MINNEAPOLIS- The convergence of the medical device and drug industries is inevitable, especially given the early success of drug-coated stents and inhaled insulin, but it could be years before the approval of combination products becomes everyday news, panelists said at the BIO Mid-America VentureForum.
Since the Midwest is known more for its established medtech and medical device industry, a workshop dealing with the reality of biotech drugs being packaged with devices seemed more than natural. But one panelist in a workshop at the Hilton Minneapolis Hotel warned not to put too much hope in the immediate future.
Peyton Anderson, CEO of Affinergy Inc., a Research Triangle Park, N.C.-based firm formed 18 months ago to develop site-specific biodelivery technologies, said combination products "in the short term are way overhyped, and in the long-term are way undervalued."
Though drug-eluting stents, such as those developed through a collaboration between Angiotech Inc. and Boston Scientific Corp., might have started the game, "we're in maybe the second inning," he said. "We had two leadoff homers" with the stents, "but we've got a lot of pitches left."
Anderson estimated that "we are about 20 to 30 years away" from drug/device combination products becoming widely used and widely accepted.
All panelists agreed that the biggest hurdle standing in the way is the regulatory requirements. Only in 2002 did the FDA establish definitions for combination products, and the final version of those regulations came out this year, said Annemarie Moseley, chairman of San Francisco-based Repair Technologies Inc., a biotech start-up focused on endogenous repair of tissue injury.
"The reality of this field is that it's just now beginning to affect us," she said.
Combination products can refer to drugs and devices that are developed together, or developed separately and packaged together, or developed and packaged separately but approved for jointly treating certain indications. Oftentimes, the greatest source of confusion is which part of the agency has the last word on product approval, and that's where the Office of Combination Products comes in.
Moseley said the OCP reviews products and determines by evaluating the primary mode of action whether a product is essentially a device or a delivery technology that introduces drugs into a patient's system. For example, she said, drug-eluting stents are devices that hold vessels open so the drug can take care of the secondary need. But an inhaled insulin product's mode of action is based on the drug's action upon the body.
At the start of the regulatory process, companies will have the OCP review their products to determine whether the drug or device side of the FDA will take the lead on the approval process.
That "makes the process more complex up front," Moseley said, but it prevents one side from "delaying things at the point of approval."
As the vice president and chief scientific officer of Northridge, Calif.-based Medtronic MiniMed Inc., Bill van Antwerp said he has had some experience with regulatory process for combination products, and not all of it has been pleasant. The company has an insulin pump therapy.
Antwerp said the OCP "seems to really get it," but the problem arises when companies are asked to duplicate clinical trials on existing products. MiniMed purchased a marketed drug from Indianapolis-based Eli Lilly & Co. to use with its pump technology, and the "drug guys at the FDA made us repeat the impurity profile," which ended up costing MiniMed an additional $2 million.
Conversely, he said, companies might have clearance for a device, such as a pump, but are required to "prove again that the pump works.
"It's that level of craziness that I don't think they've gotten to yet," Antwerp said.
But not all the challenges are regulatory-related. The development of drug/device combinations also requires the collaboration between biotech and medical device companies, and those working arrangements can spark some culture shock.
"It's a Mars and Venus thing," Anderson said, adding that collaborations with device companies usually require members of his staff "to go around and educate the engineers about biology."
To that, Antwerp replied that "our engineers also have to work with biologists," and joked that "the loneliest guy in the world is the drug guy at a device company."
Companies also have to consider the time frames, since drugs typically require longer development and trial periods before they're ready for approval. So, "when you partner, make sure you have it up front that it's going to take a lot longer than you think," Antwerp said.
Moseley said she sees the last several years as "a wake-up call" for medical device companies, which are finding they will have to learn about drug-approval processes and good manufacturing practices before they can consider combination products.
A lot of progress has been made over the last few years, she said, and "I think we'll see a lot more awareness to new products and new innovations."
The conference ended Friday.