Paired Diagnostics to Transform Pharma Industry
Biomarkers are still in early stages of discovery, and more importantly, validation. Yet what is already clear is the potential to link an indicator of a disease state with therapeutics for that disease will transform how and why medications are prescribed in the future.
A diagnostic tool linked to a drug is a disruptive technology for what has been a one-size-fits-all pharma industry. To put it another way, “If you don’t have a paired diagnostic in five years, you’re dead,” said Stan Yakatan, Co-Founder of Katan Associates.
Just as personalized music destroyed the power of the hit music culture, tailored therapy threatens the blockbuster drug market by reversing the focus, emphasizing the personal condition and not the mass-market distribution of a molecule.
Pair diagnostics not only can be used to screen patients who are candidates for a specific therapy, but they can also be used to monitor the progress, and efficacy, of the therapy for each individual.
The topic was discussed briefly in a plenary discussion on R&D and Licensing Strategies at BIO-Europe Spring 2008 when panel moderator Barbara Kosacz, Partner and Head of Life Sciences Practice, Cooley Godward Kronish put executives from Merck & Co. and Johnson & Johnson on the spot.
A special session on Biomarkers and Diagnostics at BIO-Europe Spring 2008 presented projects from four companies developing programs in this field, GEN-TREND s.r.o., Integromics, Oryzon Genomics S.A., and TriStar Technology Group, LLC. Yakatan said dealmakers in bio-pharma will be hearing much more, and more importantly, will be seeing a lot more paired diagnostics over the next year.
“Paired diagnostics provide the pharmaceutical industry with a method for determining the use of their drug
“Ultimately every pharma company is going to need a series of products for personalized medicine where there is a therapeutic paired with a monitoring system,” he told Partnering News.
To better understand the concept, he said, an extreme but good example is Clozipine from Novartis where it is essential to screen a patient before prescribing this drug because it can prove fatal to a specific population.
“If a pharma company does not get into this game they are going to have a rough time in two areas,” he said. “First the FDA is going to require drug usage monitoring. That is already on the table, though it is not yet in force. Secondly, the market is going to begin asking how you intend to monitor your drug.”
At BIO-Europe Spring, he said “We heard Merck say it got rid of its diagnostic division and we heard Johnson & Johnson’s speaker on the panel say how happy he is right now that they have kept their division.”
“Right now Roche holds the opportunity to become the leader in this field because they are the ones developing their program,” he predicted.
Related Posts
No related posts.