Lonza

Join us for a deep dive into the complexities of regulatory submissions, where we’ll explore key requirements and best practices for compiling, writing, and reviewing dossiers. Learn how Lonza’s Small Molecules team streamlines the process to ensure first-time compliance with technical and quality standards.

https://www.pharmtech.com/pt_w/regulatory-cdmo-solutions

In the complex process from development to commercial distribution, each phase poses its own challenges in terms of providing assurance of the safety, efficacy, and quality of the product being developed. Dossiers submitted to regulatory authorities need to include comprehensive data that meets the specific requirements of each authority, which is a complex task. This webinar will look at some of the requirements of the various health authorities. It will also describe how the Lonza Advanced Synthesis team uses its extensive experience to assist in getting the filing right the first time, by compiling, writing and reviewing dossiers that meet all of the technical and quality requirements.



Get insights into the expectations of health authorities

Discover the geographical spread and expertise of the Lonza team in multiple markets

Find out how the team can work with you to address the common challenges in compiling dossiers

 Regulatory Affairs Specialists/Managers, CMC Managers, and QA/QC Professionals

 Pharmaceutical Formulation Scientists, Supply Chain Managers, and Project Managers in Drug Development

 Outsourcing Managers for Contract Manufacturing, Academics/Researchers in Pharmaceutical Sciences, and Business Development Leads

 started his career as chemist, and has worked in the pharmaceutical industry for more than 20 years, including site, corporate quality and compliance, and Regulatory Affairs leadership roles. He has experience in NDA and ANDA dossier preparation for both solid oral and parenteral formulation types, including radioactive and non-radioactive products. He has covered the technical side, and also business continuity strategy planning in acquisitions and divestment. During the Covid pandemic he was the point of contact from his organization (Sun Pharma) to communicate and engage with FDA’s Drug Shortage team to ensure supply of essential medicines from the company. Praveen has attended multiple FDA meetings representing the organization that he worked and various FDA conferences. He has a master’s degree in pharmaceutical sciences.





Director, Global Head Regulatory Affairs



joined Lonza in 2016 as Chemist and Analytical Project Lead in the Quality Control QC-Launch Plant (LP) and Tides, Visp. The same year, he became Team Lead of the QC In-Process Laboratory in LP. From 2018 to 2020 he was Team Lead in Quality Control at Siegfried AG, Zofingen, Switzerland, before rejoining Lonza as Senior Specialist in the Regulatory Affairs Small Molecules Department in Basel. In 2022, he was promoted to Manager Regulatory Affairs Small Molecules, supporting several Small Molecules sites in Lonza’s global network. In 2024, was appointed as Director, Global Head of the Regulatory Affairs Team Small Molecules at Lonza, supporting five manufacturing sites across the globe. He holds a PhD in Chemistry from the University of Basel and EMPA (part of the ETH Zürich), Switzerland.

Webcasts

Webinar Date/Time: Tuesday, 8 April 2025 | 11:00 AM EDT | 5:00 PM CEST

End-to-End Regulatory CDMO Solutions: Development, Manufacturing, and Approval

Articles

Read about a material-sparing strategy for developing spray-dried intermediates (SDIs) and their tablet formulations, enhancing bioavailability for poorly soluble active pharmaceutical ingredients (APIs), using erlotinib as a case study. By integrating formulation mapping, polymer screening, and compact screening, the approach enables rapid risk identification and informed decision-making for first-round tablet formulations. 

Innovations in Linking Rational Design and Material-Sparing Strategies for Enabled Intermediates and Drug Products

Are you ready to unlock the secret to seamless commercial tech transfers in oral solid dosage manufacturing? In this webinar, industry experts will describe proven strategies for accelerated process validation, ensuring quality consistency, and making use of cutting-edge equipment. Whether you’re navigating regulatory hurdles or optimizing processes, this session will give you insights into the art of a successful pharmaceutical tech transfer.

https://www.pharmtech.com/pt_w/commercial-tech-transfers

This presentation will explore the critical aspects of manufacturing commercial tech transfers for the manufacture of oral solid dosage (OSD) products. It will provide insights into the progression of process validation for existing commercial products, ensuring consistent quality, and navigating regulatory requirements. The discussion will also highlight Lonza’s advanced equipment capabilities, showcasing the company’s role in streamlining tech transfers and enhancing operational efficiency.




Gain insight into the tech transfer process

Learn about Lonza’s equipment capabilities

Discover how to effectively navigate operational challenges


Manufacturing Science and Technology Senior Engineer
Lonza

Rebecca Peek is a seasoned engineering professional with more than a decade of industry experience in oral solid dosage (OSD) manufacturing and pharmaceutical operations. She brings a wealth of expertise in leading successful technology transfer projects, process validations, and driving commercial approvals. Rebecca has a strong foundation in biomedical engineering and managing complex initiatives that bridge technical and regulatory requirements. She is experienced in the intricacies of scaling up OSD production, optimizing manufacturing processes, and utilizing cutting-edge technologies to enhance operational efficiency. Rebecca is very experienced in the execution of end-to-end process validations, ensuring alignment with rigorous quality standards and regulatory compliance, directly contributing to the approval and launch of multiple OSD products. She routinely works with diverse cross-functional teams, including R&D, manufacturing, and regulatory affairs, to streamline workflows and processes. She holds a project management professional (PMP) certification.




Manufacturing Science and Technology Engineer
Lonza

Laura Treche is a manufacturing science and technology engineer with a strong background in oral solid dosage manufacturing. With hands-on experience in technology transfer, process scale-up, and optimization, Laura has successfully supported the transition of products into commercial manufacturing, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards. She is adept at troubleshooting, process validation, and continuous improvement, maintaining a strong commitment to product quality and operational efficiency. Laura works closely with cross-functional teams, including R&D, quality, and regulatory departments, to drive the successful commercialization of small molecules. She is an asset in aligning manufacturing processes with business goals and regulatory requirements.


Webinar Date/Time: Tuesday, March 11, 2025 | 11:00 AM EDT / 3:00 PM GMT


Commercial Tech Transfers in OSD Manufacturing

This executive summary focuses on dose-flexible manufacturing strategies and their role in drug
development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as
pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized
early in development. This presentation will focus on technical strategies that can help anticipate appropriate
timing for implementation and how to do so cost effectively while adhering to required timelines.


Flexible-Dose Development Strategies for Today's Clinical Landscape - Executive Summary

Carrier-based formulations for dry powder inhalers are carefully designed to transport extremely small particles into the lungs. Jet milling can be used to micronize these particles, with both high and low shear mixing processes used to formulate mixtures capable of carrying the fine API particles into the deep lung. This paper looks at the requirements for pulmonary delivery via carrier-based inhaled powder formulations, and how jet milling can be used to manufacture effective and stable materials for these formulations


Beyond Jet Milling: A Deep Dive into Carrier-Based Formulation and Process Optimization - Executive Summary

Meeta B. Kratz (Global Vice President, Product Management & Marketing, Lonza Capsule and Health Ingredients) talks about Lonza's future and how that works in tandem to meet client needs.