The advantages of Enabled-First-in-Human programs

By Melissa Fassbender

- Last updated on GMT

(Image: iStock)
(Image: iStock)

Related tags Pharmacology

Enabled-FIH programs integrate GMP manufacturing with clinical testing, which enables drug product manufacturing to occur in real-time prior to clinical dosing.

As a result, drug dose and product composition can be adjusted to response to the emerging clinical data​,” explained Alyson Connor,Executive Director, Exploratory Clinical Pharmacology, Quotient Clinical, told Outsourcing-pharma.com.

According to Connor, the primary objective of these programs is exactly the same as a conventional first-in-human (FIH) program, for example, testing safety, tolerability, pharmacokinetics.

The designs of these trials are also configured around the need for single and multiple ascending dose data in healthy volunteers.

However, Connor explained, “Within this design the use of Translational Pharmaceutics increases flexibility and precision. If required, multiple drug products can be assessed – for example bridging from a drug in bottle to a solid dosage form​.”

Additionally, a POC assessment can be conducted within the same Clinical Protocol.

Or, if this is not possible, the drug product can be manufactured by Quotient and supplied to the patient sites​,” added Connor. “This approach avoids the need for transfer to a CDMO until POC has been demonstrated​.”

How are the programs unique?

Using the conventional process, a drug product either needs to be very simple (so it can be prepared in a pharmacy, or bedside) or it must be manufactured in bulk at fixed dose units​,” explained Connor.

Unfortunately, this approach limits the ability to respond to emerging clinical data, which may result in reduced precision and an excess of drug product that may eventually be discarded

According to Connor, the co-location of Quotient’s GMP manufacturing facility and its clinical unit overcomes these challenges.

Manufacturing a drug product in real-time removes the need to manufacture a drug product upfront – simplifying the transition from candidate selection to FIH​,” she added.

Manufacturing smaller drug product batches of drug product (only as much that is needed for each dosing period) also reduces the amount of drug substance used, and in turn reduces costs.

Increased precision within the clinical study, and the ability to screen other formulations, ensures that an appropriate drug product (dose and formulation) is selected for POC​,” added Connor. “This allows immediate manufacture and seamless transition to POC​.”

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