Navigating The World Of Biopharmaceuticals

Biopharmaceuticals refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources. These are essentially complex biological macromolecules, having high molecular weights, or cell-based products, which are not directly extracted from native biological sources, rather are produced using biotechnology tools and methods. The following figure provides an illustrative summary of the various types of biopharmaceuticals.

Since biopharmaceuticals are produced using living organisms, they require various prokaryotic and eukaryotic systems, such as bacteria, yeasts, insect cells and mammalian cells, for their manufacturing.

Further, considering the fact that biopharmaceuticals are essentially structural analogs of various biomolecules found in the human body, they are highly specific and have fewer side effects, as compared to conventional pharmacological molecules. These therapies are also deemed to possess the potential to target and eradicate the cause of a disease at the genetic level. The Biopharmaceutical Contract Manufacturing Market is anticipated to grow at a CAGR of around 9.6%, till 2035, according to Roots Analysis.

Expression Systems for Biopharmaceuticals

As mentioned earlier, the processes associated with the manufacturing of biopharmaceuticals are complex and require highly sterile and aseptic conditions. This can be attributed to the fact that the production of biopharmaceuticals requires living expression systems. Usually, the desired gene, such as human insulin gene, when inserted into the plasmid of the host cell uses transcriptional and translational machinery of the host to express itself. It is worth mentioning that in vitro gene expression  requires a suitable host for the production of a specific gene product. Presently, several expression systems are available for manufacturing of biologics; these include (in alphabetic order) insect, mammalian, microbial and plant expression systems. It is also important to note that the use of different systems is associated with their own set of culturing requirements, advantages, and drawbacks.

The figure below provides an overview of the various expression systems used for the production of biopharmaceuticals.

Mammalian versus Microbial Expression Systems

The table presents the differences between mammalian and microbial expression systems.

S. No. Parameters Mammalian Expression Systems Microbial Expression Systems
1 Ease of working with cells Their fragile nature makes these systems difficult to handle Comparatively easier to work with / handle
2 Cost Highly expensive Moderately expensive
3 Ease of culturing cells Culturing of mammalian cells is a difficult process and requires expertise Comparatively easier to culture and do not require highly skilled personnel
4 Transfection methods Transfection is primarily done via liposome mediated transfection, electroporation and microinjection Transfection is done mainly through heat shock method
5 Post-translational modifications Post-translation modifications occur within the cell Post-translational modification is required to be done in an additional step after the release of protein / product
6 Preservation of native structure Antibody produced will be relatively closer to its native structure Antibodies can be expressed; however, their similarity to native structure is low
7 Examples Chinese hamster ovary (CHO) cells, baby hamster kidney (BHK) cells, human embryonic kidney (HEK) cells, and the WI-38 and MRC-5 cell lines (derived from fetal cells) Bacterial expression systems: Escherichia coli, Salmonella typhimurum, Vibrio cholerae and Bacillus brevis

Yeast expression systems: Saccharomyces cerevisiae and Pichia pastoris

Source: Roots Analysis

Manufacturing Process of Biopharmaceuticals

The production process of biologics can be categorized into two major stages, namely upstream and downstream processing. Upstream processing includes the production and maintenance of the working microbial expression systems, whereas downstream processing comprises of the various chemical and physical separation steps required to isolate and purify the product from the culture mixture.

The following figure highlights the various stages of the manufacturing process of a biopharmaceutical product.

Upstream Processing

Upstream processing refers to the entire process of product development, beginning from isolation of the working cell bank, incubation under appropriate conditions, and expansion of the cell culture for the synthesis of the desired biopharmaceutical product. It is worth mentioning that the upstream process chosen for a particular biologic is greatly dependent on the various characteristics of the product, such as selection of host cell lines, culture media and the appropriate bioreactor system used. Steps involved in upstream processing of biopharmaceuticals are formulation of the fermentation media, media sterilization and inoculum development.


Fermentation is the final stage of the manufacturing process and involves the synthesis of the desired product within the microbial expression systems. Fermentation processes are typically of two types (based on oxygen requirements), namely aerobic (in the presence of oxygen) and anaerobic (in the absence of oxygen). The fermentation process is usually modified to suit the oxygen requirements of the microorganisms used. Fermentation processes can also be categorized into batch, continuous / perfusion and fed-batch operations (based on the strategy used to feed the culture and culture medium into the fermenter). During batch operations, the culture medium and seed culture is added to the fermenter at the beginning of the process, after which the system is closed and only oxygen or pH adjusting agents are added. Alternatively, in a continuous system, fresh medium is added in an uninterrupted manner throughout the operating time of the reactor. Further, spent media (containing microorganisms and products) is removed from the system at the same rate at which fresh medium (containing inoculum) is added. A fed-batch system is a combination of the aforementioned processes. In this method, fresh medium (containing inoculum) is added at regular intervals, however, harvesting takes place towards the end of the operation.

Downstream Processing

Post harvesting, additional steps are required to isolate microorganisms and remove impurities, such as contaminating cell proteins, nucleic acids, endotoxins and residual processing reagents, via centrifugation, filtration and chromatography. These techniques collectively form the basis for downstream processing and are usually performed on large volumes of complex biological mixtures. These operations are intended to extract, concentrate and purify the resultant product(s). During this process, components of fermentation mixture are separated based on various parameters, such as molecular size, electric charge, solubility and binding affinities. Steps involved in downstream processing are centrifugation, filtration, chromatography and fill / finish.

Exploring Viral Vectors For Targeted Gene Therapy

Over time, gene therapy has evolved into a promising treatment option for a number of diseases, including cancers, rare inherited disorders and certain infectious diseases. In fact, gene therapies are also being developed for clinical conditions, which currently have no available treatment option. This can be attributed to the fact that gene therapies and genetically modified therapies involve the introduction of a therapeutic transgene / DNA (gene of interest) into living systems, such as a patient’s body. It is worth highlighting that the process of transgene / DNA delivery into living systems requires the use of a variety of vectors. Currently available gene delivery methods may be broadly classified into viral and non-viral categories.

Viral ­and Non-Viral Methods of Gene Transfer

Vectors may be based on viruses or other molecular methods that enable gene delivery. It is worth mentioning that non-viral vectors offer several advantages, including low immunogenicity and a large packaging capacity. However, they are usually less efficient than viral vectors. Additionally, they require certain viral characteristics, specifically related to receptor mediated uptake and nuclear translocation of DNA, in order to improve non-viral gene transfer.

Viral Vectors for Genetically Modified Therapies

Advances in the field of human genetics have enabled the identification of various Mendelian disorders. Additionally, the insights generated from the Human Genome Project have led to a better understanding of genes and their role in disease initiation and propagation, thereby, accelerating drug development research, using DNA as a therapeutic molecule. However, this field is still niche and gradually evolving in the wake of ongoing technological advancements, such as discovery of appropriate vectors, better understanding of human immunology, and development of practical approaches to select clinical targets. Early initiatives in this domain reported that mammalian viruses are an efficient tool for gene delivery, which also have the potential to be used (directly or indirectly) for the treatment of several genetic disorders.

Despite certain setbacks, which were reported in other early studies involving retroviral vectors, there were two noteworthy trials that demonstrated the successful implementation of viral vector-mediated therapeutics. These studies were conducted in patients suffering from X-linked severe combined immunodeficiency (X-SCID) (2000) and ADA-SCID (2002). It is worth mentioning that, in both trials, treated patients reported successful long-term reconstitution of immune functions in the absence of enzyme replacement therapy. Although there were certain genotoxicity-related adverse events reported in the X-SCID trial, the clinical outcomes observed in both trials markedly outperformed the standard of care therapy used. This offered the necessary evidence to support the potential of gene therapies, establishing the foundation for future improvements. It is also worth mentioning that these studies highlighted the need for gene delivery vehicles that are both safe and efficient. Viral vector manufacturing market is anticipated to grow at a CAGR of around 14%, till 2035, according to Roots Analysis.

Types of Viral Vectors

It is a well-established fact that viruses are extremely efficient in delivering genetic material into a specific target cell, whilst managing to evade the host’s immune system by using the host’s cellular machinery to synthesize various structural and non-structural proteins, which later assemble into functional viruses capable of repeating the process in other target cells. These properties make them highly attractive as gene delivery vectors. Using viruses as vectors involves the manipulation of viral genome; essentially all virulence genes are removed (to prevent viral infection) and replaced with a functional copy of a therapeutic gene(s), along with all the necessary regulatory sequences that control its expression. These modified viruses are able to carry specific target cells with high efficiency. As indicated earlier, such a method of gene delivery is called transduction; likewise, a cell modified by a virus / viral vector is said to have been transduced.

  1. Adeno-associated Viral Vectors

Adeno-associated virus (AAV) is a small virus of the Parvoviridae family that has a single stranded DNA genome. It is capable of infecting a broad range of host cells, including both dividing and non-dividing cells. It is a non-pathogenic virus that does not generate an immune response in most patients.

The AAV genome comprises of inverted terminal repeats (ITRs) at both ends of the DNA strand and two open reading frames (ORFs), namely rep and cap. Each ITR sequence consists of 145 bases that have the ability to form a hairpin structure. These sequences are required for the primase-independent synthesis of a second DNA strand and the integration of the viral DNA into the host cell genome. The rep genes encode proteins that are required for the AAV life cycle and site-specific integration of the viral genome. Whereas, cap genes encode the capsid proteins, namely VP1, VP2 and VP3.

  1. Adenoviral Vectors

Adenoviruses are members of the Adenoviridae family that typically have a double stranded DNA genome. The size of an adenoviral genome is generally around 36 kb, however, such viruses can accommodate cDNA sequences of up to 7.5 kb. When an adenovirus infects a host cell, its genetic material (DNA) is inserted into the host cell, and not into the host’s genome. Instead, it is left free in the nucleus in the form of an extrachromosomal gene segment, which is also known as an episome. The information in this episomal DNA molecule is transcribed and translated in a manner similar to that of any other gene, however, episomes are not passed on to daughter cells post replication.

  1. Lentiviral Vectors

Lentiviruses are also RNA viruses that belong to the Retroviridae family. Similar to retroviruses, they are also capable of stably inserting genetic material into the genome of a host cell. However, unlike retroviruses, these vectors can infect non-dividing cells as well. The only cells that lentiviruses cannot gain access to are quiescent cells (those in the G0 state). This is primarily because cells in the G0 phase inherently block the reverse transcription step. Examples of lentiviruses include:

  • Human immunodeficiency virus (HIV)
  • Simian immunodeficiency virus (SIV)
  • Feline immunodeficiency virus (FIV)
  • Equine infectious anemia virus (EIAV)
  1. Retroviral Vectors

Retroviral vectors are RNA viruses that belong to Retroviridae family. Within the host cell, these viruses synthesize double-stranded DNA molecules using RNA as a template; this process is facilitated by an enzyme, known as reverse transcriptase. The newly synthesized DNA can then be integrated into the chromosome of the host cell in a process that is carried out by another enzyme, known as integrase. Stable integration of the DNA synthesized from viral genome serves to modify the host cell, causing it to synthesize viral proteins. It is also worth mentioning that when the modified host cell divides, daughter cells retain copies of the viral genes and continue producing viral proteins.

  1. Other Viral Vectors

Other viral vectors are classified under the following categories:

  • Alphavirus: Alphaviruses belong to the Togaviridae family of viruses that are capable of infecting both vertebrates and invertebrates. Its genome is a single stranded RNA molecule, which is typically 11 to 12 kb, having a 5’ cap and 3’ poly-A tail. Additionally, the genome contains two ORFs that code for non-structural and structural components. In alphaviruses, the expression of viral proteins and the replication of the viral genome takes place in the cytoplasm of the host cell. It is also worth mentioning that certain retroviral and lentiviral vectors are usually pseudo typed using alphavirus envelope proteins, which facilitate the recognition and infection of a wide range of potential host cells.
  • Foamy Virus: Foamy viruses, also known as spumaretro viruses, are known to impart a characteristic foamy appearance to the cytoplasm of the cells they infect, thereby leading to the development of multinuclear syncytia. They are found in several mammals, including cats, cows and captive nonhuman primates, excluding humans. The safety profiles of foamy viruses for clinical purposes has made it a preferred choice as compared to other vectors, such as γ-retroviral vectors. In terms of being used as a gene transfer tool, they offer several unique advantages over other integrating viral vectors, such as gamma-retroviruses and lentiviruses. These include a large packaging capacity (up to 12 kb), broad host and cell-type tropism, and safer integration profile with lower risk of insertional mutagenesis. These vectors can also be used to efficiently transduce quiescent cells; since its genome remains stable (in the form of cDNA) in growth-arrested cells / quiescent cells, it can be integrated into the host genome once the cell exits the G0
  • Herpes Simplex Virus: The herpes simplex virus (HSV) is a double-stranded DNA virus that belongs to the Herpesviridae It is a neurotropic virus that is known to infect humans, which makes it a likely candidate for being used for the transfer of genes to the nervous system. The relatively large genome of the virus enables the insertion of more than one therapeutic gene into a single virion. It is therefore possible to use HSV vectors for the treatment of disorders caused by more than one defective gene. It is worth mentioning that the HSV is able to infect a wide range of cells, including muscle cells, liver cells, pancreatic cells, neurons and lung cells. Typically, these vectors are designed to encode the HSV thymidine kinase enzyme, which makes the virus susceptible to acyclovir mediated inhibition. Acyclovir is a nucleoside analogue that is used to treat HSV infections and in this case, is administered along with the oncolytic virus therapy.
  • Sendai Virus: Sendai virus is a non-segmented negative strand RNA virus, which belongs to the Paramyxoviridae It was discovered in 1953 in Japan and was primarily considered for the development of a xenotropic live-attenuated vaccine, owing to its antigenic similarity to the human parainfluenza virus type 1. The virus possesses certain unique characteristics, including a powerful capacity for gene expression, low pathogenicity and broad host range, which makes it a suitable vector candidate for the transfection of various animal cells. Despite the aforementioned benefits, vectors based on this virus are associated with inefficient chromosomal integration (of transgenes). These vectors have been used as a research tool in various life sciences domains, however, its utility as a recombinant viral vector has been identified recently. Owing to its ability to induce mucosal immunity, the vector has been significantly exploited as a vaccine platform. It has also been studied for cancer gene therapy at preclinical stage.
  • Simian Virus: Simian virus 40 (SV40) belongs to the Polyomaviridae Typically, these viruses have a circular, double-stranded DNA genome which is 5.2 kb in length. Certain genes that are transcribed at an early phase in the viral life cycle (early genes) include the large T antigen (Tag) and the small tag. Similarly, genes transcribed later during the life cycle of the virus (late genes) include the regulatory protein, agnoprotein and three structural proteins (namely VP1, VP2 and VP3). The Tag gene confers immunogenic properties to the recombinant SV40 viral vector; hence, it is deleted while developing SV40 vectors. The deletion of all the structural proteins, except the major capsid protein VP1, serves to reduce the overall size of the viral genome. The final vector genome is typically made up of the origin of replication and the encapsidation sequence, offering enough space for the incorporation of a transgene.
  • Vaccinia Virus: The Vaccinia virus belongs to the Poxviridae family; it is comprised of a linear, double-stranded DNA genome, which is approximately 190 kb in length and codes for close to 250 genes. It has the capability to replicate its genetic material in the cytoplasm of the host. Based on the composition of its outer membranes, the vaccinia virus can be divided into four types, which include intracellular mature virion, intracellular enveloped virion, cell associated enveloped virion and extracellular enveloped virion. This virus is popular owing to its use in the development of the vaccine that enabled the eradication of smallpox. With a packaging capacity of up to 25 kb of foreign DNA, the vaccinia virus can be efficiently used for the delivery of large gene sequences.

The Critical Role of Cold Chain Logistics in Healthcare

Logistics is defined as the process of planning, implementing and controlling a set of processes in order to ensure efficient shipment / storage of products from the source to the point of consumption. Specifically, cold chain logistics refer to the transportation of temperature-sensitive products from the manufacturing site to a desired destination, in a temperature-controlled supply chain. It is worth mentioning that the cold chain process has been used extensively in food, dairy and chemical industries, with an aim of preserving and extending the shelf life of various products, such as fresh agricultural products, flowers, seafood, frozen food, photographic film and other temperature-sensitive pharmaceutical chemicals / products.

Cold chain is a three-fold concept, involving certain aspects that can be co-related to science, technology and process development. In terms of science, cold chain requires the understanding of chemical and biological processes associated with the product. It is considered a technology as it relies on physical means to ensure desirable temperature conditions for perishable products throughout the supply chain. Further, as a process, it involves a series of tasks that need to be performed while manufacturing, storing, transporting, and monitoring temperature-sensitive products. Over the years, this approach has evolved to become one of the most preferred methods for storage, handling, and transportation of healthcare products. Additionally, increased approvals of biologics and incessant demand for such products have accentuated the need for a well-defined cold chain logistics process.

Comparison of Conventional Supply Chain and Cold Chain

Establishment of an elaborate logistical process is extremely crucial in order to process the shipment across the supply chain. It is worth mentioning that logistic hardware in case of cold chain is more customized, as compared to the conventional approach. However, the product packaging has been observed to be more complex in the conventional method. It is also worth highlighting that regulatory guidelines are more stringent for cold chain logistics.

The following figure highlights the steps involved in the process of supply chain.

Cold Chain Logistics in Healthcare

Over the years, cold chain industry has established its presence across various sectors, including agriculture, food and beverages, fruits, dairy, and healthcare industry. The following figure highlights the applications of cold chain across different application areas.

The overall process of cold chain logistics involves several steps, ranging from the preparation of shipments to final product verification, at the site of delivery.

Types of Healthcare Products Requiring Cold Chain Logistics

Cold chain logistics are crucial for the transportation of temperature sensitive products, such as pharmaceutical, biological and active ingredient products. It is worth highlighting that wastage of more than 20% of the temperature-sensitive products is reported during transportation, owing to lack of proper facilities. It is believed that immunization can save around two to three million deaths every year, globally. Therefore, it is imperative that the viability and efficacy of products is maintained. The following figure highlights the various healthcare products which require cold chain logistics.

As highlighted in the figure, apart from vaccines, cell / tissue therapies, human organs and other biologics, there are some other healthcare products which require cold chain logistics. These include aerosols, blood plasma samples, diagnostics kits, fertility samples, hazardous goods, laboratory specimens, medical delivery systems, medical instruments and pathology products. It is worth mentioning that these products need specific temperature ranges for optimum functioning. In fact, in a survey conducted by DHL Life Sciences, it was reported that 40% of the customers face major issues while maintaining the required temperature for their products. The ideal temperature for storage / transportation of majority of the vaccines lies in the range of +2°C to +8°C (refrigerated), while cell / tissue therapy products should be maintained at frozen (-65°C to +2°C) or cryogenic state (-196°C to -65°C), depending upon their nature. The temperature requirement for other pharmaceutical and biopharmaceutical products varies from controlled room and ambient temperature to cryopreservation.

Advantages and Limitations of Cold Chain Logistics in Healthcare

Cold chain logistics have gained attention from several industry stakeholders in the past few years, to meet the incessant demand for logistical operations for various industries. The following figure highlights the various growth drivers and roadblocks to implementing cold chain solutions in the healthcare industry.

Concluding Remarks

Over the years, cold chain logistics have become one of the most preferred method for storage, handling and transportation of temperature-sensitive products in the pharmaceutical and biotechnology industry. This can be primarily attributed to the several advantages offered by this process, such as maintenance of product efficacy and integrity at different stages of the supply chain. Further, the flexibility in the choice of transportation medium has allowed stakeholders to select the most suitable transport option, as per the delivery requirements of different products (such as pharmaceutical products and vaccines). Specifically, biologics are known to be extremely fragile in nature and are sensitive to even minor fluctuations in temperature. It is worth mentioning that around 95% of the approved biologics require cold chain in order to maintain their quality. Owing to this increasing demand for cold chain logistics, the industry has witnessed several capability expansions and facility acquisitions, which is further indicative of the growing interest of stakeholders in this segment. Further, cold chain management necessitates the maintenance and stability of the required temperature of vaccines across end-to-end supply chain, and therefore, promises the high-quality delivery of the vaccines to the healthcare, as well as non-healthcare organization across the globe.

Currently, the market for cold chain is dominated by the presence of several service providers that cater to the diverse needs of the pharmaceutical, food, dairy and chemical industry. However, in the last couple of years, stakeholders have been focused on the development of advanced tools and techniques for monitoring and tracking purposes, particularly real-time monitoring technologies, such as IoT, RFID and blockchain. Moreover, connected cold chain solutions have been observed to offer various advantages over conventional methodologies, including automation across several steps and elimination of human handling errors. We believe that, with the increasing awareness related to inherent benefits, the cold chain process is likely to be adopted by majority of the drug developers in the foreseen future.

Biopharmaceutical Contract Manufacturing: The Need of The Hour

Biologics represents one of the fastest growing segments of the pharmaceutical industry. This can be attributed to the rapid pace of innovation in this field, driven by the need for effective and personalized pharmacological interventions. Although biopharmaceuticals offer significant profit margins and have demonstrated the potential to treat a myriad of disease indications, they are generally associated with high costs of development and complex manufacturing protocols. This has compelled many biopharmaceutical developers to outsource various aspects of their operations to contract service providers. The biopharmaceutical contract manufacturing market is presently characterized by the presence of both niche, specialty companies, focused on early-stage development and production (preclinical and / or clinical scales), and one-stop-shops, which have, over time, acquired an extensive range of capabilities to cater to essentially all the product development and commercialization requirements of sponsors. Biopharmaceutical contract manufacturing market is anticipated to grow at a CAGR of around 9.6%, till 2035, according to Roots Analysis.

Overview of Contract Manufacturing in Biopharmaceutical Industry

A contract manufacturer is a third-party organization that offers services on a contract basis to other organizations. Typically, a client may approach a contract manufacturing firm after conducting initial R&D for a product and employ its services to manufacture the product, usually at larger scales. Conversely, many contract manufacturers are known to develop proprietary products and out-license them to marketing organizations. It is worth mentioning that outsourcing business operations to third party developers and manufacturers provides excellent opportunities for client organizations to access greater production capabilities and / or new products.

Additionally, there are several contract development and manufacturing companies that cater to the needs of biopharmaceutical companies worldwide. Commonly outsourced processes by biopharma clients include design, production, assembly, and distribution of lead candidates. Although contract partners may serve as stand-alone service providers in multiple areas, such as analytical testing or marketing, contract research organizations (CROs) and CMOs are slightly bigger organizations with larger service portfolios offering support services, in addition to research and / or manufacturing.

The figure below highlights the various types of third-party service providers that cater to the biopharmaceutical industry.

Need for Outsourcing Biopharmaceutical Manufacturing Operations

The following points illustrate the need for outsourcing microbial manufacturing operations to service providers:

  • Manufacturing expertise and capabilities, including design, construction and maintenance of a facility, required for production of biologics in-house involves high capital investments.
  • Requirement of higher biopharmaceutical manufacturing capacity products owing to the increasing demand for such drugs.
  • Advanced and complex technologies are required for manufacturing, as well as testing of biopharmaceuticals.
  • Availability of innovative platforms / technologies with service providers, such as XS Technologies (Lonza), pAVEway microbial expression platform (FUJIFILM Diosynth Biotechnologies), Corynex protein expression system (Ajinomoto Bio-Pharma Services) and SCOPE technology (Batavia Biosciences), that enables production of various biologics with increased efficiency.

The above-mentioned factors have compelled many small developers, as well as certain pharma giants engaged in this domain, to outsource their manufacturing operations to contract service providers. Further, the increasing demand for companies capable of offering manufacturing and development services to biopharmaceutical developers has resulted in the establishment of several CMOs and CDMOs over the past few years.

It is worth mentioning that the extent of outsourcing varies depending upon the nature of the project and other requirements. However, in some cases, simple procedures, such as cell bank characterization or virus testing, are outsourced. On the other hand, clients may also outsource the entire biopharmaceutical manufacturing process or only a particular step. It is also important to highlight that there are some virtual biopharmaceutical companies that choose to outsource almost all development and manufacturing activities, and just act as marketers / distributors of their products.

Advantages of Outsourcing Biopharmaceutical Manufacturing Operations

CMOs offer a number of benefits; some of the primary advantages of partnering with such third-party service providers are mentioned below:

  • Cost savings: Companies that partner with CMOs need not invest in establishing new facilities, employing, training and maintaining a proper workforce, and insurance policies. A number of companies outsource their business processes to developing countries where labor-costs are minimal. Additional cost benefits are derived from economies of scale. In other words, since individual CMOs service multiple consumers, they offer reduced costs for raw materials, for large scale production.
  • Access to advanced capabilities and technologies: Partnering with CMOs grants customers access to capabilities and technology platforms that they would otherwise have to procure at very high costs.
  • Validated quality control setup: Contract manufacturers have a better understanding of the manufacturing services that they offer. It is, therefore, very likely that they have stringent quality control protocols in place. Hence, it is easier for a company to rely on the expertise of a third-party manufacturer rather than establishing and validating their own processes.
  • Flexibility: This is one of the key reasons for outsourcing for many companies. The contracts of outsourcers as well as the jobs of the employees directly depend on the degree of flexibility to reflect changes in the business environment.
  • Risk Sharing: One of the crucial factors determining the net outcome of any industrial process is risk-analysis. Outsourcing a few components of an industrial process is just like shifting certain responsibilities to the outsourced vendor. Henceforth, it is a mutual understanding between the companies to handle the risk factors in a better way.

Future Perspectives

The specificity, efficacy and safety-related advantages of biologics have captured the attention of industry stakeholders and consumers. Presently, a variety of biologic drugs are being developed for a wide range of diseases, including those characterized by large target patient populations and rare disease indications, which are typically associated with smaller target patient populations and lower demands. In this competitive market, outsourcing has evolved into a viable and profitable business model. Although it is mostly the mid-sized and small players that opt to recruit the services of contract service providers, some of the larger and more established players are also known to outsource certain aspects of biologic development and manufacturing. In fact, most developers tend to rely on service providers for the development and production of low value / opportunity products, such as drugs for rare indications and biosimilars.

According to Contract Pharma’s Survey, conducted in 2023, the lack of specialized capabilities and expertise was cited among the key reasons why sponsor companies opt for outsourcing. Additionally, the ability to focus on other business priorities was identified to be another major reason for companies to recruit the services of contract service providers. It is also worth mentioning that owing to the availability of contract services organizations, several virtual companies have been established. These business entities inherently lack the physical resources to develop and manufacture their own products. As a result, virtual companies constitute a large segment of the client base of CMOs.

A review of the current scenario suggests that analytical testing, toxicity testing and fill / finish operations are among the most outsourced operations. In addition, the demand for contract services related to downstream process development is also on the rise. To exploit this demand and attract more clients, the smaller service providers are expanding their capabilities and / or partnering with other players, to expand their offerings. The growing demand for biologics, coupled to the increasing capital investments in this market, have prompted the establishment of several startups in this domain. These firms make up a notable part of the clientele of CMOs.

It is worth highlighting that there is a significant rise in the interest of stakeholders in the biopharmaceutical contract manufacturing segment; this can be validated by the increase in partnership and funding activity within this domain. Further, the growing demand for biologics has compelled the players engaged in this domain to expand their existing capabilities / capacities in order to accommodate the future needs of their clients. In addition, as mentioned earlier, innovation in this field, coupled to the development of novel fermentation technologies, has further expeditated the growth of biopharmaceutical contract manufacturing segment.

Maximizing Medicinal Potential Through Bioavailability Enhancement Technologies

Over the last couple of decades, the concept of bioavailability has garnered significant attention in the pharmaceutical industry. It is considered to be one of the most important pharmacokinetic properties of a drug. Bioavailability refers to the proportion of a drug that reaches systemic circulation unaltered, post dose administration. It is a direct consequence of the absorption potential of an active pharmaceutical ingredient (API). The bioavailability of a drug is dependent on several factors, such as solubility, route of administration and metabolism of the drug post administration.

Given the rapid increase in the number of new chemical entities (NCEs) with low solubility and considering that this trend persists in the future as well, there is likely to be a surge in the demand for technologies that facilitate bioavailability enhancement. There are a number of technologies which are already available for improving drug bioavailability. Broadly, these technologies can be distributed across three main categories, namely physical, chemical and biological approaches. However, as pharmacological interventions gradually become more complex and novel drug classes are introduced, further innovation may be required to enable the development of better bioavailability enhancement techniques / methods. Bioavailability enhancement technologies and services market is anticipated to grow at a CAGR of around 11%, till 2035, according to Roots Analysis.

Assessment of Drug Bioavailability

The pharmacological response elicited by a drug depends upon the availability of the drug in relevant concentrations at the site of action (in the patient’s blood). The true dose of a drug that an individual is exposed to is not what is administered during the dosing process; rather it is the amount of active drug substance that is available at the appropriate biological site (after dissolution, absorption and metabolism). The bioavailability of a drug has been demonstrated to be impacted by several factors, such as dosage form used, dissolution rate, hindrances posed by biological membranes and metabolic degradation, during the absorption process. The bioavailable fraction factor (F) is a term which refers to the fraction of the administered dose that actually enters into systemic circulation. Mathematically, this factor is represented as follows:

Studies in Healthy Subjects and Patients

Ideally, a drug should be tested only in patients who have been diagnosed with a particular disease for which it is being developed. However, evaluating bioavailability by conducting studies in patients suffering with the relevant disease can also produce false results, as such subjects may often be on other medications, which can have an impact on the bioavailability of the drug under evaluation. Therefore, it is necessary for bioavailability assessment studies to be conducted in young, healthy volunteers, in a controlled environment.

Different Bioavailability Assessment methods

In order to assess / evaluate bioavailability, several direct and indirect methods are presently available. The rate and extent of drug absorption are used to describe the in vivo bioavailability of a drug molecule. The aforementioned determinants can be based on various quantifiable parameters, such as concentration of active therapeutic ingredient in blood, cumulative urinary excretion rates, or other pharmacological effects. The following figure presents an illustrated representation of the different approaches used in order to evaluate the bioavailability of drugs.

Need for Bioavailability Enhancement

A study conducted on terminated drug development projects revealed that majority of the drug candidates fail in early drug development phases, due to the problems associated with their pharmacokinetic profiles, ADME (distribution, metabolism, absorption and excretion) properties and toxicity-related issues. Moreover, it is a well-established fact that the systemic / local absorption and distribution of a therapeutic intervention is directly proportional to its bioavailability. Further, it was reported that more than 90% of new chemical entities (NCEs) developed by pharmaceutical companies and nearly 40% of the top-ranking oral drugs marketed in North America and Europe are insoluble in water and hence, their low solubility can lead to deficient drug concentration, which further leads to in vivo failure. As a result, a large number of companies are now considering adopting various types of bioavailability enhancement approaches in order to ensure that their proprietary pharmacological product candidates are made bioavailable at optimal quantities at the desired site of action.

As per the USFDA’s guidelines, a drug substance is considered to be highly soluble only when its highest dose strength is soluble in less than 250 ml of water, over a pH range of 1 to 6.8 at 37℃. Similarly, a drug molecule is said to be highly permeable when the extent of its absorption in humans is determined to be more than 90% of the administered dose, based on either mass-balance, or in comparison to an intravenous reference dose.

Bioavailability Enhancement Technologies

Given the rapid increase in the number of NCEs with low solubility and considering that this trend persists in the future as well, there is likely to be a surge in the demand for technologies that facilitate bioavailability enhancement. There are a number of technologies which are already available for improving drug bioavailability. Broadly, these technologies can be distributed across three key categories, namely physical, chemical and biological approaches. However, as pharmacological interventions gradually become more complex and novel drug classes are introduced, further innovation may be required to enable the development of better bioavailability enhancement techniques / methods.

Biological Formulations for Bioavailability Enhancement

In recent years, researchers are also using biological technologies / methods for bioavailability enhancement. The following points highlight the various biological approaches that are being employed for the enhancement of drug bioavailability.

  • Cyclodextrin: Cyclodextrins are starch derivatives, having lipophilic inner cavities and hydrophilic outer surface. These are used widely for solubility and stability enhancement of drugs. Cyclodextrins have been shown to be capable of interacting with a variety of molecules to form non-covalent inclusion complexes, resulting in decreased side effects and increased bioavailability.
  • Phytosome: Phytosome is a patented technology developed by Indena to incorporate standardized plant extract or water soluble phytoconstituents into phospholipids. This results in production of molecular complexes, which enhance absorption and bioavailability.
  • Niosomes: Niosomes are the vesicular systems comprising of non-ionic surfactants, with or without the presence of cholesterol, and mimic the biological membrane. They are more stable as compared to liposomes due to oxidative degradation and hydroxylation of unsaturated fatty acids and ester bindings of phospholipids. The thin film technique can be employed for the formulation of niosomes.
  • Bilosomes: Bilosomes are an advanced form of niosomes, which are prepared by incorporation of niosomes with the bile salts to enhance their penetration properties and confer better membrane stability against the detrimental effects of bile acids. These bile salt stabilized carriers are known as blossoms and have been demonstrated to possess good biocompatibility and increased bioavailability.

Concluding Remarks

In recent years, the focus of drug developers has shifted towards the development of lipophilic drug compounds due to the increasing issues with aqueous solubility / bioavailability of these drugs. As mentioned earlier, around 90% of NCEs belong to BCS class II and IV, which are known to be associated with low solubility / permeability. Given that a large number of drugs fail to reach the market due to poor bioavailability, the industry is looking for various tools / methods to mitigate this challenge. Moreover, as many companies seek to re-formulate existing product candidates that exhibit poor bioavailability (via the 505(b)(2) pathway), the demand for novel bioavailability enhancement methods has grown significantly. It is worth mentioning that since 2000, more than 55 players offering bioavailability enhancement technologies and services have been established. Amidst growing competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor. This has led many service / technology providers to actively expand their portfolios, either through strategic acquisitions / mergers or entering into service alliances with other bioavailability enhancement companies. Moreover, as drug developers continue to evaluate novel drug targets and classes, the bioavailability enhancement domain is expected to grow at a steady pace over the next decade.

The Impact of Hyperlipidemia on Heart Health

Hyperlipidemia, a condition characterized by elevated levels of lipids (fats) in the bloodstream, is a significant risk factor for cardiovascular diseases, including heart disease. With the increasing prevalence of hyperlipidemia worldwide, understanding the connection between this condition and heart health is crucial for effective prevention and management. In this article, we will delve into the relationship between hyperlipidemia and heart health, exploring the impact of elevated lipids on the cardiovascular system and highlighting strategies to mitigate these risks.

Hyperlipidemia and Cardiovascular Risk

Hyperlipidemia, specifically high levels of low-density lipoprotein cholesterol (LDL-C) and triglycerides, has been strongly associated with the development of atherosclerosis, a condition characterized by the buildup of fatty deposits in the arteries. Atherosclerosis can lead to the narrowing and hardening of the arteries, restricting blood flow to the heart and other vital organs. Over time, this can result in various cardiovascular complications, such as coronary artery disease (CAD), heart attacks, and strokes.

The Role of LDL-C and Triglycerides

LDL-C, often referred to as “bad” cholesterol, plays a central role in the development of atherosclerosis. Elevated LDL-C levels promote the accumulation of cholesterol in the arterial walls, triggering an inflammatory response and the formation of fatty plaques. These plaques can impede blood flow, leading to complications such as angina (chest pain) or complete blockage of coronary arteries, resulting in a heart attack.

Similarly, high triglyceride levels have been associated with an increased risk of cardiovascular disease. Triglycerides are a type of fat that circulates in the bloodstream, and elevated levels can contribute to the development of atherosclerosis. Additionally, high triglyceride levels often coincide with low levels of high-density lipoprotein cholesterol (HDL-C), known as “good” cholesterol, further exacerbating the cardiovascular risk.

Impact of Hyperlipidemia on Heart Health

The presence of hyperlipidemia significantly increases the likelihood of developing heart disease. Individuals with untreated hyperlipidemia are more prone to experiencing adverse cardiac events, such as heart attacks and strokes. The accumulation of cholesterol in the arteries narrows the passageways through which blood flows, reducing oxygen and nutrient supply to the heart muscle. This deprivation can cause chest pain, shortness of breath, and potentially life-threatening complications.

It is important to note that hyperlipidemia can often go unnoticed, as it does not typically cause noticeable symptoms. Therefore, regular lipid profile screenings are essential for early detection and intervention.

Managing Hyperlipidemia for Heart Health

Fortunately, hyperlipidemia is a manageable condition, and several strategies can effectively reduce the associated cardiovascular risks. The cornerstone of management is adopting a comprehensive approach that includes lifestyle modifications and, when necessary, medication.

Lifestyle Modifications

Healthy Diet: A heart-healthy diet is crucial in managing hyperlipidemia. Focus on consuming foods low in saturated and trans fats while incorporating high-fiber options, fruits, vegetables, and whole grains. Limit the intake of processed foods, sugary beverages, and excessive alcohol.

Regular Physical Activity: Engaging in regular aerobic exercise, such as brisk walking, jogging, or cycling, can help improve lipid profiles and overall cardiovascular health. Aim for at least 150 minutes of moderate-intensity exercise per week, as recommended by health authorities.

Weight Management: Maintaining a healthy weight or achieving weight loss, if necessary, can positively impact lipid levels. Losing excess weight can lead to improved lipid profiles and a reduced risk of heart disease.

Smoking Cessation: Smoking damages blood vessels and worsens lipid imbalances. Quitting smoking is essential for optimizing heart health and reducing cardiovascular risks.


In cases where lifestyle modifications alone are insufficient to manage hyperlipidemia, healthcare providers may prescribe lipid-lowering medications. These medications, such as statins, fibrates, or cholesterol absorption inhibitors, work by reducing LDL-C levels and, in some cases, triglyceride levels. It is crucial to consult with a healthcare professional to determine the most appropriate medication and dosage based on an individual’s specific needs.


Hyperlipidemia, characterized by elevated levels of lipids in the bloodstream, poses a significant risk to heart health. The connection between hyperlipidemia and cardiovascular diseases, such as atherosclerosis and heart attacks, underscores the importance of early detection and effective management. By adopting a comprehensive approach that includes lifestyle modifications and, when necessary, medication, individuals with hyperlipidemia can reduce their cardiovascular risks and improve overall heart health. Regular screenings, adherence to a heart-healthy diet, regular exercise, weight management, and smoking cessation are key components of a proactive strategy to mitigate the impact of hyperlipidemia on heart health. By taking these steps, individuals can promote their well-being and reduce the likelihood of developing heart disease associated with hyperliplipidemia.

Revolutionizing Disease Diagnosis Through AI Driven Digital Pathology

Pathology is the science of diagnosing diseases, primarily through collecting and analyzing samples of tissues, cells and body fluids. The traditional process of pathology involves the evaluation of biopsy, wherein tissues are preserved with chemical fixatives (such as formalin) and further transferred to histology labs. Following this, the specimen undergoes a set of processes, such as treatment, embedment, sectioning, and staining. Further, the prepared histological slides are examined and evaluated under a microscope by a trained pathologist.

The process of AI-based digital pathology allows scanning of slides via computer monitors, by replacing the conventional microscopic approaches. Further, by converting glass slides to images, samples can be transmitted from diagnostic centers to pathologists within a fraction of time.

AI-based digital pathology enables identification of optimal treatment plans based on patient profiles, by utilizing digital methods for patient classification and selection for diagnostic tests.

AI has lately had an unprecedented influence on medicine and can have a significant impact in pathology. Given the massive amount of data generated by pathology, AI may present an opportunity for all pathology subdomains to innovate and offer a revolutionary care delivery model in both imaging and non-imaging applications. Owing to the advantages over conventional approaches in the field of pathology, AI based digital pathology market is anticipated to grow at a CAGR of around 8.3%, till 2035, according to Roots Analysis.

Artificial Intelligence in Digital Pathology

Driven by the ongoing digitalization of the healthcare sector, there has been an increase in the use of AI in pathology, in recent years. AI, along with its subfields of machine learning and deep learning, is quickly becoming a key technology in the healthcare sector, with the potential to transform lives and improve patient outcomes, across a wide range of medical specialties.

At present, multiple AI-based approaches have been developed and are being used to assist pathological diagnosis and research. One of these approaches includes the use of deep learning program using artificial neural networks (ANNs). In a manner similar to a biologically complex neural network of the human brain, ANNs may independently determine whether their interpretation or prediction is accurate. In addition, convolutional neural networks (a type of deep multi-layer neural network) are specialized for visual images. Convolutional networks serve as a pre-processing step that enables computer vision and machine vision models to process, examine and categorize digital pictures, or portions of images, into predefined categories.

It is worth highlighting that the new standard of treatment will incorporate AI-based digital pathology together with clinical data, biomarkers and multi-omics data. In addition, to facilitate a more effective pathology workflow, AI-based digital pathology offers a detailed and individualized picture, thereby, allowing pathologists to address the progression of complicated diseases for improved patient treatment.

Workflow of AI-based Digital Pathology

Figure below highlights information on steps involved in the usual workflow of AI-based digital pathology process.

Further, steps involved in the workflow of AI approaches in digital pathology have been briefly described below:

  1. Preparation of Tissue Sample: This process is very similar to the conventional approach. A pathologist examines a biopsy to determine its color, size and consistency. At this point, the specialist can detect symptoms of malignancy and select which areas of a specimen should be inspected under the microscope. Further, the chosen region is prepared by following multi-step processes, such as treatment of the tissue with chemicals in order to maintain its structure, mounting the specimen on a glass slide, staining to improve contrast and protecting the tissue with coverslips.
  1. Converting into Virtual Sample / Whole slide imaging (WSI): WSI or virtual microscopy is a technique that is used to enable digital pathology. Its central component, which is a WSI scanner, captures a picture of the glass slide and generates a precise electronic replica known as a virtual slide. It is worth noting that virtual slides, unlike glass slides, are easy to replicate, save, categorize and distribute. Furthermore, they may be linked to electronic health records, thereby providing a complete picture of a patient’s health.
  1. Saving a Virtual Slide: The scanner pre-processes the virtual slide automatically and stores it to on-premises or cloud storage. In order to minimize the file size, a compression approach is frequently employed before saving the slide.
  1. Viewing and Editing of Slide: In the digital process, instead of using a traditional microscope, a pathologist uses a computer display to analyze enlarged tissue samples. A slide viewing and management software is used to zoom out a tissue segment and observe its smallest features. In addition, this software allows the pathologist to view the slide from different angles, add annotations and even compare multiple images at one time.
  1. Sharing Data: Using specialized digital pathology software applications, slides are converted to an electronic format, thereby allowing them to be exchanged using the internet. These slides can be shared to gain a second opinion, as well as with patients, research facilities and other stakeholders.
  1. Reporting Results: Some image viewing systems provide reporting capabilities. However, this work is often accomplished by enabling interaction with the laboratory information or laboratory information management system (LIS/LIMS) and hospital information system (HIS).

Applications of AI-based Digital Pathology Solutions

Figure below is a pictorial summary of different applications of AI-based digital pathology solutions.

Future Perspectives

The digital revolution of pathology is projected to accelerate in the coming years, considering multiple growth drivers, including growing number of laboratories adopting high throughput digital scanning and software technologies to assist diagnostic practice. In addition, factors, including shortage of skilled pathologists in remote areas, increasing pathology workloads due to ageing populations, higher rate of cancer screening programs, rising complexity of pathology testing and time constraints, and requirement for pathology labs to outsource expertise in the field, also contributes significantly towards the need for AI-based digital pathology solutions.

Moreover, the same driving forces are pushing the development of AI-based digital pathology to assist pathologists with diagnostic issues that they confront in the present scenario. By incorporating AI-based digital pathology technologies into clinical processes, possible savings may be realized, in terms of turn-around times, as well as patient outcomes, which are enabled through better detection and repeatability. Such advancements are expected to play a significant role in increasing the overall quality of AI-based digital pathology solutions. Given the aforementioned characteristics, we anticipate that the AI-based digital pathology industry will experience substantial growth over the next decade.

Beyond HIPAA: How to Safeguard Healthcare Data in the Cloud

As we progress from securing patient information in paper filing cabinets and locked doors, healthcare is embracing modernization, leveraging technology to streamline operations and enhance efficiency.

However, as healthcare companies continue to pursue this modernized approach, new challenges arise, particularly in cybersecurity.

Breaches, misconfigurations, insider threats, third-party risks, and data loss are just a few of the new challenges we must face, and if you want to keep your practice safe, it goes beyond the requirements of HIPAA.

Ensuring the security of sensitive patient information is crucial. In this article we’ll cover real-life scenarios of potential threats, along with ways to protect healthcare data in the cloud.

The Nightmare Scenario

Picture this: a seemingly calm day at your medical practice is shattered when your phones start to ring off the hook.

Your email system has been compromised, and cyber attackers have sent phishing emails to all your patients using YOUR email account.

What’s even more concerning is that these hackers used your email to reset your password for the Electronic Medical Records (EMR) system.

As a result, they now have unrestricted entry to ALL patient files, which contain a wealth of highly sensitive information.

This nightmarish scenario not only compromises the trust of your patients but also has legal ramifications.

The HIPAA Wall of Shame

With the breach becoming known, your practice is now listed on the dreaded HIPAA Wall of Shame – a public record of healthcare organizations that have suffered data breaches affecting 500 or more individuals.

This is where the gravity of the situation hits home, as the breach becomes a glaring mark on your practice’s reputation.

The Health and Human Services (HHS) department initiates an investigation, raising the specter of potential fines and legal actions that could have far-reaching consequences for your practice.

Prevention Beyond Compliance: How to Safeguard Healthcare Data in the Cloud

The good news is that scenarios like the one described above are entirely preventable with the right cybersecurity measures in place.

Beyond adhering to HIPAA regulations, healthcare organizations must take proactive steps to enhance their cybersecurity posture in the cloud environment.

1.) Implement MFA Across All Systems

One highly effective method to enhance cloud security is by implementing multi-factor authentication (MFA) across all systems and applications.

MFA enhances security by demanding users to provide various verification methods prior to accessing the system, adding an additional layer of protection.

However, it’s crucial to avoid using text messages as the secondary authentication method, as texts can be easily intercepted by clever hackers.

Instead, opt for more secure methods such as app-based authenticators or hardware tokens.

2.) Vet Your IT Partners Thoroughly

While many healthcare practices rely on external IT companies to manage their technology infrastructure, assuming that these partners inherently know how to configure and secure systems can be a costly mistake.

Prior to engaging with an IT company, it’s imperative to thoroughly vet their cybersecurity expertise.

A quick tip – ask them for a copy of their information security policy. If they’re forthcoming with it, that’s a good sign that they have their act together.

Also ask them what standards they follow for hardening cloud applications like Microsoft 365 and Google Workspace.

You can also engage a vCISO service to dive under the covers and confirm whether or not your IT folks are doing the right things to keep you safe.

If they don’t have a good answer, look elsewhere.

3.) Geo-Blocking and Secure Access Service Edge (SASE)

Due to the worldwide scope of cyber threats, hackers can potentially launch attacks from any corner of the globe.

To counter this risk, you might want to contemplate the adoption of geo-blocking, a strategy that eliminates system access for foreign countries with a history of cybercriminal activities.

Taking this a step further, adopting a Secure Access Service Edge (SASE) approach can provide a comprehensive solution.

SASE combines network security and wide-area networking, enabling organizations to ONLY allow access to their cloud systems from company-approved computers.

4.) Education on MFA Alert Bombing

Learning from past breaches is a crucial aspect of staying ahead of cyber threats.

One notable incident involved the rideshare company Uber, where hackers leveraged a vulnerability in the organization’s MFA system.

This breach tactic, known as MFA alert bombing, involves bombarding a target with multiple MFA requests in a short period, overwhelming the victim and tricking them into clicking “Yes” on their phone to give the hackers unauthorized access.

Educating your employees about this tactic and implementing safeguards to detect and mitigate such attacks can be pivotal in maintaining cybersecurity resilience.


As healthcare organizations embrace cloud technology to enhance their operations and patient care, cybersecurity must evolve beyond compliance with HIPAA regulations.

The nightmare scenario of a data breach with severe consequences can be averted through a holistic approach that encompasses multi-factor authentication, thorough vetting of IT partners, geo-blocking, and education on emerging threat tactics.

By prioritizing these measures, healthcare providers can ensure the confidentiality, integrity, and availability of patient data while maintaining their reputation and avoiding the HIPAA Wall of Shame.

In this era of digital transformation, proactive cybersecurity measures are the prescription for a healthier and more secure healthcare ecosystem.


How To Start A Career In Medicine On The Right Note

A career in medicine sets you up for success. Besides being financially rewarding, it is a noble profession that enables you to save lives. But the journey is long and challenging. Meticulous planning and unwavering dedication can help you reach your goals.

According to the Association of American Medical Colleges, the acceptance rate for medical schools in the US hovers around 6-7%, making the field highly competitive. Even the brightest students may struggle to get in. But the growth and income prospects make the effort worthwhile.

Fortunately, there are ways to kickstart your medical career on the right note and build up from there. Here are a few actionable tips to help you begin your medical journey on a path toward success and fulfillment.

Prioritize Academic Excellence

A solid foundation for a career in medicine boils down to academic excellence from high school through your undergraduate years. Aim for top grades, especially in science and math courses, as they form the basis for medical school prerequisites.

A high GPA enhances your chances of getting into medical school and prepares you for the rigorous coursework ahead. In fact, pursuing top scores cultivates the habits of hard work early on. Consider it the first step toward your career goal of becoming a medical professional.

Gain Relevant Experience

You are never too young to start pursuing your career aspirations. Starting on the right note is about gaining hands-on experience early, even before enrolling in medical school. Find ways to get into the field and capitalize on every opportunity that comes your way.

For example, you can volunteer at hospitals, clinics, or nursing homes, shadow physicians, or work as a medical assistant. These roles provide invaluable insights into the healthcare field and showcase your commitment to future medical schools and employers.

Do not skimp on Extracurricular Involvement

Starting a career in medicine takes more than shining in academics. You need to be an all-rounder from the outset. Participation in extracurricular activities, particularly those related to healthcare or leadership, demonstrates your well-roundedness and dedication.

Join pre-medical clubs, student organizations, or community service projects to build your profile. Such activities highlight your ability to balance academics and leadership responsibilities. They also foster the right attitude required to pursue a role in the healthcare industry.

Prepare for the MCAT

The Medical College Admission Test (MCAT) is perhaps the crucial part of the journey. It is the exam that sets you up for a place in medical school, so being extra ready for it gives you a winning advantage. Research the exam early to develop an emotional commitment toward preparing for it.

Devote adequate time to study and prepare thoroughly because the test is highly competitive. Consider enrolling in MCAT prep courses, using study materials, and taking practice tests to maximize your score and get into a program of your choice.

Invest in Multiple Mini Interview (MMI) Practice

Many medical schools rely on the MMI format to assess candidates’ suitability for their programs. The interview can be challenging because it involves a series of short, timed stations where you face several ethical and situational scenarios.

To excel in MMIs, you must invest in regular multiple mini interview practice. Consider working with an MMI expert for mock interviews replicating the real challenges. You can seek feedback and develop your problem-solving abilities with regular practice. The ability to think on your feet and articulate well-reasoned responses can get you through the real process.

Develop Interpersonal Skills

Medicine isn’t just about science and knowledge of diseases and treatments. It is also about compassion and communication with your patients and their families. Developing these abilities is a part of preparing for the career.

Hone your interpersonal skills by volunteering in roles that require empathy and active listening. Learn to relate to and connect with diverse individuals for better patient interactions in the long run.

Cultivate Resilience and Perseverance

The path to a medical career can be arduous, with intense academic demands, extended training, and dire emotional challenges. You must cultivate resilience by seeking a support network of peers, mentors, and family.

Develop coping strategies to manage setbacks and struggles, as these are inevitable. Also, embrace a growth mindset to learn from failures and continue pursuing your goals.


Getting a head start in the medical profession is easier than you imagine, provided you begin on the right note. All you have to do is commit to academic excellence, interpersonal development, and constant effort to reach your goals. Also, stay dedicated to your aim because slowing down is not an option.

Medical Device Security: Safeguarding Connected Devices in the Internet of Medical Things (IoMT)

Healthcare organizations face a wide range of cyber challenges. These challenges include budget constraints for IT, ensuring full data compliance, dealing with an increased risk of cyber-attacks, and safeguarding highly sensitive medical data. With the digitalization of the healthcare industry, the Internet of Medical Things (IoMT) has emerged as a significant area of growth. Connected devices, such as remote patient monitoring devices and hospital sensors, have significantly improved healthcare outcomes for patients.

However, IoMT devices also pose a significant security concern. The number of healthcare organizations targeted by cyber-attacks has risen by 90% in just three months. Shockingly, data from Irdeto reveals that 80% of med tech firms have experienced a cyber-attack in the past five years. The proliferation of new connected devices in large networks has further exposed healthcare organizations to cyber-attacks. These facts give rise to alarming thoughts. The only solution to the problem is to take care of medical device security.

How to protect IOMT?

Implementing a strong base of general security best practices is crucial for IoMT devices. These practices should encompass well-defined incident response plans, conducting tabletop exercises, and utilizing a monitoring solution that involves human oversight to detect any anomalies in device logs.

#1 Global approach

Healthcare systems must holistically consider vulnerability remediation. Even if a patch is unavailable, there may still be options for configuration or behavior changes that can effectively mitigate or eliminate the risk associated with a specific vulnerability.

Healthcare organizations should reserve the use of micro-segmentation as a last resort, only when other solutions are not available. It is not advisable to rely on micro-segmentation as the primary security strategy.

#2 VPN protection

A VPN can be a significant help in protecting connected medical devices. In particular, it allows you to encrypt data before sending it. With a good VPN provider like VeePN, all data will be encrypted before it is sent or received. It uses a 256-bit cipher that is unbreakable. You can also install a VPN for Safari on medical staff’s computers to hide their real IP addresses and protect against DDoS or phishing attacks.

#3 Correct prioritization

Prioritizing ruthlessly is crucial. With an overwhelming number of new vulnerabilities, it is impossible to address every minor vulnerability or micro-segment of every device.

The key is to concentrate on the most severe issues that affect the most critical devices. This involves evaluating the vulnerability’s risk, the likelihood of exploitation on a specific device, and the device’s significance to your operations.

#4 Focus on preventative protection

To prevent security issues, it is crucial to avoid their creation from the outset. This necessitates considering cybersecurity risks early in the procurement process. While some organizations already prioritize this, there is a tendency for security team involvement to devolve into mere compliance theater, which fails to provide meaningful assistance.

Alternatively, a more effective approach involves analyzing real-world technical data to assess device behavior. Additionally, evaluating the manufacturer’s overall security track record is beneficial. This includes assessing their responsiveness to security issues and timely release of patches.

#5 Automated session management

Healthcare organizations can enhance their security by implementing a session management tool. It works in real-time and constantly analyzes network activity. If any actions seem suspicious to him, the system will block the connection until the circumstances are clarified. With automatic threat response, you’ll be prepared even if someone else breaks into your network. Cybersecurity must be multi-layered since we do not know at what point we will be able to stop a hacker.


During the pandemic, the healthcare industry has been transformed by IoMT, but the widespread adoption of new systems and devices has also brought new challenges and risks. Vulnerable networks have become prime targets for cybercriminals, necessitating swift action from the entire healthcare industry to strengthen defenses.

User-unfriendly EHRs pose serious risks to patient safety

Electronic health records that deliver suboptimal user experience are more likely to lead to alert fatigue and less likely to catch errors that could impact hospital safety, University of Utah Health research shows.

"Hospitals and health systems have spent more than $100 billion on EHRs over the last decade, and most believe that these systems are completely safe and usable but that is not necessarily the case," said Dr. David Classen, a professor of internal medicine at University of Utah Health

Because of this inherent risk in poorly designed electronic health records, all hospitals should "annually perform a safety check on their system to assure it is safe," said Classen, whose EHR research is published in the most recent issue of
JAMA Network Open.

Classen worked on the research project with renowned patient safety innovation leader Dr. David Bates, from Brigham and Women's Hospital, as well as scientists at University of California San Diego Health. Researchers at UC San Francisco and KLAS Enterprises also contributed.

He's not one to undersell the scope of the problem – he said the situation is not unlike software glitches that led to two Boeing 737 MAX airplane crashes in 2018 and 2019, with pilots' struggles to make the software work showing more fundamental safety issues.

EHRs' built-in safety mechanisms need to be redesigned, the study suggests.

Classen argues that, just as the Federal Aviation Administration, airline manufacturers and airlines now jointly monitor and improve airline software, something similar needs to happen with EHR vendors, hospitals and clinicians – who should collaborate to optimize EHR software for usability, provider experience and patient safety.

In inpatient settings, EHR alerts, reminders and clinical guidelines pop up to steer clinicians' decision-making, the research notes. But it's long been a known that these notifications are very often more distracting than useful.

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