Biotechnology manufacturing has seen transformative changes in recent years, with artificial intelligence and machine learning at the forefront of this evolution. To delve deeper into these advancements, we bring you insights from Ran Zheng, CEO of Landmark Bio. After two decades in life sciences on the West Coast, Ran now leads Landmark Bio in Greater Boston, making partnerships to bridge the gap between discovery research and the commercialization of advanced therapies.
In this exclusive interview, Ms. Zheng addresses the critical challenges in genetic medicines, the integration of AI & ML in manufacturing, and the strategic importance of talent management in today’s biotechnology landscape.
One of the biggest challenges in genetic medicines—such as cancer immunotherapy, gene therapy, and CRISPR/Cas9—is scaling these therapies from the research phase to the clinical and commercial stages. This complexity often creates manufacturing bottlenecks, slowing the availability of life-saving treatments. What are your organization’s key strategies to address these bottlenecks and accelerate the development and delivery of these advanced therapies to patients?
Ran Zheng: Our strategy to address manufacturing challenges in genetic medicines focuses on three key areas.
- First, we focus on accelerating the transition from bench to patient. We partner with therapeutic developers from academia and industry to translate groundbreaking research into life-changing medicines. Leveraging our extensive expertise in drug development and broad manufacturing capabilities, we streamline development activities and significantly reduce the time it takes to reach the clinic.
- Second, we prioritize reducing the cost of goods for novel therapies. We design and develop manufacturing processes optimized for specific modalities by utilizing a diverse technology toolbox. This approach improves process yield and lowers production costs, making advanced therapies more accessible.
- Third, we power our operations with advanced digital technologies. From the inception of our company, we’ve integrated digital tools not only to enhance efficiency and speed but also to provide valuable intelligence and insights into both the product and the manufacturing process.
These pillars—bench-to-patient acceleration, manufacturing cost reduction, and digitally powered operations—are central to our strategy for overcoming manufacturing bottlenecks. They allow us to drive efficiency, lower costs, and expedite the delivery of life-saving genetic medicines to patients.
As artificial intelligence and machine learning continue to gain prominence, their application in biotechnology manufacturing is becoming increasingly important. These technologies help optimize processes, accelerate drug development, and reduce costs. How are you integrating AI and ML into your manufacturing processes, and what role do these technologies play in enhancing efficiency and advancing the biotechnology field?
Ran Zheng: From the outset, we committed to investing in digital capabilities for our manufacturing facilities. While we are still in the early stages of our digital journey, the past few years have been focused on laying a strong foundation by implementing digital technologies to enable seamless data flow—from development through manufacturing to delivery.
- As we continue building our capabilities, we are now turning our attention to advanced technologies like machine learning and artificial intelligence. One transformative application uses AI and ML as copilots for manufacturing operators to predict process performance and product quality. This enables timely decision-making for intervention to potentially prevent deviations, reduce batch failures, and ensure consistent manufacturing outcomes.
- AI and ML also hold immense potential to offer intelligent insights that drive continuous improvement. By analyzing process performance over time, these technologies can help identify causal factors affecting yield and product quality and make actionable recommendations for improvements.
- For genetic medicines, I am particularly excited about leveraging data from manufacturing processes, product quality attributes, and patients to predict clinical outcomes. Technologies today generate vast amounts of data at every step of manufacturing and from advanced analytics and patient outcomes. Harnessing the power of these data may one day allow us to predict clinical outcomes for personalized treatments such as cell and gene therapies.
At Landmark Bio, we’re exploring opportunities through broad collaborations across therapeutic developers, manufacturers, and hospitals to potentially identify patterns and correlations that could yield meaningful insights. The key to success is collecting nuanced, high-quality data to train AI and ML models. With more data, models improve over time, offering better predictive power and insights. This collaborative approach—integrating manufacturers, therapeutic developers, clinicians, and data scientists—is essential for unlocking AI’s full potential in advancing the development and manufacturing of personalized medicine.
In today’s market, aligning talent strategy with overarching business objectives is critical for sustaining innovation, resilience, and operational efficiency. CEOs are increasingly tasked with steering their organizations through economic volatility while maintaining a competitive edge. From your perspective, what strategic advice would you offer to executive leaders seeking to optimize their talent management framework? How can they effectively integrate talent strategies to drive innovation and operational agility while navigating the complexities of an uncertain business environment?
Ran Zheng: “Talent is the cornerstone of our strategy, and I firmly believe that a company is nothing without its people.”
The talent strategy is deeply rooted in shared values and a unified vision, which serve as the foundation of our culture. When we bring individuals into our organization, it’s not just about fitting in—it’s about enhancing and contributing to our culture.
- In today’s business environment, this alignment becomes even more critical. Our framework aims to engage, empower, and inspire our team. We emphasize the “why” behind what we do because passion for our work drives excellence, creativity, and commitment. Working in biotechnology, I’ve had the privilege of contributing to drug development that transforms lives. That sense of purpose is the North Star of everything we do—it motivates our team to stay anchored amid uncertainty.
Building resilience is another key focus. The biotech and pharmaceutical industries are fraught with highs and lows—exciting breakthroughs as well as clinical or business setbacks. To survive, grow, and thrive, we need to be flexible, adaptable, and open to change. Change, as they say, is the only constant. Resilience enables us to learn, grow, and lead through challenging times.
When I joined the company in 2021 as its first hire, there were no teams, no facilities, and no established operations. In a span of three years in the middle of the pandemic and the so-called “biotech winter,” we stood up process development and manufacturing facilities, built a thriving team, forged strong business partnerships, and established a growing client base. This rapid transformation required our team to embrace agility and resilience, which have been instrumental in driving innovation and operational success.
As a young company with a team of 60–70 people, we’ve experienced tremendous growth. I’m proud of the dedication and commitment our team members bring to the table every day. To sustain this, we prioritize fostering an environment where everyone is aligned with our mission and core values, while also creating opportunities for our staff to learn and grow through close collaborations with leading researchers and partners in the field. For instance, we regularly invite collaborators, such as physicians and researchers, to talk about science, share their insights, and inspire our team with the real-world impacts of our work.
Seeing our projects advance toward clinical trials and knowing they will soon benefit patients is incredibly rewarding. It reinforces our belief in our mission and drives us to innovate and stay agile, even amidst challenges. Talent, after all, is not just about skill. It’s about mindset, resilience, and the shared purpose that propels us forward.
Wrapping Up
The interview highlights the critical role of talent strategy in driving success, particularly in industries like biotechnology and pharmaceuticals. The conversation emphasized the importance of aligning talent management with a shared vision and values, which is essential for fostering a resilient and innovative workforce. Leaders can navigate challenges and guide teams through uncertain environments by focusing on adaptability, resilience, and a strong sense of purpose.
The discussion also stressed the significance of continuous growth, learning, and collaboration, emphasizing building teams committed to the mission. As growth continues, maintaining a culture rooted in these principles will be key to sustaining innovation and operational agility in the long term.
Bios:
Ran Zheng: Ms. Zheng is a seasoned biotechnology industry leader with over 25 years of experience in biotechnology operations across diverse global markets. She most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company focused on HSC-based gene therapies. In this role, Ms. Zheng played a pivotal role in establishing the technical operations function and developing a robust manufacturing network while advancing the company’s product pipeline. Notably, she led the approval of Libmeldy™, the first-ever gene therapy for metachromatic leukodystrophy. Ms. Zheng has also held senior leadership roles at prominent biotechnology companies, including Genzyme (now part of Sanofi) and Amgen, where she contributed significantly to advancing innovative therapies and expanding operational capabilities.
Partha Anbil is a Contributing Writer for the MIT Sloan Career Development Office and an alum of MIT Sloan. Besides being VP of Programs of the MIT Club of Delaware Valley, Partha is a long-time life sciences consulting industry veteran, currently with an NYSE-listed WNS, a digital-led business transformation company, as Senior Vice President and Practice Leader for their Life Sciences practice.
Michael Wong is a Contributing Writer for the MIT Sloan Career Development Office and an Emeritus Co-President and board member of the Harvard Business School Healthcare Alumni Association. Michael is a Part-time Lecturer for the Wharton Communication Program at the University of Pennsylvania and his ideas have been shared in the MIT Sloan Management Review and Harvard Business Review.
