• No results found

Pharmaceutical Services Fall/Winter 2011

N/A
N/A
Protected

Academic year: 2021

Share "Pharmaceutical Services Fall/Winter 2011"

Copied!
28
0
0

Loading.... (view fulltext now)

Full text

(1)

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta

Structural Biology X-Ray Crystallography High Throughput Screening Medicinal Chemistry Synthetic Chemistry Discovery Biology Pharmacology ADME - DMPK Process R&D Formulation Analytical R&D GMP Manufacturing GLP Bioanalytical Services Non-GLP and GLP Toxicology

Fall/Winter 2011

Pharmaceutical Services
(2)

Contents

Wh

at’s New

Bioanalytical Services Unit in Shanghai Receives GLP Certificate from OECD and EU

WuXi’s New Vivarium in Shanghai Receives Continued Full Accreditation by AAALAC

WuXi AppTec Named a Top Ten Chinese Outsourcing Enterprise

Abgent, a Primary Antibody Company, Now Part of WuXi AppTec

WuXi AppTec Expands to Offer Clinical Research Services in China

Genome Sequencing Center: Coupling Genomic Information to Translational Research DNA and Gene Synthesis Center

Peptide Synthesis Center of Excellence

High Throughput Respiratory Syncytial Virus and Influenza Assays Validated WuXi Opens New Process R&D Facility in Shanghai

Accelerating Clinical Trial Materials Manufacturing

New Chemistry Facility Opening in Wuhan

Co

llaboration Spotlight

WuXi AppTec’s Medicinal Chemistry Team Co-authors Two Discovery Papers in Anti-infective and CNS Therapeutic Areas

Ev

ents

SFC 2011 Poster: Supercritical Fluid Chromatography cGMP Chiral Separation – Control Strategies

Se

rvice Spotlight

Natural Products - Gateway to Bioactive Chemical Diversity Complex CYP Structures in Drug Discovery

WuXi Ready for a New Era of Antimicrobial Therapeutics

(3)

Bioanalytical Services Unit in

Shanghai Receives GLP Certificate

from OECD and EU

Our Bioanalytical Services (BAS) unit in Shanghai received a

certificate of Good Laboratory Practice (GLP) from the Organization for Economic Cooperation and Development (OECD) and the European Union (EU).

The certificate states that WuXi’s BAS facility in Shanghai is able to carry out ADME (absorption, distribution, metabolism, and excretion)

studies, toxicokinetic and pharmacokinetic studies, and hERG assay

and biomarker studies with respect to OECD and EU principles of Good Laboratory Practice. Award of the certificate followed a

thorough review of the facility operations and records on May 9-11, 2011, by Belgian authorities.

This represents WuXi’s third successful audit of its bioanalytical lab by regulatory authorities. The facility also passed a bioequivalence

study inspection by the U.S. Food and Drug Administration (FDA)

in March 2009 and an inspection by China’s State Food and Drug

Administration (SFDA) supporting the certification of WuXi’s GLP toxicology operation in Suzhou. The BAS laboratory is now certified by the SFDA and OECD to provide GLP-compliant support for nonclinical studies. In addition, this laboratory is certified by the OECD to support clinical trials for small-molecule and biologics

pharmacokinetics and biomarker analysis.

WuXi’s Bioanalytical Services (BAS) was established in 2005.

BAS provides GLP-compliant services to analyze small-molecule drugs using liquid chromatography/mass spectroscopy and to measure biomarker/biologics and antibody immunogenicity using immunochemistry. It is the only bioanalytical laboratory in China to have passed SFDA, OECD, and FDA GLP inspections.

“As a GLP-compliant facility, BAS always treats quality and compliance as our highest priorities,” commented Dr. Jinsong Xing, Vice President of BAS at WuXi AppTec. “We maintain GLP readiness through continuous training, review of technology, and

rigorous proficiency testing. Our quality control team thoroughly

reviews all data and closely monitors the facility for compliance on a daily basis.”

Jinsong Xing, Ph.D. Vice President of Bioanalytical Service

Over 10 years’ experience in

bioanalytical area, formerly worked at BASF and then Bristol-Myers Squibb. Ph.D. from Rutgers University.

(4)

WuXi’s New Vivarium in Shanghai

Receives Continued Full

Accreditation by AAALAC

The Association for the Assessment and Accreditation

of Laboratory Care (AAALAC) Council recommended

Continued Full Accreditation for the 33,000 sqft

vivarium in Shanghai. The new state-of-the-art facility

― an expansion providing more rodent rooms for in vivo

DMPK and pharmacology studies ― underwent a full-day evaluation by the AAALAC organization in June 2011, receiving notification in October.

Rodent DMPK and discovery pharmacology efficacy testing were moved to the new facility in late 2010. “This recertification demonstrates our commitment to the humane treatment of animals and

strict quality measures that ensure responsible and reliable research,” said Chi-Chung Chan, PhD, Vice President of Biology.

WuXi AppTec offers extensive in vivo models in many therapeutic areas, such as oncology,

infectious diseases, pain, inflammation, neuroscience, immunology, diabetes and obesity. These models provide high quality support for drug development, including proof of concept, efficacy

screening, target validation, target engagement and mechanism of action studies. The larger high-tech facility allows for expansion of the pharmacology division, to develop additional therapeutic areas.

WuXi offers a comprehensive set of drug metabolism and pharmacokinetic studies supporting

discovery, preclinical, and clinical drug development for both small and large molecules. Our in vivo services offer most dosing regimens, surgical models and biological matrices across multiple rodent species. “Moving to the new facility allows for concurrent bioanalysis and ADME studies to support the pharmacokinetic assessment,” according to Hongshi Yu, PhD Senior Director Drug Metabolism and Pharmacokinetics.

AAALAC International is a private, non-profit organization that promotes the humane treatment

of animals in science. When animals are used in research, AAALAC works with institutions and researchers to ensure animal well-being.

Chi-Chung Chan, Ph.D. Vice President of Biology, Head of Oncology

Over 26 years’ experience in

pharmacology drug discovery. Formerly Senior Investigator at Merck Frosst Center for Therapeutic Research, a subsidiary of Merck and Co. BSc. in Biology from the Chinese University of Hong Kong. Ph.D. in Pharmacology

from University of Ottawa. postdoctoral

fellowship at the National Research

Hongshi Yu, Ph.D. Executive Director, Head of DMPK Testing Services

Over 15 years of industrial experi -ence in drug metabolism, pharma-cokinetics and bioanalysis spanning drug discovery and preclinical devel-opment. Formerly Section Manager at GlaxoSmithKline. B.S. and M.S. from Peking University, Ph.D. from

University of Oklahoma, postdocs at

(5)

WuXi AppTec Named a Top Ten

Chinese Outsourcing Enterprise

At the International Service Outsourcing Cooperation Conference in Nanjing, WuXi AppTec was selected as one of the Top Ten Outsourcing Enterprises in China for 2011 by China’s

Ministry of Commerce.

Dr. Ge Li, Chairman and Chief Executive Officer of WuXi AppTec, was named a Top Ten Contributor to China’s Outsourcing Industry.

China’s Ministry of Commerce (formerly Ministry of Foreign Trade and Economic Cooperation) is an executive agency of the State Council of China. It is responsible for

formulating policy on foreign trade, export and import regulations, foreign direct investments, consumer protection, and market competition and negotiating bilateral for multilateral trade agreements.

The conference highlighted the importance of Chinese outsourcing enterprises and their growing capabilities for developing business in North America, Europe, and Japan.

“WuXi AppTec is honored to be selected to this list, and I am personally gratified with my own

(6)

Abgent, a Primary Antibody

Company, Now Part of WuXi AppTec

In October 2011, Abgent, a provider of

biological research reagents and services joined, WuXi AppTec, broadening WuXi’s reach in drug discovery and development. Abgent is among the largest manufacturers of antibody reagents for research use. The company has a catalog of approximately 20,000 antibody products and serves as the original manufacturer of antibodies distributed by its own web portal along with a global distribution network. Abgent also develops and produces peptides and proteins for research and diagnostic applications.

With a talented scientific team, experienced

management and state-of-the-art

manufacturing facilities, Abgent has provided tens of thousands of antibody reagents to over 10,000 customers, ranging from research institutes, universities, and hospitals to pharmaceutical, biotech and diagnostics companies all over the world. “WuXi’s acquisition of Abgent continues our strategy of leveraging the advantages of our China-based operations to provide high-quality services and products needed by

the world’s biopharmaceutical and scientific

researchers,” said Dr. Ge Li, chairman and chief

executive officer of WuXi. “WuXi’s mission is to

build a platform that will allow anyone and any company to discover and develop drugs more

efficiently and cost effectively for patients.”

Abgent’s extensive portfolio of antibodies covers key pharmaceutical and general research areas:

• ~20K total primary antibodies • Hundreds of products for key

pharmaceutical pathways (EGFR, VEGF, Wnt, Notch, Parkinson’s, plus many more) • 4500+ antibodies against the entire

human kinome

• 200+ antibodies for autophagy research • 900+ antibodies for stem cell research • 600+ phospho-specific antibodies to the

MAP kinase and apoptosis pathways

• Comprehensive antibody sets for

methylation, acetylation, sumoylation, ubiquitination pathways.

Custom antibody production is an additional core strength of Abgent – having manufactured well over 20,000 antibodies to support both the catalog and custom antibody manufacturing service. With state-of-the-art production facilities, Abgent’s scientists currently manufacture over 4,000 antibodies per year.

Abgent brings over 150 employees and facilities

in North America and China, including of a 34,000 sqft lab in Suzhou and a 10,000 sqft lab

and office in San Diego, CA. These reagent

supply services will provide WuXi AppTec’s clients with a reliable source of antibodies for a wide range of discovery endeavors. From developing monoclonal antibody therapeutics to targeting kinases, drug discovery at WuXi has no boundaries.

Chun Wu, Ph.D.

Vice President of Biological Reagent Products and Services

(7)

Clinical Research Acquisition Opens

Doors to China’s Pharmaceutical Market

cities in China, with offices

in Shanghai, Beijing, and Guangzhou. The companies provide services in regulatory affairs, Phase I-IV clinical trial management, and clinical trial site management throughout most of the regions in China. The companies have

served both multinational and domestic Chinese pharmaceutical companies. MedKey/Jiecheng is now a wholly owned subsidiary of WuXi PharmaTech. As part of WuXi, MedKey/Jiecheng will enable WuXi’s broad customer base to focus on clinical

services required for Chinese

regulatory filings and market

access, including high quality clinical Phase I-IV studies and product registration services. The regulatory system in China is unique and evolving. “Successfully navigating through the Chinese regulatory system requires in-depth understanding of the regulations, the ability to develop and implement innovative and yet achievable strategies, as well as the skills to communicate and negotiate with the agency”, said Dr. Lin. With Dr. Lin’s experience, WuXi is prepared to assist our clients in conducting clinical trials in China and in developing strategies to help ensure the successful entry of their products into the Chinese market.

Jane Lin, M.D. Vice President, Regulatory Affairs and Clinical Development In October, WuXi announced

the acquisition of MedKey Med-Tech Development and Jiecheng Med-Tech Development, two related contract clinical research

services companies (MedKey/ Jiecheng) based in Shanghai,

China.

More and more pharmaceutical businesses turn to Chinese companies for R&D services, particularly for basic discovery and preclinical trials, because of the quality of service, fast turnaround time, and cost-effectiveness. Now WuXi AppTec is taking a step further, building a team to facilitate clinical trials in China and help pharma companies advance products into the Chinese market.

Heading this initiative is Dr. Jane Lin, Vice President of Regulatory Affairs and Clinical Development at WuXi, who has over 14 years’ experience in the pharmaceutical industry. She was formerly Medical Director at Merck Sharp & Dohme and Baxter, where she was responsible for regulatory affairs, clinical research, medical affairs, and pharmacovigilance in mainland China and Hong Kong. Her experience is indispensable for WuXi, particularly because of her thorough understanding of drug regulation agencies and clinical research environment in China. At Merck, she developed strategies to accelerate the introduction of products into the Chinese market and

accelerated the company’s

portfolio registration in China. Now at WuXi, she is working to build an outstanding clinical, regulatory, and medical team to help

customers develop and register products in China.

Fast-growing Chinese Healthcare Market

The pharmaceutical industry in China has grown rapidly in recent years. Last year, pharmaceutical sales grew by more than 20%, and are projected to grow about 20% this year as well.

China has a great potential for pharma companies looking to conduct clinical trials. “There are many positive drivers for conducting clinical trials in China, such as the regulatory agency’s enforcement of good clinical

practice (GCP); the experienced clinical investigators; the proven

track record of conducting clinical

trials; and the large population

which enables a faster patient recruitment to expedite drug clinical development,” said Dr.

Lin. “We are confident we provide

the best service for customers interested in conducting clinical trials in China.”

Existing Clinical Development Infrastructure

Founded in 2006, MedKey/

Jiecheng have approximately

(8)

Genome Sequencing Center:

Coupling Genomic Information to

Translational Research

WuXi AppTec brought together a team of leaders with over ten years’ experience to start up a dedicated center for DNA Sequencing. The center will provide Whole Genome, Exome, Transciptome, miRNA and Small RNA, ChIP Sequencing, and Sequence Capture services for clients’ samples. The center contributes to the growth of WuXi’s integrated R&D programs, such as expanding oncology drug discovery programs with cancer genome sequencing and aiding our established infectious disease unit with bacterial, viral, and microbial sequencing.

Operating out of a 6,000 sqft lab in Shanghai, the team is well equipped with industry-leading instruments including; HiSeq 2000 for ~600 GB throughput projects, Genome Analyzer II for ~60-95 95GB medium throughput projects, and the Personal Genome Machine (PGM) from Ion

Torrent for fast 0.1-1 1GB high throughput projects with a rapid turnaround of 2-3 hours. The mission of the new center is to provide effective integration of genomic technologies to maximally advance drug discovery and development by:

• Elucidating pathways affected by risk variants

• Using genomic data for risk evaluation, drug response, and drug targets • Translating biological markers into companion diagnostics

Significant developments since the inception of the Genome Center in August

2011 include whole human genome sequencing of two samples, E. Coli K12 and other bacterial genome sequencing, RNA sequencing, cancer exome sequencing from cancer cell lines, patient blood, tumor tissue, and patient derived xenograft , all showing excellent correlation with literature.

HiSeq 2000 for very high throughput

sequencing (~600 GB)

Ion Torrent for very rapid turnaround

(9)

DNA and Gene Synthesis Center

Dr. Oligo 192 DNA Synthesizer - for high throughput oligonucleotide synthesis

Peptide Synthesis Center of Excellence

WuXi AppTec provides custom peptide synthesis for pharmaceutical companies and institutes, recognizing the importance of peptides in drug discovery. The Peptide Synthesis Center of Excellence at WuXi, led by Executive Director Yan Xu in Shanghai and Senior Director Luyong Jiang in Tianjin, offers a full spectrum of high quality,

custom peptide services (non-GMP-grade), including cyclic peptides,

un-common amino acid synthesis, peptide libraries, and peptide

modifications, both in solution phase and solid phase. The Center

is equipped with state-of-the-art instruments such as the CS-Bio

CX136XT Peptide Synthesis Reactor, preparative HPLC, MS, LC-MS/MS, LC-TOF-MS, NMR.

WuXi’s strength lies in the strong organic synthesis capability and high success rate of customized building block and un-common amino acids synthesis, which provides more opportunity for peptide

modification and preparation of novel peptides to fit clients’ research

needs. WuXi AppTec has dedicated peptide synthesis and analytical teams, who have the experience and knowledge to provide the best

quality service and fast turnaround time. Our expertise lies particularly in peptide modifications, peptidomimetic, cyclic peptide, peptide

libraries and un-common amino acid synthesis, setting us apart from peptide synthesis services provided by other companies.

The DNA and Gene Synthesis center at Wuxi AppTec offers stand-alone synthesis of DNA/RNA oligonucleotides, genes and their constructs, and customized services. We have experts with more than 15 years of experience in the field to create the most technically challenging custom products. Our scientists collaborate with researchers around the world to meet customer specifications – no matter how complex. The center’s mission is to deliver high quality product at a competitive price with a fast turnaround time.

• DNA Synthesis services include: Regular and Modified DNA/RNA Oligonucleotides, Customized Primers and Probes, PNA, LNA, and Oligonucleotide Conjugates • Gene Synthesis services include: Customized Gene Synthesis, Vector Construction, Gene Optimization, and Site-Directed Mutagenesis

This well organized laboratory, operated by experienced

scientists and equipped with state-of-art instruments, will function stand-alone or in conjunction with integrated R&D programs to provide products and services to meet our clients’ research needs in biology, diagnostics, and drug discovery.

(10)

High Throughput Respiratory

Syncytial Virus and Influenza Assays

Validated

Respiratory syncytial virus (RSV) and influenza virus, contagious pathogens that cause severe

respiratory illness, can result in hospitalization and may even be deadly, especially for children, the elderly and immune-compromised individuals.

Development of vaccines and therapeutics that can reduce the impact of future outbreaks of these

pathogens is a race against time. To efficiently screen for inhibitors of RSV and influenza, WuXi

validated a high-throughput, virus/cell-based screening assay that measures the inhibition of

viral-induced cell death, often called Cytopathic Effect (CPE).

The CPE inhibition assay is highly automated and can test ~15,000 compounds per run. Rapid

screening of either a WuXi library or client’s own library can accelerate the drug discovery and lead optimization process. In collaboration with one biotech client investigating RSV virus, we were able to advance from screening to lead stage in just three months. In another collaboration

– with a client pursuing the influenza H1N1 A/Weiss/43 strain – 50,000 compounds were screened

by our single-dose CPE inhibition assay in two weeks.

Development of an antibody staining method for RSV plaque assay at WuXi

WuXi’s Infectious Disease center has experienced, highly trained researchers (10% PhD, 75% MS, and 15% BS) and well equipped, high-level facilities (BSL2, ABSL-2, BSL3-partner) that meet

or exceed international standards for in vitro and in vivo studies, allowing us to perform research projects that assist in the rapid development of therapeutics for emerging infectious diseases.

Labcyte POD™ 810 plate assembler

equipped with an Echo® 555 acoustic liquid

handler for high- throughput screening and secondary screening

(11)

WuXi Opens New Process R&D

Facility in Shanghai

WuXi is pleased to announce that its new and latest facility for R&D Process Development is

now open and in full operation. The five-story, 102,628 sqft state-of-the-art facility, located at

the company headquarters in Shanghai, serves as the center for WuXi’s process development operations, and consists of process chemistry R&D labs and scale-up facilities to accelerate pharmaceutical pipeline products into full commercialization.

The new facility, which employs more than 400 highly qualified and dedicated scientists, is an

expansion designed to meet the demand for process development and scale-up services, along with quality control/assurance and regulatory support.

All process development laboratories in the new facility are outfitted with the most advanced equipment to allow for efficient and accurate generation of processes and data for our clients.

“The new facility gives us more space for the advanced equipment in our laboratories and technology centers,” said Minzhang Chen, Ph.D., Vice President of API Development and Manufacturing Services at WuXi.

Additional Services Hosted in the New Facility

The new facility provides formulation support including dosage form/drug delivery tests,

biopharmaceutics evaluation, physicochemical characterization and developability assessment. The following technology labs are also well equipped and are in full operation:

Crystallization Technology Lab

Provides solvent screening and selection, solubility curve measurement and crystallization process development.

Process Safety Evaluation Lab

Provides reaction calorimeter and thermal screening.

Solid State Characterization Lab

Provides polymorph and salt screening, XRPD, DSC, TGA, Particle Size, and polarized light microscope.

Pressure Reaction Lab

Equipped with Ecoclave Hydrogenation Reactor System and Multiple Reactor System by Parr. Provides pressure reaction process development and hydrogenation screening.

(12)

Accelerating Clinical Trial Material

Manufacturing

WuXi AppTec is continually expanding our capabilities in small molecule early- and late- stage clinical trial material manufacturing. Some of the recent major capabilities built up at WuXi include the expansion of high throughput systems for low weight capsules, dosage forms for pediatric therapies, and bilayer tablets for combination products.

High Throughput Micro-Dosing

Reaching the ‘first in man’ clinical milestone

is an extremely demanding stage of drug development. The anticipation of completing

the first safety tests can be aggravated by

large API requirements, lengthy formulation development with excipient blends, and

additional stability testing. Our clients

needed an option for faster development that minimizes early restrictions. WuXi has

long offered API encapsulation and vial filling

using the Xcelodose 120S, which allowed for

semiautomatic capsule filling of ultra-low doses (as low as 100 ug API). But with increased

demand for higher throughput and faster delivery times, we have added the Xcelodose 600S

micro-dosing system.

The fully-automatic system allows for faster filling, with high precision at doses of 100 ug. The efficient filling capability allows us to rapidly manufacture low-fill weight capsules with very high

precision, thus minimizing any waste of valuable API. In addition, the system’s cutting-edge technology eliminates the need for excipient blending, saving more time by reducing the need for formulation development and additional stability studies.

“WuXi recognized our clients’ need for compressing their overall development timelines and reducing the cost for early-phase testing,” said Deepak Hegde, PhD, Vice President of Formulation Development Services. “Accelerating the first phase of clinical trials allows the

critical data to be completed ― enabling faster, better

informed decisions.”

Manufacturing of Dosage Forms for Pediatric Use

Another new niche capability that WuXi has built-up is the development and manufacturing of dosage forms for pediatric use. Included are both liquid and solid oral pediatric products, such as powder in bottles and sachets for reconstitution, with taste masking.

(13)

For automatic sachet filling and packaging for clinical supplies, we use the KP-503/S Automatic

Sachet Filling and Packaging Machine manufactured by the Japanese company Komatsu. The

volumetric fill machine can handle filling from 0.5 to 50ml for powders and fine granules, and can produce 20-60 pouches per minute.

WuXi recently completed a major supply of over 10,000 sachets for a large US pharmaceutical company, which is planning Phase I studies in the U.S. and Europe. With our sophisticated equipment and highly trained team, the customer was extremely happy with the very fast timelines for development and clinical manufacturing of the sachet product for pediatric use. Bilayer Tablets – Combo Products

A third new capability that WuXi has added is developing and manufacturing

bilayer tablets. This is a vital capability for developing combination drug products in which the two APIs are incompatible. Combination drug products are becoming important in the treatment

regimens for several therapeutic segments ― primarily diabetes and hypertension. They are

also an important element in the life cycle management of molecules.

WuXi’s early stage facility has four isolated manufacturing bays, which enable, the simultaneous production of up to four independent drug products.

WuXi’s facilities are compliant with US FDA and EMEA requirements and have been audited and approved by the EMA for manufacturing and packaging of tablets and capsules. Further, all the micro-dosing systems are 21 CFR Part 11 compliant. WuXi has a strong track record, evidenced by the successful delivery of over 220 batches of clinical trial material to US and European customers. WuXi has acquired a 12-station D/B

tooling Korsch XM-12 Bilayer press,

which has a top speed of 21,600

bilayer tablets per hour. This can be used for development as well as in manufacturing of clinical drug products. WuXi is already developing a bilayer tablet product for a French mulitnational company in which both components are in an extended

release form. One component is a high

dose API while the other is a very low dose API .

(14)

New Chemistry Facility Opening in

Wuhan

The debut of the Wuhan site marks a milestone in the history of WuXi AppTec. WuXi AppTec signed the collaboration investment agreement with Wuhan National Biological Industry Base in August 2010. After over a year of intense and systematic preparation work, the new site in Wuhan will be in operation in January 2012.

Wuhan is endowed with abundant human resources and advantageous geographical features. “WuXi AppTec is committed to building the Wuhan site into the largest pharmaceutical R&D service base in mid-west China,providing quality pharmaceutical R&D outsourcing services to major pharmaceutical companies and R&D institutions around the world,” said Ge Li, PhD,. The site will start out providing WuXi’s

well-established and highly respected chemistry and medicinal chemistry services. As services are added at the facility, the objective is to build a key

national for lead compound research that benefits

all our existing customers and China’s mid-west biotechnology region.

(15)

SFC 2011 Poster: Supercritical Fluid

Chromatography cGMP Chiral

Separation – Control Strategies

WuXi presented a poster

entitled “Define the Control

Strategies for cCMP Chiral

Separations” at the 5th

International Conference on Packed Column

SFC (Supercritical Fluid

Chromatography) in New York,

this July.

SFC is a cutting-edge technology that provides fast, economical and environmentally friendly chiral separation for

pharmaceuticals. SFC 2011 is organized by the Green Chemistry Group - dedicated to the advancement of environmentally sustainable chemical research and development throughout the world.

SFC separations are sustainable, cost-effective

purification solutions delivering

high levels of purity with shorter turnaround times. SFC is environmentally sustainable due to the non-toxic carbon dioxide solvent

Eugene Gong Ph.D.

Vice President, Analytical R&D

used as the mobile phase in most separations. The process is cost effective because the use of carbon dioxide reduces costly disposal fees. Faster run times

and flexible setup conditions

provide for fast turnaround. SFC separation development and GMP production of chiral pure APIs and intermediates to support CMC activities for WuXi AppTec is located within the analytical R&D group at the Shanghai facility.

WuXi AppTec has dedicated separation suites fully equipped for preparative and analytical screening and chiral analysis. The facility is fully GMP compliant, having passed several US/EU customer audits since operations began in 2009.

During early clinical development, the physiochemical properties of the molecules are not well understood and practically no clinical data are gained to link the

safety and efficacy of the drug

candidate to its stereo/optical structure. Therefore, obtaining the chiral pure product in the fastest, easiest and most economical way is critical. Chiral resolution using established separation platforms usually becomes the method of choice at this stage and for this purpose.

Each process, simple or complicated, has a control strategy to ensure a process for achieving consistent product quality. SFC chiral separation is not exceptional although it is unique when comparing to those involving chemical synthesis. In this poster presentation, we

identified the key process steps

and proposed the stepwise control strategies over the separation

process flow - from raw materials

QC through the product release. The realization of the strategies to ensure that the products comply

with the quality specifications and

regulatory requirements is also covered.

Berger SFC MultiGram III, high sample throughput preparative-scale system - five to 10 times faster than comparable high-performance LC (HPLC) setups

Please find WuXi’s poster here (http://www.

greenchemistrygroup.org/ pdf/2011/Liu2_SFC_2011_

(16)

WuXi AppTec’s Medicinal Chemistry Team

Co-authors Two Discovery Papers in Anti-infective

and CNS Therapeutic Areas

Discovery of a Pharmacologically Active Antagonist of the Two-Pore-Domain

Potassium Channel K2P9.1 (TASK-3)

ChemMedChem. doi: 10.1002/

cmdc.201100351, 14 SEP 2011

The second project focused on CNS

potassium channels, important in regulating the activity of neuronal pathways. The

medicinal chemistry collaboration with Merck & Co.’s West Point, PA and Rahway, NJ facilities resulted in a lead series, which were progressed to electrophysiological studies in vivo. The results were published in the ChemMedChem journal as a “Very Important Paper” as judged by the editors.

The goal of the team was to discover potent and selective inhibitors to facilitate target validation of the TWIK-related acid-sensitive

K+ (K2P9.1, TASK-3) ion channels. It is

believed antagonists to these channels could lead to novel therapeutic agents to treat several neurological conditions, including sleep disorders, neurodegeneration, cognitive impairment, Parkinson’s disease, Huntington’s disease and depressive disorders. Screening of 1.8 million compounds led to hits, which were optimized collaboratively by WuXi AppTec medicinal chemists and the Merck scientists, resulting in new patent applications with WuXi AppTec medicinal chemists as co-inventors.

Click here for a copy of ChemMedChem paper Tao Guo, Ph.D. Vice President of Medicinal Chemistry

Design and Synthesis of Benzenesulfonamide

Derivatives as Potent Anti-Influenza

Hemagglutinin Inhibitors

ACS Med. Chem. Lett., 2011, 2 (8), pp 603–607 The first project focused on anti-viral agents.

Working with Roche R&D center in China, WuXi contributed to the design and development of a hemagglutinin inhibitor series that prevents cytopathic effects of the A/Weiss/43 strain of the H1N1 virus.

The goal was to create analogues that exhibited antiviral activity with better metabolic stability.

Structure-activity relationship (SAR) studies

showed the salicylamide group was important for activity. Focused optimization led to a novel

series that represents the first orally bioavailable anti-influenza agents with good selectivity and

improved metabolic stability.

The work was published in the highly regarded ACS Medchem Letters journal, a division of the Journal of Medicinal Chemistry. “The publication of the paper is one of many sweet returns to our

hard work and good scientific research. Thanks

to our chemists and biologists, internal and

external, for all the contribution to the influenza

haemagglutinin project,” said Gordon Tang, PhD, Associate research investigator at Roche R&D

Center (China).

“It has been our great pleasure to contribute to this Roche-WuXi collaboration project and we are very pleased to see that the work has been published in ACS Med Chem Lett with WuXi’s chemists and biologists as co-authors,” commented Tao Guo, PhD, VP Medicinal Chemistry at WuXi AppTec.

(17)

Natural Products - Gateway to Bioactive

Chemical Diversity

Naturally derived compounds are a rich

source of pharmaceutically active compounds, representing almost one third of the world’s drug market1. WuXi offers an extensive service for drug discovery utilizing natural products. From the Center for Botanical Drug Research

(CBDR), which offers pure, refined

and crude natural extracts, to compound library development based on natural product skeletons, WuXi brings the diversity and novelty found in nature to our clients.

Centuries of natural selection pressures have produced biologically active molecules helping species survive physiological and pathological challenges. The resulting diverse range of biosynthetic pathways in plants, fungi and bacteria has provided a plethora of structures that have been used in drug discovery for the last decade, yet the depths of novelty has yet to be exhausted.

Therapies in fields from oncology to infectious

disease have exploited the evolution of these naturally bioactive molecules. WuXi’s CBDR provides natural product services from isolation

and identification of screening compounds, purification for reference standards or

biomarkers, to analytical testing and process development of compounds or mixtures.

Natural Product “Drug-Hunting” WuXi’s CBDR was established in 2010 as a modern botanical drug research provider offering pure compounds, fractions and extracts as a source for potential natural product leads for the pharmaceutical, crop science, and agrochemistry industries. The center has a team of experts with experience in natural product chemistry that offers end-to-end services such as isolation,

fractionation, purification, analytical method development and synthetic modification

of natural products from plant sources. The center provides a well characterized repository of plant extracts and makes

purified compounds and extracts available

to our clients as well as our internal team of chemists in pursuit of new botanical and semi-synthetic natural product

derived drugs. The team has identified

and characterized almost 2800 different structures, providing a reliable source of novel bioactive compounds with a high level of chemical diversity.

Traditionally, researchers investigating the potential of natural products have been concerned about small available quantities and the lack of backup supplies.

WuXi’s highly respected chemistry team,

with more than 45 dedicated natural product

chemists, has solved the problem of small

quantities. High speed purification and

separation capabilities, including SFC-MS

and efficient synthetic route design coupled

with structure elucidation, reduces concern for re-supply. “We have helped reduce average times for the isolation and structure elucidation of bioactive compounds to just a few weeks,” said Huijan Jia, PhD, head of CBDR.

(18)

To address the lack of backup supplies, WuXi has developed a process to obtain and verify samples, perform extensive quality control and archive records that has been streamlined by

the team of more than 60 trained scientists. “We

have also helped our clients with raw material sourcing and selection, literature searches and extraction method development to enable them to restock their own arsenal,” said Dr. Jia.

Kawain

Natural Product Libraries

Inspired by these “naturally selected” molecules, WuXi AppTec has dedicated a team to develop novel compounds using the unique scaffolds and a deep understanding of the drugability of molecules for human health.

Natural products provide a broad and novel diversity of compounds often with a higher percentage of bioactivity than seen through de novo combinatorial chemistry. Using the bounty of bioactive natural products to meet the challenge of lead libraries requires a combination of structure determination, compound characterization, and creative drug design through structure activity prediction and computer assisted drug design.

WuXi’s team in Shanghai has been able to utilize natural product resources as building blocks for novel nature-derived library designs. Exploring

the natural product scaffolds through different decorations and synthetic directions has enabled the creation of intriguing sets of compounds to be used in the hit-to-lead phase of drug discovery. Relying on our medchem know-how and computer aided drug design tools, we develop synthetically viable molecules that mimic the natural pharmacological space.

The therapeutic areas that we have focused

on include oncology, antiviral and CNS fields. More than 2600 compounds have been

realized, with 4700 under development. Molecules based on known natural

product scaffold starting points ― such as

Andrographolide, Galanthamine, Harman,

Sophocarpine, and Tylophorine ― have

provided novel compounds with promising biological activity. WuXi also offers custom library design based on these novel scaffolds and building blocks.

Natural Product Drug Discovery Reinvented

Over the last decade the tide of drug discovery flowed from natural products to

combinatorial chemistry, but now the tide

is flowing back with both approaches being reinvented together. Our fully integrated drug

discovery services provide high throughput screening of existing or custom natural product libraries, and lead optimization. WuXi’s experience in botanical product sourcing, interrogation, structure elucidation and quality control combined with our

synthetic and medchem know-how positions us to to assist our clients in using natural selection as a tool to discover new medicines.

1F. Petersen, CHI symposium on

“Diversity-Oriented Synthesis and Natural Product

(19)

Complex CYP Structures in Drug Discovery

CYP enzymes in drug discovery

The cytochrome P450 superfamily (CYPs) is a large and diverse group of enzymes and

isoforms that are the major enzymes involved in drug metabolism and detoxification. Many drug responses are regulated by inhibition (decreasing the metabolic activity) or induction (increasing of the biosynthesis) of these enzymes. The effects are a major source of adverse drug-drug

interaction, since changes in CYP enzyme activity made by one drug may affect the metabolism and clearance of other drugs.

In cases where a new drug inhibits the CYP-mediated metabolism of another drug, the affected drug may accumulate within the body to toxic levels or, for drugs that require the formation of an active metabolite, inhibition of the CYP-mediated activity may lower the expected response. Conversely, induction of a critical CYP enzyme may reduce activity more rapidly than expected. As an example of drug-drug interactions, consider protease inhibitors used to treat patients

infected with the human immunodeficiency and hepatitis viruses. These drugs are often used in a ‘cocktail’ with other medications, all metabolized by the CYP450 enzymes and consequently

presenting complex interactions. By understanding the unique functions and characteristics of these enzymes, drug developers may better anticipate interactions and manage drug and clinical

trial design for a specific therapeutic indication.

CYP3A4 is the most abundant cytochrome enzyme in the liver (where a majority of deactivation takes place) and is present in significant levels in the intestine (often the site where bioactivation occurs). This enzyme is involved in the metabolism of almost half of all drugs prescribed today.

Hence, the 3A4 enzyme is relevant in many clinically important drug interactions.

Another common isoform, CYP2D6, is responsible for the metabolism of many therapeutic agents. CYP2D6 has been studied extensively because it exhibits genetic polymophism ―

distinct population differences in its expression or activity. Approximately 7 to 10 percent of

Caucasians are poor metabolizers of drugs metabolized by CYP2D6 (Asians and blacks to a lesser extent). These individuals, classified as ‘poor metabolizers,’ are at risk for drug

accumulation and toxicity from drugs metabolized by this isoform. Importance of complex structures in drug discovery

Three-dimensional (3D) crystal structures of protein-ligand complexes determined by X-ray

crystallography as part of structure-based drug design have proven effective in drug discovery and development.

CYPs all have a common basic structure with six different substrate binding sites; they are

therefore able to accommodate a large variety of compounds. This structural similarity,,

however, cannot be used to predict which isoforms will be responsible for a drug’s metabolism. Understanding which isoform is involved in metabolism of a new drug is critical and often determined through in vitro assessment. Once the main CYP isoforms are identified and

implications assessed, examining the structural basis allows for the optimization of a lead compound.

(20)

By defining the structure of a drug with an important CYP enzyme, scientists can determine how

the active site of the enzyme accommodates a substrate. Analysis of CYP-substrate structure enables researchers to modify drug biomolecules in a rational way to alter their interaction and function.

Infrastructure and requirements for high precision structural analysis

The CYP enzymes are membrane-bound proteins, thus posing a difficult task for crystallization.

In addition to the native structure, the crystallization of a CYP-substrate interaction is even more challenging. This crystallization step requires a high level of precision.

WuXi’s team of ‘gene-to-structure’ scientists offers comprehensive structure resolution services that include protein expression, crystallization, structure determination and structure analysis. The team has solved the structure of the human CYP enzyme 3A4 with several bound ligands, at a resolution beyond 1.8 Å, allowing our clients to visualize how a drug interacts within the relevant binding pocket. Some 3A4 complex structures were completed at 3.0 Å resolution, which can disclose the major features about how the ligands allocate in the binding pocket. WuXi is also

close to solving a complex structure with 2D6 – the next most prolific human CYP – other CYP structures, such as 2C5 and 2C9, are under development.

The crystallization step is often considered the bottleneck for some proteins as there is no simple correlation between properties of a protein and the optimal protocol for crystallization. WuXi’s team has the know-how and equipment to streamline the process by applying a broad screening of different crystallization conditions.

To generate the high resolution 3D structure, WuXi has a strong collaboration with the Shanghai Synchrotron Radiation Facility. The collaboration provides fast access, reducing down time for clients.

As we solve these structures, which provide valuable information, the utility available to our clients increases exponentially. WuXi has vast experience in solving the structure of a wide variety of drug targets including kinases, polymerases, membrane proteins, and other protein/protein complexes. Clients obtain the structures or take advantage of them through our medchem design and ADME services. The integration of the structural biology team delivers a fast, reliable, cost-effective lead optimization service for drug discovery.

(21)

WuXi Ready for a New Era of Antimicrobial

Therapeutics

The antibacterial group at WuXi has recently built a number of experimental capacities that expand the range of services from the standard

microbiological assays (MIC, MBC, time-kill, synergy/potentiation, etc.) to customized genetic

and genomic studies of antibiotic resistance and antibacterial pharmacology.

In a pilot study with an investigational antibacterial compound, the group analyzed the compound’s frequencies of resistance in several MRSA strains and isolated a number of spontaneous and drug-induced mutants that showed marked resistance to the compound. They proceeded to characterize the resistance

profiles of these strains to several standard

antibacterial drugs, and set up company-wide

collaborations to find out the genetic and

structural basis for the observed resistance. “We isolated a large number of resistant

mutants, said Dr. Deming Xu, Senior Director Infectious Disease Research, who was in charge of the study, “and asked the Wuxi

Genomic Center (WGC) to perform

whole-genome sequencing to see if they can pinpoint the mutations that are linked to resistance.” The WGC was not informed of the nature of the antibacterial compound used in the genetic screening. “This way,” explained Dr. Hongye Sun, VP Genome Center, “we would do data processing and analysis without bias, and put

the WGC scientists to a test.” The final results

came out in less than 2 weeks, and mutations

in the target gene were unequivocally identified

in all the resistant mutants but not the starting strains. This information was then passed onto the Structural Biology Team, headed by Dr. Jian Li. All the mutation sites were mapped to the putative binding site of the antibacterial compound. In fact, the observed resistance can be readily explained by changes in the amino acids in the binding site that perturb the interactions between the compound and the target.

“This was a very exciting outcome,” said Dr. Xu, “as it demonstrated WuXi’s ability to integrate its internal resources and the quality of science its scientists can deliver.” His group is collaborating with Dr. Sun’s team to analyze resistant mutants isolated from animals exposed to therapeutic antibiotics. The genetic basis for resistance is

more complex. They want to find out how feasible

it is to apply the genomic approach to studying mechanisms of resistance in vivo.

Since last November, when Dr. Xu joined WuXi, the antibacterial group has built in vivo capacities as well. Dr. Xu explains, “Unlike other therapeutic areas, the anti-bacterial/anti-fungal in vivo biology is highly translatable. What we see in the animal models is quite predictive of what will happen in humans.” The company decided

to invest significant resources in anti-infective

pharmacology as early as the beginning of 2010. As a result, WuXi now has ABSL-2 facilities

that can host up to 5,000 rodents dedicated specifically to anti-infective research and run at least five concurrent animal models of bacterial,

viral and fungal infections. The facilities are ready to support clients with in vivo efficacy and

resistance studies, as well as pharmacokinetic and pharmacodynamics research. Further, the animal facilities have been fully accredited – for the second consecutive time – by AAALAC, the international organization that oversees the use of laboratory animals.

(22)

Dr. Xu and his team took a fast-forward approach to antibacterial pharmacology. They built animal models of local, systemic and pulmonary bacterial infections in a short period of time, after which careful validation was performed on selected few. “We want to demonstrate that WuXi has the ability to rapidly build models ready for use. But more important, we invite clients to work with us to tweak and then validate models to

meet their specific needs,” said Dr.

This graph depicts the complex structure of the antibacterial compound used in the genetic screening and its binding site in the target protein. The highlighted amino acids are those that were changed in the mutants isolated based on their resistance to the compound. The WuXi Genome

Center identified these mutations by whole-genome

sequencing, and the Structural Biology team mapped all the mutations to the binding site in the target protein.

Xu, whose responsibility extends to both in vitro and in vivo antibacterial research.

WuXi is fully committed to supporting anti-bacterial/anti-fungal research. The capacities built so far are transferable, and can be readily deployed to other pathogens. Continuing their microbiological and biochemical support to medicinal chemistry programs or independent projects, the team aims to incorporate genetics, genomics and pharmacology into customized antibacterial research programs, enabling the acceleration of studies on mechanisms of action and resistance, and in vivo properties,

including efficacy.

“WuXi has the resources to assess lead antibacterial compounds and determine if they are

progressable,” said Dr. Henry Lu, VP, Infectious Disease Research. “We remain strongly committed to our antibacterial program and can perform the highest level medicinal chemistry to advance a program to its satisfactory conclusion.”

(23)

Highlights of Biologics and Genetic

Toxicology Preclinical Services in Suzhou

Genetic Toxicology

The Genetic Toxicology Laboratory at WuXi AppTec Suzhou was established in 2009. It achieved

SFDA certification and received a statement of GLP compliance from a European OECD member

country in 2010. Within the last year, close to 100 GLP and non-GLP genetic toxicology studies have been completed.

WuXi provides a range of validated standard assays and an appropriate battery of tests to meet international regulatory requirements for pharmaceuticals, chemicals and agro-chemicals.

Emphasis is placed on producing high quality results and reports while significantly minimizing costs

and the timeframe required whenever there are tight schedules to meet. Non-GLP screening versions

of these assays can also be developed to meet specific client requirements.

WuXi’s Genetic Toxicology service offering includes: Screening Assays

• Mini Ames

• Microwell micronucleus assays

In Vitro Assays

• Ames Assay

In Vitro Chromosome Aberration Assay in CHO-WBL Cells or Human Lymphocytes

• Mouse Lymphoma Assay in L5178Y Cells

In Vitro Micronucleus Assay Using CHO-WBL Cells

In Vivo Assays

• Rodent (Rat or Mouse) Bone Marrow Micronucleus Assay • Integration into standard toxicology studies

Other

• Advice on regulatory requirements and testing strategy • GLP and analytical chemistry support

(24)

Guidance for preclinical safety assessment of biotechnology-derived pharmaceuticals has recently

been updated with the revised ICH S6 (R1) reaching Step 4 in June 2011. At WuXi AppTec our

integrated service platform for biologics development includes extensive capabilities to meet the requirements of this guideline, in line with our goal to help our worldwide customers shorten the time

and lower the cost of R&D through cost-effective and efficient outsourcing solutions. Pre-Clinical Study Capabilities

Our pre-clinical studies for biologics are customized for each product and designed to generate

meaningful results through the performance of a thorough scientific and regulatory-compliant program. WuXi AppTec’s scientific team has experience in assisting our sponsors to design repeat toxicology

studies in both rodents and non-human primates. Study designs may typically be enhanced with

pharmacodynamic and immunogenicity analyses, local tolerance evaluation (Draize measurement), and immunomodulating assessment via KLH challenge (TDAR).

Fully GLP-compliant analytical support is also available and includes analytical and bioanalytical method development and validation, as well as assessment of a test compound’s potential immunogenic or immunotoxic effects.

WuXi AppTec’s Immunology Services

• TCR/Immunohistochemistry • Immunochemistry

• Flow Cytometry

WuXi AppTec’s Toxicology Services

• FDA, OECD, SFDA Good Laboratory Practice (GLP) compliant • Complete range of studies: ――PK studies

――Dose-range finding or MTD studies ――Single dose (acute toxicity) studies

――Repeat dose (sub-acute, sub-chronic and chronic) studies Other services available at WuXi AppTec:

• Analytical Chemistry – method development, validation and sample analysis • Safety Pharmacology – CNS, respiratory and cardiovascular, hERG • Anatomic and Clinical Pathology

As WuXi AppTec is only AAALAC-accredited

CRO in China to receive

a statement of GLP

compliance from an OECD member country (Belgium) and a certificate of GLP

compliance from China’s

SFDA (State Food and Drug Administration), we help our

partners accelerate their

timelines at a significant

(25)

Chris Chen, Ph.D.

Senior Vice President and Chief

Technology Officer, Biologics Services

Over 12 years’ experience in

large-scale cell culture development and manufacturing and MBA vaccine

de-velopment. Formerly CEO of Shanghai Kanda Biotechnology; COO of Shang

-hai Celgen; Director of Process Sci

-ence and Production at Eli Lilly/AME;

Manager of BioProcess Technology at Merck. Ph.D. from University of Dela-ware. B.S. from Tsinghua University.

Hongye Sun, Ph.D.

Vice President of Operation and

Technol-ogy Platform, and Chief Operation Officer,

WuXi Genome Center

Over 10 years’ experience in DNA se -quencing technology research and

de-velopment at Applied Biosystems (now Life Technologies Corp). Led a multi-dis -ciplinary team to develop real-time single molecule DNA sequencing technologies. Ph.D. from Peking University and post-doctoral fellow at Harvard University and University of Kansas.

New Personnel

Xiao Feng Vice President of

Biological Platform Technology

Over 20 years’ experience in therapeu -tic antibody drug discovery and about 10

years’ clinic practice experience; worked as CEO at Beijing ABCO Pharmaceuticals Co.

Ltd., Vice President at GenScript USA Inc., Director at Lexicon Pharmaceuticals Inc.,

and Senior Manager at Amgen (previously Abgenix) Master’s degree in Biochemistry

and Molecular Biology from Beijing Medical University.

Linus Lin, Ph.D.

Vice President of Operation and Chemis-try, Global Head of Chemistry Technology and Services

Over 10 years of experience in the field of

synthetic chemistry and in building high

performance teams; worked at Merck as the Global Chemistry Operations Lead;

successfully delivered 7 preclinical candi-dates with one completed Phase II study. B.S. from Peking University, PhD from the University of Wisconsin, and NIH postdoc-toral fellow at Harvard University under the direction of Nobel laureate Prof E.J. Corey.

(26)

Jun Wang, Ph.D.

Senior Director,

Protein Purification,Biologics

Twenty years of extensive experi-ence in protein biochemistry and molecular biology. Formerly princi-pal scientist at Bayer Healthcare. Ph.D from chemistry department, Columbia University.

Kaylen Li

Senior Director, Regulatory Affairs

More than 15 years’ experience in phar -maceutical product registration in Chi-na. Formerly Regulatory Affairs Director at Baxter; Regulatory Affairs Senior Manager at Eli Lilly, Serono, Bayer and domestic pharmaceutical companies. B.S. in Biology from Lanzhou University.

Qiang Xu, Ph.D.

Senior Director, Bioinformatics, Genome Center

Over 8 years’ experience in phar -maceutical and biotech industry. Held multiple research positions at Novartis and Genentec. Formerly Director of R&D, Informatics and Biomarker Services at AltheaDx. B.S. from Peking University. Ph.D. from UCLA.

Sam Tadayon, Ph.D.

Senior Director, Process R&D

Over 17 years’ experience in the area of crystallization, polymorphism, and salt formation and selection. Formerly senior scientist at Wyeth Pharmaceutical/Canada. Ph.D. in Chemical Engineering from Univer-sity of Saskatchewan/Canada, post-doctorate at University of Western Ontario/Canada.

Steve Mason, M.Sc.

Vice President, Operations, Preclinical Services

Over 17 years’ experience in the CRO industry, in Europe (Huntingdon Life Sciences), North America and Asia (Charles River Laboratories). Formerly Scientific Director of Safety Pharma -cology at Charles River Montreal and Director In Vivo Sciences and Site Director at Charles River Shanghai. M.Sc. in Toxicology from RMIT Univer-sity in Australia.

Yundi Chen, Ph.D.

Senior Director, DNA Sequencing

Over 12 years’ experience in DNA sequencing. Formerly Field Applications Supervisor at Illumina and Application and Support Manager at Applied Bio-systems. Ph.D. in Biochemistry and Molecular Biology from Shanghai Jiao-tong University.

New Personnel

Jincai Li, Ph.D.

Senior Director, Cell Culture Process Development

Over 15 years of experience in bioprocess development, scale-up and tech transfer, including 6 years at Genentech and Tanox. BS from Tsinghua University. Ph.D. from University of Maryland.

Julie-Ann Cabana, B.Sc., MBA

Executive Director Business Devel-opment and Marketing, Preclinical Services

Over 12 years’ experience in the preclinical industry. Formerly Director of Business Development at Charles River Laboratories. MBA from Hautes Etudes Commerciales at the Univer-sity of Montreal, Canada.

Jill Cai

Senior Director Cell Line Development

Over 23 years of research experi -ence, including 10 years at Amgen, on antibody discovery, selection and production cell line develop-ment.

(27)

Distinguished Guest Speakers Lecture

at WuXi

Oct. 24

Prof. Richard A. Young Enzon Pharmaceuticals Topic: Contral of Cell State in Health and Disease

Oct. 21

Dr. John J. Pinwinski JJPiwinski Pharma Consulting

Topic: Identifying Leads for Discovering New Therapeutic Agents

Oct. 18

Prof. Jin-Quan Yu The Scripps Research Institute

Topic: Accelerated C-H Activation Reactions: A Shortcut to Drug Molecules from Chemical Feedstock

Oct. 11

Prof. Bin Wang Fudan University Topic: Discovery of Toeragenic Vaccine

Technology and Its Potential Clinical Applications

Sep. 26

Dr. Ting-Chao Chou Memorial Sloan-Kettering Cancer Center

Topic: The Synthetic

Panaxytriol Compounds as the Cytoprotective Agents for Cancer Chemo and Radiation Therapies

Sep. 22

Prof. Christopher Abell University of Cambridge Topic: Fragment Based Approaches in Drug Discovery and Chemical Biology

Sep. 21

Dr. Teruo Umemoto

UBE America Inc., Colorado Topic: Discovery of the New

Fluorinating Agent, FLUOLEAD,

and Practical Industrial

Processes for the Production of

Arylsulfur Pentafluorides

August 30 Dr. Shing Chang DNDI R&D

Topic: Neglected Diseases and Neglected Patients Why Do We Care

August 23

Prof. Eric Sorensen Princeton University

Topic: Design and Synthesis of Novel Molecular Scaffolds with Anti-infective Activity

August 22

Dr. Ronald M. Kim Merck Research Labs Topic: Glucagon Receptor Antagonists for the Treatment of Type 2 Diabetes

August 18

Dr. Bin-Bing Zhou

Pfizer Oncology Reasearch

Unit-East

Topic: Cancer Drug Resistance and Drug Discovery: From Checkpoints to Tumor Initiating Cells

(28)

Hui Cai, PhD, MBA

Vice President, Corporate Alliances

Phone: +1 858 361 8838 US Phone: +86 138 1732 0515 China

Email: [email protected]

Lulu Tang

Assistant Director, Customer Service

Phone: +86 21 5046 2477 Phone: +86 186 0218 4268

Email: [email protected] Naruhito Masai, PhD

Vice President, Business Development

for Japan and Specified Region Phone: +86 21 5046 3725 Phone: +86 137 6173 3955

Email: [email protected]

Learn more at: www.wuxiapptec.com Subscribe: [email protected]

Contact Us

[email protected]

[email protected]

Bill Farley

Vice President, Key Accounts

Phone: +1 651-398-4027 US

Email: [email protected]

Structural Biology X-Ray Crystallography High Throughput Screening Medicinal Chemistry Synthetic Chemistry Discovery Biology Pharmacology ADME - DMPK Process R&D Formulation Analytical R&D GMP Manufacturing GLP Bioanalytical Services Non-GLP and GLP Toxicology

Abgent at www.abgent.com greenchemistrygroup.org/pdf/2011/Liu2_SFC_2011_ WuXi’s CBDR was established in 2010 as

References

Related documents