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Summer 2011 - WuXi AppTec

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Pharmaceutical<br />

Services<br />

Structural Biology<br />

X-Ray Crystallography<br />

High Throughput Screening<br />

Medicinal Chemistry<br />

Synthetic Chemistry<br />

Discovery Biology<br />

Pharmacology<br />

ADME - DMPK<br />

Process R&D<br />

Formulation<br />

Analytical R&D<br />

GMP Manufacturing<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

<strong>Summer</strong> <strong>2011</strong><br />

GLP Bioanalytical Services<br />

Non-GLP and GLP Toxicology


Page 2<br />

What’s New<br />

Contents<br />

Dr. Ge Li Honored with BayHelix Lifetime Achievement Award<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

<strong>WuXi</strong> <strong>AppTec</strong> Invests in Greater Radiolabeling Capabilities to Support Drug Research<br />

U.S. Executives and Biotechnology Industry Organization visit China and <strong>WuXi</strong> Apptec<br />

Seasoned Industry Veterans Join <strong>WuXi</strong> Apptec<br />

New Bioanalytical Facility Based in United States Opens<br />

Service Spotlight<br />

Expertise and Resources: Building a Better Oncology Platform<br />

<strong>WuXi</strong> <strong>AppTec</strong>’s GLP Bioanalytical Services Meeting Bioequivalent Demand<br />

Pre-Clinical Research Facility<br />

Perspectives<br />

Q&A with Dr. Jerry Xu - US FDA 21st Century Challenge<br />

Distinguished Guest Speakers Lecture at <strong>WuXi</strong><br />

Dr. Richard Soll speaks at the “Powering Global Innovation” BayBio Conference<br />

Upcoming Events


Page 1<br />

Dr. Ge Li Honored with BayHelix<br />

Lifetime Achievement Award<br />

On April 10th, <strong>2011</strong>, Dr. Ge Li, <strong>WuXi</strong> <strong>AppTec</strong><br />

Chairman and Chief Executive Officer, received<br />

BayHelix Lifetime Achievement Award at the<br />

BayHelilx 8th Annual Conference in Shanghai,<br />

China.<br />

BayHelix is an organization of leaders of<br />

Chinese heritage in the global life sciences<br />

and healthcare community, aiming to shape<br />

the growth of the life sciences and healthcare<br />

industry around the Pacific Rim and beyond;<br />

foster and create business opportunities; supply<br />

and nurture the leaders for the community; and<br />

network and share information and experience.<br />

Dr. Li was honored with the BayHelix Lifetime<br />

Achievement Award in recognition of his<br />

outstanding contributions to the pharmaceutical<br />

industry in both China and the world. In the<br />

past ten years, Dr. Ge Li pioneered China’s<br />

pharmaceutical R&D CRO industry. Under Dr.<br />

Li’s leadership, <strong>WuXi</strong> <strong>AppTec</strong> industrialized<br />

pharmaceutical R&D services, transformed the<br />

pharmaceutical industry, and attracted global<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

pharmaceutical companies to shift their R&D<br />

into China.<br />

“I am honored to receive the BayHelix Lifetime<br />

Achievement Award,” commented Dr. Ge Li.<br />

“This is recognition of <strong>WuXi</strong> <strong>AppTec</strong>’s integrated<br />

R&D service model. The vision of <strong>WuXi</strong> <strong>AppTec</strong><br />

is to establish an integrated drug R&D service<br />

platform to help anyone, any company achieve<br />

real results by leveraging <strong>WuXi</strong> <strong>AppTec</strong>’s<br />

resources to discover and develop new drugs<br />

to benefit patients. Even<br />

though this is a lifetime<br />

achievement award, I’m<br />

not done yet. In next<br />

ten years, we want to<br />

build <strong>WuXi</strong> <strong>AppTec</strong> into a<br />

technology and platform<br />

company. With China’s<br />

economic development,<br />

more people will have<br />

better quality of life and<br />

demand better drugs. I<br />

will work with all <strong>WuXi</strong><br />

<strong>AppTec</strong> employees with<br />

passion to continue to<br />

serve the future needs of<br />

pharmaceutical industry.”


Page 2<br />

<strong>WuXi</strong> <strong>AppTec</strong><br />

Invests in Greater<br />

Radiolabeling<br />

Capabilities to<br />

Support Drug<br />

Research<br />

<strong>WuXi</strong> <strong>AppTec</strong> acquired radiosynthesis specialty<br />

firm Chemdepo based in Camarillo, CA in<br />

March <strong>2011</strong>.<br />

The specialty firm was established in 2007<br />

with a focus on custom synthesis of carbon<br />

14 radiolabeled compounds, and stable<br />

isotope labeled compounds. The company’s<br />

3,000 ft 2 laboratory is fully equipped and<br />

licensed for handling volatile and basic labeled<br />

compounds.<br />

Expertise includes:<br />

h 14 C labeled intermediates, organometallic<br />

complex compounds, organosilicon,<br />

boronic reagents<br />

h Custom labeling heterocyclic compounds<br />

h Asymmetric synthesis of amino acids<br />

h Synthesis of organophosphate, pesticides,<br />

nucleosides and nucleotides<br />

h Moisture sensitive 14 C labeled compounds<br />

The Chemdepo facility was an attractive<br />

partnership for <strong>WuXi</strong> <strong>AppTec</strong> due the high<br />

quality of readily available 14 C radiochemicals<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Vacuum line operation<br />

and the dedication of the custom<br />

radiosynthesis team. Chemdepo leaders Guo-<br />

Qiang Cao, PhD and Michael Chang provide<br />

almost 50 years of combined experience in<br />

radio and organic synthesis.<br />

The goals and integrity of the team align<br />

well with the <strong>WuXi</strong> <strong>AppTec</strong> commitment to<br />

excellence offering guaranteed confidentiality,<br />

fast delivery (~4 weeks), and high purity<br />

(>98%) at competitive prices. The addition<br />

of this capability will increase Wuxi <strong>AppTec</strong>’s<br />

integrated program of discovery services,<br />

preclinical testing and manufacturing<br />

operations.<br />

Liquid Scintillation Counter


Page 3<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

U.S. Executives and Biotechnology<br />

Industry Organization visit China and<br />

<strong>WuXi</strong> Apptec<br />

“For the US, Europe and Japan pharma<br />

industries struggling with an increasing need<br />

for R&D productivity and efficiency, China<br />

is an attractive resource. In addition, the<br />

Chinese market for pharmaceuticals, already<br />

the third-largest in the world, is expected<br />

to increase by 23%.” (1) Eyeing this fastmoving,<br />

attractive market, Biotechnology<br />

Industry Organization (BIO) and BioWorld,<br />

dedicated time to covering the challenges and<br />

opportunities of doing business in China.<br />

BIO’s president and CEO, Jim Greenwood,<br />

led a delegation of members to China as<br />

a prelude to their partnering conference<br />

scheduled later this year. Jim and executives<br />

from the U.S. Biotech industry spoke with Tom<br />

Wall of BioWorld regarding the status of the<br />

biotech industry in China today. <strong>WuXi</strong> <strong>AppTec</strong>,<br />

as the leading CRO in China, made headlines<br />

in this segment.<br />

Jim Greenwood proclaimed “China increasing<br />

is stockpiling bright scientists, many who were<br />

educated or worked in the U.S. and have<br />

returned. There is a deep bench of scientists<br />

able to do some very good frontline research.”<br />

1 “China’s booming pharma sector welcomes western investors” Michael Stones, in-Pharma Technologist.com, April 4, <strong>2011</strong>.


Page 4<br />

“Sea turtles (a pun meaning ‘returned from<br />

overseas’) contribute to biotech innovation<br />

in China,” Dr. Ge Li, President and CEO of<br />

<strong>WuXi</strong> <strong>AppTec</strong> noted, “with their advanced<br />

education in top U.S. schools and vast<br />

experience acquired from working many years<br />

in big pharma companies and top biotech<br />

companies in the U.S., Europe and Japan.<br />

Innovation and entrepreneurship have no<br />

boundary,” he explained. “China’s biotech<br />

industry is growing faster today because it<br />

is still at its early stage. Strong government<br />

support and great interest and commitment<br />

from returnees have also propelled the fast<br />

growth of China’s biotech industry.” (2)<br />

Joshua Boger, founder of Vertex<br />

Pharmaceuticals Inc. spoke with BioWorld<br />

about his visit to the <strong>WuXi</strong> <strong>AppTec</strong> site when<br />

selecting a partner for the manufacture of<br />

their new hepatitis C drug Incivek (Telaprevir).<br />

“Suppliers all over the world were vying for the<br />

commercial manufacturing. Our criteria are<br />

quality and speed. Can they deliver? There<br />

was not a single corner cut, you can eat off<br />

the floor.” Boger said of <strong>WuXi</strong>’s SynTheAll<br />

Pharmaceuticals manufacturing site. (3)<br />

Boger was equally impressed with <strong>WuXi</strong>’s<br />

Suzhou toxicology site “It’s the package to get<br />

an IND started. The facilities were the best I’ve<br />

ever seen.”<br />

The BIO delegation found the only things<br />

holding back the promising biotech industry in<br />

China would be a cultural lack of innovation<br />

and an under-developed intellectual property<br />

protection system.<br />

Like many First-in-China steps taken by <strong>WuXi</strong><br />

<strong>AppTec</strong>, innovation and IP protection have<br />

been ingrained into the cultural fabric of the<br />

company. As the new complex and advanced<br />

biology programs showcase the innovation and<br />

return business from dozens of top companies<br />

proves, <strong>WuXi</strong> <strong>AppTec</strong> is a trusted innovator in<br />

the drug discovery space.<br />

Contributors<br />

2 “Return of the Sea Turtles Hastens Chinese Innovation” Tom Wall, BioWorld Today, June 10th , <strong>2011</strong><br />

3 “U.S. Executives Dispel the Myths of Operating in China” Tom Wall, BioWorld Today, May 18th, <strong>2011</strong><br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Biotechnology Industry Organization<br />

(BIO), created in 1993, is the world’s<br />

largest biotechnology organization<br />

whose aim is to foster innovation<br />

through advocacy, business<br />

development and communications.<br />

BioWorld is a publication that covers<br />

news in the pharmaceutical and<br />

biotechnology industry and scientific<br />

breakthroughs worldwide. The<br />

BioWorld online web site has been<br />

internationally recognized as the most<br />

comprehensive resource for strategic<br />

biotechnology news and information.


Page 5<br />

Seasoned Industry Veterans Join<br />

<strong>WuXi</strong> Apptec<br />

Jane Lin<br />

Vice President, Regulatory Affairs and Clinical<br />

Development<br />

Over 14 years’ experience in the<br />

pharmaceutical industry. Formerly Medical<br />

Director in Merck Sharp & Dohme and<br />

Baxter responsible for regulatory affairs,<br />

clinical research, medical affairs and<br />

pharmacovigilance in mainland China<br />

and Hong Kong. M.D. from Xi’an Jiaotong<br />

University and M.P.H. from Shanghai<br />

Jiaotong University.<br />

Jason Wan, Ph.D. and MBA<br />

Vice President, Pharmaceutical Science<br />

Over 21 years’ experience in<br />

formulation and drug delivery R&D,<br />

formerly Sr. Fellow and Head of<br />

Exploratory Formulation Development<br />

for Schering Plough/Merck. Prior<br />

employers include Pfizer, Alza /<br />

JNJ, and Syntex / Roche. Ph.D<br />

in Pharmaceutical Sciences from<br />

University of Southern California and<br />

MBA from University of Michigan.<br />

Richard J. Early, Ph.D.,<br />

DABT<br />

Senior Director, Toxicology<br />

Over 10 years of experience in<br />

contract toxicology research, over<br />

25 years of academic research<br />

and teaching, board certified in<br />

toxicology (DABT), Ph.D. in Animal<br />

and Nutritional Sciences from the<br />

University of Wisconsin-Madison.<br />

Gonghua Pan<br />

Vice President of Operation<br />

Head of Program Management Office<br />

Formerly Director and Head of<br />

Asia Research operation at Pfizer,<br />

with over 16 years’ drug discovery,<br />

outsourcing management and<br />

continuous improvement experiences<br />

at Pharmacopeia and Pfizer. Ph.D.<br />

from University of Wisconsin-Madison,<br />

MBA from School of Management at<br />

Yale University and B.S. from Peking<br />

University.<br />

Jerry Xu, Ph.D.<br />

Vice President of GMP QA and<br />

Regulatory Affairs<br />

Over 20 years’ experience in the<br />

pharmaceutical industry. Formerly<br />

CMC reviewer at FDA, Director<br />

of Process Development at<br />

Pharmaceutics International, Senior<br />

Manager of Global Technical Support<br />

at Wyeth, founder of Shanghai<br />

Fleecon Biomedical Inc. Ph.D. from<br />

Northeastern University.<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Neng Yang Shih, Ph.D.<br />

Chairman of Discovery Program Review<br />

Over 25 years’ experience in medicinal<br />

chemistry and drug discovery.<br />

Formerly Executive Director and Head<br />

of Chemistry at Merck’s Cambridge<br />

site. Ph.D. in Organic Chemistry from<br />

the University of Illinois at Chicago<br />

and post-doctoral fellow at Columbia<br />

University and Harvard University.<br />

Sue McPherson, ERT<br />

Executive Director, Toxicology<br />

Over 20 years’ experience within the<br />

CRO industry, in Europe (Huntingdon<br />

Life Sciences), Canada and Asia<br />

(Charles River Laboratories).<br />

Responsibilities ranged from Study<br />

Director, Study Director trainer,<br />

Manager of Toxicology group in<br />

Shanghai and Program Manager. MSc<br />

from the University of Hertfordshire.<br />

March <strong>2011</strong> was accepted as a<br />

European Registered Toxicologist.<br />

Shuhua Han, Ph.D.<br />

Senior Director, NPII<br />

20 years of experience in<br />

immunological research, Associate<br />

Professor in Baylor College of<br />

Medicine, Ph.D. from University<br />

of London, postdoctoral fellow in<br />

University of Maryland and Duke<br />

University.


Page 6<br />

New Bioanalytical Facility Based<br />

in United States Opens<br />

New Bioanalytical Facility<br />

Opened in May <strong>2011</strong>.<br />

<strong>WuXi</strong> <strong>AppTec</strong> recently opened a Bioanalytical Facility<br />

strategically located in Philadelphia, PA to provide<br />

sample analysis for US based companies that have<br />

extremely tight deadlines. The site will test both small<br />

molecules and biologics in preclinical and clinical<br />

samples in GLP conditions. The new facility follows<br />

same quality system as China Bioanalytical operation,<br />

which has been successfully inspected by US FDA<br />

and obtained GLP accreditation from China SFDA and<br />

OECD.<br />

The facility was sited in order to offer fast turnaround<br />

time; 1-2 days for locally based companies rather than<br />

4-6 days when sending the sample to China.<br />

“We pride ourselves on the speed at which our<br />

logistics team can expedite delivery of samples, taking<br />

advantage of the Green Channel for customs clearance<br />

and the free trade zone. 95% of samples clear customs<br />

within 24 hours, but in some very sensitive trials the<br />

extra few days is worth more than the savings found<br />

by using low cost locations” says Jinsong Xing, Vice<br />

President of Bioanalytical Service.<br />

<strong>WuXi</strong> understands the time-sensitive situation<br />

encountered for certain therapeutics. <strong>WuXi</strong><br />

PharmaTech acquired <strong>AppTec</strong> back in 2007 to increase<br />

the biologics and medical device reach of <strong>WuXi</strong> but<br />

also to establish a North America presence because<br />

sometimes clients require a testing site close to their<br />

trial site. Having facilities in both the US and China<br />

enables <strong>WuXi</strong> to provide tailor-made service to our<br />

strategic partners.<br />

Obviously, the bioanalytical asset will grow to serve<br />

more clients and sample types such as large molecules<br />

and drug product analysis.<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong>


Page 7<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Expertise and Resources: Building a<br />

Better Oncology Platform<br />

<strong>WuXi</strong> <strong>AppTec</strong> has been investing in people<br />

and technology to bolster our biology and<br />

pharmacology expertise across major<br />

therapeutic areas. A dedicated and highly<br />

qualified team of oncology experts has an<br />

ambitious plan to bring our clients the most<br />

up-to-date translational models for one of the<br />

most genetically diverse diseases.<br />

The <strong>WuXi</strong> strategy of bringing together a team<br />

of top industry experts and providing resources<br />

to pursue the most advanced technologies<br />

is a resounding success. In the last one and<br />

a half years, the team has developed and<br />

validated an in vitro platform including cellbased<br />

phenotypic and biomarker assays and<br />

in vivo tumor models including > 70 cell line<br />

xenograft models, orthotopic tumor models<br />

with bioluminescent analysis, and patientderived<br />

primary tumor models.<br />

“We chose to expand the orthotopic models<br />

because they represent the next phase in<br />

cancer research,” said Chi-Chung Chan, Ph.D.<br />

Gross and bioluminescent imaging of dissected<br />

left (L) and right (R) brain lobes at the end of<br />

experiments, showing no local metastasis. Arrows<br />

indicate primary tumors.<br />

Vice President of Biology, Head of Oncology.<br />

“The subcutaneous xenografts have a place<br />

when done properly and data are interpreted<br />

appropriately, but the more sophisticated<br />

approach of implanting the tumor in the target<br />

organ eliminates one of the factors that prevent<br />

the mouse model from being highly predictive<br />

of a drug’s effectiveness in humans.”<br />

<strong>WuXi</strong> is one of the few Chinese CROs that<br />

invested in equipment and training for the<br />

Xenogen IVIS imaging system to track the<br />

progress of implanted tumor development.<br />

A recent example of the combination<br />

of orthotopic tumor growth models and<br />

bioluminescent analysis is illustrated<br />

by the U87-luc glioblastoma model. A<br />

validation study with 8 mice over 32 days<br />

provided significant evidence of the robust<br />

procedures implemented by the team. Mice<br />

micro-injected with cells in the caudate<br />

nucleus were monitored with the Xenogen<br />

instrument throughout the study. Post study<br />

histological examination of the excised tumors<br />

demonstrates the cellular heterogeneity of<br />

the orthotopic xenografts match human tumor<br />

samples.


Page 8<br />

In addition to the technical skills in developing<br />

orthotopic models, our collaboration with<br />

research hospitals in Shanghai and Beijing<br />

has enriched our portfolio with patient-derived<br />

primary tumor samples.<br />

Subcutaneous xenograft models have been<br />

an industry standard for years, lung cancer<br />

being the most successful. However, using<br />

patient-derived tumor models for phenotypic<br />

evaluation is an example of advanced use<br />

of the subcutaneous xenograft model. Our<br />

validation of a patient derived lung cancer<br />

tumor in a mouse using paclitaxel, cisplatic and<br />

gemcitabine as controls demonstrates effective<br />

screening using this model (Fig 1).<br />

Taking the patient-derived tumors one step<br />

further for efficacy evaluation, <strong>WuXi</strong> <strong>AppTec</strong><br />

has successfully established orthotopic lung,<br />

pancreas, esophagus, liver, and kidney tumor<br />

models using patient samples. Validation using<br />

standard-of-care agents including gemcitabine<br />

show the implanted pancreatic tumor in an<br />

orthotopic model behaves as expected for the<br />

human tumor, retaining the original phenotype<br />

(Fig 2).<br />

Vehicle<br />

5-FU<br />

Gemcitabine<br />

1 cm<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Tracking Tumor Models<br />

The Xenogen IVIS Lumina II imaging<br />

system is in full operation with over<br />

20 cell lines.<br />

Fig.1 Lung Cancer Patient Tumor S.C. Xenografts in Nude<br />

Mice - Tumor Volume<br />

A tumor tissue bank with reliable, complete clinical information allows us to provide a translational<br />

research link with robust animal models. Furthermore, gene expression profiling and genetic<br />

analysis of patient derived tumor models provide critical information for model selection. The data<br />

of efficacy in mouse studies and molecular characteristics of clinical samples bridge our research<br />

from bench into clinic.<br />

<strong>WuXi</strong> invests in the platform, skills and know-how to help our innovative clients advance<br />

therapies to treat cancer more effectively.<br />

Fig.2 Tumors from mouse model of patient-derived pancreatic cancer


Page 9<br />

<strong>WuXi</strong> <strong>AppTec</strong>’s GLP<br />

Bioanalytical Services Meeting<br />

Bioequivalent Demand<br />

Bioequivalence Studies- Uptick in<br />

Need for Fast Efficient Bioanalytical<br />

Studies to Support Generic Filings.<br />

<strong>WuXi</strong> <strong>AppTec</strong> offers comprehensive<br />

bioanalytical services for both innovator<br />

and generic pharmaceutical companies.<br />

Thousands of samples have been analyzed in<br />

the past year to demonstrate bioequivalence<br />

of generics often produced by the innovator of<br />

the brand name drug.<br />

In most cases an equivalent substance will<br />

have the same active ingredient, dosage<br />

form, route of administration, and be identical<br />

in strength. This is all to ensure that two<br />

products are bioequivalent - that is, they have<br />

the same clinical and safety profile. Testing<br />

for bioequivalence is the last step in showing<br />

Therapeutic Equivalence to a reference listed<br />

drug.<br />

<strong>WuXi</strong> has developed and validated testing<br />

methodologies for evaluating the plasma<br />

drug concentration for a variety of systemic<br />

drugs. High throughput sample analysis<br />

using API 4000/5000/5500 and UPLC/Tomtec<br />

instruments ensure fast turnaround times “We<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

are able to quickly emulate the methodology<br />

for the reference substance at a level of<br />

validation suitable for ANDA submission” says<br />

Joe Wong, <strong>WuXi</strong> <strong>AppTec</strong> Senior Director<br />

Bioanalytical Services. “We don’t charge for<br />

the validation of an existing method keeping<br />

down costs for our clients. In a field where<br />

speed and regulatory compliance are essential<br />

our customers rely on us because of our robust<br />

process and internal audits; our Shanghai<br />

Bioanalytical facility has passed multiple global<br />

inspections; US FDA inspected in 2009 with no<br />

483 observations and GLP-certified by OECD<br />

and sFDA.”<br />

Bioequivalence testing is usually assessed<br />

by single dose in vivo studies in healthy<br />

volunteers. The most challenging part of<br />

rapidly testing human samples is often<br />

delivering the samples from the clinic to the<br />

lab. In the 10 years that <strong>WuXi</strong> <strong>AppTec</strong> has<br />

been doing business for Western pharma, an<br />

efficient system was established for importing<br />

and exporting materials. We took this same<br />

system and applied it to human plasma<br />

samples removing any delay, allowing for<br />

fast data analysis. Over 4,500 deliveries we<br />

received without delay in 2010 alone.


Page 10<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Pre-Clinical Research Facility<br />

Supporting Global Filings with Cost Effective Solutions<br />

<strong>WuXi</strong> regularly performs acute and repeat dose toxicology studies in both small and large animals.<br />

Working closely with Multinational Pharmaceutical and Biotech companies, <strong>WuXi</strong> supports many<br />

clients in North America, Europe and Asia in their drug development efforts for international<br />

submission.<br />

Our toxicology studies in both small and large animals as well as our laboratory services are<br />

conducted in full compliance with international Good Laboratory Practice (GLP) regulations. In<br />

addition, all protocols are designed to meet the regulatory requirements of the various countries in<br />

which the products are to enter clinical trials or be marketed.<br />

By focusing on quality, scientific expertise, flexibility, and responsiveness, <strong>WuXi</strong> collaborates with<br />

its sponsors to provide cost effective solutions with meaningful and compliant results.<br />

Overview of Services<br />

● General Toxicology<br />

● Genetic Toxicology<br />

● Safety Pharmacology<br />

● Immunology<br />

● Analytical Chemistry<br />

● Bioanalysis<br />

● Toxicokinetics and pharmacokinetics<br />

As the only AAALAC-accredited CRO in<br />

China to receive GLP certification from both<br />

OECD and SFDA (State Food and Drug<br />

Administration), <strong>WuXi</strong> helps our partners<br />

accelerate their timelines at a significant<br />

cost advantage.<br />

For general inquiries please contact us at<br />

CS@wuxiapptec.com


Page 11<br />

The FDA Strategic Priorities <strong>2011</strong>-<br />

2015 guidance document was<br />

released last month. We asked Dr.<br />

Jerry Xu to answer a few questions<br />

regarding the impact of these<br />

priorities for <strong>WuXi</strong> <strong>AppTec</strong> and our<br />

clients.<br />

Jerry Xu, Ph.D. is the Vice<br />

President of GMP QA and US<br />

Regulatory Affairs. He has over<br />

20 years of experience in the<br />

US pharmaceutical industry. His<br />

former roles include CMC reviewer<br />

at FDA, Director of Process Development<br />

at Pharmaceutics International, and Senior<br />

Manager of Global Technical Support at<br />

Wyeth.<br />

Dr. Xu is responsible for managing <strong>WuXi</strong><br />

<strong>AppTec</strong>’s quality assurance for GMP<br />

operations. His oversight includes designing<br />

and setting up quality systems for the<br />

dedicated drug substance and drug product<br />

stability testing lab for Bristol-Myers Squibb.<br />

Q: The guidance document laid out five ‘crosscutting’<br />

priorities areas for the US FDA over the<br />

next five years. Which of these areas do you<br />

feel will have the most impact on <strong>WuXi</strong> and the<br />

pharmaceutical drug development space?<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Q&A with Dr. Jerry Xu - US FDA 21st<br />

Century Challenge<br />

US FDA Cooperation<br />

<strong>WuXi</strong> <strong>AppTec</strong>’s 15,750 sq. ft. facility in<br />

Shanghai was audited by the US FDA<br />

in 2009 (with no 483 observations).<br />

A: The FDA commissioner<br />

selected five areas to serve<br />

as strategic priorities over<br />

the next five years. These<br />

include efforts to: 1) Advance<br />

regulatory science and<br />

innovation; 2) Strengthen<br />

the safety and integrity of<br />

the global supply chain;<br />

3-4) Strengthen efforts to<br />

meet needs of public health<br />

and special populations;<br />

and 5) Advance medical<br />

countermeasures and<br />

emergency preparedness.<br />

Among these, I feel that the first and second<br />

will have the most impact on us. The second<br />

“Strengthen the Safety and Integrity of the<br />

Global Supply Chain”, in particular, will have<br />

impact on global pharmaceutical companies,<br />

such as <strong>WuXi</strong> in China. We expect the<br />

FDA will strengthen its compliance and<br />

enforcement activities aboard. The Agency<br />

plans to implement new programs and tools<br />

to sharpen the effectiveness of its compliance<br />

and enforcement system.<br />

WuXI <strong>AppTec</strong> is in a unique position. We<br />

compete not only in pricing but also in quality<br />

services and reliability. <strong>WuXi</strong> has stellar track<br />

record with over 100 successful customer<br />

audits, in both the drug substance and drug<br />

product arenas.As a leading CRO in Asia,<br />

we have no one to follow but ourselves.<br />

Besides building a first class quality system<br />

that serves our global pharmaceutical clients,<br />

we believe in continuous self-improvement.<br />

Our goal is to improve our service, each<br />

time better than the last. This company<br />

culture differentiates <strong>WuXi</strong> from many of our


Page 12<br />

competitors. It provides a solid foundation for a<br />

good quality system. The FDA’s new Strategic<br />

Priorities will help further <strong>WuXi</strong>’s position to<br />

serve those who seek quality services in a<br />

CRO .<br />

Q: Asia has been the subject of some specific<br />

issues regarding supply chain integrity<br />

(contaminated Heparin, melamine-tainted pet<br />

foods) for example. How does <strong>WuXi</strong> ensure<br />

the integrity of the intermediates sourced<br />

for the manufacture of API and clinical trial<br />

materials?<br />

A: <strong>WuXi</strong> has a rigorous supply chain<br />

management process in place. We audit<br />

and qualify our suppliers before sourcing<br />

raw materials and intermediates. We also<br />

have in-coming material QC process in place<br />

before releasing materials for manufacturing.<br />

We have an impeccable track-record; our<br />

qualification process has never allowed any<br />

material discrepancy to pass from our audit to<br />

our client’s product.<br />

Q: The guidance document states the FDA<br />

must require more and better information<br />

about supply chains involving more strategic<br />

and consistent coordination among foreign<br />

counterparts. Does <strong>WuXi</strong> work with the China<br />

State Food and Drug Administration (SFDA)?<br />

A: Yes, <strong>WuXi</strong> <strong>AppTec</strong>’s facilities in Suzhou,<br />

Tianjin, and Shanghai have all been inspected<br />

by the SFDA. We work extensively with the<br />

SFDA with the mutual goal of ensuring the<br />

safety of the local Chinese population. We are<br />

in support of developing a global standard.<br />

We also work with regulatory agencies in<br />

Europe; in 2009 our drug product GMP facility<br />

was certified by EMEA. Coordinating with<br />

agencies around the world enables our service<br />

to support and ensure safety for clients with<br />

global markets.<br />

My Overall Comment Summary:<br />

As a leading CRO, our goal is to build a quality<br />

system that is in line with FDA’s 21 st century<br />

initiatives, a system that is both scientifically<br />

justified and effective. We continue to improve<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

our quality system through training, through<br />

internal audits, and by working closely with our<br />

US clients to leverage each other’s expertise<br />

on quality. In the continuous process of<br />

building a first class quality system in China,<br />

we will help strengthen the safety and integrity<br />

of our client’s global supply chain outsourcing.<br />

We are confident of our quality services. We<br />

look forward to working closely with the FDA<br />

in its future inspections of our GMP facilities.


Page 13<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Distinguished Guest Speakers<br />

Lecture at <strong>WuXi</strong><br />

May 19<br />

Dr. Kun-Liang Guan<br />

UC San Diego<br />

Topic: The mTOR and Hippo<br />

April 18,<br />

Professor Sunney Xie<br />

Harvard University<br />

Topic: Hold Life Processes<br />

up to the Light: Imaging and<br />

Sequencing Single Molecules in<br />

Singe Cells<br />

April 21,<br />

Dr. Junying Yuan,<br />

Harvard Medical School<br />

Topic: A Quest to Understand<br />

the Mechanism of<br />

Neurodegeneration<br />

March 4,<br />

Dr.Jos Brands<br />

Merck<br />

Topic: The Power of<br />

Crystallization-Induced<br />

Asymmetric Transformation<br />

in Efficient Synthesis for NK1<br />

Receptor Antagonist Aprepitant<br />

May 20,<br />

Dr. Robert E. Zelle<br />

Concert Pharmaceuticals Inc.,<br />

Topic: Serendipity and Drug<br />

Discoveries—When Opportunity<br />

Knocks, Will You Be There?<br />

March 6,<br />

Dr. Daniel Long<br />

Theravance<br />

Topic: A Multivalent Approach<br />

to Drug Discovery for Novel<br />

Antibiotics: Clinical Compound<br />

TD-1792<br />

March 21<br />

Dr. Milana Maletic<br />

Merck<br />

Topic: A Medication for the<br />

Fast Food Nation: Bicyclo<br />

[2.2.2] octyltriazole Inhibitors<br />

of 11beta-HSD1 For the<br />

Treatment of Metabolic<br />

Syndrome<br />

Signaling Pathways in Cell<br />

Growth, Organ Size, and<br />

Tumorigenesis<br />

March 16,<br />

Professor Nan-Sheng Li<br />

University of Chicago<br />

Topic: Total Synthesis of<br />

Enantiomeric Pureβ-D-Mannosyl<br />

Phosphomy—coketide (C32—<br />

MPM): A Natural Product from<br />

Mycobacterium Tuberculosis32<br />

April 13,<br />

Dr. Colin D. Funk<br />

Queen’s University<br />

Topic: Lipoxygenases and<br />

Leukotrienes in Health and<br />

Disease<br />

April 6,<br />

Dr. Yu-Hui Rogers<br />

The J. Craig Venter Institute<br />

Topic: JCVI Research<br />

Overview & Application of the<br />

Next Generation Sequencing<br />

Technologies at JCVI


Page 14<br />

Dr. Richard Soll speaks at the “Powering<br />

Global Innovation” BayBio Conference<br />

Panelists and Moderator for discussion on China<br />

innovation, R&D and clinical trials<br />

BayBio, a life science association in California<br />

USA, invited <strong>WuXi</strong> <strong>AppTec</strong>’s Richard Soll to<br />

be a panelist at the plenary session “Emerging<br />

Markets Strategies for R&D Success.”<br />

The breakfast meeting was attended by over<br />

400 industry members.<br />

The panel was moderated by Gail Maderis and<br />

included a diverse base of experts including:<br />

Richard Soll, PhD,<br />

Senior Vice President, Integrated Services, <strong>WuXi</strong><br />

<strong>AppTec</strong><br />

Gail Maderis,<br />

President and CEO, BayBio<br />

Sofie Qiao, PhD<br />

President, CEO and Co-Founder, LINQ<br />

Pharmaceuticals<br />

James Sullivan, PhD<br />

Vice President, Pharmaceuticals Discovery, Abbott<br />

Gene Williams<br />

Executive Chairman, Translational Medicine India<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

WXpress | <strong>Summer</strong> <strong>2011</strong><br />

Breakfast Hall at BayBio Emerging Markets<br />

Plenary Session<br />

Upcoming Event<br />

SFC, New York, NY USA, - July 20-22,<br />

<strong>2011</strong><br />

ChemOutsourcing, Long Branch, NJ,<br />

USA, - September 12-15<br />

American College or Toxicology,<br />

Phoenix, AZ USA November 6-9, <strong>2011</strong><br />

CHPI, Frankfurt, Germany, - October<br />

25-27, <strong>2011</strong><br />

Please click the event above for the detailed<br />

information.


Learn more at: www.wuxiapptec.com<br />

Subscribe: WXPRESS@<strong>WuXi</strong><strong>AppTec</strong>.com<br />

Contact Us<br />

Hui Cai, PhD, MBA<br />

Vice President, Business Development<br />

Phone: +1 858 361 8838 US<br />

Phone: +86 138 1732 0515 China<br />

Email: hui_cai@wuxiapptec.com<br />

Naruhito Masai, PhD<br />

Vice President, Business Development<br />

for Japan and Specified Region<br />

Phone: +86 21 5046 3725<br />

Phone: +86 137 6173 3955<br />

Email: masai@wuxiapptec.com<br />

customer_service@wuxiapptec.com<br />

info@wuxiapptec.com<br />

Bill Farley<br />

Vice President, Key Accounts<br />

Phone: +1 651-398-4027 US<br />

Email: bill.farley@wuxiapptec.com<br />

Shanghai · Suzhou · Tianjin · Philadelphia · St. Paul · Atlanta<br />

Pharmaceutical<br />

Services<br />

<strong>Summer</strong> <strong>2011</strong><br />

Structural Biology<br />

X-Ray Crystallography<br />

High Throughput Screening<br />

Medicinal Chemistry<br />

Synthetic Chemistry<br />

Discovery Biology<br />

Pharmacology<br />

ADME - DMPK<br />

Process R&D<br />

Formulation<br />

Analytical R&D<br />

GMP Manufacturing<br />

GLP Bioanalytical Services<br />

Non-GLP and GLP Toxicology<br />

Lulu Tang<br />

Assistant Director, Customer Service<br />

Phone: +86 21 5046 2477<br />

Phone: +86 186 0218 4268<br />

Email: tang_lulu@wuxiapptec.com

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