Kent Grindstaff, Senior Director, Business Development & Operations, North America: An introduction

June 20, 2012

In the following, Kent Grindstaff, the head of SOLVO's subsidiary in Boston, talks about his career and his vision of SOLVO. "I did my graduate work at Washington University in San Louis, MO. For my thesis, I worked on the translational regulation and trafficking of Na, K-ATPase in immortalized epithelial models. Then I completed a senior post-doctoral fellowship in the Department of Molecular and Cellular Physiology at Stanford University, Palo Alto, CA. It was a fairly long post-doctoral training: I was there for about 5.5 years. During that time, I learned a lot about protein trafficking and how models of barriers, such as the intestine or blood-brain barrier, are established. At that point, in 2000, I made the decision whether to go to the industry or stay in the academia. In industry, I found a very interesting company, XenoPort, that had just been established. It was focused on using transporters to improve bioavailability, in the very early days, before transporters had become really popular. They were looking at creating prodrugs (i.e. compounds adding new properties to the principal drug) that would be substrates for transporters. The idea was to improve absorption and distribution of compounds with established clinical benefit through normal nutrient pathways. Today, we know a large array of transporters. There are more than four hundred known transporters in the human genome, even if for many, there is still relatively little if any practical knowledge. Their role in absorption, distribution and excretion, along with their interplay with metabolizing enzymes is appreciated as being a potential determinate of drug safety and toxicity. When I joined XenoPort, however, the transporter field was still relatively new. The company was developing transporter assays. They wanted to know the specific chemical structures that transporters recognized (SAR; structure Activity Relationship) in order to move nutrients into and across cells. XenoPort’s goal was to use this SAR information to rationally design drugs to improve issues of absorption, distribution, excretion for compounds with known clinical efficacy. I worked ten years there. The company was relatively successful, especially in the first 6-7 years. They were kind of a darling in the investment market. But then they had difficulty getting their first new drug application (NDA) approved, and had to reduce costs that were related to earlier development and focus on late-stage clinical programs. They cut all their basic research programs, and halved their workforce. I ended up working for Optivia, a transporter focused CRO (Contract Research Organization) and biotechnology company in Menlo Park, CA. I basically took scientific responsibility for all their research programs, internal discovery and contract services alike, increasing their research arm by nearly fourfold in the first 6 months. I also initiated programs to build long-term relationships with customers. As soon as a customer got a quote, I contacted them to ensure that the program we offered was really appropriate for them from a scientific perspective, and also to ensure they received the consultation services they needed. In other words, I assumed a business development and operations management role – something that I enjoyed and continue now with SOLV O. My job at Optivia got me involved in the field that SOLVO is in, i.e. transporter assays as service for the biotech and pharmaceuticals industry, and, consequently, I became very familiar with SOLVO’s market in the U.S. I had known Ernő Duda, SOLVO’s CEO, by name only at that point. We never met before. When he contacted me, it was clear to me that they needed direct representation in the U.S. in order to bring over their expertise to the North American market. While SOLVO dominated the European market where they had a well-developed sales, business development and marketing team, they were using third-party representatives or relying on strategic partnerships in the U.S. When I accepted to help set up and lead SOLVO’s subsidiary in Boston, my real interest was not in sales per se, but rather building long-term relationships; helping customers with their transporter related scientific needs in discovery programs or later stage clinical drug development and with addressing questions raised by regulatory agencies. In the past few years, regulatory agencies have taken a very keen interest in the potential role of transporters – not just in the absorption, distribution and excretion or metabolism of drugs, but also in the safety and toxicity issues arising from drug-drug interactions. At the same time, the number of people taking multiple drugs is increasing rapidly, especially in older patients, so the potential for drug-drug interactions is alarming. This has become a very hot regulatory topic both for the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and not only for new drugs, but also for compounds that are already in the market. I have always been impressed by the fact that SOLVO got into the transporter market at such an early point, back in 1999. To a great extent, this field has developed around them. Over the years, with the number of companies trying to establish services to help drug developers, the market has become very competitive. In my view, companies should be dedicated to provide not just the best assays in the market, but the most appropriate assays for their customers to address their specific needs and questions surrounding their compounds. It is one thing to offer an assay that is better than your competitor’s, but it is another thing to be focused on the best approaches to answering these quite complicated questions. I think SOLVO is working along those lines. It is a relatively large company, especially by Hungarian standards. Even by U.S. standards, SOLVO is bigger than any other transporter focused service provider. In fact, with nearly a hundred people, SOLVO is 2-3 times bigger than its nearest, strictly transporter focused competitor in the U.S. This underscores the resources and effort SOLVO can invest in bringing new products and services to the market, and the level of expertise the company can provide based on its amazing amount of in-house talent. I also have to mention SOLVO’s Chief Scientific Officer (CSO), Péter Krajcsi. He is an outstanding scientist whose approach, from my perspective, is very academic. Though he has a very good business acumen, he is driven by purely scientific questions. His objective is more than merely providing what the FDA or the EMA are asking for. He is looking for the best approaches to the relatively complicated issues raised by transporters. When planning his team’s research, he assesses what the next big requirement could be in the field. All this makes SOLVO a fairly unique company in the market. Its resources and focus on transporters sets it apart from the competition. Whether SOLVO was in Hungary or in the U.S., never really concerned me. What I was looking at was their commitment to their field, the quality of their science and the experience and expertise of their management. What mattered to me was that they provide assays that are not just good or better than their competitors’, but that they were committed to providing their customers with quality services that allow them to effectively address questions in vitro, i.e. in a laboratory environment, outside the body. In fact, the real purpose of these studies is to provide customers with understanding of transporter interactions in an in vitro setting. From the regulatory perspective, this is to help the customer decide whether or not they will have to conduct much more costly in vivo investigations (i.e. human trials) of drug-drug interactions. Spending a few thousands of dollars on in vitro studies can save a drug company millions of dollars it would need for an in vivo analysis. In vitro assays are also much more efficient from a time scale perspective. Companies using in vitro transporter assays in their clinical development programs to address possible drug-drug interactions can potentially save not only money but also time. Our goal with SOLVO’s recently opened U.S. office is to achieve the same level of respect and dominance in the North American market that the company already enjoys in Europe. For our business development in the U.S., we are going to rely heavily on the SOLVO teams in Hungary. We want to establish the SOLVO name as the leader in intellectual and technical capabilities in North America. We want to make potential customers aware that SOLVO provides the best services and products in the field of transporter assays. Customers will realize that we are here to help them. As such, we also provide consultation and education on transporters. The transporter field is rapidly developing, and appreciation of its importance is growing among drug developers and the scientific community, as well regulatory agencies, such as the FDA and the EMA. Besides their role in the pharmacokinetics (PK) of a particular drug, their significance in drug-drug interactions, drug metabolism, and safety and toxicity is becoming widely recognized. Consequently, the guidelines for what can be considered a meaningful in vitro analysis is going to develop as well. I believe that, in the next 3 to 5 years, regulatory agencies will impose increasingly rigorous criteria on these types of in vitro assays, in order to ensure that they are an accurate representation of what happens in vivo, i.e. in the human body. This means that companies in the field will need to make a joint effort to standardize these assays, and demonstrate their value in predicting what occurs in the in vivo situation. SOLVO is uniquely positioned to lead this effort. It brings a remarkable level of expertise, scientific quality and focus on transporters that is very difficult for any U.S. company to compete against. You just couldn’t establish a similar company in the U.S., since the cost would be too great. SOLVO has unparalleled resources and incredibly well established academic interactions. In many cases, the early stage research they do (that ultimately leads to their product offerings) is not based on where the market is today, but on where they think the field will be tomorrow. You can see this approach in the models SOLVO has been developing for the intestine or the blood-brain barrier, or in their hepatic models. They are working on a number of models that will be of great benefit not just for drug developers, but for anyone asking transporter related questions."

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