DCAT Week 2026: Proactive Planning for OSD Forms
In the current market, drug developers need to carefully balance sudden regulatory mandates with innovation while also managing costs and time efficiency, explains Meeta Kratz from Lonza Capsugel.
Recent regulatory decisions and an increasingly complex pipeline are making waves for oral solid dosage drug development, with companies being required to pivot rapidly and employ novel strategies to ensure success. In this exclusive interview, The Pharma Navigator sits down with Meeta Kratz, Vice President and General Manager of the Americas Business Unit at Lonza Capsugel, to analyze the criticality of proactive planning in an evolving trade and regulatory world.
The Criticality of Proactive Planning
TPN: There have been some pivotal regulatory decisions recently, such as the ban on FD&C Red No. 3, that are impacting oral solid dosage drug developers quite heavily. What immediate actions should companies be taking to navigate these changes and how can service providers help?
Kratz: In today’s evolving regulatory landscape, both in the U.S. and globally, it is critical for manufacturers to have proactive planning systems in place and build flexibility into the system from the outset so drug developers can adapt quickly as conditions change.
When regulatory agencies implement new guidance, such as the U.S. FDA’s decision to revoke authorization for FD&C Red No. 3 (erythrosine, E127), manufacturers must work with customers to reformulate products intended for this market, which can lead to delayed timelines and additional costs. Having a dedicated team in place is essential to help customers navigate these complexities and respond with speed and confidence.
For example, at Lonza Capsugel, we have a dedicated team monitoring regulatory developments and a cross-functional task force that works closely with customers to assess impact and guide transitions. We also maintain a broad portfolio of capsule options and deep formulation expertise, enabling us to support reformulation efficiently and with minimal disruption.
Focusing on Enteric Solutions
TPN: Industry has also seen an influx of more difficult to handle molecules (highly potent APIs, moisture sensitive compounds, etc.) enter into the development pipeline. What options are now available for developers to help them overcome the challenges associated with these molecules, particularly when formulating them into capsule forms?
Kratz: Oral delivery of biologics is expected to grow at a 35% compound annual growth rate from 2023–2028 (1), driven by demand for less invasive drug treatments, improved patient compliance and the potential for at-home administration. However, most new drug entities face bioavailability challenges, requiring innovative capsule-based delivery solutions to address these limitations for drug developers and their patients.
One focus for drug manufacturers is scalable enteric solutions to overcome bioavailability challenges. These solutions offer several advantages, including gentle processing that protects sensitive APIs, reliable and reproducible processes that ensure consistent enteric protection across batches, and simplified scale-up from early development through commercial production — ultimately reducing time, complexity and risk during formulation and testing.
To support the oral delivery of treatments that are easily degraded by acidic stomach conditions, we, at Lonza Capsugel, introduced Enprotect capsule, and more recently the Enprotect Size 9 capsule. These technologies enable the delivery of small molecules, peptides, proteins, and RNA-based therapeutics, as well as live biotherapeutic products — a new and innovative class of treatments. The smaller Size 9 capsule is specifically designed for pre-clinical testing in rodents with acid-sensitive drugs. Its versatile capsule technology can be used throughout clinical trials to commercial manufacturing, helping accelerate clinical development and first-in-human studies. The versatility of the bi-layer capsule design helps drug developers overcome challenges with more complex molecules while offering a customized approach.
Trends Shaping Conversations
TPN: Finally, what were some key themes of conversations at DCAT Week 2026?
Kratz: DCAT Week is always a highlight for our Lonza Capsugel team, providing an opportunity to connect with customers and partners throughout the pharma industry.
Recent changes in regulations, trade, and industry trends shaped several important topics in our discussions with customers and partners. These included strategies for bringing complex molecules to market more quickly, building greater supply chain resilience, and planning confidently in a rapidly evolving regulatory and trade environment. We valued the opportunity to engage directly with our customers and partners and explore ways to strengthen our collaboration to accelerate innovation from molecule to market.
Reference
Lonza. Lonza Launches Tailored Offering for Smart Capsules Companies Developing Oral Delivery Solutions for Biologic Drugs. Press Release, Dec. 3, 2024.
About the Interviewee
Meeta Kratz is currently the Vice President and General Manager of the Americas Business Unit at Lonza Capsugel. At Lonza Capsugel, Meeta has held several roles overseeing product management, digital transformation, omni-channel marketing, and revenue enablement, all focused on driving sustainable growth.
Prior to joining Lonza Capsugel, Meeta served as Head of Strategy, Commercial Marketing, and Data Science at Thermo Fisher Scientific, where she was a member of the Fisher Healthcare Division leadership team, shaping commercial and digital strategy across multiple channels.
Meeta’s career also includes leadership roles at Brady Corporation, Zebra Technologies, LabelMaster, and W.W. Grainger, where she has consistently driven business expansion and led high-performing, cross-functional teams to deliver impactful results.
Throughout Meeta’s career, she has been motivated by a focus on improving patient care delivery — bringing a mission-driven, patient-centric lens to the work and the teams she leads.
Image Credit: © madedee - stock.adobe.com