The path of drug discovery and development is laden with challenges. Achieving an understanding of how a drug works before embarking on expensive clinical trials is the desired route for having a successful outcome. Knowledge of the mechanism by which a drug acts and the development of pharmacodynamic assays as a drug enters clinical trials favors regulatory approval. This information enables better dosing through monitoring of the drug's effects on the targeted pathway in the patient.
Learning how a drug works can help stratify clinical trials to focus on those patients most likely to respond. The development of such screens to determine which drugs are more likely to benefit a patient is being pushed by the FDA's Critical Path Initiative to improve the chances for drug approval.
Even when a drug's mechanism is understood, it is often difficult to predict its side effects. Potential or real off-target effects can be assessed at any stage of the drug development path.
Mechanistic studies take time, and delays to the drug development process are not welcomed. Nevertheless, in the long run, mechanistic knowledge and the development of specialty tests are certainly worthwhile before and during the ambiguous world of clinical trials—this knowledge can increase the chances for drug approval, save money, time, and, most importantly, the lives of patients.
At MLM Labs, we have more than 100 cumulative years of experience in mechanistic and pharmacodynamic studies. We have facilitated regulatory approval of over ten drugs and devices through our development of customized assays, performance of pharmacodynamic or hemocompatibility testing, and investigating off-target effects of small molecules and biologics. We also aid in the characterization of biosimilars and early-stage compounds for IND submissions.
Pharmacodynamic Testing includes various platforms and therapeutic areas:
- Biomarkers using multiple platforms
- Cardiac physiology
- Cancer biology
- Cell or cell line phenotypic assays
- Cell bioenergetics
- Coagulation (comprehensive routine or customized assays)
- Device Hemocompatibility
- Fibrinolysis panels
- Immunogenicity testing
- Platelet antigen and platelet function tests using multiple platforms
- Signal transduction assays
- Spectral flow cytometry
- IP and Western blots
We look forward to discussing with your team how we can help facilitate your clinical trials by training clinical sites on proper venipuncture, sample handling and processing, sample storage, and sample shipment to CirQuest for biostorage or for biomarker or cell-based assays.