The Industry Challenge 

TIME & MONEY: Drug development is a costly, complicated and lengthy process. On average, it takes 12 years and $359 million to bring a new drug from the research lab to market. Many virtual, startup or small companies discover chemicals that likely have medicinal benefits, but are unable to bring them to market due to limited funding. While partnering with academia may seem like a cost-effective solution for small businesses, indirect fees or ownership/intellectual property sharing requirements can result in higher total costs than those found partnering with a standard CRO.

ACCURACY: The early discovery phase is one of the most challenging parts of the drug development process. On average, only five of every 5,000 drugs that begin preclinical testing make it to human testing.

The Client Challenge
Likarda was approached by a client with a complex chemical entity and was asked to provide research during the discovery phase of the drug development process. Likarda was tasked with:

  • Providing the phenotypic screen and toxicity assay
  • Finding the most responsive disease for the client’s active pharma ingredient (API)
  • Validating the effects of the API on the disease
  • Quantifying the toxicity levels using in vivo testing

The client requested that Likarda assist them from the early testing phase through Investigational New Drug (IND) submission.

The Solution

Utilizing its unique 3D technology, Likarda was able to provide the early 3D phenotypic screen and sensitive toxicity assay. The phenotypic screen resulted in an accurate indication of the most responsive cancer for the client’s active pharma ingredient (API).

Following the phenotypic screen, Likarda provided a toxicity assay utilizing its patented 3D microplate technology. With this discovery tool, Likarda is able to create up to 200 cell spheroids in the same well space that competitors use to create 1 spheroid (in a 384-well plate). This unique 3D assay is 3–5 times more sensitive than standard tests, allowing Likarda to provide clients with quicker results that are more predictive of the in vivo effects of test compounds. Leveraging technology allows Likarda to give its clients more data sooner — saving substantial time and money.

Likarda is able to create over 55,000 cell clusters in the same area that competitors use to create 384 clusters.

The Results

When it came time to move from in vitro testing to in vivo testing, Likarda was able to utilize its strong network of partnering universities and CROs to give its client a one-stop-shop for research needs. During in vivo testing, Likarda was able to validate the hypothesized effect and quantify low toxicity levels in rodents.

In addition to leveraging its unique technology and partnerships to move APIs through the
pipeline at breakneck speed, Likarda also performed a variety of traditional CRO services and assisted its client through the preclinical data collection process that is required to file an Investigational New Drug (IND) submission.

Likarda bridged the gap between discovery and pre-clinical studies for its client without added hassle. The team was able to carry out all necessary steps of the early drug discovery phase — from receiving the new chemical entity (NCE) to Investigational New Drug (IND) submission in just over a three-year timeframe and at 60% of the standard cost of typical development strategies.

Likarda is able to create over 200,000 cell clusters in the same area that competitors use to create 384 clusters.

The Results

When it came time to move from in vitro testing to in vivo testing, Likarda was able to utilize its strong network of partnering universities and CROs to give its client a one-stop-shop for research needs. During in vivo testing, Likarda was able to validate the hypothesized effect and quantify low toxicity levels in rodents.

In addition to leveraging its unique technology and partnerships to move APIs through the pipeline at breakneck speed, Likarda also performed a variety of traditional CRO services and assisted its client through the preclinical data collection process that is required to file an Investigational New Drug (IND) submission.

Likarda bridged the gap between discovery and pre-clinical studies for its client without added hassle. The team was able to carry out all necessary steps of the early drug discovery phase — from receiving the new chemical entity (NCE) to Investigational New Drug (IND) submission in just over a three-year timeframe and at 60 percent of the standard cost of typical development strategies.