Personalized medicine

One of our clients, a specialty care player, wanted to pioneer in personalized medicine in its leading therapeutic area.

Many questions aroused: is the field ready? Are we legitimate? How to tell the story around this positioning? To answer, we identified the scientific and medical elements supporting a need for personalized medicine, and then decipher whether our client’s history, portfolio, products and strengths would fit this medical need.

Finally, we defined a strategic action plan enabling to activate its positioning in personalized medicine and structured a storytelling for the field force to use within the medical ecosystem.

For a consortium of public and private health actors, developing both diagnostic tests and personalized medicine therapies, Alcimed has deciphered the regulatory frameworks of the 3 areas considered (USA, Japan and EU5), to identify their specificities. A field investigation allowed us to specify the regulatory changes to be anticipated.

The P&R (Price & Reimbursement) processes and their challenges were also examined in order to identify a preferential access model to optimize the launch of such individualized medicine products in each zone.

We assisted a leading player in the field of CAR-T therapies in preparing the launch of its new treatment and in defining its market access strategy in the United States, Canada and Europe. CAR-Ts are highly personalized technologies that require a high level of specialization to be delivered to patients, and therefore not all healthcare centers are ready to administer them. In this context, and in order to define the market access strategy for its new treatment, we helped our client to:

1. Understand and identify which centers would have the capacity to deliver CAR-Ts.
2. Analyze the bottlenecks for approval in the in-scope markets.
3. Consequently, define the actions to be implemented to ensure access to its new CAR-T therapy.

After an investigation conducted in more than 200 healthcare centers in the United States, Canada and Europe, our analysis brought us to recommend to our client the next key steps to be taken in order to develop the skills of each center and to promote rapid access to their new treatment.

In order to develop personalized treatment in its very specific therapeutic area, one of our pharmaceutical client in Asia wanted to take benefits from potential existing genetic profiling campaigns.

Alcimed identified and characterized all the current research programs and initiatives related to patient profiling on the targeted disease in the area. Given their expected and first actual results, we were able to assess the way these outcomes could influence personalized prescription practices, and the ability of our client to leverage on these results or programs.

The results for our client? A comprehensive landscape of the ecosystem around patient profiling in its pathology, strong insights on prescribers and patients behaviors, and some partnering opportunities!

Alcimed helped one of its leading immunotherapy clients understand how to position itself in personalized medicine, and what arguments to put forward to differentiate itself from the competition.

Through bibliographic research and interviews with experts, our team investigated the expectations of the various players in this specific healthcare chain with regard to personalized medicine, and how our client could legitimize its position in this field from a scientific and medical point of view.

This research enabled us to build a precise sales pitch for medical sales representatives and MSLs, and to prepare the materials used during a webinar and a congress with the medical functions.

On behalf of a pharmaceutical company, Alcimed has studied the regulatory constraints linked to the marketing and P&R (price and reimbursement) of personalized medicine products in the US, Japan, France, Belgium, Germany and the 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 understanding and comparing the measures in place in each geographical zone, we drew up a table of the regulatory changes expected in the short and medium term for each zone. This step was followed by the creation of a guide to best practices to be put in place to meet the regulatory challenges, intended for our client’s local subsidiaries.

Finally, we identified pricing and reimbursement issues, and advised our client on the best business model to optimize its launch.

One of our customers, a major player in the field of medical devices, wanted to explore the relevance of developing personalized drug delivery devices based on patient physiology, and to assess the commercial opportunity.

To do this, we investigated the potential market for such devices worldwide, segmenting this market and investigating the pathologies of interest, the depth of the market, and the possible evolution of this market in the future. To do this, we looked at the products under development, and the level of competitive intensity by mapping the players in the field, the target application market and the patents filed.

At the end of our investigation, we were able to provide a clear recommendation on the relevance of development in ‘personalised medicine and the nasal cavity’.

Alcimed worked with a pharmaceutical company to determine how to activate its positioning in personalized medicine within the allergy ecosystem.

To do this, we first established a narrative around the personalization of treatments in this field by highlighting the laboratory’s strengths identified during a working session with the teams. Secondly, we defined the activities and projects that would enable the laboratory to embody this positioning in its ecosystem.

Finally, we were able to provide our client with a clear, solid and differentiating strategic positioning based on scientific and medical arguments, a narrative for the teams in the field to harmonize the discourse and enable them to make it their own, and finally a roadmap for embodying this positioning in the ecosystem.