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Case Studies

Case Study 1 – A newly formed venture capital-funded company with intellectual property rights to a novel technology conceived >20-years ago was now working expeditiously toward treatment of a new disease indication and sought Walker Downey & Associates, Inc. guidance in the completion of IND-enabling studies. The company had strong research and development skills, but lacked the internal experience to complete the pivotal studies of their product, which was regulated as a biologic/device combination product. More specifically, the company required preclinical expertise in a porcine animal model in addition to a facility capable of conducting polymerase chain reaction (PCR) biodistribution studies. Walker Downey & Associates, Inc. first designed the needed studies (two separate studies were run concurrently) by “concept protocol” for discussion at the client’s Type-B pre-IND meeting with the FDA. After receiving FDA concurrence (no changes were required in the concept protocols by FDA) the team from Walker Downey & Associates, Inc. recommended several qualified CROs with comparators for client decision-making. Once the facility was selected by the client, Walker Downey & Associates, Inc. was asked to oversee the studies. Walker Downey & Associates, Inc. in conjunction with the selected CRO was able to complete the required studies on time and on budget. The client’s IND was subsequently approved and they were able to proceed to Phase I clinical testing. They are currently designing Phase II and III clinical trials with their product.

Case Study 2 – Dr. McLain conducted preclinical due-diligence for a client interested in partnering with a smaller company with patent rights to a novel and proprietary hormone dependent prostate cancer vaccine. His due diligence report expressed “in favor” of the collaboration after minor selected issues were addressed. The client moved forward with the partnership based on this due diligence report and provided first-round financing. Unfortunately, the client was acquired by a larger company the following year and this particular partnership opportunity was dissolved. Subsequently, the smaller company established a partnership with an even larger international pharmaceutical company and expects to obtain clinical proof of principle for this product in the first half of 2007. Notably, prostate cancer is a serious condition that affects increasing numbers of men worldwide and is the most frequently diagnosed cancer in males. About one-third of all men have at least some cancerous prostatic cells at the age of 50, with the incidence increasing to as many as 90 percent at the age of 90. In the United States and Europe alone, about 80,000 men die each year from prostate cancer. The commercial opportunity for therapeutics targeting this market is predicted to reach $3.5 billion by 2007.

Case Study 3 Walker Downey & Associates, Inc. helped to facilitate an ~ $1 million dollar testing exemption for a client by helping to design and coordinate a series of pivotal nonclinical studies for a biologic/device combination product that FDA/CBER/CDRH accepted for application to the sponsors proposed future modifications to the product line. The strategic proposal for systemic toxicity, genotoxicity, and reproductive toxicity was well received by the FDA “as prepared” without modification. Two similar products described in the strategy documents were immediately exempted from similar testing based on the rationale provided. Preclinical cost savings to the sponsor for the two exempted products amounted to in excess of one million dollars.

Case Study 4 – Walker Downey & Associates, Inc. facilitated a client's critical IDE submission which included a late-stage change in product sterilization method. Our strategy was to employ the ISO 10993-18:2005 standard (chemical characterization) to demonstrate equivalency of the two sterilization methods, thus supporting the relevance of the original biocompatibility safety data in the overall assessment of newly sterilized product. Walker Downey & Associates, Inc. formulated the strategy, helped to place the studies and then wrote the Expert Opinion to justify the position.

Case Study 5 – The breadth of experience at Walker Downey & Associates, Inc. has prompted a Florida-based medical device company to retain these services through clinical testing. Walker Downey & Associates, Inc. initially provided a due-diligence review of the company’s preclinical documentation for their respective device classification, and recommended additional tests to strengthen the 510(k) submission. Walker Downey & Associates, Inc. contributed to the 510(k) submission by writing a biocompatibility testing summary, a risk assessment of active ingredients, and several Expert Opinions on related matters.

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