Addressing the challenge in translational medicine
Truly Labs is a contract research organisation based at Medicon Village with a focus on in vitro and in vivo preclinical research services, from strategic plans through study design to evaluation and analysis of the data.
The step from preclinical trials to clinical trials can be a challenging one, and a lot of otherwise promising drugs fall by the wayside.
“The challenge in translational medicine is when companies start to look at drug efficacy at phase II and find that their drug isn't working as they expected. This is very disappointing, and failure at this stage is costly”, says Karin von Wachenfeldt, CEO Truly Labs.
To deal with this challenge, the Lund-based research organisation Truly Translational set up Truly Labs in 2015. Using its experience in drug development to create tailor-made in vitro and in vivo services, Truly Labs helps companies to understand whether their drugs have potential in the clinic as early as possible in the drugss life cycle, and this approach could help to lower the very high attrition rates in early drug development.
Understanding impact before moving on
To achieve accurate results, Truly Labs consultants look for efficacy markers that can be used both in preclinical and in clinical studies. For example, they perform biomarker analysis, animal and human cell assays, multiplexing, PK/PD experiments and whole body imaging to create correlations between in vitro and in vivo outcomes and animal and human responses. This helps to better understand mode of action, dose, exposure at the target and efficacy, allowing a clearer picture of what the impact of the drug will be when it moves into human studies.
Truly Labs covers a range of important therapy areas, including inflammation, oncology, respiratory diseases, gastrointestinal disease, and autoimmune diseases, and provides expertise in preclinical in vivo inhalation pharmacology services. These therapeutic areas are driven by market needs and by the background expertise of the Truly Labs’ team, largely originating from Astra Zeneca’s inhalation and respiratory team. Truly Labs is a part of the Medicon Valley Inhalation Consortium.
The role of translational research
Translational research is not just important for a company’s internal development programs. It makes up an important part of packages provided for potential licensees and investors, and for dossiers for regulatory authorities for approval of clinical trial plans, and eventually, for marketing authorization.
“We are not just an average preclinical CRO. We know how to develop drugs, and we know what kind of data and what level of quality is needed to get approval to go into the clinic or to attract a pharma partner”, says Karin von Wachenfeldt.
Truly Labs’ team prides itself on having a customer-centric approach. “Because we understand the time and financial challenges in drug development, especially for smaller biotech companies, when our customers come to us with a request for a study, we will discuss their program with them. We will jointly identify the critical data to be generated, and in this process take the translational aspects into account. We want to make sure that our customers carry out the right studies, of the right size and at the right time”.
Karin von Wachenfeldt continues: "Flexibility is key to how we work – for some companies we act effectively as their internal laboratories, and for others we work on specific questions or models”.
This customer-centricity does not stop at the end of the project. Through its network of contacts, Truly Labs’ team can help its customers to find outsourcing partners for other services, such as toxicity and safety studies.