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• What Is R&D?
• Understanding R&D
• Types of R&D
• Pros and Cons
• Considerations
• R&D vs. Applied Research
• Who Spends the Most?

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Research and Development (R&D) Definition, Types, and Importance

Investopedia / Ellen Lindner

What Is Research and Development (R&D)?

The term research and development (R&D) is used to describe a series of activities that companies undertake to innovate and introduce new products and services. R&D is often the first stage in the development process. Companies require knowledge, talent, and investment in order to further their R&D needs and goals. The purpose of research and development is generally to take new products and services to market and add to the company's bottom line .

Key Takeaways

• Research and development represents the activities companies undertake to innovate and introduce new products and services or to improve their existing offerings.
• R&D allows a company to stay ahead of its competition by catering to new wants or needs in the market.
• Companies in different sectors and industries conduct R&D—pharmaceuticals, semiconductors, and technology companies generally spend the most.
• R&D is often a broad approach to exploratory advancement, while applied research is more geared towards researching a more narrow scope.
• The accounting for treatment for R&D costs can materially impact a company's income statement and balance sheet.

Understanding Research and Development (R&D)

The concept of research and development is widely linked to innovation both in the corporate and government sectors. R&D allows a company to stay ahead of its competition. Without an R&D program, a company may not survive on its own and may have to rely on other ways to innovate such as engaging in mergers and acquisitions (M&A) or partnerships. Through R&D, companies can design new products and improve their existing offerings.

R&D is distinct from most operational activities performed by a corporation. The research and/or development is typically not performed with the expectation of immediate profit. Instead, it is expected to contribute to the long-term profitability of a company. R&D may often allow companies to secure intellectual property, including patents , copyrights, and trademarks as discoveries are made and products created.

Companies that set up and employ departments dedicated entirely to R&D commit substantial capital to the effort. They must estimate the risk-adjusted return on their R&D expenditures, which inevitably involves risk of capital. That's because there is no immediate payoff, and the return on investment (ROI) is uncertain. As more money is invested in R&D, the level of capital risk increases. Other companies may choose to outsource their R&D for a variety of reasons including size and cost.

Companies across all sectors and industries undergo R&D activities. Corporations experience growth through these improvements and the development of new goods and services. Pharmaceuticals, semiconductors , and software/technology companies tend to spend the most on R&D. In Europe, R&D is known as research and technical or technological development.

Many small and mid-sized businesses may choose to outsource their R&D efforts because they don't have the right staff in-house to meet their needs.

Types of R&D

There are several different types of R&D that exist in the corporate world and within government. The type used depends entirely on the entity undertaking it and the results can differ.

Basic Research

There are business incubators and accelerators, where corporations invest in startups and provide funding assistance and guidance to entrepreneurs in the hope that innovations will result that they can use to their benefit.

M&As and partnerships are also forms of R&D as companies join forces to take advantage of other companies' institutional knowledge and talent.

Applied Research

One R&D model is a department staffed primarily by engineers who develop new products —a task that typically involves extensive research. There is no specific goal or application in mind with this model. Instead, the research is done for the sake of research.

Development Research

This model involves a department composed of industrial scientists or researchers, all of who are tasked with applied research in technical, scientific, or industrial fields. This model facilitates the development of future products or the improvement of current products and/or operating procedures.

$42.7 billion of research and development costs later, Amazon was granted 2,244 new patents in 2020. Their patents included advancements in artificial intelligence, machine learning, and cloud computing.

Advantages and Disadvantages of R&D

There are several key benefits to research and development. It facilitates innovation, allowing companies to improve existing products and services or by letting them develop new ones to bring to the market.

Because R&D also is a key component of innovation, it requires a greater degree of skill from employees who take part. This allows companies to expand their talent pool, which often comes with special skill sets.

The advantages go beyond corporations. Consumers stand to benefit from R&D because it gives them better, high-quality products and services as well as a wider range of options. Corporations can, therefore, rely on consumers to remain loyal to their brands. It also helps drive productivity and economic growth.

Disadvantages

One of the major drawbacks to R&D is the cost. First, there is the financial expense as it requires a significant investment of cash upfront. This can include setting up a separate R&D department, hiring talent, and product and service testing, among others.

Innovation doesn't happen overnight so there is also a time factor to consider. This means that it takes a lot of time to bring products and services to market from conception to production to delivery.

Because it does take time to go from concept to product, companies stand the risk of being at the mercy of changing market trends . So what they thought may be a great seller at one time may reach the market too late and not fly off the shelves once it's ready.

Facilitates innovation

Improved or new products and services

Expands knowledge and talent pool

Increased consumer choice and brand loyalty

Economic driver

Financial investment

Shifting market trends

R&D Accounting

R&D may be beneficial to a company's bottom line, but it is considered an expense . After all, companies spend substantial amounts on research and trying to develop new products and services. As such, these expenses are often reported for accounting purposes on the income statement and do not carry long-term value.

There are certain situations where R&D costs are capitalized and reported on the balance sheet. Some examples include but are not limited to:

• Materials, fixed assets, or other assets have alternative future uses with an estimable value and useful life.
• Software that can be converted or applied elsewhere in the company to have a useful life beyond a specific single R&D project.
• Indirect costs or overhead expenses allocated between projects.
• R&D purchased from a third party that is accompanied by intangible value. That intangible asset may be recorded as a separate balance sheet asset.

R&D Considerations

Before taking on the task of research and development, it's important for companies and governments to consider some of the key factors associated with it. Some of the most notable considerations are:

• Objectives and Outcome: One of the most important factors to consider is the intended goals of the R&D project. Is it to innovate and fill a need for certain products that aren't being sold? Or is it to make improvements on existing ones? Whatever the reason, it's always important to note that there should be some flexibility as things can change over time.
• Timing: R&D requires a lot of time. This involves reviewing the market to see where there may be a lack of certain products and services or finding ways to improve on those that are already on the shelves.
• Cost: R&D costs a great deal of money, especially when it comes to the upfront costs. And there may be higher costs associated with the conception and production of new products rather than updating existing ones.
• Risks: As with any venture, R&D does come with risks. R&D doesn't come with any guarantees, no matter the time and money that goes into it. This means that companies and governments may sacrifice their ROI if the end product isn't successful.

Research and Development vs. Applied Research

Basic research is aimed at a fuller, more complete understanding of the fundamental aspects of a concept or phenomenon. This understanding is generally the first step in R&D. These activities provide a basis of information without directed applications toward products, policies, or operational processes .

Applied research entails the activities used to gain knowledge with a specific goal in mind. The activities may be to determine and develop new products, policies, or operational processes. While basic research is time-consuming, applied research is painstaking and more costly because of its detailed and complex nature.

Who Spends the Most on R&D?

Companies spend billions of dollars on R&D to produce the newest, most sought-after products. According to public company filings, these companies incurred the highest research and development spending in 2020:

• Amazon: $42.7 billion
• Alphabet.: $27.6 billion
• Huawei: $22.0 billion
• Microsoft: $19.3 billion
• Apple: $18.8 billion
• Samsung: $18.8 billion
• Facebook: $18.5 billion

What Types of Activities Can Be Found in Research and Development?

Research and development activities focus on the innovation of new products or services in a company. Among the primary purposes of R&D activities is for a company to remain competitive as it produces products that advance and elevate its current product line. Since R&D typically operates on a longer-term horizon, its activities are not anticipated to generate immediate returns. However, in time, R&D projects may lead to patents, trademarks, or breakthrough discoveries with lasting benefits to the company. 

What Is an Example of Research and Development?

Alphabet allocated over $16 billion annually to R&D in 2018. Under its R&D arm X, the moonshot factory, it has developed Waymo self-driving cars. Meanwhile, Amazon has spent even more on R&D projects, with key developments in cloud computing and its cashier-less store Amazon Go. At the same time, R&D can take the approach of a merger & acquisition, where a company will leverage the talent and intel of another company to create a competitive edge. The same can be said with company investment in accelerators and incubators, whose developments it could later leverage.

Why Is Research and Development Important?

Given the rapid rate of technological advancement, R&D is important for companies to stay competitive. Specifically, R&D allows companies to create products that are difficult for their competitors to replicate. Meanwhile, R&D efforts can lead to improved productivity that helps increase margins, further creating an edge in outpacing competitors. From a broader perspective, R&D can allow a company to stay ahead of the curve, anticipating customer demands or trends.

There are many things companies can do in order to advance in their industries and the overall market. Research and development is just one way they can set themselves apart from their competition. It opens up the potential for innovation and increasing sales. But it does come with some drawbacks—the most obvious being the financial cost and the time it takes to innovate.

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Building an R&D strategy for modern times

The global investment in research and development (R&D) is staggering. In 2019 alone, organizations around the world spent $2.3 trillion on R&D—the equivalent of roughly 2 percent of global GDP—about half of which came from industry and the remainder from governments and academic institutions. What’s more, that annual investment has been growing at approximately 4 percent per year over the past decade. 1 2.3 trillion on purchasing-power-parity basis; 2019 global R&D funding forecast , Supplement, R&D Magazine, March 2019, rdworldonline.com.

While the pharmaceutical sector garners much attention due to its high R&D spending as a percentage of revenues, a comparison based on industry profits shows that several industries, ranging from high tech to automotive to consumer, are putting more than 20 percent of earnings before interest, taxes, depreciation, and amortization (EBITDA) back into innovation research (Exhibit 1).

What do organizations expect to get in return? At the core, they hope their R&D investments yield the critical technology from which they can develop new products, services, and business models. But for R&D to deliver genuine value, its role must be woven centrally into the organization’s mission. R&D should help to both deliver and shape corporate strategy, so that it develops differentiated offerings for the company’s priority markets and reveals strategic options, highlighting promising ways to reposition the business through new platforms and disruptive breakthroughs.

Yet many enterprises lack an R&D strategy that has the necessary clarity, agility, and conviction to realize the organization’s aspirations. Instead of serving as the company’s innovation engine, R&D ends up isolated from corporate priorities, disconnected from market developments, and out of sync with the speed of business. Amid a growing gap in performance  between those that innovate successfully and those that do not, companies wishing to get ahead and stay ahead of competitors need a robust R&D strategy that makes the most of their innovation investments. Building such a strategy takes three steps: understanding the challenges that often work as barriers to R&D success, choosing the right ingredients for your strategy, and then pressure testing it before enacting it.

Overcoming the barriers to successful R&D

The first step to building an R&D strategy is to understand the four main challenges that modern R&D organizations face:

Innovation cycles are accelerating. The growing reliance on software and the availability of simulation and automation technologies have caused the cost of experimentation to plummet while raising R&D throughput. The pace of corporate innovation is further spurred by the increasing emergence of broadly applicable technologies, such as digital and biotech, from outside the walls of leading industry players.

But incumbent corporations are only one part of the equation. The trillion dollars a year that companies spend on R&D is matched by the public sector. Well-funded start-ups, meanwhile, are developing and rapidly scaling innovations that often threaten to upset established business models or steer industry growth into new areas. Add increasing investor scrutiny of research spending, and the result is rising pressure on R&D leaders to quickly show results for their efforts.

R&D lacks connection to the customer. The R&D group tends to be isolated from the rest of the organization. The complexity of its activities and its specialized lexicon make it difficult for others to understand what the R&D function really does. That sense of working inside a “black box” often exists even within the R&D organization. During a meeting of one large company’s R&D leaders, a significant portion of the discussion focused on simply getting everyone up to speed on what the various divisions were doing, let alone connecting those efforts to the company’s broader goals.

Given the challenges R&D faces in collaborating with other functions, going one step further and connecting with customers becomes all the more difficult. While many organizations pay lip service to customer-centric development, their R&D groups rarely get the opportunity to test products directly with end users. This frequently results in market-back product development that relies on a game of telephone via many intermediaries about what the customers want and need.

Projects have few accountability metrics. R&D groups in most sectors lack effective mechanisms to measure and communicate progress; the pharmaceutical industry, with its standard pipeline for new therapeutics that provides well-understood metrics of progress and valuation implications, is the exception, not the rule. When failure is explained away as experimentation and success is described in terms of patents, rather than profits, corporate leaders find it hard to quantify R&D’s contribution.

Yet proven metrics exist  to effectively measure progress and outcomes. A common challenge we observe at R&D organizations, ranging from automotive to chemical companies, is how to value the contribution of a single component that is a building block of multiple products. One specialty-chemicals company faced this challenge in determining the value of an ingredient it used in its complex formulations. It created categorizations to help develop initial business cases and enable long-term tracking. This allowed pragmatic investment decisions at the start of projects and helped determine the value created after their completion.

Even with outcomes clearly measured, the often-lengthy period between initial investment and finished product can obscure the R&D organization’s performance. Yet, this too can be effectively managed by tracking the overall value and development progress of the pipeline so that the organization can react and, potentially, promptly reorient both the portfolio and individual projects within it.

Incremental projects get priority. Our research indicates that incremental projects account for more than half of an average company’s R&D investment, even though bold bets and aggressive reallocation  of the innovation portfolio deliver higher rates of success. Organizations tend to favor “safe” projects with near-term returns—such as those emerging out of customer requests—that in many cases do little more than maintain existing market share. One consumer-goods company, for example, divided the R&D budget among its business units, whose leaders then used the money to meet their short-term targets rather than the company’s longer-term differentiation and growth objectives.

Focusing innovation solely around the core business may enable a company to coast for a while—until the industry suddenly passes it by. A mindset that views risk as something to be avoided rather than managed can be unwittingly reinforced by how the business case is measured. Transformational projects at one company faced a higher internal-rate-of-return hurdle than incremental R&D, even after the probability of success had been factored into their valuation, reducing their chances of securing funding and tilting the pipeline toward initiatives close to the core.

As organizations mature, innovation-driven growth becomes increasingly important, as their traditional means of organic growth, such as geographic expansion and entry into untapped market segments, diminish. To succeed, they need to develop R&D strategies equipped for the modern era that treat R&D not as a cost center but as the growth engine it can become.

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Choosing the ingredients of a winning r&d strategy.

Given R&D’s role as the innovation driver that advances the corporate agenda, its guiding strategy needs to link board-level priorities with the technologies that are the organization’s focus (Exhibit 2). The R&D strategy must provide clarity and commitment to three central elements: what we want to deliver, what we need to deliver it, and how we will deliver it.

What we want to deliver. To understand what a company wants to and can deliver, the R&D, commercial, and corporate-strategy functions need to collaborate closely, with commercial and corporate-strategy teams anchoring the R&D team on the company’s priorities and the R&D team revealing what is possible. The R&D strategy and the corporate strategy must be in sync while answering questions such as the following: At the highest level, what are the company’s goals? Which of these will require R&D in order to be realized? In short, what is the R&D organization’s purpose?

Bringing the two strategies into alignment is not as easy as it may seem. In some companies, what passes for corporate strategy is merely a five-year business plan. In others, the corporate strategy is detailed but covers only three to five years—too short a time horizon to guide R&D, especially in industries such as pharma or semiconductors where the product-development cycle is much longer than that. To get this first step right, corporate-strategy leaders should actively engage with R&D. That means providing clarity where it is lacking and incorporating R&D feedback that may illuminate opportunities, such as new technologies that unlock growth adjacencies for the company or enable completely new business models.

Secondly, the R&D and commercial functions need to align on core battlegrounds and solutions. Chief technology officers want to be close to and shape the market by delivering innovative solutions that define new levels of customer expectations. Aligning R&D strategy provides a powerful forum for identifying those opportunities by forcing conversations about customer needs and possible solutions that, in many companies, occur only rarely. Just as with the corporate strategy alignment, the commercial and R&D teams need to clearly articulate their aspirations by asking questions such as the following: Which markets will make or break us as a company? What does a winning product or service look like for customers?

When defining these essential battlegrounds, companies should not feel bound by conventional market definitions based on product groups, geographies, or customer segments. One agricultural player instead defined its markets by the challenges customers faced that its solutions could address. For example, drought resistance was a key battleground no matter where in the world it occurred. That framing clarified the R&D–commercial strategy link: if an R&D project could improve drought resistance, it was aligned to the strategy.

The dialogue between the R&D, commercial, and strategy functions cannot stop once the R&D strategy is set. Over time, leaders of all three groups should reexamine the strategic direction and continuously refine target product profiles as customer needs and the competitive landscape evolve.

What we need to deliver it. This part of the R&D strategy determines what capabilities and technologies the R&D organization must have in place to bring the desired solutions to market. The distinction between the two is subtle but important. Simply put, R&D capabilities are the technical abilities to discover, develop, or scale marketable solutions. Capabilities are unlocked by a combination of technologies and assets, and focus on the outcomes. Technologies, however, focus on the inputs—for example, CRISPR is a technology that enables the genome-editing capability.

This delineation protects against the common pitfall of the R&D organization fixating on components of a capability instead of the capability itself—potentially missing the fact that the capability itself has evolved. Consider the dawn of the digital age: in many engineering fields, a historical reliance on talent (human number crunchers) was suddenly replaced by the need for assets (computers). Those who focused on hiring the fastest mathematicians were soon overtaken by rivals who recognized the capability provided by emerging technologies.

The simplest way to identify the needed capabilities is to go through the development processes of priority solutions step by step—what will it take to produce a new product or feature? Being exhaustive is not the point; the goal is to identify high-priority capabilities, not to log standard operating procedures.

Prioritizing capabilities is a critical but often contentious aspect of developing an R&D strategy. For some capabilities, being good is sufficient. For others, being best in class is vital because it enables a faster path to market or the development of a better product than those of competitors. Take computer-aided design (CAD), which is used to design and prototype engineering components in numerous industries, such as aerospace or automotive. While companies in those sectors need that capability, it is unlikely that being the best at it will deliver a meaningful advantage. Furthermore, organizations should strive to anticipate which capabilities will be most important in the future, not what has mattered most to the business historically.

Once capabilities are prioritized, the R&D organization needs to define what being “good” and “the best” at them will mean over the course of the strategy. The bar rises rapidly in many fields. Between 2009 and 2019, the cost of sequencing a genome dropped 150-fold, for example. 2 Kris A. Wetterstrand, “DNA sequencing costs: Data,” NHGRI Genome Sequencing Program (GSP), August 25, 2020, genome.gov. Next, the organization needs to determine how to develop, acquire, or access the needed capabilities. The decision of whether to look internally or externally is crucial. An automatic “we can build it better” mindset diminishes the benefits of specialization and dilutes focus. Additionally, the bias to building everything in-house can cut off or delay access to the best the world has to offer—something that may be essential for high-priority capabilities. At Procter & Gamble, it famously took the clearly articulated aspiration of former CEO A. G. Lafley to break the company’s focus on in-house R&D and set targets for sourcing innovation externally. As R&D organizations increasingly source capabilities externally, finding partners and collaborating with them effectively is becoming a critical capability in its own right.

How we will do it. The choices of operating model and organizational design will ultimately determine how well the R&D strategy is executed. During the strategy’s development, however, the focus should be on enablers that represent cross-cutting skills and ways of working. A strategy for attracting, developing, and retaining talent is one common example.

Another is digital enablement, which today touches nearly every aspect of what the R&D function does. Artificial intelligence can be used at the discovery phase to identify emerging market needs or new uses of existing technology. Automation and advanced analytics approaches to experimentation can enable high throughput screening at a small scale and distinguish the signal from the noise. Digital (“in silico”) simulations are particularly valuable when physical experiments are expensive or dangerous. Collaboration tools are addressing the connectivity challenges common among geographically dispersed project teams. They have become indispensable in bringing together existing collaborators, but the next horizon is to generate the serendipity of chance encounters that are the hallmark of so many innovations.

Testing your R&D strategy

Developing a strategy for the R&D organization entails some unique challenges that other functions do not face. For one, scientists and engineers have to weigh considerations beyond their core expertise, such as customer, market, and economic factors. Stakeholders outside R&D labs, meanwhile, need to understand complex technologies and development processes and think along much longer time horizons than those to which they are accustomed.

For an R&D strategy to be robust and comprehensive enough to serve as a blueprint to guide the organization, it needs to involve stakeholders both inside and outside the R&D group, from leading scientists to chief commercial officers. What’s more, its definition of capabilities, technologies, talent, and assets should become progressively more granular as the strategy is brought to life at deeper levels of the R&D organization. So how can an organization tell if its new strategy passes muster? In our experience, McKinsey’s ten timeless tests of strategy  apply just as well to R&D strategy as to corporate and business-unit strategies. The following two tests are the most important in the R&D context:

• Does the organization’s strategy tap the true source of advantage? Too often, R&D organizations conflate technical necessity (what is needed to develop a solution) with strategic importance (distinctive capabilities that allow an organization to develop a meaningfully better solution than those of their competitors). It is also vital for organizations to regularly review their answers to this question, as capabilities that once provided differentiation can become commoditized and no longer serve as sources of advantage.
• Does the organization’s strategy balance commitment-rich choices with flexibility and learning? R&D strategies may have relatively long time horizons but that does not mean they should be insulated from changes in the outside world and never revisited. Companies should establish technical, regulatory, or other milestones that serve as clear decision points for shifting resources to or away from certain research areas. Such milestones can also help mark progress and gauge whether strategy execution is on track.

Additionally, the R&D strategy should be simply and clearly communicated to other functions within the company and to external stakeholders. To boost its clarity, organizations might try this exercise: distill the strategy into a set of fill-in-the-blank components that define, first, how the world will evolve and how the company plans to refocus accordingly (for example, industry trends that may lead the organization to pursue new target markets or segments); next, the choices the R&D function will make in order to support the company’s new focus (which capabilities will be prioritized and which de-emphasized); and finally, how the R&D team will execute the strategy in terms of concrete actions and milestones. If a company cannot fit the exercise on a single page, it has not sufficiently synthesized the strategy—as the famed physicist Richard Feynman observed, the ultimate test of comprehension is the ability to convey something to others in a simple manner.

Cascading the strategy down through the R&D organization will further reinforce its impact. For example, asking managers to communicate the strategy to their subordinates will deepen their own understanding. A useful corollary is that those hearing the strategy for the first time are introduced to it by their immediate supervisors rather than more distant R&D leaders. One R&D group demonstrated the broad benefits of this communication model: involving employees in developing and communicating the R&D strategy helped it double its Organizational Health Index  strategic clarity score, which measures one of the four “power practices”  highly connected to organizational performance.

R&D represents a massive innovation investment, but as companies confront globalized competition, rapidly changing customer needs, and technological shifts coming from an ever-wider range of fields, they are struggling to deliver on R&D’s full potential. A clearly articulated R&D strategy that supports and informs the corporate strategy is necessary to maximize the innovation investment and long-term company value.

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• Research and Development (R&D) | Overview & Process

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Companies often spend resources on certain investigative undertakings in an effort to make discoveries that can help develop new products or way of doing things or work towards enhancing pre-existing products or processes. These activities come under the Research and Development (R&D) umbrella.

R&D is an important means for achieving future growth and maintaining a relevant product in the market . There is a misconception that R&D is the domain of high tech technology firms or the big pharmaceutical companies. In fact, most established consumer goods companies dedicate a significant part of their resources towards developing new versions of products or improving existing designs . However, where most other firms may only spend less than 5 percent of their revenue on research, industries such as pharmaceutical, software or high technology products need to spend significantly given the nature of their products.

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In this article, we look at 1) types of R&D , 2) understanding similar terminology , 3) making the R&D decision , 4) basic R&D process , 5) creating an effective R&D process , 6) advantages of R&D , and 7) R&D challenges .

TYPES OF R&D

A US government agency, the National Science Foundation defines three types of R&D .

Basic Research

When research aims to understand a subject matter more completely and build on the body of knowledge relating to it, then it falls in the basic research category. This research does not have much practical or commercial application. The findings of such research may often be of potential interest to a company

Applied Research

Applied research has more specific and directed objectives. This type of research aims to determine methods to address a specific customer/industry need or requirement. These investigations are all focused on specific commercial objectives regarding products or processes.

Development

Development is when findings of a research are utilized for the production of specific products including materials, systems and methods. Design and development of prototypes and processes are also part of this area. A vital differentiation at this point is between development and engineering or manufacturing. Development is research that generates requisite knowledge and designs for production and converts these into prototypes. Engineering is utilization of these plans and research to produce commercial products.

UNDERSTANDING SIMILAR TERMINOLOGY

There are a number of terms that are often used interchangeably. Thought there is often overlap in all of these processes, there still remains a considerable difference in what they represent. This is why it is important to understand these differences.

The creation of new body of knowledge about existing products or processes, or the creation of an entirely new product is called R&D. This is systematic creative work, and the resulting new knowledge is then used to formulate new materials or entire new products as well as to alter and improve existing ones

Innovation includes either of two events or a combination of both of them. These are either the exploitation of a new market opportunity or the development and subsequent marketing of a technical invention. A technical invention with no demand will not be an innovation.

New Product Development

This is a management or business term where there is some change in the appearance, materials or marketing of a product but no new invention. It is basically the conversion of a market need or opportunity into a new product or a product upgrade

When an idea is turned into information which can lead to a new product then it is called design. This term is interpreted differently from country to country and varies between analytical marketing approaches to a more creative process.

Product Design

Misleadingly thought of as the superficial appearance of a product, product design actually encompasses a lot more. It is a cross functional process that includes market research, technical research, design of a concept, prototype creation, final product creation and launch . Usually, this is the refinement of an existing product rather than a new product.

MAKING THE R&D DECISION

Investment in R&D can be extensive and a long term commitment. Often, the required knowledge already exists and can be acquired for a price. Before committing to investment in R&D, a company needs to analyze whether it makes more sense to produce their own knowledge base or acquire existing work. The influence of the following factors can help make this decision.

Proprietariness

If the nature of the research is such that it can be protected through patents or non-disclosure agreements , then this research becomes the sole property of the company undertaking it and becomes much more valuable. Patents can allow a company several years of a head start to maximize profits and cement its position in the market. This sort of situation justifies the cost of the R&D process. On the other hand, if the research cannot be protected, then it may be easily copied by a competitor with little or no monetary expense. In this case, it may be a good idea to acquire research.

Setting up a R&D wing only makes sense if the market growth rate is slow or relatively moderate. In a fast paced environment, competitors may rush ahead before research has been completed, making the entire process useless.

Because of its nature, R&D is not always a guaranteed success commercially. In this regard, it may be desirable to acquire the required research to convert it into necessary marketable products. There is significantly less risk in acquisition as there may be an opportunity to test the technology out before formally purchasing anything.

Considering the long term potential success of a product, acquiring technology is less risky but more costly than generating own research. This is because license fees or royalties may need to be paid and there may even be an arrangement that requires payments tied to sales figures and may continue for as long as the license period. There is also the danger of geographical limitations or other restrictive caveats. In addition, if the technology changes mid license, all the investment will become a sunk cost. Setting up R&D has its own costs associated with it. There needs to be massive initial investment that leads to negative cash flow for a long time. But it does protect the company from the rest of the limitations of acquiring research.

All these aspects need to be carefully assessed and a pros vs. cons assessment needs to be conducted before the make or buy decision is finalized.

BASIC R&D PROCESS

Foster Ideas

At this point the research team may sit down to brainstorm. The discussion may start with an understanding and itemization of the issues faced in their particular industry and then narrowed down to important or core areas of opportunity or concern.

Focus Ideas

The initial pool of ideas is vast and may be generic. The team will then sift through these and locate ideas with potential or those that do not have insurmountable limitations. At this point the team may look into existing products and assess how original a new idea is and how well it can be developed.

Develop Ideas

Once an idea has been thoroughly researched, it may be combined with a market survey to assess market readiness. Ideas with true potential are once again narrowed down and the process of turning research into a marketable commodity begins.

Prototypes and Trials

Researchers may work closely with product developers to understand and agree on how an idea may be turned into a practical product. As the process iterates, the prototype complexity may start to increase and issues such as mass production and sales tactics may begin to enter the process.

Regulatory, Marketing & Product Development Activities

As the product takes shape, the process that began with R&D divides into relevant areas necessary to bring the research product to the market. Regulatory aspects are assessed and work begins to meet all the criteria for approvals and launch. The marketing function begins developing strategies and preparing their materials while sales, pricing and distribution are also planned for.

The product that started as a research question will now be ready for its biggest test, the introduction to the market. The evaluation of the product continues at this stage and beyond, eventually leading to possible re-designs if needed. At any point in this process the idea may be abandoned. Its feasibility may be questioned or the research may not reveal what the business hoped for. It is therefore important to analyze each idea critically at every stage and not become emotionally invested in anything.

CREATING AN EFFECTIVE R&D PROCESS

A formal R&D function adds great value to any organization. It can significantly contribute towards organizational growth and sustained market share. However, all business may not have the necessary resources to set up such a function. In such cases, or in organizations where a formal R&D function is not really required, it is a good idea to foster an R&D mindset . When all employees are encouraged to think creatively and with a research oriented thought process, they all feel invested in the business and there will be the possibility of innovation and unique ideas and solutions. This mindset can be slowly inculcated within the company by following the steps mentioned below.

Assess Customer Needs

It is a good idea to regularly scan and assess the market and identify whether the company’s offering is doing well or if it is in trouble. If it is successful, encourage employees to identify reasons for success so that these can then be used as benchmarks or best practices. If the product is not doing well, then encourage teams to research reasons why. Perhaps a competitor is offering a better solution or perhaps the product cannot meet the customer’s needs effectively.

Identify Objectives

Allow your employees to see clearly what the business objectives are. The end goal for a commercial enterprise is to enhance profits. If this is the case, then all research the employees engage in should focus on reaching this goal while fulfilling a customer need.

Define and Design Processes

A definite project management process helps keep formal and informal research programs on schedule. Realistic goals and targets help focus the process and ensures that relevant and realistic timelines are decided upon.

Create a Team

A team may need to be created if a specific project is on the agenda. This team should be cross functional and will be able to work towards a specific goal in a systematic manner. If the surrounding organizational environment also has a research mindset then they will be better prepared and suited to assist the core team when ever needed.

Whenever needed, it may be a good idea to outsource research projects. Universities and specific research organizations can help achieve research objectives that may not be manageable within a limited organizational budget.

ADVANTAGES OF R&D

Though setting up an R&D function is not an easy task by any means, it has its unique advantages for the organization. These include the following.

Research and Development expenses are often tax deductible. This depends on the country of operations of course but a significant write-off can be a great way to offset large initial investments. But it is important to understand what kind of research activities are deductible and which ones are not. Generally, things like market research or an assessment of historical information are not deductible.

A company can use research to identify leaner and more cost effective means of manufacturing. This reduction in cost can either help provide a more reasonably priced product to the customer or increase the profit margin.

When an investor sets out to put their resources into any company, they tend to prefer those who can become market leaders and innovate constantly. An effective R&D function goes a long way in helping to achieve these objectives for a company. Investors see this as a proactive approach to business and they may end up financing the costs associated with maintaining this R&D function.

Recruitment

Top talent is also attracted to innovative companies doing exciting things. With a successful Research and Development function, qualified candidates will be excited to join the company.

Through R&D based developments, companies can acquire patents for their products. These can help them gain market advantage and cement their position in the industry. This one time product development can lead to long term profits.

R&D CHALLENGES

R&D also has many challenges associated with it. These may include the following.

Initial setup costs as well as continued investment are necessary to keep research work cutting edge and relevant. Not all companies may find it feasible to continue this expenditure.

Increased Timescales

Once a commitment to R&D is made, it may take many years for the actual product to reach the market and a number of years will be filled with no return on continued heavy investment.

Uncertain Results

Not all research that is undertaken yields results. Many ideas and solutions are scrapped midway and work has to start from the beginning.

Market Conditions

There is always the danger that a significant new invention or innovation will render years of research obsolete and create setbacks in the industry with competitors becoming front runners for the customer’s business.

It is important for any business to understand the advantages and disadvantages of engaging in Research and Development activities. Once these are studied, then the step can be taken towards becoming and R&D organization.

In the meanwhile, it is good practice to inculcate a research mind set and research oriented thinking within all employees, no matter what their functional area of expertise. This will help bring about new ideas, new solutions and an innovative way of approaching all business problems, whether small or large.

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Articles on Research and development (R&D)

Displaying 1 - 20 of 114 articles.

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Pharma’s expensive gaming of the drug patent system is successfully countered by the Medicines Patent Pool, which increases global access and rewards innovation

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Australia’s future depends on science. Here’s what our next government needs to do about it

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Will the government’s $2.2bn, 10-year plan get a better return on Australian research? It all depends on changing the culture

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Latest government bid to dictate research directions builds on a decade of failure

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Research and development (R&D) and the product lifecycle

Imagine a young boy searching through the December edition of Intertoys , the Dutch version of the Toys-R-Us magazine. The magazine has over 150 toys, including molding clay, step bikes, board games, M.A.S.K and G.I Joe action figures, Transformers, ThunderCats, and tons more.

His eyes are focused on the pages dedicated to LEGO. The boy finds himself overcome with joy, thinking about all the possibilities to expand his LEGO city. Will he ask for the police station, the gas station, or maybe the medieval castle? He tries to imagine how each enhances his city and the additional stories they can bring.

This young boy was me back in 1986.

LEGO delivered on its mission to inspire and develop the builders of tomorrow. How do I know that to be true? Well, here I am as a product leader who is curious and enjoys experimenting and trying new ways to devise, innovate, and to meet and exceed customer needs.

LEGO is a prime example of a company that recognizes the value of being customer-obsessed, researching, observing, experimenting, and trying over and over again to build what excites and inspires generations to come. It truly harnesses the power of research and development (R&D).

In this guide, we’ll explore what R&D is, the different types of R&D, and how it can inform product development. We’ll also show you how research and development influence go-to-market and help determine whether a launch is successful.

What is research and development (R&D)?

Research and development (R&D) refers to activities and investments directed toward creating new products, improving existing products, streamlining processes, and pursuing knowledge.

The main purpose of R&D is to promote innovation and, in doing so, drive growth and increase competitiveness. Additionally, by improving processes and finding efficiency gains, R&D can lead to cost savings.

In some industries, R&D is necessary for regulatory compliance and to maintain or improve product quality.

R&D example

For an example of how R&D can impact a company’s growth, let’s look a LEGO’s research and development process.

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LEGO works to create new building block shapes and designs and endeavors to improve their performance and safety on an ongoing basis. One of LEGO’s primary R&D efforts aims at developing sustainable production methods.

In 2015, the company invested nearly $150 million into sustainable materials R&D . It’s important to its mission to leave a positive impact on the planet for future generations to inherit.

We’ll refer to the LEGO examples throughout this guide to show what research and development efforts look like in the real world.

Research and development (R&D) vs. product development

It’s tempting to say that R&D and product development are one and the same, but while they overlap, not all product development is R&D.

To qualify as true, authentic, and real R&D, an activity must meet specific criteria that make it SUPA (yes, I just created that acronym).

SUPA stands for:

• Systematic — R&D must follow a systematic approach to solving problems or creating new products
• Advancement — R&D must involve either the creation of new knowledge, a significant improvement to existing knowledge, or a significant advancement in overall understanding
• Purpose — R&D must have the primary purpose of creating new knowledge, improving existing products radically, or creating new ones
• Uncertainty — There must be an element of uncertainty or risk involved in the work. This means you can’t always anticipate the outcome with confidence

As a product manager, most of the above should be familiar. As Marvin Gaye would have said, R&D and product management work together just like music .

R&D and the product development lifecycle

Research provides you with the necessary information and insights to inform and guide your product design. Development helps you bring ideas to life, validate them and then build and commercialize them.

The product development lifecycle is as follows:

• Ideation and concept development
• Design and prototyping
• Development
• Launch and commercialization

Let’s zoom in on each stage to see how R&D plays a role in every aspect of product development.

1. Research

The research phase involves systematically gathering market data, understanding the competitive landscape, and assessing customers in their current use of your product and their unmet needs. R&D helps you find the next big thing or game changer that gains you more market share.

2. Ideation and concept development

This step focuses on generating new ideas and concepts that push the boundaries of what you know. It requires looking at new ideas at a high-level and evaluating their potential feasibility.

3. Design and prototyping

Dip your toes further into the development waters — but make sure not to step on a LEGO while doing so.

The design and prototyping stage is where you create your hypothesis, conduct experiments, create designs, and prototype solutions to validate the assumptions made.

4. Development

During the development stage, any prototypes that fail to deliver advancements are abandoned. Those passing the validation are ready for development consideration.

5. Launch and commercialization

The activities described above will aid in making informed decisions about the product launch , pricing , and go-to-market strategy .

Example: How does R&D influence go-to-market?

Let’s refer back to our example:

LEGO was hugely successful through R&D when bringing the LEGO Mindstorms line to market.

This line empowers users to build and program robots using LEGO bricks and a microcomputer. The creation of the product line involved a multidisciplinary approach. It combined expertise in product design, software engineering, and electronics.

The R&D process started with research that identified the need for a product that allowed users to experiment with and learn about robotics.

LEGO then went through intensive ideation iterations and decided to work with experts in the field to design a system that would be easy to use and accessible to people of all ages and skill levels.

The design and prototypes were thoroughly tested and proved to validate assumptions .

The resulting product was a great success.

3 types of R&D

There are several types of research and development that you can pursue. Each type requires different approaches, resources, expertise, and generates different outcomes.

You can choose to focus on one or more R&D types, depending on your strategic objectives, resources, and capabilities.

Let’s have a look at the three major types of R&D:

Basic research

Applied research, experimental development.

Basic research aims to increase knowledge and understanding of a particular subject, with no immediate application in mind.

LEGO continuously explores new methods for connecting building blocks to each other. This research could involve looking into new materials or design principles that could improve the strength and stability of the connections between the blocks.

Applied research focuses on solving specific practical problems and developing new or improved processes, services, or products.

To reduce its carbon footprint, LEGO is researching a new plant-based plastic for its building blocks. This new material, made from sugarcane, replaces traditional petroleum-based plastic.

Experiment research involves designing, building, and testing a prototype to evaluate the feasibility and potential of new processes, services, or products.

LEGO is developing building sets that incorporate augmented reality (AR) technology. The R&D effort combines applied research with experimental development, as the company seeks to create a new product that utilizes AR to enhance the building and play experience.

How to incorporate R&D into the product development process

So you want to incorporate R&D into your product development process. Kudos to you!

Practice makes perfect. Before looking at a few ways to do this, it is important to remember that incorporating R&D into your product development process is a continuous endeavor and requires adjustments along the way.

The following strategies will help you incorporate R&D:

Prioritize R&D

Foster a culture of innovation.

• Embrace experimentation

Build user-centered

Collaborate with external partners.

The obvious one here is to ensure that R&D is a priority within your company and resources are freed up. This could include dedicating a portion of the budget, allocating capacity, or setting aside dedicated R&D time.

Encourage a culture in your company that values and supports innovation, experimentation, and risk-taking. It could include encouraging employees to pursue their own interests and providing them with the resources to do so.

Embrace experimentation, prototyping, and testing

R&D-ers love experimenting and testing their assumptions through building hypotheses, prototyping, and testing. It allows you to validate ideas, refine designs, identify and address any issues or limitations before bringing a product to market. As a product manager, you probably already have incorporated some of these practices. If not, I highly encourage you to do so.

To find an opportunity you will need to discover and unravel a need. User-centered building helps ensure that products and services are designed with the end-user in mind, leading to better, more effective problem-solving, and solutions to meet the needs of the people who will be using them.

Consider partnering with external organizations, such as universities, research institutes, or other companies, to help drive R&D. This can provide access to additional resources, expertise, and perspectives.

Example: How does R&D influence product development?

Referring back back to our example:

LEGO places a strong emphasis on user-centered design. It conducts user research to understand their needs, preferences, and behaviors and incorporate those findings into product design and development.

LEGO also collaborates with a variety of external partners, including universities, research institutions, and other companies, to drive innovation and R&D. For example, it has worked with the Massachusetts Institute of Technology (MIT) on several projects.

LEGO uses rapid prototyping and testing to iterate and improve its products and encourage employees to be creative and innovative. It does this through the LEGO IDEAS program, which provides a platform for employees to submit and vote on new product ideas.

How to analyze and interpret the results of R&D

It goes without saying that analyzing and interpreting the results of research and development is crucial. How else will you validate or disprove hypotheses, determine the success or failure, and inform future R&D decisions?

Here are some steps that will help you out:

• Define the objectives and hypothesis
• Gather and organize data
• Analyze the data
• Interpret the results
• Validate the results
• Communicate the results
• Use the results to inform future R&D decisions

1. Define the objectives and hypothesis

When you want to analyze results, it’s crucial to have a clear understanding of what you set out to achieve and what you expected to see.

2. Gather and organize data

Collect all relevant data and organize it in a way that allows for easy analysis and interpretation.

3. Analyze the data

Use appropriate statistical methods to analyze the data, such as hypothesis testing, regression analysis, or analysis of variance (ANOVA).

4. Interpret the results

Based on the analysis, interpret the results and draw meaningful conclusions. This may involve identifying patterns, correlations, or relationships between variables.

5. Validate the results

Validate the results by checking for consistency, accuracy, and reliability. It may also be necessary to perform additional tests or experiments to confirm or refute the results.

6. Communicate the results

Communicate the results of the R&D project to stakeholders, including management, investors, customers, and employees. This may involve presenting data, charts, graphs, or other visual representations of the results.

7. Use the results to inform future R&D decisions

Use the results of the R&D project to inform future R&D decisions, including what to research next, what to improve, and what to commercialize.

Proper analysis and interpretation of R&D results are crucial to make informed decisions and drive innovation and growth.

There are various strategies you can implement in your product process. It is key to define your objective and expected results and have a structured process to validate R&D success.

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About the report.

The development of innovative medicines has evolved dramatically over the past decade. This study assesses the activity and landscape of research and development (R&D) in 2018, the productivity levels of the clinical development process and how key trial-trends will transform clinical development over the next five years.  The features and development path of both newly launched therapies and pipeline therapies are examined along with shifts in the companies bringing these drugs to the market. This report puts forth a proprietary Clinical Development Productivity Index that reflects changes in trial complexity, success and duration over time. Eight key trends driving change in clinical development are explored and their expected quantitative impact on productivity through 2023 are discussed.

The research included in this report was undertaken independently by the IQVIA Institute for Human Data Science as a public service, without industry or government funding. None of the analytics in this report are derived from proprietary sponsor trial information but are instead based on proprietary IQVIA databases and/or third-party information.

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• v.10(2); 2021 May

Inside the story about the research and development of COVID-19 vaccines

Shrina p. patel.

Ramanbhai Patel College of Pharmacy, Charusat University, Anand, India.

Gayatri S. Patel

Jalpa v. suthar.

The ongoing coronavirus threat from China has spread rapidly to other nations and has been declared a global health emergency by the World Health Organization (WHO). The pandemic has resulted in over half of the world's population living under conditions of lockdown. Several academic institutions and pharmaceutical companies that are in different stages of development have plunged into the vaccine development race against coronavirus disease 2019 (COVID-19). The demand for immediate therapy and potential prevention of COVID-19 is growing with the increase in the number of individuals affected due to the seriousness of the disease, global dissemination, lack of prophylactics, and therapeutics. The challenging part is a need for vigorous testing for immunogenicity, safety, efficacy, and level of protection conferred in the hosts for the vaccines. As the world responds to the COVID-19 pandemic, we face the challenge of an overabundance of information related to the virus. Inaccurate information and myths spread widely and at speed, making it more difficult for the public to identify verified facts and advice from trusted sources, such as their local health authority or WHO. This review focuses on types of vaccine candidates against COVID-19 in clinical as well as in the preclinical development platform.

Introduction

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) originated in Hubei Province, China, in December 2019 (and possibly earlier, though unrecognized), as a pneumonia-causing disorder [ 1 ], most likely the result of natural selection in animal hosts (bats, pangolins) before the zoonotic transition [ 2 ]. Seven members of this viral family are now known to infect humans, three of whom have the potential to cause severe respiratory diseases [ 3 ]. Coronaviruses (CoVs) are positive-sense, single-stranded Coronaviridae family (subfamily Coronavirinae) RNA viruses that infect a broad range of hosts to produce diseases ranging from the common cold to severe/fatal diseases [ 4 ]. The novel virus was initially named “2019-nCoV” by the International Committee on Virus Taxonomy. It was changed to “SARS-CoV-2” since it was found to be the sister virus of an extreme acute respiratory syndrome (SARS-CoV) [ 5 ]. The ongoing threat of coronavirus emerging in China has spread rapidly to other countries and has been declared by the World Health Organization (WHO) as a global health emergency [ 6 ].

Virus genetic sequencing shows that it is a beta coronavirus that is closely related to the SARS virus [ 7 ]. Currently, immunization prevents 2–3 million deaths from more than 20 life-threatening diseases that are now being controlled by vaccinations, and work is underway at an unprecedented pace to make coronavirus disease 2019 (COVID-19) a vaccine-preventable illness [ 8 ]. To accelerate the research and development process and to establish new standards and standards to prevent the spread of the coronavirus pandemic and care for those affected, WHO brings together the world's scientists and public health practitioners [ 7 ]. In human medical intervention, vaccines are one of the monumental achievements in mitigating the dispersion and effects of infectious diseases [ 9 ]. Vaccines are the most useful method for contagious disease prevention because they are more cost-effective than treatment and reduce morbidity and mortality without long-lasting effects [ 10 ]. Preventive and therapeutic vaccines will be of fundamental significance as the most obvious way to safeguard public health [ 11 ]. Since the coronavirus shares substantial sequence homology with two other lethal coronaviruses, SARS and Middle East respiratory syndrome (MERS), the vaccines identified could potentially promote the design of anti-SARS-CoV-2 vaccines. It is essential to establish safe and effective vaccines to contain the COVID-19 pandemic, eradicate its spread, and eventually prevent its future recurrence [ 12 ]. By exposing individuals to antigens, vaccination can produce long-lasting immunity to drive the production of immunological memory before meeting live pathogens. Thus the resulting immunity can be mediated by the activation of humoral antibodies and the effector function of cellular T-cells [ 13 ]. The full development path for an effective SARS-CoV-2 vaccine will involve th e cooperation of industry, government, and academia in unprecedented ways, each contributing its strengths [ 14 ].

It is a difficult task to develop a SARS-CoV-2 vaccine to control its spread and help remove it from the human population since there is a lack of knowledge on its biological properties, epidemiology, individual immune responses to it, and so forth [ 15 ]. The S protein is the critical target of vaccine production since it includes a receptor-binding domain (RBD) and viral functions. It will be essential to confirm the clinical significance of the SARS-CoV-2 binding and neutralizing antibody titers and their ability to predict efficacy [ 16 ]. Only in a significant clinical efficacy study would it be possible to confirm the association between antibody titers and defense against COVID-19 [ 17 ]. For any frequently used vaccine, there is a theoretical risk that vaccination could cause subsequent infection with SARS-CoV-2 more severe. This has been confirmed in feline coronaviruses and has been observed in some SARS-CoV-1 animal vaccine challenge models [ 18 ].

The key benefit of next-generation vaccines is that they can be produced based on sequence data alone [ 19 ]. If the viral protein(s) that are essential for the defense against infection or disease and therefore for inclusion in the vaccine is established, the availability of coding sequences for the viral protein(s) is sufficient to start the production of the vaccine rather than to rely on the ability to grow the virus [ 20 ]. This makes these platforms extremely adaptable and dramatically accelerates the production of vaccines, as is evident from the fact that the majority of currently underway clinical trials of COVID-19 vaccines include a next-generation platform [ 19 ]. A prospective pharmaceutical manufacturer must send an application to a regulatory authority such as the Food and Drug Administration (FDA) to examine the new vaccine after a possible vaccine has been announced by a researcher [ 21 ].

The demand for immediate therapy and potential prevention of COVID-19 is growing [ 22 ] with the increase in the number of individuals affected due to the seriousness of the disease, global dissemination, lack of prophylactics, and therapeutics [ 23 ]. Attempts are being made to establish secure and successful methods for prophylactics [ 24 , 25 ]. Several vaccines are in different phases of clinical trials [ 6 ], but there is a lack of prophylactics in the present scenario [ 26 ]. Several attempts have been made to create COVID-19 vaccines to avoid the pandemic condition as well as the S-protein SARS-CoV-2 has been used for most of the emerging vaccine candidates. In Fig. 1 , the overview of vaccine candidates in their respective ongoing clinical phases depicts the percentage of vaccine candidates amongst which the majority of developing vaccines is in phase 1/2. The data shown below in the graph is assessed until 15 October 2020, in the pipeline of vaccine development and registered clinical trials globally.

In Fig. 2 , the overview of the global COVID-19 vaccine landscape in clinical development depicts that there are seven major types of vaccine candidates for COVID-19 is illustrated as (inactivated, non-replicating viral vectors, replicating viral vectors, protein subunit, nucleic acid-based, and virus-like particles [VLP]), showing the percentage of candidate vaccines that are currently under clinical development. The nucleic acid-based platform includes both RNA vaccines and DNA vaccines. Among the seven types of vaccine candidates, protein subunit-based vaccines constitute the highest 31% in clinical development. In contrast, VLP-based vaccine and replicating viral vectors comprises the lowest as 5% in the clinical development.

In Fig. 3 , the overview of global COVID-19 vaccine landscape in preclinical development depicts that there are 10 significant types of vaccine candidates for COVID-19 is illustrated as (inactivated, replicating bacteria vector, DNA, live attenuated virus, non-replicating viral vectors, protein subunit, t-cell based, replicating viral vectors, RNA, and VLP), showing the percentage of candidate vaccines that are currently under preclinical development. Among the 10 types of vaccine candidates, protein subunit-based vaccines constitute the highest 36% in clinical development whereas T-cell based vaccine and replicating bacteria vector comprises the lowest at 1% in the preclinical development globally.

RNA-Based Vaccine

As a result of considerable developments in biotechnology, due to their higher potency, short development cycles, low-cost product, and safe administration, mRNA vaccines represent a substantial improvement over traditional vaccine strategies [ 27 ]. The mRNA is an evolving platform that is non-infectious and non-integrated and has almost no possible risk of insertional mutagenesis. Antigen discovery, sequence analysis, and optimization, screening of modified nucleotides, delivery system discovery, and immune response and safety assessment tests are the sequential events in the mRNA vaccine production process [ 28 ]. In vaccines, two primary forms of RNA are investigated: virally derived, RNA self-replicating, and mRNA non-replicating. The antigen and the necessary viral replication machinery are typically self-replicating RNAs, whereas conventional mRNA-based vaccines encode only the antigen of interest with 50 and 30 untranslated regions (UTRs) [ 27 ].

The immunogenicity of mRNA can be decreased, and changes can be made to enhance the stability of these vaccines [ 29 ]. Furthermore, anti-vector immunity is also resisted as mRNA is the minimally immunogenic genetic vector, allowing repeated administration of the vaccine [ 30 ]. This platform has empowered the rapid vaccine development program due to its flexibility and ability to reproduce the structure and expression of the antigen as seen in the course of natural infection [ 31 ]. A possible benefit of mRNA vaccines is the convenient availability of a portable mRNA “printing” facility for large-scale production of mRNA [ 32 ].

mRNA-1273 (Moderna TX Inc.)

It is a vaccine composed of lipid nanoparticle (LNP) encapsulated synthetic mRNA that codes for SARS-CoV-2 full-length, pre-fusion stabilized spike protein (S) [ 33 ]. It has the potential to induce an antiviral response that is highly S-protein specific. Also, it is known to be relatively harmless since it is neither composed of the inactivated pathogen nor of the live pathogen sub-units [ 34 ]. To perform the phase II trials, the vaccine has received FDA fast-track approval. The company published the interim antibody data for phase I of eight participants who received different levels of dose [ 33 ]. For the participants receiving 100 µg dose, neutralizing antibody levels were significantly higher than those observed in convalescent sera. In the 25 µg and 100 µg dose cohorts, the vaccine was found to be primarily safe and well-tolerated. In comparison, three participants reported systemic symptoms of grade 3 following administration of the second 250 µg dose level [ 26 ]. The possible benefits of a prophylactic vaccine mRNA strategy include the ability to replicate natural infection to induce a more effective immune response and the ability to incorporate multiple mRNAs into a single vaccine [ 12 ].

On 24 February 2020, Moderna declared that it had released the first batch of mRNA-1273 against SARS-CoV-2 for human use, prepared using the methods and strategies outlined in its previous patents. mRNA-1273 vials have been shipped to the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), to be used in the United States in the proposed phase 1 study [ 35 ]. In collaboration with researchers at the NIAID Vaccine Research Centre, Moderna reports that mRNA-1273 is an mRNA vaccine targeting a prefusion stabilized form of the S protein associated with SARS-CoV-2, which was chosen by Moderna [ 32 ]. Patent application WO2018115527 describes vaccines consisting of mRNA encoding at least one MERS coronavirus antigen, preferably an S protein or an S protein fragment (S1), an envelope protein (E), a membrane protein (M), or a nucleocapsid protein (N), all of which have been successful in inducing an immune response unique to the antigen [ 33 ]. Intradermal administration of a LNP-encapsulated mRNA mixture encoding MERS-CoV S proteins into mice has been shown to result in vivo translation and humoral immune response induction [ 12 ].

BNT162b1 (BioNTech, Fosun Pharma, Pfizer)

BNT162b1 is a codon-optimized mRNA vaccine that codes for the essential target of the neutralizing antibody virus, trimerized SARS-CoV-2 RBD [ 29 ]. The vaccine shows improved immunogenicity due to the addition of the foldon trimerization domain of T4 fibrin-derived to the RBD antigen. In 80 nm ionizable cationic LNPs, the mRNA is encapsulated, which guarantees its efficient delivery [ 31 ]. In phase 1/2 clinical trials, elevated levels of RBD-specific immunoglobulin G (IgG) antibodies with a geometric mean concentration were found to be 8 to 46.3 times the convalescent serum titer. Whereas, the SARS-CoV-2 neutralizing antibody geometric mean titers were found to be 1.8 to 2.8 times the convalescent serum panel [ 29 ]. With no adverse effects, mild and transient local reactions and systemic events were observed. The data review did not, however, assess the protection and immune response beyond 2 weeks after the second dose administration [ 31 ].

Report of available effectiveness, tolerability, and immunogenicity results from an ongoing placebo-controlled, observer-blinded dose-escalation study in healthy adults 18–55 years of age, randomized to receive two 21-day separate doses of 10 µg, 30 µg, or 100 µg of BNT162b1, a nucleoside-modified LNP mRNA vaccine encoding trimerized SARS-CoV-2 spike glycoprotein dose-dependent, usually mild to moderate, and temporary, was the local reactions and systemic events [ 29 ]. The BNT162b1 vaccine candidate now being clinically studied integrates such nucleoside modified RNA and encodes the SARS-CoV-2 spike protein RBD, a primary target of virus-neutralizing antibodies [ 31 ]. Sera's RBD-binding IgG and SARS-CoV-2 neutralizing titers increased both at the dose level and after the second dose. Geometric mean neutralizing titers were 1.8 to 2.8 times those of a panel of human sera convalescent COVID-19. These findings help further evaluation of this candidate for the mRNA vaccine [ 33 ]. By adding a T4 fibritin-derived “foldon” trimerization domain, the RBD antigen expressed by BNT162b1 is modified to improve its immunogenicity by a multivalent display. The RNA vaccine is formulated in LNPs for more effective delivery to cells after intramuscular injection [ 31 ]. In Table 1 , potential RNA-based vaccine candidates are listed below for COVID-19 which are in the clinical development phase and registered globally [ 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ].

COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; LNP, lipid nanoparticle; NIAID, National Institute of Allergy and Infectious Diseases; P/B, prime/boost; RBD, receptor-binding domain.

Viral Vector-Based Vaccines

Viral vector-based vaccines have a high degree of protein expression and long-term stability, inducing strong immune responses [ 46 ]. These include vaccines focused on chemically weakened viruses used to bear antigens or pathogens of concern for immune response induction [ 47 ]. A possible prophylactic strategy against a pathogen is a viral vector-based vaccine. These vaccines are highly selective in transmitting genes to the target cells, are highly effective in gene transduction, and are useful in inducing immune responses [ 48 ]. They have a long-term and high level of antigenic protein expression and thus have an excellent potential for prophylactic use as these vaccines activate and facilitate cytotoxic T cells, eventually contributing to the elimination of infected virus cells [ 46 ]. The generation of immunity to the vector is an essential consideration for the development of virus vectored vaccines, which could impede the antigen-specific response to boost vaccination [ 49 ]. Reports from preclinical and clinical trials suggested that adequate safety can be obtained from a single dose [ 50 ].

Ad5-nCoV (CanSino Biologics Inc., Beijing Institute of Biotechnology)

A four-fold increase in RBD and S protein-specific neutralizing antibodies was observed within 14 days [ 51 ]. Ad5-nCoV is a recombinant type-5 adenovirus (Ad5) replication-defective vector expressing the recombinant SARS-CoV-2 spike protein. It was prepared by cloning, together with the plasminogen activator signal peptide gene, an optimized full-length gene of the S protein in the Ad5 vector devoid of genes E1 and E3 [ 29 ]. The vaccine was constructed from the Microbix Biosystem using the Admax system. A positive antibody reaction or seroconversion of immunization was identified in phase I clinical trials and peaked at day 28, post-vaccination. Also, the response of CD4+T cells and CD8+T cells peaked at day 14 post-vaccination. However, the pre-existing anti-Ad5 immunity has partially restricted the reaction of both the antibody and the T cell [ 51 ]. The study would further assess the antibody response in recipients between 18 and 60 years of age who received one of three doses in the study, with follow-up at 3- and 6-months post-vaccination [ 29 ].

Coroflu (University of Wisconsin-Madison, FluGen, Bharat Biotech)

M2SR, a self-limiting variant of the influenza virus that is modified by spike protein sequence insertion of the SARS-CoV-2 gene. Besides, the vaccine expresses the influenza virus' hemagglutinin protein, thereby triggering an immune response to both viruses [ 52 ]. The M2SR is self-limiting and, since it lacks the M2 gene, does not undergo replication. It is capable of entering the cell, thereby causing immunity to the virus [ 32 ]. It is delivered intra-nasally, mimicking the normal viral infection pathway. Compared to intramuscular injections, this route stimulates many immune system modes and has higher immunogenicity [ 52 ].

LV-SMENP-DC (Shenzhen Geno-Immune Medical Institute)

By using SMENP minigenes to engineer dendritic cells (DC) with a lentiviral vector expressing the conserved domains of the structural proteins SARS-CoV-2 and protease [ 29 ], the LV-SMENP-DC vaccine is prepared. Subcutaneous vaccine inoculation introduces antigen-presenting cell antigens, which eventually cause cytotoxic T cells and produce an immune response [ 48 ].

ChAdOx1 (University of Oxford)

The recombinant adenovirus vaccine ChAdOx1 was developed using codon-optimized S glycoprotein and synthesized at the 5 ends with the leading tissue plasminogen activator (tPA) sequence [ 50 ]. The SARS-CoV-2 amino acid coding sequence (2 to 1273) and the tPA leader have been propagated in the shuttle plasmid. This shuttle plasmid is responsible for the coding between the Gateway recombination cloning site of the main immediate-early genes of the human cytomegalovirus (IE CMV) along with tetracycline operator sites and polyadenylation signal from bovine growth hormone (BGH) [ 29 ]. In the bacterial artificial chromosome, the adenovirus vector genome is built by inserting the SARS-CoV-2 S gene into the ChAdOx1 adenovirus genome's E1 locus. In the T-Rex human embryonic kidney 293 (HEK-293) cell lines, the virus was then allowed to replicate and purified by ultracentrifugation of the CsCl gradient [ 53 ]. The absence of any subgenomic RNA from preclinical trials in intra-muscularly vaccinated animals is suggestive of improved immunity to the virus [ 50 ]. Previous studies have proposed that the immune response should be marshalled by a single shot [ 53 ]. In Table 2 , potential viral vector-based vaccine candidates are listed below for COVID-19 which are in the clinical development phase and registered globally [ 45 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 ].

COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; RBD, receptor-binding domain; MVA, modified vaccinia Ankara.

Protein Subunit-Based Vaccines

Subunit vaccines, safer and more straightforward to manufacture, present a host with high immunogenicity with one or few antigens, but need adjuvants to evoke a strong defensive immune response [ 62 ]. A subunit vaccine is a synthetic peptide or recombinant antigenic protein-dependent vaccine which is essential for long-term protection and a therapeutic invigoration of the immune response [ 63 ]. The subunit vaccine exhibits low immunogenicity and requires an adjuvant's additional assistance to potentiate the vaccine-induced immune responses. An adjuvant may improve the biological half-life of the antigenic material, or the immunomodulatory cytokine response may be improved. The use of an adjuvant, therefore, helps to overcome the shortcomings of the protein subunit vaccines [ 64 ]. Subunit vaccines may be designed to concentrate the immune response on the neutralization of epitopes, thus preventing the development of non-neutralizing antibodies that may encourage disease-related antibody-dependent enhancement [ 65 ]. Antigenic proteins thought to cause a defensive immune response are used in protein subunit vaccines. The S protein of SARS-CoV-2 is the most appropriate antigen to induce neutralizing antibodies against the pathogen [ 13 ]. The S protein is comprised of two subunits. In the S1 subunit, the N-terminal domain, RBD, and receptor-binding motif (RBM) domains are found, while the S2 subunit consists of FP, HR 1, and 2 [ 62 ]. The virus reaches the cell by endocytosis using S-protein mediated binding to the human angiotensin-converting enzyme 2 (hACE2) receptor. Therefore, S-protein and its antigenic fragments are key objectives for the establishment of a subunit vaccine [ 63 ]. A complex protein with two conformation states, i.e., a pre-fusion and post-fusion state, is the S glycoprotein [ 62 ]. Therefore, the antigen must maintain its surface chemistry and the profile of the initial pre-fusion spike protein to retain the epitopes for igniting good quality antibody responses. Also, targeting the masked RBM as an antigen, it will increase the neutralizing antibody response and enhance the overall efficacy of the vaccine [ 66 ].

NVX-CoV2373 (Novavax Inc., Emergent BioSolutions)

NVX-CoV2373 is a nano-particle-mediated immunogenic vaccine-mediated on coronavirus S-protein, the recombinant expression of stable pre-fusion [ 67 ]. In the baculovirus system, the protein has been stably expressed. By inducing high levels of neutralizing antibodies, the company aims to use the matrix-M adjuvant to strengthen the immune response against the SARS-CoV-2 spike protein [ 35 ]. A single immunization in animal models resulted in a high level of anti-spike protein antibodies that blocked the binding domain of the hACE2 receptor and could elicit SARS-CoV-2 wild-type virus-neutralizing antibodies [ 68 ].

Molecular clamp stabilized spike protein vaccine candidate

It is being developed in partnership with GSK and Dynavax by the University of Queensland [ 29 ]. The University will have access to the vaccine adjuvant (AS03 Adjuvant) platform technology, which is believed to enhance the response of the vaccine and reduce the amount of vaccine needed per dose [ 69 ]. The University is developing a stabilized pre-fusion, recombinant viral protein subunit vaccine based on the molecular clamp technology. It has been established that this technology induces the development of neutralizing antibodies [ 34 ].

PittCoVacc (University of Pittsburgh)

It is a recombinant SARS-CoV-2 vaccine based on the micro-needle array (MNA) that involves administering rSARS-CoV-2 S1 and rSARS-CoV-2-S1fRS09 (recombinant immunogens) [ 70 ]. A significant increase in statistically significant antigen-specific antibodies was found in the mice models in preclinical studies at the end of 2 weeks [ 29 ]. Furthermore, even after sterilization using gamma rays, the immunogenicity of the vaccine was maintained. Statistically, relevant antibody titers confirm the feasibility of the MNA-SARS-CoV-2 vaccine at the early stage and even before boosting [ 70 ].

Triple antigen vaccine (Premas Biotech, India)

It is a multi-antigenic VLP vaccine prototype in which an engineered Saccharomyces cerevisiae expression platform (D-CryptTM) co-expresses the recombinant spike, membrane, and envelope protein of SARS-CoV-2 [ 71 ]. The proteins then, like the VLP, undergo self-assembly. The biophysical characterization of the VLP was simultaneously given by the transmission electron microscopy and allied analytical data [ 29 ]. After more research and development, this prototype has the potential to engage in preclinical trials as a vaccine candidate. Besides, cost-effectively, it is assumed to be safe and easy to produce on a mass scale [ 71 ]. In Table 3 , potential protein subunit-based vaccine candidates are listed below for COVID-19 which are in the clinical development phase and registered globally [ 45 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 ].

COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; HIV, human immunodeficiency virus; RBD, receptor-binding domain; FIH, first-in-human; FDA, U.S. Food and Drug Administration.

DNA-Based Vaccines

A typical DNA vaccine is a plasmid DNA molecule that codes for the host immune system to be presented with one or more antigens [ 62 ]. They have the advantages of stability and successful delivery over mRNA vaccines [ 84 ]. Still, since they are needed to reach the nucleus, they have the risk of vector mutations and incorporation into the host genome [ 85 ]. DNA vaccines reflect a revolutionary approach, followed by a wide variety of immune responses, by the direct injection of plasmids encoding antigens [ 86 ]. The most groundbreaking approach to vaccination is the introduction of the DNA vaccine that codes for the antigen and an adjuvant that stimulates the adaptive immune response [ 87 ]. The transfected cells express the transgene, which gives a steady supply of transgene-specific proteins very similar to the live virus [ 84 ]. Also, immature DCs, which eventually present the antigen on the cell surface to the CD4 + and CD8 + T cells in combination with the major histocompatibility complex (MHC) 2 and MHC 1 antigens, endocytose the antigen material, thereby stimulating both successful humoral and cell-mediated immune systems [ 87 ]. DNA vaccines are considered safe and stable and can be developed easily, but their immunogenicity and immune response efficiency in humans have not yet been demonstrated [ 21 ].

INO-4800 (Inovio Pharmaceuticals)

It is an anti-SARS-CoV-2 prophylactic DNA vaccine. It uses the SARS-CoV-2 codon-optimized S protein sequence to which an immunoglobulin E (IgE) leader sequence is attached [ 29 ]. Using BamHI and XhoI, the SARS-CoV-2 IgE-spike sequence was synthesized and digested. Under the management of IE CMV, and BGH polyadenylation signal, the digested DNA was incorporated into the expression plasmid pGX0001 [ 85 ]. In preclinical studies, the existence of functional antibodies and the response of T cells indicate that the vaccine will produce an efficient immune response within seven days after vaccination [ 88 ]. The vaccine has entered phase I clinical trials (phase I: {"type":"clinical-trial","attrs":{"text":"NCT04336410","term_id":"NCT04336410"}} NCT04336410 ) and it is anticipated that this phase of clinical trials will be completed by July, with participants receiving 1.0 mg of INO-4800 by electroporation with CELLECTRA 2000 per dosing visit. The research will assess the immunological profile, efficacy, and tolerability of the candidate vaccine in healthy human adults upon intradermal injection and electroporation [ 29 ]. INO-4800 and the previous Inovio vaccine INO-4700 express either SARS-CoV-2-S or MERS-CoV-S inside the same DNA vector, respectively [ 85 ]. The vaccine is delivered by intramuscular injection, accompanied by injection site electroporation. The need for electroporation could restrict INO-4800's ability to be expanded to the scales necessary for a global pandemic and may be difficult to handle globally [ 13 ].

bacTRL (Symvivo Corporation)

Symvivo Corporation's bacTRL platform uses the engineered probiotic Bifidobacterium longum to deliver a SARS-CoV-2-S expressing DNA vaccine into intestinal cells. The first-in-man study of the bacTRL platform will also be a phase I study of the COVID-19 vaccine, so no prior immunological results are available [ 13 ]. In Table 4 , DNA-based vaccine candidates are listed below for COVID-19 which are in the clinical development phase and registered globally [ 89 , 90 , 91 , 92 , 93 , 94 ].

COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

Virus-Like Particles Vaccine

VLPs are particles that form spontaneously, consisting of many co-expressed or mixed structural viral proteins. Several commercial vaccines are based on VLPs, such as hepatitis B and human papillomavirus vaccines [ 95 ]. Without the need for adjuvants, these vaccines can be constructed and used. Only when antigens with neutralizing epitopes are extensively investigated is the production of such vaccines possible [ 22 ]. A VLP is a self-assembled nanostructure incorporating essential viral structural proteins. VLP is similar to true viruses' molecular and morphological features but is non-infectious and non-replicating due to the absence of genetic materials [ 26 ]. Successful applications of VLP have been proved by vaccinological and virological study [ 95 ]. In the ongoing battle against the COVID-19 pandemic, the development of SARS-CoV-2 VLPs is highly in demand as an accessibly safe and relevant substitute for naturally pathogenic viruses [ 26 ]. A study suggested the possible use of plant biotechnology for the development of low-cost COVID-19 vaccines and plant-made antibodies for diagnosis, prophylaxis, and therapy [ 22 ].

In the current research, we have established SARS-CoV-2 VLPs effectively, using the mammalian expression system [ 47 ], which helps maintain specific patterns of protein glycosylation [ 22 ]. For the efficient formation and release of SARS-CoV2 VLPs among the four SARS-CoV-2 structural proteins, we have shown that membrane protein (M) expression and small envelope protein (E) are essential [ 47 ]. Also, the corona-like structure presented in SARS-CoV-2 VLPs from Vero E6 cells is more stable and unified in comparison with those from HEK-293 T cells. Our data show that the molecular and morphological characteristics of native virion particles in SARS-CoV-2 VLPs make SARS-CoV-2 VLPs a promising candidate vaccine and a powerful tool for research into SARS-CoV-2 [ 96 ]. The immunogenic composition composed of MERS-CoV nanoparticle VLPs containing at least one trimer of S protein formed by baculovirus overexpression in Sf9 cells was disclosed in patent application WO2015042373 by Novavax in 2015 [ 35 ]. When administered along with their patented adjuvant Matrix M, this VLP preparation induced a neutralizing antibody response in mice and transgenic cattle. Sera preparations from vaccinated cattle (SAB-300 or SAB-301) were also injected into Ad5-hDPP4 transduced BALB/c mice before the MERS-CoV challenge [ 22 ]. With a single prophylactic injection, both SAB-300 and SAB-301 were able to protect these mice from MERS-CoV infection [ 96 ]. On 26 February, Novavax announced that due to their prior experience dealing with other coronaviruses, including both MERS and SARS, animal testing of possible COVID-19 vaccine candidates had begun. Using their recombinant nanoparticle vaccine technology along with their proprietary adjuvant matrix-M, their COVID-19 candidate vaccines targeting the S protein of SARS-CoV-2 were created [ 35 ].

UMass Medical School researchers have developed a framework to create vaccines using VLPs, which one scientist claims may be a successful and safer alternative to a COVID-19 vaccine. Trudy Morrison, Ph.D., professor of Microbiology & Physiological Systems, said her work on a VLP-based respiratory syncytial virus vaccine that can be modified to COVID-19 causes severe lower respiratory tract disease in young children and the elderly. And some of the problems inherent in the production of vaccines from inactivated or live viruses will be avoided [ 97 ].

Medicago, a biopharmaceutical company, headquartered in Quebec City, announced the successful development of a coronavirus VLP only 20 days after the SARS-CoV-2 (COVID-19 disease virus) gene was obtained [ 29 ]. The manufacturing of VLP is the first step in the development of the COVID-19 vaccine, which will now undergo preclinical protection and efficacy testing. They plan to negotiate clinical testing of the vaccine with the relevant health authorities by summer (July/August) 2020 once this is done. Medicago uses its technology platform to create antibodies against SARS-CoV-2. These antibodies to SARS-CoV-2 might theoretically be used to treat people who are infected by the virus. In part, this study is sponsored by the Canadian Institutes for Health Research [ 98 ]. In Table 5 , potential VLPs-based vaccine candidates are listed below for COVID-19 which are in the clinical development phase and registered globally [ 81 , 99 ].

VLP, virus-like particle; COVID-19, coronavirus disease 2019; RBD, receptor-binding domain; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; HBsAg, Hepatitis B surface antigen.

Current Updates

To bring this pandemic to an end, a large share of the world needs to be immune to the virus. The safest way to achieve this is with a vaccine. Vaccines are a technology that humanity has often relied on in the past to bring down the death toll of infectious diseases. Within less than 12 months after the beginning of the COVID-19 pandemic, several research teams rose to the challenge and developed vaccines that protect from SARS-CoV-2, the virus that causes COVID-19. Now the challenge is to make these vaccines available to people around the world.

To resume a normal lifestyle, free from government lockdowns, and fear of continuing pandemic waves over the coming months, the world is anxiously awaiting a safe, successful vaccine to protect against COVID-19. Innovative ties with both pharmaceutical companies and medical start-ups are joining hands with scientists across the continents to repurpose medications, create vaccines, and devices to hinder the progress of this overwhelming pandemic. A large number of vaccine candidates for COVID-19 based on different platforms have already been identified. Current review shows preclinical as well as in clinical development of vaccine candidates, wherein, five major vaccine platforms for COVID-19 namely RNA, DNA, viral vector, protein subunit, and VLP which constitutes 10, 2, 10, 14, and 2 vaccine candidates globally in clinical development as of 15 October 2020. Among all the vaccine platforms, extensive research and development are going on protein subunit-based vaccine which has the maximum candidates in the clinical development.

A significant amount of hindrance to the rapid production of vaccines is the length of clinical trials. With several phases, including the preclinical stage and clinical development, which is a three-phase process, the vaccine development process is very laborious. However, if adequate data is already available, it has been proposed that a few stages be skipped to accelerate the achievement of a vaccine faster with a rapid regulatory review, approval, development, and quality control. By looking towards pandemic conditions, the scientific fraternity will be ready for any harmful situation to overwhelmed opportunities. Therefore, the current situation has given the world a new perspective to facilitate research in the worst circumstances and hasten the drug development process.

No potential conflict of interest relevant to this article was reported.

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Research: How Different Fields Are Using GenAI to Redefine Roles

• Maryam Alavi

Examples from customer support, management consulting, professional writing, legal analysis, and software and technology.

The interactive, conversational, analytical, and generative features of GenAI offer support for creativity, problem-solving, and processing and digestion of large bodies of information. Therefore, these features can act as cognitive resources for knowledge workers. Moreover, the capabilities of GenAI can mitigate various hindrances to effective performance that knowledge workers may encounter in their jobs, including time pressure, gaps in knowledge and skills, and negative feelings (such as boredom stemming from repetitive tasks or frustration arising from interactions with dissatisfied customers). Empirical research and field observations have already begun to reveal the value of GenAI capabilities and their potential for job crafting.

There is an expectation that implementing new and emerging Generative AI (GenAI) tools enhances the effectiveness and competitiveness of organizations. This belief is evidenced by current and planned investments in GenAI tools, especially by firms in knowledge-intensive industries such as finance, healthcare, and entertainment, among others. According to forecasts, enterprise spending on GenAI will increase by two-fold in 2024 and grow to $151.1 billion by 2027 .

• Maryam Alavi is the Elizabeth D. & Thomas M. Holder Chair & Professor of IT Management, Scheller College of Business, Georgia Institute of Technology .

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Developing the aging research workforce from the earliest career stages March 27, 2024

A key part of NIA’s mission is to develop the careers of research scientists and clinicians focused on aging topics, including Alzheimer’s disease and related dementias, but how early can we start cultivating an interest? Focusing on the earliest stages of education is one promising approach. That’s why NIA supports programs to provide aging research education beginning with pre-kindergarten children and expanding to include high school students and teachers, undergraduates, and postbaccalaureate researchers.

If you are an educator, mentor, or student seeking funding for your work to help train the next generation of scientists, NIA has three options available, all of which have Spring 2024 application due dates.

Training with a lifetime impact

Our training trio includes the Expanding Research in Alzheimer’s and related dementias (ERA), Advancing Diversity in Aging Research (ADAR), and Science Education Partnership Award (SEPA) programs. Students supported by these programs describe the high-tech training experience as having a lasting impact for mentoring and inspiration in their careers.

NIA has previously featured the ERA program in our blog and would like to remind readers that ERA includes two parts that both provide research experiences in Alzheimer’s and related dementias research. One supports summer programs for high school students, undergraduate college students, or K-12 science teachers focused on enhancing participants’ understanding of dementia. The other supports immersive one- to two-year programs for recent baccalaureate graduates focused on robustly preparing participants to pursue advanced degrees and other research-related career opportunities in the Alzheimer’s field. Apply for our ERA programs by May 24, 2024.

Through the ADAR research education program, NIH supports the development and implementation of research programs for a diverse pool of undergraduate college students. The proposed education programs support intensive aging research experiences to prepare undergraduate students to transition into strong, research-focused advanced degree programs or competitive private sector research careers in aging-related disciplines. Apply to the current NIH ADAR funding opportunity by May 25, 2024.

SEPA is a trans-NIH program that supports educators to design activities that encourage pre-college students (pre-kindergarten to grade 12) from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies in science, technology, engineering, and mathematics (STEM). Through SEPA, NIH funds two types of projects: classroom-based projects for pre-college students and teachers, and informal science education projects conducted in outside-the-classroom venues such as science centers, museums, and libraries. Apply to develop a SEPA program at your organization by June 7, 2024.

Reach out with your questions

Join NIA in supporting early career investigators to pursue aging research careers! If you’re planning to apply for SEPA, ADAR, or ERA’s upcoming deadlines, NIA’s training officers are happy to answer your questions at [email protected] . If you are a mentor or student who has benefited from these or similar programs, please leave a comment below!

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Congress gives research into kids and social media a cash infusion

Welcome to The Technology 202. A special thanks to Rep. Jamie Raskin (D-Md.) for taking the time to speak with me for today’s newsletter while dealing with the tragic bridge collapse in his home state. Today:

Congress gives research into children and social media a cash infusion

Researchers scrutinizing how social media impacts children’s health recently got a key assist as lawmakers tucked fresh funding for the cause into their sprawling spending legislation. 

Federal appropriators this year re-upped $15 million in funding for a program directing the National Institutes of Health and Department of Health and Human Services to lead studies examining technology’s impact on children’s development and mental health. With Congress initially allocating $15 million last year, total investment is now up to $30 million.

The initiative, first proposed by Sen. Edward J. Markey (D-Mass.) and Rep. Jamie Raskin (D-Md.), is one of the federal government’s most significant attempts yet to map out how much digital platforms are contributing to issues like depression, anxiety and drug abuse among youth.

The funding will provide “a critical window into Big Tech’s impact on the nation’s young people,” including topics like how exposure to racist posts may harm minority youths and how screen time could affect sleep, Markey said in an interview Wednesday. 

“You can’t manage what you don’t measure,” he said.

The 2023 appropriations helped NIH fund 26 grants looking into how tech impacts children, totaling $15.1 million, according to a fact sheet shared by Markey’s office. 

That included new research into “the effects of screen light exposure and stimulating media content on sleep regulation,” the impact on “race-related stereotypic content” on racial minorities and whether “social media experiences promote or diminish adolescents’ mental well-being.”

Next week, the agency is planning a meeting “to discuss the current state of and future directions for research on the positive and negative effects” of tech and digital media, which could serve as a launching point for additional projects under the program.

“It’s a tiny sum of money in the scope of the federal budget, but it will be used to investigate a matter that is of the utmost concern to families across America,” Raskin told me Wednesday.

But some researchers said that the federal government is still investing far too little and that it could be years before the time-intensive research fully bears fruit. 

Mitch Prinstein , chief science officer at the American Psychological Association, said that while he was “grateful” for lawmakers’ attention to the issue, another $15 million “is really just scratching the surface of what’s necessary.” 

 Major studies looking into children’s mental health can cost millions, and long-term research into areas like development could take half a decade or more to complete, noted Prinstein, who also serves as a psychology professor at the University of North Carolina. 

Fully grasping “how to best help children” could take “at least 10, if not 50, times more in funding” from the federal government, he argued.

There are also questions about the longevity of the program, which requires lawmakers to appropriate new funds annually to keep it afloat. 

Markey said he was “very hopeful” that their initiative would be “a foundation that’s going to lead to substantial additional funding for the study of this young person mental health crisis.”

“We will have to figure out some way to have a continual source of research and interpretation on the question of children’s health and social media,” Raskin said.

The appropriations package extended the previous year’s funding for the program, although the dollar amount is not explicitly linked in the bill text, according to a Markey aide who spoke on the condition of anonymity because they were not authorized to publicly speak on the matter.

The push to probe potential links between youth mental health and social media comes as lawmakers forge ahead with sweeping new proposals, from expanding guardrails for children online to restricting their access to platforms altogether. 

Many of those efforts face opposition from industry and digital rights groups, who argue they threaten to shut young people off from positive online resources and experiences, particularly marginalized youth. 

While lawmakers are calling for additional research in the area, “we know enough already to put an end to Big Tech’s invasive data practices, especially those involving children,” said Markey, who has spearheaded efforts to expand children’s privacy protections at the federal level.

“We need all the information we can get to inform public policy,” Raskin said. 

Government scanner

Oregon’s governor signs right-to-repair law that bans ‘parts pairing’ (The Verge)

Israel deploys expansive facial recognition program in Gaza (New York Times)

AI is making financial fraud easier and more sophisticated, Treasury warns (Bloomberg News)

Hill happenings

AI leaders press advantage with Congress as China tensions rise (New York Times)

Inside the industry

Amazon loses court fight to suspend E.U. tech rules’ ad clause (Reuters)

Competition watch

Amazon spends $2.75 billion on AI start-up Anthropic in its largest venture investment yet (CNBC)

Privacy monitor

Extremists in U.S. are increasingly doxxing executives, officials (Bloomberg News)

Workforce report

Apple turns to longtime Steve Jobs disciple to defend its ‘walled garden’ (Wall Street Journal)

Princess Catherine cancer video spawns fresh round of AI conspiracies (By Tatum Hunter)

• A quick note: Tuesday’s newsletter was updated to clarify that the U.S. Marshals Service was enlisted for some, not all, of the executives under subpoena during the Senate hearing in January on child online safety.
• Columbia University hosts an event , “AI’s Impact on the 2024 Global Elections,” today at 1:30 p.m.
• AEI hosts an event , “Connecting America: Getting Taxpayers Their Money’s Worth in Broadband Expansion,” today at 2 p.m.

Before you log off

The six victims presumed dead in the Baltimore bridge collapse were fathers, husbands and hard workers; at least some of them had traveled to this country for a life they hoped would be prosperous and long. https://t.co/SRaMbJUkUI — The Washington Post (@washingtonpost) March 27, 2024

That ’ s all for today — thank you so much for joining us! Make sure to tell others to subscribe to  The Technology 202 here . Get in touch with Cristiano (via email or social media ) and Will (via email or social media ) for tips, feedback or greetings!

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March 27, 2024

Purdue researchers create biocompatible nanoparticles to enhance systemic delivery of cancer immunotherapy

Purdue University researchers are developing and validating patent-pending nanoparticles (left) to enhance immunotherapy effects against tumors. The nanoparticles are modified with adenosine triphosphate, or ATP, to recruit dendritic cells (right), which are immune cells that recognize tumor antigens and bring specialized immune cells to fight off tumors. (Images provided by Yoon Yeo)

PLGA nanoparticles modified with ATP slowly release anti-cancer drugs and recruit immune cells to fight tumors

WEST LAFAYETTE, Ind. — Purdue University researchers are developing and validating patent-pending poly (lactic-co-glycolic acid), or PLGA, nanoparticles modified with adenosine triphosphate, or ATP, to enhance immunotherapy effects against malignant tumors.

The nanoparticles slowly release drugs that induce immunogenic cell death, or ICD, in tumors. ICD generates tumor antigens and other molecules to bring immune cells to a tumor’s microenvironment. The researchers have attached ATP to the nanoparticles, which also recruits immune cells to the tumor to initiate anti-tumor immune responses. 

Yoon Yeo leads a team of researchers from the College of Pharmacy , the Metabolite Profiling Facility in the Bindley Bioscience Center , and the Purdue Institute for Cancer Research to develop the nanoparticles. Yeo is the associate department head and Lillian Barboul Thomas Professor of Industrial and Molecular Pharmaceutics and Biomedical Engineering; she is also a member of the Purdue Institute for Drug Discovery and the Purdue Institute for Cancer Research.

The researchers validated their work using paclitaxel, a chemotherapy drug used to treat several types of cancers. They found that tumors grew slower in mice treated with paclitaxel enclosed within ATP-modified nanoparticles than in mice treated with paclitaxel in non-modified nanoparticles.

“When combined with an existing immunotherapy drug, the ATP-modified, paclitaxel-loaded nanoparticles eliminated tumors in mice and protected them from rechallenge with tumor cells,” Yeo said.

The research has been published in the peer-reviewed journal ACS Nano .

Challenges to systemic immunotherapy delivery

Immunotherapy is a promising approach to fighting cancer, but Yeo said it does not benefit a large population of patients because they do not have the powerful immune cells needed to combat tumors. 

“Pharmacological agents to activate immune cells can directly be given to tumors,” Yeo said. “Then the immune system can fight not only the treated tumors but also nontreated tumors in distant locations as the activated immune cells circulate in the bloodstream.”

However, Yeo said most tumors with poor prognoses are not always locatable or accessible. Therefore, they may not be effectively treated by local therapy. She and her team envisioned systemic delivery of immunotherapy, but there are challenges.

“For successful systemic administration, active ingredients that stimulate anti-tumor immune responses need to be simultaneously present in tumors to exert concerted effects on the target,” Yeo said. “The ingredients also must maintain their activity until they reach tumors, but not cause toxic off-target effects. Moreover, the carriers traditionally used in local drug delivery offer limited utility in systemic application because they may not be compatible with blood components.” 

Yeo and her colleagues used biocompatible polymeric nanoparticles to deliver immunotherapy compounds and modified them to safely activate the immune system. 

“We employed poly (lactic-co-glycolic acid), or PLGA, nanoparticles based on the strong track record of the polymer in FDA-approved products and its routine use in the systemic delivery of poorly water-soluble drugs,” Yeo said.

Tests verified the ATP-modified PLGA nanoparticles were well tolerated in mice upon multiple systemic injections. They were able to recruit dendritic cells, the immune cells that recognize tumor antigens and bring specialized immune cells to fight off tumors. 

“Moreover, the nanoparticles were shown to control the release of paclitaxel to minimize its systemic toxicity,” Yeo said.

The next development steps

Yeo and her colleagues will continue their work on the ATP-modified nanoparticles.

“We are currently working on improving the delivery of the nanoparticles to tumors and combining them with other treatments that will circumvent the resistance to the nanoparticle-delivered immunotherapy,” Yeo said. “To finance these efforts, we will apply for continued support from the National Institutes of Health. We are also open to industry partnerships to take this technology to the clinic.”

Yeo disclosed the nanoparticles innovation to the Purdue Innovates Office of Technology Commercialization , which has applied for a patent from the U.S. Patent and Trademark Office to protect the intellectual property. Industry partners interested in developing the compound or commercializing it for the marketplace should contact Joe Kasper, assistant director of business development and licensing — life sciences, at [email protected] , about track code 69546 .

Yeo and the research team received funding from the National Institutes of Health, the National Center for Advancing Translational Sciences, the Indiana Clinical and Translational Sciences Institute, and the Purdue Institute for Cancer Research.

About Purdue University

Purdue University is a public research institution demonstrating excellence at scale. Ranked among top 10 public universities and with two colleges in the top four in the United States, Purdue discovers and disseminates knowledge with a quality and at a scale second to none. More than 105,000 students study at Purdue across modalities and locations, including nearly 50,000 in person on the West Lafayette campus. Committed to affordability and accessibility, Purdue’s main campus has frozen tuition 13 years in a row. See how Purdue never stops in the persistent pursuit of the next giant leap — including its first comprehensive urban campus in Indianapolis, the new Mitchell E. Daniels, Jr. School of Business, and Purdue Computes — at https://www.purdue.edu/president/strategic-initiatives .

About Purdue Innovates Office of Technology Commercialization

The Purdue Innovates Office of Technology Commercialization operates one of the most comprehensive technology transfer programs among leading research universities in the U.S. Services provided by this office support the economic development initiatives of Purdue University and benefit the university’s academic activities through commercializing, licensing and protecting Purdue intellectual property. In fiscal year 2023, the office reported 150 deals finalized with 203 technologies signed, 400 disclosures received and 218 issued U.S. patents. The office is managed by the Purdue Research Foundation, which received the 2019 Innovation & Economic Prosperity Universities Award for Place from the Association of Public and Land-grant Universities. In 2020, IPWatchdog Institute ranked Purdue third nationally in startup creation and in the top 20 for patents. The Purdue Research Foundation is a private, nonprofit foundation created to advance the mission of Purdue University. Contact [email protected] for more information.

Writer/Media contact: Steve Martin, [email protected]

Source: Yoon Yeo, [email protected]

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Developmental crossroads in the brain

Brain development is a highly orchestrated process involving numerous parallel and sequential steps. Many of these steps depend on the activation of specific genes. A team led by Christian Mayer at the Max Planck Institute for Biological Intelligence discovered that a protein called MEIS2 plays a crucial role in this process: it activates genes necessary for the formation of inhibitory projection neurons. These neurons are vital for motion control and decision-making. A MEIS2 mutation, known from patients with severe intellectual disability, was found to disrupt these processes. The study provides valuable insights into brain development and consequences of genetic mutations.

Nerve cells are a prime example for interwoven family relations. The specialized cells that form the brain come in hundreds of different types, all of which develop from a limited set of generalized progenitor cells -- their immature 'parents'. During development, only a specific set of genes is activated in a single progenitor cell. The precise timing and combination of activated genes decide which developmental path the cell will take. In some cases, apparently identical precursor cells develop into strikingly different neurons. In others, different precursors give rise to the same nerve cell type.

The complexity is mind-blowing and not easy to disentangle in the lab. Christian Mayer and his team set out to do so nevertheless (Diversity research in the brain). Together with colleagues in Munich and Madrid, they now added another puzzle piece to our understanding of neuron development.

Inhibitory cell relations

The scientists studied the formation of inhibitory neurons that produce the neurotransmitter GABA -- cells, which are known to display a broad range of diversity. In the adult brain, inhibitory neurons can act locally, or they can extend long-range axons to remote brain areas. Locally connected "interneurons" are an integral part of the cortical circuit, reciprocally linking cortical neurons. Long-range "projection neurons," on the other hand, primarily populate subcortical regions. They contribute to motivated behavior, reward learning and decision-making. Both types, interneurons and projection neurons, originate in the same area of the developing brain. From here, the newborn neurons migrate to their final locations in the brain.

Using a barcoding approach, Christian Mayer and his team followed the family relationships between precursor cells and young inhibitory neurons. They discovered that a protein called MEIS2 plays an important role when a precursor cell 'decides' whether it should turn into an interneuron or into a projection neuron: MEIS2 assists the cellular machinery to activate the genes that are required for a precursor cell to become a projection neuron.

A protein with a far-reaching impact

To advance this development, MEIS2 works together with another protein, known as DLX5. When MEIS2 is missing or doesn't function correctly, the development of projection neurons is stalled and a larger fraction of precursor cells turns into interneurons instead. However, MEIS2 can't do the job by itself. "Our experiments show that MEIS2 and DLX5 have to come together at the same time, and in the same cells," explains Christian Mayer. "Only the combination of the two will fully activate the genes that drive projection neuron development."

The importance of this process is underscored by previous reports on a MEIS2 variant that was found in patients with intellectual disabilities and a delayed development. Due to a small change in the MEIS2 gene, a slightly different protein is produced. The team around Christian Mayer tested this MEIS2 variant in their experiments and found that it leads to a failure to induce the specific genes needed to form projection neurons. "The inability of MEIS2 to activate the genes essential for the formation of projection neurons may contribute to neurodevelopmental disorders, such as those observed in patients with mutations in the gene encoding this protein," says Christian Mayer.

The complex control by genes

Intrigued by this discovery, the researchers delved into the mechanism by which MEIS2 activates projection neuron specific genes. "Patients with mutations in MEIS2 suffer from a diverse range of effects, like irregularities in digits, impaired lung to brain development, or intellectual disabilities. At a first look, these symptoms have nothing in common," relates Christian Mayer. "This shows, how important it is to understand that genes often have very different roles in different parts of the body."

The genome has millions of non-coding regulatory elements like enhancers, promoters, and insulators. These elements don't actually code for proteins themselves, but they act like switches, controlling when and where genes turn on and off. "Enhancers, which are part of the genome, are like interpreters in the cell. If MEIS2 and DLX5 are present together, a specific set of enhancers becomes active. It is this specific set of enhancers that induces projection neuron genes in the brain. In other parts of the body, MEIS2 interacts with other proteins to induce different sets of enhancers," explains Christian Mayer.

Recent large-scale whole exome sequencing studies in patients have provided a systematic and highly reliable identification of risk genes for neurodevelopmental disorders. Future studies focusing on the molecular interactions between the proteins encoded by these risk genes, such as MEIS2, will pave the way for a comprehensive understanding of the biological mechanisms underlying neurodevelopmental disorders.

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Materials provided by Max-Planck-Gesellschaft . Note: Content may be edited for style and length.

Journal Reference :

• Elena Dvoretskova, May C. Ho, Volker Kittke, Florian Neuhaus, Ilaria Vitali, Daniel D. Lam, Irene Delgado, Chao Feng, Miguel Torres, Juliane Winkelmann, Christian Mayer. Spatial enhancer activation influences inhibitory neuron identity during mouse embryonic development . Nature Neuroscience , 2024; DOI: 10.1038/s41593-024-01611-9

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