Accelerating Advanced Therapy Pipelines and Viral Vector Commercialisation
An executive interview with Felix Hsu, senior vice president and global head at Wuxi Advanced Therapies. we take a strategic look at accelerating advanced therapy pipelines and viral vector commercialisation through greater predictability
There are now several regulatory measures in place to fast-track advanced therapies to the market. What are your internal strategies for biotech CEOs to enable their teams to gain quicker market access while enhancing their pipeline?
There are several regulatory measures to fast-track advanced therapies. Some of the internal strategies include developing the proper infrastructure to support supply chain activities, data management (development and clinical) and technical writing e.g. product life cycle management to support Type B meeting, pre-IND, end-of-phase or pre-BLA meetings and technical packages to support designation applications. It is a great opportunity to leverage and apply for multiple designation programs e.g. fast track designation, breakthrough designation and RMAT designation. As part of these programs, firms have direct access and communication with CBER where they will provide guidance on efficient drug development. It is recommended to utilise these meetings as well as PRE-BLA meetings with CBER to discuss Priority Review and Accelerated Approval options in order to increase speed to market. In addition, we create and utilise late phase packages designed to support clinical trial endpoint needs (data collection, evaluation, documentation) as well as commercial launch e.g. PPQ, BLA Submission and Pre-Approval Inspection.
One of the important measures is the development timeline. By leveraging an experienced and technologically advanced CDMO like us, clients can reduce their product development time and move from target identification to FIH in record time. Additional value for working with an experienced partner includes manufacturing process Improvements (such as world-class suspension platform), close up process, mitigating risk, enhancing performance, processing TAT, the efficacy of the product, yield, multi-indication and the mechanism of action drug development to enhance the pipeline with greater predictability.
What are the pitfalls to account for?
On the other hand, there are a few pitfalls to account for, such as lack of clarity in regulatory guidance in these new therapies, and inadequate trial design and/or targeted endpoints. There are also system and software limitations for data management, including reporting. Additional pitfalls are the new therapeutic frontier lack/limited talent pool and technology development.
How can CDMOs help reduce already complex manufacturing challenges? How can WuXi Advanced Therapies offer innovators greater predictability?
In an already complex manufacturing process, there are many challenges. Not all CDMOs are alike and not all CDMOs can provide the process development services to get the initial process that innovators develop to one that can be manufactured at GMP and scale. In addition, few can work with the client on analytical development of their key assays, setting up the QC testing and managing the supply chain and manufacturing for the client.
However, WuXi Advanced Therapies can do both of these processes. We can complete analytical method development for the customer and then manufacture from phase I to commercial and provide product release and QC testing. This allows the innovator to keep the entire development, manufacturing and testing with one company and not have to tech transfer after the early clinical phase. It also allows the innovators more time to decide whether or not they want to build their own manufacturing facility. By doing the early commercial manufacturing, WuXi Advanced Therapies gives the customer more time to better gauge the true demand of the market assisting them in making better decisions on the size and set up of their manufacturing facility. If they do build their own facility, WuXi Advanced Therapies can serve as a secondary manufacturing site helping them from a risk management standpoint and providing additional commercial supply capacity.
How can greater predictability provide a stronger case for investors?
Greater predictability will provide a much stronger case for investors as it will ensure a clear path to success, reduce the time of development and see an earlier return on investment. In addition, greater predictability in manufacturing allows investors more flexibility on how to spend their money. They can use more of their capital to work on more targets and clinical trials, allowing them to treat more diseases. It increases the likelihood of having a successful clinical product and reduces the risk that occurs when taken by companies that build facilities before they have started their clinical trials or when they are in early phase clinical trials. By building their own manufacturing facility later in the clinical process, companies have a better idea of the true market potential and demand.
Is there any knowledge, data and innovation that is being used to provide a competitive advantage to innovators?
CDMOs are trying to set up manufacturing platforms where possible to improve the predictability of process development and manufacturing for the client. They are also looking at the latest technologies available in the market to improve the processes and yields. By building on the important lessons learned from both vaccine and biologics, earned experience working on multiple gene and cell therapies and technology development capabilities built over time, WuXi Advanced Therapies can provide the clients many competitive advantages.
Manufacturing capacity and supply chain is a huge bottleneck for our industry. How are you improving to tackle this challenge?
It is a huge bottleneck in our industry. WuXi Advanced Therapies is tackling these challenges by developing platforms for manufacturing to improve the predictability and time to clinical phases for clients. Having platforms allows a company to better manage its raw materials and carry inventory for manufacturing. WuXi Advanced Therapies is also actively partnering with their key suppliers to try to manage their fluctuations in demand and to ensure a better supply of raw materials. WuXi Advanced Therapies has expanded our manufacturing capacity and capability in the last several years and now has over 280,000 square feet for cell and gene therapy. We have incorporated a modular design for our facilities, so clients tailor the manufacturing suites to better meet their manufacturing needs. WuXi Advanced Therapies is reducing the complexities of manufacturing by providing integrated platforms that enable cell and gene therapies to be developed, manufactured, and released faster and with greater predictability.
About the interviewee:
Felix Hsu is the Senior Vice President and Global Head at WuXi Advanced Therapies, located in Philadelphia, PA. He has nearly 31 years of experience in the life sciences industry and serves as an Advisory Board Member on the Jefferson Institute for Bioprocessing. He has also held executive and senior positions at WuXi AppTec and Medtronic. He studied at the University of Michigan – Stephen M. Ross School of Business where he earned a Masters in Business Administration and Management.
Find out more at advancedtherapies.com