Summer 2011 - WuXi AppTec
Summer 2011 - WuXi AppTec
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 />
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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 />
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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 />
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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 />
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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 />
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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