As biotechnology products evolve the regulatory frameworks governing Chemistry, Manufacturing, and Controls (CMC) and Quality must keep pace. Yet, innovators face persistent barriers that delay development, complicate global alignment, and stifle the adoption of transformative technologies.

This session will explore how industry and regulatory agencies are responding to these challenges through convergence initiatives, reliance frameworks, and digital modernization. Drawing on insights from the National Academies’ workshop Barriers to Innovations in Pharmaceutical Manufacturing, we will examine the interplay between regulatory expectations, industry capabilities, and emerging technologies. The session will also rethink traditional boundaries by exploring cross-industry approaches and how they apply to biologics development.

Key themes include:

- Innovation:  Broaden perspectives by engaging external experts and industries to foster collaboration and apply cross-sector insights.

- Policy and partnership opportunities: Public–private collaborations like FDA’s Emerging Technology Program and NIIMBL to de-risk innovation, promote regulatory convergence, and foster informal engagement between regulators and industry.

- Regulatory inertia and divergence: Existing frameworks often struggle to accommodate novel technologies, leading to inconsistent global standards, lifecycle maintenance burdens, and risk-averse review practices.

- Technical and operational hurdles: Legacy systems, inflexible processes, and limited analytical capabilities hinder real-time quality assurance and process intensification.

- Control strategy transformation: Industry leaders advocate for science- and risk-based approaches, including mechanistic modeling and attribute-based control strategies to ensure product quality and accelerate development.

Panelists will share real-world experiences and strategic recommendations, including:

- Promoting global regulatory convergence and collaborative reviews.

- Leveraging prior knowledge and modeling to streamline development.

- Refocusing regulatory submissions on scientific justification rather than volume.

- Creating incentives for adopting advanced manufacturing and analytics.

- Aligning post-approval change management with existing and future ICH guidelines.

Attendees will gain actionable insights to navigate global regulatory landscapes, advocate for policy changes, and implement transformative technologies across the product lifecycle.

Session Speakers:

Enabling Global Pharmaceutical Innovation

Roger Nosal, Vaxcyte, Inc.

Unlocking CMC Innovation: Science and Risk‑Based Paths to Global Progress

Ingrid Markovic, Novartis Pharmaceuticals Corporation

Enabling the Future of Biopharmaceutical Manufacturing Through Collaborative Innovation
Riley Myers, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

Additional Panelists:

Elana Cherry, Health Canada

Anjali Shukla, CDER, FDA

Anjali Shukla

Appearances