This track is designed for forward-thinking professionals in the biotech and biopharmaceutical industries who are looking to sharpen their competitive edge. It examines how operational agility, workforce readiness, and cultural transformation intersect to enable sustained innovation, resilience, and compliance across the product lifecycle.
The Backbone of Biotech Success: Why This Track Matters
Operational readiness has traditionally focused on systems, processes, and technologies—but today, success depends equally on people. This track highlights how leading biotech organizations are:
- Upgrading capabilities across teams and functions to handle increasingly complex global manufacturing and regulatory environments
- Building high-performance cultures that embrace change, continuous learning, and innovation
- Aligning operational, regulatory, and commercial goals to drive seamless execution in an unpredictable landscape
Through a mix of case studies, expert panels, and real-world examples, attendees will gain actionable strategies to improve execution, reduce risk, and empower teams to lead through transformation.
What to Expect: Must-See Track Sessions at the 2025 ISPE Biotechnology Conference, 2–3 June
1. “Global Readiness and Program Excellence in Process Performance Qualification (PPQ)”
Presented by Varun Choudhary, Global Project Manager with Moderna, this session provides a firsthand look at Moderna’s strategic approach to operational readiness for pivotal commercial milestones and global PPQ efforts. Attendees will learn how a standardized readiness framework supports cross-functional alignment, risk management, and accelerated execution across global markets.
Key takeaways:
- Building a scalable global readiness model
- Aligning regulatory, operational, and commercial priorities
- Fostering a culture of agility and excellence in execution
2. Panel Discussion on “Cultural Excellence: What Are Companies Doing to Build a Culture That Drives Innovation and Development for the Future?”
Culture is not just a buzzword—it’s a business imperative. In this thought-provoking panel, industry leaders from Sequence, MilliporeSigma, and Northeastern University will discuss how cultural excellence fuels operational resilience and innovation. From overcoming change resistance to developing adaptive mindsets, the conversation will center on how empowering people drives biotech transformation.
Discussion topics:
- Building cultures of innovation and agility
- Training for adaptability and continuous learning
- Bridging the gap between technical excellence and people development
3. “Are You Ready for It?”
In the wake of the COVID-19 and RSV health crises, agility in technology transfer became mission-critical. This session, presented by Nassim Farrokhzad, Associate Director with AstraZeneca, dives into AstraZeneca’s real-world application of agile and lean methodologies to accelerate tech transfer during global emergencies—without compromising quality or compliance.
What you’ll learn:
- Streamlining processes under high-pressure scenarios
- Ensuring readiness for future public health emergencies
- Maintaining flexibility while navigating regulatory complexity
The Bigger Picture: Driving Resilient and Future-Ready Operations
The Operational Readiness and Cultural Excellence track does more than showcase best practices—it reframes how companies should think about transformation. This isn’t just about keeping up with innovation; it’s about creating environments where innovation thrives organically through empowered people, aligned systems, and a shared vision for excellence.
Whether you're scaling up for a global launch, implementing new digital tools, or shifting your culture to embrace new ways of working, this track will deliver insights that you can immediately apply within your organization.
Join the Conversation
The biotech industry is entering an era where the ability to learn fast, adapt swiftly, and lead courageously is what will separate leaders from laggards. Participate in sessions in the Operational Readiness and Cultural Excellence track at the 2025 ISPE Biotechnology Conference to hear directly from pioneers who are charting the course for the next generation of biotech manufacturing.
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Use the code 25BIO300 at checkout to receive $300 off In-Person All Access Pass registration for the 2025 ISPE Biotechnology Conference. *Restrictions apply.
