The Center For Breakthrough Medicines' Newest Leaders Talk Advanced Therapy Development, Manufacturing

By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1

The Center for Breakthrough Medicines (CBM) is a fully integrated cell and gene therapy contract development and manufacturing organization (CDMO) that enables rapid development and commercialization of advanced therapies. Their single-site approach helps customers to accelerate speed to market while mitigating risk via robust platform technologies, advanced supporting analytics, and integrated program and supply chain management. Their vision and execution are supported by a first-class team of seasoned scientists and biopharmaceutical leaders with a unique approach to CDMO relationships that put the client and patient first.

Just recently, I had the opportunity to connect with four of CBM’s newest leaders — Sybil Danby, Senior Vice President, Business Development & Strategy; Eileen Brett, Vice President of Project Leadership; Dana Cipriano, Vice President of Testing and Analytical Services; and Emily Moran, Vice President of Viral Vector Manufacturing about their respective roles, the future of manufacturing, their plans to work with the Greater Philadelphia Area’s universities and biotechs to enable advanced therapy development and commercialization, and much more.

Explain your new role with the Center for Breakthrough Medicines and why it is important to bringing the facilities online.

Emily: Manufacturing is the heart of what we do, and I am focused on crafting and engaging an approach to manufacturing that looks one step past the customer to their customer: the patient.

I am building out our team and our processes to ensure that we are offering robust, reliable processes that optimize yield, recovery, safety, and efficacy for the life of that process. I am also working to ensure that we remain closely aligned with the Process Development teams from program initiation through to technology transfer, execution, and final batch release.

Dana: I have been able to play a pivotal role in ensuring that CBM effectively develops an end-to-end solution including complex analytics and comparability testing from early-stage development through to commercialization activities. I am most intently focused on continually auditing and refining our testing and analytical services offer, which entails technology review and implementation of the most relevant technologies and services. It also means scouting the next generation of industry advances to see where we may be able integrate a new technology, or even augment our services, and building out our teams of scientific experts to benefit our customers.

Sybil: This is a unique role because I am in Business Development, but I get to work from the ground up, building an organic structure to meet customer needs, instead of trying to leverage what already exists or piece it together through acquisitions or mergers. I have been able to play an active role in bringing CBM to the place it is today and continue to play a critical role in the strategic capabilities and resources planning.

We are doing something different here, and it is so fulfilling to be a part of it. My favorite part of the job is getting out there and talking to our customers and colleagues to see what the pain points are and how we can eliminate those pain points. I am also enjoying developing the BD team, and bringing in top-quality talent that understands what our customers are trying to achieve.

Eileen: Within the space of Program Management, I am focused on aligning customers with the right teams within CBM team to deliver true E2E (end-to-end) solutions. We are operating with a unique model that is driven by the timeline and budget, while keeping an eye on any change management needs. The goal is to develop partnerships with each customer so that they feel confident letting us handle the development and commercialization work so that they can remain focused on innovating new life-changing and life-saving advanced therapies.  

Explain Discovery Labs and its relationship to CBM.

Eileen: The Discovery Labs is a real estate venture to create a life-sciences community campus in King of Prussia, at the heart of Cellicon Valley. The team at Discovery Labs is working to create an ecosystem that encourages innovation, quality of life, and accessibility. The location includes eating options, a fitness center, an auditorium for a lecture or patient testimonials, meeting space, and more that is all inhabited by scientists, engineers and business professionals who are passionate about changing the world by bringing treatments and cures to patients.

Sybil: The Center for Breakthrough Medicines is a contract development and manufacturing organization (CDMO) located at the Discovery Labs campus in King of Prussia and is an affiliate of the Discovery Labs. That said, CBM is an individual entity, focused on offering end to end CDMO services that enhance the speed to market and probability of success for our customers. CBM is the only truly single-source CDMO solution in the United States offering discovery support, process development, analytical development, plasmid DNA manufacturing, viral vector manufacturing, cell processing, testing and specialized clinical services under one roof. 

Emily: It is important to note that our business at CBM is not limited to the scope of partners located within The Discovery Labs. However, the location can act as a critical enabler for progression of CGTs from discovery to market because the CDMO services are complemented by the access to real estate. This enables customers to consider a hybrid buy versus build solution that can grow with them as their needs evolve.

Dana:  CBM is so much more than a CDMO.  Imagine wanting to understand the clinical or patient perspective better and having folks like Children’s Hospital of Philadelphia (CHOP) right on campus where we can exchange non-confidential information that can help us better develop drugs that are easier for pharmacists and nurses to prep and deliver.  How can you not be energized?

How will CBM partner and collaborate with the Greater Philadelphia Area’s (GPA) biotechs and universities to enable advanced therapy development and commercialization?

Sybil: We have been fortunate to already work with local GPA biotech companies and universities that are looking to optimize their technology and therapy solutions. We are well positioned to do so with capacity and capabilities for advanced therapies for manufacturing, and by offering platforms to rapidly progress programs and remove development and manufacturing bottlenecks. The GPA location and extensive real estate portfolio also gives partners the opportunity to directly collaborate with us, and even expand their own operations as our neighbor.

Eileen: CBM belongs to numerous GPA organizations offering proactive insight and industry leadership. We participate in conferences, speak at roundtables, and help local academic institutions establish curriculum to address the significant talent deficit in the field.

Emily: We want our GPA biotech, academic, and research neighbors to know what we are here with a comprehensive offer to support your needs. We can deliver:

1. Platform technology for early-stage companies that do not have an established manufacturing process
2. GMP manufacturing capacity, knowhow, materials, testing and supply chain management
3. A comprehensive one-source solution for cell and gene therapy development and manufacturing
4. Outsource and insource solutions for ATMP development and manufacturing with the capability to grow-in place at our 1 million square foot site
5. The most experienced team that will partner with companies to expedite speed to market and treat patients in need

Dana:  We will continue to pursue GPA biotechs and academics as partners for active assessment of new technologies that can improve analytics data and bring quality and speed to the development of next generation medicines. From a talent perspective, we are working with local GPA universities and trades to establish training academies, both on and off site at CBM, which will allow for the continued development of technologies and execution of complex analytics.

As a part of your new role, how will you work with Philadelphia Area existing cell and gene companies?

Sybil: We offer a unique solution to our GPA neighbors that is right “in their backyard”, and it is an honor to be able to offer such a complete solution. We know that by working together with our GPA partners, we can overcome supply chain or productivity challenges with a science-focused and technology-driven approach. 

Dana:  We will continue to work with existing companies in the GPA to understand the challenges and opportunities of working with CGT products. We want to identify new ways that the data we get from analytics and testing can be leveraged to bring these advanced therapies to market more effectively.

Emily: Similarly, we are committed to continuing to evolve our manufacturing approach to ensure we are always working in an efficient, patient-centric manner. And with the level of capacity that we bring to the table, we see CMB as a great asset to the GPA—we know that we can contribute to keeping a pipeline of promising therapies moving through to this market.

Eileen: As we approach a tipping point toward the industrialization of CGTs we have also seen the importance of breaking down silos that prevent learning, and what better place to start than here? In my role, and across CBM, we will continue to advocate for and mold curricula for local academia to ensure that trained talent for advanced therapeutics is available.

How will CBM affect the cell and gene sector nationally (and internationally)?

Emily: The platform technologies and expertise for efficient and repeatable CGT manufacturing are scarce, and we are ready to change that. Our development team embraces trusted modalities as well as new technology to increase yield, recovery, safety, and efficacy for our customers. We are finding that balance between trusted services and platform processes while taking the leap to new and potentially disruptive technologies that this industry needs. This approach makes CBM poised to be a game changer in the industry.

Sybil: There is also a major capacity crunch in our industry, delaying the availability of advanced therapies for the patients who so desperately need them. We are offering a one-source solution addressing the supply/demand imbalance in the industry to partners in the GPA, and around the world. We have everything our partners need for development through to commercialization under one umbrella. 

Dana:  We have established a platform approach that will allow clients to improve the speed by which analytical methods can be executed and validated.  And we can support analytical programs for clients that have a manufacturing program with CBM, or as a stand-alone testing program to support clients’ analytical needs globally. This allows the industry to access to what they need, with the assurance that all procedures and methods meet standards for global regulations and phase appropriate approvals. 

Eileen: I cannot wait to take this international!  One thing we have learned from COVID is our ability to work and collaborate remotely.  With the state-of-the-art IT and quality systems we plan to employ will allow clients to access their data and watch their batches being manufactured live via a secure network, we will be able to partner with biotechs and universities anywhere and will recruit in top talent to support our global customers locally, as appropriate.

Explain you vision for CBM’s impact on the cell and gene sector.

Dana:  Innovation and execution go hand in hand at CBM.  We are hiring not only experienced talent in cell and gene therapy, but also new talent to advance the careers of young scientists, operations staff, and improve the overall knowledge and training for the CGT industry.  We encourage companies and academics to challenge us with ideas and new technologies to see how we can work together.

Eileen: CBM delivers foundational development and manufacturing plans that can be customized based on customer needs. We employ a Phase Appropriate Quality philosophy allowing us to build a solid foundation in early development, without burdening early development with late development requirements.  In turn, this allows clients to race faster to FIH to obtain crucial information regarding an asset’s ability to potentially help patients.

Emily: And we are not your typical CDMO. We offer end-to-end services, which makes life easier for clients, but also for our CBM Team. We are committed to building foundational systems to make the way we work easier for our partners and the internal CBM family. We are working on a comprehensive plan to create an environment that promotes not only excellence in execution, but Work Life Balance. CBM is a place to come, to stay, to grow and thrive.

Sybil: It is an amazing time to be in the CGT sector, and we are hiring! https://bullseyehiringsolutions.com/companies/the-center-for-breakthrough-medicines

We are committed to recruiting talent with diverse experiences from CDMOs, entrepreneurial Biotechs, large Pharma, Academia, and more. We have a welcoming culture that values and listens to all voices.

I strongly recommend that people consider how their skills might contribute to the development of CGTs and what kind of company culture they are looking for. We have a lot to offer and are excited about growing the team.