Faster, Higher, Stronger

What does drug discovery have in common with the Olympics? NGP asked Pharmatest’s Rami Käkönen about competitiveness and the preclinical games.

It will soon be the Olympic year, so the term Faster, Higher, Stronger will be seen on many occasions in the coming months. What does it have in common with drug discovery? When you look at such pharma business headlines as: “Impatient investors require faster results”, “The stakes are ever higher for pharma industry” and “Competition in the market getting stronger”, perhaps the allegory is not so far-fetched after all. Perhaps sports and science are more alike than you would first think.

Each new drug candidate’s path from bench to bedside is a long and grueling marathon. It takes dedication and hard work to finish the race, let alone to win the first prize. In drug discovery, the race can last anywhere from 10 to 15 years. The prize is waiting at the finishing line, but in order to get the first-mover advantage you’ll need to manage your resources, assess the competition and, if necessary, adjust your strategy in mid-race to keep your advantage. Above all, you will need to optimize your performance.

An athlete doesn’t carry all the supplies needed for the race on his back, and neither should a pharmaceutical or biotech company try to perform all the necessary work in-house. The demands to accelerate the pipeline while cutting costs at the same time has lead many companies into an impasse. How do you achieve more with less?

Running light – lose the extra pounds
Outsourcing has long been a standard option in such drug development stages as early discovery, manufacturing and clinical trials for small and big pharma alike. However, the recent years have seen rapid growth in preclinical contract research organizations (CROs) as more and more pharmaceutical companies are streamlining their operations in order to cut costs and improve efficiency. These new-generation CROs are highly scientific, flexible and often specialized in a specific field of research. This strategy allows them to make substantial R&D investments within a relatively narrow field of research, enabling them to create unique, innovative and cost-efficient services for drug discovery, and staying constantly at the forefront of the latest scientific achievements of their field.

Pharmatest Services is an example of such a CRO, focused completely on a narrow niche market of preclinical efficacy research in bone biology. We provide our customers with a quick access to drug candidate efficacy data with its tailor-made research services. These services are designed specifically for early stage lead-validation in therapeutic areas such as osteoporosis, cancer-induced bone disease and osteoarthritis. Pharmatest offers complete sets of services for these therapeutic areas, ranging from unique in vitro efficacy assays to highly predictive animal models such as rat ovariectomy/orchidectomy or systemic cancer bone metastasis models. The in vitro assays, for example, are developed and validated in-house, and are available exclusively from Pharmatest. These assays are designed with speed and efficiency in mind. Using our in vitro research solutions, customers can sift through large amounts of potential new drug compounds to find the most efficient candidates in a fraction of the time it takes with more conventional early lead validation methods.

Stay lean and flexible
Collaboration with a preclinical CRO gives the sponsor ‘on-demand’ access to highly specialized research resources, freeing their own resources for other use. The customer thereby has constant access to the latest research tools without any R&D, personnel or equipment investments. Along with savings, flexibility is undeniably another major advantage of collaboration between a preclinical CRO and its sponsor. A long-term agreement is often preferred by companies, whose pipeline focuses on musculoskeletal diseases or oncology, whereas a project-by-project approach is favored by others.

A long-term agreement integrates our expertise and facilities closely to the sponsor’s infrastructure, almost as if they were a part of it. This provides the customer with an instant access to the research resources at predestined terms immediately when they are needed. Sometimes, however, a project-to-project based collaboration, where study protocols can be modified to fit the customer’s project-specific needs, is more advantageous. The customer is free to choose from carefully selected and meticulously validated research models. In Pharmatest’s case this means that the service selection has been designed to provide its customers with everything from the entry-level in vitro efficacy assays to complex disease animal models including, for example, FDA and EMEA approved large regulatory osteoporosis studies or complex and innovative cancer bone metastasis models. This way the customer can perform all preclinical efficacy research with one partner, or simply choose to get some extra expertise with bone histomorphometry.

Regardless of the type of collaboration, the use of a specialized preclinical CRO will radically increase customers’ research output while helping them to keep their fixed costs low. Partnering with a specialized CRO also gives the customer a ‘toll-free’ hotline to an expert advisor. Whenever the customer needs help in designing a study, or interpreting study results, they have the CRO’s scientific expertise at their disposal. This is in the interest of both parties and one of the foundations of a successful collaboration.

Don’t hold back, but don’t give everything
Knowing how to pace yourself is without a doubt one of the keys to success in any long race. Like the saying goes: ‘In order to finish first, first you have to finish’. In other words, it’s never good to max out your resources long before you are even within the sight of the final stretch. An athlete can do this by balancing his own supplies and those provided by the service team, creating a perfect combination of performance and longevity. A pharmaceutical company can achieve the same by sharing a part of the research workload with a preclinical CRO.

If you give everything you have right from the starting line, it is very unlikely that you will ever even see the finish line. In the drug discovery race there’s also one more reason not to run until you drop. While an athlete can always take some time to recover before the next race, a pharmaceutical company may not have that luxury. In fact, it is probably running many races simultaneously. All the more reason to let someone else carry some of the water for you and keep you ahead of the competition.

More information about Pharmatest’s research solutions can be found at www.pharmatest.fi

Currently the Chief Marketing Officer of Pharmatest Services, Rami Käkönen has a background that mixes science with commerce. He started his career in pharmaceutical business as a CEO of a Finnish market research and marketing design company specializing in the biochemical industry. In 1999, Käkönen was introduced to bone biology when he moved to San Antonio, where he worked for three years in small animal imaging and bone biology research at the University of Texas Health Science Center at San Antonio and Institute for Drug Development.