Project Archives

• Worked with the business development and external opportunity groups of a major animal health company to complete a comprehensive review of a therapeutic area, including the most recent human and animal research, a database of small and medium sized companies working in the area, and a listing of leading research laboratories.

• Reviewed key parts of a sponsor submission for a novel antibiotic for use in production animals, and worked with the client to improve the substance and detail of the submission to better meet the FDA Center for Veterinary Medicine expectations.

• Developed net-present-value and marketing models for a company considering a significant partnering opportunity

• Our regulatory and clinical development team worked with an ex-US company to develop a detailed estimate of the costs and timing to achieve FDA/CVM approval of a companion animal product. As part of this activity, we outlined the scope of the required safety and efficacy studies. Once the company decided to proceed, our regulatory team worked with the sponsor and company scientists to develop an extensive background package in support of a meeting with the CVM.

• A New Jersey company with cutting edge technology in human health contacted us regarding the potential for animal applications for other compounds in their series. We developed a comprehensive analysis of the technical issues related to proof of concept studies for companion and production animals, found potential academic scientists who might participate in such work, and performed an analysis of the technical and regulatory issues. We then completed a business analysis of the opportunity, including market potential, competition, cost to market and other parameters to help the company decide the best approach to getting additional value from veterinary applications of their compounds.

• A company interested in applying their novel technology to animal health hired us to complete a survey of all major drugs currently marketed in animal health, and develop parameters to help the company choose the most promising drug, species and indication for their technology. We continue to work with their business development group to plan strategy and assess business opportunities in animal health.

• Under a retainer agreement, we work with a mid-size biotechnology company developing a number of animal-health related products. Our work includes developing a variety of financial and market models, assessing potential partners, and evaluating costs and timing for projects in the pipeline. We work closely with the client’s in-house business development group, serving as a cost-effective way to extend the client’s capabilities on an as-needed basis.

• We developed cost and timing estimates for a technology transfer company with interesting technology related to production animal reproduction control. This analysis and our continued commitment to provide technical and regulatory support have helped attract an important partner that will finance the next steps in this product development, which will be overseen by AlcheraBio.

• Defined regulatory issues, wrote background material, and conducted successful initial meetings with FDA Center for Veterinary Medicine for three clients with innovative new products for animal health.

• Assessed competitive issues to help define strategic direction for an early stage company that focuses on animal health.

• Designed, wrote the protocol, and analyzed the results of a key proof of concept study for a fertility monitoring device under development by Pheromone Sciences, Toronto, Canada (www.pheromonesciences.com) To read an archived press release, click here.

• Worked with a major animal health company to assess the regulatory issues related to a novel drug delivery system

• Developed extensive technical marketing and training documents in support of the launch of a major new animal health product

• Conducted an analysis of the potential costs and regulatory issues related to establishing a GMP facility for manufacturing vaccines for a university technology transfer group

• Evaluated grant proposals in the area of veterinary medicine for a major nonprofit foundation

• Completed due diligence on behalf of a major venture capital group evaluating a potential investment in a biotechnology company developing animal based products.

• Evaluated a new product area for a major international animal health company, including regulatory issues, market, competitive overview, and comprehensive bibliography

• Reviewed licensing materials of a biotech company interested in partnering with a major animal health company

• Developed an agenda, reviewed background materials, and successfully conducted an initial meeting between an innovative international biotech company and the FDA Center for Veterinary Medicine

• Developed an overview and competitive, pricing, and key issues analysis for a human-health biotech company interested in exploring the possibility of extending its technology to animal health

• Served as a "virtual" licensing group on behalf of a major animal health company by attending a major biotechnology meeting, identifying participating companies with technologies relevant for animal health, and summarizing the company information in an extensive report that included pinpointing the most promising in terms of animal-health potential

• Provided detailed information on competition, regulatory and manufacturing issues, and market characteristics as part of the business plan of an international biotech company interested in attracting financing for animal-health product development

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