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The pharmaceutical industry is in the midst of fundamental changes. The changes have been brought on by the increasing concerns over expiry of patents for major blockbuster drugs, weak product pipelines, heightened awareness of drug safety, globalisation, competition from generics and growing value considerations with regards to access to and reimbursement of new speciality therapeutics. These issues, and more, have forced top pharmaceutical companies to change their current course, in search of a stable and sustainable path that can help them maintain and improve their current profitability
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Functional service has been ranked high among the buzz words of the clinical research industry. Both sponsor organisations and service providers are equally excited about the opportunities this model offers and the potentially win-win situation it provides to them. Sponsor organisations typically send individual protocol-related service RFPs (request for proposals) to CROs and follow-up with contract negotiations. Sponsors have realised the benefits of reduced oversight and contract management a complete functional service outsourcing model offers saving valuable time and resources. Depending
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The pharmaceutical market in Asia has undergone a paradigm shift in the past few years. The major global pharmaceutical companies have shifted their focus to this region to drive their revenue growth. Moreover, the domestic companies in Asia are also actively participating in the global drug development process. At present, the pharmaceutical market in the region is challenging due to changes in the competitive landscape, increasing R&D costs, and the need to develop the right marketing strategies.

In 2005, the pharmaceutical market in Asia was estimated to be around US$ 21 billion and is
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There are many potential benefits that can be derived from IT outsourcing. Apart from cost savings, access to resources is also a driving force behind the outsourcing phenomena. With the right outsourcing partner enabling a flexible allocation of resources, IT projects can be scaled rapidly and affordably. Success or failure of outsourcing often has less to do with the provider and more to do with the customer. This is because discovery R&D organisations are rarely equipped to manage IT and have great difficulty specifying and implementing their goals. If any organisation has a poor track rec
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In the ever-evolving realm of pharmaceutical research and development (R&D), the powerful wave of digitalization is restructuring conventional methodologies and paving the way for a novel era of ingenuity and streamlined processes. Termed digital transformation, this profound shift entails the strategic infusion of cutting-edge information technologies into established drug discovery and development procedures. Leading this revolution are technologies like big data analytics, artificial intelligence (AI), blockchain, and telemedicine. Digital transformation signifies a potential revolution in
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Today there are more than 10,000 known rare diseases, defined by the European Union as conditions that affect less than 1 in 2,000 people and by the United States as those that affect fewer than 200,000 people. The vast majority of rare diseases are caused by or associated with detrimental mutations in protein-coding genes, making them prime candidates for correction with novel gene therapies and other gene-based medicines. Thanks to scientific advances in genetic engineering technologies over the last 20 years, clinical trials testing gene therapies and other gene-based medicines are more co
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Data can be used to analyze genomes, prescribe pharmaceuticals in the pharmaceutical and biotechnology industries, and a variety of other applications. Now that data has become "BIG DATA," analyzing it has become a whole new field of "Analytics and Data Science." The cost of genome structure analysis has decreased from ten million dollars in 2007 to one thousand dollars thanks to analytics. On the basis of big data analysis, a cancer treatment was prescribed. It can be used in a variety of industries and enterprises. There are numerous firms that are solely dependent on analytics, as well as
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Digital transformation in the pharma industry involves the use of technology to streamline operations, enhance patient engagement, and improve the efficiency of clinical trials. It also involves the adoption of different methods like data analytics and integration, artificial intelligence, machine learning, cloud computing, and services, etc. to drive innovation and improve patient outcomes.

The pharmaceutical industry has been a pillar of healthcare for decades, but with the advancement of digital technologies, it is undergoing a major transformation. Digital technologies have the potenti
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In the past few decades, nanotechnology has emerged as one of the most important approaches for cancer diagnosis and therapeutics. More recently, nanoparticle (NP) based specific drug delivery approaches have gained attention of researchers and clinicians to take one step towards specific tissue/organ specific drug delivery against cancer. NPs display an adaptable role in disease/cancer diagnosis and treatment and showed several advantages over the other conventional techniques. NPs and NP-based drugs are very selective and efficient towards specific cancer cells, tissues and organs. The sele
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Menarini Asia-Pacific is just over a decade old, having established its regional headquarters in Singapore back in November 2011. Over the past decade, the island-nation’s positioning has changed from just a pharmaceutical manufacturing outpost to an international biomedical hub that encompasses the entire innovation and manufacturing value chain.

Globally, there remains an unmet need for advanced research in healthcare biotechnology and diagnostics. Singapore’s reputation for quality research and development (R&D), supportive operating environment, and talent pool made it an easy decision
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In recent years, the United States has witnessed a remarkable phenomenon in the pharmaceutical industry: the departure of several major generic pharmaceutical manufacturers. The rationale behind this exodus is a subject of great interest, as it potentially carries profound implications for the nation's healthcare system and economy. This article attempts to delve into the reasons why these generic pharmaceutical manufacturers are moving their operations away from the US, exploring key factors such as regulatory challenges, intellectual property protection, cost pressures, and emerging interna
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Now more so than ever, biotechnology companies face resource constraints and the perils of drug devel-opment. Strategic partnerships, fostering synergistic growth, become crucial. This article explores diverse partnership models, from licensing to equity, beyond mere finances. While replete with benefits, challenges like intellectual property and cultural disparities persist. Effective communication and shared vision are vital, making these collaborations a potent force for accelerated innovation in advancing medical science.
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Artificial intelligence (AI) has revolutionized the pharmaceutical industry by providing innovative solutions in drug discovery, design, and manufacturing. In recent years, AI has become increasingly useful in drug manufacturing, offering several benefits such as increased speed, efficiency, accuracy, and cost-effectiveness. AI techniques, such as machine learning, natural language processing, and deep learning, are being used to mine vast amounts of data and extract meaningful insights that aid in drug development.
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The concepts of Big Data and Big Data Analytics have been around for some time but it has only been since the late 1990’s, with the confluence of genomic and transcriptomic data, along with increased use of EHR’s and access to claims data, that Big Data has arrived at the shores of pharma and healthcare. This rapid and accelerating access has been frequently represented by Hokusai’s tidal wave (Figure 1) but this metaphor may be hiding the real challenges that we need to face to deliver more effective diagnoses, drugs and patient outcomes. A potential evolution of this model, to embrace the
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In recent years clinical research trial designs have gradually started to change from fully paper and brickand-mortar sites (traditional trials) to digital-enabled designs utilizing decentralized solutions, which allow participant visits to be conducted remotely, rather than designated brick-and-mortar sites. In this article, we will spend time on the importance of embedding digital and decentralized solutions during early trial development. In recent years, clinical research trial designs have started to change from fully paper and brick & mortar sites (traditional trials) to digital-enabled
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What if pharmaceutical organisations could accurately forecast adverse events or quality compliance issues before they took place, or receive real-time feedback throughout the drug lifecycle directly from patients to eliminate lead times and delays?

To bring this into reality, pharmaceutical PV organisations need to move into a “digitalised future” where technology plays a key role in PV processes. This includes automating and streamlining the information streams to reduce complexity, from case processing to reporting. Once automated, companies need to begin to look to artificial intellige
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Artificial Intelligence (AI) and machine learning-based technologies have the potential to transform healthcare because they offer new and important insights derived from the vast amount of data generated during the delivery of healthcare every day. The capacity of AI to learn from real-world feedback and improve its performance makes this technology uniquely suited as Software as a Medical Device (SaMD) and is responsible for it being a rapidly expanding area of research and development. Clinical pharmacy practice may undergo major change due to the implementation of this technology. The cha
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Controlling the industrial crystallisation process poses a significant obstacle in the production of drugs and numerous other products. Digitisation of the crystallisation process now allows for radical change by increasing process automation to control overall crystallisation. The main pillars of Pharma 4.0 are process automation, improved control strategies, data visualisation, cloud edge storage, chemometrics, and mathematical modelling technologies. SmartCrys is a revolutionary integrated process control system that harnesses the mainstays of Pharma 4.0 with the combination of PAT tools i
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The 21st century pharmaceutical and biotech sector has come a long way from its heritages in 19th century pharmacy, with differentiated contract testing services business models. Traditional contract research testing services that follow the outsourcing model offer low-cost options to pharma that come with advantages and disadvantages. With New Approach Methodologies (NAM) being developed and encouraged by the FDA and CDER, there is a new business process and markets emerging parallel to outsourcing models. These new business processes impregnated with robotic process automation through artif
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This article introduces the concept of glocalisation and describes why it is has become the essential strategic capability. It will contrast the increasingly global nature of the pharma market, both supply and demands sides, with the continuing importance of locally-specific market conditions, such as market access, competitive environment, healthcare systems and market segments.The implications of this 'local needs in a global market' situation is that firms need to develop superior capabilities in "glocalisation" (the adaptation of a core, global strategy to local market conditions). The ar