Shanghai Medicilon Inc.

The use of rodents as a model for human cancer has been an important tool in the development and translation of innovative anti-cancer therapies. The service that we provide makes use of xenograft tumor models in immune deficient (nu/nu) mice, as well as transgenic and conditional/knock-in based engineered models that target known tumor promoting pathways. Genetic and phenotypic characterization of both xenograft tissue and genetically engineered animals allows the correlation of drug-target interaction, as well as the ability to test predictions of pathway-targeted anti-tumor efficacy. To test synergistic activity, novel therapeutics—generated both from within UCSF as well as externally—are tested alone and in rational combinations and dosing sequences. Tumor response to therapeutics is detected by a combination of direct tumor measurement and molecular imaging methods. Cell/tissue culture and engraftment The PTC has expertise in high volume cell culture, and maintains a larg

There were an estimated 410,000 new cases of lung cancer and 353,000 deaths from  lung cancer in Europe in 2012 . This makes lung cancer the fourth most common cancer site (after female breast, 464,000 cases, colorectal, 447,000 cases, and prostate, 417,000 cases) but the leading cause of cancer death in Europe. It is a frequent and deadly disease. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer accounting for 85% of all lung cancer cases, and although numerous studies have documented a higher risk for developing NSCLC among smokers, non-smokers also develop lung cancer. This suggests that there are additional risk factors involved in developing this disease. It is thought that both somatic gene mutations (mutations that can occur in the cancer), as well as germline gene mutations (mutations that are inherited), contribute to NSCLC carcinogenesis. Somatic epidermal growth factor receptor (EGFR) mutations occur more frequently in females and in East Asian

Nov. 18-21, 2014 Centre de Convencions Internacional Barcelona (CCIB) Barcelona, Spain Late Registration Deadline: Friday, Nov. 14, 2014 Symposium Co-Chairpersons Jean-Charles Soria, Institut Gustave-Roussy, Villejuif, France (EORTC) Lee J. Helman, National Cancer Institute, Bethesda, Md., USA (NCI) Jeffrey A. Engelman, Massachusetts General Hospital, Boston, Mass., USA (AACR) Symposium Website View Program Register Now and Save Hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR), the 2014 Symposium will bring together over 2,000 academics, scientists, and pharmaceutical industry representatives from across the globe to discuss innovations in drug development, target selection and the impact of new discoveries in molecular biology . During the last few years, numerous innovative agents have been discovered as a result of tremendous developments i

Our one-stop comprehensive Integrated Service utilizes our Biology, Chemistry, and Preclinical services for the convenience of our clients. This route features the insight and expertise of our entire management team and a more economical solution to advancing your breakthroughs. Hit–>IND Filing Lead Optimization–>IND Filing Preclinical Candidate–>IND Filing Biology: Protein Production Protein Crystallization, Co-crystallization & Soaking 3-D Structural Determination Molecular Modeling & SBDD Screening & Profiling In Vitro Pharmacology In Vitro ADMET Chemistry Medicinal Chemistry & Lead Optimization Design & Synthesis of Focused Libraries  Computational Chemistry & CADD Custom Synthesis & Scale-up Synthesis Analytical Chemistry Preclinical ADME: Bioanalytical Services; Preclinical PK & TK; Metabolism Services Animal Disease Models: Cancer; Metabolic Disease; CNS Disease; Inflammation & Immunological Disease Toxic

Our CMC department focuses on establishing large-scale synthetic routes along with formulation development and quality control, our drug categories can be proprietary drugs or generic drugs. All studies are complied with ICH and SFDA guidelines. Feasibility study  Project planning Synthesis Establish synthesis “Freeze” the synthesis Establish large-scale Formulation Development Pre-formulation testing Formulation development Process optimization IVIV correlation Scale up Analytical Development Establish HPLC methods for API, impurities, isomers and drug product  Develop HPLC method for stability testing  Conduct HPLC method validation  Set API and drug product specifications Stability Study Perform stability study for API and drug product under ICH & SFDA guidelines Regulatory Submissions Prepare documentation for regulatory submissions Prepare supporting documentation and data package Our CMC experts with decades of

Our structural biology department offers services supporting structure-based drug discovery from determination of novel targets to final structures. Our platform is one of the earliest established structural biology platform in China and has been certified by the Shanghai government. Enzymatic-Based Assay Multiple Technology Platforms Lance Assay Alphascreen Assay Z’-LYTE Assay Adapta Assay Kinase-Glo Assay ADP-Glo Assay Ligand Binding ELISA Assay HTRF Assay Diversified Targets and Applications Kinases GPCR Proteases Transcription Factors Cytokines Metabolic Enzymes Biomarker Protein Binding Protein Interacting Compound screening Cell-Based Assay Cytotoxicity Assay Apoptosis Assay Cell Migration Assay Cell Invasion Assay HTRF Cell-based Assay Immunostaining Assay Immunofluorescence Assay (96/384 wells) Reporter Gene Assay (GFP/Luc) Radioactive Ligand/receptor Binding Assay Cellular Uptake Assay Gene Knockdown Assay MicroRNA Overexp

Well-designed and well-validated analytical methodology is critical to data integrity and central to our approach. We work closely with clients to ensure that our methodology will yield accurate results. Meanwhile, our precise quality systems ensure that all the facilities, equipment, methods, practices, records, and controls are tightly compliant with our regulations, study protocols, and standard operating procedures. Supporting chemistry FTE, custom synthesis and scale up synthesis High throughput purification and analysis capability Structure and purity determination Impurity characterization Chiral purity 2 on-site NMR, one equipped with auto-sampler 3 LC-MS, equipped auto-sampler Water content &residual solvent Certification of analysis (COA) Find out more " www.medicilon.com "

We utilize medicinal chemistry and computational chemistry to design and synthesize drug-like templates and libraries of compounds to increase our clients' compound collections. The annual capacity of library production is more than 100,000 compounds. Design and synthesis of focused libraries Solution phase parallel synthesis Hands on experience in solid phase synthesis Automated purification capability Find out more " www.medicilon.com "

Pharmacokinetics Services Our pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our services are non-human primate, canine, mice, rat, rabbit and hamster. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai government. Preclinical Pharmacokinetics Method development and validation (GLP,Non-GLP) Bioanalysis Pharmacokinetics (Tumor bearing rodents, Bioavailability, Crossover studies, Cassette (N in 1) dosing and analysis, effects of gender on pharmacokinetics, BBB penetration ) Stability in vehicles and plasma Drug interaction studies In vitro metabolic stability CYP 450 inhibition Plasma protein binding studies Distribution studies Excretion studies Prediction an

Medicilon's toxicology department has professional teams with rich experience in toxicology studies. We offer high-quality data and rapid turnaround period to support drug discovery and development. Our toxicological studies are conducted in various animal species. The toxicological evaluation from dose design, in-life studies to histology and pathology testing along with toxicokinetics studies are all compliant with GLP or NON-GLP standards. Our study platform is certified as one of the Shanghai Public Service Research Platforms. Animal Facilities 50,000 Sq. ft.  total  area 12,500 Sq. ft. for function area 12,500 Sq. ft. for Canine housing: maximum capability for 350 canines 12,500 Sq. ft. for Nonhuman Primate housing: maximum capability for 400 NHPs 12,500 Sq. ft. for Barrier system for Rodent housing: Separate SPF and non-SPF area; maximum capability for 5000 animals of SPF area and 500 animals of non-SPF area Design and Operation of the facility are under interna

Medicilon's Pharmacology department functions in accordance with the needs of our customers for a variety of effective animal models used to detect drug effectiveness. We offer non-human primates, dogs, mice, and rats, rabbits, guinea pigs, amongst others in our services. At present, we have various proven effective animal models, furthermore, our staff’s rich experience operate with strong theoretical basis is while still being flexible enough for custom development of various types of models to meet the requirements of our clients. View more about medicilon's service, www.medicilon.com

We have sucessfully supplied one client 6 kgs of product with eight synthetic steps within a very short period, including reaction optimization. High quality products in multi-kilogram quantities Process development, Route scouting and optimization On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services

Medicilon has synthesized over 10,000 individual compounds from gram to kilogram quantities, and many compounds are synthesized with more than ten synthetic steps. The overall synthesis success rate is over 95%. High quality products from mg to kg scale Reagents, intermediates, building blocks, and scaffolds Preparation of API or reference standards Development of synthetic routes for impurities and metabolites   On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services

We utilize medicinal chemistry efficiently and cost-effectively to progress our client’s drug discovery projects to candidate nomination, preclinical development, and IND. Hit to lead and/or lead optimization Rational drug design Computer aided drug design (CADD) Structure Activity Relationship (SAR) campaign Final lead optimization and candidate nomination Process development of preclinical candidate Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services

Medicilon’s Biology department has extensive research experience in the fields of molecular biology, cell biology, structural biology and in vitro biology. From initial construction of cDNA library to drug design as well as from protein purification to structural determination and assays, we provide a complete set of biological services.  We operate a 12,000 sq. ft. biology facility on our campus with various kinds of state-of-the-art equipments and multiple biological technology platforms for biological research. Our experienced and professional team offers advanced technology and high-quality services to conduct customized studies, which greatly promote the speed of drug research.

Medicilon ’s Preclinical department has extensive and professional knowledge in drug metabolism/pharmacokinetics, pharmacology studies as well as toxicology . We offer high-quality and  cost-effective data with rapid turnaround time to support drug development, preclinical studies and clinical research. Our services cover various aspects of preclinical services, including protocol designing, in-life studies, sample analysis, professional data analysis, IACUC review, and preparation of documents for IND filing. Over 50%  of our employees have MS and PhD degrees, and over 10% of our employees have significant foreign education and/or working experiences. Medicilon and MPI Research established a joint venture from 2008-2010 to set up a state-of-the-art 50,000 Sq. ft. animal facility fully accredited by AAALAC and in compliance with US GLP and China FDA GLP. Our services facilitate the evaluation of the safety and marketing of life-changing compounds for our clients.