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In the fast paced R&D world, every biotech is looking for an edge to keep them ahead of their competitors and to help them achieve their goal of either getting a drug to human clinical trials or to a stage that attracts a big pharma partner. In my 10 years of experience working for small biotech companies in San Diego, I found that there are multiple strategic areas during R&D where a biotech company can benefit from outside help.
The biotech companies for which I worked were focused on research. We had great scientists who excelled at identifying unique chemical or biological entities that showed promise in the in vitro assays. The excitement continued as we switched to in vivo and animal studies to prove our hypothesis. Unfortunately, we didn’t have a dedicated group of experts that could help devise an appropriate regulatory strategy, and so we frequently conducted studies that were scientifically interesting but did not support future human trials. We didn’t understand that a long-range strategic plan for our nonclinical studies would have saved both time and money. We could have used a contract research organization (CRO) to identify the right vendors to run toxicology tests, to determine the type and number of animal studies required to support human trials, and to locate the most appropriate vendors to help in the scale up of our test compound. A great CRO would have advanced our development program while allowing our scientists to do what they did best – conduct the science.
Since I’ve been at Cato Research, I’ve come to understand the benefits and expertise that a CRO can bring to an early stage biotech. I’ve been on project teams that have successfully helped biotech companies devise their strategic plan and achieve their goals and even search for additional venture capital funding. If my previous employers had brought in a CRO to help in the R&D stage, they might still be around. Give your research scientists the edge they need to make the best choices and take advantage of the expertise that a CRO can provide.
This is a post by Kathy Grako, Ph.D. Kathy is a Clinical Scientist in Cato Research‘s San Diego, CA office.
Related articles:
- CRO industry poised for recovery–followed by a shakeout (fiercebiotech.com)
- Rising From the Ashes of Pfizer: The Michigan Contract Research Organization Cluster (fool.com)
