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505(b)(2) Success Requires More Than Just Science

At the JP Morgan Conference/Biotech Showcase this year, we encountered a record number of companies engaged in 505(b)(2) development. We also had meetings with investors and buyers with their checkbooks open to finance or acquire the more than 80 products we have in development. Unfortunately, many of our clients are not ready for this money. Peter Meath, who heads the Life Science Group at J.P. Morgan’s Commercial Banking business, commented why clients may have difficulty obtaining financing: “at the earliest stages, companies tend to be extremely science-based. It is their bread and butter. They live and breathe it every day, so their communication tends to be heavily weighted toward the scientific aspect of what they’re doing, whether it is the drug type, formulation, platform, and so on. Those companies often overlook the need to pay similar attention to the economic and market aspects of the products they are developing.”

More Than Science

505(b)(2) development more than science

At Camargo, we focus on commercial success for our clients’ products, not just regulatory approval. We provide early assessments of the potential market – including interviewing healthcare providers, looking at payor and potential competitor products. Such insight informs the development requirements to obtain, for example, the labeling language that will be required to promote the advantages of the product.

This early market assessment, coupled with Camargo’s track record of obtaining the most efficient development program, best positions our clients’ product to attract investors and buyers in today’s marketplace.

We look forward to learning more about your program and ways we can help. Contact us.

Author: Ken Phelps, President and CEO, Camargo Pharmaceutical Services