PharmaLegacy Laboratories is a preclinical Contract Research Organization (CRO) providing specialty pharmacology services in Oncology, Bone, Inflammation, Immune Diseases, and Orthopaedics in Tissue Repairs and Tissue Engineering. The core business of PharmaLegacy business includes in developing and running specialized animal models to test drug candidates and medical devices for their pharmacological effects and biocompatible repairs, along with the adjacency studies of in vitro biology and PK/PD.
Backed by a US private equity investment, PharmaLegacy is strategically located in the heart of the Biotech and Pharmaceutical Base of Zhangjiang High Tech Industrial Park, Shanghai. The company has a 45,000 square-ft facility with SPF labs. Their facility can house > 10,000 rodents and non-rodent animals.
Darren Ji ,MD, PhD, MBA, Chief Executive Officer
Formerly, Bioscience Business Development Executive, Procter & Gamble Company; Responsible for deal-makings valued over $1 billion; Seasoned leader in pharmaceutical R&D project management.
Jeff Duan MD,General Manager
Formerly, Head of Pharmacology, Hutchison Medipharma (Shanghai); US board-certified MD; Extensive drug R & D experience in US and China biotech industry. Board member of Shanghai Experimental Animal Committee; Successful Submission of USD and China INDs.
Mei-Shu Shih DVM, PhD Chief Scientific Officer
Formerly, Research Director of SkeleTech/ MDS and a research veterinary pathologist familiar with GLP operations; Over 25 years in research and specialized contract research services; Highly published and recognized in global bone professional communities.
Webster S.S. Jee PhD,VP of Business Development (Interim)
A pioneer of bone histomorphometry and one of the best recognized names in bone science; Authored over 300 scientific publications and book chapters. President of Webb Bone Finishers, Inc.
Ray Takigiku PhD,VP of QA/QC
Formerly, an executive at Procter & Gamble Pharmaceuticals, where he was part of the leadership team behind the development of blockbuster osteoporosis drug Actonel®.
Tom Tillotson,VP of Corporate Planning
A successful repeater entrepreneur with deep experience in operation and corporate planning. Successful history of managing international businesses, particularly across the US and Asia.
The founding members of their team have an outstanding service record with multinational companies in both pharmaceutical and device industries. Among them are Pfizer, Eli Lilly and P&G Pharmaceuticals.
1. Specialty Areas:
High quality science and specialized knowledge are cornerstones of PharmaLegacy’s specialty services. Their service models are fully validated to ensure the highest level of accuracy, reproducibility and consistency.
1.1. Pharmacology Models
Bone Metabolism, Inflammation, Immune Diseases, In Vitro Assays, Oncology, Orthopaedics & Tissue Engineering, Preclinical Safety Assessment (LD50, MTD, Acute and Subacute toxicity)
Densitometry, Hard and Soft Tissue Histology, immuno-hisochemistry, Histomorphometry, Micro-CT and Image Analyses, in vivo bioluminacence imaging technology
1.3. BioAnalyticals and BioMarkers
PK/PD, Blood Chemistry, BioMarkers
Bending, Compression, Indentation, Tensile, Torsion
Biocompatibility, Skin Sensitivity, Tissue Repair, Tumor Regression
2. Research Models
2.1. Bone Disease & Osteoporosis: Multiple factors affect normal bone metabolism, and consequentially quality of life. At PharmaLegacy, the scientists are world renown and have cumulated more than a century of experiences in bone physiopathology, especially in osteoporosis. Their IND/IDE filing expertise has enabled multiple drug candidates to reach market success. SOP-driven GLP quality assurance operations are committed to successfully driving your programs.
2.2. Oncology: The increasing number of drug candidates that target specific gene expressions and small molecular receptors have created a great challenge to pharmaceutical and biotech companies to carefully select agents demonstrating safety and clinical benefits.At PharmaLegacy they provide various animal models to assist cancer researchers in biological and mechanistic studies. In particular they have comprehensive models in immunodeficient rodents as screening tools to support drug efficacy assessment.
2.3. Orthopaedics & Tissue Engineering: Orthopaedics corrects injuries or disorders of the skeletal system and associated muscles, joints and ligaments. Modern technologies in tissue engineering revolutionize tissue and/or organ repairs for function recovery. Combinations of stem cells, small molecules and biologics in biocompatible scaffolds are used to restore structural and functional deficit in bone, cartilage, facet joints, intervertebral disc, ligament/tendon and teeth. Efficacy and safety data in animal models is required to predict the biological effects of the product in humans.
2.4. Inflammation & Immune Diseases:Therapeutic candidates that aim to reduce and/or eliminate excessive inflammatory response that harms the host tissues/organs are often specifically designed to target a pathway of sequential host reactions to the causative agents. At PharmaLegacy, the scientists are versatile and familiar with the models in testing the efficacy and safety for the chosen candidates of various signal pathways.
They have collected and validated virtually all widely used industry protocol models available and work to meet international standards in both consistency and accuracy. Their animal models and established experimental procedures are validated according to proven industry benchmarks (validated by MNCs and against reference compounds).
3. Adjacency Services
3.1. PK/PD Profiling
property characterization (F, T1/2, Cmax, Tmax, CL, Vss, AUC), typically in mouse, rat, dog and monkey
Assessment of hepatic first pass effect and biliary excretion
Drug permeability assay (CaCO2)
Metabolic stability (microsomes, S9 and hepatocytes)
CYP inhibition (IC50, Ki) for DDI
CYP reaction phenotyping
Plasma protein binding assays
3.2. Preliminary Toxicity Assessment
Rising dose 7-day and 14-day tox studies (mice / rats)
Dermal toxicity (rabbits)
GI irritation study (dogs)
Blood chemistry and histology
3.3.In vitro Studies
Cell culture and assays
Gene expression analysis
Mechanism-based inhibitor testing
4. Consulting Services
5. Facilities and Operations Services
PharmaLegacy has 45,000 ft2 laboratory and vivarium space. Rooms under SPF condition are available for housing animals and conducting pharmacological models. Large animal rooms can accommodate rabbits, dogs, mini-pigs and non-human primates. Modern surgical suites allow multiple surgeries be performed simultaneously. Video-audio systems facilitate distant monitoring of surgeries and procedures by clients. The animal care and laboratory procedures follow AAALAC standards and GLP guidelines.
They have state of art equipment to meet various needs for pharmacology and analytical measurements, such as LC/MS/MS, Roche Mira Plus CC Chemistry Analyzer, Buxco Unconstrained Whole Body Plethysmorgraphs, Norland-pDEXA, Stratec-pQCT, Scanco- Micro-CT 40, MTS-Bionix 858, Faxitron-Mx-20, EXAKT, Leica Polycut S, Leica-RM -2255, OsteoMeasure, Real-time RT-PCR.
6. Data Collection and Report Preparation
At PharmaLegacy, data collection and reporting are incorporated into a premium database system that is Part 11 compliant. Data generated by specific functional groups are linked to the database and are reviewed by the lead scientists. Corrections to entries are electronically recorded automatically for quality assurance. Audited reports by our Quality Assurance Unit can be generated in a short time frame, when GLP status is required, to meet our clients filing schedules.