> Return to Models

Introduction
Cancer is a serious public health concern and results in over 500,000 deaths annually in the US alone. Cancer kills one in four Americans, and is second only to cardiovascular disease as the most common cause of death. Treatment for most cancers is insufficient even when detected early. As a result, pharmaceutical and biotechnology companies are rushing to develop the cancer drugs of tomorrow contributing to an estimated $45 billion (and growing) worldwide market for cancer therapeutics.

Biomodels contributes to the drug development process by providing a cost-effective outsourcing opportunity enabling companies to rapidly identify lead compounds for testing in humans. Our holistic approach recognizes that the needs and pressures facing companies of various sizes and in different stages are not the same. We use standardized tools and platforms that are refined in-house in combination with our x years of industry expertise to design customized client solutions. As for all clinical indications, Biomodels strives to maintain a collaborative client relationship in which the flow of information and ideas goes in both directions, with both short and long-term goals in mind.

Integrated Pipeline
Oncology client engagements typically begin with an informational session to identify client-specific needs and issues and to map out a forward-looking strategy designed to meet client expectations. At Biomodels, we do not simply “perform experiments”; studies are conducted as part of an integrated pipeline founded on testable hypotheses in which results are continually assessed with the final goal in mind. Frequently this is the filing of an IND.

Platform and Models
Biomodels’ has developed a comprehensive platform supporting preclinical oncology studies. At the base of the platform is our experience with established models; these include multiple cell lines (for each of the most commonly studied neoplasms) with well-characterized in vitro cytotoxicity profiles to standard of care agents. The tumor forming capability and drug responsiveness of each cell line has also been assessed in vivo and is linked to matched tissue samples (tumors with associated protein, RNA, DNA, and serum) to facilitate baseline comparisons to client compounds in efficacy and mechanism of action studies. This effort allows us to rapidly evaluate the efficacy agents against relevant models while also developing a parallel clinical marker strategy.

We can customize animal models to client needs/timelines and offer feedback on model selection to support a robust decision making path. In addition to standard xenograft studies, we have experience with syngeneic models, combination studies (e.g., chemotherapy and radiation), and pharmacokinetics/pharmacodynamics modeling. The effort can be customized to provide the project a rational preclinical package with clear relevance to the IND submission and Phase I implementation. Available mechanism of action data provided by the client can be used to guide the development of a pharmacodynamic model for the agent being studied. At Biomodels, we pay close attention to such valuable mechanistic information as it can be used further enhance the value of the molecule under development by adding to both the preclinical and clinical understanding of the molecule.

Value Added Services
Biomodels routinely provides individually tailored value added services at all stages of the engagement including special reports and presentations in support of corporate relations and external fundraising as well as assistance with the preparation of abstracts, posters, manuscripts, and press releases.

Experience
Client engagements are actively managed by Enrique Alvarez, the Oncology Group Leader. Dr. Alvarez oversees two PhD scientists and a team of technicians, all of whom play an active role in the assessing of data quality and providing feedback on client studies. Dr. Alvarez has over 10 years experience in the biotechnology/pharmaceutical industry with particular expertise in general pharmacology, oncology/inflammation in vivo modeling, molecular and cell biology, and small molecule and protein therapeutics. He is an experienced leader who excels at strategic development of therapeutic agent and in the preparation of preclinical packages for regulatory submissions.

> Return to Models