Virtual clinical trial technology vindicated

By Mike Nagle

- Last updated on GMT

Related tags Clinical trials Pharmacology Pharmaceutical industry Clinical trial

The use of virtual patients to simulate clinical trials on
computers can forecast their results, potentially optimising drug
development and saving the pharmaceutical industry billions.

The completion of a pilot scheme run by Optimata, creators of the Virtual Patient Technology, on preclinical data provided by Eli Lilly has prompted the US-based pharmaceutical company to initiate an extended collaboration.

According to a Research & Consultancy Outsourcing Services (RCNOS) report called "World Pharmaceutical Market (2007)​", annual spending on clinical trials in the US is around $25bn. This is only exacerbated by increasingly complex clinical trials that involve a larger mix of diverse, globally based patients.

Although outsourcing the trials to developing countries can help keep costs down, the inevitable end result is that the patient foots the bill in the form of more expensive drugs.

As Guy Malchi, CEO of Optimata explained to "Out of eight oncology drug candidates, only one reaches the market and although one fails for safety reasons, the other six fail for other reasons."

Virtual patients can enable pharma companies to design more focused clinical trials ensuring those drugs that can be successful will make it to the market.

Malchi explained that on the other hand: "We can expedite a no-go decision before a pharma company spends a lot of time and money and raises the hopes of patients that you'll be able to help them."

The technology can also shorten clinical development time. Malchi outlined how, for example, in Phase I oncology trials designed to find a maximum suitable dose of the drug candidate, the starting dose is often too low and is increased too slowly. Instead, a virtual clinical trial could be used to discover this information and "ensure a much greater proportion of the trial is spent when the patients are actually responding to the therapy."

The technology uses mathematically-based models to accurately predict how patients or patient populations respond to a particular compound and therefore forecast the results of a clinical trial. This data can then be optimised for a given trial endpoint while taking into account, Food & Drug Administration (FDA) constraints.

The software does this by combining models of human physiology, specific diseases and the therapeutic impact of a compound and allows for an unlimited number of 'virtual trials' to be carried out on a wide range of dosages, treatment schedules and patient population characteristics. It can also be used to suggest suitable combination therapies for a given drug.

The new software is the fruit of 20 years of research and currently specialises in cancer drug trials but Malchi explained that the company plans to branch out into other therapeutic areas in the next year.

"We also have a new strategic direction,"​ said Malchi. "We are in the process of screening discontinued oncology compounds for in-licence to create our own pipeline."

"We want to turn scrap into success"

This includes compounds that may have failed previous clinical trials.

As Malchi puts it: "The technology can work like a GPS: it can find another direction to get to the promised land."

Eli Lilly is not alone in putting their trust in Optimata. The company has previously worked with Novartis and Israel-based BioLineRx.

Malchi added: "We are also very close to agreeing two more projects with two very large pharmaceutical companies.

The pilot project with Eli Lilly assisted in the clinical trial design of a novel anti-cancer cytotoxic compound and will now be expanded into additional drug candidates. Financial details of the collaboration were not disclosed.

Related topics Preclinical Research

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