Jon Rojas, President & CEO
As the President and CEO of WCCT Global, a full-service CRO located in Southern CA, Jon Rojas observes the unique challenges faced by both large pharma companies and small and virtual biotechs. While large pharma often requires that their partners possess the expertise to carry out specialized testing on various compounds, smaller biotech companies typically require more guidance on improving their chances at regulatory approval and securing additional funding for their programs. Jon is proud that WCCT is able to serve both.
Jon also comments on the unique needs of pharmaceutical companies which intend on taking their products to the global market. In this scenario, companies need to perform an ethnic sensitivity or “ethnobridging” study, which will include volunteers of various ethnic backgrounds (most commonly first generation Japanese). Ethnobridging studies can help to eliminate the need to duplicate early phase studies in regions outside of the US, which can be costly and time-consuming.
When it comes to their smaller clients, WCCT provides support by helping them identify the development pathway and funding strategy which is most likely to produce favorable results, thus positioning them for success both with regulatory bodies and their potential investors. “To my understanding, there aren’t many other CROs who provide these services to small development firms. Most CROs are only concerned with managing the studies, and don’t involve themselves this early on in the process. In this way, I feel that WCCT is a true partner to these small and virtual biotech firms: we understand their unique needs well before they have reached the clinical development stage of their projects.”
With a focus on early clinical development, WCCT operates at two physical locations to carry out research.
WCCT is regularly participating in pivotal studies that will ultimately help determine the success of potential new drugs…we have been an excellent development partner and have helped pharma to achieve their goals
The unit in Cypress hosts typical Phase-I studies in normal healthy volunteers such as single ascending dose, multiple ascending doses, drug-drug interaction and bioequivalency, as well as more complex studies designs. The Costa Mesa facility is geared towards early phase studies incorporating special patient populations as well as Influenza Challenge studies. “The traditional way of performing flu studies was to wait until the flu is in season and enroll patients then, which presents a number of challenges,” says Rojas. “Using the Flu Challenge Model, WCCT is able to perform flu studies by enrolling healthy volunteers and inoculating them with the flu. Furthermore, this model, and our upgraded facility can be used to test treatments for other viral diseases.”
WCCT is all set to expand around therapeutic areas that are in need of more expert-level development partners during the early phases such as ophthalmology, gastroenterology, and in patients with renal or hepatic impairment. Adjacently, the company is also continuing to focus on developing partnerships with companies from Asia that are planning to license their compounds in the U.S.
When asked why he thinks WCCT made PharmaTech’s “Top 10 CROs” list, Rojas muses on the number of times WCCT has been approached by the FDA in the past few years, “There’s a misconception out there that being approached for an audit by the FDA is automatically something to be feared—the way I see it, if the FDA is taking a consistent interest in our organization, it’s not because WCCT is making mistakes or failing to be compliant, it’s because WCCT is regularly participating in pivotal studies that will ultimately help determine the success of potential new drugs. I think our recent regulatory history will demonstrate that we have been an excellent development partner and have helped pharma to achieve their goals.”