Scaling for Growth with a Modern Solution

This video provides an in-depth exploration of Resilience's "digital first" strategy for scaling biomanufacturing of next-generation therapeutics, featuring insights from Elliot Menschik, their Chief Digital Officer. Menschik, with a background spanning physician-scientist, engineer, repeat founder, CXO, startup investor, and time at AWS, details how Resilience is building a modern, cloud-native infrastructure to overcome the inherent difficulties in manufacturing advanced modalities like cell and gene therapies, biologics, and vaccines. The discussion highlights the company's unique approach to growth through rapid mergers and acquisitions (M&A) and its deliberate choices in technology, including the implementation of Veeva for quality solutions.

Menschik explains that the traditional biomanufacturing process is often costly, time-consuming, artisanal, highly manual, and error-prone, limiting access to life-changing therapeutics. Resilience aims to disrupt this by creating a "Biocloud" – a standardized platform of best practices and innovative technologies across various modalities. This involves a significant investment in digital components to enhance performance, reduce errors, improve scalability, ensure visibility, and bolster security. The company's strategy is to democratize access to advanced biomanufacturing know-how and technology, drawing inspiration from the efficiency and scalability pioneered by cloud computing in the IT industry.

The conversation delves into the challenges and strategies associated with Resilience's rapid growth, which includes acquiring numerous manufacturing facilities. To integrate these diverse sites, many of which operate on legacy, manual systems, Resilience employs a "factory in the box" approach. This involves designing and implementing a "resilient standard architecture" – a consistent stack of applications and underlying components – into each new facility. This standardized stack serves new customers immediately, with a long-term plan to transition existing customers onto this modern infrastructure. When selecting enterprise applications, such as Veeva for quality, Resilience prioritizes interoperability (requiring APIs), cloud-friendliness (SaaS-based), and a robust security posture, reflecting a tech company's rigorous standards. Menschik also emphasizes a data-driven culture, automation of GxP validation, and a commitment to transparency with partners, allowing them to see real-time manufacturing and quality data.

Key Takeaways:

• Addressing Biomanufacturing Inefficiencies: Traditional manufacturing of next-generation therapeutics (cell/gene therapy, biologics) is characterized by high cost, lengthy timelines, artisanal processes, manual labor, and susceptibility to errors, often hindering promising therapies due to CMC (Chemistry, Manufacturing, and Controls) issues and regulatory hurdles.
• The "Biocloud" Paradigm: Resilience's core innovation is the "Biocloud" concept, which aims to standardize and industrialize biomanufacturing through platforms, best practices, and new technologies. This approach seeks to democratize access to advanced manufacturing capabilities, increase speed to market, and build confidence for therapeutic innovators.
• Digital-First, Cloud-Native Strategy: Resilience is fundamentally a technology company, investing intensely in digital components to drive out errors, enhance scalability, create visibility, and ensure robust security across its biomanufacturing operations. This "digital first" and "cloud native" philosophy is central to their operational model.
• Strategic M&A Integration: When acquiring facilities, Resilience implements a "factory in the box" strategy, deploying a "resilient standard architecture" (applications and infrastructure) into each new site. This allows new customers to immediately benefit from the modern stack, with a phased approach to migrate existing operations.
• Rigorous Application Selection Criteria: For enterprise applications like Veeva, Resilience prioritizes three key criteria: strong interoperability (requiring robust APIs for electronic data exchange), cloud-friendliness (SaaS-based, avoiding on-premise installations), and a high-level security posture comparable to leading tech companies.
• Data-Driven Automation and Predictability: Drawing from a tech background, Resilience emphasizes a relentless focus on data, automation, and predictability to optimize processes and operate efficiently, applying these principles to biopharma manufacturing contexts, including the automation of GxP validation.
• Transparency as a Competitive Advantage: Resilience believes in radical transparency with its therapeutic innovator partners, providing them full visibility into manufacturing and quality data. This philosophical shift aims to build greater confidence and accountability, challenging the traditional opaque relationships in outsourced manufacturing.
• Bridging Tech Security and Pharma Quality: Integrating acquired facilities and diverse teams requires harmonizing the security posture of a tech company with the stringent quality requirements of biopharma. This involves aligning risk management principles and terminology (e.g., "correction of error" in tech vs. "CAPA" in pharma).
• Leveraging Hyperscale Cloud Providers: The company champions the use of hyperscale cloud providers (AWS, Azure, Google Cloud) for their effectively infinite compute and storage, high availability, and advanced services. This allows Resilience to focus on solving harder biomanufacturing problems rather than replicating IT infrastructure.
• Programmatic Implementation Approach: For large-scale system rollouts like Veeva across a network of sites, Resilience advocates for a comprehensive, multi-year "program" approach rather than serialized individual projects. This strategic outlook, often seen in large enterprises, is crucial for avoiding "implementation limbo" and achieving integrated outcomes.

Tools/Resources Mentioned:

• Veeva: Specifically Veeva Vault applications for quality management.
• AWS (Amazon Web Services): Mentioned as a pioneer in cloud computing and a benchmark for cloud-native operations.
• Microsoft Azure: Mentioned as another major cloud computing provider.
• Google Cloud: Mentioned as another major cloud computing provider.

Key Concepts:

• Biocloud: Resilience's proprietary concept for standardizing and industrializing biomanufacturing through platforms, best practices, and innovative technologies, akin to cloud computing for IT.
• Digital First: A strategic approach where digital technology is at the core of all operations, decision-making, and customer interactions from the outset.
• Cloud Native: An approach to building and running applications that exploits the advantages of the cloud computing delivery model, emphasizing scalability, resilience, and flexibility.
• Interoperability (APIs): The ability of different information systems, devices, or applications to connect, communicate, and exchange data seamlessly using Application Programming Interfaces (APIs).
• Security Posture: The overall security status of an enterprise's networks, systems, and data, reflecting its ability to prevent and respond to cyber threats.
• GxP Validation: The process of ensuring that systems and processes used in regulated industries (like pharma) meet Good x Practice (e.g., Good Manufacturing Practice) requirements and consistently produce results that meet predefined specifications.
• CAPA (Corrective and Preventive Action): A system for dealing with nonconformities, deviations, and defects in regulated industries, aimed at identifying root causes and preventing recurrence.
• Factory in the Box: Resilience's strategy for integrating acquired manufacturing sites by deploying a standardized, pre-designed digital and operational architecture into each facility.
• Programmatic Implementation: A strategic approach to large-scale technology deployments that views multiple related projects as a single, long-term program with integrated goals, resources, and timelines, rather than as isolated, sequential projects.

Examples/Case Studies:

• Resilience's Rapid Growth: The company grew from 15 to over 1500 employees in a year, acquiring facilities from Sanofi (Boston), a standalone contract manufacturer (Florida), and Bluebird Bio (Durham) to rapidly scale its biomanufacturing capacity.
• Gilead's Digital Capabilities: Mentioned by the interviewer, Gilead's SVP of Quality, Valerie Brown, uses digital capabilities to connect processes and share data with outsourced partners, enabling supply elasticity, as demonstrated during the Remdesivir (Veklury) ramp-up for COVID-19.