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.

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." -

Balancing Change and Certainty in Manufacturing

According to research, for example, the bio/pharmaceutical manufacturing market should witness compound annual growth in the region of 11% between 2022 and 2027 (2), thanks in part to advancing manufacturing technologies. "Most recently, biopharmaceutical manufacturing has been impacted by pressures on supply chain," specifies Antonio Crincoli, vice president of Engineering, Pharma and Consumer Health, Catalent. [...]there is a focus on quality management systems that ensure data integrity and governance, and that digitization occurs with appropriate validation, also, where necessary, that there is segregation of operating systems to eliminate risk of corruption." Antonio Crincoli, Catalent "PAT and an emphasis on process understanding have been embraced by the majority of pharmaceutical manufacturers, and there are several case studies where both artificial intelligence (Al) and machine learning (ML) have led to improved quality or increased yield, even in good manufacturing practice (GMP) facilities," adds Byrd.

Trial Decline

According to the Association of the British Pharmaceutical Industry (ABPI) there has been a significant decline in the number of industry clinical trials nitiated in the UK. "The COVID-19 pandemic has accelerated the decline in ate-stage industry clinical research in the UK, compared to its global peers," said Richard Torbett, chief executive of the ABPI in a press release (3). Findings from an ABPI report into the state of clinical trials in the UK has shown that consistently slow and variable set up times for clinical trials encountered in the NHS are causing some pharmaceutical companies to look elsewhere for clinical research (4). [...]a close relationship is needed between government and the life sciences sector now more than ever to ensure the country does not fall too far behind its global competitors.

Coming Up to ISO IDMP Standards

A revised series of standards from the International Organization for Standardization (ISO), the identification of medicinal products (IDMP), were formulated for the creation of an integrated global data source for medicinal products (1). From an International Council for Harmonization (ICH) perspective, the standardized product identification would be able to support multiple processes, but in the EU, new legislation came into force in 2016 concerning data submission on authorized medicines, to primarily optimize connection of pharmacovigilance (PV) signals to products. ingredients, batches, and so on, using standardized data, replacing the existing Article 57 database. XEVMPD provides for more limited data fields than are required for IDMP submissions, but it has paved the way for data exchange as a means of product information delivery and discovery, reducing reliance on static documents. Making a fundamental change to regulatory information management approaches now, then, is likely to pay dividends in the long run-once multiple documents can be built from one definitive data set based on agreed international standards.

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.

Safeguarding Biologies-Blending Engineering Ingenuity and Managerial Excellence

Many best practices and lessons learned have emerged in recent years as pharma/life sciences companies, along with their third-party logistics partners and vendors that supply specialized packaging and monitoring solutions, have all weathered the COVID-19 pandemic together and continued to support ongoing growth in the pipeline of therapeutic products that must be continuously maintained at refrigerated, frozen, or ultra-frozen temperatures. Cold chain planning and execution "... continues to be impacted by not only the pandemic but by other factors, such as air cargo capacity being down, instability related to inflation, the Russia/Ukraine conflict, and more, but despite it all, you still have patients depending on what you're delivering," notes Rob Coyle, senior vice president, healthcare strategy, Kuehne+Nagel. "With careful planning, we're often able to replace active shippers with passive units by leveraging existing infrastructure, ongoing advances in insulation materials, phase-change materials (PCM), and container designs, using advanced GPS and other monitoring devices to ensure continuous access to real-time location, temperature, and other data," adds Scott Ohanesian, senior vice president, commercial operations, QuickStat, a Kuehne+Nagel company. Technology advances "The Holy Grail for the pharma cold chain is 'how do I get perfect service at a more economical price?'" says Dan Gagnon, vice president of global strategy for UPS Healthcare.

Bioscience laboratory practicals, projects and placements in a Covid-19 world

The aim of this review is to discuss alternatives to the traditional practicals, undergraduate projects and student placements that are presently being disrupted by Covid-19. We focus on bioscience higher education (biology, biomedical sciences) with an emphasis on the laboratory sciences. In the context of a shifting environmental and political landscape, we consider whether higher education institutions can deliver the latest bioscience skills and knoweldge sought by employers through the use of virtual learning. To take the pressure off being in the laboratory, we suggest that there may be opportunities to reduce lab teaching, and in doing so, meet industry needs for more computational and policy-related knowledge. There may be opportunities for academic teams to build relationships with local businesses and industry partners to find new solutions, and think about how agility can be incorporated into curriculum design to accommodate the rapidly changing external environment. In this paper we share examples of how the authors work together to enhance student employability. Further research is required to understand the views of each stakeholder – student, academic and business or industry partners - in order to fully understand the context of the problems and possible solutions. [ FROM AUTHOR] Copyright of Journal of Biological Education (Routledge) is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Supply Chain Vulnerabilities in a Post-Pandemic World

[...]what could that look like? "In an ideal world, I'd like to see life sciences supply chains break down the linear and functional siloed approach that exists today to become a dynamically connected ecosystem that integrates the full supply chain network in a collaborative and optimized way," says Stephanie David, vice president, Pariveda. In addition to inherent flaws in the foundational setup of the supply chain and the need for fewer manual processes, there are functional shortcomings as well-particularly with regards to cold chain storage and distribution. [...]more importantly, I believe that the supply chain's robustness will depend on the appetite for innovation and the ability of life sciences supply chain leaders and the skills of their organization (people) to drive the acceleration and adoption of digital capabilities required to effect change across the end-to-end supply chain," says David. "Because the supply chain is the operational backbone of life sciences companies, it is important that supply chain leaders can connect and clearly articulate the value and business outcomes of these initiatives to the wider enterprise-sales, marketing, operations, finance, etc."

Moving Clinical Operations Forward During Pandemic

In the short and long term, sponsors should think through: * Protocol modifications to incorporate remote patient and site assessments or other virtual elements. * Patient visit requirements and anticipated data collection challenges. * Effective resumption of activities when the pandemic situation improves. * Improvements to risk management planning.8 * Overall impact on clinical trial and clinical program timelines (including time to approval). [...]each passing day brings new information about the spread of COVID-19 globally. [...]to plan for the short and long term, sponsors should go back to the drawing board and reevaluate overall clinical study design, including patient eligibility, feasibility, enrollment, timelines, and budgets against the evolving global landscape. [...]alarming projections indicate that socialdistancing countermeasures may need to be in place well into 20219, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

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.

Driving Clinical Speed and Agility Post-COVID

More CROs are adopting CDMS to eliminate downtime when making amendments, regardless of the visits and rules impacted.4 A cc eler at e da ta cleaning The use of new external data sources in trials increased during the pandemic, presenting numerous challenges for data managers. Remote data sources The increased adoption of decentralized approaches represents a positive development in the industry, and CROs are leading the charge to enable a more patient-centric, digital clinical trial. With an integrated approach, shown in Figure 2 above, pharma companies and CROs can streamline processes like remote monitoring, allowing clinical research associates to seamlessly navigate from monitoring visits to subject case books for SDV.

Automating Biopharma Manufacturing

"With the advance of data science enabling factors such as easy access to scalable memory and computing resources;our growing competence in collecting, storing, and contextualizing data;advances in robotics;[and] the quickly evolving method landscape driven by the open-source community, the benefits of automation and simulation are becoming accessible in the notoriously complicated realm of biopharma manufacturing," says Marcel von der Haar, head of product strategy data analytics at Sartorius. "Plug-and-play" capabilities of automation systems, which enable flexible manufacturing and faster technology transfer, are more important than ever, he says. Walvax Biotech's new COVID-19 mRNA vaccine plant in China is another example of an intelligent and digital plant;it uses Honeywell's batch process control, building and energy management solution systems, and digital twins to monitor assets (5). "Automation brings in the data for machine learning to model the dynamic processes of cell growth and map it against the multiple dimensions provided by advanced sensors," explains Brandl.

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.

Digitalization Moves Forward in Pharma Equipment and Processes

Digital technologies that could meet these new challenges and aid manufacturing scale-up and speed to market, such as automated digital data collection and augmented and virtual reality (AR/VR) remote collaboration tools, were already available and had been adopted by some, but the new demand spurred greater adoption. "There is a cultural aspect to digitalization because it's a significant investment that results in changes to the operational structure of a facility;it is beneficial when the digitalization comes from the top," explains Yvonne Duckworth, automation engineer and Industry 4.0 subject matter expert at the CRB Group, a life sciences engineering and construction company. Machine sensors and process analytical technology (PAT) instruments can communicate directly with data collection systems using the NoT. Efficient development and tech transfer for mRNA vaccine manufacturing The data analysis and clear communication allowed by digital tools has demonstrated its benefits for process development and technical transfer, making time to market faster.

Trends in International Arbitration: The Fallout from COVID-19

[...]of the disruptions caused by the COVID-19 pandemic, global arbitration has adapted to a 'new normal'. Arbitration trends A number of trends are emerging with respect to life sciences disputes that are anticipated to continue for the foreseeable future, including in particular: * A greater number of disputes arising out of global supply chain disruptions, and use of the pandemic as a defence to contractual non-performance * An increase in disputes over earn-out clauses and pre-closing covenants in M&A transactions * A rise in investor-state claims brought by investors against states for breach of international investment protection agreements * More insolvent parties in arbitrations, which pose particular challenges * An increase in third-party funding of significant claims in international arbitration * The continued use of efficient procedures by arbitral tribunals, including paperless proceedings and remote hearings. Earn-out arrangements are usually intended to bridge the gap between diverging valuations of the target company by the buyer and the seller at the time of closing-in addition to the upfront purchase price, the seller of a business receives further payouts if and when the target company achieves certain agreed performance targets over an agreed period of time after closing. [...]the seller trades the certainty of a lower upfront payment for a potential higher pay-out in the future. [...]party funding of claims Third-party funding of significant claims is now a common feature in international arbitration and has become available in jurisdictions that previously were subject to regulatory restrictions.

Overcoming the Challenges of COVID-19

Agile and inventive pandemic response augurs in future-ready clinical trial management The onset of a global health emergency set innovation engines rolling, with active participation across the clinical research spectrum to find effective solutions. Here are 5 landmark solutions that were woven into the existing clinical trial fabric, with agility and innovation, to strengthen processes and make it relevant to current needs and beyond. 1.Accelerated trials to market lifesaving drugs faster When scientists began the process of developing a vaccine against COVID-19 in early 2020, the fastest vaccine that had been developed till then was the mumps vaccine in 4 years during the early 1960s. Navitas Life Sciences' OneClinical® Analytics platform is an artificial intelligence tool that has been shown to reduce clinical trial monitoring costs by 50% while bringing down cycle time by 30%.3 The near-real-time data insights gained from such tools aid in taking proactive corrective action helps resolve critical clinical trial issues at the onset, allowing intelligent deployment of resources.

5 Ways DCTs Can Positively Impact Trial Diversity

The problem became so concerning that FDA expanded its guidelines for enhancing the diversity of clinical trial populations.3 Despite recent and profound medical and technological advances, there is limited evidence of these changes moving the needle toward more equitable clinical trial recruitment or improved health outcomes for racial and ethnic minorities. According to data compiled by Shonda Anderson-Williams, healthcare and life sciences digital transformation leader at Microsoft, diverse companies outperform the competition by 35%. The key to change is meeting people where they are. [...]any organization looking to make inroads with new populations must first acknowledge the historical facts that got us where we are, and then work to move past it. 4. Center the human Factor in decentralized trials Relying on digital technology to the exclusion of human interaction misses out on the texture of relationships and the very foundation of trustbuilding-a critical component of effectively en gaging communities of color who may often carry justifiable baggage.