Thursday, November 18, 2010

Delivering Compliance

This week I completed a series of exploratory interviews with a handful of well-placed individuals in big pharma whose roles – to varying degrees – involve drug delivery.

In the course of those conversations, an intriguing intersection emerged. Please permit me to connect the dots as I see them.

Point number one: Big pharma wants partners. More than ever. This is not for lack of internal resources, but simply the smart hedging of innovation bets.

Of course, you know this.

Moreover, big pharma is disinterested in hearing anything further about “traditional” delivery options; they want access to decidedly unconventional modalities: monoclonal antibodies, proteins, peptides…This is the future.

I’m sure this, too, comes as little surprise.

Then why is it that almost across the board, unprompted, these well-placed, big pharma shoppers – whose roles at least touch on if not specialize in delivery – expressed mild to serious frustration with a perceived lack of innovation in the drug delivery marketplace?

Or as one big pharma R&D expert put it: “I would not be surprised if in a few years many of these drug delivery companies go out of business or at best find themselves barely treading water because their only clients are generics.”

Point number two: big pharma is not only keen on innovative delivery from an efficacy standpoint, although this is obviously a priority; manufacturers are also under tremendous and increasing pressure to make a cost/benefit case to payers, regulators, NGOs, politicians, etc. and they believe that innovative drug delivery could play a key role in making that case, especially with regard to second and third generation pharmaceuticals.

These same big pharma folk – again, just the handful I spoke with – also generally doubt that drug delivery providers really account for formulary implications when they “innovate,” let alone recognize the potential opportunity.

So, here’s the intersection I promised earlier. It’s based on an innovation that might traditionally fall under another category, although I’m not clear what that category might be in this context. Ingestible event delivery?

Many of you may already be familiar with this technology. It’s a form of wireless physiologic data collection. It caught my eye back in May in an “extreme tech” article for Scientific American and has since been approved for use in the EU.

I’m speaking of the Raisin™ System by Proteus Biomedical – aka the “radio pill” – an edible sensor implanted in a pill which, triggered by digestion, transmits discrete drug response data that may purportedly be used to monitor compliance and assess efficacy per individual for a variety of conditions: diabetes, cardiovascular disease, sleep disorders, organ transplants, psychological disorders, infectious disease and more.

Novartis and Medtronic are backing the radio pill, and research by the former has reportedly yielded more than 200% increases in compliance. I won’t pretend to be an actuary in order to translate that into financial implications, but if the technology were to be optimized, would billions be a reasonable guess?

What really struck me about this smart little hybrid pill isn’t the technology, although one must admit it’s darn clever.

The real disruption here is that one of the most mundane and traditional of delivery modes – the pill – has been co-opted for diagnostics and compliance improvement by adding a chip the size of a grain of sand.

And if it bears fruit, it will most assuredly make that critical cost/benefit case by potentially saving mountains of money in preventable hospitalization costs.

This certainly puts a new twist on what we mean by efficacy from a drug delivery perspective. Now that’s innovation!

Marc Dresner is a former trade journalist and marketer, whose background includes a six-year stint as executive editor of Pharma Market Research Report, a confidential newsletter for marketing research professionals specializing in biopharma, health care, medical devices and related fields. He is currently a communications lead for IIR USA.

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