Integrated Drug Discovery Service
Sundia has a good track record of successful integrated small molecule drug discovery programs for our clients. Sundia has been building our scientific and managerial team based on the needs of our clients in the pharmaceutical and biotech industry to provide integrated drug discovery services. Our team is led by very experienced scientists in related disciplines.
- Sundia medicinal chemistry team is overseen by vice presidents of chemistry, who run the operation and project management. The team has average of over 10 years of working experience in pharmaceutical/biotech industry in the United States. In addition, we have many middle managers with various organic and medicinal chemistry backgrounds and strong research team as well. With this team, we are capable of supporting medicinal chemistry projects including CNS, oncology, inflammation, pain, and metabolic diseases.
- Sundia biology service is headed by vice president of biology. Our research team has broad experience on research background for neurodegenerative diseases including Alzheimer’s disease, Parkinson disease, peripheral neuropathy, and retinal degeneration, oncology including kinases, and metabolic diseases. We develop animal models for several diseases, especially for CNS targets and cancer models.
- Sundia biology team can provide services in molecular biology, assay development, drug target identification and validation. The team can support drug discovery targets of enzymes including kinases, nuclear receptors, GPCRs, and ion channels. We can provide protein expression and protein purifications, binding assays, and cell based assays for variety biological targets.
- Sundia DMPK team can provide quality services in in vitro assays including MDCK or Caco-2 assays, HLM and RLM assays as well as CYP profiling and CYP inhibition studies. Sundia also provide in vivo PK studies in various animal species (mice, rats, hamsters, pigs, rabbits, beagle dogs and rhesus/cyno monkeys). We provide full DMPK evaluations and TK study as well. We also provide large molecular PK study and bio-analytical services.
- Sundia integrated drug discovery services are supported by our analytic department, pre-formulation department, scale-up chemistry and process chemistry. We provide high quality, efficient and cost-effective integrated drug discovery services, from lead generation, lead optimization to pre-clinical candidate profiling and selection. Most importantly, Sundia has successfully demonstrated to our clients in the last several years that we can deliver pre-clinical and clinical new molecular entity from hits.
- Our preclinical development& Regulatory Affairs department has extensive experience in managing preclinical projects and has achieved successful approval in 2 application programs of IND in SFDA for our clients.
- IND preparation for NME:
Acceptable PK profile (with a validated bio-analytical method including metabolite study).
Demonstrated in vivo efficacy/activity (dose-dependent study and PK/PD study).
Acceptable safety margin (toxicity in rodents or dogs when appropriate including TK study).
GMP manufacture and formulation feasibility study including stability test.
Acceptable drug interaction risk.
- Drug Discovery & Research
- Pharmaceutical Development
- New Drug Preclinical Development