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Wednesday, April 14, 2010
BIOMEDevice Forum panelists talk of life sciences' cross sections
By Julie M. Donnelly
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Next week, the BIOMEDevice Forum opens at the Boston Convention and Exhibition Center. The conference focuses on convergence and cross-sector collaborations in the biotechnology, medical device, in vitro diagnostics, and pharmaceutical industries. The theme is opportunities and challenges for disruptive technologies at the cross sections of the life sciences. MHT staff writer Julie M. Donnelly interviewed two of the speakers.
Attorney Dykeman sees growth in combo devices
David Dykeman, a shareholder and patent attorney at Boston law firm Greenberg Traurig LLP, is a panelist at the event, sharing his expertise about the intellectual property pathway for success with combination drug-device innovations. Dykeman discussed how a life sciences company’s IP strategy and regulatory strategy must be closely linked.
What do you think is the current opportunity for drug-device combination products?
Well, the best known product in this category is the drug-eluting stent. They didn’t exist before 2003, and now they bring in billions of dollars. We’re just scratching the surface now.
Does the Food and Drug Administration “get” combination products?
The FDA has been challenged by having so many changes in leadership, but as more and more combination products go through the regulatory system, the FDA will develop a more interdisciplinary program. Right now, the FDA has three choices. They can classify the product primarily as a drug and send it to the CDER (Center for Drug Evaluation and Research), they can classify it primarily as a biologic and send it to CBER (Center for Biologic Evaluation and Research) or they can classify it primarily as a device and send it to CDRH (Center for Devices and Radiologic Health).
Should young companies try to influence how the FDA classifies their product?
In many cases, you want to increase the odds of being classified as a device. Approval time is quicker, and clinical trials cost less — one study showed it costs an average of $2 million and three and a half more years to get a product classified as a drug approved, versus one classified as a device.
Patents only last 20 years. It can take 15 to 18 years to get a drug approved, then there’s just a few years left of exclusivity. But by writing the patents and FDA submissions emphasizing the device mechanism, talking first about that mechanism in the patent, that can help. Also, you can make an argument based on other comparable products that have been designated as devices. If few comparable products are classified as devices, that’s going to be harder.
There’s so much uncertainty about the time to market — how is that affecting investment in this area?
Combination products introduce a challenge for investors. It’s often a disruptive technology, which means it’s high risk, high reward. With this kind of regulatory environment, something unexpected could happen that could add significant time and cost to the equation. But if it succeeds, the rewards can be very high.
What are some of the most exciting combination products out there?
Drug delivery is really hot, using nanoparticles to deliver a drug right to certain cells. Another exciting space is diagnostics that can then deliver a drug, if they find the disease in question. We can imagine a world where the patient goes into the ER, gets a diagnosis and a therapy all in one.
Pervasis’ Hamermesh: Reimbursement OK smooths path to market
Josh Hamermesh, senior vice president of strategic and corporate development at Cambridge-based Pervasis Therapeutics Inc., will be a participant in the keynote panel. (He was also a panelist at MHT’s recent BioForum.) The company’s lead product, Vascugel, is a drug candidate is used in conjunction with synthetic grafts for hemodialysis access. The company is ready to launch its Phase 3 trial for the potential treatment.
What’s your feeling about the regulatory pathway for combination products?
For us, our product is classified as a biologic, and this works well for us. That’s because the reimbursement is very straightforward. There’s a longer path to approval, but the reimbursement is more favorable than an implant or device, both in terms of the price and the breadth of payers who will cover it. We also just received a so-called SPA, a special protocol assessment, from the FDA. In some ways, this helps derisk the regulatory process a little because we know what the endpoints are, the trial is designed proactively, so we don’t find out later that the FDA wanted to see something different.
How do you see the investment climate for products like yours?
We have very committed investors who have supported us for awhile, but it’s been a difficult climate out there for small companies with any innovative technology. But there are signs that the economy is starting to get better now.
In what way would you say that your product could be game-changing?
We have two formulations using endothelial cells. One is Vascugel, and that is for use in surgical procedures, with synthetic grafts in the arm, for end-stage renal disease. It aims to improve outcomes, since these grafts have high failure rates, by boosting the natural healing process. This is a complementary product. But our other formulation, PVS-10200 is used in percutaneous — less invasive — procedures. It’s used to assist stents in keeping blood vessels open. But some early research shows that angioplasty plus our product could have a good outcome in and of itself, and perhaps obviate the need for stents.
Should companies like Boston Scientific be quaking in their boots?
We think that all stent companies should be paying attention to this if it could improve outcomes. We’re currently enrolling patients in a phase 1/2 trial to figure out what role this treatment will play. PAD (peripheral artery disease) is so complex, so hard to treat, that there need to be many treatments: balloons, stents, biologics, maybe together, maybe instead of one another.
Will the changing payment environment and the emphasis on cost containment spur new innovations?
Everyone wins when technological innovation improves patient outcomes. There are tremendous costs to high failure rates. There’s a health economics argument to be made to invest in technologies that prevent or delay interventions — which in this case Vascugel does.
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