founder, CEO and managing director of vivoPharm
Q: How would you describe your company's work to a layman?
A: We are testing novel or potential novel therapeutics ... for their safety, toxicity and efficacy. Efficacy is the effectivity to treat a disease.
What is vivoPharm's overall role in cancer research?
We are supporting the pharmaceutical industry, biotech industry and universities in their drug development projects and also in early drug selection processes to let them know the performance and safety of the drugs, that they can make decisions for future development to go with their novelty for IND (investigational new drug) application with the FDA. (The application) must be applied for before you can do the first experiment. It has to be approved by the FDA or any other authority in the world (with) the same principle.
Tell us about your in vitro studies.
In vitro studies are also provided by vivoPharm, especially in Hershey. That's a very early step in a drug development phase. That is more about screening of targets, screening of suitable models to be used in a later stage of drug development to characterize the effects of the new drug. In our place here, it's feeding in approximately 20 to 25 percent of our revenues.
If you take the whole thing, we've named ourselves "integrated service." That means we start very early, which is the in vitro possibility of testing (and) biological activity in different areas. Then, we'd go into testing in vivo and then into safety, toxicology and pharmacokinetics to support the IND application with the FDA. (Editor's note: "In vitro" means in an artificial environment, or outside a living body; "in vivo" means inside a living body, according to Merriam Webster.)
What is also important is that we work to a worldwide-recognized standard, which is called GLP, and that stands for "good laboratory practice." Without that standard, you cannot support applications with the FDA for an IND.
How did vivoPharm come to be in the Hershey area?
That was arranged specially by HCAR, the Hershey Center for Applied Research, and by the commonwealth.
We had been contacted by their office in Sydney (Australia) four or five years ago. They gave a presentation and introduced the Pennsylvania area, especially here in Hershey, to the audience in Australia, which is where vivoPharm is from originally and still has its headquarters in Australia.
Constant talks over four years culminated three years ago in Washington, D.C., in a meeting we held and the agreement to come here. There was some financial support, of course. ... In principle, the logical place would have been California, because it's much easier to access. However, with the special situation here, the potential for business development and the excellent facilities, we just decided to fly five hours more from Sydney to Pennsylvania.
What changes do you anticipate for your field in the next five to 10 years?
We will have some changes definitely in our methodology, how we assess activity of compounds. We are planning at the moment to go much more into the imaging analytical concept, so at the moment we can detect tumors ... but only if they are attacked with light emissions. Other techniques which are used in clinics, like MRI, we outsource at the moment and plan to get some of that technology at vivoPharm.
The other direction we move further in is we believe with our good reputation with our customers and helping them from a very, very early stage in development (and then into research and development), ... the major part for us is to open for our clients the remaining part of the drug development as well. In Australia, we already do bioanalytical work for clinical studies.
Ralf Brandt is a specialist in oncology who obtained his Ph.D. in Germany in 1991. He worked at the National Institutes of Health in Bethesda, Md., and later entered the pharmaceutical industry in Germany and Switzerland.
Brandt spent time with MD Anderson Cancer Center in Houston and entered the biotechnology industry while in Texas. Today, he splits his time between vivoPharm in Hershey and Australia.
His hobbies include flying and building radio-controlled helicopters.