Terms Beginning With 'f'

Fast Track Designation

What is the Fast Track designation?

Fast Track designation is a process that is meant to accelerate the development and expedite the review of medicines or drugs focusing on the treatment of serious indications and capable of addressing unmet medical requirements. The purpose of this designation is to find an important new treatment for early access to the patient. The Fast Track designation addresses a comprehensive range of severe disease indications.

In other words, the Fast Track designation process is made to facilitate the drug development, accelerate the Food and Drug Administration (FDA) review of drugs for serious indications, and address an unmet medical need.

Establishing whether a disease is serious or not is based on assessment. In general, the judgment is based on the drug’s ability to make an impact on factors such as day-to-day functioning and survival, among others. Also, if left untreated, the condition could progress from less severe disease to a more serious one.

Some examples of serious diseases that can progress to more severe levels, if left untreated, include Alzheimer’s disease, heart failure, cancers, and AIDS. Other conditions like depression, diabetes, and epilepsy are also considered to be serious.

What is the Fast Track Program?

The Fast Track program facilitates the expedited development and review of new drugs or biological drugs that are intended to-

  • Treat serious or life-threatening diseases.
  • Demonstrate the potential for addressing unmet medical needs.

Sponsors or drug developers usually apply for a Fast Track designation during the investigational new drug (IND) phase of drug development.

What are the requirements to apply for Fast Track designation?

Any medicine that is being developed for treatment or prevention of an indication with no approved current treatment is directed at an unmet medical need. If there are already available treatments, a Fast Track drug must demonstrate a few benefits over the available treatment. These benefits include-

  • Demonstrating superior effectiveness and impact on severe consequences or improved effect on severe outcomes.
  • Preventing serious side effects or adverse effects of an already existing treatment.
  • Enhancing the detection or diagnosis of a severe disease where early diagnosis results in a better outcome.
  • Reducing clinically substantial toxicity or adverse drug reaction with an already available treatment that is common & triggers discontinuation of the drug.
  • Capability of addressing emerging or expected public health requirements.

What is the purpose of the Fast Track designation?

Fast Track designation is an approach to make a new drug quickly available for patients suffering from serious diseases. It could be considered as an approach to avoid the progression of a serious indication to become more severe or life-threatening. There are four approaches of FDA to make new drugs available as quickly as possible, and Fast Track designation is one of these four approaches.

The remaining three are priority review, breakthrough therapy, and accelerated drug approval.

What are the incentives for a drug after it receives a Fast Track designation?

After a drug receives Fast Track designation, it is eligible for some specific incentives. These incentives help drug developer to get early approval for that particular drug. The benefits are-

  • Regular meetings with the Food and Drug Administration regarding the discussion of the development plan of a drug and to make sure the collection of appropriate information required to support approval of the drug.
  • The drug developer could get more frequent written communication from the FDA regarding such the design of the planned clinical trials and usage of biomarkers.
  • With the Fast Track designation, the drug can get eligibility for accelerated approval & priority review if all the relevant criteria are met.
  • This designation can offer rolling review authorization to the drug company. The rolling review means that a drug developer can submit completed sections of its biologics license application (BLA) or new drug application (NDA) for review by the FDA. The company does not need to wait until every section of the new drug application is completed before the full application can be reviewed.

NDA or BLA review usually does not start till the drug manufacturer has submitted the complete application to the FDA.

Once a drug is granted Fast Track designation, early and regular interaction between the FDA and a drug manufacturer is encouraged during the complete drug development as well as the review process. The communication frequency confirms that questions and concerns are settled immediately, often leading to earlier drug approval and access of the drug by patients.

Who can apply for Fast Track designation?

A pharmaceutical company or a sponsor that is manufacturing a drug to treat the condition with no existing therapy can request an application for Fast Track designation. The application can be started at any time throughout the process of drug development.

If the drug has significant advantages over existing therapies and the unmet medical need requirement is fulfilled, then also a drug manufacturer must apply the Fast Track designation.

After the application, the FDA will review the request and decide within two months based on whether the drug fulfils an unmet medical need in a serious indication.

Recent Examples of Drugs/Biologics receiving Fast Track designation

Fast Track designation for a vaccine against ongoing life-threatening COVID-19

Pfizer Inc (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a vaccine for the ongoing pandemic. The companies announced that two of their four investigational vaccine candidates BNT162b1 and BNT162b2, from their BNT162 mRNA-based vaccine program, received Fast Track designation from the FDA. The vaccine developers stated that this designation was granted based on the initial data from Phase 1/2 clinical trials of BNT162 as well as animal immunogenicity studies.

With this designation, the vaccine developers got the opportunity to work closely with the FDA through the clinical development of their BNT162 mRNA-based vaccine program.

Bristol Myers Squibb Granted Fast Track designation for Opdivo (nivolumab) plus Yervoy (ipilimumab) Combination

Bristol Myers Squibb had received a Fast Track designation grant from the FDA for Opdivo plus Yervoy administered concomitantly for the first-line treatment of patients having metastatic or recurrent NSCLC (non-small cell lung cancer). Additionally, the FDA has also granted priority review to the combination of Opdivo plus Yervoy.

In the recent past, the absolute return approach of Investing has turned out to be one of the fastest-growing investment strategies worldwide. A lot of financial advisors talk about such investments providing absolute returns. So, what exactly are the “Absolute Returns” and are they are promising? What is meant by Absolute return? Absolute return computes the increase or decrease, in an asset over a period of time, as a proportion of the original investment amount. The focus here is only on that specific asset or portfolio and not related market events. Absolute returns only consider the price movement for any specified time period. Absolute return, reckons an investment’s performance without considering the expanse of time for which investment was committed. Absolute returns can be computed for a quarter, semi- annual, annual period, 3-year duration or more. Absolute Returns are independent of Market movements and thus do not draw relative comparisons. It is one of the most commonly used investment performance metric in Hedge Funds and Mutual Funds. How to compute Absolute return? Suppose an investor Mr. Rich, invested AUD 50,000 5 years back, and the current value of his investment is AUD 75,000. The Absolute return on Mr. Rich’s investment would be 50 %, calculated using- Copyright © 2021 Kalkine Media Pty Ltd Copyright © 2021 Kalkine Media Pty Ltd So, Copyright © 2021 Kalkine Media Pty Ltd Absolute returns are just returns from point of time to other. The notion of an 'absolute return' seems very attractive to get investors’ attention as it ignores the relative market movement and promises an appreciation with zero correlation to markets. Anyhow, Absolute Return technique of computing investment yields is an apt way of calculating return on investment, predominantly in the early stages. There are numerous other types of return metrics an investor can look for later on. Major 4 types mattering most to investors being –  Absolute Return, Relative Return, Total Return & CAGR. What is the difference between Absolute Return, Relative Return, Total Return & CAGR? Absolute return refers to the gain/ loss in a single investment asset/ portfolio but to comprehend how their investments are acting relative to various market yardsticks, relative return is taken into consideration.   Relative return is the excess or deficit an asset achieves over a timeframe matched to a market index. Benchmark Return – Absolute return, gives the Relative return also called sometimes as alpha. Example, if S&P index gives a 10% return during a given period and one’s investment portfolio gives an absolute return of 12% then relative return on investment is positive/ excess 2%. Total returns take into account the effect of intermittent incomes as well as dividends. For example, in an equity investment of AUD 200 having current value AUD 240, the company also declares a dividend of AUD 10 during the year. Total returns will take into account this $10 dividend too. Thus, Total returns on the investment of AUD 200 now will be 25.00% = {(240+10-200)/200} x 100 Absolute and Total returns are easy to calculate as performance metrics, but the real challenge is when comparisons are drawn based on time period of return. Here comes in CAGR, it takes into account the term of the investment too, thus giving a more correct and comparable picture. It is computed as: CAGR (%) = Absolute Return / Investment period (equated in years) Consider for example, two investment options: One where investor earns absolute returns of 10% in 24 months and another where investor earns 5% absolute returns in 9-month duration. So, CAGR would be- For option one: CAGR = 5.00% i.e.  10%/2 (24 months/12 months is equals to 2 years) For option two: CAGR = 6.66% i.e. 5%/0.75 (9 months/12 months is equals to 0.75 years) What’s wrong with just measuring investment performance using Absolute Returns? Absolute returns will only tell an investor how much his/her investments grew by; they do not tell anything about the speed at which investments grew. When people talk about their real estate investments and say, “I bought that house for X in the year 2004. It’s worth 4X today! It has quadrupled in 17 years.” This is an application of absolute return. The drawback here is that it takes into account only the capital appreciation and doesn’t draw comparison with options having different time horizons. Investors can rely on this measure of investment performance only if they are looking for higher returns, without bothering how fast they were generated. Absolute return also doesn’t convey much about an investment compared to relative markets. Then, why do Hedge Fund/ Mutual Fund Managers choose an Investment strategy based on Absolute returns? Absolute returns should be used at times when investors are willing to shoulder some risk in exchange for a prospective to earn excess returns. This is irrespective of the timeframe and Fund administrators who measure portfolio performance in relation of an absolute return typically aim to develop a portfolio that is spread across asset categories, topography, and economic phases. They are looking for below mentioned points in their portfolios- Positive returns- An absolute returns approach of investment targets at producing positive returns at all costs, irrespective of the upside & downside market movements. Independent of yardsticks- The returns are in absolute terms and not in comparison to a benchmark yield or a market index. Diversification of portfolio- With the intention of distribution of risk, among different investment options producing positive returns in diverse ways a mixed bag of absolute return assets give a diversified investment portfolio. Less volatility- The total risk of investment is spread across the different asset held in such a portfolio. Ensuring less overall volatility in collective returns. Actively adjustable to market movements– Usually, investments look for positive returns with zero market correlation. Market shares a negative correlation with absolute return investments and vice versa. In any investment atmosphere, there are varied investment strategies and goals. Absolute return investment strategies are looking to avoid systemic risks using unconventional assets and derivatives, short selling, arbitrage and leverage. It is appropriate for investors who are prepared to bear risk for short and long-term gains.

A report of overdue customer invoices and credit memos. It is an indicator of the financial health of the customers of the company, and regular reviewal of it would enable to track and control the liquid cash flow in the company.

Accounts receivable financing is a method of selling accounts receivables to obtain cash for the company's operations. Accounts receivable is one of the liquid assets and can be tracked using the quick ratio.

What is the Dark Web?  The dark web is one such portion of the World Wide Web which is not accessible by regular search engines. The dark web is considered a hotbed for criminal activities, and it is much more than that. Various websites exist on an encrypted network inside the dark web. Standard web browsers and programs cannot find these websites. Once inside the dark web, different sites and pages can be accessed like one does on the web. Scientists believe that the internet we see is only 4% of the entire ocean of the web, meaning the 96% consists of the "Deep and Dark Web".  The user interface used in the dark web is usually internet-based, but it utilises special software which is not part of the standard ones. There are dozens of web browsers to surf the internet, but they all work in the same way. These standard browsers use ports and protocols to request, transfer and view data on the Internet. The website you access may look familiar, but as you enter, it may be illegal or something familiar but otherwise not monitored by anyone else. Therefore, the deep web and the dark web are famous for being anonymous. Also read: Cyber Espionage Campaign: Strings that tie China, Australia and the US How to access dark web browser? In order to access a few areas which are restricted, the user may need a password and a process to follow. A special software called TOR (The Onion Router) or the Freenet has these non-standard connections. These browsers are unlike standard internet browsers and have a process to access. They allow the users to browse around the dark web and are focused on keeping the user identity anonymous. If hacked or accessed, the regular web browser can easily provide user information such as who the user is and whereabouts. Though the dark web is providing 100% anonymity, federal agencies have been successful in tracking down criminal activities on the dark web. It is often said that the person you are talking to on the dark web could either be an FBI agent or a criminal. Image: Kalkine   What happens inside the world of the dark web?  The dark web is famous for allowing sinister activities, but many users go on the dark web to access information which otherwise may not be accessible on standard internet. Such as users from extremely oppressive governments who cut access to the world for their citizens. Unfortunately, such confidential environments also provide open platforms to criminals, terrorists and other such individuals involved in illegal activities.   Hence, experts advise users to not access the dark web even out of curiosity as it is a lawless environment. There have been many incidents where innocent, curious users were trapped and forced to get involved in criminal activities or their digital devices hacked and compromised without their knowledge.  A study conducted by a University of Surrey researcher Dr Michael McGuires in 2019, Into the Web of Profit, shows that the dark web has become worse in recent times. Since 2016 of all the listings on the dark web suggested, 60% could harm companies. Everything illegal and criminal can be found on the dark web, it also has other legitimate options such as chess clubs or book clubs, but because of the anonymity, the user will not know whom he/she is interacting with. Inside the dark web, anonymity and lawless nature make the crimes which exist otherwise in our society hard to trace.  The payment procedure inside the dark web is also different from the World Wide Web. Most often, Bitcoin and Monero cryptocurrency are used for the transactions.    RELATED READ: Knock Knock! Cybercriminal at Your Doorstep   What’s the difference between the deep web and dark web? The dark web is part of the entire deep web and is hidden from regular browsing access. Most people confuse the deep web and the dark web as one entity. It is not. The deep web content includes anything hidden and restricted behind the security wall such as content which otherwise requires paywall or sign-in or blocked by the author. Content which cannot be easily accessible on regular internet such as medical records, membership websites, paid content are available on the deep web; hence it is also called Invisible Web.  No one really knows the total size of the internet, but the experts believe that the standard World Wide Web consists of only 4% internet, the deep web consists of 90% and dark web consists of 6% of the entire internet.  ALSO READ: Technology has changed the way we work amid the COVID-19 crisis: A look at in-demand technologies Image: Kalkine     Also read: It happens again, NZX being bullied by Cyber-attackers- Down for the fourth day   What kind of risk companies face due to the dark web?  The Into the Web of Profit report listed below threats various organisations around the world are facing, especially the ones who have weak or insufficient cybersecurity measures.   Malware attacks Distributed denial of service (DDoS) attacks Botnets Trojan, keyloggers, exploits  Espionage  Credentials access  Phishing  Refunds Customer data Operational data Financial data Intellectual property/ trade secrets    Also read: Cybersecurity and the Requirement of a Resilient Environment in Australia  Are there advantages and disadvantages to the dark web?  The dark web provides complete anonymity, the users get complete privacy to perform any activity, be it illegal or legal. Many countries in the world still have authoritarian regimes offering no civil rights to their people. To such oppressed lot, the dark web provides an opportunity to access news, information, data and also express their views. The dark web is also a perfect place for law agencies to map criminal activities while being undercover. It is also easy to commit gruesome crimes through the dark web as it is complicated and lawless. Criminals can easily use the dark web to compromise someone's privacy, steal data or private information or even hire someone to commit murder.  Do internet users need to be concerned about the dark web?  The simple answer is no unless the user is using the dark web. Study says that most young people visit the dark web out of curiosity. They do not want to indulge in any criminal activity but want to see how the hidden and secret world of the dark web operates. And that is where the possibility of the electronic device IP address getting hacked by other criminals to perform their criminal activities lies.  The earliest use of darknet dates back to the year 2000. Freenet was created at the University of Edinburgh based on a student research paper. Ian Clark wrote the paper in 1999 on the possibility of such an encrypted internet base. Freenet was created to oppose censorship and provide a platform for free speech. The most powerful dark web is TOR, and it was created by the United States government to have a secure encrypted communication in case of emergency and complete disaster. Even today, many law agencies are secretly active inside the world of the dark web to gain access in the criminal world and stay one step ahead.

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