Dr Christine Allen, Co-Founder and CEO of Intrepid Labs tells Lu Rahman why the company’s technology has the ability to streamline the drug development process and improve the success rate of getting drugs to market.

Intrepid Labs is the first spin-off from the University of Toronto’s Acceleration Consortium, which received a $200 million grant – the largest federal grant ever awarded in Canada – in 2023. 

“Intrepid, which was co-founded by myself, Professor Alán Aspuru-Guzik, and Drs Pauric Bannigan and Riley Hickman, leverages machine learning (ML), advanced robotics, and extensive expertise in formulation science to revolutionise the way drugs are formulated,” says Dr Christine Allen, co-founder and CEO of Intrepid Labs.

Allen says that the company’s proprietary AI-driven robotic platform can rapidly consider a formulation design space comprising billions of possible formulations to identify the optimal formulation for a given drug. 

“We think there’s tremendous potential for our platform to streamline today’s drug development process and improve the success rate of getting drugs to market. Our business model is two-pronged: We’re working with pharmaceutical partners, while simultaneously advancing our wholly owned pipeline of reformulated drugs that have come off patent.”

Revolutionising next-gen drugs with ML

Intrepid’s ‘self-driving’ platform takes an active pharmaceutical ingredient and a target product profile to select, prepare and characterise a starting formulation via semi-autonomous or autonomous workflows. 

“Our experiment planning algorithm is then retrained iteratively on data from each cycle, with oversight from our team of experts. Ultimately, this approach accelerates a months-long process to just days, uses fewer resources, and enables optimised formulations informed by a comprehensive exploration of complex, interdependent design choices,” Allen explains.

Adding value to the drug development process

According to Allen, traditionally, formulation design has been a trial-and-error process that’s slow and expensive. “Companies often settle for a reasonably effective off-the-shelf formulation – derived from what has worked for a similar molecule in the past – rather than a formulation tailored specifically to the new drug,” says Allen. 

“The vast majority of the formulation design space is yet to be explored. Out of 10 billion possible formulations using currently approved materials for the oral administration of a drug, we estimate that only about 20,000 have been prepared and characterised to date. However, more than 90% of new drug candidates fail due to efficacy or toxicity issues, highlighting the limitations of this conventional approach in unlocking the full therapeutic potential of a new drug,” she adds. 

Allen explains that one of these unexplored formulations could completely transform the properties and performance of a drug (e.g., oral formulation of semaglutide, which enhances its absorption and effectiveness in entering the bloodstream).

“By improving efficacy and reducing toxicity through more effective formulation, our approach can dramatically improve drug development success rates,” she says.

“Our data-driven approach can efficiently explore the formulation design space, refining multiple objectives — such as particle size, solubility and dissolution rate — simultaneously. We can then test the resulting formulation and rapidly iterate until an optimal formulation is obtained, thereby shortening drug development timelines. Additionally, our approach can concurrently refine formulation development objectives related to economics and/or environmental sustainability alongside properties of the formulation itself, such as overall cost of goods, manufacturability, hazardous waste, and energy consumption,” outlines Allen.

Since Intrepid Labs’ approach is not limited by formulations that have worked in the past, Allen reveals that it can also add value to the drug development process by discovering entirely new drug delivery technologies, and by rescuing drug candidates that may have failed in human trials.

Using technology to overcome pharma challenges

“Ultimately, our goal is to use Intrepid’s technology to improve how we develop and deliver drugs to patients. One of our areas of focus is to tailor formulations to specific patient populations. For example, reformulating oral drugs for chronic disease into long-acting injectables can help tremendously with medication adherence in geriatric populations who may have difficulty swallowing or experience a decline in short-term memory,” Allen says. 

Another example in which the company has also already made great strides is the reformulation of a paediatric drug to remove ethanol and a known allergen, improve ease of administration and oral bioavailability of the drug.

“Longer term, we’re excited about a future in which our technology can enable custom formulations that can be prepared on-demand to meet the needs of individual patients, she says.

From DDW Volume 25 – Issue 4, Fall 2024 Read the digital issue

Biography:

Christine Allen is a scientist, entrepreneur and leader in drug development. She is a professor at the University of Toronto, and internationally acclaimed for her research, with more than 170 publications, and numerous successful collaborations with clinical and industry partners. She is CEO and Co-Founder of Intrepid Labs.