Something that we hear everywhere we go – conferences, business meetings, networking events – is companion diagnostics. They accompany a lot of the developments around personalized medicine, digitalization and cost reduction and they are important to almost all stakeholders in Life Sciences. Including me and you.
What are companion diagnostics?
Companion diagnostics describe a simplified version of tests that determine whether or not a specific therapy is likely to be successful in a specific case. That means that it diagnoses whether a patient belongs to a patient group that “fits” the therapy. It can either assist a new drug or enhance the precision of an existing therapy. This obviously means that companion diagnostics can help make a drug or therapy more efficient also in terms of costs.
From a legal point of view companion diagnostics are still a bit problematic since the regulatory framework has not yet adapted to them. Largely because it seems to be difficult to grasp the companion diagnostics product group or product category. That, of course, makes it hard to determine which regulations apply and which department is “responsible”, ultimately slowing down approval processes.
Who is involved?
As indicated above companion diagnostics require close cooperation between all the actors involved, in order to effectively apply them. This is how they can achieve a positive impact on all stakeholders. The variety of stakeholders include patients, pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine. Ultimately everyone who benefits from improved therapy options, cost containment and revised and harmonized regulatory requirements.
How does it affect us all?
The age of personalized therapies has come to stay and drug and therapy developments have to adapt to that. Companion diagnostics require a level of collaboration that includes all the stakeholders. And as we’ve learned above: they are quite a lot! Essentially that means that the Life Sciences industry needs to do a lot of work towards synchronizing diagnostic developments, invest in more diagnostic expertise to “adopt a more integrated, evidence-based approach to drug development“ (Quelle). And that affects really everyone in the business, from Pharma companies to partners, to Executive Search. Executives are looking at a different picture with companion diagnostics and so are we!