Development and economic pressures continue to reign over pharma and biopharma firms, and as such, compels them to outsource some of their R&D activities, including discovery research — an area that previously was often kept in-house. The preclinical market has seen a relatively steady stream of work in expanded service areas, which offers the potential for further growth as specialized services and technologies continue to improve the compound selection process and outcomes.
 
Jean Pierre Wery, president of Crown Bioscience, a drug discovery and development service provider specializing in translational platforms dedicated to the therapeutic areas of oncology and metabolic disease, provides his perspective on the preclinical market, and discusses the growth of translational technologies, stability of drug discovery activities, as well as near term-expectations. －KB
 
Contract Pharma: Are there any notable trends in the preclinical space?
 
Jean Pierre Wery: It used to be that only specific preclinical activities, such as chemical synthesis of intermediates, reagent production, etc., were considered for outsourcing. Nowadays however, literally every preclinical research activity, from target discovery to the generation of a clinical candidate — including activities intimately linked to IP generation — is being considered for outsourcing. In most companies, every preclinical research program has a defined outsourcing strategy associated with it.
 
CP: Are you seeing an increase in IND-enabling study activity?
 
JPW: We see a steady state in IND-enabling activities from Western companies. However we see a sharp increase in activities from Asian companies, which represent a much heightened interest and investment from these companies in bringing innovative medicines to the Asian markets.
 
CP: Are you seeing growth in specific services areas?
 
JPW: Since our company specializes in oncology and metabolic diseases, we have seen a sharp increase in in vivo pharmacology work. In oncology, there apparently is a significant increase in outsourcing traditional Xenograft work. Although this technology is available inside many pharmaceutical and biotech companies, there seems to be a much greater interest in outsourcing these activities to CROs. We also have seen a much higher demand for the use of Patient Derived Xenograft (PDX) models. These models have turned out to be very predictive of the way a given molecule will behave in human patients, and therefore offer a unique translational opportunity for promising clinical candidates.
 
Of particular interest is the use of these PDX models in “mouse clinical trials,” where you test your compounds in many such models (in 100 PDX lung cancer models for instance). Such a study can give you critical insights on which patient might benefit from your drug and how these patients could be selected in a clinical trial. This in turn can significantly increase the probability of success of a compound’s clinical development.
 
Crown has been active in the development of these PDX technologies and has a large collection of characterized PDX models (both Caucasian and Asian) and most of these models are kept “live,” which means that they can be deployed almost immediately in a “mouse clinical trial”. In metabolic diseases, Crown has a large collection of naturally diabetic monkeys. Since rodent models in diabetes are not always very predictive of future clinical outcome, many companies have been using our monkey models prior to committing to a clinical trial to learn more about their compounds and to decrease the risk of failure after an expensive clinical development program.
 
CP: Do you see increased outsourcing from certain sectors? (small, mid-size, big pharma/biopharma, start ups, etc.)
 
JPW: We continue to see significant growth in outsourcing from Western pharmaceutical companies, which represents the expanded role that outsourcing is playing in the execution of preclinical research programs. We also notice, probably because a more favorable funding environment in the U.S., an increase in the number of start-up companies, many of those operating very much as “virtual” companies, and therefore very interested in strategic outsourcing relationships. And as I mentioned, we have seen a very strong growth in the demand from Asian companies for outsourcing of preclinical research activities, which represents an increased focus in bringing innovative medicine to the Asian markets.
 
CP: What do you anticipate with capacity and pricing in the next quarter?
 
JPW: We expect to operate at full capacity in the future and we expect pricing to be steady or increasing slightly.
 
CP: Are there any specific service areas your company is looking to add or expand?  
 
JPW: Crown will continue to provide support for all preclinical research activities, from target identification to the generation of a clinical candidate. However, we certainly have a particular interest in the development and deployment of unique translational technologies. One of the biggest challenges for our customers is the rate of failure in Phase II clinical trials. We believe that innovative translational approaches (such as the PDX platform) have the potential to change that situation and to significantly improve the efficiency of bringing important novel medicines to the market. So, we will continue to develop and acquire interesting translational technologies. We’ll also be looking for ways to better use these technologies and will be working closely with clinical organizations.