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A framework to evaluate pre-clinical CRO vendors based on both technical and commercial capabilities
June 12, 2018
By: Anne Gimalac
Senior Business Consultant, Aston Life Sciences
There is a wide spectrum of business needs that require a thorough market landscape exercise, from searching a new service provider for outsourcing activities, to scouting a candidate for a specific investment opportunity. As a foundation, a robust and reliable market research process is instrumental as the result may lead to an important multi-year investment in the face of uncertainty and risk. So how to get a wide-angle view of all players within a specific market? How to reduce and manage the business risk by selecting the best one(s) and thus mobilizing the best resources possible to contribute to the company’s business objectives? As a senior business consultant mandated by my client and project sponsor,1 I had to evaluate the market landscape of highly specific toxicology assessment offerings, ranging from in vitro and in vivo to in silico studies on preclinical samples. In order to do so, I collaborated with a company,2 which developed several proprietary methodologies, tools and models that became a standard for the evaluation and selection of suppliers in the information technology (IT) market. We co-developed an evaluation model which helped ascertain how well preclinical contract research organization (CRO) service providers performed. This article describes how we adapted their own fact-based methodology and graphical treatment, and how we applied it to selectively evaluate specific parts of the CRO market. Company selection The first challenge was to filter among many CRO players, most of them being very well established in general toxicology for preclinical studies, but very few being specialized in emerging offerings that are becoming increasingly attractive for biopharmaceutical companies. At first I screened marketed business insight reports to access consolidated data about the preclinical CRO market and its key players. However the information contained within these reports appeared to be mostly obsolete and incomplete, as the CRO market is evolving very quickly, together with the clients’ needs. So I had to scan the market “manually,” starting from service providers known by my client, and extending to companies found at partnering events, on the internet and on LinkedIn. The difficulty was to find those that were proposing emerging capabilities for preclinical samples, such as: Omics. Looking beyond genomics, transcriptomics and proteomics, for lipidomics and metabolomics capabilities; Toxicology. Looking beyond general toxicology on rodents, for in vitro models and non-rodent in vivo models used in inhalation/respiratory toxicology; Bioinformatics. Looking beyond clinical biostatistics for computational biology/causal biological network modeling to simulate disease pathways; and Crowdsourcing platforms. To innovate and complement internal know-how or even platforms that offer the verification/in depth scientific review of study finding. The second challenge was to define and apply a structured methodology to better evaluate and segment the CROs, thus allowing to compare and position offerings along a number of dimensions and criteria. The main source of information was their website and some high-level corporate brochures, where details were hard to find, or described in different ways from one CRO to another. Do they have proprietary technologies? What are their accreditations and certifications? Which companies are GLP compliant? Are they located in EU, U.S., or Asia? Do they have expertise to provide toxicology package for IND filing? Do they have bio-banking capacities? Company information gathering I finally identified 44 CROs focusing their service portfolio in preclinical areas of interest. The compilation of company information, grouped in different categories (Table 1), was a key step of the process in order to populate the future evaluation model for a rationale evaluation and scoring of vendors. So I leveraged multiple channels for extracting publicly available facts about these 44 companies, and collecting them in one integrated table. The channels I used were mostly company websites, company profiles on LinkedIn, downloadable commercial brochures, press releases announcing strategic partnering deals, financial reports and IP databases. In order to ensure the robustness of facts, I double-checked them across sources whenever possible. However I did not interview directly the companies or their customers.
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