Low drug solubility and its corresponding impact on bioavailability have remained a primary cause of concern with several marketed as well as clinical stage drugs. According to the Journal of Analytical and Pharmaceutical Research, 70% of the 50 drugs approved by the USFDA in 2021 were poorly soluble. Moreover, approximately 40% of marketed pharmacological products and close to 90% of drug candidates under development, have been associated with solubility and / or permeability issues, resulting
...read moreRNA therapeutics are known to target specific genetic sequences of individual patients, in order to provide more effective treatment options for a wide range of disorders, with fewer side effects. These therapies are currently being developed using different types of RNA-based molecules, including coding RNAs (such as mRNA) and non-coding RNAs (such as interfering RNAs (RNAi), antisense oligonucleotides (ASO) and RNA aptamers). The development of RNA-based therapeutics initially gained momentum
...read moreNucleic acid-based therapies have been demonstrated to be capable of targeting genetic blueprints in order to enable treatment of a range of disease indications. Over the years, an increasing number of nucleic acid-based therapies have received regulatory approval, highlighting the therapeutic potential and growing popularity of this class of therapeutics. Consequently, this has created increased demand for vectors, which can effectively deliver such therapies. In this context, it is important t
...read moreSince the mid-twentieth century, computing devices have continually been explored for applications beyond mere calculations, to emerge as machines that possess intelligence. These targeted efforts have contributed to the introduction of artificial intelligence, the next-generation simulator that employs programmed machines possessing the ability to comprehend data and execute the instructed tasks. The progress of artificial intelligence can be attributed to machine learning, a field of study imp
...read moreThe therapeutic approach involving the injection of healthy cells in the human body to replace the diseased / non-functioning cells, in order to regulate certain functions, is referred to as cell therapy. In the past few years, this therapeutic approach has emerged as one of the key areas of interest in the healthcare sector, given its ability to treat diseases which were previously considered untreatable. Consequently, driven by the benefits offered by cellular therapies and recent approvals gr
...read moreGenotoxicity refers to the property of hazardous (physical, chemical and biological) agents to cause damage to genetic information present within a cell. It is worth mentioning that this damage can lead to formation of mutations, activation of mistimed event and direct DNA damage. Further, researchers have been able to link the mutations caused by genetic toxicology to various disease indications, including several oncological and genetic disorders. In addition, it is believed that the changes i
...read moreThe process of drug development, beginning from the discovery of a molecule to its commercial launch, takes around 10-15 years and capital investments worth USD 4-10 billion. It is a well-known fact that only a small proportion of molecules, which are selected for further investigation during the initial stages of research, are actually translated into product candidates. Given the complexities involved in the drug discovery process, the overall research and development (R&D) expenditure in
...read moreThe early stages of research related to drug discovery, including the identification of a relevant biological target and a viable lead compound, play an important role in the overall success of a drug candidate in preclinical and clinical studies. The process of drug development, beginning from the discovery of a pharmacological lead to its commercial launch, is estimated to take around 10-15 years, involving capital investments in the range of USD 4 billion - USD 10 billion. Over time, the comp
...read moreDigital health is a broad concept that encompasses telemedicine, teleconsultation, remote monitoring, connected devices, digital health platforms and health applications. The outbreak of COVID-19 pandemic has propelled the usage of digital technologies in order to receive healthcare, remotely. The revolutionary developments in digital health have transformed medicine and biomedical science as well as promoted early disease diagnosis and treatment. In addition, several FemTech startups are focuse
...read moreViral clearance and viral testing refers to the detection and elimination of viral contaminants, using a wide array of methods, to ensure the product’s safety for human use. Over the past few years, viral clearance and viral testing has emerged as one of the key pre-requisites for biopharmaceutical regulatory approvals. It is worth mentioning that, till date, over 630 biologics have already been approved by the Food and Drug Administration (FDA), while more than 8,000 biopharmaceuticals ar
...read moreIn the past few years, modular facilities or prefabricated buildings have emerged as a promising alternative to the conventionally built pharma / biotech manufacturing facilities. Modular manufacturing facility construction involves building of structures using prefabricated modular units, off-site, under controlled factory setting; these modular manufacturing units are later assembled on site. It is interesting to note that off-site construction can eliminate 60%-90% of the weather-related proj
...read moreAccording to the National Health Council, nearly 40% of the adult population in the US is diagnosed with at least one chronic condition, such as diabetes, asthma, and hypertension. The annual cost burden associated with chronic diseases in the US is around USD 3.8 trillion. A major share of expenses incurred by patients living with a chronic disorder is driven by the frequent need to medicate, which may require repeated visits to hospitals / out-patient clinics. This has prompted stakeholders to
...read moreTissue injury and dysfunctioning commonly occurs in humans; however, not in all cases, the tissue regeneration capability of a human body is able to cope up with the damage caused. The conventional approach used to deal with this type of trauma involves transplantation of damaged tissues or organs; this is further associated with several limitations, including non-availability of compatible organ donor, risk of graft rejection (due to the body’s immunological reaction) and post-surgical in
...read moreDigital therapeutics are clinically validated solutions that are delivered as applications, software and online programs, demonstrating the capability to facilitate positive outcomes when employed in the management of clinical conditions. These therapeutics are designed to engage patients in personalized treatment or disease prevention programs, through mediating behavioral or psychological modifications. The primary benefits of digital therapeutics include reduction of treatment related costs,
...read moreOver the years, various studies have validated the successful use of tumor-infiltrating lymphocytes (TILs) in treating patients diagnosed with refractory diseases. TILs are a heterogeneous population of mononuclear lymphocytes that comprise of T-cells, B-cells, NK cells and macrophages isolated from the tumor. These lymphocytes selectively mediate the elimination of tumor cells. Ongoing and planned clinical research initiatives in this direction are driven by encouraging results achieved in past
...read moreDigital Therapeutics, popularly known as DTx, represent a digital health solution which delivers medical interventions directly to the patients in order to treat, manage and prevent a disease. Such solutions usually employ evidence based and clinically validated software or technologies, in order to capture real-time patient data and provide improved curative response. Considering the ongoing digitization efforts and transformation of the healthcare sector, digital therapeutics have garnered sig
...read moreBlockchain technology, also referred to as distributed ledger technology (DLT), serves an integral part of the pharmaceutical supply chain. It enhances the trackability and traceability of drugs and other pharmaceutical products, thereby reducing the prevalence of counterfeit drugs and medicine. The drug discovery process, which involves the identification of a relevant biological target and a corresponding pharmacological lead, is deemed crucial to the clinical success of a drug candidate. Howe
...read moreMonkeypox is a viral disease, which is usually transmitted to humans from animals. The disease is known to have symptoms similar to those observed in smallpox patients, although it is considered to be clinically less severe. Monkeypox has recently emerged as a prominent orthopox virus affecting public health. In May 2022, multiple cases of the disease were reported in several non-endemic countries, thereby making monkeypox a disease of global concern. Consequently, in July 2022, the World Health
...read moreLong-acting drug delivery is an innovative drug delivery approach which allows sustained action of a drug for weeks, months or years after single administration and maintains its optimal therapeutic level in the patient’s body. Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to the long-acting drug delivery of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, ne
...read moreThe concept of 3D printing has been one of the biggest revolutions across the globe. Various industry stakeholders and academicians have undertaken several initiatives to further develop / improve this technology for a variety of applications. One such application area is 3D bioprinting that includes the printing of living cells and enables the development of highly complex tissues that mimic the structure and performance ability of desired organ, within the body. Although 3D bioprinting results
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