Stages of Discovery & Development

From Concept to IND

Your Partner in Drug Discovery

With a deep understanding of the complexities, we adapt to support you throughout the discovery and development process. In the crucial first phase – where promising drug candidates are identified – our expertise plays a vital role in advancing your program towards preclinical safety evaluation.

Meadowhawk provides industry standard WinNonlin generated PK data analysis for studies across the discovery continuum.

Exploratory Services

Identify promising starting points for your drug discovery journey.

Lead Optimization

Refine your drug candidates to improve their potency, efficacy, and PK/PD profile.

IND Enabling

Support generating the data package required to submit your drug candidate for clinical trials.

Exploratory Stage Drug Development

Exploratory Stage Drug Development

Meadowhawk accelerates early drug discovery with efficient in vivo ADME studies. Our bi-coastal facilities, AAALAC-accredited and stocked with common rodent strains (CD-1, C57bl/6, Sprague Dawley, and Wistar-Han), enable rapid study initiation within days of receiving your test article. We perform discrete/cassette studies with various dosing routes and biofluid collection methods, minimizing sample volume requirements.

Our state-of-the-art LCMS service, equipped with Sciex 7500 and Shimazu LC40 instruments, analyzes single or multiple analytes in samples as small as 2µL. For larger volumes, we offer diagnostic probes for deeper data quality insights. Additionally, we have established a rapid “off-the-shelf” assay for human IgG-based test articles, eliminating lengthy method development and accelerating decision-making. Our expertise extends to various biologics testing, supporting your research on a broad range of drug candidates.

Lead Optimization

Lead Optimization

Validating and further refining promising candidates with confirmatory in vivo studies, our scientists work closely with you to refine and optimize leads through targeted modifications.

We conduct detailed PK (pharmacokinetics) studies, including discrete dosing, various administration routes, and formulation screening. We also explore salt form variations, food effects, and gender differences.

Beyond standard biofluid collection, we perform terminal necropsies to analyze various tissues. Metabolic cages allow us to collect bile, feces, and urine for a complete picture of drug metabolism and excretion. Using LCMS and Immunoanalytical platforms, our in-house bioanalytical team deploys assays to stricter data quality requirements to ensure data accuracy for these critical studies. We routinely perform dose-proportionality studies and use selective tissue analysis to understand drug distribution.

IND-Enabling Studies

IND-Enabling Studies

Meadowhawk offers a one-stop solution for drug development, combining efficacy studies with precise PK/dosing data to establish safe and effective drug levels. This approach guides further assessments through dose tolerability studies. Our expertise includes multi-day, multi-dose studies in appropriate rodent species, along with specialized models for complex PK/PD correlations and tissue distribution mapping.

We develop robust LCMS assays satisfying GLP performance criteria, analyzing a wide range of samples. Beyond standard methods, our team offers custom immunoassay development for diverse therapeutic areas, ensuring consistency throughout your research.

Similarly, our immunoassay (IA) protocols undergo rigorous qualification validation with fit-for-purpose development and specialized reagents for precise sample analysis at this critical stage. This comprehensive approach provides you with a deep understanding of your lead candidates’ behavior in vivo.

“We think outside the box to get the best fit between each client’s specific needs and our industry-leading expertise.”

Sujoy Dutta

Director, Immunoanalytical Services

Get Results Fast

With individualized service and quick study starts, see how we deliver.

Why Work With Us