Overview of Pharmaceutical Strategy for Europe (2020) and enlightenment to China's pharmaceutical field.

Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation.Copyright © 2022 by the Author(s).

ROCKY ROAD AHEAD FOR NEW FDA CHIEF CALIFF

Final Senate approval by a historically narrow 50-46 vote came only after the White House and Califf's supporters lobbied hard to gain sufficient support, a success that is very different from Califf's 89-4 approval back in 2016. Pressure to help control the high cost of prescription drugs will continue to drive FDA support for developing complex generic drugs and biosimilars. There is pressure to clarify rules governing e-cigarettes;a need to address serious health problems arising from contaminated food and seafood, including significant volumes of imported products;and the safety of cosmetic products, dietary supplements, sunscreens, and other non-prescription products raise additional complex issues.

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.

Cold Comfort for Bio/Pharma

The COVID-19 pandemic highlighted how vital cold chain is for the pharmaceutical industry, particularly as some vaccines needed to be produced, transported, and stored at -70 °C. Market projections for cold chain logistics of pharmaceuticals are projected to grow at a compound annual growth rate of 9.03% by 2025, which is reported to be driven by greater global demand for pharmaceuticals, increasing initiatives to promote cold chain, and more demand for reefer containers from the pharma industry (1). Gilmore (Tower Cold Chain): Putting the European success of the COVID-19 vaccine rollout to one side, the demand for effective temperature-controlled packaging solutions in the pharmaceutical supply chain has increased significantly in recent years. Today, the cold chain is grappling with additional challenges: serving a global market, driving out costs and waste, addressing capacity and resource constraints, and dealing with continually mounting regulations-all whilst handling valuable pharmaceutical cargo. Cold chain logistics providers must invest in the latest on-board equipment built into containers to track temperature and location, and to make data available to partners and customers in real time, to prevent or mitigate loss.

Changes Afoot: 2022 Outlook for Pharma and its People

[...]we've seen more companies diversifying their portfolios and investing in therapies for rare diseases so that advanced therapies, and in particular, gene therapies-which were deemed experimental and risky when I was involved with the European Medicines Agency's Committee for Advanced Therapies some 10-12 years ago-take centre stage," Schneider continues. The year's expectations were unsurprisingly centred around COVID-19 for Martin Lush, global vice president. "Many big pharma companies will continue down the path of externalising services for small molecules and/or known molecules maintenance, to keep their focus on novel molecules," she explains. [...]of this complexity, there can be much negotiation and, hence, delay in access to medicines, he explains.

Building Up to a Bright Future

Dissolution testing is an integral part of pharmaceutical development, providing drug companies with the analytical ability to determine the efficacy, bioequivalence, and bioavailability of the active drug substance, as well as control quality, stability, and consistency of the final drug product. [...]there is also a shift in focus to more novel and personalized dosage forms that is happening within the bio/pharma industry, requiring modifications to many different areas of drug development and manufacturing, including dissolution testing, Spisak added. Novel formulations can pose challenges when using standard apparatus;nanoparticles, for example, are not necessarily sufficiently separated from the dissolution medium with standard techniques. [...]modification of the instrumentation, such as that found in Agilent's NanoDis system, is required to ensure an accurate prediction of in-vivo performance of the drug product can be made.

Injecting Innovation into Drug Packaging

According to Jens Kürten, group senior director, Communication and Marketing, Gerresheimer, there are nine megatrends that will both characterize and influence the pharmaceutical packaging market. Whether the drug be injected intravenously or subcutaneously, at home or in a hospital setting, there are various needs that should be considered prior to choosing the 'best-fit' packaging, he adds. [...]packaging requirements for pharmaceuticals change over time as the lifecycle of the drug continues," Stöcker states. [...]customers request more eco-friendly options to reduce or avoid plastic. [...]it has been necessary to design the packaging for the vaccines with these specific requirements in mind to ensure the safety and efficacy of the therapeutic product are protected.

Demonstrating the Value of Collaboration

[...]of the search for effective vaccines and treatments for COVID-19 being a priority, the development and manufacture of other treatments have been delayed, he adds. Through these industry collaborations, many developers have gained benefits, such as reduced time-to-market for new products, he specifies. [...]Quick believes that there will be more companies leaning towards outsourced services in the future, for development work and commercialization phases too. Given the disruption to the global pharmaceutical supply chain that has been experienced during the pandemic, O'Sullivan predicts that there will be opportunities for API suppliers in Europe, and elsewhere, to prosper from increased local demand, so long as the capacity and flexibility to deliver the required quantities are on available. [...]we will see significant investment by European API suppliers in expanded production capacity and capabilities in 2021 in order to attract Europe-based customers on the look-out for new local partners," he says. [...]Cruz emphasizes the rise of electronic health and customer records across Europe as an exciting prospect, particularly as it can lead to companies gaining a greater insight into treatments and customer needs.

A Bright Outlook

Bolstered by the increased public awareness of healthcare, expanding government activity-particularly in the vaccine sector-and rapid actions taken by bio/pharma companies in reaction to the pandemic, the pharma industry is expected to experience continued growth in 2021. "The industry will continue to benefit from favourable demographic and lifestyle factors, innovations, and a diminishing threat from expiring patents in addition to the shot in the arm for the whole sector from the COVID-19 pandemic, whose impact goes beyond the vaccines," said Olaf Tblke, head of corporate ratings at Scope and lead healthcare-sector analyst, in a press release (1). According to recent insight from McKinsey, M&A is a critical aspect to a pharmaceutical company's recovery within the new normal (3).

Securing the Supply Chain

According to market research, the API market is expected to experience a compound annual growth rate of 6.7% in the forecast period of 2020-2027 (1). "The low-cost benefits of manufacturing APIs and drug products within Asia has helped to turbocharge the generic drug industry and expand global access to a range of lower-cost medication options," says Meudt. "The shift has been positive for patients, allowing consumers to benefit from lower cost drugs from US Food and Drug Administration (FDA) and European Union (EU) inspected current good manufacturing practice (cGMP) facilities while still maintaining quality, innovation, and allowing efficient drug development and commercialization routes," he says. "While manufacturing cost will always be important, pharmaceutical companies are increasingly selecting their long-term CMOs based upon other factors including security of quality and supply, regulatory track record, data control, and environmental sustainability.

Making Every Effort

While the majority of the world is in isolation to try to slow the spread of the virus responsible for COVID19, companies and regulatory bodies in the bio/pharma industry are facing numerous challenges and committing significant efforts to support the development of novel therapeutics and monitor supply chains. Some notable drugs and vaccines for COVID-19 in development are: * Messenger RNA vaccines, from CureVac and BioNTech, are in preclinical stages. * Remdesivir, from Gilead Sciences, originally developed to treat Ebola, is in Phase III clinical trials. * SNG001, from Synairgen Research, is an inhaled formulation of interferon-beta-1a that is entering Phase II clinical trials. * Chloroquine and hydroxychloroquine are currently being investigated in clinical trials and are being donated by various companies for evaluation. The emptying of the shelves can be attributed to the, as of yet unproven, link with the drug having efficacy in the treatment of COVID-19. [...]in this current climate, it is imperative that pertinent scientific information that can be of reassurance and informative be disseminated with due diligence and care.

A Little More Respect

According to research from GlobeScan, stakeholders have a tendency to believe that the pharma industry's reputation is poor, with a particularly negative environment seen in Canada and the United Kingdom caused by campaigns from nongovernmental organizations or films (2). Great effort required As pharma companies continue to forge ahead, collaborating with others that may be considered as competitors in a 'normal' situation, there is a chance that the overall reputation of the industry can be further improved. PatientView, "Pharma Reputation in 2018Among UK Patient Groups-Falls Due to Brexit and Other Factors," Press Release, 16 July 2019.

The Elephant (or Donkey) in the Room

With the United States presidential election merely days away (set to take place on 3 Nov. 2020), the world's gaze has shifted to the race for the White House and whether there will be a Republican or Democrat taking office. [...]if this circumstance were to change, there would be potential consequences for European pharma companies that have a presence in or deal with the US. If the Democrats win the presidency and have control over Congress, it is expected that foreign and generic-drug manufacturers would benefit as a result of lower market entrance barriers.

Vaccine Administration: The Growing Role of Prefilled Syringes

(Note: The MIDAS database reflects vaccine doses that are dispensed with a prescription in retail or hospital settings, so the COVID-19 vaccines and other public-health-administered vaccines are not fully reflected in that data set.) Stamoran adds, "However, across the rest of the world, vial-based vaccines still make up the majority of the volume dispensed." [...]there is plenty of room for growth for this newer administration device. [...]PFS are now widely used for annual flu shots, heparin injections, and a growing list of injectable therapies across multiple disease states. According to a 2021 article authored byGuillaume Lehee, R&D Innovation Leader for BD Medical-Pharmaceutical Systems, the use of PFS to vaccinate 300 million individuals in the United States in the event of a future pandemic could save more than three million hours of healthcare practitioners' time (1). [...]today's PFS are not yet proven to be compatible with ultrafrozen temperatures as the existing glass materials and other components may not stand up to the extremely low required temperatures," explains Stamoran.

A study of optimal portfolio selection using quadratic programming modelling: Evidence from Indian pharmaceutical industry during COVID-19 times

Purpose: The present study aims to test the Quadratic Programming model for Optimal Portfolio selection empirically. Need for the Study: All the investors who buy financial products are motivated to obtain higher profits or, in other words, to maximise their returns. However, the high returns are often accompanied by higher risks, and avoiding such risks has become the primary concern for all investors. There is a great need for such a model to maximise profits and minimise risk, which can help design an investment portfolio with minimum risk and maximum return. The Quadratic Programming model is one such model which can be applied for selected shares to build an optimised portfolio. Methodology: This study optimises the stock samples using a two-level screening of correlation coefficient and coefficient of variation. The monthly closing prices of the NSE-listed Indian pharmaceutical stocks from December 2019 to January 2022 have been used as sample data. The Lagrange Multiplier method is used to apply the model to achieve the optimal portfolio solution. Based on the market reality, the transaction costs have also been considered. The Quadratic programming model is further optimised to achieve the optimal portfolio for the select stocks. Findings: The traditional portfolio theory and the modified quadratic model gives similar and consistent results. In other words, the modified quadratic model asserts the accuracy of the conventional portfolio model. The portfolio constructed in the present study gives a return much higher than the return of the benchmark portfolio of Nifty Fifty, indicating the usefulness of applying the Quadratic Programming model. Practical Implications: The construction of an optimal portfolio using the traditional or modified Quadratic model can help investors make rational investment decisions for better returns with lower risks. © 2023 by Chetna and Dhiraj Sharma.

Track-and-Trace Progress Benefits Supply-Chain Security Efforts

COVID-19 vaccines, approved under emergency use authorization, were not required to meet serialization requirements, but they have been properly labelled to meet US Food and Drug Administration (FDA) requirements, he says, complete with 2D barcodes with GTIN, lot, and expiry date. The company decided to serialize its Diprovan anesthetic, a workhorse generic product, using radio frequency identification tags containing the four identifiers (2). "If an agent is handling your product on your behalf, they need to leverage GS1 Standards including GTINs for products [and] global location numbers (GLNs) for physical locations, and share data electronically using electronic product code information services (EPCIS) to capture events from manufacturing to serialization [and] capping to shipping.

Prioritizing Cleaning Validation

Among the observations noted were failure to maintain clean and sanitary conditions;lack of written procedures for cleaning and decontamination of the vessels used to transport and store materials at the site;and no formal requirements to clean and sanitize these vessels after each use. [...]documentation must include the names and signatures of staff performing the work, as well as the product batch number, cleaner expiry date, and disinfectants used. Single-use systems and equipment have eliminated some of those problems, but they persist for hybrid plants still using stainless steel equipment. More work is also being done to use analytical methods to reduce the subjectivity of visual inspection, but Forsyth hasn't seen any consistentlyin place from the time of marketing authorization application (MAA) filing.

COVlD-19 vaccine Distribution: Preparing for the Unexpected

In December 2020, two shipments of the vaccine experienced temperature excursions in which product was actually kept at overly cold temperatures (3). Urgent need to protect data One problem that vaccine developers and regulatory agencies need to address is the urgent need to protect data, says Nigel Thorpe, technology director with Secure Age, which specializes in enterprise data encryption using a public key infrastructure platform. For operators on the plant floor, the efforts required are fraught with potential error, especially during shift changes, says Jim Evans, director of Verista, Inc.'s vision, connectivity, and automation division. Raw materials The speed with which vaccines have been developed and are being distributed pose important questions centred around variability. If we're having a raw materials shortage when the vaccines haven't even been scaled up, what will happen when they get full approval?" he asks.