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What does the FDA Inspection Mean to STA and its Customers?

THE NEWS: The United States Food and Drug Administration (FDA) inspectors gave STA, WuXi’s small molecule process R&D and manufacturing business unit, a clean bill without 483 after a general GMP and Pre-Approval Inspection. We sat down with Minzhang Chen, Vice President and General Manager of STA, to discuss this important STA milestone. QUESTION: What was the outcome of the inspection? Chen: The take home message is that no FDA Form 483 was issued. We place a big emphasis on quality at our manufacturing plants – it’s vital to both clients and patients – so we’re very pleased FDA recognized our efforts. QUESTION: What is the significance of the visit? Chen: STA aims to become one of the only facilities in China after FDA approval to manufacture commercial New Molecular Entity (NME) intermediates and APIs. Our clients can source intermediates and active pharmaceutical ingredients from STA for the US market, and know they will receive a high-quality, reliable supply. QUESTION: What sort of projects can you now support? Chen: STA’s mission has been to build a fully integrated small molecule API development and manufacturing platform on which we can support all client needs for APIs from tox studies all the way through clinical studies to commercial launch. The outcome of FDA inspection  completes the last piece of this platform and takes STA to the next level of bettering serving our customers.

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Genome Center: The Only CLIA-Certified Clinical Laboratory in China

The United States Department of Health and Human Services has awarded WuXi’s genome center CLIA (Clinical Laboratory Improvement Amendments) status. We caught up with Hongye Sun, VP and CTO of WuXi’s Genomics Center, to get the lowdown on the news. QUESTION: What does the CLIA certification mean to WuXi and its clients? SUN: We are now the first CLIA certified genomics clinical laboratory in China. It allows us to participate more fully in one of the most exciting areas of drug development. Gene sequencing is opening our eyes to the underlying causes of disease, and helping identify better ways to treat illnesses. As a CLIA-certified lab, we can support our partners in this mission by running clinical trial gene sequencing projects. No other lab in China has the certification to offer this service. QUESTION: What was the process for winning CLIA certification? SUN: The early planning dates back to before the genomics center opened in 2011. We foresaw clinical gene sequencing becoming ever more important, so installed CLIA-level quality management systems and worked to validate a number of assays. It culminated in U.S. government audit recognizing our efforts and granting us CLIA certification. QUESTION: How does the clinical gene sequencing service complement WuXi’s other offerings? SUN: It really continues our efforts to build an industry leading open-access technology and capability platform. Anyone can leverage these capabilities to discover and develop therapeutic products to benefit patients. It’s exciting that we can put that power in the hands of more people, and ultimately it furthers our main goal – to improve patient care.

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A Conversation with Carl Firth, CEO of ASLAN Pharmaceuticals

Since setting up in 2010, Singapore-based ASLAN Pharmaceuticals has shaken up drug development with its innovative, virtual approach to advancing therapeutic candidates. Fresh from winning the Red Herring Top 100 Asia Award 2013, ASLAN CEO Dr. Carl Firth spoke about the company’s model, drug development in Asia, and what to look out for in the coming years. What motivated you to found ASLAN? My co-founders and I spent most of our careers working in big pharma. Though over the years we’ve heard a lot about changing development paradigms and approaches, barring a few notable examples, the industry is developing drugs today in roughly the same way it was 20 years ago. We set up ASLAN to execute creative development strategies leveraging high quality, innovative clinical centers in Asia. What is ASLAN’s business/development model, and what are the benefits of this approach? ASLAN aims to create value in early clinical development. We in-license preclinical and phase 1 compounds from global pharma and biotech companies, typically acquiring global rights, and focus development on diseases more prevalent in Asia, like gastric cancer. We develop these drugs through clinical proof of concept before licensing to a pharma partner for global phase 3 development and commercialization. By working in Asia with an innovative model, we believe we can develop drugs more creatively, faster and more efficiently than our peers. As a virtual company, how would you rate the standard of service providers in Asia? We’ve always believed that a small company like ASLAN can be more creative, agile and efficient than a larger one, but that means we are also critically dependent on our partners to help us execute our clinical and manufacturing strategy. Traditionally, Asia has been a center for late-stage clinical studies and large -scale manufacturing, so though there are many service providers in Asia today, only a handful have experience with early-stage clinical studies – typically the more established players in China, Taiwan and India. For instance, Wuxi AppTec supports our clinical supply manufacturing for all our compounds. The quality of the service provided is generally very high, but it does help that we have a team on the ground. Trying to run a clinical study remotely across multiple time zones without a local team would be challenging. Where does China fit in your plans? Though we have no plans to conduct global phase 3 studies – we will rely on our partners to help us there – we are planning to conduct late-stage development in selected Asian countries, including China. We have set up an office in Taiwan and are setting up an office in China. Through these, we plan to conduct clinical development to support regional studies and – for some of our compounds – to carry out local development activities. Related Links: ASLAN Pharmaceuticals secures US$22M in Series B financing led by Cenova Ventures (Source: ASLAN Pharmaceuticals)  

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WuXi Partners with QB3 on its New Incubator in San Francisco

WuXi is partnering with QB3 on its new incubator in San Francisco. The 24,000-square foot biosciences incubator is the latest expansion of the highly-successful QB3 program, which supports entrepreneurs with cutting-edge science. We sat down with Associate Director of QB3 and General Manager of QB3 Partners, Douglas Crawford, to talk about the partnership and expansion. QUESTION: Can you provide some background on QB3 and what you do? CRAWFORD: QB3 was set up in 2000 to foster the development of innovative startups. We do this in a variety of ways, but I’d single out two as being particularly important. Firstly, our industry partners help QB3 startups identify technical risks, which is a big challenge for young companies. And secondly, we help finance research through our venture fund, Mission Bay Capital. We’re really pleased to have WuXi’s support in both these areas. QUESTION: How does the new expansion help you further this mission? CRAWFORD: It gives us more space! We already have two facilities near the UCSF Mission Bay campus, and another two in Berkeley, but to support more great science we need another site. At 24,000-square foot the new incubator, QB3@953, is our biggest yet. When we’re at capacity we expect to house up to 30 startups. Ultimately, that means we’re supporting a lot more innovative work than we could before. QUESTION: How has your experience with earlier incubators shaped QB3@953? CRAWFORD: We’ve become even more focused on helping startups make the most of every dollar. So, entrepreneurs can start by renting just one bench, and then pay for space in super-freezers or use of centrifuges as and when they need to. It’s about flexibility, really. And we try to leverage collective scale to lower costs and simplify logistics too. Lab gloves are dispensed centrally, for example. Anything that frees up great researchers to focus on doing innovative science is a good thing. Related Links: QB3 to Collaborate with Johnson & Johnson Innovation on New Incubator (Source: The Wall Street Journal) QB3, partnership to open new, large life sciences incubator (Source: San Francisco Business Times)

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An Interview with Dr. Lawson Macartney, CEO of Ambrx Pharmaceuticals

An interview with Dr. Lawson Macartney, CEO of Ambrx Pharmaceuticals, on the co-development of an ADC therapeutic for HER2-Positive breast for cancer in China.   THE NEWS: This month’s Inside Perspective features Dr. Lawson Macartney, CEO of Ambrx Pharmaceuticals. Ambrx recently announced a deal in which it would co-development a therapeutic for HER2-positive breast cancer with China-based Zhejian Medicine Co. WuXi will handle preclinical, clinical trials and toxin manufacturing. ZMC will hold commercial rights to the compound in China, Ambrx holds rights in the rest of the world, collecting royalties on Chinese sales. QUESTION: Ambrx has an industry-leading ADC technology platform and a number of notable partnerships with western pharmas like Merck and BMS. Why the expansion into China?   Macartney: Accessing the China market is becoming an increasingly important objective within Ambrx. Developing and manufacturing biologics within China to world class standards is a relatively new paradigm. We look forward to integrating these efforts into our global development strategy. QUESTION:From a business perspective, this three-party deal is very creative and intriguing. Could you explain the strategy?  Macartney: This partnership is unique. It allows us to team up with China’s leading pharmaceutical and CRO companies to efficiently access the China market, an opportunity that we would otherwise miss if we were not to combine our respective efforts. This is an innovative deal structure that allows us to gain access to China while also reducing time and R&D costs. QUESTION: What’s one thing you learned putting together this deal that could benefit other companies looking to develop drugs to sell in China? Macartney: Build strong relationships with those that you do business with. This will better enable the collaborations to overcome obstacles and take advantage of opportunities. Related Links: Expediting Development of Biologics in China: From Strategy to Regulatory Expectations and Beyond Ambrx and Zhejiang Medicine Co. Ltd. Form Collaboration to Develop and Commercialize Ambrx’s Antibody Drug Conjugate for Breast Cancer

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