NICE, FRANCE--In a presentation called “From Cells to Sales: Commercial Opportunities and Challenges of Optical Molecular Imaging as a Clinical Tool,” Shahram Hejazi from AVA Biomed Partners explained to attendees at the recent World Molecular Imaging Congress (September 10–13, 2008) how and why new technologies succeed. Hejazi served as president of Carestream Molecular Imaging (formerly Kodak Molecular Imaging Systems) until June when he stepped down and began a consulting firm. He described a promising market for optical molecular imaging--after describing a less promising scenario.
Key for about 90% of medical technologies are these four stages of commercialization, said Hejazi:
- Technology development
- FDA approval
- Market adoption
“The FDA,” he noted, “has two mandates: Expediting the transfer of new products into the marketplace, and keeping bad products off the market.” He described the complex, expensive, and lengthy multi-phase trials required for FDA approval of new therapeutics and devices--the most demanding of the agency’s three-tiered approval processes--and the similarly onerous process of securing approval for insurance reimbursements.
Then he said, “But the most difficult barrier is market adoption.” He noted that a new tool must be easy to operate, provide significant economic value, and must not alter workflow. “Is it possible to create another PET (positron emission tomography)?” he asked, referring to that technology’s widespread adoption. “Yes…but.” he said, and reiterated his warning that commercialization of new medical modalities are extremely expensive and time consuming.
A pharmaceutical tool
Hejazi painted a much brighter picture, though, when he turned his attention to the application of optical molecular imaging technology as a pharmaceutical tool. He said that the clinical trial market, which is expected to grow from about $25 billion in 2007 to well over $30 billion in 2009, includes a $2 billion market just for imaging tools. “The opportunity to expedite drug development is huge,” he said, explaining that by far the largest chunk of that $2 billion is in Phase II/III trials--more than Phase I and Phase III/IV combined.
Used as a drug development tool, market adoption barriers would not be as significant as they would be for patient care applications. “There is no reimbursement challenge, and the FDA requirements are relatively easy,” he said, explaining that the FDA’s less rigorous requirements apply for both devices and imaging agents.
He noted that molecular imaging is particularly useful and attractive in instances where the drug development cycle is very long. “Especially neurological diseases,” he said, “where change happens over years,” rather than fast-growing cancers, for instance, where tumor growth can easily be seen over days or weeks. He used Alzheimer’s disease as an example, saying that molecular imaging could help reduce observation time “from years to days.”
Seen through this lens, molecular imaging meets the criteria Hejazi introduced at the beginning of his talk for commercial success of new technologies. To be successful, he said, new technologies must add significant value, address a real need, and be priced for economical adoption by the market.