In this podcast, we talked with Ken Chen, MBA, Senior Director, Regulatory Affairs, WuXi Biologics about staying current with regulatory changes. We discussed how WuXi Biologics recently began publishing a quarterly summary of regulatory updates on new or revised guidance documents from the various global regulatory agencies and how this is a valuable resource for anyone in the biological drug development arena.
I began the article by asking Ken what prompted WuXi Biologics to begin publishing these regulatory updates. Ken explained that WuXi Biologics works with companies from around the globe in all facets of product discovery, development and GMP manufacturing and across the full drug development continuum from preclinical to commercialization. Due to the nature of the services they provide, they need to provide an optimal regulatory CMC strategy and thus remain up-to-date with the relevant global regulatory expectations. They work proactively to minimize regulatory risks by identifying regulatory changes or new hurdles in advance and thus if needed they can rapidly perform gap analysis and formulate a strong risk mitigation strategy.
We then discussed how having these updates provides a win-win for both WuXi Biologics and their clients. Ken described how the companies that are working with WuXi Biologics are filing INDs and BLAs in various jurisdictions and WuXi Biologics must provide results and documentation that will be a part of those filings. Hence, WuXi Biologics must adhere to the quality and GMP standards required in those various geographic venues.  He went on to say that since they are such a large organization and because they provide a one-stop, single-source development platform it was imperative that they develop an internal mechanism to keep their entire staff up-to-date with the relevant, wide ranging and rapidly evolving regulatory updates and expectations.
I asked Ken about other resources available with regulatory updates. He said that there are other resources available and that they use some of these to help put their update together, but many are not organized by agency and topic. In addition, most and are not as wide-ranging, from a global perspective, as what they felt like they needed for their team. They decided that a quarterly update was just the right size for teams to digest and, if necessary, act on to stay current without disrupting normal daily operations. They thought that offering the translations of relevant NMPA updates and documents would be unique to current industry resources.
Next I asked Ken about whether the updates were just for the regions in which WuXi Biologics has operations – China, Europe and the United States. He clarified that they work with clients to file INDs in many countries around the world not just in the U.S., China and countries currently and formerly governed by the European Medicines Agency or EMA. Some of those other countries include Australia, Korea, Singapore and Japan, thus their updates need to include the regulatory requirements from those countries as well. They also review updates coming from Health Canada, ICH, WHO and PICs amongst others if relevant to biological therapeutics and vaccine development.
I was curious about why they decided to make these updates available to the greater industry. Ken explained that many of the leaders at WuXi Biologics came from drug development companies both large and small from around the globe and they wished that they would have had a similar consolidated and comprehensive update. Ken said that although many larger companies have similar teams assembling this information, many smaller companies do not have the same resources. WuXi Biologics thought that their update would be valuable for them, especially for companies wishing to file in multiple jurisdictions.  They also provide a translated update of the new Chinese regulations, and they believe this provides value to even lar...