Companion diagnostics (CDx)

Alcimed supported a player in the pharmaceutical industry in assessing the potential for using a pancreatic cancer biomarker as a companion test.

Based on an in-depth technical and economic study of the various existing diagnostic technologies for pancreatic cancer, we were able to estimate the added value of a new specific biomarker in this environment, specify its advantages and its positioning. Drawing inspiration from other CDx cases, we were able to identify the most suitable business model, and thus assess the potential market for the companion diagnostics considered.

Our discussions with players in the sector throughout this project also resulted in operational recommendations for market entry strategy for this new companion test.

Alcimed studied, on behalf of a pharmaceutical company, the regulatory constraints related to the marketing and P&R (price and reimbursement) of personalized medicine products on the markets for the US, Japan, France, Belgium, Germany and UK. In particular, we assessed the specificities of each country and the procedures to be followed for the co-development of a CDx with a drug.

After having understood and compared the measures in place between the geographical areas, we have drawn up a table of the regulatory changes expected in the short and medium term for each area. This step was the subject of the creation of a guide of good practices to be put in place to deal with regulatory challenges, intended for our client’s local subsidiaries.

Finally, we identified the issues around pricing and reimbursement terms to advise our client on the preferred business model to optimize its launch.

In order to help our client, a major pharmaceutical company, to define the best partnership strategy to implement in the field of CDx, we have proposed an original mapping, allowing to visualize the current partnerships linking pharmaceutical laboratories and diagnostic players, and to decipher its structuring characteristics.

Some major strategic partnership plans were drawn up, which we were able to compare and prioritize according to the specific situation and expectations of our client. On the strategic option chosen, we identified the relevant diagnostic players in the context of co-development, and thus informed the choice of our client on the best partner.

The first step of this project was to carry out an in-depth study to understand and map the national health systems in France and Belgium with regard to personalized medicine products, both drugs and companion tests. We then assessed the impact that these new practices will or could have on these healthcare systems. Finally, we assessed their impact on national reimbursement systems.

Thanks to the analysis of the expected impact of personalized medicine, we were able to provide our client with the knowledge and tools necessary to address the issues of standards and regulations in these two countries.

Alcimed accompanied its client, a pharma player, in identifying the key criteria for the success of their gene therapy clinical trials.

To do so, we started by benchmarking existing programs on a worldwide basis and especially the use of companion diagnostics in these trials. The approach began with a broad scale identification of gene therapy clinical programs for heart failure, cardiovascular diseases, and other therapeutic areas, of which the top 5 most relevant were selected and assessed. The main success and failure factors of all 5 were evaluated through existing literature and interviews with key opinion leaders. The key learnings were analyzed to build a target opportunity profile for a gene therapy asset. The use of companion diagnostics was one of these key learnings for a successful gene therapy clinical trial.

Thanks to our work, we enabled our client to develop a better understanding of the reasoning behind current gene therapy programs’ choices of endpoints and other key clinical trial features.

Alcimed worked with a global medical device leader to better understand pharmaceutical companies’ strategies in companion diagnostics, and in particular the kind of partnerships they use to establish.

We first identified and contacted a list of pharmaceutical companies with potential of partnering because of their portfolio and their characteristics. By interacting with them, we analyzed their strategies and needs in companion diagnostics, and we designed the ideal partner profile our client should target. During the investigation, we were even able to identify several companies who were actually interested in going further with our client.

In the end, the client was able to have a better understanding of pharma’s needs regarding companion diagnostics, and to focus its business development resources on companies with higher chances of establishing potential partnerships.