Unraveling the Mysteries of 505(b)(2) Applications – Identifying Ideal Products for Cost-Effective Development

06 May 2014
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After celebrating 10 years of being in the right place at the right time, Ken Phelps, President and CEO of Camargo Pharmaceutical Services, can now enjoy the fact that his gamble paid off when he created the company with Dr. Ruth Stevens in 2003.

Ken saw an opportunity that wasn’t being met in the industry, which is why he started Camargo. Camargo was one of the first companies to specialize in the 505(b)(2) pathway, which enables companies to get their drugs to market quickly.


Established in 1984, the 505(b)(2) application process provides a method to develop drugs, relying in part on publicly available information. The standard 505(b)(1) regulatory pathway for new drugs can take as many as 15 years to FDA approval, requiring a huge investment and stumbling points. The 505(b)(2) pathway enables new drugs to be approved based at least in part upon previously approved research and data. Because of this, the 505(b)(2) pathway significantly reduces this enormous development time, enabling a new drug approval within 36-54 months.

A need for more drug approvals
“The pharmaceutical marketplace needs more safe and effective drugs,” Ken told SelectScience. “There is so much potential; for example, the world chronically needs cancer drugs for approval.” Bio-molecules are the ‘hot’ product for the industry, especially in cancer research, but these products take so much time and investment. Companies, especially small CROs, are now looking at their drug pipelines and other areas they can impact to increase revenues.

We asked Ken the secret to getting these products through the approval process so rapidly and with such a success rate; they have been the driving force behind many of the 505(b)(2) approvals in the last year alone. He told SelectScience that the key to getting a drug approved is to review four main aspects by using his company’s ‘Ready 4 Action’ assessment:

Commercial: Which drugs are worth doing?
An understanding of the dynamics of a drug and its current therapeutic use is required. This can be achieved with quantitative and qualitative market research and direct consultation with expert physicians. Therapeutic areas that need more pharmaceutical products can also be analyzed to answer this question.

Regulatory: What changes can be made?
An essential part of ensuring a drug will be approved is direct and frequent interaction with the FDA. Multiple pre-IND FDA meetings are important for two reasons: to ensure an efficient and low risk development plan and to ensure the developer has the most up-to-date requirements for approval.

Scientific: Is it feasible to make the drug product?
By evaluating the chronically lacking therapeutic areas through market research, the correct language to use on a label and the expense required to make the changes to the drug, a sponsor can begin assessing the factors that contribute to the feasibility of the manufacture of a new drug.

Medical: Does the product have a clear niche in the medical specialty?
An ability to assess the safety, stability and efficacy of any drug changes and the ability to make these changes are paramount. Again direct consultation with healthcare professionals can provide important information such as dosage changes and suggested drug improvements.

In short, using publicly available information, such as safety data, sponsors can predict what changes to the product can alter the safety issues. Ken told SelectScience, “It is important to consult directly with physicians in order to understand the drug shortfall of the market as well as to see the impact of prescription rates and where they are associated.” Above all, according to Ken, the ability to react and an intense knowledge of what is required by the agencies involved are priceless attributes.

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Camargo Pharmaceutical Services
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Michelle Maxwell
Drug Discovery Editor