Hetal Patel, Chief Executive Officer of Biologos, discusses how early attention to manufacturability, regulatory strategy, supply-chain resilience and process control can help biopharma companies move faster while preparing for commercial scale.
For emerging biopharma companies, speed, quality and scalability cannot be treated as separate priorities. As products progress towards commercialisation, decisions around process design, raw materials, manufacturing capacity, regulatory strategy and supply continuity increasingly determine whether innovation can translate into reliable commercial production.
In this Women of the Future conversation with BioPharma BoardRoom,Hetal Patel, Chief Executive Officer of Biologos, explores how advanced analytics, automation and standardised manufacturing platforms can improve predictability and efficiency. She also reflects on leadership through uncertainty, the importance of trusting specialist expertise, and why giving women early exposure to commercial, operational and P&L responsibility can strengthen the pipeline of future biopharma executives.
What are the most important challenges facing biopharma companies as they seek to develop and scale innovative products while maintaining quality and consistency?
As companies scale products, they face increasing complexity in process development, raw materials, suppliers, analytical methods and manufacturing capacity. Regulatory requirements introduce additional challenges as products progress toward commercialization.
Thinking about scalability earlier can help companies manage these challenges more effectively. Processes should be designed with manufacturability, supply continuity and cost in mind while maintaining quality, rather than addressing these considerations once a product is further along. Close collaboration across R&D and manufacturing, quality and supply chain teams and external partners can help create a reliable process designed to scale.
How is the industry’s approach to biologics development and manufacturing evolving, and where do you see the greatest opportunities for innovation?
There is growing emphasis on accelerating development timelines while building processes that can scale efficiently from development through commercial production. Achieving that scale also requires greater consistency and careful management of cost.
Technologies that offer greater process control and flexibility could create significant opportunities for innovation. Advanced analytics, automation and more standardized manufacturing platforms can help improve optimization and predictability as processes scale.
What do you believe companies need to do differently to build more resilient and efficient biopharma supply chains?
A more resilient supply chain starts with a clear understanding of where risks exist. Data on critical suppliers, materials and capacity can help companies identify potential points of failure and understand their current position. From there, companies can manage risk more proactively by reducing unnecessary dependence on single sources, working closely with strategic suppliers and managing inventory in line with the needs of the business.
How can smaller and emerging biopharma companies balance speed to market with increasingly complex regulatory and quality expectations?
With commercialization as the end goal, smaller and emerging biopharma companies should involve regulatory and quality teams early in the development process. This helps to identify potential issues before they become costly delays. The most effective companies recognize that meeting regulatory and quality requirements are not opposing goals to speed. A well-designed regulatory affairs/quality assurance (RA/QA) system can improve decision-making and optimize the speed to market.
What experiences have most shaped your approach to leadership as a woman in the biopharma industry?
I learned early in my career that effective leadership is less about having every answer and more about asking the right questions and listening to the expertise around you. Some of the experiences that have shaped me most have involved leading through ambiguity and making difficult decisions while still being accountable for the outcome.
As a woman in the industry, I have also learned to have confidence in my own perspective, which has helped me become a more decisive and resilient leader. Those experiences have shaped my approach to leadership that is centered on building strong teams, creating trust, and giving talented people the opportunity to do their best work.
What changes would you like to see across the industry to help more women progress from entry-level positions into executive leadership?
There has to be a focus on giving women meaningful opportunities to lead early in their careers, including roles that build experience beyond their existing areas of strength. Exposure to financial, commercial and operational responsibilities can help develop the broader strategic experience needed for executive leadership.
Sponsorship is particularly important. Senior leaders can play an active role by advocating for women to take on stretch assignments and profit and loss (P&L) responsibility, as well as opening up opportunities at the executive level. Greater transparency around career paths, compensation and promotion criteria can also broaden access to these opportunities and help build a stronger leadership pipeline.
