Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.

Excipients are essential to the formulation of drug products because they enable the effective delivery of drug substances and can account for as much as 80–90% of the drug product formulation. Despite the exposure that excipients pose to patients, currently there is no independent pathway for approval or assessment of novel excipients.

Other materials, which have higher levels of exposure, have established approval procedures. For example, food additives—including flavorants and colorants—can be approved via a petition to FDA or through the Flavor and Extract Manufacturers Association generally accepted as safe (GRAS) process. Cosmetic ingredients undergo the Personal Care Products Council’s well-accepted Cosmetic Ingredient Review process.

Many excipients used in approved drugs are listed in FDA’s Inactive Ingredient Database (IID); however, most have been used for decades and few were initially developed specifically for use as pharmaceutical ingredients. Novel excipients are those compounds not listed in the IID or compounds listed in the IID, but intended to be used for a new route of administration, at a higher dosage level or modified in some way, such as co-processed excipients that have been combined and enhanced in a physical manner through particle engineering.

New challenges require new tools

The lack of an independent approval pathway for all of these types of novel excipients is creating significant challenges for drug formulators. “In recent years, there have been astonishing advances in the fundamental understanding of disease biology leading to remarkable treatments for once deadly diseases. Many drug candidates for these transformative and breakthrough treatments suffer from very poor physical and/or chemical properties,” observes Eric A. Schmitt, senior director of pharmaceutics at AbbVie and co-leader of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) Working Group on novel excipients.

For oral drug candidates, excipients that can mitigate challenges associated with poor aqueous solubility and/or permeability can enable drug development for these otherwise potentially undevelopable candidates, Schmitt notes. For parenteral delivery, driven by the growth of macromolecules, there are significant needs for excipients that can improve solubility and chemical and physical stability, and reduce viscosity, he says.

“Similarly, tolerability (e.g., pain on injection for parenteral medicines), acceptability (e.g., taste for pediatric patients), and manufacturability challenges can all hinder the development of innovative medicines,” Schmitt says. “These challenges occur across therapeutic modalities, routes of administration, and dosage form types. Novel excipients, or expanded use scenarios of existing excipients, can provide formulation scientists much needed tools to address these challenges,” he concludes.

Novel dosage forms in use and under development today also have unique needs. “The industry as a whole is evolving to different methods for dosage and delivery—transdermal, mucoadhesive, and targeted immunotherapies for instance—that require unique solutions that in many cases cannot be provided by IID-listed options and will only be possible through the introduction and acceptance of novel excipients,” says Meera Raghuram, director of regulatory and sustainability with Lubrizol Life Science.

The bottom line, according to David R. Schoneker, president/owner/consultant with Black Diamond Regulatory Consulting, is that drugs today present different formulation challenges, and the numerous excipients used for 100 years no longer resolve these issues, nor do they enable optimization of new manufacturing methods such as continuous processing and 3D printing.

“It is important,” stresses Nigel Langley, global technology director for pharma solutions at BASF, “to think about novel excipients as offering a means for designing functionality to address specific problems given the challenges that drug developers currently face. Without fit-for-purpose excipients, many unmet needs will simply remain unmet,” he states.

Strong perceived risk prevents use of novel excipients

Novel excipient approvals, however, are tied to new drug approvals, which adds risk to an already high-risk endeavor. It is natural that adding additional risk with an unapproved excipient will be avoided and only pursued as a very last resort, according to Schmitt. “Tying a new drug product approval to a novel excipient approval essentially doubles the risk of regulatory approval and significantly increases the cost of development. Even worse, if either one fails, the investment in both is lost,” he says.

There have also been examples in the past, notes Priscilla Zawislak, global regulatory affairs advocacy manager at IFF and immediate past-chair of the International Pharmaceutical Excipients Council (IPEC)-Americas, of drug developers being told by FDA that they really should use only excipients listed in the IID. “Hearing such comments can be very discouraging for pharmaceutical companies that have invested time and effort with novel excipients,” she says.

It is also frustrating for companies producing novel excipients, adds Langley. “Drug developers may want to use novel excipients in formulations that can be developed without them to provide improved quality or performance. Without an independent approval process, however, they rarely do so unless the potential reward outweighs the higher risk. Excipient manufacturers, therefore, don’t have any incentive to develop new products that may not bring a return for 15–20 years,” he asserts.

Some of the risks is perceived, because most novel excipients have more supporting toxicity data than the older approved excipients ever had, according to Schoneker. “It is the uncertainty that results from the lack of an established pathway that is the problem,” he states.

There is real risk, though, asserts Raghuram, due to FDA’s silence on the issue, the lack of any specific policy, and the chance that an application containing a novel excipient might land in the hands of an new drug application reviewer that doesn’t really understand how to do this type of assessment. “The awareness of issues related to safety of novel excipients is limited, and this is not surprising as there is no guidance available. It also cannot be expected that considerations related to innovation or an assessment of the positive impact of a novel excipient on the drug landscape will be part of a drug regulatory review process. An independent safety review process is, therefore, very important for novel excipients.”

Negative consequences already occurring

A 2020 US Pharmacopeia (USP) survey of 264 respondents who formulated or supervised the formulation of generics, branded medicines, biologics, or biosimilars during the past five years revealed the extent to which drug developers find the lack of access to novel excipients a problem (1). Eighty-four percent said that currently used excipients have imposed limitations on drug development. Seventy-seven percent experienced challenges using novel excipients in advancing formulations through drug development for the US market, with regulatory acceptance, approvals, and other requirements the most common challenges. Forty percent felt compelled to reformulate a drug product for the US market because of an excipient’s limitations, while 28% experienced a discontinuation of drug development as a result of excipient limitations.

The internal structure of pharmaceutical companies that says risk must be managed has led to limited use of novel excipients, even if it means lower performing formulations are pursued, according to Langley. Today, Schmitt agrees, there is a high barrier to using novel excipients in drug development, which can stifle drug product design and potentially lead to suboptimal products with respect to pill burden, injection volume, stability, etc., as well as less efficient and/or robust manufacturing processes.

“What we have today is product development by IID and acceptance of ‘good enough’, rather than quality by design,” Schoneker asserts. In some cases, development projects have actually been halted because to move forward would require the use of novel excipients, meaning patients have therefore not had access to medications that could help them, he adds. In many cases, novel excipients have been available and shown to solve the specific issues, but the drug developers could not justify the perceived risk of using them.

While there is no lack of ideas or energy around the concept of novel excipients, given the hesitancy on the part of drug developers to use them and the lack of a path to market, the business model for excipient suppliers has become impractical, according to Raghuram. “Very few excipient companies are willing to invest resources in innovation and development,” she observes.

“At a time when we have never needed novel excipients more, there is too much uncertainty about using them and thus little reason for anyone to actually develop them. Due to the lack of an appropriate pathway for bringing products forward, very few companies are making decisions to get involved in real novel excipients any more. The only advances we are seeing are minor modifications to existing excipients, and in a few cases, co-processed excipients,” comments Schoneker.

Independent approval pathway could address uncertainty

If an independent approval or qualification pathway for novel excipients was established, then the requirements would be defined and everyone would know what must be done, says Zawislak. “FDA expectations would be clearer and more interest would be created in using novel excipients,” she says. For excipients that have FDA opinions generated and made public, drug developers would also know that there is safety data to support their use, at least for certain intended levels, Schoneker adds.

“Not only would an independent approval pathway encourage pharmaceutical companies to evaluate novel excipients, it would also give excipient suppliers a path to market that does not involve waiting 15–20 years,” observes Langley. Indeed, once an excipient receives a favorable review, suppliers can present that product to pharmaceutical companies and show that it has already been reviewed and therefore represents a higher likelihood of success, according to Zawislak.

Langley also believes such a pathway would act as a catalyst to stimulate innovation and collaboration between pharmaceutical companies and excipient suppliers. “An independent approval or qualification pathway for novel excipients could facilitate development, not only potentially reducing the attrition rate, but would also allow for a more cost-effective development process,” he states.

Access to more patient-friendly delivery solutions could also improve patient compliance, adds Katherine Ulman, principal consultant at KLU Consulting. Meanwhile, a new pathway may also lead to an update of the FDA guidance related to excipient safety, which was issued more than 15 years ago. In fact, IPEC is currently working on the revision of the 1996 Safety Guide for Pharmaceutical Excipients to incorporate current thinking related to safety evaluation techniques. IPEC hopes to publish this revised guide later in 2021.

True for both branded and generic drugs

For branded drugs, novel excipients could be used to optimize drug product performance and presentation, and possibly develop candidates that were deemed undevelopable, leading to transformative medicines with optimized patient presentations, according to Schmitt.

For generic drugs, novel excipients based on new chemical entities may not be appropriate for use; they would be best suited for use with innovator drugs that must go through clinical studies rather than bioequivalence studies. But other types of excipients including co-processed excipients and existing excipients used at higher levels or via different routes of administration, as well as food ingredients used for the first time as excipients, should be suitable for generic drugs. Because these materials have much less safety risk associated with them, the level of safety data required for assessment is typically lower.

“Novel excipients based on new chemical entities should go through a more drug-like approval process, while those based on existing excipients should have a less rigorous approval process that would enable their use by the generic-drug industry,” Schoneker asserts. If this approach was taken, generic-drug developers could make better quality products more efficiently and leverage advances in manufacturing techniques. Co-processed excipients or excipients used at higher levels, for example, might allow more cost-effective manufacture or improve patient compliance while still ensuring bioequivalence of generic formulations.

FDA proposed pilot program promising start

In early December 2019, FDA published a Federal Register Notice requesting comments on a proposed pilot program for reviewing the toxicology studies of a limited number of novel excipients via and process independent of the investigational new drug, new drug application, and biologics license application processes (2). Any novel excipient found to be safe under the proposed Novel Excipient Qualification Pilot Program would be listed in the IID with acceptable use levels. In the Federal Register Notice, the agency sought input on seven topics, including what criteria should be evaluated for novel excipients and whether such a program would help overcome the hesitancy of pharmaceutical companies to use them.

By the time the docket closed in early February 2020, 26 respondents had provided overwhelming support for the program (3). There has since, however, been no official public announcements from the agency regarding next steps. “We know FDA is working on the program, but we don’t know what they are going to do or when,” observes Schoneker.

Industry eager to move forward

The pharmaceutical industry’s perspective, according to Schmitt, is that in the past 20 years, tremendous advances have been made with respect to both small- and large-molecule drug substances, but formulators are still limited to the same excipients that were available two decades earlier with very few new excipients approved.

“We believe this situation is a direct consequence of the historical approval process for novel excipients and are excited to partner with FDA in this pilot program. We are very encouraged and hope to capitalize on this momentum by seeing the program implemented and novel excipients enter the assessment process in 2021. We also urge readers to encourage their organizations to consider novel excipients when they can make a difference and take advantage of the pilot program if/once it is implemented,” Schmitt states.

The proposed FDA pilot program is the first solid development following many years of effort on the part of excipient suppliers, pharmaceutical companies, IPEC-Americas, the IQ Consortium, and USP to reach out to and educate the agency on this important issue. “For the first time, we are seeing the possibility of a path forward that will encourage excipient innovation and in turn drug product innovation in ways that haven’t been possible before,” Schoneker asserts.

“That is tremendously exciting, and we are eager to work together with FDA to bring the program to fruition,” adds Langley. IPEC-Americas is also willing to provide suggestions for possible candidates for the pilot program that could serve as a means for seeing how the process might work. “We would love to have that kind of discussion with the agency once the decision is made to take the next steps,” Schoneker says. In addition, IPEC also has a team of toxicologists from around the world developing a new safety guide with information FDA might find useful for the proposed assessment process, according to Ulman.

Longer term, there is hope that ultimately some level of global consistency can be achieved regarding the approval of novel excipients. Doing so will be critical to realize the benefits of the US pilot program for patients, according to Schmitt. “The biopharmaceutical industry develops treatments for patients across the globe and a harmonized approach will be required,” he explains. One possible solution would be to have the topic addressed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.

References

1. T. Mitchell, et al., Pharm Tech, 44, (6) 38-43 (June 2020).
2. FDA, “Novel Excipient Review Program Proposal; Request for Information and Comments,” Notice, Federal Register, 84 FR 66669, 66669-66671.
3. FDA, “Comments on FDA Novel Excipient Review Program Proposal,” FDA Docket Number FDA-2019-N-5464-0001, www.regulations.gov, accessed Feb. 12, 2021.

About the author

Cynthia A. Challener, PhD, is a contributing editor to Pharmaceutical Technology.

Article Details

Pharmaceutical Technology
Vol. 45, No. 3
March 2021
Pages: 24–29

Citation

When citing this article, please refer to it as C, Challener, “Novel Excipients Needed More Than Ever Before,” Pharmaceutical Technology 45 (3) 2021.

Fonte: Novel Excipients Needed More Than Ever Before (pharmtech.com)

Below is an updated list of 36 of the most talked-about drugs and treatments for Covid-19. For each entry, we review the evidence for or against its use, based on published scientific findings and consultation with experts.

This list provides a snapshot of the latest research on the coronavirus, but does not constitute medical endorsements. Always consult your doctor about treatments for Covid-19. You can also consult the Covid-19 Treatment Guidelines from the National Institutes of Health and the World Health Organization’s “living guideline” for Covid-19 drugs. Both of these documents are regularly updated based on new research.

For the current status of vaccine development, see our Coronavirus Vaccine Tracker.

WIDELY USED: These treatments have gained strong endorsements from medical organizations for Covid-19 patients or are already used widely by doctors and nurses to treat patients hospitalized for many diseases that affect the respiratory system.

NOT CURRENTLY AUTHORIZED: These treatments received emergency use authorizations to treat previous variants of the coronavirus, but are no longer authorized because of the prevalence of the Omicron variant.

PROMISING EVIDENCE: Early evidence from studies on patients suggests effectiveness, but more research is needed. This category includes treatments that have shown improvements in morbidity, mortality and recovery in at least one randomized controlled trial, in which some people get a treatment and others get a placebo.

TENTATIVE OR MIXED EVIDENCE: Some treatments show promising results in cells or animals, which need to be confirmed in people. Others have yielded encouraging results in retrospective studies in humans, which look at existing data rather than starting a new trial. Some treatments have produced different results in different experiments, raising the need for larger, more rigorously designed studies to clear up the confusion.

NOT PROMISING: Evidence gathered so far does not indicate that these treatments work against Covid-19.

PSEUDOSCIENCE OR FRAUD: These are not treatments that researchers have ever considered using for Covid-19. Experts have warned against trying them, because they do not help against the disease and can instead be dangerous. Some people have even been arrested for their false promises of a Covid-19 cure.

EVIDENCE IN CELLS, ANIMALS or HUMANS: These labels indicate where the evidence for a treatment comes from. Researchers often start out with experiments on cells and then move onto animals. Many of those animal experiments often fail; if they don’t, researchers may consider moving on to research on humans, such as retrospective studies or randomized clinical trials. In some cases, scientists are testing out treatments that were developed for other diseases, allowing them to move directly to human trials for Covid-19.

Fonte: https://www.nytimes.com/interactive/2020/science/coronavirus-drugs-treatments.html

Drug products usually contain inactive, non-medicinal substances other than the therapeutic agent(s). These substances are called excipients, and they are intentionally included in a drug product to serve different pharmaceutical purposes, thus ensuring product acceptability in terms of manufacturability, appearance and performance.

In tablet formulation, excipients are usually combined at various quantities with the active drug substance(s) to produce tablets that are of standard quality. The type and quantities of each excipient used depend on the type of tablet desired and the process employed.

Classes of excipients used in the manufacture of tablets

Excipients used in tablet formulation may be classified into two groups:

1. Those that help to impart satisfactory processing and compression characteristics to the formulation e.g. bulking agents/diluents, binders, glidants, and lubricants.
2. Those that help to give additional desirable physical characteristics to the compressed tablets e.g., disintegrants, surface acting agents/ surfactants, colours, flavours and sweetening agents (as in the case of chewable tablets), polymers or hydrophobic materials (as in the case of controlled-release tablets).

Read More…

Consumer demand for new and innovative drug, over-the-counter, and regulated consumer products is helping to fuel the growth of the excipient market. According to American Pharmaceutical Review‘s article, the excipients market could reach $9.9 B by 2021:

Building on Strength: Excipient Supply Chain Prepares to Meet Global Demand

Posted: December 22, 2017
American Pharmaceutical Review
By Nigel Walker

The excipient market is enjoying a growth period. According to market and trend analysis firm Grand View Research, demand for stabilizers anti-adherents, bulk fillers/diluents, lubricants, disintegrants, binders, coatings, polymers and other performance-enhancing ingredients is projected at 744,621 tons by 2020. Every category of excipients is predicted to rise steadily over the foreseeable future, and at a healthy, sustained, compound annual growth rate (CAGR). The ongoing rise in the demand for safe, affordable, and effective medications is affecting all sectors of the industry. This is not limited to excipient suppliers, who are refining their strategies to retain and grow market share.

Research & Markets projects the overall market for excipients will reach $7.7 billion by 2022, with a CAGR of 7.3%.2 On the low end of recent estimates is reports firm IndustryARC’s projected $5.4 billion total market value, stemming from a 6.2% CAGR. Even more optimistic, research firm Mordor Intelligence, anticipates the global pharmaceutical excipients market will reach $9.9 billion by the end of 2021, sustained by a 7.2% CAGR that began in 2016. Regadless of how large the market eventually turns out to be, it will likely be substantial and capable of sustaining this growth, indicative of the industry overall

Read more…

These COVID-19 tests fall into three main categories: PCR, antigen and antibody. Dr. Aneesh Mehta, chief of infectious diseases services at Emory University Hospital in Atlanta, Ga., broke down the differences between them—and what to keep in mind if you decide to get tested.

PCR tests

The majority of COVID-19 testing happening in the U.S. right now uses polymerase chain reaction (PCR) technology. These tests detect disease by looking for traces of the virus’ genetic material on a sample most often collected via a nose or throat swab. The U.S. Centers for Disease Control and Prevention (CDC) considers PCR tests the “gold standard” of COVID-19 testing, but, like all tests, they’re not perfect. Studies have suggested as many as 30% of COVID-19 PCR test results are inaccurate. (For comparison, the CDC in 2018 estimated that rapid flu tests have about the same rate of incorrect results.)

With COVID-19 tests, false negatives seem to be much more common than false positives—so if you get a positive result, you very likely do have the virus. If you get a negative result but have coronavirus symptoms or recently encountered someone sick with the virus, you should still self-isolate until symptoms subside…

Read More

Font: BY JAMIE DUCHARME  AUGUST 20, 2020 8:00 AM EDT

• AstraZeneca dismisses reports it is in talks with the US government over a potential Emergency Use Authorisation for its COVID-19 vaccine, AZD1222. AstraZeneca “has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility,” the company says in a statement.

24 August:

• Moderna says it has concluded advanced exploratory talks with the European Commission to supply 80 million doses of its COIVD-19 vaccine candidate, mRNA-1273. The potential purchase agreement provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.

• Catalent Cell & Gene Therapy says it will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland. Catalent will prepare the facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance starting late in the third quarter of 2020. The agreement expands on Catalent’s previous agreement with AZ that its facility in Anagni, Italy, will provide large-scale vial filling and packaging of AZD1222.

23 August:

• The US Food and Drug Administration issues an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients. The agency says that “based on scientific evidence available, …this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.” The EUA authorizes the distribution of COVID-19 convalescent plasma in the US and its administration by health care providers to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19…

Read More

Font: https://www.globalpharmainsights.com/

FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.

The guidance provides recommendations on the following:

• pathways for use of investigational COVID-19 convalescent plasma
• patient eligibility
• collection of COVID-19 convalescent plasma, including donor eligibility and donor qualifications
• labeling, and
• record keeping

Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product.  A health care provider must participate in one of the pathways described below.  FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma.  Health care providers or acute care facilities should instead obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.

Excerpts from the guidance document are provided below. 

Background

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States (U.S.) from threats including emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.

One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19.  Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.

Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials…

Read More

Font: https://www.fda.gov/

On January 30, 2020, the WHO declared the COVID-19 outbreak a public health emergency of international concern and, in March 2020, began to characterize it as a pandemic in order to emphasize the gravity of the situation and urge all countries to take action in detecting infection and preventing spread. Unfortunately, there is no medication that has been approved by the FDA, gone through controlled studies and demonstrated an effect on the virus for this global pandemic. Although there are cures for illnesses and developments made by leaps and bounds in our day, the strongest and most effective weapon that society has against this virus that is affecting not just health but also economics, politics, and social order, is the prevention of its spread. The main points in preventing the spread in society are hand hygiene, social distancing and quarantine. With increased testing capacity, detecting more COVID-19 positive patients in the community will also enable the reduction of secondary cases with stricter quarantine rules.Keywords: COVID-19, Turkey, prevention, quarantine, social distancing, community

1. Introduction

In late 2019, a novel coronavirus, now designated SARS-CoV-2, was identified as the cause of an outbreak of acute respiratory illness in Wuhan, a city in the Hubei province of China. In February 2020, the World Health Organization (WHO) designated the disease COVID-19, which stands for coronavirus disease 2019. The clinical presentation of 2019-nCoV infection ranges from asymptomatic to very severe pneumonia with acute respiratory distress syndrome, septic shock and multi-organ failure, which may result in death [1]. On January 30, 2020, the WHO declared the COVID-19 outbreak a public health emergency of international concern and, in March 2020, began to characterize it as a pandemic in order to emphasize the gravity of the situation and urge all countries to take action in detecting infection and preventing spread.

The virus that causes COVID-19 is thought to spread mainly from person to person, mainly through respiratory droplets produced when an infected person coughs or sneezes. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. Other routes have also been implicated in the transmission of coronaviruses, such as contact with contaminated fomites and inhalation of aerosols, produced during aerosol generating procedures. Transmission of SARS-CoV-2 from asymptomatic individuals (or individuals within the incubation period) has also been described. However, the extent to which this occurs remains unknown [2]…

Read More

Font: Articles from Turkish Journal of Medical Sciences are provided here courtesy of The Scientific and Technological Research Council of Turkey

Often, when I explain what I do for a living being a management consultant, I get asked why companies hire consultants in the first place.

As much as I hate to hear it, the question makes sense: At first glance, it can be puzzling why companies wouldn’t just solve their own problems—whether it be a cost reduction effort or a new market entry—well, themselves. But there are many reasons companies really need consultants (and why I am able to stay employed working on some of the coolest challenges in the business world!).

If you’ve ever considered becoming a consultant—or hiring one—read a little more below about how we can help companies out.

They Want an Outside Eye

You know how sometimes when you’re dealing with an issue in your life, you turn to friends and family for their opinions? Companies often need this, too, especially when making tough decisions. Often times, clients have a perspective on how to solve the problem they are facing but want to make sure that what they’re thinking is correct (or that they aren’t so close to the challenge that they’re missing the obvious answer). So, they turn to consultants to come in and provide their opinion.

But this isn’t just any opinion: Because consultants often work with many different companies and may have worked through this problem in the past with someone else, they can really provide a perspective based on what they’ve seen work (or not) before. And given this experience, they can often bring new and innovative ideas or possible challenges to the table that clients probably wouldn’t have been able to see on their own.

They Need Extra Horsepower

Sometimes the problems companies need solving are really important, but they don’t necessarily have the manpower to focus on them. Companies still have to focus on their day-to-day operations, after all, and new projects typically require reprioritizing employees’ core job responsibilities. But hiring new employees to fill these gaps doesn’t always make sense either, seeing as many of these projects are one-offs. Whether it’s a cost reduction program requiring a dedicated team of six for a year or even a post-merger integration that requires a team of 100 for a month, clients might struggle to get the teams in place to do this critical work.

In instances like this, consultants basically serve as temporary, highly skilled employees. We’re not full-time employees of the company, so it is often cheaper to use us than hire someone new. Because we switch around companies often, we’re used to the fast learning curve, and onboarding us is easier. And, by using consultants, companies don’t have to pull their employees away from their actual jobs.

They Want Specialized Skills

Another, and perhaps the most common, reason that companies hire consultants is to gain access to a specialized skill set that might not exist in house. By engaging a consulting firm, you get access to a group of professionals that has skills ranging from Lean Six Sigma process design to finance organization structures. These highly specialized people would not only be expensive to hire for, but the company might not have enough work to keep said employees busy year round. But, thanks to consultants, companies can bring in that skill set on demand when they need it.

They Want a Safe Zone

Sometimes, when companies are working on a challenging problem or a controversial project, it can be hard for them to make decisions or take the necessary actions without getting wrapped up in emotions or politics. So, they bring in consultants to provide an unbiased eye and do some of the dirty work for them.

If you remember Up in the Air, George Clooney was engaged to go around the country conducting employment terminations on behalf of his clients. Likewise, clients might engage us for major restructurings or controversial projects so that they can ensure they’re handled by an external party that’s both experienced in and a bit removed from these types of activities. We can also provide the back-up and confirmation for a client that is attempting to run with a new idea that might not be well-received within an organization, without any risk to our day jobs or career.

As you can see, consultants really support companies in a lot of ways—and as a consultant you get to dig into a lot of tough situations. It’s not easy work, but for problem-solvers like me, it’s exciting work. If it sounds up your alley, learn a little more about how to get a consulting job of your own!

Photo of office building courtesy of Shutterstock.