Clinical Logistics

Clinical Trials

Drug Discovery

Industry Leader Insight

Q1 2018

WuXi AppTec Laboratory Testing Division

<h3 class="p1"><span style="color: #008ace">WuXi AppTec has continued to build a comprehensive offering through organic growth and acquisition. Its Laboratory Testing Division is poised to play a key role in propelling the open-access capability and technology platform company forward with a full range of integrated testing services. As an organization, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&amp;D through cost-effective and efficient solutions.</span></h3>
<h4><span class="s1" style="color: #008ace">The Laboratory Testing Division</span></h4>
<p><span style="background-color: transparent">The Laboratory Testing Division covers nearly all testing capabilities involved in drug and medical device development, from early-stage R&amp;D to clinical diagnostics. It was formed in December 2013, when all of WuXi’s testing capabilities were combined into one powerhouse unit, adding a full range of DMPK, toxicology, bioanalytical, analytical and clinical diagnostics services to create a vast portfolio of IND- and NDA-enabling services.</span></p>
<p></p>
<p><span class="s2">Our progress since then has remained constant. Over the last four years, the Laboratory Testing Division has evolved to become a fully-integrated testing platform supporting customers across the full scope of drug discovery and development. We are continuously evolving to meet the ever-changing needs of our clients and global patient populations.</span></p>
<p class="p1"><span class="s1">Acquisition is a key component of our expansion strategy. One of the most recent changes to our division has been the addition of the Medical Device Testing Unit, formerly referred to as AppTec. The company, which specialized in medical device testing, was acquired by WuXi in January 2008. At the time of its acquisition, it was one of the top three medical device testing companies in the US. In October 2017, WuXi AppTec acquired ResearchPoint Global, a US-based CRO, in order to continue to build a more robust clinical CRO offering.</p>
<p></span></p>
<p class="p1"><span class="s1"><img loading="lazy" src="https://thatsnice-testing3.com/legacy/Q1%202018%20/PA_Q118_Wuxi_Sidebar1.gif" alt="PA_Q118_Wuxi_Sidebar1.gif" width="716" height="516"></p>
<p></span></p>
<h4><span style="color: #008ace">Platform to Patient</span></h4>
<p><span class="s2">At its core, WuXi is a platform company that is committed to enabling innovative therapies to benefit patients. The Laboratory Testing Division offers comprehensive solutions that stem from this commitment, enabling customers to take their projects from lab to patient on an accelerated timeline. Our “Platform to Patient” philosophy speaks to the many layers that comprise the organization’s vision, as it emphasizes the value of consistently delivering high-quality study data from early through late phases of development, while also serving to connect the Laboratory Testing Division to the other areas of the WuXi business.</span></p>
<p class="p3"><span class="s2">As an integrated testing platform, the Laboratory Testing Division is uniquely positioned to aid our customers in all of their testing and development needs. Our goal is to ensure our clients are able to deliver innovative medicines faster and more cost-effectively. To best address any request, the Laboratory Testing Division is divided into three key platforms—preclinical drug development, clinical drug development and medical device testing. </span></p>
<p>&nbsp;</p>
<div class="callout">
<h4 class="callout-title"><span style="color: #008fd1">When customers work with us, they are working with a partner fully committed to the success of their project.</span></h4>
</div>
<h4>&nbsp;</h4>
<h4><span style="color: #008ace">WuXi Plus IND Form WIND </span></h4>
<p class="p2"><span class="s2">Our preclinical drug development services support the testing, document preparation and regulatory submission for Investigational New Drug (IND) applications. Our commitment to meeting all goals within an accelerated timeline and hands-on program management, coupled with extensive expertise in both US and China-specific regulations, makes us fully equipped to support the full scope of any drug development program. WuXi and IND combine together to form our “WIND” program, which takes customers from the initial steps of document preparation all the way through to submission. Our IND-enabling services include CMC and analytical development, bioanalytical solutions, full-scale <i>in vitro</i> and<i> in vivo</i> ADME and PK/PD, as well as preclinical and clinical toxicology safety assessments. </span></p>
<p class="p3"><span class="s2">WIND combines our open-access capability and technology platform, program management and regulatory support services to facilitate our customers’ global IND applications, designing customized solutions that fit the needs of each individual project. Our team of regulatory experts support IND submissions to global regulatory bodies, including the CFDA and FDA.</span></p>
<h4><span style="color: #008ace">Complete Clinical Development</span></h4>
<p class="p2">The transition from preclinical to clinical studies should be seamless. As we provide support at all levels and across all phases, our goal is to ensure that regardless of when we take on a project, we are able to successfully progress it though each development stage, leveraging our vast range of technical capabilities. Our clinical development services include, but are not limited to: small molecule and biologics quantitation, generic/biosimilar and innovator study support, biomarker testing, PK Met ID, mass balance (hot &amp; cold), CYP, Phase II enzyme and transporter substrate phenotyping, chronic and subchronic toxicology, Seg I-III DART studies, carcinogenicity studies, juvenile toxicology, four-week batch impurity testing, late-phase commercial analytical development, stability studies, regulatory CMC and project management.</p>
<p class="p2">&nbsp;</p>
<div class="callout">
<h4 class="callout-title"><span style="color: #008fd1">Our commitment to meeting all goals within an accelerated timeline and hands-on program management, coupled with extensive expertise in both US and China-specific regulations, makes us fully equipped to support the full scope of any drug development program. </span></h4>
</div>
<h4 class="p1"><span class="s1" style="color: #008fd1">&nbsp;</span></h4>
<h4><span style="color: #008ace">Partnering through Medical Device Testing</span></h4>
<p class="p2">When customers work with us, they are working with a partner fully committed to the success of their project. We understand the challenges associated with getting a medical device to market, and our scientists have the expertise and experience to proactively support this endeavor within an ever-changing regulatory environment.</p>
<p class="p3"><span class="s2">What definitively sets us apart — as an organization, business unit and testing platform — is our people. Our medical device testing experts not only serve on international standards committees as active participants, but as leaders. In addition to keeping us in tune with the shifting regulatory environment, our leading chemists work alongside our toxicologists to provide comprehensive toxicological risk assessments. We not only provide guidance but adopt a customized strategy for each individual program. The vast number of diverse products that our experts have tested makes us an unquestionable authority in this space.</span></p>
<h4><span style="color: #008ace">A Forward Looking Joint Venture: WuXi and the Mayo Clinic</span></h4>
<p class="p2"><span class="s2">As part of our commitment to delivering value to patients worldwide and our vision that ‘every drug can be made and every disease can be treated’, in January 2018 WuXi AppTec Group formed a joint </span>venture with the Mayo Clinic to introduce testing capabilities and clinical diagnostic services to the Chinese market. This venture will bring novel esoteric tests to market faster, benefiting patients in both China and the US.</p>
<p class="p3">The partnership with the Mayo Clinic elevates our portfolio of diagnostic services and will serve to accelerate research in the lab. The outcome will be the transformation of discovery tests and the diagnostic landscape, as well as precision medicine — not only in China but also worldwide. Through the collaboration with Mayo, we&#8217;re committed to building a leading diagnostic services operation in China and co-developing in ways that will benefit our patients, doctors, and innovative collaborators in all corners of the world.</p>
<div class="callout">
<h4 class="callout-title"><span style="color: #008fd1">At its core, WuXi is a platform company that is committed to enabling innovative therapies to benefit patients.</span></h4>
</div>
<h4><span style="color: #008ace"><br />Life, Technology, and Discovery</span></h4>
<p class="p2">The Laboratory Testing Division is commonly referred to as “LTD” for short. We have made use of this internal acronym, developing it into the meaningful slogan: “Life, Technology and Discovery” — an all-embracing reflection of our capabilities as a testing platform. We stand for these three tenets, which truly summarize where we see our company in the future. Our focus is strongly on the US and China, and we have expansion plans for both. Specifically, the expansion of our New Jersey facility for DMPK and Bioanalytical services, with the opening of a new building in Cranbury, is taking place in early 2018.</p>
<p></p>
<p><img loading="lazy" src="https://thatsnice-testing3.com/legacy/Q1%202018%20/PA_Q118_Wuxi_Sidebar2.gif" alt="PA_Q118_Wuxi_Sidebar2.gif" width="716" height="615"></p>
<h4 class="p1"><span class="s1" style="color: #008fd1"></p>
<p></span></h4>
<h4><span style="color: #008ace">Overcoming the Challenges of a Rapidly Progressing Organization</span></h4>
<p class="p2">Although our organization’s growth is overwhelmingly positive, one of the challenges of growing so rapidly is addressing any doubts concerning where everyone fits, and how we can all work together to accomplish one overarching goal. Of course, our evolution is an ongoing process. <span class="s2">Internally, we are relying on program management to play a key role in how our divisions are perceived.</span></p>
<p class="p2"><span class="s2"><span class="Apple-tab-span"> </span>Ultimately, the Laboratory Testing Division — or LTD — stands for just what we are capable of — our testing capabilities are limitless. Regardless of whether a client comes to us with one single compound, or hundreds of thousands of compounds, LTD can do the testing, evaluate that the targets are druggable, go through all the necessary preclinical testing and eventually conduct testing in clinical trials. It has been tremendously exciting to watch our Laboratory Testing Division’s growth over the last four years into the integrated testing powerhouse it is today, and we are wholeheartedly looking forward to what lies ahead in the coming years.&nbsp;</span></p>
<hr>
<p><span style="background-color: transparent"><br /><strong><span style="color: #008ace"><span style="font-size: 15px"><span style="color: #000000">Contributors<br /></span><br />Eugene Gong, Ph.D.</span></span></strong><br /></span><span style="font-size: 15px"><span style="background-color: transparent"><strong><span style="color: #008ace">Vice President, Head of Technology Operations &amp; Analytical &amp; Regulatory CMC</span></strong><br /></span></span><span style="background-color: transparent;font-size: 15px">Dr. Eugene Gong has over 20 years of experience in drug product development (from IND to NDA), technology operations and global regulatory filing. Prior to joining WuXi AppTec as the head of analytical R&amp;D in 2006, Dr. Gong gained extensive pharmaceutical industry experience, having held positions of increased managerial responsibility for Pfizer (formerly Wyeth), Boeringer Ingelheim and Allergan (formerly Forest Laboratories). Dr. Gong received his Ph.D. in biophysical chemistry from New York University in 1997, and his B.A. in chemistry from Peking University.</span></p>
<p><strong><span style="color: #008ace"><span style="font-size: 15px">Ed Amat</span></span></strong><br /><strong><span style="font-size: 15px;color: #008ace">Vice President of International Sales &amp; Marketing</span></strong><br /><span style="font-size: 15px">Ed Amat has over 27 years of successful performance in senior sales leadership, sales, marketing, public relations and client services in the pharmaceutical industry. Previously, Ed worked for MPI Research as Senior Director of Sales for North America and Europe, leading to Vice President of Global Sales and Marketing. Prior to MPI, Ed held pharmaceutical commercial functions at Pfizer and legacy companies, having been recognized with multiple sales and leadership awards. Ed is a former principal owner of a diagnostic medical testing company and recently served as a commercial officer with a drug manufacturing software company.</span><br />&nbsp;</p>

Creating Comprehensive Solutions through Laboratory Testing