Online Extra: Preclinical Perspectives

A turbulent preclinical past is giving way to a more optimistic future. Earlier in the drug development process, providers are finally seeing an uptick in sponsor demand for specialized services, after paring away at excess capacity and trying to right-size preclinical operations. Chris Chengelis, Ph.D., chief scientific officer at WIL Research, commented, “We are seeing an increased demand for specialty services because fewer CROs offer them. Specialized services require more highly trained technicians in the area, and some services have high barriers of entry. Particularly, we are seeing opportunities in developmental and reproductive toxicology (DART). The demand for DART services has gone up, which is reflective of the fact that more companies are moving their compounds into higher phases of development, while concurrently decreasing their internal DART capacity. Other opportunity areas include infusion capabilities, inhalation capabilities and metabolite identification.”

Some providers are looking to expand certain service areas. Steve Barkyoumb, senior vice president of Global Operations and Safety Assessment at WIL Research, added, “We are focusing our immediate attention on discovery services and lead optimization. This is to support the growing trend by pharma companies to outsource earlier and earlier in the drug development continuum.”

Nancy Gillett, corporate executive vice president and chief scientific officer at Charles River Laboratories, remarked, “There are a couple of areas in which we’d like to expand. We are moving earlier into the drug discovery and development process and will be focusing more on in vitro and in vivo pharmacology research models. The demand for biologics and biosimilars has increased and we happen to have a great deal of experience and resident expertise in these areas. We have scientists with hands-on experience through the entire drug development process, as well as experts from regulatory agencies.”

Providers are seeing increased sponsor demand for services such as biomarkers, biosimilars, orphan drugs, as well as certain therapeutic areas. “For a client and CRO to have a successful relationship, the CRO must provide all of the necessary activities and expertise in all of the areas in which the client operates,” remarked Ms. Gillett. “The most appealing therapeutic areas are those with the greatest unmet medical needs and typically reside in three areas: oncology, neurodegenerative diseases and metabolic diseases. Specifically though, we have seen an increased demand for biosimilars. This is true for biomarkers as well. A program has a distinct advantage if there is a biomarker indicative of either efficacy or an adverse event that is discovered in a preclinical environment and can be utilized in a clinical environment.”

So, where is pharma/biopharma drug development heading? According to Jamie Macdonald, chief operating officer at INC Research, “The cost-cutting trend of recent years will be replaced by more innovative and out-of-the box approaches to bring new drugs to market, while still growing shareholder value. Biopharma companies are looking for new methodologies that improve the quality of perspectives and information available to enable rapid and informed decision making across the drug development process.”

“INC Research is developing sophisticated tools that maximize value in accelerated proof of concept (APoC) approaches in early drug development. The new tools will combine commercial data with scientific data early in the drug development process to help predict the chances of a commercially successful outcome, thus facilitating the ability to make sound go/no-go decisions earlier in the process,” added Mr. Macdonald.