Pharmacokinetics, a fundamental pathfinding tool in early drug development
CTC Clinical Trial Consultants counts on pharmacokineticists with widespread experience of drug development and scientific guidance among its coworkers. With their expertise, they provide support from the early preclinical stage through phase II clinical studies, for example in the choice of compound(s), starting doses, and modelling in preparation for patient trials.
Johan Bylund is an associate professor of pharmacology and Senior Scientific Advisor at CTC. He holds a PhD in Pharmacology and a Pharmacy degree and has over 15 years of experience with Big Pharma and smaller biotech-companies, as well as the CRO industry, specializing in drug metabolism and pharmacokinetics (DMPK). Johan has worked with small molecules, peptides, oligonucleotides and protein drugs, from the early preclinical phase to clinical development and phase I/II trials. Recently, the U.S. Food and Drug Administration (FDA) approved one of the drugs that Johan helped develop for the treatment of spinal muscular atrophy (SMA).
“It’s very exciting to take part of the preclinical phase of drug development and then be able to follow up in clinical trials”, he explains.
At CTC, Johan Bylund is a key player in the design of the very first clinical trials for a new candidate drug. Among other things, he performs predictions of the drug’s pharmacokinetic (PK) and pharmacodynamic (PD) properties, defines safety margins and recommends starting doses for trials where new candidate drugs are given to human test subjects for the very first time, so-called “First-In-Human” trials. He also contributes to the parts of the Investigator’s Brochure (IB) that deal with DMPK and PK/PD and participates in regular safety committee meetings in dose escalation studies.
“In preparation for a safety committee meeting I analyse the available PK and PD data so that I can present it to the committee and enable them to choose the correct dose for the next dosage group. I also perform risk assessments and give advice before and during any ongoing clinical trial, for example about dosage simulations, drug interactions, metabolism investigations and biomarkers.”
Bengt Dahlström, Chief Scientific Officer at CTC, explains that PK/PD modelling is a crucial tool in the planning and design of new studies:“We can investigate what could potentially happen if we changed the dose, what the possible interactions with other drugs could be or what we expect to happen in a patient with impaired liver or kidney function.”
As the head of scientific operations at CTC, Bengt serves as a mentor for the clinical research managers. He provides guidance when it is time to advance strategies in the development of new drugs and when it is time to implement new methods at CTC, like microdialysis and Expert Precision QT (EPQT). An important part of Bengt’s and Johan’s work is to look at the relationship between drug effect and drug exposure to ensure that the new drug will have the best possible chance to work for the patient. As part of the planning stage of new clinical trials, Bengt Dahlström also participates in scientific advisory meetings together with CTC’s customers at the Swedish Medical Products Agency (Läkemedelsverket).
“Our mission is to give our clients the chance to determine whether there is a scientific basis for the continued investment in a new drug candidate as early as possible in the process. The decision must be based on solid pharmacokinetic data, a well characterized safety profile and, of course, effect studies,” says Bengt.
The client thus has the chance to get in touch with CTC’s pharmacokineticists already at the early stage of drug development to get help with scientific and regulatory questions regarding both the preclinical program and the clinical development plan. As a full-service CRO, CTC can take a holistic approach to the guidance, planning, project management and clinical conduct of trials in our own in-house clinics.
“We have the possibility to assist the client all the way; from the crucial choice of the appropriate compound to proof-of-concept. CTC has a well proven and cost-efficient development model, which I have helped develop since the start of the CRO industry in Sweden in the 1980s”, adds Bengt.
Bengt Dahlström, like Johan Bylund, is an associate professor and holds a PhD in the field of pharmacology. He is one of the founders of CTC and has over 40 years of experience of clinical pharmacology and pharmacokinetics. Both are driven by the chance to contribute to the development of new treatments for patient groups with unmet medical needs. They are also eager about keeping Sweden’s good international standing when it comes to research and development within the Life Science industry.
“We want to continue being a part of the strong Life Science infrastructure in Sweden and by doing so contribute to making Sweden a more attractive country for clinical trials, both for national and international companies”, Bengt concludes.