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The Camargo Way Case Studies FDA Regulatory and Strategic Development Case Study

Combination Product Expertise and Target Market Knowledge Create Commercial Success

Challenge: An international company needed a partner with regulatory and strategic development expertise to realize the full potential of their product: a catheter tailored to meet the specific needs of a drug designed to cure an organ cancer.


Background

The client’s catheter device worked by mixing an off-the-shelf drug powder with a combination of polymers, to yield a solution that gelled at body temperature.

With FDA approval, this potentially curative treatment could substantially increase quality of life for patients and reduce overall treatment costs compared to the current standard of care, which involved surgery and subsequent maintenance therapies.

When the company initially met with the Camargo team, they outlined their current strategy: focus on device approval for the catheter, targeting surgeons who treat patients with this type of organ cancer.

The company had not considered two key factors:

  • If a device and drug are needed together under a specific set of instructions, they can be packaged and labeled together as a combination product. Until recently, rules surrounding combination products were at odds in the US and EU, resulting in confusion and misinformation on the topic.
  • Given the potentially curative power of the company’s therapy, the treatment decision was much more likely to be made by the patient’s specialist, not their surgeon.

   

Solution

With considerable combination product and commercial market identification experience, the Camargo team worked with the client to:

  • Correctly recognize the product category and convince the FDA to agree to a combination product. Furthermore, given the drastic improvement in efficacy, Camargo made the case to the FDA for Orphan Drug status, with fast-track review.
  • Clearly identify the specialty medical market: specialists, not surgeons.

   

Outcome

The FDA granted Orphan Drug status with fast-track review. Moreover, the new strategy changed the way the client approached their product development and marketing efforts. With better supported ROI, the client went public, raising money to accelerate the product development of this and other related products. They also rebranded with a new product name to reflect their focus on therapeutic impact, not technology.

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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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