigational sites ensure site engagement with heightened interest and attention to the target patient population.

APPLYING PRE-PANDEMIC BENCHMARKS TO ASSESS FUTURE SPEED STRATEGIES

To name but a few: they have rapidly mobilized scientific and operating teams;entered into an unprecedented number and variety of co-development arrangements;scaled-up manufacturing capabilities;and leveraged technology solutions and advanced analytics to access and analyze data from animal and early human studies and from commercially available therapies treating other diseases. Clinical trial durations and scope metrics were obtained from summaries of drug approvals available on the FDA website, from medical reviews, and from the ClinicalTrials.Gov website. [...]Phase III clinical trial durations have increased by more than 6% between the two time periods, from an average of 26.8 months in the 2008-2013 period to an average of 28.5 months per individual trial in the 2014-2018 timeframe. Very high variation was observed around the mean number of participants per clinical trial and this variation has increased over time. Mean clinical duration for non-orphan drug approvals increased substantially (16.2 months) in the 2014-2018 period, whereas mean regulatory review duration for non-orphan drugs decreased by one month.

Risk responses strategies of companies belonging to manufacturing clusters in Puerto Rico

PurposeThis paper discloses the risk management response strategies and the perceived effectiveness of the strategies employed by companies operating within manufacturing clusters in Puerto Rico from 2016 until 2020, the second year of the coronavirus disease 2019 (COVID-19) pandemic.Design/methodology/approachThe research design consists of questionnaire-based survey responses from companies belonging to manufacturing clusters, followed by semi-structured interviews and secondary sources of information.FindingsThe results reveal the risk responses used to manage specific risk types. Albeit respondents' dependency on an assortment of company-centric and cluster-bound risk response strategies, the perception is that the former is more effective when adequate local sources are available and the latter when the cluster has strong interconnectedness among the cluster's members.Research limitations/implicationsFurthermore, there is a generalized belief that long-term cluster-bound strategies are required to complement individual companies' overall risk management strategies.Originality/valueThis paper demonstrated that due to the volatility, uncertainty, complexity and ambiguity (VUCA) nature of the Caribbean region, mixed risk management might result in better and more favorable long-term performance.

Designed, Conducted and Implemented Training Module for Key Employees in Biotechnology Industry

In Biotechnology industry, training is the only way to nourish the scientific and technical skills of the key employees. There are numerous ways to train the employees through theoretical and practical knowledge-based training modules for Inhouse training, On-job training, task-specific training, hands-on training, external training, refresh training, combined Inhouse and On-job training, etc. The Training Cycle is a part of training that plays a crucial role in designing, conducting, and implementing exclusive and customized training modules. It contains various steps, such as identifying deficiencies, designing inputs and outputs, and identifying the learning strategy and effectiveness of the training module, and should be evaluated through a simple grading method. Based on the available literature, trainees can improve their subject knowledge through successive training sessions. In the pandemic spreading of COVID-19, the author has an opinion on how to design and execute their training modules effectively for upgrading the scientific and technical skills of key employees in biotechnology industries like production and quality control departments. Therefore, it is suggested that they may design, conduct, and implement their developed and customized training modules for the key employees of the production and quality control departments of any biotech industry. The industries can use these training modules effectively, as described in this article. It can also be a versatile tool for developing exclusive, customized, and effective training modules.

A Shot to Save the World

[...]it was an awful time to sell shares- the stock market was under pressure, biotech stocks were wilting, and few investors wanted to pay a lot for a German company with few signs of success. A few days later, Şahin rang the bell at the New York Stock Exchange, a wan smile on his face. Moderna was planning its very first phase two clinical study for a vaccine and was nowhere near a late-stage trial for any of its products.

An Overview of Investigational Drugs for the Treatment of Covid-19

SARS-CoV-2 has been emerged from Wuhan in China and has now shacked out more than 200 Countries and territories all over the world. World’s best scientists are contributing and endeavouring to find drugs, immuno-modulators and vaccines for the treatment of COVID-19. SARS-CoV-2 virus is a betacoronavirus and positive-stranded RNA virus that originates from the Coronaviridae family. The most important structural proteins of SARS-CoV-2 are spike trimeric (S) protein, membrane (M) protein, envelop (E) protein and the nucleocapsid (N) protein. The SARS-CoV-2 begins its life cycle, when the S protein binds with the host cells receptor ACE2 (angiotensin-converting enzyme 2). The viral protein(M) and genome (Protein-N) RNA eventually get assembled into virions (with Protein-S and HE), Endoplasmic reticulum and Golgi apparatus. According to the various research reports, there aremore than 50 drugs, immunomodulators and vaccines that may be effective against COVID-19. Some drugs had shown the in vitro activity against MN1 -https://media.proquest.com/media/hms/PFT/1/Dn72N?_a=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%3D%3D&_s=zUuGTksgyVFKqrcRhToSnSU0YCM%3D ERS-CoV, SARS-CoV and SARS-CoV-2. The aim of this review is to highlight the properties,structure, life cycle of SARS-CoV-2 and description of the agents which show potential efficacy against SARS-CoV-2.

Recombinant subunits of SARS‐CoV‐2 spike protein as vaccine candidates to elicit neutralizing antibodies

ObjectivesThe spike protein has been reported as one of the most critical targets for vaccine design strategies against the SARS‐CoV‐2 infection. Hence, we have designed, produced, and evaluated the potential use of three truncated recombinant proteins derived from spike protein as vaccine candidates capable of neutralizing SARS‐CoV‐2 virus.MethodsIn silico tools were used to design spike‐based subunit recombinant proteins (RBD (P1), fusion peptide (P2), and S1/S2 cleavage site (P3)). These proteins were checked for their ability to be identified by the anti‐SARS‐CoV‐2 antibodies by exposing them to COVID‐19 serum samples. The proteins were also injected into mice and rabbit, and the antibody titers were measured for 390 days to assess their neutralization efficiency.ResultsThe antibodies that existed in the serum of COVID‐19 patients were identified by designed proteins. The anti‐spike antibody titer was increased in the animals injected with recombinant proteins. The VNT results revealed that the produced antibodies could neutralize the cultured live virus.ConclusionTruncated subunit vaccines could also be considered as robust tools for effective vaccination against COVID‐19. Using a combination of in silico, in vitro, and in vivo experiments, it was shown that the injection of spike‐based truncated recombinant proteins could stimulate long‐lasting and neutralizing antibody responses.

The Covid-19 Pandemic and the Importance of Financing the Biotechnology Industry in South Africa

Whether it is a government research institution, a public-private partnership, or a private enterprise, the South African biotechnology industry requires funding for the biotechnology industry. Our goal with this research is to look into the role of venture capital (VC) in financing biotech enterprises and demonstrate how VC finance could aid in the development of diagnostic kits and vaccines for Covid-19 or future pandemics in South Africa. Moreover, the study aims to provide policymakers with a clear image of the importance of funding the biotechnology sector as recognized by the industry's key players. We employed a questionnaire and an interview survey with the key agencies in biotechnology eco-system to understand the role of biotechnology funding, notably during the Covid-19 pandemic. Overall, participants believe that South Africa's biotechnology lags behind that of other developing countries, but that it has the potential to grow greatly with enablers. It is also regarded immature, fragmented, and fractured due to a lack of financing and a committed organization to organize operations. The South African biotechnology venture capital business is in its infancy stage, risk-averse, conservative in its investment power. In addition, the response time to the pandemic, financial coordination for Covid-19 research, a lack of communication between authorities, and several labs out of operation owing to full-lockdowns have all been noted as problems.

The Effect of COVID-19 on Stock Prices of the Biotech Sector in Taiwan ROC

This study discusses the impact of COVID-19 on the biotech industry vs. TSEC Taiwan 50 Components stocks. We found that the price of stocks in the biotech sector in Taiwan increased due to the COVID-19 pandemic. The financial leverage ratio did not significantly affect the stock price of biotech companies during the COVID-19 pandemic. The number of confirmed diagnosed cases in Taiwan decreases the stock price of biotech companies, for high ROA. In contrast, the number of confirmed diagnosed cases in Taiwan increases the stock price of biotech companies, for high ROE. Investors have more confidence in the biotech firms with shareholder returns during the COVID-19 pandemic.

The Shortcomings of COVID-19 Testing in Ecuador: Time to Incentivize Research and Innovation.

The COVID-19 pandemic hit Ecuador severely. The country caught the attention of international media due to its high death toll and overwhelmed healthcare system. The clinical diagnostics system was rapidly overloaded, and the import of PCR tests was delayed. The case of Ecuador illustrates how middle-income countries rely heavily on the importation of biotechnological products for their healthcare systems. The Ecuadorian experience during the COVID-19 pandemic serves as a call for the formation of policies for the development of the biotechnological industry.

Primum Non Nocere

Concerns include uncertainties about the long-term effects of foreign mRNA on human cellular physiology and the possibility of vaccine-enhanced disease severity, which may not be unlikely with the current disease presentation of COVID-19. On 11 December 2020, under strong political pressure, the Food and Drug Administration (FDA) in the United States granted an emergency use authorisation for the first of these mRNA-based vaccines. "The pharmaceutical company was responsible for the design and conduct of the trial, data collection, data analysis, data interpretation and the writing of the manuscript" (2). Interpretation Proponents of the mRNA vaccines state that based on what we know now (which is extremely far from everything) about cell physiology and our immune system, long-term negative effects of the newly designed mRNA vaccines are unlikely and that the ratio of risk to expected benefit may be small.

Securitizing the Climate Crisis: Racial Geographies of Empire and the Agri-Fintech Frontier

Both companies explicitly brand their financial services in terms of the climate crisis, marketing their insurance products as tools that can, as Pula's website declares, "power the resilience and profitability of smallholder farmers" (Pula n.d.). In this article, I trace an emerging agri-fintech/U.S. security state nexus by reading narratives driving index insurance projects alongside two sets of U.S. government documents: 1) U.S. intelligence community assessments that de- scribe climate change and food insecurity as threats to American national security interests and 2) U.S. global food security policy and strategy documents. [...]of the global economic recession precipitated by the pandemic, a growing num- ber of farmers and food workers worldwide have fallen into conditions of hunger and poverty with those across sub-Saharan Africa experiencing some of the most drastic increases in food insecurity. Yet, at the same time, key institutional actors, such as the Gates Foundation and the U.S. Agency for International Development (USAID) are doubling down on their market-driven approach to managing food insecurity, largely through continued efforts to bring smallholder, subsistence farmers into international supply chains (Clapp and Moseley 2020).