Finding New Pathways for Combination Products

Combination products are creating some challenges that must be overcome with input from multiple industries.

October 1, 2008

3 Min Read
Finding New Pathways for Combination Products

FROM THE EDITORS


The convergence of medical devices, pharmaceuticals, and biologics has been under way for a few years now, and it is creating new challenges in these related but separate industries. Converging areas such as genomics, proteomics, and nanotechnology have created new diagnostic and therapeutic possibilities. Moreover, they have presented a new avenue for product innovation and an opportunity for the development of more personalized medicine.

That shift, of course, brings changes that are akin to starting a new company. Companies that venture into the converging world of combination products must take an integrated approach to defining their strategy, their development process, and their company's organization, said Dennis Goldberg, president and CEO of Transport Pharma. Goldberg spoke at the BIOMEDevice conference in September. The company is a specialty pharmaceutical firm, with a dermal product pipeline based on the combination of medical electronics, materials engineering, formulation chemistry, and skin biology.

The development of combination products requires dedicated and collaborative efforts, open and flexible communication, and input from across multiple disciplines. Many times, development of such products won't even fit into a company's current business model. Goldberg suggests that companies developing such products need to have expertise in all of the relevant core competencies in order to provide guidance to vendors. Transport's team, for example, is comprised of experienced engineers, chemists, biologists, and experts in clinical development regulatory affairs.

The advent of combination products has also meant changes at FDA, and will likely mean further evolution of the agency's approach to convergent technologies. The Office of Combination Products (OCP) was established by FDA in 2003 to identify and assign these products to the lead FDA review center—CDRH, the Center for Drug Evaluation and Research (CDER), or the Center for Biologics Evaluation and Research (CBER). In 2007, FDA issued decisions on 57 combination products, 27 of which went through CDRH.

“In the current conservative FDA environment, the standard is very high,” Goldberg said. His company split its application into two parts: a new drug approval and a 510(k) submission. “We provided CDRH with a pullout of the 510(k) to make it easier for [the center] to review the portion that was applicable to the device.”

Many of the first products to be submitted to FDA involved combining diagnostics or devices with drugs, but this is shifting with the integration of diagnostics and devices with sophisticated instrumentation and information technologies. In that environment, he said, FDA looks for guidance from the company.

Read previous coverage of combination products here.

“[OCP] is only a gatekeeper,” Goldberg said, referring to OCP's role in simply determining the appropriate center for a product based on its primary mode of action.

As life sciences companies begin to develop more products that cross boundaries, the regulatory landscape will also shift. It will be critical for you to provide input to FDA to ensure that the model that evolves is one that works for you.

The organization of a convergence company looks very different from a medical device company, and certainly the regulatory path is more complex. Combination products have the potential to offer greater therapeutic benefits than drugs, devices, or biologics on their own, and as such, will continue to drive the direction of new products that address the trend toward personalized medicine.

Sherrie Conroy for the Editors

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