ACCELERA and CROss Alliance Come Together to Make Pre-Clinical to...
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ACCELERA and CROss Alliance Come Together to Make Pre-Clinical to Clinical Phase Effortless

Pharma Tech Outlook | Thursday, May 20, 2021

The two companies' management teams have decided to take a step forward and combine their services into an FIM translation package for a limited number of projects.

FREMONT, CA: Moving from the pre-clinical to the early clinical phase of drug development is often a time-consuming and challenging process. ACCELERA, a premium tier Contract Research Organization (CRO), and CROss Alliance, a private, Swiss, regional Contract Research Organization (CRO), have proposed a solution to this problem to provide an effective time and cost-saving solution with improved results, if possible. The collected data must be checked after the pre-clinical process is completed, and the related safety and PK information must be incorporated into the design of the First in Human (FIH) study protocol. This critical move normally necessitates a significant amount of time and the participation of various experts, and additional consulting fees. ACCELERA and CROss have joined forces to close this distance, speeding up and lowering the cost of the process.

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Furthermore, and with a significant effect that is often overlooked, the analytical methods designed for pre-clinical safety studies must be re-developed for the human matrix (plasma or serum & urine). This is usually performed in a separate facility, which will have to start from scratch with method setup and validation. Extra time and resources must be factored in this time as well.

Suppose one is working with a large, fully integrated preclinical and clinical Contract Research Organization (CRO). In that case, they will almost certainly have access to an internal translational team to meet this need and streamline the process from pre-clinical to FIH. For various purposes, global CROs that work from pre-clinical to clinical do not manage all projects from small to mid-sized BioTech and pharma firms. Smaller CROs can sometimes provide more tailored and customized work, both in the pre-clinical and clinical fields, that fits better with the company's soul or investment allowances.

A New Opportunity on The Market

ACCELERA and CROss Alliance are two multinational CROs that specialize in pre-clinical and early-stage clinical research, respectively. Both businesses have been around for a long time. While being in separate countries, Italy and Switzerland are very familiar with each other and have previously worked on various projects due to their proximity (about 1 hour by car). The two companies' management teams have decided to take a step forward and combine their services into an FIM translation package for a limited number of projects.

The aim is to work in tandem and put the relevant skills into a collaborative team to achieve the following goals:

Time-Saving By:

Bridging the gap between pre-clinical and clinical phases. Depending on the form of submission, you will receive the Investigator's Drug Brochure, the Clinical Synopsis, and, if necessary, a Clinical Site(s) Feasibility assessment after the pre-clinical IND enabling program.

Ensure the pre-clinical data and experience are incorporated into the Clinical Study Synopsis as soon as possible. This will make it possible to:

Early awareness of the test item's pharmacology and toxicity mechanism;

Integrated evaluation of formulation options to gain a clear view of the entire path across pre-clinical and clinical studies;

Available predictable animal PK/PD models at ACCELERA, which will interact with CROss clinical PK experts in the determination of the optimal dosing regimen;

Early consideration of the test item's pharmacology and toxicity mechanism.

Cost Savings By:

Integrating the creation and validation of bioanalytical methods in animal and human matrices;

Free information transfer and scientific support between ACCELERA's Program Manager and CROSS' Medical Writers;

No overheads for this seamless service.

Assure simplicity and clarity by offering, negotiating, and contracting the two sections separately, the pre-clinical production at ACCELERA and the clinical phase(s) at CROss.

Assure engagement, since both CROss and ACCELERA will determine if the therapeutic indication targeted and the project's pre-clinical criteria fall within their respective fields of expertise and experience before committing.

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