First PhD defense for CORS
On 13 July 2020, Asbjørn Nøhr-Nielsen defended the first PhD thesis funded by CORS. The thesis’ title is Pharmacokinetic-Pharmacodynamic Modelling of Fixed-Dose Combinations: A Regulatory Perspective.
Asbjørn’s thesis is the result of a collaboration between the Department of Drug Design and Pharmacology, CORS, the Department of Public Health and Conrig Pharma.
Combination drug therapy is becoming a central part of the treatment strategies for many diseases where monotherapy has so far not given sufficient efficacy or to improve adherence in complex medication regimens. PK/PD modeling in the development process of fixed-dose combination drugs may save time and resources and thereby lower developmental costs and ease access to the market. The aim of Asbjorn Nøhr-Nielsen’s thesis was to explore, develop, and validate the use of modeling tools for the development of fixed-dose combinations.
The thesis concludes that modeling tools should to a greater degree be incorporated in the development of fixed-dose combinations as they assist in determining efficacy and provide valuable information to guide drug development.
His thesis resulted in 3 publications:
- Body of evidence and approaches applied in the clinical development program of fixed‐dose combinations in the European Union from 2010‐2016. Nøhr‐Nielsen A, De Bruin ML, Thomsen M, Pipper CB, Lange T, Bjerrum OJ, Lund TM. Br J Clin Pharmacol. 2019;(July 2018):1–12.
- Demonstrating Contribution of Components of Fixed-Dose Drug Combinations Through Longitudinal Exposure-Response Analysis. Nøhr‐Nielsen A, Lange T, Forman JL, Papathanasiou T, Foster DJR, Upton RN, Bjerrum OJ, Lund TM. AAPS J 2020 222 22:1–14.
- Pharmacodynamic modelling reveals synergistic interaction between docetaxel and SCO-101 in a docetaxel-resistant triple negative breast cancer cell line. Nøhr‐Nielsen A, Bagger SO, Brünner N, Stenvang J, Lund TM. Eur J Pharm Sci 2020 105315.
The Assessment Committee was composed of Associate Professor Uffe Kristiansen (Chairperson), Dr. Troels Bergmann and Professor Janet Mifsud.
The supervisors were Associate Professor Trine Meldgaard Lund (principal supervisor, Department of Drug Design and Pharmacology), Professor Emeritus Ole Jannik Bjerrum (Department of Drug Design and Pharmacology), Associate Professor Theis Lange (Department of Public Health, replacing Christian Pipper), PhD Mikael Thomsen (Conrig Pharma) and Professor Marie Louise De Bruin (CORS).