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Case Studies

Camargo Pharmaceutical Services collaborates with pharmaceutical and biotechnology firms worldwide to address their research and development, clinical manufacturing, clinical trial and regulatory challenges. Whatever the client needs—from strategic counsel on the market viability of a new drug compound to a jumpstart for stalled clinical trials—Camargo consistently responds with the efficiency and performance excellence that sets our strategic drug development services apart.

Reformulating Drugs for Pediatric Application

Clinical Program Development
Drug Product Feasibility Assessment

FDA Insight: Camargo petitions the FDA to gain determination in client's favor

IND Preparation and Submission
NDA Fast-Track Application
Pharmacokinetics

Reformulating Drugs for Pediatric Application

Expertise to develop one of the first liquid statins for children

Challenge	Assist in reformulating drugs currently approved for adult consumption into appropriately dosed pediatric applications.
Details	Madeira Therapeutics, a privately held, specialty pharmaceutical company focused on providing safe and effective medicine to pediatric patients, utilizes the FDA’s 505(b)(2) approval method to expedite the drug development process. Madeira is in the process of developing a cholesterol-lowering statin in a stable liquid dosage form as well as an effective and well tolerated oral analgesic. Currently, more than 70% of drugs prescribed for children lack FDA approval. The growing need in the pediatric pharmaceutical market to reduce off-label prescribing can be addressed by determining pediatric applicability of preexisting drugs and including proper labeling instructions for children.
Value	Camargo’s expertise in the 505(b)(2) process and thorough understanding of the unique regulatory guidelines involved with pediatric drug development has provided Madeira with vital insight to accelerate new drugs through the approval process. Camargo has helped Madeira in obtaining an FDA agreement to conduct a single study in children for approval, planning regulatory and drug development strategies for the European market and designing a water-free formulation to overcome the instability of statins in water-based formulations. As a result of this partnership, Madeira is developing one of the first ever liquid statin drugs for children.

Clinical Program Development

Camargo's strategic outsourcing yields client benefits

Challenge	Manage ambitious study plan within a tight budget
Details	A small pharmaceutical company was unable to implement their ambitious study plan within budget, and they had exhausted all their site and vendor contacts. Camargo's drug development knowledge and network, as well as our volume of business, enabled us to bring multiple projects into proven, qualified sites and negotiate for the best prices and preferential timing of study start-ups. This client's projects were placed with several of Camargo's preferred service providers, known for their quality and reliability.
Value	The client company's studies were completed on time and on budget. Total savings across the entire drug development program implemented by Camargo: more than $350,000.

Drug Product Feasibility Assessment

European firm seeks U.S. market entry via 505(b)(2) filing

Challenge	Determine optimal strategy for entry into U.S. market
Details	A European pharmaceutical company sought Camargo's assistance with entering the U.S. market via a 505(b)(2) NDA filing for their drug candidates, developed with proprietary drug delivery technology. Their plan included transfer of both manufacturing and clinical studies to U.S. service providers. Prior to further client decisions about manufacture or clinical development, Camargo conducted a comprehensive feasibility assessment. Our goal: to achieve in-depth understanding of critical factors affecting the U.S. market potential, including need in the therapeutic area, the competitive environment, payer acceptance in the drug treatment category, and regulatory considerations.
Value	Armed with the assessment, the Camargo client was able to plan its market-entry strategy and prioritize the products with the highest potential market value. Camargo's detailed timeline and cost analyses, both of which were key elements of the assessment, educated the client about drug development timeframes and costs before embarking on the projects.

FDA Insight

Camargo petitions the FDA to gain determination in client's favor

Challenge	Assert to the FDA that a drug was not withdrawn from sale for reasons of safety or effectiveness.
Details	In 2007, Camargo was retained by a client to determine the regulatory status of ORUDIS tablets. Camargo presented the FDA with a citizen petition with relevant arguments for assertion that the product was not withdrawn for safety or efficacy reasons. The FDA reviewed the information as well as its independent investigation and made the determination in the client's favor.
Value	The FDA determined that ORUDIS KT (ketoprofen) tablets, 12.5 milligrams (mg), were not withdrawn from sales for reasons of safety or effectiveness. This determination will allow the FDA to approve abbreviated new drug applications (ANDAs) for ketoprofen tablets, 12.5 mg. Food and Drug Administration. (2007, August 14).

IND Preparation and Submission

Fast-Track Re-Submittal of pre-IND

Challenge	Prepare and submit an FDA guidance-compliant pre-IND package
Details	When our client's pre-IND submission was refused by the FDA, Camargo was engaged to quickly prepare and submit an FDA guidance-compliant pre-IND package. Camargo's team of regulatory experts tackled the task and completed it within three weeks. In addition to bringing top-notch medical writing, data analysis and research skills to the project, we understand FDA reviewers' requirements and the appropriate methodologies for each type of application.
Value	Thanks to FDA acceptance of the pre-IND package prepared by Camargo, our client was able to proceed expeditiously with drug development. Meanwhile, in the course of reviewing the documents, Camargo had discovered that several clinical studies included in the proposed IND budget were redundant and unnecessary. Elimination of these studies resulted in savings for our client of approximately $200,000.

NDA Fast-Track Application

Camargo expedites approval of NDA application

Challenge	Disarm skepticism among sponsor's senior management that any faster regulatory path than a traditional NDA submission would be accepted by the FDA
Details	When the FDA rejected a sponsor's application for orphan drug status for a key drug in its pipeline, the sponsor approached Camargo for alternate strategies to expedite approval. Camargo's team of regulatory experts recommended the FDA fast track application approach. The team educated the sponsor about the FDA fast track drug development program, and advised the sponsor of the appropriate data to include in the application. The sponsor promptly provided the data to Team Camargo. Within four weeks, Camargo's regulatory, research and medical writing team had submitted an application to the FDA. It included the data necessary to make the case for fast track review of the sponsored drug. Within six weeks of submission to the FDA, the agency approved the fast track application.
Value	Thanks to the efforts of Team Camargo, the sponsor's drug achieved high priority within the FDA, thus accelerating review and time to approval.

Pharmacokinetics

Client wins with unique Camargo methodology

Challenge	Demonstrate equivalency of clinical and commercial batches of the same drug
Details	The FDA challenged a client company's drug equivalency claims, so the firm turned to Camargo for expert assistance. Camargo's team of experts in CMC, pharmacokinetics and toxicology addressed this problem with a unique solution: the drug equivalence was demonstrated using interspecies scaling. The team used the available primate data to create accurate projections about the drug equivalency, rather than taking traditional approaches which would have required further studies. The result: positive equivalency results and a compelling presentation to the FDA.
Value	In addition to the FDA presentation, Camargo helped the client develop much greater insight into the overall drug development strategy. The interspecies scaling data was exhibited in a poster presentation at a major medical meeting, and investor confidence in the sponsor company soared. In addition, Camargo's work represented a cost savings of approximately $350,000, as some of the client's planned drug equivalence studies were no longer required.