Interview Questions Drug Discovery Innovation Programme
To get the things started, Tell us something about you?
Admescope (Symeres Finland) is a contract research organization supporting the discovery and development of pharma and biotech industry with tailor-made ADME-Tox services whether it is a small molecule or biologics. Admescope is specialized in drug metabolism, drug interactions, pharmacokinetics and bioanalysis.
Our services cover the whole ADME-Tox area, ranging from early screening assays to highly tailored and detailed studies. We believe in customer specific requirements and such we ensure high quality data by optimizing the conditions according to the compounds characteristics rather than using generic protocols. We work with our customers as a Team involving our scientist early on to save time for ourclients. Data interpretation is a key for right conclusions thus all data can be supplied with interpretation and context for the customer to help in understanding the real meaning of the numerical values and observations. Our team of experts consists of chemists, biochemists, pharmacologists and technicians, all with long experience and strong expertise in the ADME space. Combination of our expertise and state-of-the-art instrumentation enables us to deliver high scientific and technical quality, always on time.
Since 2020 Admescope is part of the integrated drug discovery services portfolio of the Symeres organization with more than 500 scientists.
What is the goal of your R&D initiatives to strengthen your market position?
The goal of our R&D activities is to provide best in class services for our clients and fulfill all their needs whether it is a more exotic enzyme, administration route or study set-up. We at Admescope early on realized the need to provide ADME-Tox services not only for small molecules, but for biologics as well. Beyond our current portfolio such as peptide mapping, released N-glycan profiling, protein characterization, targeted protein quantification (LC/MS and ELISA), in vivo pharmacokinetic studies and biomolecular interactions several R&D activities are ongoing to cover the whole spectra of the biologic space.
How should the roles of individual enzymes and transporters in metabolism be defined in order to comprehend the possibility of drug-drug interactions?
The FDA, EMA, PMDA guidelines for drug-drug interaction studies suggest that the investigational drugs should be tested for their potential to inhibit or induce metabolic enzymes and drug transporters that are associated with clinically relevant drug-drug interactions. According to these guidelines clinical drug-drug interaction studies should be designed and initiated based the results of the in vitro drug-drug interaction studies. Additionally, the role of individual enzymes and transporters in metabolism and disposition of the investigational drugs should be characterized, to understand the potential for drug-drug interactions due to inhibition or induction of mechanisms dictating its pharmacokinetics.
Our services include identification of the enzymes metabolizing the new chemical entity itself, and high-quality assays for inhibition and induction of CYP and UGT, as well as inhibition towards some less common metabolizing enzymes, such as FMO, MAO, CES, AOX and NAT. We also offer drug-drug interaction services include assays for in vitro characterization of the inhibition potential of a new chemical entity towards transporters recommended in the regulatory guidance and some additional transporters with potential clinical relevance. The in vitro data, with estimates on local plasma and tissue concentrations in vivo, can be used to evaluate whether further clinical investigation is advisable.
How crucial is the evaluation of drug-drug interaction risk for drug safety?
Evaluation of drug-drug interaction risk is an important part of drug safety assessment required by the drug regulatory authorities. Guidelines defines decision trees and cut-off values for risk calculation which should be strictly followed for regulatory submission. These guidelines also defines whether in-vitro experiments are enough, or in-vivo experiments should be conducted. In case of significant drug-drug interaction the label of the drug should indicate dose reduction or elevation, in several cases co-administration is prohibited.
In What Outcomes Do You Think 18th Drug Discovery Innovation Programme Will Help You?
We are looking forward to hearing the current scientific insights, and discussions from leading global pharmaceutical R&D executives. We are happy to learn how new technologies and innovative processes are fundamentally changing what the drug discovery research will look like in the next two to five years. We are also looking forward to networking with R&D executives to exchange ideas in person.