EXECUTIVE INTERVIEW - Resilience Rising: Advancing Therapies That Transform Lives

Resilience is poised to make an impact in biopharmaceutical manufacturing, addressing complex challenges in the development and manufacturing of life-saving and life-sustaining drugs. The company remains deeply committed to building a more resilient future, partnering with its customers to help bring transformative medicines to patients. Drug Development & Delivery recently interviewed Dr. Susan Billings, Chief Commercial Officer of Resilience. In this interview, she discusses pressing issues in the CDMO space, the opportunities driving innovation, and how Resilience is shaping the future of drug substance and drug product manufacturing. Having spent over a decade in the CDMO industry before a 2-year pivot to a TechBio startup, she is excited to return to the sector, bringing a renewed focus on building and growing Resilience’s business.

Q: How has Resilience adapted to a changing market landscape since its founding in 2020?

A: Resilience was founded in 2020 with a bold mission: to ensure uninterrupted access to essential medicines, even in the face of challenges like those experienced during the pandemic. At a time when global supply chains were disrupted and critical raw materials and intermediates became scarce, Resilience recognized the need for a new approach to biomanufacturing that prioritized resilience, innovation, and patient access.

From the outset, we were fortunate to be well-funded, allowing us to thoughtfully and strategically invest in areas where we could make the greatest impact. This foundation enabled us to focus on technology-driven solutions and the advancement of biomanufacturing in critical areas such as viral vaccines, biologics, cell and gene therapy. For example, our facility in Allston, MA, has been reconfigured and optimized – with continuous manufacturing and several modular single use reactors to support early clinical through commercial drug substance biologics to further strengthen our market position to meet growing industry demands and proximally located in one of the largest life science ecosystems in the world.

Over the past 4.5 years, we’ve continued to evolve, leveraging cutting-edge technologies and building capabilities that align with the industry’s most pressing needs. While the pandemic heightened awareness of supply chain vulnerabilities, our efforts have remained steadfast: to provide access to medicines and ensure that patients receive the therapies they depend on without disruption. This commitment to innovation and strategic focus has positioned Resilience as a trusted partner in addressing both current and future challenges in the biopharma landscape, notably for the development and manufacturing of cell and gene therapies as well as other large molecule biologics.

Q: How does Resilience’s name influence its mission and approach to partnering with clients?

A: Our name, Resilience, embodies exactly who we are and what we stand for. Born during one of the most challenging periods of our time, we entered the market amidst a global pandemic, only to face a rapidly shifting geopolitical and funding landscape that tested the entire industry. Yet, true to our name, we have adapted, persevered, and emerged stronger. We are dedicated to delivering innovative biomanufacturing solutions and transforming challenges into opportunities for growth and impact.

Q: Where do you see the greatest opportunity in the industry? In what areas is Resilience investing?

A: One of the greatest opportunities in the industry today remains the plight to combat cancer. This pursuit unites R&D and manufacturing organizations across all segments, including large pharma, mid-market biotech, emerging start-ups, CDMOs, and service providers. The shared passion to better understand the complex biology of cancer, develop therapies, and provide manufacturing options that can either extend life for late-stage patients or potentially provide life-changing cures drives incredible motivation to continue innovating. At Resilience, we remain committed to investing in and advancing cell therapy manufacturing with recent innovations, such as our DAR-T offering, that streamline vein-to-vein timelines of two weeks or less, reducing overall cycle times for autologous CAR-T cell therapies, ideal for treating B-cell malignancies, solid tumors, and auto-immune disorders. Additionally, we are investing in the development of another platform to shorten biomanufacturing release testing timelines, delivering realized benefits for overall cell therapy production.

Another significant opportunity in the industry is the growing momentum around GLP-1 therapeutics, which have expanded from their initial use in diabetes management to address obesity, weight loss, and even conditions like sleep apnea. This evolution has created tremendous potential for service providers and CDMOs to support the increasing demand for injectable products in this space. At Resilience, we have and will continue to prioritize investments in aseptic drug product formulation and manufacturing to become one of the fastest growing providers in the world for injectable products.

Staying ahead of industry trends is critical for any CDMO to succeed, but especially for a newer company like Resilience. As such, we have strategically chosen to invest in areas where we can deliver the most value to our clients and their patients. While the market landscape for certain modalities, such as gene therapy, has shifted, we’ve used these changes as opportunities to reassess priorities and focus on technologies and capabilities that align with current and future demands, particularly in autologous cell therapy and aseptic drug product manufacturing.

Q: What are companies looking for in a CDMO? What sets Resilience apart from other CDMOs?

A: Companies are seeking a trusted partner that can provide high quality, right first time delivery of products and services without compromising regulatory compliance. Resilience distinguishes itself in this area by acquiring facilities built to the highest industry standards, ensuring quality assurance and regulatory integrity that mitigate risks for our partners’ IND filings and clinical trial timelines. Innovators are seeking a company with robust quality procedures and regulatory experience that safeguards their BLA filings and overall program success.

Resilience is more than a CDMO – we are a partner in innovation. While many traditional CDMOs adhere to legacy processes, Resilience was designed to challenge the status quo. Our digital and technology-first mindset, including advanced automation and industry leading equipment, drives efficiency for our clients, without compromising quality or regulatory compliance. Additionally, our 4.5-year-old roots are unique: we’ve combined the energy of a new company with the proven expertise of people and facilities acquired from leading pharmaceutical and contract manufacturing organizations. This blend allows us to innovate and respond to our clients’ needs rapidly while maintaining the highest standards of quality and reliability.

Q: Where are the biggest hurdles in process or technology, and is Resilience doing anything to address them?

A: The biomanufacturing industry faces significant challenges in the production of cell and gene therapies. For autologous cell therapies, one of the most pressing hurdles is the incredibly short manufacturing timeline required for a vein-to-vein process. Personalized therapies demand highly customized production, precise coordination, and strict quality control, all within a matter of days. This complexity not only impacts scalability but also creates substantial cost pressures for innovators, making it challenging to bring these therapies to a broader patient population.

Resilience has focused on addressing these challenges with solutions designed to improve efficiency, scalability, and cost-effectiveness. For cell therapy, our recently launched DAR-T platform exemplifies this approach by dramatically reducing manufacturing timelines for CAR-T therapies from 7–14 days to as little as 3 days. This process not only accelerates delivery to patients but also enhances the quality of the cells, yielding younger and more potent phenotypes that improve clinical outcomes. For our partners, the platform also reduces labor and material costs, making these therapies more accessible and scalable.

We take great pride in our ability to overcome one of the challenges in cell therapy manufacturing: meeting the critical turnaround time required to deliver these life-saving treatments to patients. By focusing on innovative solutions like our DAR-T platform, we’re not only streamlining the process but also ensuring that therapies reach patients faster without compromising quality.

Q: With the changes that Resilience has experienced over the past 6 months, where do you see the company in 2 years?

A: In two years, I see Resilience as a recognized CDMO leader in biomanufacturing, delivering comprehensive end-to-end solutions from discovery through commercialization. We are reshaping our network to be well-positioned to meet growing demand in cell therapy, drug substance biologics, and sterile fill/finish for injectable products.

We’re actively exploring opportunities to enhance our capabilities in complementary areas that support our downstream expertise in manufacturing and commercialization. This includes expanding our offerings for biologics and cell therapies, such as CAR-T and other cell types, while optimizing manufacturing processes to deliver sustainable, scalable, high-quality solutions. We are also prioritizing investments in expanding our aseptic fill/finish capacity to address the increasing demand for injectable products, ensuring we can meet the needs of our partners at every stage of their programs.

By strategically ‘rightsizing’ our network and refining our capabilities, Resilience is positioned to become the best version it can be with an agile, focused, and innovative mission as an industry leader in biomanufacturing. These efforts are guided by a clear roadmap that prioritizes quality, scalability, and sustainability, enabling us to help innovators navigate the complexities of biomanufacturing and deliver life-saving therapies to patients with greater speed and efficiency.

Our journey as a company has been one of adaptation and perseverance, staying true to our name and mission. Resilience has faced market and industry challenges head-on, emerging stronger and more focused on delivering value to our partners and the patients they serve. As we continue to grow, we are committed to advancing the capabilities of biomanufacturing, ensuring access to life-saving therapies, and setting the standard for excellence in the industry.